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
Preliminary amendment filed on 07/14/2023 is acknowledged. Claims 19-30 were canceled and claims 3-10, 12, and 15-18 were amended. Claims 1-18 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/US2022/014456, filed on 01/29/2022 and claims benefit of provisional application 63/143,321 filed on 01/29/2021.
Information Disclosure Statement
The information disclosure statements (IDS) dated 07/15/2023 and 10/31/2024 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, the IDS document has been placed in the application file and the information therein has been considered as to the merits.
Claim Objections
Claims 12 and 18 are objected to because of the following informalities: there is a period after the phrase “vitamin C” instead of a comma. Appropriate correction is required.
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 1-18 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.
Regarding claim 1, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 2-12 are rejected for being dependent upon a rejected claim base. For purposes of applying prior art, the examiner will interpret the “such as influenza, rhinovirus, or betacoronavirus infection” as not further limiting.
Claim 3 recites the limitation "the subject" in the third line. There is insufficient antecedent basis for this limitation in the claim. The examiner will interpret the phrase as “a subject”.
Claim 13 recites the limitation “wherein the N-acetyl glucosamine is in a prophylactically effective amount for preventing an influenza, a rhinovirus, or a betacoronavirus infection.” In light of the 112(a) enablement rejection written below, it is unclear what “a prophylactically effective amount for preventing an influenza, a rhinovirus, or a betacoronavirus infection” would be considered. Therefore, for the purposes of applying prior art, the examiner will interpret instant claim 13 as “a pharmaceutical composition comprising N-acetyl glucosamine, and optionally a pharmaceutically acceptable carrier or excipient, wherein the N-acetyl glucosamine is in an amount for treating an influenza, a rhinovirus, or a betacoronavirus infection.”
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for treating an illness caused by a viral infection or treating an influenza, a rhinovirus, or a betacoronavirus infection by administering a N-acetyl glucosamine, it does not reasonably provide enablement for preventing a disease or condition caused by or associated with a viral infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
With respect to the claimed method, attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered and those most relevant to the cited claims are discussed below.
Nature of the invention: The invention is drawn to a method of preventing illness caused by a viral infection or treating an influenza, a rhinovirus, or a betacoronavirus infection comprising administering a prophylactically effective amount of N-acetyl glucosamine and the method prevents one or more symptoms of the betacoronavirus infection.
Relative skill of those in the art: The relevant art is pharmaceutical formulations, which is a mature art where practitioners receive specialized training and earn advanced degrees during the course of their study. There is a voluminous amount of published material describing research, best practices and practical application of compositions and techniques to the medical field. The relative skill of those in the art is high.
Breadth of claims: The claims are broad with respect to the concept of prevention. The full scope of the instant claims covers the entire definition of treatment and prevention as well any adverse effects from a viral infection. The instant specification defines the phrase “prophylactically effect amount” to refer to an amount of an agent (such as NAG) that elicits the biological or medicinal response in a subject that is sought by a person which includes prevention of the symptoms of the disease or disorder associated with infection by a viral pathogen, prevention of infection by a viral pathogen, inhibition of the progression of viral infection, inhibition of the progression of symptoms associated with viral infection, prevention of the onset of symptoms associated with viral infection, prolonging negativity for viral infection of a subject that has tested negative for a virus, and prolonging the asymptomatic status of a subject that has tested positive for the presence of a virus (instant specification paragraph 050). In the absence of a limiting definition of “prevention” in the instant specification the full scope of the claims encompasses the entire definition of tertiary prevention, which covers reducing the occurrence of or eliminating a symptom or condition. The term “prevention” is assumed to take on the customary meaning known to those skilled in the art. Specifically, “prevention” is defined according to the Institute for International Medical Education (Wojtczak, 2002) as: the goals within the field of medicine to promote health, to preserve health, to restore health when it is impaired, and to minimize suffering and distress. Customarily prevention is sub-classified as primary (the protection of health by personal and community wide effects), secondary (the measures available to individuals and populations for the early detection and prompt and effective intervention to correct departures from good health) and tertiary (the measures available to reduce or eliminate long-term impairments and disabilities, minimize suffering caused by existing departures from good health, and to promote the patient's adjustment to irremediable conditions). Tertiary prevention is most relevant as used in the context of the instant invention. Thus, the intent of the method, as interpreted by a skilled practitioner of the medical or pharmaceutical arts, would include that which reduces the occurrence of, or eliminates, a disease or condition caused by or associated with a betacoronavirus infection to an individual.
Amount of guidance/Existence of working examples: The instant specification does not provide a working example of in vitro or in vivo administration of N-acetyl glucosamine to a subject with a viral infection.
State of the prior art/Predictability or unpredictability of the art: Wang et al. (Cell Research, published February 4, 2020, see PTO-892) is drawn to the evaluation of the antiviral efficiency of five FAD-approved drugs including ribavirin, penciclovir, nitazoxanide, nafamostat, chloroquine and two well-known broad-spectrum antiviral drugs remdesivir (GS-5734) and favipiravir (T-705) against a clinical isolate of 2019-nCoV in vitro. As indicated by the instant specification (instant specification paragraph 003), 2019-nCoV is a betacoronavirus. Wang teaches that at the time of publication there was no specific treatment against the novel coronavirus. Wang showed that the compounds tested in vitro had antiviral efficiency against 2019-nCoV (Figure 1, page 270). Wang teaches that further in vivo tested should be assessed (column 1, page 271) Weiss et al. (Microbiology and Molecular Biology Reviews, published December 2005, see PTO-892) is drawn to a review of the coronavirus pathogenesis (title). Wiess teaches that SARS infection exhibits a wide clinical course, characterized mainly be fever, dyspnea, lymphopenia, and lower respiratory tract infection. Weiss further teaches that airborne droplets from infected patients may be the main route of transmission (page 649, column 1).
Quantity of experimentation: Prevention is difficult to determine due to the inability to control who will contract the condition. There is no disclosure or suggestion in the art or the specification on how to determine prevention. One of ordinary skill in the art would have to conduct a myriad number of experiments comprising trial and error administration of the claimed compositions to both healthy individuals and individuals with viral infections to determine if the claimed compositions can be used in the fully claimed scope prevent a disease or condition caused by a viral infection. Genetech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors as discussed above, e.g., the breadth of the claims, the amount of guidance provided, the state/unpredictability of the art and the lack of working examples, one of skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims, with no assurance of success. Instant claims 2, 5-12, and 14-18 are rejected for being dependent on a rejected claim base.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 13 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (US 2007/0042995 A1, published 02/22/2007, see PTO-892).
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 exemplified the administration of a composition comprising a 10% aqueous solution of N-acetyl-D-glucosamine to rabbits experiencing serious toxic symptoms for three days and found that the inflammations were alleviated and the rabbit secretion products were normal (paragraph 37). 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).
Accordingly, the instant claim is anticipated by the teachings of the prior art.
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, 3, and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (US 2007/0042995 A1, published 02/22/2007, see PTO-892).
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).
Regarding instant claims 5 and 6, 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).
Regarding instant claims 7-9, 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 100-1000mg per day (paragraph 0014) and said medicament is administered 1-4 times daily (claim 3).
Xu does not exemplify preventing an illness caused by a viral infection.
It would have been prima facie obvious before the effective filing date of the claimed invention to administer a prophylactically effective amount of N-acetyl glucosamine to prevent an illness caused by a viral infection 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 administer a prophylactically effective amount of N-acetyl glucosamine to prevent an illness caused by a viral infection because Xu teaches that N-acetyl glucosamine can be administered to a patient to control the systematic symptoms caused by infections of virus. One would have a reasonable expectation of success because Xu teaches that N-acetyl glucosamine can be administered to a patient to control the systematic symptoms caused by infections of virus.
Regarding instant claims 7-9, it would have been prima facie obvious before the effective filing date of the claimed invention to administer the N-acetyl glucosamine twice a day at a dose of about 300 mg to about 300 mg per dose to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to administer the N-acetyl glucosamine twice a day at a dose of about 300 mg to about 300 mg per dose because Xu teaches that N-acetyl glucosamine can be administered to a patient from 1-100000 mg per day and from 1-4 times daily. One would have a reasonable expectation of success because Xu teaches that N-acetyl glucosamine can be administered to a patient from 1-100000 mg per day and from 1-4 times daily. 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 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (US 2007/0042995 A1, published 02/22/2007, see PTO-892) as applied to claim 1 above, and further in view of Baysal et al. (www.preprints.org, published 05/24/2020, see PTO-892).
Instant claim 1 is rejected as discussed above.
The teachings of Xu are discussed above.
Xu does not teach that the virus is a betacoronavirus such as SARS-CoV-2.
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 illnesses caused by viruses such as 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 Xu teaches that N-acetyl-D-glucosamine may be used to treat symptoms of viruses such as coronaviruses.
Claims 1 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Dushenkov et al. (WO 2006/128032 A2, published 11/30/2006, see PTO-892).
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). Dushenkov defines the term "effective amount" refers to the amount of a therapy which is sufficient to reduce or ameliorate the severity, duration of a disorder or one or more symptoms thereof, prevent the advancement of a disorder, cause regression of a disorder, prevent the recurrence, development, or onset of a disorder or a symptom thereof, or enhance or improve the prophylactic or therapeutic effect(s) of another therapy (paragraph 0041).
Dushenkov does not exemplify administration of N-acetyl glucosamine to a subject. Dushenkov does not exemplify administration of N-acetyl glucosamine and one ore more additional supplement agents.
It would have been prima facie obvious before the effective filing date of the claimed invention to administer an effective amount of N-acetyl glucosamine and 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 administer the composition comprising N-acetyl glucosamine and a supplemental agent to a subject 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 Dushenkov teaches the administration of N-acetyl glucosamine and that additional therapies may be used including supplements such as Vitamin B3, Vitamin C, or Vitamin E.
Claim 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dushenkov et al. (WO 2006/128032 A2, published 11/30/2006, see PTO-892) and Baysal et al. (www.preprints.org, published 05/24/2020, see PTO-892).
The teachings of Dushenkov are discussed above.
Dushenkov further teaches a pharmaceutical composition comprising a theaflavin composition, a glucosamine composition, and optionally one or more other prophylactic or therapeutic agents (paragraph 0033). Dushenkov teaches the dosage of a glucosamine composition administered to prevent, treat, manage, or ameliorate a condition associated with inflammation or one or more symptoms thereof in a patient is a unit dose of 0.1 mg to 3000 mg, 100 mg to 2500 mg, 150 mg to 2000 mg, 200 mg to 1500 mg, 500 mg to 1000 mg, 200 mg to 500 mg, 0.1 mg to 25 mg, 1 mg to 50 mg, or 10 mg to 100 mg (paragraph 0223).
Dushenkov does not teach that the virus is an influenza virus, a rhinovirus, or a betacoronavirus infection.
The teachings of Baysal are discussed above.
It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Dushenkov and Baysal by modifying the pharmaceutical composition comprising an effective amount of N-acetyl glucosamine as taught by Dushenkov to be used for the prevention of a betacoronavirus infection, such as 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 modifying the pharmaceutical composition to comprise an effective amount of N-acetyl glucosamine as taught by Dushenkov to be used for the prevention of a betacoronavirus infection
treat SARS CoV-2 as taught by Baysal because Dushenkov teaches that N-acetyl-D-glucosamine can be used to treat systematic symptoms caused by 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 Baysal teach that N-acetyl D-glucosamine can treat coronaviruses.
Regarding instant claims 14 and 15, it would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Dushenkov and Baysal by modifying the pharmaceutical composition comprising an effective amount of N-acetyl glucosamine by optimizing the amount of the N-acetyl glucosamine to be between 200 mg or about 2100 mg or 300 mg to about 900 mg as taught by Dushenkov to arrive at the claimed invention. It would have been prima facie obvious to optimize the amount of the N-acetyl glucosamine because Dushenkov teaches that the dosage of glucosamine may be between 0.1mg to 3000mg. One of ordinary skill in the art would have a reasonable expectation of success because Dushenkov teaches that the that the dosage of glucosamine may be between 0.1mg to 3000mg. 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).
Regarding instant claims 16-18, it would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Dushenkov and Baysal by modifying the pharmaceutical composition comprising an effective amount of N-acetyl glucosamine by adding additional supplement agents 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 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 Dushenkov teach the pharmaceutical composition of N-acetyl glucosamine and Dushenkov teaches that additional therapies may be used including supplements such as Vitamin B3, Vitamin C, or Vitamin E.
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 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 14-19 of copending Application No. 18/024,399. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to a method of treating a subject having a viral infection, such as influenza, rhinovirus, or betacoronavirus infection with a therapeutically effective amount of N-acetyl glucosamine and a pharmaceutical composition comprising N-acetyl glucosamine and one or more additional supplement agents and therefore anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693