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
Filed 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 election of species without traverse in the reply filed on 05/29/2026 is acknowledged.
The examiner also acknowledges applicants election of the following species:
A process of preparing compound 26, comprising reaction of Ac-[1-7]-OH-cyclic with H-[8- 13]-NH2.
Claims 27 and 31 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The claims are 1-2, 8-9, 15-16, 18, 24-27, 29, 31, 55-57, 66, 69-71, 77 and 131 are examined on merits in this office action.
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 1-2, 8-9, 15-16, 18, 24-27, 29, 31, 55-57, 66, 69-71, 77 and 131 are rejected under 35 U.S.C. 103 as being unpatentable over Brunner (US2010/0249370A1) in view of Champion (Adrenomedullin, 1998, 103-126. Editor(s): Martinez, Alfredo; Cuttitta, Frank. IOS Press: Amsterdam, Neth., CODEN: 65WDAQ), Galeotti (CA2954411A1) and Sun (WO2021/146441A1).
For claims 1-2:
Brunner teaches a method of preparing monocyclic peptide [see formula (I) in page 1] comprising coupling a monocyclic peptide fragment [see formula (V) in page 1] with a linear chain peptide [see unprotected at N-terminus of formula (IV) in page 1], wherein the method is performed in solution [see claims 1-21].
Difference is that Brunner is silent on exemplifying their method to make applicants elected product from their corresponding elected reactants.
The above deficiency can be cured or explained based on the following case law and cited art below:
The use of analogous reactants in a known process is prima facie obvious. In re Durden, 226 USPQ 359 (1985). Once the general reaction has been shown to be old, the burden is on Applicants to present reasons or authority for believing that a group on the starting material would take part in or affect the basic reaction and thus alter the nature of the product or the operability of the process. In looking at the instant claimed process as a whole, as stated in In re Ochiai, 37 USPQ 2d 1127 (1995), the claimed process would have been suggested to one skilled in the art.
In this case, both applicants and the reactants of Brunner are peptides or having backbone of peptide bonds, and are interpreted as analogous reactants.
Further, Champion teaches the following monocyclic peptide fragment:
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The backbone or core structure of above is identical to applicants monocyclic peptide fragment.
With regard to applicants linear chain peptide fragment, Galeotti teaches the following peptide:
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[see attached abstract from STN search].
The backbone or core structure of above is identical to applicants monocyclic peptide fragment.
Applicants product, elected compound 26, is known in the art. For example, Sun teaches a compound [see SEQ ID NO:104 in page 91], which is identical to applicants elected compound 26.
So, applicants product is known, and fragment condensation of monocyclic peptide fragment with linear peptide fragment is also known. In addition, structurally similar reactants with identical backbone to the peptide of applicants reactant peptides are also known. Therefore, it is obvious to make applicants monocyclic peptide from their corresponding reactants, regardless whether reactants are known or not, because the criticality is in the coupling reaction, with a reasonable expectation of success, in light of guidance from the prior art on fragment coupling in peptide synthesis.
For claims 8-9:
Above cited art, both Brunner and Champion, teach a monocyclic peptide fragment, wherein the ring is cyclized through a side chains of two amino acids, wherein the bond is disulfide bond.
For claim 15:
Both Brunner and Galeotti teach linear peptide having no branches.
For claim 16:
Both Brunner and Champion, teach a monocyclic peptide fragment comprises a ring which is appended by at least one peptide chain containing at least one amino acid.
For claim 18:
In examine 1, Brunner teaches cyclizing a linear peptide fragment to form a monocyclic peptide fragment.
For claims 24-26, 29, 55-57:
In examine 1, Brunner teaches cyclizing a linear peptide fragment to form a monocyclic peptide fragment.
Champion and Galeotti teach reactant peptides having same backbone or core structure of applicants reactants.
Cited art also teaches possible protecting groups.
Though cited art does not teach applicants identical reactant peptide fragments, but as explained under For claims 1-2 above, the criticality is not in the reactants, absent evidence to the contrary.
For claim 66:
Deprotecting is a common practice in the art. For example, Brunner teaches deprotecting the final product [see 0011].
For claim 69:
See For claims 24-26, 29, 55-57 above.
For claims 70-71:
In examine 1, Brunner teaches cyclizing a linear peptide fragment to form a monocyclic peptide fragment.
Deprotecting is a common practice in the art. See the cited art.
For claim 77:
Recited limitation is nothing but fragment coupling, which is common practice in the art. See 0007-0009 in the teachings of Brunner.
For claim 131:
Yield depends on many reaction conditions. In absence of limitations in the claim(s), such as solvent and temperature etc., this limitation is expected.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, fragment coupling, applicants product, structurally similar reactants 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.
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 method 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 claimed 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.
Nonstatutory Double Patenting Rejection
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.
Claims 1-2, 8-9, 15-16, 18, 24-27, 29, 31, 55-57, 66, 69-71, 77 and 131 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US copending patent application number 18/579,062.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a method for preparing monocyclic peptide or a salt thereof, comprising coupling a monocyclic peptide fragment with a linear chain peptide fragment, wherein the monocyclic peptide fragment is a peptide containing between 4 and 11 amino acid residues; wherein the monocyclic peptide fragment comprises a ring containing between 4 and 8 amino acid residues;wherein the linear chain peptide fragment is a peptide containing between 4 and 10 amino acid residues; and wherein an amide bond is formed between the monocyclic peptide fragment and the linear chain peptide fragment.
The claims of copending application are drawn to a product, which is monocyclic peptide [see dependent claims for the species].
So, the product is common in both cases.
First, product is not distinct from its process of making, and so these are not separable. Second, the specification of copending application disclosed its preparative methods.
Further MPEP 804 states the following:
The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Accordingly, the claims are obvious over the claims of copending application. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not been patented yet.
Conclusion
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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