Skip to main content

Full text of "USPTO Patents Application 10849551"

See other formats


United States Patent and Trademark Office 



UNITED STATES DEPARTMENT OF COMMERCE 
United States Patent and Trademark Office 
Address: COMMISSIONER FOR PATENTS 
P.O. Box 1450 

Alexandria, Virginia 22313-1450 
www.uspto.gov 



I ATTORNEY DOCKET NO. | CONFIRMATION NO. 



APPLICATION NO. 



FILING DATE 



FIRST NAMED INVENTOR 



10/849,551 



05/20/2004 



7590 02/24/2006 

MCDERMOTT, WILL & EMERY 
600 13th Street, N.W. 
Washington, DC 20005-3096 



Jeffrey Moscow 



50229-435 



7209 



EXAMINER 



BUNNER, BRIDGET E 



ART UNIT 



PAPER NUMBER 



1647 

DATE MAILED: 02/24/2006 



Please find below and/or attached an Office communication concerning this application or proceeding. 



PTO-90C (Rev. 10/03) 



OfficG Action Summarv 


Application No. 

10/849,551 


Applicant(s) 

MOSCOW ET AL 


Examiner 

Bridget E. Bunner 


Art Unit 

1647 





~ The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -■ 
Period for Reply 



A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 1 MONTH(S) OR THIRTY (30) DAYS, 
WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION. 

- Extensions of time may be available under the provisions of 37 CFR 1 .136(a). In no event, however, may a reply be timely filed 
after SIX (6) MONTHS from the mailing date of this communication. 

- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication. 

- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133). 
Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any 
earned patent term adjustment. See 37 CFR 1.704(b). 

Status 

1 )[3 Responsive to communication(s) filed on 15 February 2005 . 
2a)D This action is FINAL. 2b)D This action is non-final. 

3) D Since this application is in condition for allowance except for formal matters, prosecution as to the merits is 

closed in accordance with the practice under Ex parte Quayle, 1935 CD. 11, 453 O.G. 213. 

Disposition of Claims 

4) E3 Claim(s) 1-40 is/are pending in the application. 

4a) Of the above claim(s) is/are withdrawn from consideration. 

5) D Claim(s) is/are allowed. 

6) D Claim(s) is/are rejected. 

7) D Claim(s) is/are objected to. 

8) M Claim(s) 1-40 are subject to restriction and/or election requirement. 

Application Papers 

9) D The specification is objected to by the Examiner. 

10)D The drawing(s) filed on is/are: a)D accepted or b)D objected to by the Examiner. 

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a). 

Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d). 
1 1 )□ The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152. 

Priority under 35 U.S.C. § 119 

12)D Acknowledgment is made of a claim forforeign priority under 35 U.S.C. § 1 19(a)-(d) or (f). 
a)D All b)D Some * c)D None of: 

1 .□ Certified copies of the priority documents have been received. 

2. D Certified copies of the priority documents have been received in Application No. . 

3. Q Copies of the certified copies of the priority documents have been received in this National Stage 

application from the International Bureau (PCT Rule 17.2(a)). 
* See the attached detailed Office action for a list of the certified copies not received. 



Attachment(s) 

1) □ Notice of References Cited (PTO-892) 

2) CD Notice of Draftsperson's Patent Drawing Review (PTO-948) 

3) CD Information Disclosure Statement(s) (PTO-1449 or PTO/SB/08) 

Paper No(s)/lv1ail Date . 



4) 0 Interview Summary (PTO-4 13) 

Paper No(s)/Mail Date. . 

5) C] Notice of Informal Patent Application (PTO-152) 

6) □ Other: . 



U.S. Patent and Trademark Office 
PTOL-326 (Rev. 7-05) 



Office Action Summary 



Part of Paper No./Mail Date 02212006 



Application/Control Number: 10/849,551 
Art Unit: 1647 



Page 2 



Election/Restrictions 
1 . Restriction to one of the following inventions is required under 35 U.S.C. 121 : 

I. Claims 1-4, drawn to a method of screening candidate substances of the OCT6 
transporter, classified in class 435, subclass 4. 

II. Claims 5-7, drawn to a method of screening potential anti-leukemia agents 
comprising determining viability of a mammalian cell line which expresses OCT6 
incubated in the presence of the test compound and identifying the test compound 
as a potential anti-leukemia agent if the compound causes cell death, classified in 
class 435, subclass 4. 

Ill Claims 8-9, drawn to a test kit comprising a mammalian cell line overexpressing 
OCT6 and an antibody or compound which does not react with OCT6, classified 
in class 435, subclass 325. 

IV. Claims 10-20, drawn to an immunogenic composition comprising a substrate that 
binds selectively to an OCT6 transporter, classified in class 530, subclass 387.1, 
for example. 

V. Claims 21-25, drawn to a method of treating a hematological malignancy 
comprising administering an OCT6 substrate which binds specifically or 
selectively to the OCT6 protein, classified in class 424, subclass 130.1, for 
example. 

VI. Claims 26-40, drawn to a method for the treatment of leukemia or a method of 
impairing a leukemia cell blast comprising administering a substrate that 
selectively binds to the OCT6 transporter gene, classified in class 514, subclass 
44. 

The inventions are distinct, each from the other because of the following reasons: 

a. Inventions I-II and V-VI are unrelated. Inventions are unrelated if it can be shown 
that they are not disclosed as capable of use together and they have different 
modes of operation, different functions, or different effects (MPEP § 806.04, 
MPEP § 808.01). Inventions I-II and V-VI are different methods because they 
require different ingredients, process steps, and endpoints. Groups I-II and V-VI 
are different methods requiring different method steps, wherein each is not 
required, one for another. For example, Group I requires search and consideration 
of screening candidate substances of the OCT6 transporter by determining 



Application/Control Number: 10/849,551 
Art Unit: 1647 



Page 3 



whether the test agent is a substrate for OCT6, which is not required by the other 
inventions. Group II requires search and consideration of screening potential anti- 
leukemia agents comprising determining viability of a mammalian cell line which 
expresses OCT6 incubated in the presence of the test compound and identifying 
the test compound as a potential anti-leukemia agent if the compound causes cell 
death, which is not required by the other inventions. Group V requires search and 
consideration of administering an OCT6 substrate which binds specifically or 
selectively to the OCT6 protein, which is not required by the other inventions. 
Group VI requires search and consideration of administering a substrate that 
selectively binds to the OCT6 transporter gene, which is not required by the other 
inventions. Furthermore, the distinct steps and products require separate and 
distinct searches. The inventions of Groups I-II and V-VI have a separate status 
in the art as shown by their separate search requirements. As such, it would be 
burdensome to search the inventions of Groups I-II and V-VI together. 

b. Although there are no provisions under the section for Relationship of 
Inventions" in M.P.E.P. § 806.05 for inventive groups that are directed to 
different products, restriction is deemed to be proper because these products 
constitute patentably distinct inventions for the following reasons. Groups III-IV 
are directed to products that are distinct both physically and functionally, are not 
required one for the other, and are therefore patentably distinct. For example, the 
mammalian cell line overexpressing OCT6 and the antibody/compound which 
does not react with OCT6 of Group in have a different structure and function than 
the substrate that binds selectively to an OCT6 transporter of Group IV and may 
be used in materially different methods. 

Additionally, searching the inventions of Groups DI-IV would impose a serious 
search burden. The inventions have a separate status in the art as shown by their 
different classifications and separate search requirements. The technical 
literature searches for the inventions of Groups III-IV are not coextensive. 



Application/Control Number: 10/849,551 
Art Unit: 1647 



Page 4 



c. Inventions III and I are related as product and process of use. The inventions can 
be shown to be distinct if either or both of the following can be shown: (1) the 
process for using the product as claimed can be practiced with another materially 
different product or (2) the product as claimed can be used in a materially 
different process of using that product. See MPEP § 806.05(h). In the instant 
case, the cell line overexpressing OCT6 and the control antibody can be used in 
materially different methods, such as cell growth and survival assays. 

d. Inventions IV and V are related as product and process of use. The inventions can 
be shown to be distinct if either or both of the following can be shown: (1) the 
process for using the product as claimed can be practiced with another materially 
different product or (2) the product as claimed can be used in a materially 
different process of using that product. See MPEP § 806.05(h). In the instant 
case, the OCT6 substrate that binds the OCT6 transporter of Group IV can be 
used in materially different methods, such as diagnostic assays or cell culture 
assays. 

e. Inventions IV and I/II/VI are unrelated because the product of Group IV is not 
used or otherwise involved in the processes of Groups I/II/VI. 

f Inventions III and II/V/VI are unrelated because the product of Group III is not 
used or otherwise involved in the processes of Groups I/II/VI. 

2. Because these inventions are independent or distinct for the reasons given above and the 
inventions require a different field of search (see MPEP § 808.02), as well as have acquired a 
separate status in the art in view of their different classification, restriction for examination 
purposes as indicated is proper. 



Application/Control Number: 1 0/849,55 1 Page 5 

Art Unit: 1647 

3. This application contains claims directed to the following patentably distinct species: 
A detectable substance or label: 

a. extrinsically activatable enzymes 

b. prosthetic groups 

c. fluorescent materials 

d. luminescent/bioluminescent materials 

e. radioactive materials 

f positron emitting metals using various positron emitting tomographies 

g. nonradioactive paramagnetic metal ions 

h. immunogenic tag peptide sequences 

i. extrinsically activatable toxins 

j. extrinsically activatable quenching agents 
k. antibodies 

The species are independent or distinct because each requires separate, non-coextensive 
searches. For example, a technical literature search for fluorescent labels may not result in 
relevant art with respect to labels with positron emitting metals using various positron emitting 
tomographies. 

Applicant is required under 35 U.S.C. 121 to elect a single disclosed species for 
prosecution on the merits to which the claims shall be restricted if no generic claim is finally 
held to be allowable. Currently, claims 1-2 and 8 are generic. 

Applicant is advised that a reply to this requirement must include an identification of the 
species that is elected consonant with this requirement, and a listing of all claims readable 



Application/Control Number: 1 0/849,55 1 Page 6 

Art Unit: 1647 

thereon, including any claims subsequently added. An argument that a claim is allowable or that 
all claims are generic is considered nonresponsive unless accompanied by an election. 

Upon the allowance of a generic claim, applicant will be entitled to consideration of 
claims to additional species which depend from or otherwise require all the limitations of an 
allowable generic claim as provided by 37 CFR 1 . 141 . If claims are added after the election, 
applicant must indicate which are readable upon the elected species. MPEP § 809.02(a). 

4. This application contains claims directed to the following patentably distinct species: The 
substrate/compound that selectively binds the OCT6 transporter protein, wherein the 
substrate/compound is: 

1. a cytotoxic agent 

m. is coupled with a cytotoxic agent 

The species are independent or distinct because each requires separate, non-coextensive 
searches. For example, a technical literature search for a cytotoxic agent may not result in 
relevant art with respect to compounds labeled with a cytotoxic agent. 

Applicant is required under 35 U.S.C. 121 to elect a single disclosed species for 
prosecution on the merits to which the claims shall be restricted if no generic claim is finally 
held to be allowable. Currently, claims 16-17, 21, 34 are generic. 

Applicant is advised that a reply to this requirement must include an identification of the 
species that is elected consonant with this requirement, and a listing of all claims readable 



Application/Control Number: 1 0/849,55 1 Page 7 

Art Unit: 1647 

thereon, including any claims subsequently added. An argument that a claim is allowable or that 
all claims are generic is considered nonresponsive unless accompanied by an election. 

Upon the allowance of a generic claim, applicant will be entitled to consideration of 
claims to additional species which depend from or otherwise require all the limitations of an 
allowable generic claim as provided by 37 CFR 1.141. If claims are added after the election, 
applicant must indicate which are readable upon the elected species. MPEP § 809.02(a). 

The examiner has required restriction between product and process claims. Where applicant 
elects claims directed to the product, and a product claim is subsequently found allowable, withdrawn 
process claims that depend from or otherwise include all the limitations of the allowable product claim 
will be rejoined in accordance with the provisions of MPEP § 821 .04. Process claims that depend 
from or otherwise include all the limitations of the patentable product will be entered as a matter 
of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. 
Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted 
after allowance are governed by 37 CFR 1.312. 

In the event of rejoinder, the requirement for restriction between the product claims and 
the rejoined process claims will be withdrawn, and the rejoined process claims will be fully 
examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined 
claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 
103, and 1 12. Until an elected product claim is found allowable, an otherwise proper restriction 
requirement between product claims and process claims may be maintained. Withdrawn process 
claims that are not commensurate in scope with an allowed product claim will not be rejoined. 



Application/Control Number: 1 0/849,55 1 Page 8 

Art Unit: 1647 

See "Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re 
Brouwer and 35 U.S.C. § 103(5)/' 1 184 O.G. 86 (March 26, 1996). Additionally, in order to 
retain the right to rejoinder in accordance with the above policy, Applicant is advised that the 
process claims should be amended during prosecution either to maintain dependency on the 
product claims or to otherwise include the limitations of the product claims. Failure to do so 
may result in a loss of the right to rejoinder. 

Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 
does not apply where the restriction requirement is withdrawn by the examiner before the patent 
issues. See MPEP § 804.01. 

Applicant is advised that the reply to this requirement to be complete must include (i) an 
election of a species or invention to be examined even though the requirement be traversed (37 
CFR 1.143) and (ii) identification of the claims encompassing the elected invention. 

The election of an invention or species may be made with or without traverse. To reserve 
a right to petition, the election must be made with traverse. If the reply does not distinctly and 
specifically point out supposed errors in the restriction requirement, the election shall be treated 
as an election without traverse. 

Should applicant traverse on the ground that the inventions or species are not patentably 
distinct, applicant should submit evidence or identify such evidence now of record showing the 
inventions or species to be obvious variants or clearly admit on the record that this is the case. In 



Application/Control Number: 10/849,551 



Page 9 



Art Unit: 1647 

either instance, if the examiner finds one of the inventions unpatentable over the prior art, the 
evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention. 

Applicant is reminded that upon the cancellation of claims to a non-elected invention, the 
inventorship must be amended in compliance with 37 CFR 1 .48(b) if one or more of the 
currently named inventors is no longer an inventor of at least one claim remaining in the 
application. Any amendment of inventorship must be accompanied by a request under 37 CFR 
1 .48(b) and by the fee required under 37 CFR 1 . 17(i). 

Any inquiry concerning this communication or earlier communications from the 
examiner should be directed to Bridget E. Bunner whose telephone number is (571) 272-0881. 
The examiner can normally be reached on 8:30-4:30 M-F. 

If attempts to reach the examiner by telephone are unsuccessful, the examiner's 
supervisor, Brenda Brumback can be reached on (571) 272-0961. The fax phone number for the 
organization where this application or proceeding is assigned is 571-273-8300. 

Information regarding the status of an application may be obtained from the Patent 
Application Information Retrieval (PAIR) system. Status information for published applications 
may be obtained from either Private PAIR or Public PAIR. Status information for unpublished 
applications is available through Private PAIR only. For more information about the PAIR 
system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR 
system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 



BEB 

Art Unit 1647 
21 February 2006 




BRIOQETBUNNER 
PATENT EXAMINER