Prosecution Insights
Last updated: October 04, 2026
Application No. 18/664,812

COMPOSITION COMPRISING PPAR-MODULATOR AND AN UROLITHIN DERIVATIVE AND USES THEREOF

Final Rejection §102§103§112
Filed
May 15, 2024
Priority
May 06, 2021 — EU 21305586.6 +2 more
Examiner
BURKETT, DANIEL JOHN
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
INSERM
OA Round
2 (Final)
63%
Grant Probability
Moderate
3-4
OA Rounds
11m
Est. Remaining
96%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allowance Rate
62 granted / 99 resolved
+2.6% vs TC avg
Strong +33% interview lift
Without
With
+33.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
64 currently pending
Career history
138
Total Applications
across all art units

Statute-Specific Performance

§101
3.0%
-37.0% vs TC avg
§103
18.6%
-21.4% vs TC avg
§102
21.1%
-18.9% vs TC avg
§112
42.0%
+2.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 99 resolved cases

Office Action

§102 §103 §112
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 . Status of Claims Claims 1-9 are pending in the instant application. Withdrawn Objections/Rejections Applicant’s amendment is sufficient to overcome the rejection of Claims 1-4 under 35 U.S.C. 112(b). This rejection is hereby withdrawn. Applicant’s amendment is sufficient to overcome the rejection of Claims 1-2 under 35 U.S.C. 102(a)(1). This rejection is hereby withdrawn. Applicant’s amendment is sufficient to overcome the rejection of Claims 3-4 under 35 U.S.C. 103. This rejection is hereby withdrawn. Claim Objections Claims 2 and 5-6 are objected to because of the following informalities: Claim 2 recites the variables “R1”, “R2”, and “R3”. For consistency with Claim 1, from which Claim 2 depends, these variables should be presented as “R1”, “R2”, and “R3”. Claims 5-6 are drawn to a medicament. It is unclear whether the recited “medicament” is intended to be a compound, a composition, or a complex composition. Clarification is required. Appropriate correction is required. Claim Rejections - 35 USC § 112 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. The rejection of Claim 6 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 is maintained. Applicant has traversed this rejection in view of the amendment on the basis that the amended claim limitations remove the structural variability allowing for compounds that are not urolithin A. While the examiner acknowledges that this is true, Claim 6 still fails to further limit Claim 5, from which it depends. Claim 5 is drawn to a medicament comprising urolithin A. Urolithin A is a single compound. The structure of urolithin A is provided at Page 7 of the instant specification: PNG media_image1.png 149 201 media_image1.png Greyscale Therefore, by definition, urolithin A is a compound of Formula I wherein R1 and R2 are OH and R3 is H. Claim 6 fails to further limit Claim 5, as it merely recites the structure of urolithin A without introducing an additional limitation to the medicament. 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 Rejections - 35 USC § 103 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. The rejection of Claims 5-6 under 35 U.S.C. 103 as being unpatentable over Auwerx et. al. (WO 2018/108991 A2; cited on Applicant’s Information Disclosure Statement filed May 15th, 2024; cited in non-final rejection mailed May 14th, 2026; hereinafter referred to as Auwerx) is maintained. Regarding Claims 5-6, Claim 5 is drawn to a medicament comprising a PPAR-modulator that is bezafibrate, fenofibrate, or a combination thereof, urolithin A, and a pharmaceutically acceptably excipient. Applicant has traversed this rejection on the basis that Auwerx’s disclosure of individual compounds does not obviate the claimed medicament, as Auwerx teaches conventional formulation of an active ingredient, but not a formulation comprising urolithin A and a PPAR-modulator co-located in a single medicament. Further, the Applicant states that the “same purpose” rationale oversimplifies the teachings of Auwerx and the claimed invention, as Auwerx categorizes urolithin A and PPAR-modulators separately. The Examiner does not find these arguments persuasive. Applicant distinguishes the mechanisms by which urolithin A and the PPAR-modulators bezafibrate and fenofibrate enhance mitochondrial proteostasis. With respect to Claims 5-6, this is moot, as despite distinct mechanisms of action, Uorlithin A, bezafibrate, and fenofibrate are recognized in the prior art by Auwerx as enhancing mitochondrial proteostasis. Therefore, a person having ordinary skill in the art would have found it prima facie obvious to formulate a medicament comprising urolithin A and a PPAR-modulator that is bezafibrate or fenofibrate, due to the recognition in the art that each of these compounds are useful for the same purpose. As the instant Claims 5-6 are drawn to a medicament, this motivation is sufficient to direct a person having ordinary skill in the art to formulate the instantly claimed medicament, as per MPEP 2144.06, I., “”It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…. [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F. 2d 846, 850, 205 USPQ 1068, 1072 (CCPA 1980)”. Regarding Applicant’s statement that the “same purpose” rationale is erroneous, regarding instant Claims 5-6, Applicant’s arguments are moot, as the claims are drawn to a medicament, not a method of use thereof. Therefore, the common function of the compounds, i.e. enhancing mitochondrial proteostasis, as established by Auwerx sufficiently motivates a person having ordinary skil in the art to combine the aforementioned compounds in a single medicament. 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. The provisional rejection of Claims 1-6 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of copending Application No. 18/559,020 (reference application) is maintained and extended to newly presented Claims 7-9. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and reference claims are drawn to an overlapping pharmaceutical composition with a common use. In the remarks received August 7th, 2026, Applicant acknowledges this rejection, and states, “At this time no terminal disclaimer will be filed. However, Applicant will file a terminal dislciamer upon allowance of any of claims 1-6 of this application or claims 1-5 of co-pending Application No. 18/559,020.” To this end, the rejection is maintained. For clarity of the record, the grounds of this rejection are revisited below: Instant Claims 1-4 and 7-9 differ from the reference application in that the reference application is drawn to a pharmaceutical composition whereas the instant claims are drawn to a method comprising administration of a composition. Both the instantly claimed method and the reference claims are drawn to a composition comprising a PPAR-modulator and a compound of formula I wherein formula I is urolithin A and wherein the PPAR-modulator is bezafibrate or fenofibrate. While the reference claims are drawn to the composition itself and not a method, beginning at Page 18 of the reference application’s specification teaches several examples in which the claimed composition is administered as instantly claimed. Introduction of matter disclosure in the reference application’s specification is proper here, as per MPEP 804, II., B., 1., “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.” Regarding instant Claims 5-6, a medicament comprising a PPAR-modulator that is bezafibrate, fenofibrate, or a combination thereof, urolithin A, and a pharmaceutically acceptable excipient reads on the reference claims 1-5, drawn to a pharmaceutical composition comprising a PPAR-modulator that is bezafibrate or fenofibrate, urolithin A, and a pharmaceutically acceptable excipient. While the instant claims are drawn to a medicament rather than a pharmaceutical composition, as, in view of the reference application’s specification as described above, the reference application’s claims to a pharmaceutical composition are intended to be employed as a medicament. Therefore the reference application’s Claims 1-5 read on instant Claims 5-6. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The following rejections are necessitated by amendment 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 1-2, and 7-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for treating Costello syndrome, Barth syndrome, and Noonan syndrome wherein the compound of Formula I is urolithin A, does not reasonably provide enablement for a method of treating or preventing any cardiac disease or for treatment when the compound of Formula I is not urolithin A. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. Nature of the invention: The invention is drawn to a method of treating and/or preventing cardiac disease comprising administering a composition comprising a PPAR-modulator and a compound of formula I. Breadth of the invention: The scope of the claimed invention is very broad, as it is drawn to the treatment or prevention of any cardiac disease. This includes a number of distinct diseases with mutually exclusive etiologies. State of the prior art and predictability in the art: With respect to the treatment of cardiac disease, Flora et. al., (“A Brief Review of Cardiovascular Diseases, Associated Risk Factors and Current Treatment Regimes”, Current Pharmaceutical Design, 2019; hereinafter referred to as Flora) represents the state of the prior art. At Page 4063, First Paragraph of First Column, Flora teaches cardiovascular diseases are “a cluster of disorders that are associated with the heart, the vasculature of the brain, or blood vessels, and predominantly includes coronary and ischemic heart disease, deep vein or arterial thrombosis, and cerebrovascular disease.” With respect to treatment of cardiac disease, at Page 4067, Fifth Paragraph of Second Column, Flora teaches treatment of cardiac disease “does not offer a complete cure from the cardiovascular conditions. Its effectiveness is limited to an extent, which only prevents or reduces any further progression of an already persisting condition.” At Page 4076, First Paragraph of Second Column, Flora states “While maintaining a healthy lifestyle is the key to prevent the onset of CVDs, its progression can be greatly reduced by an early diagnosis, which also determines the extent of success of the treatment.” Taken together, Flora teaches the treatment of cardiac disease is unpredictable. Moreover, prevention via pharmaceutical intervention is not supported by the prior art. The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F. 2d 833, 839, 166, USPQ 18, 24 (CCPA 1970). In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F. 2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F. 2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F. 2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657. Level of ordinary skill in the art: An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems. The amount of direction provided and working examples: Several examples describing the effects of treatment of the claimed method are disclosed beginning at Page 23 of the instant specification. Example 1 demonstrates a zebrafish model of Costello syndrome, in which the zebrafish were administered bezafibrate and/or urolithin A. The combination treatment resulted in increased embryo survival and reduced the numbers of animals presenting with genetic developmental defects. Example 2 demonstrates mitochondrial proteostasis stimulation in zebrafish treated with a combination of bezafibrate and urolithin A. Example 3 demonstrates the effects of administering the combination of bezafibrate and urolithin A to whole zebrafish animals as a model of Costello syndrome. Example 4 demonstrates treatment of the administration of the combination of bezafibrate and urolithin A in treating Barth syndrome. Example 5 demonstrates the efficacy of treatment of Costello syndrome in a mouse model by administering a combination of urlothin A and bezafibrate. Example 7 demonstrates the efficacy of treatment of a Noonan syndrome model in zebrafish with the urolithin A and bezafibrate combination. No examples have been provided in which a compound of formula I that is not urolithin A have been administered, nor are there any examples demonstrating prevention of a cardiac disease, or any examples in which a disease other than Costello syndrome, Barth syndrome, or Noonan syndrome has been treated. These limited examples are insufficient to enable the breadth of the scope instantly recited. Quantity of experimentation needed to use the invention based on the content of the disclosure: The quantity of experimentation needed is undue experimentation. As referenced above, the examples instantly disclosed are drawn to the treatment of Costello syndrome, Barth syndrome, and/or Noonan syndrome. No examples have been provided in which a compound of Formula I other than urolithin A has been administered. Therefore, the practice of the instantly claimed invention would require a person having ordinary skill in the art not only to identify and/or develop methods to determine the effect of administering a combination of compound of Formula I with a PPAR-modulator for the prevention and/or treatment of cardiac diseases other than those mentioned, but also to employ these methods, with no assurance of success. Genentech Inc. v Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”. Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person having ordinary skill in the art would have to engage in undue experimentation to practice the full scope of the claimed invention as noted above. Claims 3-4 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. The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1977); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQD at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398. Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F. 2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of a certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found to not have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below. In the instant case, Claims 3-4 are drawn to methods of administering a composition to a subject “at risk of developing a cardiac disease with contributing mitochondrial dysfunction”. No disclosure is provided in the instant specification describing a subject at risk of developing a cardiac disease with contributing mitochondrial dysfunction. In fact, the instant specification is silent with respect to a subject at risk of developing a cardiac disease with mitochondrial dysfunction. Because of this, Applicant has failed to provide sufficient written description to support this limitation in Claims 3-4. Claim Rejections - 35 USC § 103 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claims 1-2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Auwerx et. al. (WO 2018/108991 A2; cited on Applicant’s Information Disclosure Statement filed May 15th, 2024; cited in non-final rejection mailed May 14th, 2026; hereinafter referred to as Auwerx). Applicant traversed the previous rejection of Claims 1-2 under 35 U.S.C. 102(a)(1) on the basis that Auwerx does not disclose administering a pharmaceutical composition comprising both a PPAR-modulator and a compound of formula I for treating or preventing a cardiac disease. Additionally, Applicant notes that Auwerx discloses urolithin A in a list of mitophagy-inducing compounds and bezafibrate in a list of lipid-metabolism modulators. Applicant also notes the definition provided in the specification for a cardiac disease with contributing mitochondrial dysfunction. Finally, Applicant states that “Auwerx does not provide a reasoned direction to select a compound of formula I, such as urolithin A, from one functional category and combine with a PPAR-modulator, such as a fibrate, from a separate category for treatment or prevention of cardiac disease.” The examiner does not find this argument persuasive. First, the definition of “cardiac disease with contributing mitochondrial dysfunction” is moot with respect to Claim 1, as Claim 1 is drawn more broadly to the treatment and/or prevention of a cardiac disease. At Page 17, Paragraph 0063, Auwerx teaches compounds that enhance mitochondrial proteostasis can be compounds that induce mitophagy, including urolithin A and urolithin B. As noted at instant Claim 2, urolithin A is a compound of Formula I as instantly recited. At Page 17, Paragraph 0064, Auwerx teaches compounds that enhance mitochondrial proteostasis can be compounds that modulate lipid metabolism, including bezafibrate. At Claim 1, Auwerx teaches a method of treating an amyloid-β peptide disease in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a compound that enhances mitochondrial proteostasis. At Claim 2, Auwerx teaches the compound induces mitochondrial unfolded protein response, mitochondrial biogenesis, or mitophagy. Claim 15 is drawn to the administration of urolithin A to practice the method. At Claim 17, Auwerx teaches administering bezafibrate to practice the method. At Claim 28, Auwerx teaches the amyloid-β peptide disease can be an amyloid heart disease. Treating an amyloid heart disease reads on the broadly recited limitation of treating a cardiac disease. Taken together, Auwerx teaches that both urolithin A and bezafibrate are useful to be administered for treatment of an amyloid heart disease. Per MPEP 2144.06, “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).” Taken together, this results in the practice of Claims 1-2 and 9 with reasonable expectation of success. Conclusion Claims 1-9 are rejected. No claim is allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday. 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, Jeffrey Murray can be reached at (571) 272-9023. 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. /D.J.B./ Examiner, Art Unit 1624 /BRENDA L COLEMAN/ Primary Examiner, Art Unit 1624
Read full office action

Prosecution Timeline

May 15, 2024
Application Filed
May 14, 2026
Non-Final Rejection mailed — §102, §103, §112
Aug 07, 2026
Response Filed
Aug 27, 2026
Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
63%
Grant Probability
96%
With Interview (+33.2%)
3y 4m (~11m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 99 resolved cases by this examiner. Grant probability derived from career allowance rate.

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