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 .
Claims 1-8, 10-11, 14-36 are pending and under examination.
Priority
The instant application is 371 of PCT/2021/070483, which claims priority of US Provisional 63/055,063 filed on 7/22/2020 and EP 20192415.6 filed on 8/24/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 1/19/2023, 8/28/2024 and 8/6/2025 have been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such 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, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such 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, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 8, 14, 17, 22, 25-26, 29, and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description in this case only sets forth a compound #4 or #10 having a FULLY DEFINED peptide amino acid sequence, wherein all variables arrive to a compound that reduces body weight in a subject in need thereof, and therefore the written description is not commensurate in scope with “a compound having 16 variable positions out of 39 amino acids that can reduce body weight in a subject in need thereof”.
The claims broadly encompass millions of peptide with variable amino acids of SEQ ID NO: 15 that reduces body weight in subject in need thereof. The claims do not require that a compound of amino acid sequence of SEQ ID NO:15 possess any particular feature or structure that may body weight when administered to a subject in need thereof.
The specification at pg.44-61, discloses compounds #1- #35 having variation at two positions in a FULLY DEFINED peptide and compared it with semaglutide and Tirzepatide in Table 7. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. Some of the factual considerations that are weighed when determining a written description include the level of skill and knowledge in the art, the disclosure of complete or partial structures, the disclosure of physical and or chemical properties, adequate disclosure of the functional characteristics, the correlation between structure and function, and disclosure of methods of making.
In the instant case, the specification pg.44-61, discloses compounds #1- #35 having variation at two positions in a FULLY DEFINED peptide and compared it with semaglutide and Tirzepatide in Table 7. The specification does not describe structure of the peptide needed for reducing body weight in a subject in need thereof.
The specification discloses that the synthesis of semaglutide Tirzepatide are done using methods disclosed in WO 2006/097537 or WO 2016/111971 (page 69). WO 2016/077220 (IDS of 1/19/2023) discloses a GIP/GLP-1 co-agonist peptide having SEQ ID NO: 2 that comprises alpha-aminoisobutyric acid (AIB) at position 2 and 20 that reduces blood glucose. The specification does not disclose sufficient number of representative of compounds that comprises variant combinations represented in SEQ ID NO: 15 of claim 1. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed.
Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1 "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
Vas-Cath Inc. V. Mahurka, 19 USPQ2d 1111, states that applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (see Vas-Cath at page 1116).
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B (1), the court states an adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.
As discussed above, the skilled artisan cannot envision the detailed genus of “compounds having amino acid (16 variants) of SEQ ID NO: 15” and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of making a mutation. The compound itself is required. See Fiers v.Revel, 25USPQ2d 1601 at 1606 (CAFC 1993) and Amgen v.Baird, 30 Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 148 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class.
Therefore, only the compounds #4 or #10 for reducing body weight in a subject in need thereof, but not the full breadth of the claim meets the written description provision of 35 U.S.C. §112, first paragraph.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-7, 8 and 14-34 are rejected under 35 U.S.C. 103 as being unpatentable over Vignati et al. (IDS, WO 2012/088379) in view of Nuijens et al. (WO 2019170918, also claims priority to US 20190345529) and US Pat. No. 8,551946).
The instantly claimed invention is broadly drawn to a compound comprising a peptide and a substituent; wherein the amino acid sequence of the peptide is: YX2EGTFTSDYSIYLX15X1X17AAX20X21FVX24WLLX28GGPX32X33X34X35X36X37X38X39 (SEQ ID NO.: 15) wherein X2 is Aib X15 is Dor E:X16 is EorK,X17is Q or K, X20 is Aib, X21 is E or K, X24 is N or Q, wherein the substituent is attached to the peptide via a lysine (K) residue in position 16, 17 or 21, wherein the substituent is
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(claims 1,4,14,26), wherein X32-39 are absent (claim 2), wherein X32-X35 is SSGA (claim 3), wherein the amino acid sequence represented by SEQ ID NO: 10, and a method of reducing body weight using the same.
Vignati et al. teach methods for treating obesity and metabolic disorders with GIP and GLP-1 receptor agonist (abstract). They teach administering GLP-1/GIP a weekly dosage of 1 mg to 40 mg [0008]. They teach GLP-1/GIP peptides having amino acids including SEQ ID NO: 5-94, 99-169, 173-413 (see paragraph [0012]) and the composition is administered through subcutaneous, intravenous or intramuscular injection [0013]. They teach that the conservative substitution includes polar, negatively charged residues: Asp, Asn, Glu Gln or cysteine [0030]. They teach that the disclosed amino acid sequences 5-94, 99-169, 173-262 have extended half-life [0044]. They teach that C-terminus having amide [0108].They teach attaching heterogenous moieties such as PEG to increase the half-life of the peptide [0044]. They teach that a hydrophilic polymer is attached with amino acid positions 16, 17, 21, 24, or 29, after 29 at an added amino acid position [0049]. They teach that the polymer can be 1 kD to 100 kD [0060]. They teach to attach alky group of any size which and be C12, C14, C16 C18 C20 of higher carbon fatty acids [0067]. They do not teach to attach a substituent wherein the substituent is:
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. Further, they do not teach a compound having amino acid sequence of SEQ ID NO: 10 as recited in claims 6-7.
Nuijens et al. (WO 2019170918) teach semaglutide, liraglutide and GLP-1 where they teach attaching a substituent such as
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to increase the half-life of the peptide see below:
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Neither Vignati et al. nor Nuijens et al. teach a GIP agonist having amino acid sequence of SEQ ID NO: 10.
DiMarchi et al teach a GLP-1 peptide for reducing obesity having an amino acid sequence of SEQ ID NO: 33 which is 97.5% identical to the instantly claimed amino acid sequence of SEQ ID NO: 10 and the only difference is a conservative amino acid E to D (see below).
us-18-016-947-10.rai search result header
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Result #5 , generated by 12 identical sequences
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Therefore, it would have been prima facie prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a peptide having 100% sequence identity as taught by DiMarchi et al and attach a substituent
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as taught by Nuijens et al. to increase the half-life of an incretin GLP-1 to attach with a compound of claim 1 as taught by Vignati et al. it would have been obvious to do so because the peptide taught by DiMarchi et al is almost identical except one conservative amino acid (aspartic acid to glutamic acid). Additionally, one would have been motivated to do so because Nuijens et al teach using a substituent
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to increase the half-life of GLP-1 peptide. Further, one would have a reasonable expectation of success in using the polypeptide taught by DiMarchi et al having 98% sequence identity (only a single conservative amino acid difference) and attach a substituent as taught by Nuijens et al to reduce body weight in a subject in need thereof. Therefore, the instantly claimed invention would have been obvious over the combined teachings of the references.
Double Patenting
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 1-6, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 14-15 of copending Application No. 18/017,041 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because a compound comprising a peptide and substituent, wherein in the substituent is
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and the compound comprises amino acid sequence of SEQ ID NO: 15 are taught by claims 1-7 and 14-15 of US Application No. 18/017,041.
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, 8 and 14-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 14-15 of copending Application No. 18/017,041 in view of Vignati et al (IDS, WO 2012/088379) in view of DiMarchi et al. ( US Pat. No. 8,551946).
Claims 1-7 and 14-15 of copending Application No. 18/017,041 teach a compound having amino acid sequence of SEQ ID NO: 47 which is identical to the amino acid sequence of SEQ ID NO: 15 being instantly claimed (i.e.,
A compound comprising a peptide and a substituent; wherein the amino acid sequence of the peptide is: YX2EGTFTSDYSIYLX1s5X16X17AA X 20X21 FV X24W LLX2gGGPX 32X33 X34X35 X36X37 X38.X39 (SEQ ID NO.: 15); wherein X2 is Aib, X15 is D or E, X16 is E or K, X17 1s Q or K, X20 is Aib, X21 is E or K, X24 is N or Q, X28 is A or E, X32 18 S or absent, X33 18 S or absent, X34 1s G or absent, X35 is A or absent, X36 is P or absent, X37 1s P or absent, X38 1s P or absent, and X39 is S or absent) and a substituent to attach with the compound wherein the substituent is:
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Claims 1-7 and 14-15 of copending Application No. 18/017,041 do not teach to attach the substituent at position 16 of the compound and do not teach a sequence of SEQ ID NO:10.
Vignati et al. teach methods for treating obesity and metabolic disorders with GIP and GLP-1 receptor agonist (abstract). They teach administering GLP-1/GIP a weekly dosage of 1 mg to 40 mg [0008]. They teach GLP-1/GIP peptides having amino acids including SEQ ID NO: 5-94, 99-169, 173-413 (see paragraph [0012]) and the composition is administered through subcutaneous, intravenous or intramuscular injection [0013]. They teach that the conservative substitution includes polar, negatively charged residues: Asp, Asn, Glu Gln or cysteine [0030]. They teach modifying C-terminus with amide [0108]. They teach that the disclosed amino acid sequences 5-94, 99-169, 173-262 have extended half-life [0044]. They teach attaching heterogenous moieties such as PEG to increase the half-life of the peptide [0044]. They teach that a hydrophilic polymer is attached with amino acid positions 16, 17, 21, 24, or 29, after 29 at an added amino acid position [0049].
DiMarchi et al teach a GLP-1 peptide for reducing obesity having an amino acid sequence of SEQ ID NO: 33 which is 97.5% identical to the instantly claimed amino acid sequence of SEQ ID NO: 10 and the only difference is a conservative amino acid E to D (see below).
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Result #5 , generated by 12 identical sequences
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Therefore, it would have been prima facie prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a peptide having 97.5% sequence identity as taught by DiMarchi et al (SEQ ID NO: 10 of instant claims 6-7) for reducing body and attach a substituent at position 16 or 17 as taught by Vignati et al wherein the substituent is:
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as taught by claims 1-7 and 14-15 of copending Application No. 18/017,041. It would have been obvious to do so because the peptide taught by DiMarchi et al is almost identical except one conservative amino acid (aspartic acid to glutamic acid). Additionally, one would have been motivated to do so because Vignati et al teach using similar compound for reducing obesity. Therefore, the instantly claimed invention would have been obvious over the combined teachings of the references.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-8, 14-34 are rejected.
It is noted to Applicant that Compound #4-#17 of claim 10 have been searched and they are free of prior art.
Claims 10-11 and 35-36 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674