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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-6, drawn to a compound of formula (I), a pharmaceutically acceptable salt or a composition thereof, as well as the species compound 1001 (wherein Rx ad Ry are –(C=S)NR7R8, R7 is H, and R8 is phenyl; and R9 is H) in the reply filed on 6/26/2025 is acknowledged. The traversal is on the ground(s) that there is nothing in either WO2016/039749 A1 or WO2007/076055 A2 that suggest the modifications made in the instant application. This is not found persuasive.
WO2016/039749 A1 (‘749) discloses macrocyclic peptides that inhibit interactions between PD-1/PD-L1 and CD80/PD-L1. ‘749 teaches a variety of macrocyclic compounds, including several where Rx or Ry are groups other than “-H” (see, for instance, Examples 6267, 6269, 6276, 6288, 6391), that can be used in methods of treating disease, particularly cancer. Thus, these positions have some degree of flexibility in terms of the identity of the Rx and Ry groups.
WO2007/076055 A2 (‘055) discloses compositions and methods to inhibit PAR receptors that are useful in the treatment of diseases associated with abnormal cellular proliferation, angiogenesis, inflammation, and cancer. ‘055 teaches many compounds capable of targeting PAR receptors composed of aromatic rings such as those recited in the instant claim 1. ‘055 further teaches that the processes by which these chemical changes are made to molecules of interest are well known to those skilled in the fields of medicinal chemistry, drug, discovery, drug development; synthetic methods to assemble the molecules taught are also disclosed by ‘055.
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of ‘749 to incorporate the teachings of ‘055 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to do so as both references are drawn to compounds used to treat cancer. Further, one of ordinary skill in the art would have been motivated to do so as both references are drawn to inhibition of protein-protein interactions as a means to treat cancer and other diseases. Thus, the common technical feature among the instant claims is not a special technical feature as it does not make a contribution over the prior art in view of ‘749 and ‘055.
Additionally, as stated in the restriction requirement, as provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c). In the instant case, the claims are drawn to a product and multiple processes of use of said product. Therefore, in addition to a lack of unity stemming from the lack of a special technical feature that makes a contribution over the prior art, the presence of multiple distinct process claims alone makes the restriction requirement proper based on 37 CRF 1.475 (c).
The requirement is still deemed proper and is therefore made FINAL.
The elected compound 1001, wherein Rx and Ry are both –(C=S)NR7R8, R7 is H and R8 is phenyl; and R9 is H, is free of the art:
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. The closest prior art is WO2020/237081 A1, which discloses compound 1025. The differences between compound 1025 of WO2020/237081 A1 and the elected compound 1001 shown in the boxes below:
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.
WO2020/237081 A1 does not teach the instant compound 1001, nor does it make obvious why Rx and Ry should be -(C=S)NR7R8, wherein R7 is H and R8 is phenyl. Therefore, it is novel and non-obvious. Additionally, the genus of compounds wherein Rx and Ry are
–(C=S)NR7R8 also appear to be free of the art. Accordingly, under Markush practice, the elected species was broadened to include compounds of Formula I wherein Rx ad Ry are –(C=O)NR5R6.
Claim Status
Claims 1-13 are pending under examination. Claims 2, 3, and 7-13 are withdrawn as non-elected species (claims 2 and 3) and inventions (claims 7-13). Claims 6, 7, 8, 10, 12, and 13 are currently amended.
Priority
The instant application is the 371 national stage entry of PCT/US2020/057875, filed 10/29/2020, which claims priority to the provisional application 62/931,995, filed 11/7/2019; 62/930,654, filed 11/5/2019; and 62/927,739, filed 10/30/2019. The priority date of 10/30/2019 is acknowledged.
Information Disclosure Statement
The IDS submitted on 9/14/2023 is being considered.
Specification
The disclosure is objected to because of the following informalities: [0042] lists examples of tricyclic groups but these are bicyclic heterocyclic groups. Appropriate correction is required.
The use of the terms Tween 60, Span 80 (both [0087]) and Tween-20 ([01001]), which are trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 1 is objected to because of the following informalities: on the second page, lines 9-10, the limitation "substituted with 0-4 R.
Claim 1 is further objected to for duplicative commas in the third line from the bottom of page 2, immediately after “heterocyclic group”. Appropriate correction is required.
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.
Claims 1 and 4-6 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 1 recites “R6 is selected from…, wherein R4 is substituted with 0-4 R6a groups;” (see page 2, line 16). R4 defines other potential Rx and Ry groups, wherein the group is
–(C=O)OR4 but not when the group is –(C=O)NR5R6. Consequently, the scope of claim 1 is indefinite. Further, by virtue of their dependency on claim 1, claims 4-6 are hereby rejected for this same reasoning. For purposes of examination, R4 is being interpreted as R6.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 4-6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wang et al. (WO2020/237081 A1, effectively filed 5/21/2019).
The applied reference has a common assignee 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. 102(a)(2) 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) if the same invention is not being claimed; 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 in the reference 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.
Wang teaches macrocyclic peptides that bind to PD-L1 and are capable of inhibiting the interaction of PD-L1 with PD-1 and CD80 (Abstract). Wang teaches the following compound on Pg 85:
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Compound 1048 meets the limitations of claim 1, wherein Rx ad Ry are –(C=O)NR5R6, wherein R5 is H, R6 is a bicyclic heterocyclyl group, wherein R6 is substituted with 1 R6a group; R6a is C1 alkyl and R9 is H, thereby anticipating claims 1, 4, and 5.
Wang further teaches that the compounds described, such as 1048, can be included in pharmaceutical compositions ([0272]), thereby anticipating claim 6.
Conclusion
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658