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REMARKS 



SEP 1 8 2006 



The Examiner has cited a number of decisions of the Board of Patent Appeals and 
Interferences and the courts in regard to the rejection of Applicants' claims for lack of 
enablement under 35 U.S.C. 112, first paragraph. One of these decisions is In re Fisher 
166 USPQ18 of the CCPA. In re Fisher is a regularly cited case in Board and court 
decisions on enablement. Applicants have previously given reasons for why they believe 
that In re Fisher supports their position that all of Applicants 1 claims rejected for lack of 
enablement are in fact enabled- 

Applicants herein are presenting an application of In re Fisher to the facts of the 
present prosecution that they have not previously presented. Applicants are submitting 
this in a Response After Final rejection in the hope that this new look at In re Fisher may 
avoid the necessity of filing an appeal brief. 

Applicants respectfully requests the Examiner and Supervisor Examiner to 
reconsider the rejection of Applicants' claims that have been rejected for lack of 
enablement in view of these new comments on In re Fisher and related decisions of the 
USPTO Board of Patent Appeals and Interferences and court decisions. 

In In re Fisher 1 66 USPQ 1 8 two claims (4 and 5) were under appeal. Claim 4 was 
directed to "A method ... for producing ACTH [adrenocorticotropic hormones] 
preparations having potencies ranging from 111% to 230% of standard and containing no 
more than 0.08 units of vasopressin and no more than 0.05 units of oxytocin per 
International Unit of ACTH, which limits are said to be tolerable to humans." 166 USPQ 
18, 20. "The claim recites that the product must contain 'at least* 24 amino acids in a 
specified sequence." 166 USPQ 18, 21. To avoid a reference to Li, having a publication 
date prior to the filing date, the appellant relied on its parent application of which the 
application under appeal was a continuation-in-part. The CCPA states; 

Appellant's parent application, therefore, discloses no products, 
inherently or expressly, containing other than 39 amino acids, yet the 
claim includes all polypeptides, of the recited potency and purity, having 



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at least 24 amino acids in the chain in the recited sequence. The parent 
specification does not enable one skilled in the art to make or obtain 
ACTH's with other than 39 amino acids in the chain, and there has been 
no showing that one of ordinary skill would have known how to make or 
obtain such other ACTH's without undue experimentation. As for 
appellant's conclusion that the 25th to 39th acids in the chain are 
unnecessary, it is one thing to make such a statement when persons 
skilled in the art are able to make or obtain ACTH having other than 39 
amino acids; it is quite another thing when they are not able to do so. In 
the latter situation, the statement is in no way "enabling" and hence lends 
no further support for the broad claim. We conclude that appellant's 
parent application is insufficient to support a claim as broad as claim 4. 
For this reason we affirm the board's rejection of claim 4 as unpatentable 
over the Li references. 

From this statement, it is clear that the reason for why the CCPA did not find the claims 
under appeal patentable was that the applicant did not teach how to make ACTH with 
anything but 39 amino acids and there was no evidence in the record that a person of skill 
in the art knew how to make ACTH with anything but 39 amino acids. It is also clear that 
if persons of skill in the art knew how to make ACTH with more or less than 39 amino 
acids, the claims would not have been found not enabled. 

In regard to the rejection of Fisher claims 4 and 5 for lack of enablement the CCPA 

states: 

We have already discussed, with respect to the parent application, the 
lack of teaching of how to obtain other-than-39 amino acid ACTHs. That 
discussion is fully applicable to the instant application, and we think the 
board was correct in finding insufficient disclosure due to this broad 
aspect of the claims. 1 66 USPQ 1 8. 23. 

Thus the claims in Fisher were found not enabled because the Fisher application did not 
teach how to make "other-than-39 amino acid ACTHs" and there was no evidence in the 
record that persons of skill in the art knew how to make "other-than 39 amino acid 
ACTHs." 

In regards t the rejection for enablement, the CCPA further states: 

The issue thus presented is whether an inventor who is the first to 
achieve a potency of greater than 1 .0 for certain types of compositions, 
which potency was long desired because of its beneficial effect on 
humans, should be allowed to dominate all such compositions having 



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potencies greater than 1.0, including future compositions having 
potencies far in excess of those obtainable from his teachings plus 
ordinary skill. 166 USPQ 18, 23. 

Thus the CCPA rhetorically asks the question whether the first person to discover a 
composition having a potency greater than 1 where such potency is of significant value 
should be allowed a claim "including future compositions having potencies far in excess of 
those obtainable from his teachings plus ordinary skill " 

The CCPA answers this rhetorical question stating: 

It is apparent that such an inventor should be allowed to dominate the 
future patentable inventions of others where those inventions were 
based in some way on his teachings. 1 66 USPQ 18,24 

From this statement is clear that applicants such as the Applicants of the present 
invention "should be allowed to dominate the future patentable inventions of others where 
those inventions were based in some way on his teachings." In the present application it 
is undisputed that the high Tc materials discovered by others after Applicants' discovery 
"were based in some way on [Applicants'] teachings." 



The CCPA further states in In re Fisher in regards to later inventions of other: 

Such improvements, while unobvious from his teachings, are still within 
his contribution, since the improvement was made possible by his work. 
166 USPQ 12, 24 

Thus in the present application "while [the high Tc materials discovered by others after 
Applicants' discovery may be] unobvious form [Applicants'] teachings, [they] are still 
within [Applicants'] contribution, since the improvement was made possible by 
[Applicants 1 ] work," Applicants respectfully submit that the Examiner agrees with this 
when the Examiner states at page 8 of the Final Action: 

Such is the basis of applicants invention. The examiner does not deny 
that the instant application includes "all know principles of ceramic 
science", or that once a person of skill in the art knows of a specific type 
of composition which is superconducting at greater than or equal to 26K, 
such a person of skill in the art, using the techniques described in the 
application, which included all principles of ceramic fabrication known at 

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the time the application was initially filed, can make the known . « nnng 

superconductive compositions. (Emphasis in the original.) »> tr • 0 

The Examiner states here the that "The examiner does not deny ... that once a person of 
skill in the art knows of a specific type of composition which is superconducting_ at greater 
than or equal to 26K such a person of skill in the art, using the techniques described in 
the application, ... can make the known superconductive compositions." (Emphasis in 
the original.) Thus Applicants respectfully submit that it is the Examiner's finding of fact 
that the "known superconductive compositions" are " based in some way on [applicants'] 
teachings" and thus under In re Fisher Applicants "should be allowed to dominate the 
future patentable inventions of others." 

At page 8 of the Final Action the Examiner further states: 

The numerous 1.132 declarations, such as those of Mitzi, Shaw, 
Dinger and Duncombe, and the Rao article, are directed to production 
of know superconductive materials. 

The Affidavits of of Mitzi, Shaw, Dinger and Duncombe (Attachments 16, 17, 18, 
and 19 of Fifth Supplementary Amendment dated March 1 , 2004 and the Affidavit 
of Shaw dated April 14, 2005, the Affidavit of Dinger dated April 4, 2005 and the 
Affidavit of Tsuei dated April 4, 2005 (the last three affidavits are referred to 
herein as the DST Affidavits)) state: 

Once a person of skill in the art knows of a specific type of composition 
described in the Bednorz-Mueller application which is superconducting at 
greater than or equal to 26°K, such a person of skill in the art, using the 
techniques described in the Bednorz-Mueller application, which includes all 
principles of ceramic fabrication known at the time the application was 
initially filed, can make the compositions encompassed by the claims of the 
Bednorz-Mueller application, without undue experimentation or without 
requiring ingenuity beyond that expected of a person of skill in the art of the 
fabrication of ceramic materials. This is why the work of Bednorz and 
Mueller was reproduced so quickly after their discovery and why so much 
additional work was done in this field within a short period after their 
discovery. (See paragraph 8 of the DST Affidavits.) 

Thus the Examiner agrees with Applicants' affiants. 

The Examiner further states at page 9 of the Final Action: 

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What is not a "matter of routine experimentation" in this complex, 
unpredictable art is arriving at superconductive compositions outside the 
scope of the allowable claims (e.g., subsequently discovered BSCCO or 
Tl-systems as disclosed in Rao (see response filed 3/8/05, pages 
141-143). 

Applicants respectfully disagree. Applicants believe that this statement is inconsistent 
with the Examiner's earlier statement above "that once a person of skill in the art knows 
of a specific type of composition which is superconducting at greater than or equal to 26K, 
such a person of skill in the art, using the techniques described in the application, ... can 
make the known superconductive compositions." (Emphasis in the original.) Applicants 
respectfully submit that this statement of the Examiner is stating that within the meaning 
of the US patent law the art of high Tc material is predictable. Additional support for this 
view is below. Applicants believe what the Examiner is really saying is: 

What is not ..."[obvious]" in this complex, [predictable] art is arriving at 
superconductive compositions outside the scope of the allowable claims 
(e.g., subsequently discovered BSCCO or Tl-systems as disclosed in 
Rao .... 

However In re Fisher permits "[s]uch Improvements, [which] while unobvious from 
[Applicants'] teachings, are still within [Applicants'] contribution, since the improvement 
was made possible by [Applicants'] work." Thus under In re Fisher Applicants are entitled 
to their generic claims even though later workers may have discovered unobvious 
species within the scope of Applicants' generic claims for which such later workers may 
be entitled to patent claims to such later discovered potentially unobvious species. That 
there may be potentially patentable unobvious species, not specifically identified by 
Applicants' teaching, does not mean, under In re Fisher, that Applicants have not fully 
enabled the genus that their claims cover. In re Fisher clearly permits an applicant to be 
allowed a generic claim covering species not explicitly taught that are not obvious 
patentable species within the scope of Applicants' claims. 

Stated in another way, In re Fisher permits a first discoverer of an invention to be 
allowed a generic claim if the first discoverer teaches how to "make and use" species that 



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come within the scope of the generic claim. To be allowed the generic claim In re Fisher 
does not require the first discoverer to specifically teach or to suggest every species that 
comes within the scope of the generic claim or to provide a theory which can be used to 
"theoretically predict" species that come within the scope of the generic claim. If In re 
Fisher required such specific teaching, suggestion or "theoretical predictability" then it 
would not be possible, as In re Fisher states, "that such an inventor should be allowed to 
dominate the future patentable inventions of others where those inventions were based in 
some way on his teaching," because the future inventions of others would not be 
patentable since the earlier discoverer to be allowed the generic claim would have taught 
or suggested those future inventions or would have provided a theory to predict their 
existence and thus such future inventions would be anticipated or obvious in view of the 
earlier disclosure with the allowed genius claim. This is clearly not what In re Fisher 
stands for. 

The Examiner further states at page 9 of the Final Action in regards to later 
discovered materials u [t]he examiner respectfully maintains that the instant disclosure has 
not provided sufficient guidance to produce such materials." Applicants respectfully 
submit that this statement is inconsistent with the Examiner's earlier statement above 
"that once a person of skill in the art knows of a specific type of compo sition which is 
superconducting at greater than or equal to 26K such a person of skill in the art, using the 
techniques described in the application, ... can make the known superconductive 
compositions" (emphasis in the original.) in which the Examiner states that later 
discovered species are fabricated according to Applicants' teaching which means that 
Applicants' teaching has guidance on "how to make" the hight Tc materials that come 
within the scope of Applicants 1 claims. Moreover, as described in detail in the prosecution 
of this application, the later discovered high Tc materials are consistent with the specific 
teaching of Applicants' original disclosure (see the DST Affidavits). Thus Applicants' 
teaching has sufficient guidance to practice Applicants 1 claimed invention. Guidance is 
not predicting in advance what species will work, but is guidance on how to "make and 
use" the claimed invention as explicitly stated in 35 USC 112, paragraph one. As stated 



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above, it is Applicants' understanding that the Examiner agrees that Applicants have 
taught how "to make and use" the claimed invention. 

That a patent applicant can be allowed a claim that dominates the latter discovered 
patentable invention of others means that the claim allowed includes within its scope the 
patentable invention of the later discover. For the later discovered invention to be 
patentable over the teaching of the earlier disclosure means that the earlier disclosure 
cannot teach or suggest the later discovered invention. Thus, In re Fisher clearly 
acknowledges that the earlier applicant is entitled to a generic claim that includes within 
its scope that which it does not specifically teach nor suggest, but which it teaches how "to 
make and use" which is the only requirement of 35 USC 112, first paragraph. 

The Examiner further states at page 9 of the Final Action 

At page 125 of the response filed 1/31/05, applicant argues In re Fisher 
(166 USPQ 18] emphasizing "It is apparent that such an inventor should 
be allowed to dominate the future patentable inventions of others where 
those inventions were based in some way on his teachings". The 
examiner respectfully submits the remaining statements of Fisher are 
equally important 

It is equally apparent, however, that he must not be permitted to achieve 
this dominance by claims which are insufficiently supported and hence, not 
in compliance with the first paragraph of 35 USC 1 12. That paragraph 
requires the scope of the claims must bear a reasonable correlation to the 
scope of enablement provided by the specification to persons of ordinary skill 
in the art... In cases involving unpredictable factors such as most chemical 
reactions... Ihe scope of enablement obviously varies inversely with the 
degree of unpredictability of the factors involved. 

As described in detail above it is clear that the reason for why the CCPA in In re Fisher 
did not find the claims under appeal patentable was that the applicant did not teach how to 
make ACTH with anything but 39 amino acids and there was no evidence in the record 
that a person of skill in the art knew haw to make ACTH with anything but 39 amino acids. 
The situation is different here. As stated above, it is Applicants' understanding that the 
Examiner's own finding of fact is that the "known superconductive compositions" are 
"based in some way on [applicants'] teachings," Moreover the complex chemistry does 
not have to be understood to fabricate samples as stated in the book "Copper Oxide 

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Superconductors" by Charles P. Poole, et al. (Poole 1988) (See H 48 of DST AFFIDAVITS) 
which states at page 59: 

[clopper oxide superconductors with a purity sufficient to exhibit zero 

resistivity or to demonstrate levitation (Early) are not difficult to synthesize. 

We believe that this is at least partially responsible for the explosive 

worldwide growth in these materials. 

Poole 1 988 further states at page 61 : 

[i]n this section three methods of preparation will be described, namely, the 
solid state, the coprecipitation, and the sol-gel techniques (Hatfl). The 
widely used solid-state technique permits off-the-shelf chemicals to be 
directly calcined into superconductors, and it requires little familiarity with 
the subtle physicochemlcal process involved in the transformation of a 
mixture of compounds into a superconductor. 

Since skilled artisans can fabricate samples without knowing the "subtle physiochemical 
process involved" and without a detailed theory, this art is predictable. The statement 
from In re Fisher as quoted above that tt [i] in cases involving unpredictable factors such as 
most chemical reactions" explicitly does not state that all chemical reactions are 
unpredictable. In fact in the present invention, as stated by Poole 1988 quoted above, to 
make superconductors "requires little familiarity with the subtle physiochemical processes 
involved in the transformation of a mixture of compounds into a superconductor." This is 
one of the reasons for why Poole 1988 also states, as quoted above, that the 
superconductors "are not difficult to synthesis" and for why Poole 1988 also States as 
quoted above "that this is at least partially responsible for the explosive worldwide growth 
in these materials" shortly after Applicants' discovery. Thus the facts of the instant 
application are different from the fact of In re Fisher where the claims were found not 
enabled because, as stated above, the CCPA found that the Applicant there did not teach 
how to make "other-than-39 amino acid ACTHs" and there was no evidence in the record 
that persons of skill in the art knew how to make "other-than 39 amino acid ACTHs." 
Consequently, the invention of In re Fisher may have been one of those "most chemical 
reactions" that involve unpredictable factors, but in contradistinction, the present 
invention is one of those chemically related applications that fall outside what the CCPA 
means by "most chemical reactions" since the present invention does not involve 



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"unpredictable factors" since as stated by Poole 1988 the chemistry does not have to be 
understood to make the superconductors since the methods to make these 
superconductors are so well know. All that is needed is routine experimentation to 
fabricate samples. (See DST AFFIDAVITS) There is no evidence to the contrary. 
Applicants respectfully submit that the Examiner has cited no evidence to the contrary 
and has presented no argument to the contrary. As stated above Applicants respectfully 
submit that the Examiner is viewing later discovered species that may be nonobvious in 
view of Applicants' teaching as a reason to find Applicants generic claims as being not 
enabled. As described above, Applicants respectfully submit that such a view is 
inconsistent with In re Fisher which clearly permits a finding that a generic claim is 
enabled even though there may be later discovered nonobvious species within its scope. 
When an Examiner allows a species claim to a later applicant as a nonobvious species, 
with unexpectedly better results.in view of a prior art patent that claims a genus- which 
includes the latter discovered species, the Examiner is not, by allowing the claim to the 
latter discovered species, rendering the earlier claimed genus invalid for the lack of the 
earlier disclosure enabling the latter discovered patentable species. It is routine practice 
for an Examiner to allow a later discovered species with unexpected results in view of an 
earlier prior art patent that claims a genus that include such species where the newly 
discovered species is made in the same way as taught in the earlier disclosure. See 
MPEP sections 16.02, 2144.08. 

On the same day that the CCPA decided in re Fisher, the CCPA decided in re Irani 

166 USPQ 24. The issue in In re Irani was whether claims directed to a crystalline 

anhydrous form of a compound, ATMP, was obvious in view of prior art to a glassy form 

a ATMP, The CCPA stated at 1 66 USPQ 24, 26 

we are not convinced that the references of record would lead one of 
ordinary skill in the art to expect that ATMP would exist in a crystalline, 
anhydrous form or, assuming such an expectation, that the references 
would render obvious a method by which such ATMP could be produced. 

The CCPA further stated at 166 USPQ 24, 27 

As stated above, even assuming that one skilled in the art could have 
predicted with reasonable certainty that crystalline anhydrous ATMP 

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could be produced, we are not convinced by this record that it would also 
have been obvious how this could be achieved. We note that neither the 
examiner nor the board has contended that a suitable process would 
have been obvious. 

Thus it is clear from In re Irani that 

even assuming that one skilled in the art could have [theoretically] 
predicted with reasonable certainty that [a compound] could be produced, 
we are not convinced by this record that it would also have been obvious 
how this could be achieved [that is, that there is how to "make and use" 
predictability of the compound.] 

Consequently, it is clear that "theoretical predictability" is not synonymous with "how to 
make and use" predictability. 35 USC 112, first paragraph requires 
"how-to-make-and-use predictability," but not "theoretical predictability." (See the 
Affidavit of News submitted 04/12/2006 which discusses in detail theoretical 
predictability). Thus even if at the time of Applicants" discovery species of high Tc 
superconductors, could not be "theoretically predicted," this does not mean that 
Applicants have not taught how to "make and use" their claimed invention. As noted 
above the Examiner's statement that The examiner does not deny ... that once a person 
of skill in the art knows of a specific type of composition which is superconducting at 
greater than or equal to 26K, such a person of skill In the art, using the techniques 
described in the application, ... can make the known superconductive compositions" 
(Emphasis in the original.) acknowledges that Applicants have taught how to "make and 
use" their olaimed invention. Thus the field of high Tc superconductivity is a predictable 
art subsequent to Applicants' discovery and based on Applicants' teaching. 

In In re Wands 858 F.2d 731 , 742 (Fed. Cir. 1988); 8 U.S.P.Q.2D 1400 the CAFC 
stated in a concurring opinion "(The inventor] must provide sufficient data or authority to 
show that his results are reasonably predictable within the scope of the claimed generic 
invention, based on experiment and/or scientific theory. " Thus experiment or theory is 
sufficient to establish predictability. And as stated above by the Examiner "a person of 
skill in the art, using the techniques described in the application, which included all 
principles of ceramic fabrication known at the time the application was initially filed, can 

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make the known superconductive compositions." There is no requirement to know in 

advance all examples enabled by their teaching. Thus the field of High Tc 

superconductivity is predictable within the meaning of In re Wands. 

The Examiner's reference to "subsequently discovered BSCCO or Tl-systems " 

suggests that it is the Examiner's view that for Applicants to be allowed a generic claim 

applicants must know in advance all materials that can be used to practice Applicant's 

claims. The CAFC has stated in Sri Int'l v. Matsushita Elec. Corp., 775 F.2d1 107, 1 121 

(Fed. Cir. 1985); 227 USPQ 577, 586 that this is not necessary: 

The law does not require the impossible. Hence, it does not require that 
an applicant describe in his specification every conceivable and 
possible future embodiment of his invention. The law recognizes that 
patent specifications are written for those skilled in the art, and requires 
only that the inventor describe the "best mode" known at the time to him 
of making and using the invention. 35 U.S.C. § 1 1 2. 

Applicants have shown that persons of ordinary skill in the art as of Applicants discovery 
can practice applicant's claims to their full scope and the Examiner has, in Applicants 
view as stated above, agreed with this. The DST Affidavits describe in detail what 
persons of skill in the art knew prior to Applicants' discovery and how that knowledge 
together with Applicants' teaching lead others to discover other species within the scope 
of Applicants' claims. 



The CAFC has further stated: 

An applicant for patent is required to disclose the best mode then known 
to him for practicing his invention. 35 U.S.C. § 1 12. He is not required to 
predict all future developments which enable the practice of his Invention 
in substantially the same way. " Hughes Aircraft Co. v. United States, 
717 F.2d 1351, 1362 (Fed. Cir. 1983);39 USPQ2d 1065. 

This is exactly what applicants have done. Thus Applicant's claims are enabled. The 
CAFC further states in regards to future developments: 

Enablement does not require the inventor to foresee every means of 
implementing an invention at pains of losing his patent franchise. Were 
it otherwise, claimed inventions would not include improved modes of 
practicing those inventions. Such narrow patent rights would rapidly 
become worthless as new modes of practicing the invention 
developed, and the inventor would lose the benefit of the patent 



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bargain. Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1071 
(Fed. Cir. 2005), 

The Examiner's position in regards to the enablement of applicants' claims is inconsistent 
with the CAFC's position that "Enablement does not require the inventor to foresee every 
means of implementing an invention." Thus Applicant's claims are enabled and 
respectfully request that the rejection for lack of enablement be withdrawn. 

The Examiner in the Final Action dated 1 0/20/ 2005 at page 4 refers to a article by 
Schuller et al. which states in the passage from Schuller et al. quoted by the Examiner 
u [o]f course, 'enlightened' empirical searches either guided by chemical and materials 
intuition or systematic searches using well-defined strategies may prove to be fruitful. It is 
interesting to note that empirical searches in the oxides gave rise to many 
superconducting systems" See the Affidavit of Newns submitted 04/12/2006 H 18. The 
DST AFFIDAVITS describe what a person of skill in the art knew prior to Applicants' 
discovery upon which the systematic empirical study was based in view of Applicant's 
teaching- The Affidavit of News shows how this systematic empirical study is in principal 
the same as a systematic theoretical investigation when a well developed theoretical 
formalism exists. Thus Applicant's claims are predictable within the meaning of 35 U.S.C. 
1 1 2, first paragraph, and thus enabled. In the response submitted 01/28/2005 at pages 
148-150 applicants applied the MPEP H 2164.01 (a) Undue Experimentation Factors from 
In re Wands. Applicants respectfully request the Examiner to review and reconsider this 
analysis. 

The CCPA has stated in In re Marzzocchi 169 USPQ 367,369 (1971): 

the Patent and Trade-mark Office (PTO) bears the initial burden 
of providing reasons for doubting the objective truth of the 
statements made by appellants as to the scope of enablement. 
Only when the PTO meets this burden, does the burden shift to 
appellants to provide suitable evidence indicating that the 
specification is enabling in a manner commensurate in scope 
with the protection sought by the claims. 

The only reasons given by the Examiner to "[doubt] the objective truth of the statements 
made by [Applicants] as to the scope of enablement" is that there is no theory for high Tc 

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superconductivity and that Applicants describe examples that do not show high Tc 
properties. As stated above, in Applicants* view, the CCPA and the CAFC, have stated 
that "theoretical predictability' and knowledge in advance of all species that come within 
the scope of genus claims is not required under 35 USC 1 1 2, first paragraph. All that 35 
USC 112, first paragraph requires is "how-to-make-and-use predictability" which, as 
stated above, Applicants understand, from the Examiner's comments, that the Examiner 
agrees Applicants teaching provides M how-to-make-and-use predictability." 

In a presidential decision of the USPTO Board of Patent Appeals and Interferences, the 
Board states: 

The examiner notes that only a small group of species of the claimed 
genus have been prepared. However, the Examiner offers no 
reason why one skilled in the art could not "make" the claimed 
compounds. Ex parte Bhide 42 USPQ 1441 , 1447. 

Consequently, the Board agrees with the statement of the CCPA in In re Marzocchi 
quoted above. As stated above, it is Applicants' understanding of the Examiner's 
comments that all know high Tc superconductors can be made following Applicants' 
teaching. Thusthe Examiner "offers no reason why one skilled in the are could not "make 
the" species that come within the scope of Applicants 1 genus claims. 

In Ex parte Chen, an unpublished decision reported at 61 USPQ 1 025, 1 028, the Board of 
Patent Appeals and Interferences held claims to transgenic carp not unpatentable for lack 
of enablement stating: 

In responding to appellants' arguments, the examiner urges that the 
level of experimentation is undue and points to the success rate 1% or 
20 out of 1 746 attempts for the integration of the gene into the 
embryos described in the specification, (Answer, pages 6 and 14). 
However, the examiner offers no evidence which would reasonably 
support a conclusion that one skilled in this art would regard this rate 
of success for the integration of the rtGH gene as evidencing undue 
experimentation. We remind the examiner that some experimentation 
may be required as long as it is not undue. In re Vaeck 941 F.2d 488, 

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496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). Appellants' disclosure 
explicitly describes the methodology to be used to arrive at the 
claimed transgenic carp. As the record now stands, the numbers 
emphasized by the examiner would reasonably appear to reflect the 
need for a repetitive procedure, rather than un-due experimentation by 
those wishing to practice the invention. 



Notwithstanding that the specification in Ex parte Chen disclosed only a 1% success rate 
in the examples described in the specification, the Board found the claims enabled since 
some experimentation may be needed to determine which examples work and which do 
not. The claims were found enabled since the experimentation was not undue. The need 
for a repetitive procedure to determine which examples have the desired result does not 
render the claims not enabled. That is, there was "how-to-make-and-use predictability" in 
the Ex parte Chen invention even though there appeared to have been no "theoretical 
predictability" and even though the Ex parte Chen applicant could not predict in advance 
or specifically teach in advance of experimentation which species had the desired result. 
Thus, that Applicants' specification describes examples that either do not show a Tc 
greater than or equal to 7.26 K or examples that have phases with and without a Tc 
greater than or equal to 26 K does not mean that they have not enabled their genus 
claims. Consequently, when the Examiner states as quoted above that M [t]he examiner 
does not deny . . . that once a person of skill in the art knows of a specific type of 
mmnosition whinh is superconducting at greater than or equal to 26K, such a person of 
skill in the art, using the techniques described in the application, ... can make the known 
superconductive compositions" (Emphasis in the original.), the Examiner is 
acknowledging that persons of skill in the art knew how to make species that come within 
the scope of Applicants' genus claims. That the species within this genus which have the 
desired high Tc property may be determined experimentally and not by a theoretical 
means according to the Board's decision in Ex parte Chen, does not mean that Applicants 
genus claims are not enabled. The CCPA agrees with this when it states: 

What the dissent seem to be obsessed with is the thought of catalysts which 
won't work to produce the intended result. Applicants have enabled those 
in the art to see that this is a real possibility, which is commendable 
frankness in a disclosure. Without undue experimentation or effort or 

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expense the combinations which do not work will readily be discovered and, 
of course, nobody will use them and the claims do not cover them. The 
dissent wants appellants to make everything predictable in advance, which 
is impracticable and unreasonable. In re Angstadt. 190 USPQ 214, 219. 

From this it is clear that 35 U.S.C. 112, first paragraph, does not require everything to be 
predictable in advance and permits the determination of the combinations that will and 
will not work by experimentation that is not undue. 

The USPTO Board of Patent Appeals and Interferences in Ex parte Jackson 217 
USPQ 804 (Bd. App. 1982) states at 217 USPQ 804, 806-807: 

The first paragraph of 35 U.S.C. 1 12 requires that the disclosure of an 
invention be "in such a full, clear, concise and exact terms as to enable any 
person skilled in the art to which it pertains or with which it is most nearly 
connected, to make and use the same ... Decisional law has interpreted the 
statutory requirement as dictating that sufficient information be given in the 
application so that one of ordinary skill in the art can practice the invention 
without undue experimentation. ... 

The determination of what constitutes undue experimentation in a give case 
requires the application of a standard or reasonableness, having due regard 
for the nature of the invention and the state of the art. ... 

The test is not merely quantitative, since a considerable amount of 
experimentation is permissible if it is merely routine, or if the specification in 
question provides a reasonable amount of guidance with respect to the 
direction in which the experimentation should proceed to enable the 
determination of now to practice a desired embodiment of the invention 
claimed. 

The Board states at 21 7 USPQ 806 "The issue squarely raised by [the] rejection [of 
claims] is whether or not a description of several newly discovered strains of bacteria 
having a particularly desirable metabolic property in terms of the conventionally 
measured culture characteristic and a number of metabolic and physiological properties 
would enable one of ordinary skill in the relevant art to independently discover additional 
strains having the same specific desirable metabolic property, i.e., the production of a 
particular antibiotic." Thus the Board in Ex parte Jackson would find a disclosure enabling 
that permits "one of ordinary skill in the relevant art to independently discover additional" 

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high Tc materials that come within the scope of Applicants' generic claims, in particular in 
view of the Examiners' finding that "The examiner does not deny . . . that once a person of 
skill in the art knows of a specific type of composition which is superconducting a t greater 
than or equal to 26K such a person of skill in the art, using the techniques described in 
the application, can make the known superconductive compositions." (Emphasis in 
the original.) 

The Board in Ex parte Jackson further states at 217 USPQ 808 "The problem of 
enablement of processes carried out by microorganisms were uniquely different from the 
field of chemistry generally. Thus, we are convinced that such recent cases as In re 
Angstadt 537 F.2d 498, 190 USPQ 214 (CCPA 1976) and In re Geerdes 491 F,2d 1260, 
180 USPQ 789 (CCPA 1974) are in apposite to this case* Therefore, since the present 
application is not directed to biotechnology or microorganism invention, the decision of Ex 
parte Jackson does not apply, but In re Angstadt and In re Geerdes do apply. 

Applicants note that the Board's decision in Ex parte Jackson that in determining 
whether there is enablement "a considerable amount of experimentation is permissible if 
it is merely routine, or if the specification in question provides a reasonable amount of 
guidance with respect to the direction in which the experimentation should proceed to 
enable the determination of how to practice a desired embodiment of the invention 
claimed." As stated above the Examiner agrees that the known high Tc superconductors 
can be made as described by Applicants. Thus Applicants have "provided guidance with 
respect to the direction in which the experimentation should proceed to enable the 
determination of how to practice a desired embodiment of the invention claimed," 

The Board in Ex parte Jackson further states at 217 USPQ 808 "The 
experimentation involved in the ordinary chemical case, including [In re Angstadt and In 
re Geerdes], usually arise in testing to establish whether a particular species within the 
generic claim language will be operable in the claimed process." As stated herein the 
method of "testing" to establish whether a particular species within the generic claim 
language will be superconductive with a T c > 26 5 K is well known prior to Applicants 1 



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discovery. Also, the process for making the compositions is well known prior to the 
Applicants' discovery. 

Applicants have extensively discussed In re Angstadt 190 USPQ 214 in their 
response dated 01/28/2005 in response to office action dated 07/28/2004 titled 
"Amendment." According to In re Angstadt 190 USPQ 214, 218 in an unpredictable art, 
§1 12 does not require disclosure of a test with every species covered by a claim. As 
stated herein it is Applicants' position that the present application is not directed to an 
unpredictable art. The CCPA states: 

To require such a complete disclosure would apparently necessitate a 
patent application or applications with "thousands" of examples ... More 
importantly, such a requirement would force an inventor seeking adequate 
patent protection to carry out a prohibitive number of actual experiments. 
This would tend to discourage inventors from filin o patent applications in an 
unpredictable area since the patent claims would have to be limited to those 
embodiments which are expressly disclosed. A po tential inf rinoer could 
readily avoid "literal" infringement of such claims by merely finding another 
analogous catalyst complex which could be used in "forming 
hydroperoxides " (Emphasis Added) 

Under In re. Angstadt, a patent application is not limited to claims covering embodiments 

expressly disclosed in their specification even in an unpredictable art. The CCPA In re 

Angstadt further states "[applicants] are not required to disclose every species 

encompassed by the claims even in an unpredictable art" 190 USPQ 214, 218. 

(Emphasis in the original}. The CCPA further states that: 

"what is a maximum concern In the analysis of whether a particular claim is 
supported by the disclosure in an application, is whether the disclosure 
contains sufficient teaching regarding the subject matter of the claims as to 
enabled one of skill in the art to make and to use the claimed invention. 
These two requirements 'how to make" and 'how to use' have some times 
been referred to in combination as the 'enablement requirement'... The 
relevancy may be summed up as being whether the scope of enablement 
provided to one of ordinary skill in the art by the disclosure as such as to be 
commensurate with the scope or protection sought by the claims. (190 
USPQ 21 4,47 citing In re Moore 1 69 USPQ). 

The enablement requirement is "how to make" and "how to use" the claimed invention and 
does not include knowledge in advance of all species that come within the scope of the 
claim. B [C]ommensurate with the scope of protection sought by the claims" is "how to 

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make" and "how to use" the claimed invention which, as stated above, in Applicants' view 
the Examiner has acknowledged Applicants have satisfied by the Examiner stating that 
"The examiner does not deny . . . that once a person of skill in the art knows of a specific 
type of composition which is superconducting at greater than or equal to 26K, such a 
person of skill in the art, using the techniques described in the application, ... can make 
the known superconductive compositions." (Emphasis in the original.) 

The Board in Ex parte Jackson cited In re Geerdes 180 USPQ 789. The Court in In 
re Geerdes at 180 USPQ 793 states in reversing a rejection of claims under 35 U.S.C. 
112. first paragraph, for lack of enablement "the area of technology involved here in not 
particularly complex and there is no evidence in the record to indicate that one of skill in 
the art would not be able to make and use the claimed invention." The area of technology 
involved in the present application in regard to making high T c materials was well known 
prior to Applicants' discovery and the Examiner agrees that known high Tc materials can 
be made according to Applicants' teaching. 

The Court in In re Geerdes further states at 180 USPQ 993 "The Board expressed 
concern that 'experimentation' is involved in the selection of proportions and particle sizes, 
but this is not determinative of the question of scope of enablement. It is only undue 
experimentation that is fatal." There is no evidence that undue experimentation is needed 
"to make" materials to practice Applicants' claims. 

The Court in In re Geerdes further states at 180 USPQ 793 "we cannot agree with 
the Board's determination that the claims are inclusive of materials which would not 
apparently be operative in the claimed process ... of course it is possible to argue that 
process claims encompass inoperative embodiments on the premise of unrealistic or 
vague assumptions, but that is not a valid basis for rejection." In the present application 
the Examiner's basis for rejection of Applicants' claims is impermissibly premised on 
unrealistic or vague assumptions, such as examples cited by Applicant having a T c < 26 8 K 
and statements such as the theory of high Tc Superconductivity is not understood. As 
noted above whether or not there is a theory of high Tc superconductivity is not 

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RECEIVED 
CENTRAL FAX CENTER 



SEP 1 8 2006 

determinative of whether the art of high Tc superconductivity is "unpredictable." An art is 
unpredictable if "how to make and use" is not well understood. If the existence of a theory 
enhances an understanding of "how to make and use," the theory increases the level of 
"predictability" of the art. If persons of ordinary skill in the art know "how to make and use" 
the claims of the invention, the absence of a theory does not result in the art being 
unpredictable. 

That there may be later discovered species not specifically identified or suggested 
by Applicants' teaching may result in patents issued to the discovers of the later 
discovered species, but this does not mean that Applicants have not taught "how to make 
and use" such later discovered species even if there is no "theoretical predictability" so 
long as Applicants have taught how "to make and use," which Applicants assert they have 
done and for which it is Applicants' understanding of the Examiner's comments that this 
is also the Examiner's understanding. As stated above the Board, CCPA and the CAFC 
have held that experimental determination using known procedures even where such 
known procedures produce species that do not have the desired result satisfies the 
enablement requirement. For the reasons given herein, it is Applicants' position that 
under In re Fisher and the other decisions referred to herein Applicants' claims are 
enabled and Applicants respectfully request the Examiner to withdraw the rejection of 
Applicants' claims under 35 USC 1 12, first paragraph, for lack of enablement. 

Please charge any fee necessary to enter this paper and any previous paper to 
deposit account 09-0468. 

Respectf^My^uBTrr^ted, 



Date: September 18, 2006 



r 




Dr. Daniel P <4$&etfis;lEs<f 
Reg. No. 32,053 
Phone No. (914) 945-3217 



IBM Corporation 

Intellectual Property Law Dept. 

P, O. Box 21 8 

Yorktown Heights, New York 1 0598 



Serial No. 08/479,810 



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