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 .
Applicant’s Response Dated July 22, 2025
In the Response dated July 22, 2025, claims 1, 3, and 5-14 were amended; claims 2 and 4 were canceled; and claims 15-16 were added. Claims 1, 3, and 5-16 are pending. An action on the merits of claims 1, 3, and 5-16 is contained herein.
The rejection of claims 1, 3, and 5-14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is maintained for the reasons of record as set forth in the last Office Action dated April 22, 2025. Newly added claims 15-16 are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons of record and is not repeated separately.
The rejection of claim 6 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, has been rendered moot in view of applicant’s amendment dated July 22, 2025.
The rejection of claims 1, 3, and 5-6 under 35 U.S.C. 102(a)(1) as being anticipated by Giroud-Gerbetant, Judith, et al. "A reduced form of nicotinamide riboside defines a new path for NAD+ biosynthesis and acts as an orally bioavailable NAD+ precursor." Molecular metabolism 30 (2019): 192-202 (Giroud-Gerbetant) is maintained for the reason of record as set forth in the last Office Action dated April 22, 2025.
The rejection of claims 1, 3, and 5-14 under 35 U.S.C. 103 as being unpatentable over GLAXOSMITHKLINE INTECCLECTUAL PROPERTY (NO.2) LIMITED WO 2015/186114 A1 (GSK) and Giroud-Gerbetant, Judith, et al. "A reduced form of nicotinamide riboside defines a new path for NAD+ biosynthesis and acts as an orally bioavailable NAD+ precursor." Molecular metabolism 30 (2019): 192-202 (Giroud-Gerbetant) in combination is maintained for the reason of record as set forth in the last Office Action dated April 22, 2025. Newly added claims 15-16 are also rejected under 35 U.S.C. 103 as being unpatentable over GLAXOSMITHKLINE INTECCLECTUAL PROPERTY (NO.2) LIMITED WO 2015/186114 A1 (GSK) and Giroud-Gerbetant, Judith, et al. "A reduced form of nicotinamide riboside defines a new path for NAD+ biosynthesis and acts as an orally bioavailable NAD+ precursor." Molecular metabolism 30 (2019): 192-202 (Giroud-Gerbetant) for the reason of record as applied to claims 1, 3, and 5-14 and is not repeated separately.
Rejections Set Forth in the Office Action Dated April 22, 2025
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, 3, and 5-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1 and dependent claims thereof, the claims are drawn to a “method of promoting protective immunity and/or for preventing and/or treating bacterial or viral infections and/or for limiting immune mediated pathology following infection in an individual in need thereof”. Page 4 of the specification discloses (emphasis added):
“Prevention” includes reduction of risk, incidence and/or severity of a condition or disorder. The terms “treatment,” “treat” and “to alleviate” include both prophylactic or preventive treatment (that prevent and/or slow the development of a targeted pathologic condition or disorder) and curative, therapeutic or disease-modifying treatment, including therapeutic measures that cure, slow down, lessen symptoms of, and/or halt progression of a diagnosed pathologic condition or disorder; and treatment of patients at risk of contracting a disease or suspected to have contracted a disease, as well as patients who are ill or have been diagnosed as suffering from a disease or medical condition. The term does not necessarily imply that a subject is treated until total recovery. The terms “treatment” and “treat” also refer to the maintenance and/or promotion of health in an individual not suffering from a disease but who may be susceptible to the development of an unhealthy condition. The terms “treatment,” “treat” and “to alleviate” are also intended to include the potentiation or otherwise enhancement of one or more primary prophylactic or therapeutic measure. The terms “treatment,” “treat” and “to alleviate” are further intended to include the dietary management of a disease or condition or the dietary management for prophylaxis or prevention a disease or condition. A treatment can be patient- or doctor-related.
The term “promotion”, “to promote”, “promoting” means enhancing, boosting, or accelerating a physiological response, for example protective immunity.
The recitation “an individual in need thereof” renders the claim(s) indefinite as the recitation has not been defined in the claim(s) or specification. Thus, one of ordinary skill in the art would not have been apprised of the metes and bounds of an individual applicant intends for the invention to be limited to. For example, the examiner notes that applicant submits “The objective means of augmenting macrophage response to infection in an individual. This enables effective achievement of the methods recited in amended claim 1, in a manner which is independent of the type of pathogen.” in the second paragraph, on page 8 of applicant’s response. In the opinion of the examiner, the claims do not require that the individual have or had a bacterial or viral infection or any other disease or condition or have been in contact with a pathogen. If it is applicant’s intent that “an individual in need thereof” is to limited as suggested on page 8 of applicant’s response, the claims should be amened to more clearly reflect applicant’s intent.
Thus, the rejection is maintained based upon the preponderance of evidence.
Claim(s) 1, 3, and 5-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giroud-Gerbetant, Judith, et al. "A reduced form of nicotinamide riboside defines a new path for NAD+ biosynthesis and acts as an orally bioavailable NAD+ precursor." Molecular metabolism 30 (2019): 192-202 (Giroud-Gerbetant).
Applicant's arguments filed July 22, 2025 have been fully considered but they are not persuasive. Applicant argues that Giroud 1) does not describe 1,2-dihydro-1-beta-D-ribofuranosyl-3-pyridinecarboxamide or 1,6-dihydro-1-beta-D-ribofuranosyl-3-pyridinecarboxamide and 2) fails to describe a method of promoting protective immunity and/or preventing or treating bacterial or viral infections and/or limiting immune mediated pathology following infection involving delivering an effective unit dose form of any of the claimed NRH forms.
Applicant’s arguments have been fully considered; however, the administration (e.g., delivery) of 1,2-dihydro-1-beta-D-ribofuranosyl-3-pyridinecarboxamide or 1,6-dihydro-1-beta-D-ribofuranosyl-3-pyridinecarboxamide is not required to meet the limitations of the instant claims. As acknowledged by applicant, Giroud-Gerbetant describes that 1,4-dihydro-1-beta-D-ribofuranosyl-3-pyridinecarboxamide (i.e. one of the NRH forms recited in amended Claim 1) is effective in treating cisplatin-induced acute kidney injury. Thus, applicant’s argument is not persuasive.
Regarding applicant’s second argument, artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art. In construing process claims and references, it is the identity of manipulative operations which leads to finding of anticipation. In the instant case, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. As set forth in the last Office Action, Giroud-Gerbetant teaches administering NRH (250 mg/kg) to mice injected with cisplatin in an acute kidney injury disease model (e.g., a rodent undergoing medical treatment) to evaluate the potential therapeutic actions of NRH. The mice employed in the disease model of Giroud-Gerbetant embraces an instant “individual in need thereof”. Administration of 250 mg/kg of NRH embraces “delivering to the individual an effective unit does form of reduced nicotinamide”. Giroud-Gerbetant teaches all of the instantly claimed elements.
Thus, the rejection is maintained based upon the preponderance of evidence.
Claim(s) 1, 3, and 5-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over GLAXOSMITHKLINE INTECCLECTUAL PROPERTY (NO.2) LIMITED WO 2015/186114 A1 (GSK) and Giroud-Gerbetant, Judith, et al. "A reduced form of nicotinamide riboside defines a new path for NAD+ biosynthesis and acts as an orally bioavailable NAD+ precursor." Molecular metabolism 30 (2019): 192-202 (Giroud-Gerbetant) in combination.
Applicant's arguments filed July 22, 2025 have been fully considered but they are not persuasive. Applicant argues that the compounds of GSK are not a reduced nicotinamide riboside recited in claim 1. Applicant submits that GSK refers to treatment of viral infections and treatment or prevention of viral infections and to use as antifungal agents. Applicant submits that these uses are of “nicotinamide riboside ester and carbonate preparations and pharmaceutical or cosmetic compositions of the invention.” Applicant further submits that Claim 1 is novel over a combination of GSK and Giroud. Applicant submits that Giroud describes that one of the claimed NRH forms is effective in treating kidney damage resulting from the administration of cis-platin. That is, Giroud describes that 1,4- dihydro-1-beta-D-ribofuranosyl-3-pyridinecarboxamide is effective in treating an iatrogenic (or drug-induced) disease. Applicant submits that this teaching provides no indication to the skilled person that the claimed NRH forms would be effective in promoting the immune response during and after an infection.
Applicant’s arguments have been fully considered; however, as set forth in the last Office Action, in determining the differences between the prior art and the claims, the question under 35 U.S.C. 103 is not whether the differences themselves would have been obvious, but whether the claimed invention as a whole would have been obvious. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871 (Fed. Cir. 1983); Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983).
Obviousness does not require absolute predictability. The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. As set forth on pages 11-12 of the last Office Action, it would have been obvious to one of ordinary skill in the art to substitute a nicotinamide riboside analog of GSK in a method of preventing or treating a viral infection in a subject in need thereof with NRH. The nicotinamide riboside analog(s) of GSK and NRH have close structural similarities. The analog(s) of GSK and NRH share a common utility of being a NAD precursor. Further, Giroud-Gerbetant teaches that NRH acts as a more potent and faster NAD precursor than NR in mammalian cells and tissues. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.
Thus, the rejection is maintained based upon the preponderance of evidence.
Conclusion
Claims 1, 3, and 5-16 are pending. Claims 1, 3, and 5-16 are rejected. No claims are 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.
Contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shaojia Jiang can be reached at (571) 272-0627. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/