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 .
DETAILED ACTION
This office action is in response to applicant’s reply filed on April 27, 2026.
Restrictions/Elections.
Applicant's election with traverse of Group I (Claims 43-52) in the reply filed on April 27, 2026, is acknowledged.
The traversal is on the ground(s) that:
“It is stated in 37 CFR § 1.475(b) that "[a]n international or 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" as set forth in sections (1)-(5). Based on a review of claims 43-58 for Groups I-VII, it is apparent that the claims are indeed "drawn only to one of the following combinations of categories" as set forth in 37 CFR § 1.475(b)(1)-(5). In particular, the
claims are drawn only to 37 CFR § 1.475(b)(2), which is directed to "[a] product and a process of use of said product.".
This is not found persuasive because:
The inventions listed as Groups I through VII do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: The inventions are drawn to multiple methods and multiple products, therefore as per 37 CFR § 1.475(a)-(d), applications containing claims drawn to more than one categories of invention (as defined by section (b)) are not considered to have unity of invention (see particularly section (c)).
The requirement is still deemed proper and is therefore made FINAL.
Applicant further election of the compound TP-7-01:
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is also acknowledged.
Status of Claims
Claims 43-58 are currently pending and are the subject of this office action.
Claims 53-58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on April 27, 2026.
Claims 43-52 are presently under examination.
Priority
The present application is a 371 of PCT/US2021/028357 filed on 04/21/2021 which claims priority to provisional application No. 63/012,981 filed on 04/21/2020.
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 43-52 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.
1) Claim 43 recites:
“a renin-angiotensin system (RAS) modulator including pirfenidone (PFD) linked to a first antioxidant including tempol”.
First, pirfenidone (PFD) is not a renin-angiotensin system (RAS) modulator, as such RAS cannot include pirfenidone, much less pirfenidone linked to tempol.
Second, how is the RAS or PFD “linked” to “a first antioxidant including tempol”? Even though the term link or linker is commonly used when describing organic molecules, Applicant has not provided any restrictions to the term “linker” in which case it can be any molecule or group of atoms that links the RAS or PDF to a first antioxidant including tempol. Further, the specification does not provide any example of what constitutes a linker.
Third, what is encompassed by “first antioxidant, besides tempol? Neither the claims nor the specification provides any guidance regarding what is encompassed by a “first antioxidant”.
2) Claim 44 recites:
“The pharmaceutical composition of claim 43, wherein the renin- angiotensin system (RAS) modulator further includes at least one of an angiotensin receptor blocker (ARB), angiotensin (1-7), an HMG-CoA reductase inhibitor, or an angiotensin- converting-enzyme (ACE) inhibitor.”
The use of the word further is confusing, since RAS modulators already comprise ARBs, angiotensin (1-7), HMG-CoA reductase inhibitor and ACE inhibitors.
3) throughout the claims, Applicant recites the words “comprising” and “including” instead of “consisting of”, which means that the molecules can encompass anything else besides a RAS modulator a linker and tempol.
4) Claim 48 recites “the second antioxidant” without exemplifying, neither in the claims nor in the specification, what a “second antioxidant” encompasses.
5) Claim 49 recites:
“The pharmaceutical composition of claim 48, wherein the renin-angiotensin system modulator includes the pirfenidone linked to the first antioxidant and the angiotensin receptor blocker linked to the second antioxidant.”
Same as before, how can a RAS modulator include “pirfenidone linked to a first antioxidant”? RAS modulators do not comprise antioxidants. RAS modulators can include ARBs, HMG-CoA reductase inhibitors, ACE inhibitors, etc., but do not encompass antioxidants. And again, what is encompassed by first antioxidant and by second antioxidant?
Similar issues with claims 50-52.
From all the above, it is difficult to understand what exactly is being claimed:
1- is it a composition comprising a molecule consisting of pirfenidone linked to an antioxidant, wherein the antioxidant is tempol?
2- does the composition also comprise a RAS modulator linked to an antioxidant?
3- what else do these molecules “comprise”?
The metes and bounds of the claims are not clearly identified.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 43-52 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claims 43-52 encompass pharmaceutical compositions comprising RAS modulators or pirfenidone linked to an antioxidant which comprises tempol (see 112 (b) above.
M.P.E.P. #2163 states: “An applicant shows possession of the claimed invention by describing the claimed invention with all its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention….one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process”.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the Federal Circuit stated that “the hallmark of written description is disclosure.” A specification adequately describes an invention when it “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. at 1351. “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbott Labs, 636 F.3d 1341, 1348 (Fed. Cir. 2011).
The description requirement of the patent statute requires a description of an actual invention, not merely an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984) (holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate’). This matter is of particular importance in the evaluation of claims drawn to a chemical genus which identifies a core compound bearing variable substituents. It has been held that “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification...demonstrates that the applicant has invented species sufficient to support a claim to a genus” with such breadth. Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2D 1161, 1171 (Fed. Cir. 2010). An adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties of species falling within the genus sufficient to distinguish the genus from other materials. Id., quoting Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997).
However, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. Ariad, 94 USPQ2D at 1171. 35 U.S. C. 112, first paragraph, requires a description of the invention that “clearly allow[s] persons of ordinary skill in the art to recognize that the inventor invented what is claimed.” Ariad at 1172, quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (1562-63) (Fed. Cir. 1991) (emphasis added). A sufficient disclosure is one which reasonably conveys to one having ordinary skill in the art that the inventor had possession of the claimed subject matter as of the filing date of the application in question. Vas-Cath, 935 F.2d at 1563. The description must reasonably describe the invention, not simply indicate a result which one might achieve if one actually made the invention. Eli Lilly, 119 F.3d at 1568. To properly evaluate whether an applicant has complied with the written description requirement therefore requires an analysis of whether the skilled artisan would recognize, from the description provided, the applicants were in possession of sufficient compounds representing the full breadth of diversity of the genus claimed.
A description of a chemical genus will usually comprise a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the members of the genus, which features constitute substantial portion of the genus. See Univ. of California vs. Eli Lilly, 43 USPQ 2d 1398, 1406 (Fed. Cir. 1997). This is analogous to enablement of a genus under section 112 first, by showing enablement of a representative number of species within the genus. A chemical genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus.
Here, applicants have claimed an extraordinarily large genus of chemical compounds encompassed by the instant claims. First, there is no definition or limitation to the word “linker”, which in its broadest interpretation can comprise any conceivable arrangement of atoms and molecules. Second, even if one assumes that the claimed molecules consist of a RAS modulator linked to tempol and/or pirfenidone linked to tempol, how are these molecules being linked? For example, if one takes telmisartan and tempol, which part of the telmisartan molecule is the linker attached to? Is it the carboxylic acid, or to one of the benzene rings, or to one of the Nitrogen atoms?
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Further, since these molecules include (i.e. comprise) a RAS modulator or pirfenidone linked to an antioxidant which includes (i.e. comprises) tempol, and since the word “comprising” or “including” do not exclude other components, essentially any other structure can be part of the molecules claimed.
Finally, there are no examples of “first antioxidant” and “second antioxidant”
In summary, when considering the enormous variety of linkers known, the variety of antioxidants, the different points of attachments between the so-called linkers and the RAS modulators, and due to the use of the word including, which essentially does not exclude any other structure to be part of the claimed molecules, the number of possible molecules claimed is enormous.
In contrast, the specification discloses only 5 molecules that consist of a RAS modulator linked to tempol: TP-1-01, TP-2-01, TP-3-01, TP-4-01 and YK-4-250, and one molecule consisting of pirfenidone linked to tempol: TP-7-01. The only linkers are either -O- or -COO-, and the only antioxidant is tempol. This small set of compounds cannot be viewed as being reasonably representative of the genus of compounds in its claimed scope because no readily apparent combination of identifying characteristics is provided, other than the disclosure of those specific species as examples of the claimed genus, and in no way either represent the breadth of variable moieties which applicants have claimed, nor permit the skilled artisan to recognize that such claim breadth was actually in the applicants possession as of the time of filing the instant application.
Given the broad scope of the claimed subject matter, Applicant has not provided sufficient written description that would allow the skilled in the art to recognize that Applicant was in possession of most the compounds claimed.
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.
NOTE: for prior art purposes, it is going to be assumed that claims 43-45 encompass a RAS modulator linked to tempol (see 112 (b) above).
Claim(s) 43-45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown et. al. (US 2012/0196896).
For claims 43-45, Brown teaches the following compound:
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which consists of telmisartan (an ARB) linked to tempol.
Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1) Claims 43-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,311,526. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘526 patent claims methods of treatment comprising the administration of compounds identical or similar to what is claimed in instant claims 43-45.
2) Claims 43-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9,233,949. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘949 patent claims compounds identical or similar to what is claimed in instant claims 43-45.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
May 12, 2026.
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