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 .
Please DO NOT ENTER the amendment filed on January 5, 2026.
Response to Election/Restriction filed on March 12, 2026 is acknowledged.
Claims 1-34 have been cancelled.
New claims 35-52 have been added.
Claims 35-52 are pending in this application.
Restriction
Applicant’s election without traverse of Group 10 (claims 28 and 32, now new claims 35 and 51) and election without traverse of SEQ ID NO: 133 as the species of a single disclosed species of a fully defined peptide sequence and
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in the reply filed on March 12, 2026 is acknowledged. Restriction is deemed to be proper and is made FINAL in this office action. Claims 36, 49-50 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Because spacer is optional, claims 39-40 and 43-44, drawn to a spacer is hereby withdrawn. Claims 35, 37-38, 41-42, 45-48 and 51-52 are examined on the merits in this office action.
Please note: Applicant indicates the following:
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. Instant SEQ ID NO: 133 is NOT a species of SEQ ID NO: 16. Instant SEQ ID NO: 133 is broader than instant SEQ ID NO: 16. Instant SEQ ID NO: 16 is a defined peptide sequence; instant SEQ ID NO: 133 has multiple variables that encompasses instant SEQ ID NO: 16. Thus, instant SEQ ID NO: 16 is a species of instant SEQ ID NO: 133.
Thus, SEQ ID NO: 16 was searched as a species and examined on the merits in this office action.
Objections
The drawings are objected to because some figures have shadings that make the figures hard to see (see for example, Fig. 1). Additionally, some figures are missing the X and/or Y axis labels (see for example, Fig. 2B, 7C, 7D, 9A-9F, 10, etc.). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The abstract is objected to for the following minor informality:
The abstract recites, “A novel…compositions comprising the novel parathyroid hormone…” Applicant is recommended to remove the term “novel” from the abstract. For example, the abstract is recommended to recite, “A parathyroid hormone derivative is provided that has an extended…Compositions comprising the parathyroid hormone derivative conjugate…”
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.
Rejections
35 U.S.C. 112(b)
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.
Claims 35, 38, 41-42, 45 and 51 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.
Claim 35 recites the following:
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. The metes and bounds of the claim is unclear. It is unclear what the variables X35, X53, X12, X16, X17 are referring to. Claim 35 recites SEQ ID NO: 16 which is:
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. The sequence of SEQ ID NO: 16 only has one variable: X33. Therefore, it is unclear what the variables X35, X53, X12, X16, X17 are referring to. Because claims 38, 41-42, 45 and 51 depend from indefinite claim 35 without clarifying the point of confusion, claims 38, 41-42, 45 and 51 are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
35 U.S.C. 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 37 and 46-48 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 37 recites:
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. Claim 37 depends from claim 35. Claim 35 recites:
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. Instant SEQ ID NOs: 7 and 12 are broader than the instant SEQ ID NO: 16.
Claim 46 recites:
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. Claim 46 depends from claim 35. Claim 35 recites:
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. Instant SEQ ID NO: 12 is broader than the instant SEQ ID NO: 16. Claims 47-48 depend from claim 46 and these claims are also rejected under 35 U.S.C. 112(d).
U.S.C. 103
17. 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.
18. 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.
19. 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.
20. 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.
21. Claim(s) 35, 37-38, 41-42, 45-48 and 51-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horten-Andersen et al (WO 2018060310), as evidenced by Lau et al (WO 2005027978) in view of De Thesis (Indiana University, Department of Chemistry, 2007, pp. 1-137).
22. Horten-Andersen et al teach the peptide of instant SEQ ID NO: 16 (see SEQ ID NO: 53:
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). Horten-Andersen et al teach a pharmaceutical composition comprising the peptides for use in treating, controlling or preventing condition that can be treated, controlled, delayed or prevented with PTH chosen from hypoparathyroidism, hyperphosphatemia…(see throughout the reference, for example, pp. 1-4). Horten-Andersen et al teach fatty acid derivatives and refers to WO 2005027978 (see p. 81, for example). As evidenced by Lau et al, the fatty acids include C16-C30 fatty acids (see pp. 12-15, for example). Lau et al teach GLP-1 peptide analogs with fatty acid derivatives. Horten-Andersen et al further teach conjugates, for example, conjugated to functional group of the side chain of amino acids (see for example, pp. 51-77).
The difference between the reference and the instant claims is that the reference does not teach the dipeptide of
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23. However, De thesis teaches the dipeptide of
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(see pp. 42-43, 48, 54, for example). De thesis teaches the conjugation of the dipeptide to GLP-1 like peptides/insulin analogs. De thesis teaches the design of peptide-based prodrug chemistry and its application to glucagon-like peptide I (Title). De thesis teaches that a prodrug should extend and improve the pharmacodynamics of the peptide hormone (see p. vi). De thesis teaches that dipeptides were covalently attached to the N-terminus of GLP (see p. 41). De thesis teaches that dipeptide extensions of peptides were designed to sterically assist the cleavage of the amide bond (see p. 46).
24. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Horten-Andersen et al, as evidenced by Lau et and De thesis because all references teach hormone peptide conjugates (e.g., PTH, insulin, GLP-1) that extends the life of the peptides. One of ordinary skill in the art would be motivated to combine with a reasonable expectation of success, since Horten-Andersen et al teach the PTH analog that has been modified with fatty acids and conjugation at the N-terminal end of the PTH, Lau et al teach the fatty acids that were used in the Horten-Andersen et al PTH analogs, and De thesis teaches that adding the dipeptide at the N-terminal end of the hormone peptides (such as insulin and GLP-1), the dipeptides extended and improved the pharmacodynamics of the peptide hormones, and that the attachment to the N-terminus of GLP sterically assisted in the cleavage of the amide bond. One of ordinary skill in the art would reasonably expect the same effect by combining the teachings of Horten-Andersen et al as evidenced by Lau et al, and De thesis. Therefore, the combined art is prima facie obvious over instant claims 35, 37-38, 41-42, 45-48 and 51-52.
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
5/26/2026
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