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 .
Amended claims 1-6, 8-20 are pending.
Response to Applicants Remarks 07/30/2026 is at the end of maintained rejections.
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.
Claim(s) 1-6, 8-20 are rejected under 35 U.S.C. 103 as being unpatentable over NPL Document A7 Drks00021214: 2020-04-06, NPL Document A17 Shakoor, Maturitas, vol. 144, 15 August 2020, pages 108-111, NPL Document A8, Jiang, Research Square 23 October 2020 (Document D10), NPL Document A16 Mario, "Nicotinamide Riboside - The Current State of Research and Therapeutic Uses", NUTRIENTS, vol. 12, no. 6, 31 May 2020, page 1-22, Schwarz WO2017182347, Georg US10426765 and Wätzig US10758552, Heer, J.Biol. Chem. (2020)295(52) 17986–17996, Schentag US 20150071994, Hulley, Designing Clinical Research, 4th Edition, pages 1-367, 2013; and Chidambaram Pediatr Invest 2019 Dec; 3(4): 245-252.
Drks00021214 (German clinical trial) titled Improvement of the nutritional status regarding nicotinamide (vitamin B3) and the course of COVID-19 disease", teaches that a nutritional intervention with nicotinamide can support the therapy of COVID-19. In particular the frequency of severe disease progression in COVID-19 patients can decrease if they supplement 1,000 mg of nicotinamide. D1 also teaches that nicotinamide can reduce virus replication and support the body's defense mechanisms for a wide variety of virus types, e.g. vaccinia, HIV, enteroviruses of hepatitis B.
Shakoor, titled "Be well: A potential role for vitamin B in COVID-19", teaches a composition comprising nicotinamide or nicotinic acid for use in the treatment of viral infections, such as influenza, severe acute respiratory syndrome (SARS) or HIV (page 4, line 3 - line 4; page 7, line 5 - line 1O; page 7, line 25 - line 26;
Jiang, titled "Treatment of SARS-CoV-2 induced pneumonia with NAO+ in a mouse model", teaches the use of the use of nicotinamide adenine dinucleotide (NAO) in the treatment of COVID-19 patients.
Mario titled "Nicotinamide Riboside - The Current State of Research and Therapeutic Uses" teaches the antiviral effect of nicotinamide riboside (NR) in patients with HIV or hepatitis B. NR is also described as a potential therapeutic against COVID-19.
The teachings of Schwarz, Georg, Wätzig, Heer, Schentag, Hulley and Chidambaram
even though, not drawn to the treatment of the specific disease states of instant claim, as explained below do teach the formulation characteristics of the instant claim 1 and do suggest the use of the formulation in the treatment of Covid.
Schwarz teaches a microcapsule, comprising a core containing vitamin B3, the use of such a microcapsule as a medicament, nutraceutical, dietary supplement, food ingredient or food, and the use of such a microcapsule in the therapy and/or prophylaxis of a multitude of diseases. The present invention further relates to formulations and compositions comprising such a microcapsule and a method for producing for such a microcapsule. According to Schwarz at page 1, line 8-20 administration of vitamin B3 [comprising nicotinic acid (NA) and nicotinamide (NAM)] has recently and surprisingly been demonstrated to have beneficial effects beyond nutritional vitamin supplementation. When delivered in controlled release formulations targeting the lower small intestine and/or colon, vitamin B3 has been shown to have beneficial effects on the intestinal microbiota, resulting in a significant amelioration of intestinal inflammation and substantial changes in the intestinal microbiota in mouse models
The teachings of Wätzig and Georg are drawn to efficacy of NAM controlled-release formulations. Wätzig and Georg teach pharmaceutical composition comprising one, two or more active substance(s) selected from nicotinic acid; nicotinamide; tryptophan; a compound that converts in the body of an animal (e.g., a human body) into nicotinic acid, nicotinamide or tryptophan; nicotinamide adenine dinucleotide (NAD); nicotinamide adenine dinucleotide phosphate (NADP); an intermediate in the biosynthesis of NAD or NADP; and a tryptophan dipeptide, for positively influencing the intestinal microbiota, wherein the pharmaceutical composition is designed for a delayed release so that it releases (e.g., partially releases, selectively releases) in the lower small intestine, the colon or both.
Highlighted below are details of the Wätzig and Georg formulations as applicable to the limitations of the recited formulations of base claim 1 (details of the limitations of (a), (b) and (c) ):
Georg teaches
PNG
media_image1.png
844
816
media_image1.png
Greyscale
and Wätzig teaches
PNG
media_image2.png
968
844
media_image2.png
Greyscale
As such the position taken is that the claimed elements/ limitations with respect to
disease states (claims (1,) 2, 13, 15, 14, 11, 19, 20),
controlled delayed, oral claim 8, 9, 17
breakfast! In the morning , daily activity, claims 10, 12
dosage and two formulations (more on this below) claim 4, 5, 6, 11, 16, 18
are taught in the cited references and within the purview of one of skill in the art, for example, Drks00021214 is clinical trial refence.
Further claim language such as
PNG
media_image3.png
54
578
media_image3.png
Greyscale
PNG
media_image4.png
16
214
media_image4.png
Greyscale
are found in the teachings of Schentag, Hulley and Chidambaram; also see
https://shms-prod.s3.amazonaws.com/media/editor/147459/L3_Pharmaceutical_Excipients__Types_of_Tablets.pdf.
and https://www.organicfacts.net/health-benefits/cereal/barley-grass.html;
Schentag teaches invention provides oral vaccine formulations which deliver an antigen in the vicinity of the distal ileum and the area of the ileal Brake and/or the appendix. These vaccines are useful in the treatment and/or prevention of variety of disorders, including viral and bacterial infections and cancers. Related methods of treatment which use the oral vaccine formulations of the invention are also provided. ). Schentag is directed to microencapsulation of microparticles [0132, 0144], thus making microcapsules, where the formulation comprises a plurality of cores comprising an antigen and optional adjuvant and a pharmaceutically excitable excipient with a first shellac enteric coating encapsulates the antigen and a second enteric coating of shellac encapsulates the first coating (claim 1). Schentag also teach adding a nutritional substance (claims 9 and 12) which is synonymous with “ileal break hormone releasing substance” [0040, 0052]. Schentag teach nutritional substances include barley grass, which as evidenced by Nagdeve, M., contains niacin (vitamin B3), alfalfa and chlorella which both with contain B complex, which include vitamin B3 as well. Schentag teach adding sodium carbonate as an excipient as well as buffering agents [0058]. Schentag teach coating the nutritional substance with an enteric coating such as shellac which can comprise two or more compositions [0054]. Schentag teach a “pill within a pill” composition in Figure 5 with inner membrane and outer membrane as shown below:
PNG
media_image5.png
589
643
media_image5.png
Greyscale
.
Hulley and Chidambaram teach how and what of designing clinical research
Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Also note that the discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use.
As MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-10.2019], "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer."
All the claimed limitations of active agent, disease targets and the(why (biochemical mechanism) and how formulating for intestinal/colon delivery are taught in the prior art.
As such nothing unobvious is seen in the claims.
The art made of record and not relied upon is considered pertinent to applicant's disclosure.
Qin, Gut ACE2 Expression, Tryptophan Deficiency, and Inflammatory Responses The Potential Connection That Should Not Be Ignored During SARS-CoV-2 Infection Cellular and Molecular Gastroenterology and Hepatology (2021), 12(4), 1514-1516.e4.
Lines, WO 2008/011363 Document D6 discloses a composition comprising nicotinamide or nicotinic acid for use in the treatment of viral infections, such as influenza, severe acute respiratory syndrome (SARS) or HIV (page 4, line 3 - line 4; page 7, line 5 - line 1O; page 7, line 25 - line 26;claims 1,13,32,35,36).
and the following Applicant provided NPL documents See IDS 05/25/2023.
PNG
media_image6.png
306
784
media_image6.png
Greyscale
PNG
media_image7.png
30
812
media_image7.png
Greyscale
PNG
media_image8.png
34
808
media_image8.png
Greyscale
.
Response to Applicants Remarks filed 07/30/2026.
Applicants opening statements:
PNG
media_image9.png
298
636
media_image9.png
Greyscale
With the above, Applicant implies about 10 pages of Examiner’s write-up is an improper analysis but proceeds to respond with about 7 pages of write-up. A quicker, easier way to deal with improper, erroneous, office actions would be by contacting this Examiner’s Supervisor, Director or Commissioner. This would facilitate compact prosecution.
Applicant arguments are not persuasive.
The arguments focus on
PNG
media_image10.png
22
220
media_image10.png
Greyscale
This phrase appears 11 times in Applicants Remarks. According to Applicant, the combination of the teachings taken together, there is no suggestion or motivation or teaching for the claimed method.
While acknowledging (Remarks page 3, last paragraph onto page 4) that the cited references of Drks00021214, Jiang, Mario and Heer taken together provide for
PNG
media_image11.png
48
488
media_image11.png
Greyscale
according to Applicant, there is no TSM in this combination of citations for
PNG
media_image12.png
50
610
media_image12.png
Greyscale
Applicant points to disclosure for the demonstration of achieving symptom reduction.
The issue here is not whether there is any support in the specification, but rather, the disclosed results obtained are expected (that is obvious) in view of the combination of teachings in the prior art.
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.
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office
Detailed Response:
Applicant is encouraged to use word search Technique to locate in the office action AND in the cited references teachings relevant to the claim.
PNG
media_image13.png
68
612
media_image13.png
Greyscale
PNG
media_image14.png
158
654
media_image14.png
Greyscale
PNG
media_image15.png
20
168
media_image15.png
Greyscale
Remarks at page 4
PNG
media_image16.png
54
642
media_image16.png
Greyscale
It is noted that
the word ‘COVID’ appears 7 times
the word SARS appears 4 times
in the rejection.
The rejection is not under Claim Rejections - 35 USC § 102.
Position taken is that
the combined teachings in the cited art does teach
PNG
media_image17.png
86
628
media_image17.png
Greyscale
and
that the POSITA here is one with a PhD and/or MD degree.
PNG
media_image18.png
18
294
media_image18.png
Greyscale
Remarks at page 4
PNG
media_image19.png
50
638
media_image19.png
Greyscale
The position taken is POSITA is fully aware of these
PNG
media_image20.png
18
140
media_image20.png
Greyscale
in addition to, from the teachings of the cited references.
PNG
media_image21.png
24
274
media_image21.png
Greyscale
Again it is reminded that the rejection is based on the combination of the teachings and what is/are under the purview of the POSITA, and just not relied only on
PNG
media_image22.png
22
226
media_image22.png
Greyscale
,
(see Remarks page 5 line 8).
The web noted by the Applicant is at page 8 of the previous action. The web page noted here is preceded by
--
PNG
media_image23.png
174
578
media_image23.png
Greyscale
--
PNG
media_image24.png
20
72
media_image24.png
Greyscale
Remarks at page 4
PNG
media_image25.png
50
622
media_image25.png
Greyscale
According to Applicant, the inherency argument is misplaced, based on
PNG
media_image26.png
18
106
media_image26.png
Greyscale
.
The position taken is that
PNG
media_image27.png
20
164
media_image27.png
Greyscale
.and the inherency rationale is consistent with the cited MPEP.
PNG
media_image28.png
18
240
media_image28.png
Greyscale
At once obvious in this section is the what the active ingredient is. It is not the plethora of possibilities as base claim 1 recitation:
PNG
media_image29.png
250
586
media_image29.png
Greyscale
Likewise, what
PNG
media_image30.png
50
620
media_image30.png
Greyscale
. provides for
PNG
media_image28.png
18
240
media_image28.png
Greyscale
is not pointed out under this section.
The word ‘surprising’ appears multiple times in this section. Many of the relevant information, such as dose, what is/are the specifics of the formulation, timing are not found as limitations in the base claim. Routinely used generic terms are used in the base claim to define these factors that allegedly provide for
PNG
media_image28.png
18
240
media_image28.png
Greyscale
.
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
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.
Claim(s) 1-6, 8-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. US10426765, further in view of NPL Document A7 Drks00021214: 2020-04-06, NPL Document A17 Shakoor, Maturitas, vol. 144, 15 August 2020, pages 108-111, NPL Document A8, Jiang, Research Square 23 October 2020 (Document D10), NPL Document A16 Mario, "Nicotinamide Riboside - The Current State of Research and Therapeutic Uses", NUTRIENTS, vol. 12, no. 6, 31 May 2020, page 1-22, Schwarz WO2017182347, Heer, J.Biol. Chem. (2020)295(52) 17986–17996, Schentag US 20150071994, Hulley, Designing Clinical Research, 4th Edition, pages 1-367, 2013 and Chidambaram Pediatr Invest 2019 Dec; 3(4): 245-252.
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
Response to Applicants Remarks filed 07/30/2026.
Applicants Remarks at page 8
PNG
media_image31.png
50
626
media_image31.png
Greyscale
PNG
media_image32.png
46
628
media_image32.png
Greyscale
Applicants arguments are not persuasive.
PNG
media_image33.png
50
626
media_image33.png
Greyscale
PNG
media_image34.png
20
480
media_image34.png
Greyscale
Examiner
maintains
PNG
media_image35.png
18
292
media_image35.png
Greyscale
THIS ACTION IS MADE FINAL. 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 NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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, Andrew Kosar can be reached at (571) 272-0913. 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.
/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
Prosecution Insights