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Applicants: Goodman et al. 
Application No.: 09/876,311 
Examiner: M. A. Gottschalk 


No claims have been amended herein. Claim 7 was cancelled in a previous Response. 
Claims 8-13 and 17-19 have been withdrawn from consideration. Claims 1-6, 14-16, 20, and 21 
are presented for the Examiner's review and consideration. Applicants beheve the remarks 
herein serve to clarify the present invention and are independent of patentability. 

In response to the Restriction Requirement, Applicants elect Group I (claims 1-6 and 14- 
16), with traverse . The Examiner interprets Group I as drawn to a method for rewarding disease 
management programme participants based on their participation in health-related programmes. 
Applicants reserve the right to file one or more divisional applications directed to the non- 
elected subject matter in this application. 

Pursuant to 37 C.F.R. § 1.111 and § 1 . 143, Apphcants hereby traverse the requirement for 
restriction and request reconsideration thereof in view of the following remarks. 

The Examiner asserts that Groups I and II are related as subcombinations disclosed as 
usable together in a single combination. The Examiner further asserts that each group has a 
separate utility; Group I as an incentive program and Group II as a method of treating tobacco 
addiction. Thus, the Examiner concludes that restriction is proper because the subcombinations 
are distinct from each other and separately usable. 

Applicants respectfully disagree. Two or more claimed subcombinations are usually 
restrictable when the subcombinations do not overlap in scope and are not obvious variants. See 
MPEP 806.05(d). In the instant case, both Groups are drawn to a method for incentivising 
members of a disease management programme to comply with the programme. The method 
includes, inter alia, three general steps; first defining parameters, referred to in the specification 
as "programme areas" or "measurables", by which to measure compliance with the disease 
management programme; next providing a system for awarding points to members according to 
compliance with the defined parameters; and allocating rewards to the members based on the 
amounts of acquired points. Both methods include these three general steps, however the 
method of Group I encompasses all programme areas, while the method of Group II 
encompasses selective programme areas, for example, an exercise program, a smoking program. 

Applicants: Goodman et al. 
Application No.: 09/876,311 
Examiner: M. A. Gottschalk 

and an education program. Thus, the claims of Groups I and II are both drawn to incentive 
programs which clearly overlap in scope, and therefore are not properly restrictable. 

The courts have recognized that it is in the public interest to permit an applicant to claim 
several aspects of his/her invention together in one application, as the Applicants have done 

The CCPA has observed: 
We believe the constitutional purpose of the patent system is promoted by encouraging 
applicants to claim, and therefore describe in the manner required by 35 U.S.C. § 1 12, all aspects 
as to what they regard as their invention, regardless of the number of statutory classes involved. 

In re Kuehl, 456 F.2d 658, 666 117 U.S.P.Q. 250, 256 (CCPA 1973). This interest is consistent 
with the practical reality that a sufficiently detailed disclosure supporting claims to one aspect of 
an invention customarily is sufficient to support claims in the same application to another aspect 
of the invention. For example, in the instant case. Groups I (claims 1-6 and 14-16) and II 
(claims 20-21) encompass different aspects of the same method, wherein the method of Group II 
recites selective programme areas rather than all programme areas as in the method of Group I. 

Furthermore, the Examiner classifies the invention of Group II in Class 514, subclass 
813. The subject matter of Class 514, subclass 813 is defined by the USPTO as encompassing 
compositions for treating addiction to tobacco. Emphasis added. Neither Group includes claims 
drawn to compositions for treating tobacco addiction or any other addiction. Group II 
encompasses a method which includes using test results as a measurable indicator of compliance 
with a program. Even if one were to assume incorrectly that some type of cotinine composition 
is claimed, the claims still could not be properly classified in Class 514, subclass 813, as cotinine 
is a metabolite of nicotine that evidences nicotine intake, and thus is used as a diagnostic and not 
as a composition for treatment. 

Thus, in contrast to the Examiner's assertion. Group II (claims 20-21) can not be used as 
a method to treat tobacco addiction. As noted above, the claims do not recite any method for 
treatment of tobacco addiction or any other addiction. Nor do they recite any compositions for 


Applicants: Goodman et al. 
Application No.: 09/876,311 
Examiner: M. A. Gottschalk 

treatment of addiction. In these claims, a smoking programme is selected as one of the 
measurable parameters and whether a member is awarded points or not in this area is based upon 
results of a cotinine test. The instant invention is drawn to methods designed to encourage 
people to comply with a programme, measure their compliance, and reward them accordingly. 
No treatments or compositions are claimed. 

Additionally, Applicants respectfully point out that claims 1-6 and 14-16 have already 
undergone several examinations on the merits. As established above, the methods of claims 1 
and 20 overlap in scope. Thus, the Examiner should not be burdened by additional searching, as 
a search of the method should already have been conducted. 

Applicants respectfully suggest that, in view of the continued increase of official fees and 
the potential limitation of an applicant's financial resources, a practice which arbitrarily imposes 
restriction requirements may become prohibitive and thereby contravene the constitutional 
purpose to promote and encourage the progress of science and the useful arts. 

It is vital to all applicants that restriction requirements issue only with the proper 
statutory authorization, because patents issuing on divisional apphcations which are filed to 
prosecute claims that the Examiner held to be independent and distinct can be vulnerable to legal 
challenges alleging double patenting. The third sentence of 35 U.S.C. § 121, which states that a 
patent issuing on a parent application "shall not be used as a reference" against a divisional 
application or a patent issued thereon, does not provide comfort to applicants against such 
allegations. The Court of Appeals for the Federal Circuit has declined to hold that § 121 protects 
a patentee from an allegation of same-invention double patenting, Studiengesellschaft Kohle 
GmbHv. Northern Petrochemical Co., 784 F.2d 351, 355, 288 U.S.P.Q. 837, 840 (Fed. Cir. 
1986). In Gerber Garment Technology Inc. v. Lectra Systems Inc., 916 F.2d 683, 16 U.S.P.Q. 
2d 1436 (Fed. Cir. 1990), the court held that § 121 does not insulate a patentee from an 
allegation of "obviousness-type" double patenting, and in fact affirmed the invalidation on 
double patenting grounds of a patent that had issued from a divisional application filed following 
a restriction requirement. Furthermore, it is far from clear that the step of filing a terminal 
disclaimer is available to resolve a double patenting issue that arises after the issuance of a 


Applicants: Goodman et al. 
Application No.: 09/876,311 
Examiner: M. A. Gottschalk 

patent on the divisional application. 

All these considerations indicate that the imposition of a restriction requirement with 
inadequate authority can lead to situations in which an applicant's legitimate patent rights are 
exposed to uncertainty and even extinguished. Accordingly, to protect a patentee's rights and to 
serve the public interest in the legitimacy of issued patents, Applicants respectfully urge the 
Examiner not to require restriction in cases such as the instant application, wherein a single 
inventive idea (method of incentivising compliance with a disease management programme) is 

Based upon all of the above. Applicants respectfully request reconsideration and 
withdrawal of the restriction requirement. 

In the event that the restriction requirement is made final. Applicants respectfully request 
that the withdrawn claims (claims 8-13 and 17-21) be rejoined and examined upon allowance of 
claims 1-6 and 14-16 in accordance with the procedure as set forth in MPEP 821.04. 


Applicants: Goodman et al. 
Application No.: 09/876,311 
Examiner: M. A. Gottschalk 


In light of the foregoing remarks, the claims, as presented herein, are now in condition 
for an examination on the merits, and early action is respectfully requested. If any questions 
remain regarding this Response or the application in general, a telephone call to the undersigned 
would be appreciated since this should expedite the prosecution of the application for all 
concerned. No fees are believed to be due at this time. However, please charge any fee required 
(or credit any overpayment) to the Deposit Account of the undersigned. Account No. 503410 
(Docket No. 7802-A08-002). 

Respectfully submitted, 

/ Paul D. Bianco / 

Paul D. Bianco, Reg. No. 43,500 

Customer Number: 33771 

21355 East Dixie Highway 
Suite 115 

Miami, Florida 33180 
305-830-2600 (telephone) 
305-830-2605 (facsimile)