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 .
Response to Election/Restriction filed on April 25, 2026 is acknowledged.
Claims 4-6 have been cancelled.
Claims 1-3 and 7-10 are pending in this application.
Restriction
5. Applicant’s election without traverse of Group 1 (now claims 1-3 and 7-8) and the election of species wherein W is a single bond, U1 is
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and U2 is
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(Apc) without traverse in the reply filed on April 25, 2026 is acknowledged. The restriction is deemed to be proper and is made FINAL in this office action. Claims 9-10 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claims 1-3 and 7-8 are examined on the merits in this office action.
Priority
6. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in CHINA 202110343062.2 (3/30/2021). A certified copy of the foreign priority document has been filed. However, a certified English translation has not been filed. Until a certified English translation is submitted, the effective filing date is 3/25/2022.
Objections
7. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “A polypeptide compound having a structure shown…salt thereof Experimental results show…” at lines 1-3 of the abstract. There appears to be a period missing from between “salt thereof” and “Experimental results”. Applicant should correct these informalities. See MPEP 608.01(b).
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
8. Claim 1 is objected to for the following: Claim 1 has been amended to recite, for example:
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. The strikethrough did not clearly delete the structures from the claim. Applicant is required to correct the amendment to the claim 1.
Rejections
U.S.C. 112(b)
9. 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.
10. Claims 1-3 and 8 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
11. Claim 1 recites, “A polypeptide compound having a structure represented by formula I
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…W is selected from a single bond, a D-amino acid and an L-amino acid…U2 is a single bond, or is selected from any one of the following structures…” It is unclear how the variables U2 and W can be each a single bond because the variables U2 and W are situated at the C-terminal end of the peptide as indicated in the structure provided
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. There is no attachment points for U2 and W since U2 and/or W is each a single bond. It is unclear how a single bond can form a bond. Therefore, the metes and bounds of the claim is unclear. Because claims 2-3 and 8 depend from indefinite claim 1 without clarifying the point of confusion, claims 2-3 and 8 are also rejected under 35 U.S.C. 112(b).
12. Claim 3 recites, “The polypeptide compound according to claim 1, wherein the W is selected from a single bond and alanine, arginine, asparagine…”It is unclear if the W is “a single bond” or “a single bond and alanine”. Additionally, if W is a single bond, it is unclear how a single bond can form a bond. The metes and bounds of the claim is unclear.
13. Claim 8 recites, “A composition comprising the polypeptide compound according to claim 1, and an acceptable auxiliary agent.” It is unclear what is encompassed within “auxiliary agent”. The instant specification does not clearly define what is an “auxiliary agent”. The specification discloses “…the auxiliary agent includes, but is not limited to, carriers, diluents, excipients or auxiliary agents, among others, which are well known to those skilled in the art.” The metes and bounds of the claim is indefinite. It is unclear what agents are encompassed within “auxiliary agents, among others”.
U.S.C. 103
14. 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.
15. 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.
16. 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.
17. 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.
18. Claims 1-3 and 7-8 is/are rejected under 35 U.S.C. 103 as being obvious over Meng et al (CN 113045625, 3/30/2021, with publication date of 6/29/2021, Google Patent English translation used and enclosed herein) in view of Dong et al (US Patent No. 8871706) as evidenced by DeCroos et al (WO 2015/134567) and Dong et al (WO 2011/115871, filed with IDS).
The applied reference has a common Inventors (Meng, Fu, Li, Liu, Xu, Gao and Li) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
19. Meng et al teach polypeptides as growth hormone secretagogue receptor agonists (see Title). Meng et al teach that the polypeptide compound show higher agonistic activity to GHSR-1a, has a small toxic and side effects (see abstract, for example). Meng et al teach
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(see claim 1). Meng et al teach the general formula
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(see claim 2). Meng et al teach that U1 is selected from:
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(see claim 7). Meng et al teach different compounds having the structures
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(see claim 8, for example). Meng et al teach that a composition comprising the polypeptide, and an acceptable adjuvant, carriers, diluents, excipients, sterile water, saline, buffers and so on (see p. 18, lines 30-34, for example).
The difference between Meng et al and instant claims is that Meng et al does not teach wherein U2 is a single bond, or is selected from any one of the following structures:
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.
20. However, Meng et al teach the modified arginine residue (e.g., arginine has guanidine
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while Meng et al show a compound having a urea modified guanine
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).
21. Further, Dong et al teach vast number of different ghrelin analogs (see for example, Table 1). Dong et al teach, for example,
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. Example #8 has and Example #27, for example, teach the same D-Bal-D-Trp-Phe, but the N-terminal of #8 is H-Inp and the C-terminal of #8 is Lys-NH2; the N-terminal of #27 is H-Inp and the C-terminal of #27 is Apc-NH2. Additionally, Dong et al teach different N-terminal and C-terminal residues/components that make up the different ghrelin analogs. As evidenced by DeCroos et al H-Inp-(D)Bal-(D)Trp-Phe-Apc-NH2 has the structure
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(see for example, FIG. 24).
22. Additionally, Dong et al (WO 2011/115871, filed with IDS) teach different ghrelin analogs
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(see for example, pp. 6-9; Table 1, pp. 13-15; Table 2, pp. 16-18; and claim 3).
23. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Meng et al, Dong et al as evidenced by DeCroos et al, and Dong et al, since all of the references teach analogs of ghrelin. One of ordinary skill in the art would be motivated to combine and try with a reasonable expectation of success, since Dong et al and Dong et al teach different number of analogs substituting at the N-terminal end, the C-terminal end at the residues involved in the core structure with different amino acid residues and amino acid analogs, such as Apc, 2Nal, 1Nal and so on.
It has been held that under KSR that “obvious to try” may be an appropriate test under 103. The Supreme Court stated in KSR, When there is motivation “to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727,_,82 USPQ2d 1385, 1397 (2007).
The skilled artisan would have had reason to try substituting the N-terminal and C-terminal components of ghrelin with the reasonable expectation that at least one would be successful. Dong et al and Dong et al teach different number of ghrelin analogs having substitutions at N-terminal, C-terminal and the residues at the core structure. Thus, substituting the urea component back to the guanine component to arrive at the arginine residue and substituting the N-terminal and/or C-terminal ends with Apc or other amino acid analogs is a “the product not of innovation but of ordinary skill and common sense,” leading to the conclusion that invention is not patentable as it would have been obvious. Therefore, the combined art is prima facie obvious over instant claims 1-3 and 7-8.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE HA/Primary Examiner, Art Unit 1654
6/16/2026
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