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 . 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.
Priority
The instant application is a 371 of PCT/US21/40102 filed on 07/01/2021, which claims domestic benefit to US provisional application no. 63/046,889 filed on 07/01/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/17/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
The claim amendments and remarks filed on 10/17/2025 is acknowledged. Claims 33, 40-42, and 45-50 are amended. Claims 1-32, 38, and 51-54 are cancelled.
Accordingly, claims 33-37 and 39-50 are pending and being examined on the merits herein.
Withdrawn Rejections
The 35 USC 112(b) rejection over claims 40-42 are withdrawn in view of amended claims 40-42 now reciting “NMN” in place of “active agent”.
The 35 USC 102 rejection over Parikh for claims 33, 36-37, and 43-50 are withdrawn in view of the newly added limitation “by injection” in claim 33, which has narrowed the scope of the claims.
The 35 USC 103 rejection over Parikh in view of Kristian for claim 39 is withdrawn in view of the newly added limitation “by injection” in claim 33, which has narrowed the scope of the claims.
The nonstatutory double patenting rejections for claim 33 and 39 over ‘994 and ‘960 in view of Parikh and Kristian is withdrawn in view of the newly added limitation “by injection” in claim 33, which has narrowed the scope of the claims.
Claim Objections
Claim 45 is objected to because of the following informalities:
Claim 45 recites “… than placebo in improving in preventing worsening of kidney function …”. A conjunction appears to be missing in the recited portion “in improving in preventing” and should be changed to “in improving or in preventing”.
Appropriate correction is required.
New and Amended Rejections Necessitated by the Amendments filed on 10/17/2025
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 33, 36-37, and 40-50 are rejected under 35 U.S.C. 103 as being unpatentable over Parikh et al. (US11116784B2 in PTO-892 dated 06/20/2025).
Parikh et al. discloses a method of treating acute kidney injury (AKI) in a subject comprising administering to a subject in need thereof a therapeutically effective amount of a nicotinamide adenine dinucleotide (NAD)/niacinamide (NAM) pathway agonist, wherein the NAD/NAM pathway agonist is a small molecule selected from nicotinamide adenine dinucleotide (NAD); niacinamide (NAM); nicotinamide mononucleotide (NMN); nicotinamide riboside (NR); and P7C3 and analogs thereof (see claim 1 of Parikh et al.). Parikh et al. discloses that pharmaceutical formulations for oral administration are in a daily amount of between 1-100 mg/kg bodyweight per day (see column 37, lines 27-35). Parikh teaches lower dosages can be used, in contrast to administration orally, into the blood stream, into a body cavity of into a lumen of an organ (see column 37, lines 27-40).
Parikh demonstrates in Example 1.3 that NAM was administered by intraperitoneal injection at a dose of 400 mg/kg in 8–12 week-old male mice followed by assessment of renal NAM and NAD abundances (see column 48 lines 37-55). Parikh further demonstrates in FIG. 17A that NAM supplementation increased renal NAD levels and also demonstrates in FIG 4C that the injected NAM attenuated AKI when injected 18 hours after the onset of ischemic renal injury. Furthermore, Parikh et al. demonstrates that kidney function, as measured by serum creatinine, rapidly improved in NAD/NAM agonist administrated animals in comparison to a vehicle (placebo) (see Figs 4A-H and column 5, lines 45-67), which meets the limitations of instant claims 43-45.
Even though Parikh does not demonstrate administering NMN by injection, it would have been prima facie obvious before the effective filing date of the claimed invention to have selected NMN as the NAD/NAM pathway agonist in Parikh and to further administer the NMN by injection for treating AKI as disclosed in Parikh to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation because Parikh provides guidance that a NAD/NAM pathway agonist, which includes NMN, can be effective for treating AKI, and further demonstrates the injection of a similar NAM compound that was effective in treating AKI. Therefore, an ordinary skilled artisan could have predictably considered administering alternative NAD/NAM pathway agonist compounds such as NMN by injection to effectively treat AKI with a reasonable expectation of success.
Furthermore, even though Parikh et al. does not teach that the administration of their NAD/NAM agonist resulted in improving the recited biomarkers in instant claim 33 as well as in instant claims 46-50 in comparison to a placebo, the improvement of these recited biomarkers in the instant claims would naturally flow from the teachings of Parikh because Parikh provides guidance of administering via injection an effective amount of the same NMN compound to the same subject population having acute kidney injury as described above. MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
In regards to instant claims 40-42, it would have also been prima facie obvious before the effective filing date of the claimed invention to have administered via injection a daily amount as recited in claims 40-42 because it would only require routine optimization to arrive at the claimed daily amount range based on Parikh et al. providing guidance of a daily oral dose of 1-100 mg/kg bodyweight per day as well as suggesting lower dosages into the blood stream such as by injection. See MPEP 2144.05 section II.
Claim(s) 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Parikh et al. (US11116784B2 in PTO-892 dated 06/20/2025), as applied to claims 33 and 40-42 above, and further in view of Hirsch et al. (Kidney International, published online 05/16/2020 in PTO-892 dated 06/20/2025).
The teachings of Parikh et al. are as described above.
The difference between Parikh et al. and the claimed invention is that Parikh et al. does not disclose treating an acute kidney injury that is a symptom or result of SARS-CoV-2 infection and further testing said subject for SAR-CoV-2 infection and kidney function.
Hirsch et al. discloses that acute kidney injury (AKI) occurs frequently among patients with COVID-19 (see Abstract). Hirsch et al. discloses that of the 5,449 patients that were admitted with Covid-19, 1,993 (36.6%) developed AKI, and that AKI was primarily seen in Covid-19 patients with respiratory failure, with 89.7% of patients on mechanical ventilation developing AKI compared to 21.7% of no-ventilated patients (see Abstract). Hirsch et al. concludes that the development of AKI in patients hospitalized for COVID-19 conferred a poor prognosis (see page 215, right column).
It would have been prima facie obvious to combine Parikh et al. and Hirsch et al. before the effective filing date of the claimed invention by administering the NMN of Parikh et al. to a patient population having acute kidney injury as a result of SARS-CoV-2 infection as disclosed by Hirsch et al. to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Hirsch et al. provides guidance that acute kidney injury frequently occurs for patients with COVID-19, and that the development of AKI for patients with COVID-19 resulted in poor prognosis. Furthermore, it would be routine to further test the subject for SARS-CoV-2 infection and kidney function after administering the NMN of Parikh et al. to a patient population having acute kidney injury as a result of SARS-CoV-2 infection as disclosed by Hirsch et al in order to monitor the condition of the patient.
Claim(s) 39 is rejected under 35 U.S.C. 103 as being unpatentable over Parikh et al. (US11116784B2 in PTO-892 dated 06/20/2025), as applied to claims 33 and 40-42 above, and further in view of Sinclair et al. (US20150313930A1 in PTO-892).
The teachings of Parikh et al. are as described above. Furthermore, Parikh et al. discloses that their NAD/NAM pathway agonist compounds can treat ischemic tissue injury, ischemic stroke, or myocardial infarction (see column 2, lines 8-13).
The difference between Parikh et al. and the claimed invention is that Parikh et al. does not discloses that NMN is in the form of a salt.
Sinclair teaches methods for the treatment of diseases or disorders associated with mitochondrial dysfunction (see Abstract). Sinclair teaches that in an embodiment, this method comprises administering the subject an effective amount of an agent that increases the level NAD+ (see paragraph 0031). Sinclair teaches that the disease associated with deregulation of mitochondrial homeostasis can be kidney failure, ischemia, and among others (see paragraph 0031). Sinclair teaches that the agent is an NAD+ precursor, such as NMN or a salt thereof, or an NMN prodrug and be administered at a dose of between 0.5-5 grams per day (see paragraph 0031). Sinclair teaches pharmaceutical compositions that contain the NAD+ increasing agent can be administered via injection (see paragraph 0175).
It would have been prima facie obvious to combine Parikh et al. and Sinclair et al. before the effective filing date of the claimed invention by modifying the NMN of Parikh et al. to be in a salt form as disclosed by Sinclair et al. to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with reasonable expectation of success because Sinclair provides guidance of administering salt forms of NMN via injection in similar dosage amounts to treat a similar kidney failure condition as well as the same ischemia.
Response to Arguments
Applicant’s arguments filed on 10/17/2025 have been fully considered in so far as they apply to
the rejections of the instant office action, but were not persuasive.
Applicant states that the presence of a pharmacodynamic effect, such as the NAD+ increase described by Parikh, should not be conflated with the presence of clinical efficacy, as claimed in the present application. Applicant points to the teachings of Pencina (in IDS filed 10/17/2025) that pharmacodynamic activity does not guarantee clinical efficacy and therefore is not inherently present, especially in complex disease states like AKI.
Applicant states that Pencina demonstrates MIB-626 (NMN) was administered orally to hospitalized COVID-19 patients with AKI. Applicant states oral NMN administration significantly increased blood NAD+ level however there was no statistically significant difference between the NMN and placebo groups in serum creatinine, cystain C, or other marks of AKI (KIM-1, NGAL), inflammatory markers (CRP, IL-6, TNF-alpha). Therefore, Applicant states that NMN did not produce a statistically significant improvement in kidney function AKI biomarkers, inflammation, or disease severity compared to placebo in COVID-19 patients with AKI when administered orally. Applicant states that Pencina demonstrates at least for oral NMN in AKI/COVID-19, the efficacy associated with the claimed biomarkers is not necessarily present through administration of the active compound in all modes and at all dosages. Applicant states that Pencina suggest other routes of administration such as intravenous to raise NAD+ levels more rapidly than the oral route. Therefore, Applicant concludes that Parikh does not anticipate each and every feature of the instant claims explicit or inherently.
In regards to these arguments, the teachings of Pencina do not demonstrate that improvement in the recited biomarkers would not be necessarily present in the teachings of Parikh because Pencina discloses that oral administration of MIB-626 may not have a significant effect on AKI biomarkers, whereas Parikh demonstrates injection of a NAD/NAM agonist and further provides evidence that the injected NAD/NAM agonist did attenuate AKI. Parikh, as described above, provides guidance of administering via injection an effective amount of the same NMN compound to the same subject population having acute kidney injury, and therefore would necessarily result in improvement of the recited biomarkers.
Applicant states that the 103 rejection over Parikh for claims 33 and 40-42 is nonobvious because Parikh provides a broad dosage range and does not teach or suggest which dose could result in the specific efficacy endpoints, as well as the necessity of achieving efficacy over placebo in the claimed biomarkers.
In response to this argument, Parikh provides guidance of 1-100 mg/kg per day oral dosage as well as suggesting lower dosages into the blood stream such as by injection for treating AKI. Furthermore, MPEP 2143.02 (I) states “Conclusive proof of efficacy is not required to show a reasonable expectation of success” and further states that "the expectation of success need only be reasonable, not absolute". Therefore, an ordinary skilled artisan could have routinely optimized with these recited dosages of Parikh to arrive at the amounts per day recited in claims 40-42. It is noted that MPEP 2144.05 III recites “Applicants can rebut a prima facie case of obviousness by showing the criticality of the range. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).”. Furthermore, Applicant can also rebut a prima facie case of obviousness by showing evidence of unexpected results from injecting the claimed NMN compound compared to oral administration. Applicant states that the 103 rejection over Parikh in view of Kristian for claim 39 is nonobvious because Kristian merely discloses that NMN, in salt form, may be used to treat certain neuropathophysiological conditions including ischemia, and that Kristian only discusses NMN and its salts for neuroprotection and not for AKI or in relation to the specific efficacy endpoints claimed. Applicant states that Kristian does not provide any teaching of suggestion regarding the claimed method.
In response to this argument, new 103 rejection over Parikh in view of Sinclair for claim 39 does not cite Kristian, rendering this argument moot.
Amended Rejections Necessitated by the Amendments filed on 10/17/2025
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.
Claims 33, 36-37, and 40-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,878,994 (‘994) in view of Parikh et al. (US11116784B2 in PTO-892 dated 06/20/2025).
Claim 1 of ‘994 recites a compound having a structure represented by Formula (I). Claim 29 of ‘994 recites a method of treating inflammation and increasing NAD+ in a subject by administering the compound of claim 1 of ‘994. Claim 26 of ‘994 recites “… the inflammation is a symptom of or a cause of asthma…, acute kidney injury (AKI)… “.
The difference between the claims of ‘994 and the claimed invention is that the claims of ‘994 do not recite a method of treating AKI by administering NMN.
The teachings of Parikh are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the compound of ‘994 with the NMN of Parikh with the recited dosages of Parikh et al. and further administer by injection as recited in Parikh to arrive at the claimed invention. One of ordinary skill in the art would have made these modifications with a reasonable expectation of success because both the claims of ‘994 and Parikh recite that their respective compounds can be administered to a subject to treat a symptom of AKI and for boosting NAD+. See MPEP 2144.05 section II. Furthermore, Parikh demonstrates that NAM via injection attenuated AKI. Therefore, an ordinary skilled artisan could have chosen from a finite list of predictable solutions with a reasonable expectation of success. Lastly, even though the combination of the claims of ‘994 and the teachings of Parikh et al. described above do not teach the improvement of the recited biomarkers in instant claim 33 as well as in instant claims 46-50 in comparison to a placebo, the improvement of these recited biomarkers in the instant claims would naturally flow from the combination of the claims of ‘994 and the teachings of Parikh et al. described above because the combination of the claims of ‘994 and the teachings of Parikh et al. described above provides guidance of administering via injection an effective amount of the same NMN compound to the same subject population having acute kidney injury as described above. MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
Claims 33-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,878,994 (‘994) in view of Parikh et al. (US11116784B2 in PTO-892 dated 06/20/2025) and Hirsch et al. (Kidney International, published online 05/16/2020 in PTO-892 dated 06/20/2025).
The combination of the claims of ‘994 and teachings of Parikh et al. are as described above.
The difference between the combination of the claims of ‘994 and teachings of Parikh et al. and the claimed invention is that the combination of the claims of ‘994 and teachings of Parikh et al. do not disclose treating an acute kidney injury that is a symptom or result of SARS-CoV-2 infection and further testing said subject for SAR-CoV-2 infection and kidney function.
The teachings of Hirsch are as described above.
It would have been prima facie obvious to combine the claims of ‘994 and Parikh et al. with Hirsch et al. before the effective filing date of the claimed invention by administering the NMN as suggested by the combination of the claims of ‘944 and Parikh et al. to a patient population having acute kidney injury as a result of SARS-CoV-2 infection as disclosed by Hirsch et al. to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Hirsch et al. provides guidance that acute kidney injury frequently occurs for patients with COVID-19, and that the development of AKI for patients with COVID-19 resulted in poor prognosis. Furthermore, it would be routine to further test the subject for SARS-CoV-2 infection and kidney function in order to monitor the condition of the patient.
Claims 33 and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,878,994 (‘994) in view of Parikh et al. (US11116784B2 in PTO-892 dated 06/20/2025) and Sinclair et al. (US20150313930A1 in PTO-892).
The combination of the claims of ‘994 and teachings of Parikh et al. are as described above. Furthermore, Parikh et al. discloses that their NAD/NAM pathway agonist compounds can treat ischemic tissue injury, ischemic stroke, or myocardial infarction (see column 2, lines 8-13).
The difference between the combination of the claims of ‘994 and teachings of Parikh et al. and the claimed invention is that the combination of the claims of ‘994 and teachings of Parikh et al. do not disclose that the NMN is in a salt form.
The teachings of Sinclair are as described above.
It would have been prima facie obvious to combine the claims of ‘994 and Parikh et al. with Sinclair et al. before the effective filing date of the claimed invention by modifying the NMN as suggested by the combination of the claims of ‘994 and Parikh et al. to be in a salt form as disclosed by Sinclair et al. to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with reasonable expectation of success because Sinclair provides guidance of administering salt forms of NMN via injection in similar dosage amounts to treat a similar kidney failure condition as well as the same ischemia.
Claims 33, 36-37, and 40-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-82 of copending Application No. 18/722,960 (‘960) in view of Parikh et al. (US11116784B2 in PTO-892 dated 06/20/2025).
Claim 55 of ‘960 recites a compound having a structure represented by Formula (I). Claim 81 of ‘960 recites a method of treating inflammation and increasing NAD+ in a subject by administering a compound of claim 55 of ‘960. Claim 78 of ‘960 recites “the inflammation is a symptom of or a cause of asthma…, acute kidney injury (AKI)…”.
The difference between the claims of ‘960 and the claimed invention is that the claims of ‘994 do not recite a method of treating AKI by administering NMN.
The teachings of Parikh are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the compound of ‘960 with the NMN of Parikh with the recited dosages of Parikh et al. and further administer by injection as recited in Parikh to arrive at the claimed invention. One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because both the claims of ‘960 and Parikh recite that their respective compounds can be administered to a subject to treat a symptom of AKI and for boosting NAD+. See MPEP 2144.05 section II. Furthermore, Parikh demonstrates that NAM via injection attenuated AKI. Therefore, an ordinary skilled artisan could have chosen from a finite list of predictable solutions with a reasonable expectation of to arrive at the claimed invention. Lastly, even though the combination of the claims of ‘960 and the teachings of Parikh et al. described above do not teach the improvement of the recited biomarkers in instant claim 33 as well as in instant claims 46-50 in comparison to a placebo, the improvement of these recited biomarkers in the instant claims would naturally flow from the combination of the claims of ‘960 and the teachings of Parikh et al. described above because the combination of the claims of ‘960 and the teachings of Parikh et al. described above provides guidance of administering via injection an effective amount of the same NMN compound to the same subject population having acute kidney injury as described above. MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
This is a provisional nonstatutory double patenting rejection.
Claims 33-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-82 of copending Application No. 18/722,960 (‘960) in view of Parikh et al. (US11116784B2 in PTO-892 dated 06/20/2025) and Hirsch et al. (Kidney International, published online 05/16/2020 in PTO-892 dated 06/20/2025).
The combination of the claims of ‘960 and teachings of Parikh et al. are as described above.
The difference between the combination of the claims of ‘960 and teachings of Parikh et al. and the claimed invention is that the combination of the claims of ‘960 and teachings of Parikh et al. do not disclose treating an acute kidney injury that is a symptom or result of SARS-CoV-2 infection and further testing said subject for SAR-CoV-2 infection and kidney function.
The teachings of Hirsch are as described above.
It would have been prima facie obvious to combine the claims of ‘960 and Parikh et al. with Hirsch et al. before the effective filing date of the claimed invention by administering the NMN as suggested by the combination of the claims of ‘960 and Parikh et al. to a patient population having acute kidney injury as a result of SARS-CoV-2 infection as disclosed by Hirsch et al. to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Hirsch et al. provides guidance that acute kidney injury frequently occurs for patients with COVID-19, and that the development of AKI for patients with COVID-19 resulted in poor prognosis. Furthermore, it would be routine to further test the subject for SARS-CoV-2 infection and kidney function in order to monitor the condition of the patient.
This is a provisional nonstatutory double patenting rejection.
Claims 33 and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-82 of copending Application No. 18/722,960 (‘960) in view of Parikh et al. (US11116784B2 in PTO-892 dated 06/20/2025) and Sinclair et al. (US20150313930A1 in PTO-892).
The combination of the claims of ‘960 and teachings of Parikh et al. are as described above. Furthermore, Parikh et al. discloses that their NAD/NAM pathway agonist compounds can treat ischemic tissue injury, ischemic stroke, or myocardial infarction (see column 2, lines 8-13).
The difference between the combination of the claims of ‘960 and teachings of Parikh et al. and the claimed invention is that the combination of the claims of ‘960 and teachings of Parikh et al. do not disclose that the NMN is in a salt form.
The teachings of Sinclair are as described above.
It would have been prima facie obvious to combine the claims of ‘960 and Parikh et al. with Sinclair et al. before the effective filing date of the claimed invention by modifying the NMN as suggested by the combination of the claims of ‘960 and Parikh et al. to be in a salt form as disclosed by Sinclair et al. to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with reasonable expectation of success because Sinclair provides guidance of administering salt forms of NMN via injection in similar dosage amounts to treat a similar kidney failure condition as well as the same ischemia.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant states to hold the double patenting rejections in abeyance until allowable subject matter is found. Since allowable subject matter has not been found, the double patenting rejections are maintained.
Conclusion
No claim is found allowable.
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 DAVID H CHO whose telephone number is (571)270-0691. The examiner can normally be reached M-F 8AM-5PM.
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, Scarlett Goon can be reached at 571-270-5241. 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.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693