DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Amendment after Non-final office action filed on 6/9/2026 is acknowledged.
3. Claim filed on 6/9/2026 is acknowledged.
4. Claim 1-69, 83 and 84 have been cancelled.
5. Claims 70-82 and 85-89 are pending in this application.
6. Claims 70-81 and 85-89 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/5/2026.
7. Applicant elected with traverse of Group 3 (claims 82-84) and elected without traverse of SCLLADDN (SEQ ID NO: 2) as species of decoy peptide; and a subject having a neurologic disease or disorder as species of subject in the reply filed on 2/5/2026.
Please note: In view of Applicant’s amendment to the claim, the Examiner is interpretating the elected species of subject is one having a neurologic disease or disorder associated with one of the conditions recited in instant claim 82.
Restriction requirement was deemed proper and made FINAL in the previous office action. Group 3 is drawn to a method of reducing or preventing cardiac hypertrophy in a subject, wherein the method comprises administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a decoy peptide and a pharmaceutically acceptable carrier, wherein the decoy peptide consists of the sequence having the amino acid sequence of SEQ ID NOs: 2, 5, 6, 9, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, or 57, wherein the subject has 5-HT2A receptor autoantibodies that bind to the second extracellular loop region of the 5-HT2A receptor, and wherein the subject has type 2 diabetes, a microvascular disease or disorder, hypertension, obesity, microvascular angiopathy, retinitis pigmentosa, refractory hypertension, primary open angle glaucoma, diabetic dyslipidemia, hypertriglyceridemia, type 2B hyperlipidemia, or a combination thereof, thereby reducing or preventing cardiac hypertrophy in the subject. A search was conducted on the elected species; and prior art was found. Claim 82 is examined on the merits in this office action.
Withdrawn Objections and Rejections
8. Objection to the specification is hereby withdrawn in view of Applicant's amendment to the specification.
9. Objection to the drawings is hereby withdrawn in view of Applicant's amendment to the drawings.
10. Objection to claim 83 is hereby withdrawn in view of Applicant's amendment to the claim.
11. Rejection to claims 82 and 83 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (written description) is hereby withdrawn in view of Applicant's amendment to the claim.
12. Rejection to claims 82 and 84 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (scope of enablement) is hereby withdrawn in view of Applicant's amendment to the claim.
13. Rejection to claims 82 and 83 under 35 U.S.C. 102(a)(1) as being anticipated by Paterno et al (US 2016/0376340 A1) is hereby withdrawn in view of Applicant's amendment to the claim.
Maintained/Revised Objections
14. (Revised due to Applicant’s amendment to the claim) Claim 82 remains objected to for the following minor informality: Claim 82 contains the acronym “5-HT2A”. An acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, for example, serotonin 2A (5-HT2A). The abbreviation can be used thereafter.
Furthermore, Applicant is suggested to amend claim 82 as “…wherein the decoy peptide is selected from the group consisting of SEQ ID NOs: 2, 5, 6, 9 and 34-57, wherein the subject…”.
Response to Applicant's Arguments
15. Applicant’s amendment to the claim introduces additional minor issues into instant claim 82. Therefore, the objection is deemed proper and is hereby maintained.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 102(a)(1)
16. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
17. (Revied due to Applicant’s amendment to the claim) Claim 82 remains rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zimering (Endocrinol Diabetes Metab J., 2019, 3, pages 1-27, filed with IDS).
The instant claim 82 is drawn to a method of reducing or preventing cardiac hypertrophy in a subject, wherein the method comprises administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a decoy peptide and a pharmaceutically acceptable carrier, wherein the decoy peptide consists of the sequence having the amino acid sequence of SEQ ID NOs: 2, 5, 6, 9, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, or 57, wherein the subject has 5-HT2A receptor autoantibodies that bind to the second extracellular loop region of the 5-HT2A receptor, and wherein the subject has type 2 diabetes, a microvascular disease or disorder, hypertension, obesity, microvascular angiopathy, retinitis pigmentosa, refractory hypertension, primary open angle glaucoma, diabetic dyslipidemia, hypertriglyceridemia, type 2B hyperlipidemia, or a combination thereof, thereby reducing or preventing cardiac hypertrophy in the subject.
Zimering, throughout the literature, teaches diabetes is associated with a substantially increased risk of certain neurovascular and neurodegenerative complications, e.g. stroke, dementia, Parkinson’s disease, major depressive disorder; peptide 1 (Q..N-18) consisting of the amino acid sequence QDDSKVFKEGSCLLADDN (identical to the decoy peptide of instant SEQ ID NO: 1) binds to IgG autoantibodies in type-2 diabetes having neurovascular complications, wherein such IgG autoantibodies cause 5-HT2A receptor activation via binding to the second extracellular loop region of the 5-HT2A receptor, for example, page 1, the 1st and 2nd paragraphs in Section “Introduction”; and page 2, Section “Synthetic peptide synthesis”. Zimering further teaches associations among diabetic angiopathy, neurodegenerative disorders and certain systemic autoimmune diseases with increased level of IgG autoantibodies that binds to 5-HT2A receptor, second extracellular loop region, and linear synthetic peptide; and peptide 1 (Q..N-18) inhibits DM autoantibody-induced N2A neurite retraction, for example, page 4. Section “Increased 5-HT2AR synthetic peptide binding in protein-A eluates from subsets of diabetic angiopathy and/or neurovascular complications” and “Dose-dependence and titer of diabetic protein-A eluate binding to Q..N-18”; page 5, Section “Soluble ECL2 peptide inhibits DM autoantibody-induced N2A neurite retraction”; and pages 19-23,Tables 6-10. Zimering also teaches peptide 2 consisting of the amino acid sequence SCLLADDN (identical to the decoy peptide of instant SEQ ID NO: 2) protects against autoantibody neurotoxicity, in that it nearly completely prevents (99%) IgG-induced acute neurite withdrawal induced by pathologies’ IgG autoantibodies in ten of ten patients tested and provides substantial neuro protection against accelerated neuron loss, for example, page 5, Section “Sub region-specific 5-HT2AR, ECL2 peptide protects against autoantibody neurotoxicity”; and pages 24-26, Tables 12-14. Although Zimering is silent about the carrier used to dissolve either peptide 1 (Q..N-18) or peptide 2, since both peptides are used to treat cells, one of ordinary skilled in the art would understand and reasonably expect these peptides are dissolved in a pharmaceutically acceptable carrier.
Therefore, in view of the teachings of Zimering as a whole, one of ordinary skilled in the art would immediately envision a method of protecting against accelerated neuron loss in type 2 diabetic subject having neurovascular and neurodegenerative complications, e.g. stroke, dementia, Parkinson’s disease, major depressive disorder, wherein the method comprises administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of decoy peptide 2 consisting of the amino acid sequence SCLLADDN (identical to the decoy peptide of instant SEQ ID NO: 2) and a pharmaceutically acceptable carrier, and wherein the type 2 diabetic subject has 5-HT2A receptor autoantibodies that bind to the second extracellular loop region of the 5-HT2A receptor.
With regards to the limitations “a method of reducing or preventing cardiac hypertrophy in a subject” and “thereby reducing or preventing cardiac hypertrophy in the subject” recited in instant claim 82, these are result-oriented limitations. In the instant case, the method above comprises administering the same decoy peptide to the same subject, therefore, the method above would result in the same effect, i.e. reducing or preventing cardiac hypertrophy in a subject.
Thus, the method above reads on SCLLADDN (SEQ ID NO: 2) as the elected species of decoy peptide; and a subject having a neurologic disease or disorder as the elected species of subject. And it meets the limitations of instant claim 82.
Since the reference teaches all the limitations of instant claim 82; the reference anticipates instant claim 82.
Response to Applicant's Arguments
18. Applicant argues that “Zimering does not teach the decoy peptide as currently claimed.”
19. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about instant rejection, the Examiner would like to point out that in the instant case, as stated in Section 17 above, Zimering explicilty teaches peptide 2 consisting of the amino acid sequence SCLLADDN (identical to the decoy peptide of instant SEQ ID NO: 2) protects against autoantibody neurotoxicity, in that it nearly completely prevents (99%) IgG-induced acute neurite withdrawal induced by pathologies’ IgG autoantibodies in ten of ten patients tested and provides substantial neuro protection against accelerated neuron loss. Therefore, Zimering teaches the decoy peptide as currently claimed. Thus, the rejection is deemed proper and is hereby maintained.
Obviousness Double Patenting
20. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
21. (Revised due to Applicant’s amendment to the claim) Claim 82 remains rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of US patent 11306122 B2 and in view of Zimering (Endocrinol Diabetes Metab J., 2019, 3, pages 1-27, filed with IDS).
22. Instant claim 82 is drawn to a method of reducing or preventing cardiac hypertrophy in a subject, wherein the method comprises administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a decoy peptide and a pharmaceutically acceptable carrier, wherein the decoy peptide consists of the sequence having the amino acid sequence of SEQ ID NOs: 2, 5, 6, 9, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, or 57, wherein the subject has 5-HT2A receptor autoantibodies that bind to the second extracellular loop region of the 5-HT2A receptor, and wherein the subject has type 2 diabetes, a microvascular disease or disorder, hypertension, obesity, microvascular angiopathy, retinitis pigmentosa, refractory hypertension, primary open angle glaucoma, diabetic dyslipidemia, hypertriglyceridemia, type 2B hyperlipidemia, or a combination thereof, thereby reducing or preventing cardiac hypertrophy in the subject.
23. Claims 1-20 of US patent 11306122 B2 are drawn to a decoy peptide consisting of the sequence of QDDSKVFKEGSCLLADDN (SEQ ID NO: 1), or a fragment thereof, wherein the fragment of SEQ ID NO: 1 consists of 4 to 9 amino acids in length, and wherein the decoy peptide inhibits the binding of 5-HT2A receptor autoantibodies to a second extracellular loop region of the 5-HT2A receptor; a pharmaceutical composition comprising such decoy peptide and a pharmaceutically acceptable carrier; and a method of treating a subject with a disease or disorder, the method comprising: administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising a decoy peptide comprising the sequence of SEQ ID NO: 2 and a pharmaceutically acceptable carrier, wherein the disease or disorder is a metabolic disease or disorder, a cardiovascular or a microvascular disease or disorder, or a neurodegenerative disease or disorder; a method of treating a subject with a neurologic disease or disorder, the method comprising: administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising a decoy peptide comprising the sequence of SEQ ID NO: 2 and a pharmaceutically acceptable carrier, wherein the neurologic disease or disorder is neuropathy, dementia, major depressive disorder or Parkinson's disease; and a method of inducing sedation in a subject, the method comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising a decoy peptide comprising SEQ ID NO: 2, and a pharmaceutically acceptable carrier.
24. The difference between the method recited in instant claim 82 and claims 1-20 of US patent 11306122 B2 is claims 1-20 of US patent 11306122 B2 do not explicitly teach the subject having 5-HT2A receptor autoantibodies that bind to the second extracellular loop region of the 5-HT2A receptor recited in instant claim 82.
However, in view of the teachings of Zimering as set forth in Section 17 above, it would have been obvious to one of ordinary skilled in the art to apply the decoy peptide and/or the pharmaceutical composition and/or modify the methods recited in claims 1-20 of US patent 11306122 B2 and treat the subject recited in instant claim 82.
With regards to the limitations “a method of reducing or preventing cardiac hypertrophy in a subject” and “thereby reducing or preventing cardiac hypertrophy in the subject” recited in instant claim 82, these are result-oriented limitations. In the instant case, the method developed above comprises administering the same decoy peptide to the same subject, therefore, the method developed above would result in the same effect, i.e. reducing or preventing cardiac hypertrophy in a subject.
25. (Revised due to Applicant’s amendment to the claim) For the same/similar reasoning/rational as the rejection set forth in Sections 21-24 above, instant claim 82 remains rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of US patent 12122853 B2 and in view of the teachings of Zimering (Endocrinol Diabetes Metab J., 2019, 3, pages 1-27, filed with IDS) as set forth in Section 17 above.
Response to Applicant's Arguments
26. With regards to the ODP rejection over claims of US patent 11306122 B2, Applicant argues that “Applicant respectfully requests that this rejection be held in abeyance until such time that the Examiner finds allowable subject matter in this case.”; and the amended claim 82 differs from claim 6-20 of US patent 11306122 B2.
27. Applicant's arguments have been fully considered but have not been found persuasive.
Please note: In view of Applicant’s amendments to the claim, Zimering (Endocrinol Diabetes Metab J., 2019, 3, pages 1-27, filed with IDS) is cited as a prior art reference in instant rejections.
In response to Applicant’s arguments about the ODP rejection over claims of US patent 11306122 B2, the Examiner would like to point out that in the instant case, as stated in Section 24 above, in view of the teachings of Zimering as set forth in Section 17 above, it would have been obvious to one of ordinary skilled in the art to apply the decoy peptide and/or the pharmaceutical composition and/or modify the methods recited in claims 1-20 of US patent 11306122 B2 and treat the subject recited in instant claim 82.
Furthermore, it appears to the Examiner that Applicant fails to argue about the ODP rejection over claims of US patent 12122853 B2.
Taken all these together, until a proper terminal disclaimer is filed and approved by the Office, these double patenting rejections are maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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