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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
Files information disclosure statements (IDS) comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Response to Restriction
Applicant's response to restriction requirement and election of group IV corresponding to claims 10-13, without traverse, in the reply filed on 06/26/2026 is acknowledged.
Examiner also acknowledges applicants’ election of SEQ ID NO:1 (HGDGSFSDEMNTILDNLAARDFINWLIQTRITD-GGGGS-K) linked to the fatty acid coupler as a species for the elected group, which reads claims 10-12.
Claims 1-9 and 13-20 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 10-12 are examined, in light of elected species, on merits in this office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The claim recites the word “preferably”, which renders the claims indefinite for the following reasons:
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(d). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "preferable" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance in the definitions for a, b, c and PEG, claim recites the broad recitation, and the claim also recites the narrower statement of the range/limitation.
Claim Rejections - 35 USC § 103
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wen (US2019/0241639A1) in view of Timm (CN 1705681 A), Betts (Bioinformatics for Geneticists. Ch.14, Edited by M.R.Barnes and I.C.Gray, 2003, John Wiley & Sons, Ltd), Trier (PLOS ONE, Oct 2014, vol.9, issue 10, 1-10), Lee (Biochemical Pharmacology, 2018, 151, 59-68) and Suzuki (J.Med.Chem., 2020,63,905-927).
For claim 10:
Wen teaches various GLP-2 sequences in the form of fusion proteins [see 0006-0009], wherein the GLP-2 sequence can be represented by the following sequence:
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[see SEQ ID NO:2]. Wen teaches that a GLP-2 derivative according to the invention can be obtained by N-terminal amino acid substitution, C-terminal amino acid insertion, deletion or peptide modification. The inserted or substituted amino acids may be native L-amino acids or a non-native D-amino acid. [see 0009].
Wen further teaches that GGGGS as a linker sequence at C-terminus of GLP-2 sequences [see 0013, 0027-0028 and Table 1].
Differences between Wen and instant claim(s) are as follows:
(i) Wen silent on Arg at position 30;
(ii) Wen silent on Lys with coupler at C-terminus via amide bond.
With regard to (i) of above, substitutions of amino acids in GLP-2 at various positions are well known in the art. For example, Timm teaches Arg at position 30 and also teaches the following GLP-2 sequence:
His-X2-X3-Gly-X5-Phe-X7-X8-X9-X10-X11-X12-X13-X14-X15 -X16 X17-X18-Ala-Arg-X21-Phe-Ile-X24-Trp-Leu-Ile-X28-Thr-Arg-Ile-Thr-X33,
wherein X2 is Gly, X3 is Asp, X5 is Ser, X7 is Ser, X8 is Asp, X9 is Glu, X10 Met, X11 is Asn, X12 is Thr, X13 is Ile, X14 is Leu, X15 is Asp, X16 is Asn, X17 is Leu, X18 is Ala, X21 is Asp, X24 is Asn, X28 is Gln, X33 is Asp. [See claim 1].
In light of above definitions, the above sequence is identical to applicants elected SEQ ID NO:1.
In addition to above, Betts teaches that Lys can be substituted with Arg [see pages 304-305].
Above suggests that Arg and Lys are exchangeable and are equivalent. Case law holds that the mere substitution of an equivalent (something equal in value or meaning, as taught by analogous prior art) is not an act of invention; where equivalency is known to the prior art, the substitution of one equivalent for another is not patentable. See In re Ruff 118 USPQ 343 (CCPA 1958).
With regard to (ii) of above, Lys linked to a coupler is nothing but acylation of Lys, which is well established in the art for GLP sequences, because of its advantages in stabilizing the protein and also it increases half-life of GLP etc., as evidenced from the following art:
Trier teaches acylation of Lys on GLP-2 via a amide bond [see Fig.2] and also teaches advantages of acylation [see abstract and its corresponding text in the document].
Therefore, a skilled person in the art would be motivated to incorporate Lys the sequence, specifically at C-terminus, since terminal amino acids are flexible in nature. Such modifications are known in the art. For example, Lee teaches incorporation of Lys with fatty acid at C-terminus shows superior properties [see abstract, Fig.2, and Table 2].
For claim 11:
Both Trier [see Fig.2] and Lee [see Fig.2 and Table 2] teach fatty acid couplers.
For claim 12:
Claimed fatty acid and linkers are known in the analogous art. For example, Suzuki teaches applicants claimed fatty acid and liker, on Lys side chain in Tirzepatide [see Fig.5].
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components, such as GLP-2 sequence, chemical modifications, coupler and linkers etc., were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed product with a reasonable expectation of success.
A combination of prior art references is only proper if a person of ordinary skill in the art (POSA) at the time of the invention, faced with the same problem, would have been motivated to combine their teachings with a reasonable expectation of success. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Here, the technical fields and problems addressed by the references are not distinct from that of the present invention.
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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