DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/16/25 has been entered.
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 6/16/25 are acknowledged. Any objection or rejection from the 12/16/24 office action that is not addressed below is withdrawn based on the amendments.
Previously, an agent of antibody and a patient population that is overweight was elected. Based on the claim amendment of 3/6/24, the elected agent of antibody no longer reads on the claims. Claim 16 requires recombinant human DBI which is an 87 amino acid protein (first paragraph of background). The search was conducted on recombinant human DBI. Claim 23 refers to a modified DBI which does not fall within the scope of claim 16.
Claim 23 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/31/23.
Claims 1-15 have been canceled.
Claim 31 has been added as a new claim.
Claims 16-22 and 24-31 are being examined.
Priority
The priority information is provided in the filing receipt of 2/2/23.
Claim Rejections - 35 USC § 103
Claims were previously rejected based on the references cited below. Since claim 31 has been added as a new claim the rejection is updated to address such claim.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16-22 and 24-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prayaga et al. (WO 01/25436 04-2001 as cited with IDS 9/26/22; ‘Prayaga’) in view of Conti et al. (as cited with IDS 9/6/22; ‘Conti’).
Prayaga teach the administration of a polypeptide in an amount sufficient to treat anorexia (claims 26-27) where the polypeptide can be SEQ ID NO:6 (claim 1). Prayaga teach that endozepines have various biological effects and that the endozepine family includes diazepam binding inhibitor including human DBI (page 1 lines 20-30) and Prayaga teach that the sequence can be human (page 109 lines 19-25). Prayaga recites numerous peptides which are described as similar to various DBI including human which include SEQ ID NO: 6 (claim 1; Table 14A pages 17 line 21 – page 18; Table 18 pages 21 line 18 – page 22 line 7; Table 21 pages 23 line 24 – page 24; Table 27I page 37). Prayaga teach a generic formula for muscle mass raising sequences (page 117 lines 1-5). Prayaga shows the sequence of human DBI (also called ACBP) (page 18 Table 15) which comprises QATVGDINTERPGMLDFTGK which is of the generic formula for a muscle mass raising sequence. Prayaga teach recombinant methods for producing the polypeptides (page 1 lines 6-8). Prayaga teach that administration can be intravenous (page 82 lines 20-22).
Prayaga does not provide a specific example where human DBI is administered to a subject.
Conti teach humans with anorexia nervosa with an average body mass index of 15.4 (page 626-627 connecting paragraph). Conti teach that the fasting levels of diazepam-binding inhibitor (DBI) was assessed and found to be reduced in patients with anorexia nervosa (abstract). Conti teach that DBI modulates the biosynthesis of neuroactive steroids including several involved in orexigenic (i.e. stimulate appetite) activities (page 626 paragraph connecting columns 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Prayaga because Prayaga teach the administration of a polypeptide in an amount sufficient to treat anorexia (claim 27) where the polypeptide sequence can vary (claim 1). Prayaga recites human DBI (page 1 lines 20-30) and Conti teach that DBI modulates the biosynthesis of neuroactive steroids including several involved in orexigenic (i.e. stimulate appetite) activities (page 626 paragraph connecting columns 1-2). Further, Conti teach that the fasting levels of diazepam-binding inhibitor (DBI) was assessed and found to be reduced in patients with anorexia nervosa (abstract). In addition, Prayaga teach a generic formula for muscle mass raising sequences (page 117 lines 1-5). Prayaga shows the sequence of human DBI (also called ACBP) (page 18) which comprises QATVGDINTERPGMLDFTGK which is of the generic formula for a muscle mass raising sequence. Thus, one would have been motivated to administer human DBI to those with anorexia. The claims would have been obvious because they correspond to the substitution of one known element (human DBI) for another (an endozepine such as SEQ ID NO:6 of Prayaga) (compare MPEP 2143 I B). In the instant case, Conti teach that DBI modulates the biosynthesis of neuroactive steroids including several involved in orexigenic (i.e. stimulate appetite) activities (page 626 paragraph connecting columns 1-2) thus teaching the function of DBI. One would have had a reasonable expectation of success since Prayaga teach the administration of a polypeptide in an amount sufficient to treat anorexia (claim 27) where the polypeptide sequence can vary (claim 1) and Conti teach that DBI modulates the biosynthesis of neuroactive steroids including several involved in orexigenic (i.e. stimulate appetite) activities (page 626 paragraph connecting columns 1-2).
In relation to the administering as recited in claim 16, Prayaga teach the administration of a polypeptide in an amount sufficient to treat anorexia (claim 27).
In relation to the polypeptide of clam 16, Prayaga teach human DBI (page 1 lines 20-30). Prayaga teach recombinant methods for producing the polypeptides (page 1 lines 6-8).
In relation to the subject of claims 16-20, Prayaga teach the administration of a polypeptide in an amount sufficient to treat anorexia (claim 27). Conti teach humans with anorexia nervosa with an average body mass index of 15.4 (page 626-627 connecting paragraph) (the instant specification defines underweight as a BMI below 18.5, page 7 lines 23-24 of substitute specification).
In relation to claims 21-22 and 24-29, the active step of the claims is administering. Since the prior art suggest administering the claimed polypeptide it would function as claimed.
In relation to claim 30, Prayaga teach that administration can be intravenous (page 82 lines 20-22).
In relation to claim 31, Prayaga teach the administration of a polypeptide in an amount sufficient to treat anorexia (claim 27). Conti teach humans with anorexia nervosa with an average body mass index of 15.4 (page 626-627 connecting paragraph).
Response to Arguments - 103
Applicant's arguments filed 6/16/25 have been fully considered but they are not persuasive.
Although applicants argue about the teachings of Prayaga or Conti alone, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Although applicants argue that Prayaga does not provide for human DBI administration, the instant rejection is a 103 rejection and as such any single reference does not necessarily anticipate the claims. Prayaga teach the administration of a polypeptide in an amount sufficient to treat anorexia (claims 26-27) where the polypeptide can be SEQ ID NO:6 (claim 1). The claims would have been obvious because they correspond to the substitution of one known element (human DBI) for another (an endozepine such as SEQ ID NO:6 of Prayaga) (compare MPEP 2143 I B).
Although applicants argue that there is no reasonable expectation of success based on a teaching on page 658 of Conti, the Conti reference does not include page 658. Further, applicants recite ‘levels were not directly to body weight’. The meaning of this phrase is unclear. It appears that something is missing in the phrase. MPEP 2143.02 II recognizes that obviousness does not require absolute predictability. Prayaga teach the administration of a polypeptide in an amount sufficient to treat anorexia (claims 26-27) where the polypeptide can be SEQ ID NO:6 (claim 1). Prayaga teach a generic formula for muscle mass raising sequences (page 117 lines 1-5). Prayaga shows the sequence of human DBI (also called ACBP) (page 18 Table 15) which comprises QATVGDINTERPGMLDFTGK which is of the generic formula for a muscle mass raising sequence. Thus, the function of raising muscle mass was known. Further, Conti teach that DBI modulates the biosynthesis of neuroactive steroids including several involved in orexigenic (i.e. stimulate appetite) activities (page 626 paragraph connecting columns 1-2). Any conflicting results quotation in Conti appears to be in the context of a depressive state which is not required by the instant claims. With respect to expected functionality, Conti teach that the fasting levels of diazepam-binding inhibitor (DBI) was assessed and found to be reduced in patients with anorexia nervosa (abstract). Conti teach that DBI modulates the biosynthesis of neuroactive steroids including several involved in orexigenic (i.e. stimulate appetite) activities (page 626 paragraph connecting columns 1-2). Further, Prayaga teach the administration of a polypeptide in an amount sufficient to treat anorexia (claims 26-27) where the polypeptide can be SEQ ID NO:6 (claim 1). Prayaga teach a generic formula for muscle mass raising sequences (page 117 lines 1-5). Prayaga shows the sequence of human DBI (page 18) which comprises QATVGDINTERPGMLDFTGK which is of the generic formula for a muscle mass raising sequence.
Double Patenting
The double patenting rejections are new rejections necessitated by the filing of application 19221186
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16-22 and 24-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 19221186 (reference application; ‘186’). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
186 recites administering a therapeutically effective amount of an agent (claim 1) and specifically refers to SEQ ID NO:1 as the agent (claim 6). 186 recites that the subject suffers from anorexia nervosa (claim 4) and is underweight (claim 2).
In relation to the administering as recited in claim 16, 186 recites administering a therapeutically effective amount of an agent (claim 1).
In relation to the polypeptide of clam 16, 186 recites administering a therapeutically effective amount of an agent (claim 1) and specifically refers to SEQ ID NO:1 as the agent (claim 6) which is the same as instant SEQ ID NO:1
In relation to the subject of claims 16-20, 186 recites that the subject suffers from anorexia nervosa (claim 4) and is underweight (claim 2). 186 recites human diseases and refers to humans (claim 18).
In relation to claims 21-22 and 24-29, the active step of the claims is administering. Since the administering step is taught, the claimed polypeptide it would function as claimed.
Claims 16-22 and 24-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 19221186 in view of Prayaga et al. (WO 01/25436 04-2001 as cited with IDS 9/26/22; ‘Prayaga’) in view of Conti et al. (as cited with IDS 9/6/22; ‘Conti’).
This is a provisional nonstatutory double patenting rejection.
186 recites administering a therapeutically effective amount of an agent (claim 1) and specifically refers to SEQ ID NO:1 as the agent (claim 6). 186 recites that the subject suffers from anorexia nervosa (claim 4) and is underweight (claim 2).
186 does not recite the details of claims 30-31.
Prayaga teach the administration of a polypeptide in an amount sufficient to treat anorexia (claims 26-27) where the polypeptide can be SEQ ID NO:6 (claim 1). Prayaga teach that endozepines have various biological effects and that the endozepine family includes diazepam binding inhibitor including human DBI (page 1 lines 20-30) and Prayaga teach that the sequence can be human (page 109 lines 19-25). Prayaga recites numerous peptides which are described as similar to various DBI including human which include SEQ ID NO: 6 (claim 1; Table 14A pages 17 line 21 – page 18; Table 18 pages 21 line 18 – page 22 line 7; Table 21 pages 23 line 24 – page 24; Table 27I page 37). Prayaga teach a generic formula for muscle mass raising sequences (page 117 lines 1-5). Prayaga shows the sequence of human DBI (also called ACBP) (page 18 Table 15) which comprises QATVGDINTERPGMLDFTGK which is of the generic formula for a muscle mass raising sequence. Prayaga teach recombinant methods for producing the polypeptides (page 1 lines 6-8). Prayaga teach that administration can be intravenous (page 82 lines 20-22).
Conti teach humans with anorexia nervosa with an average body mass index of 15.4 (page 626-627 connecting paragraph). Conti teach that the fasting levels of diazepam-binding inhibitor (DBI) was assessed and found to be reduced in patients with anorexia nervosa (abstract). Conti teach that DBI modulates the biosynthesis of neuroactive steroids including several involved in orexigenic (i.e. stimulate appetite) activities (page 626 paragraph connecting columns 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 186 because 186 recites administering a therapeutically effective amount of an agent (claim 1) and specifically refers to SEQ ID NO:1 as the agent (claim 6). 186 recites that the subject suffers from anorexia nervosa (claim 4) and is underweight (claim 2). Prayaga teach the administration of a polypeptide in an amount sufficient to treat anorexia (claim 27) where the polypeptide sequence can vary (claim 1). Prayaga recites human DBI (page 1 lines 20-30) and Conti teach that DBI modulates the biosynthesis of neuroactive steroids including several involved in orexigenic (i.e. stimulate appetite) activities (page 626 paragraph connecting columns 1-2). Further, Conti teach that the fasting levels of diazepam-binding inhibitor (DBI) was assessed and found to be reduced in patients with anorexia nervosa (abstract). Since the references relate to treating anorexia one would have been motivated to combine the teachings. Thus, one would have been motivated to administer human DBI to those with anorexia including specific patients (as taught by Conti) and via known methods (as taught by Prayaga). Conti teach humans with anorexia nervosa with an average body mass index of 15.4 (page 626-627 connecting paragraph). Prayaga teach that administration can be intravenous (page 82 lines 20-22). One would have had a reasonable expectation of success since 186 recites administering a therapeutically effective amount of an agent (claim 1) and specifically refers to SEQ ID NO:1 as the agent (claim 6). Prayaga teach the administration of a polypeptide in an amount sufficient to treat anorexia (claim 27) where the polypeptide sequence can vary (claim 1) and Conti teach that DBI modulates the biosynthesis of neuroactive steroids including several involved in orexigenic (i.e. stimulate appetite) activities (page 626 paragraph connecting columns 1-2).
In relation to the administering as recited in claim 16, 186 recites administering a therapeutically effective amount of an agent (claim 1).
In relation to the polypeptide of clam 16, 186 recites administering a therapeutically effective amount of an agent (claim 1) and specifically refers to SEQ ID NO:1 as the agent (claim 6) which is the same as instant SEQ ID NO:1
In relation to the subject of claims 16-20, 186 recites that the subject suffers from anorexia nervosa (claim 4) and is underweight (claim 2). 186 recites human diseases and refers to humans (claim 18). Conti teach humans with anorexia nervosa with an average body mass index of 15.4 (page 626-627 connecting paragraph).
In relation to claims 21-22 and 24-29, the active step of the claims is administering. Since the administering step is taught, the claimed polypeptide it would function as claimed.
In relation to claim 30, Prayaga teach that administration can be intravenous (page 82 lines 20-22).
In relation to claim 31, Prayaga teach the administration of a polypeptide in an amount sufficient to treat anorexia (claim 27). Conti teach humans with anorexia nervosa with an average body mass index of 15.4 (page 626-627 connecting paragraph).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658