Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Pursuant to the amendment dated 01/12/2026, claims 1, 9, 13-16 and 19 were amended, claims 7 and 20-32 were canceled, and claim 34 was newly added. Claims 1-6, 8-19, and 33-34 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/US2021/048991, filed on 09/03/2021 and claims benefit of provisional application 63/074,602 filed on 09/04/2020 and provisional application 63/142,669 filed on 01/28/2021.
Information Disclosure Statement
The information disclosure statements (IDS) dated 10/29/2025 and 01/12/2026 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Withdrawn Rejections
Applicant’s amendment, filed on 01/12/2026, with respect to the rejection of claims 1-19 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, has been fully considered and is persuasive. Applicant has amended independent claims 1 and 14 to replace the phrase “such as” with the phrase “selected from”. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 01/12/2026, with respect to the rejection of claim 14 under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (US 2007/0042995 A1, published 02/22/2007, see IDS dated 03/02/2023), has been fully considered and is persuasive. Applicant has amended claim 14 to add the limitation that the infection is a betacoronavirus infection which is not taught by Xu. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 01/12/2026, with respect to the rejection of claim 33 under 35 U.S.C. 102(a)(1) as being anticipated by PubChem (PubChem SID 368756742, published and last modified 05/25/2018, see IDS dated 03/02/2023), has been fully considered and is persuasive. Applicant successfully argued that Pubchem does not exemplify the correct stereochemistry of the instantly claimed compound. The rejection is hereby withdrawn.
New and Modified Grounds of Rejection
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is 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.
Claim 13 recites the limitation "the patient" in the second line. There is insufficient antecedent basis for this limitation in the claim. Claim 1, on which claim 13 depends, recites “a subject” and a subject and a patient are not necessarily the same thing.
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.
Claims 1-6, 8-9, 14-16 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (US 2007/0042995 A1, published 02/22/2007, see IDS dated 03/02/2023) and Baysal et al. (www.preprints.org, published 05/24/2020, see PTO-892 dated 09/10/2025).
Xu is drawn to use of N-acetyl-D-glucosamine or pharmaceutically acceptable salts thereof in the manufacture of a medicament for treating local lesions or systematic symptoms caused by infections of virus or bacteria (abstract). Xu teaches the systematic toxic symptoms caused by endotoxemia and local ectotoxic lesions, such as fever, headache, vertigo, delirium, nausea, emesis, and general malaise (paragraph 0002). Xu teaches that the viral infections are commonly caused by viruses such as coronaviruses and rhinovirus (paragraph 0003). Xu teaches the use of N-acetyl-D-glucosamine or pharmaceutically acceptable salts thereof in the manufacture of a medicament for controlling local lesions and systematic symptoms caused by infections of virus or bacteria (claim 1). Xu teaches a method for controlling local lesions and systematic symptoms caused by infections of virus or bacteria, wherein a pharmaceutical composition comprising an effective amount of N-acetyl-D-glucosamine or pharmaceutically acceptable salts thereof is administered to a patient (claim 4). Xu teaches a method wherein said pharmaceutical composition is a preparation suitable for intravenous injection, subcutaneous injection, intramuscular injection, or intra-peritoneal administration (claim 5). Xu exemplified an acute toxicity test including oral administration (paragraph 0026). Xu exemplifies testing of N-acetyl-D-glucosamine (10% aqueous solution) a dose of 2 mL every time, 3 times per day, for 3 consecutive days (paragraph 0037). Xu teaches a method wherein the dose of said pharmaceutical composition for an adult patient is 1-100000 mg per day based on the active component (claim 6), preferably 100-10000 mg per day (paragraph 0014) and said medicament is administered 1-4 times daily (claim 3).
Xu does not teach that the coronavirus is a betacoronavirus infection. Baysal is drawn to the study of the genetic uniformity of a specific region in SARS-CoV-2 genome and in-silico target-oriented repurposing of N-acetyl-D-glucosamine (title). Baysal teaches that CoVs are classified into four genera as alpha, beta, gamma, and delta CoVs (page 2). Baysal teaches that a docking data analysis supports a strong protein-ligand interaction of N-acetyl-D-glucosamine with spike receptor-binding domain bound with ACE2 (PDB 6M0J) and RNA-binding domain of nucleocapsid phosphoprotein (PDB 6WKP) from SARS CoV-2. Therefore, binding of N-acetyl-D-glucosamine to these proteins could inhibit SARS CoV-2’s replication (abstract).
It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Xu and Baysal by treating SARS CoV-2 as taught by Baysal using an N-acetyl glucosamine as taught by Xu to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to treat SARS CoV-2 with N-acetyl-D-glucosamine as taught by Xu because Xu teaches that N-acetyl-D-glucosamine can be used to treat coronaviruses and Baysal teaches that it may also be used to inhibit SARS CoV-2. One of ordinary skill in the art would have a reasonable expectation of success because Baysal teaches that N-acetyl-D-glucosamine may be used to inhibit SARS CoV-2 and both Xu and Baysal teach that N-acetyl D-glucosamine can treat coronaviruses.
Regarding claims 3 and 4, it would have been prima facie obvious before the effective filing date of the claimed invention to use the method taught by the combination of Xu and Baysal to treat viral symptoms such as delirium with N-acetyl-D-glucosamine as taught by Xu to a patient with SARS-CoV-2 as taught by Baysal to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to use the method taught by the combination of Xu and Baysal for treatment of the symptoms of a viral infection of a coronavirus because Xu teaches that the composition may be used to treat the symptoms such as delirium of a viral infection such as that by coronaviruses and Baysal teaches that N-acetyl-D-glucosamine may be used to inhibit SARS-CoV-2. One of ordinary skill in that art would have a reasonable expectation of success because Xu teaches that a composition comprising N-acetyl-D-glucosamine may be used to treat the symptoms of a viral infection.
Regarding claims 8-9 and 15-16, it would have been prima facie obvious before the effective filing date to combine the teachings of Xu and Baysal by optimizing the concentration within the range and the number of times administered per day as disclosed by Xu to treat SARS-CoV-2 as taught by Baysal to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to optimize the concentration within the range disclosed and the number of times to be administered per day because Xu teaches that the N-acetyl-D-glucosamine may be administered to a patient between 100-1000 mg per day up to 4 times per day and exemplified the administration of a 10% N-acetyl glucosamine solution three times per day. One of ordinary skill in the art would have a reasonable expectation of success because Xu teaches that the N-acetyl-D-glucosamine may be administered to a patient between 100-1000 mg per day up to 4 times per day and Xu teaches that N-acetyl-D-glucosamine may be used to inhibit SARS-CoV-2. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, 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). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Claims 10-13 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (US 2007/0042995 A1, published 02/22/2007, see IDS dated 03/02/2023) and Baysal et al. (www.preprints.org, published 05/24/2020, see PTO-892 dated 09/10/2025) as applied to claims 1 and 14 above, and further in view of Dushenkov et al. (WO 2006/128032 A2, published 11/30/2006, see PTO-892 dated 09/10/2025).
Claims 1 and 14 are rejected as discussed above.
The teachings of Xu and Baysal are discussed above.
Xu further teaches that the most usual symptoms of viral infections include inflammations (paragraph 0003).
The combined teachings of Xu and Baysal do not teach the addition of supplemental agents such as Vitamin A, Vitamin B, vitamin C, vitamin D, or zinc to the pharmaceutical composition comprising N-acetyl-glucosamine.
Dushenkov is drawn to compositions and methods for the prevention and treatment of conditions associated with inflammation (title). The inflammation could be the result of a viral infection (paragraph 0003). Dushenkov teaches administering to a subject in need thereof an effective amount of a theaflavin composition, an effective amount of a glucosamine composition, and optionally one or more other therapies (abstract). The glucosamine may be n-acetyl glucosamine (paragraph 0022). The one or more other therapies could be Vitamin B3, Vitamin C, and Vitamin E (paragraph 090). Dushenkov teaches that the theaflavins compositions may include natural products and their derivatives (paragraph 0122).
It would have been prima facie obvious to combine the combined teachings of Xu and Baysal with the teachings of Dushenkov before the effective filing date of the claimed invention by modifying the pharmaceutical comprising N-acetyl glucosamine taught by Xu by adding a supplemental agent such as Vitamin B3, Vitamin C, or Vitamin E as taught by Dushenkov to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to modify the composition comprising n-acetyl glucosamine to add a supplemental agent because Dushenkov teaches that n-acetyl glucosamine and additional therapies such as Vitamin B3, Vitamin C, or Vitamin E may be used to treat inflammation caused by viral infections. One of ordinary skill in the art would have a reasonable expectation of success because both Xu and Dushenkov teach that viral infections can cause inflammation and both teach the administration of n-acetyl glucosamine and Dushenkov teaches that additional therapies may be used including supplements such as Vitamin B3, Vitamin C, or Vitamin E.
Response to Arguments
Applicant's arguments filed 01/12/2026 have been fully considered in so much as they apply to the amended claims but they are not persuasive.
Regarding the 112(b) rejection over instant claim 13, applicant argues the rejection over the phrase “the patient” was overcome by amending to “a patient”. The argument is not persuasive. The amendment was not entered on claims dated 01/12/2026 and therefore the rejection is maintained.
Applicant argues that the alleged combination of the references fails to teach or suggest all of the claim limitations of the amended claims and that the person of ordinary skill in the art would not have had a reasonable expectation of success to arrive at the amended claims. Applicant argues that the amended independent claims 1 and 14 contain the elements of the amounts of the N-acetyl glucosamine that Xu and Baysal fails to disclose. The argument is not persuasive. Xu teaches a composition comprising N-acetyl glucosamine and a method of treating a viral disease such as a rhinovirus or coronavirus with the composition by administering to an adult a dosage of 100-1000mg per day up to 1-4 times daily and Baysal teaches that N-acetyl glucosamine binds to SARs-Cov-2 and could inhibit replication of the virus. Therefore, one of ordinary skill in the art would have a reasonable expectation of success of applying the method of treating a viral infection such as a coronavirus with a composition of N-acetyl glucosamine at a dosage of 100-1000mg per day up to 1-4 times daily as taught by Xu to a subject suffering from SARS-CoV-2 as Baysal teaches that N-acetyl glucosamine may inhibit the replication of the virus.
Applicant argues that the applicant showed significant results when administering N-acetyl-D-glucosamine to patients suspected of having COVID-19 such as delayed symptom onset and reduced occurrence of hypertension compared to a control group. The argument is not persuasive. According to the instant specification, patients were only administered NAG after the patients were in the emergency room already with COVID-19 symptoms (instant specification paragraph 0136). Therefore, NAG was not administered until after symptom onset and cannot account for a delayed symptom onset. The decreased hypertension and all data from Table 2 was data provided of the clinical characteristics upon admission and prior to NAG administration. Additionally, antiviral administration was more frequent in the NAG group compared to the control group and it would be difficult to differentiate the effect of the antivirals versus the NAG with the presented data (instant specification paragraph 0143).
Allowable Subject Matter
Claim 33 is allowed.
Instant claim 33 is drawn to a compound with the formula (a) or a pharmaceutically acceptable salt thereof (Figure 1). The closest prior art is Pubchem SID 3687567412 (PubChem SID 368756742, published and last modified 05/25/2018, see IDS dated 03/02/2023). Pubchem does not teach the specific beta enantiomer of the instant claim and does not teach any modifications to the compound. Further, Pubchem does not disclose any utility of the compound and therefore there is no reason to prepare a specific anomer, thus rendering the instant claim non-obvious over the closest applicable prior art of Pubchem.
(a)
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(b)
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Figure 1. (a) Instant claim 33 formula (b) Pubchem formula SID 3687567412.
Conclusion
Claim 33 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.
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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693 /SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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