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 .
Claim(s) 1-15 is/are pending and are currently under examination.
Information Disclosure Statement (IDS)
The information disclosure statement (IDS) submitted on January 6, 2025 has been considered by the Examiner; however, the IDS contains references that are in a foreign language. The relevant portions of 37 CFR § 1.98 (a) and (b) state:
(a) Any information disclosure statement filed under § 1.97 shall include the items
listed in paragraphs (a)(1), (a)(2) and (a)(3) of this section...
(2) A legible copy of:
(i) Each foreign patent;
(ii) Each publication or that portion which caused it to be listed, other than U.S. patents and U.S. patent application publications unless required by the Office;
(iv) All other information or that portion which caused it to be listed.
(3)(i) A concise explanation of the relevance, as it is presently understood by the individual designated in § 1.56(c) most knowledgeable about the content of the information, of each patent, publication, or other information listed that is not in the English language. The concise explanation may be either separate from applicant’s specification or incorporated therein.
(ii) A copy of the translation if a written English-language translation of a non-English-language document, or portion thereof, is within the possession, custody, or control of, or is readily available to any individual designated in § 1.56(c).
(b)(4) Each foreign patent or published foreign patent application listed in an
information disclosure statement must be identified by the country or patent office which issued the patent or published the application, an appropriate document number, and the publication date indicated on the patent or published application.
(5) Each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication.
Accordingly, the references have been considered to the extent presented in the English language; as presented and accompanied by reference document which is an English language equivalent or translation, to the extent cited in the instant Application’s disclosure, or as cited by the Examiner in a PTO-892. References which have been considered have been initialed (fully considered) or also annotated in the IDS (to indicate the extent considered). References which have not been considered have been lined through. In the instant case, the Foreign Patent Document ( Cite No. 1) lacks an accompanied reference document which is a full English language equivalent or translation, and therefore has only been considered fully (i.e. only those portions for which an English translation has been provided were considered).
Please note, Applicant is also required to provide page numbers and/or a page sheet count in the citation.
Specification & Claim Objections
The claims and/or disclosure is objected to because of the following informalities:
Claim 7 appears to contain a typographical/grammatical error wherein the claim recites “wherein the nutritional composition is capable as an RNA-dependent RNA polymerase (RdRp) inhibitor” which renders the claim unclear as to what the nutritional composition is capable of. Appropriate correction is suggested.
The above are considered necessary grammatical corrections; however, is not exhaustive of all possible informalities, as examination is not made for the purpose of securing grammatical perfection.
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(s) 1-5 is/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.
The term “inhibiting” in claim(s) 1-5 is a relative term which renders the claim indefinite. The term “inhibiting” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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 6-7, 13-15 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for inhibiting binding of a SARS-CoV-2 spike protein to a human angiotensin-converting enzyme 2 (ACE2); inhibition of an activity of a main protein (mpro) of SARS-CoV-2; inhibition of an activity of a papain-like protein (PLpro) of SARS-CoV-2; and/or inhibition of an activity of the RdRp of the SARS-CoV-2, does not reasonably provide enablement for inhibiting survival or an (i.e any and/or all) RNA virus infections. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, "Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue', not 'experimentation"' (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations" (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Undue experimentation would be required to practice the invention as claimed due
to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples in the specification; nature of the invention; state of the
prior art; relative skill level of those in the art; predictability or unpredictability in the art;
and breadth of the claims. In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
(1) The nature of the invention and (2) the breadth of the claims:
Applicant’s claims are broadly drawn to a nutritional composition for inhibiting survival of an RNA virus, consisting of an astaxanthin extract and at least one probiotic extract, wherein the at least one probiotic extract is selected from the group consisting of a lipoteichoic acid and a peptidoglycan and method of using the same. However, Applicant’s specification only demonstrates the composition for inhibiting influenza A and/or SARS-CoV-2 (see FIGs. 1-7B). Thus, the claims taken together with the specification imply a breadth greater than supported by the disclosure.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The prior art teaches the development of anti-viral compositions is unpredictable and time-consuming. The state of the art is such that astaxanthin and probiotics (i.e. lipoteichoic acid and/or peptidoglycan) were each known to have antioxidant, anti-inflammatory, and immunomodulatory properties, as taught by Talukdar, et al. and Nayebi, et al. (as of record below). However, the treating of influenza A and/or SARS-CoV-2 with astaxanthin and probiotics as claimed remained unresolved at the time of the instant effective filing date for the breadth claimed. Since the therapeutic treatment of all RNA viruses with astaxanthin and probiotics remained largely unresolved, means for treating all RNA viruses is highly predictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high, generally that of a person with a background in organic and/or synthetic extracts of genus/species containing astaxanthin and probiotics (i.e. lipoteichoic acid and/or peptidoglycan), the preparations, and/or components thereof suitable for treating RNA viruses, as such were not recognized in the art as useful therapeutics therefore. Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
Applicant’s claims are drawn to a astaxanthin and probiotics (i.e. lipoteichoic acid and/or peptidoglycan) for inhibiting RNA virus. Applicant must demonstrate a significant number of working instances. Applicant’s specification does not set forth any evidence the claimed composition(s) and/or uses thereof is/are able to broadly practiced as instantly claimed for all RNA viruses (providing only some examples for influenza A and/or SARS-CoV-2).
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by the Talukdar, et al. and Nayebi, et al. (as of record below), and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention as instantly claimed. The broad recitation of “RNA virus” may include a wide range of viruses (e.g. polio, influenza) with different structures, replication strategies, host interactions, targets, mutation rates, and general mechanism of actions. Accordingly, in view of the high unpredictability and the lack of guidance provided in the specification, on of ordinary skill in the art would be burdened with undue experimentation to practice the invention as broadly claimed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product (i.e. nutritional composition); thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claim recites a nutritional composition for inhibiting survival of an RNA virus, consisting of an astaxanthin extract and at least one probiotic extract, wherein the at least one probiotic extract is selected from the group consisting of a lipoteichoic acid and a peptidoglycan (as disclosed in claim 1 of the instant application). Thus, the claim(s) do recite a product of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or “man-made.” Thus, each of the extracts in turn is a mixture of the naturally occurring compounds found in the particular plants. Combining the extracts from the individual plants leads to a combination of the naturally occurring compounds from each of the plants. Thus, the claims are drawn to mixtures of naturally occurring products.
There is no indication that mixing the specified extracts together as commensurate in scope with the stated claims changes the structure, function, or other properties of the extracts in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, each plant extract is only a mixture of the naturally occurring compounds found in the plant. Each extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. Thus, any markedly distinct effect would not be shown for the whole scope of the broadly claimed invention. Accordingly, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, Applicant’s claim(s) is/are directed to a nutritional composition consisting of an astaxanthin extract and at least one probiotic extract, wherein the at least one probiotic extract is selected from the group consisting of a lipoteichoic acid and a peptidoglycan. Applicant’s claim is directed to a composition with an intended use for inhibiting survival of an RNA virus. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element in the claims is the combination of extracts. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Mixing specific compounds does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, mixing the ingredients together does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field (for example, do not broadly or specifically recite dosage form(s) and/or the therapeutically-effective amounts of the material), and merely recites the natural materials themselves or a multiplicity of natural materials.
In addition, applicant’s intended use of inhibiting survival of an RNA virus is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5-6, 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Talukdar, et al., “Potential of natural astaxanthin in alleviating the risk of cytokine storm in COVID-19”, Biomedicine & Pharmacotherapy, Vol. 132, 2020, in view of Nayebi, et al., “Probiotic supplementation: A prospective approach in the treatment of COVID-19”, Nutr Health. 2022, Vol. 28(2) 163-175.
The instant claim(s) is/are of record, drawn to the following: a nutritional composition consisting of an astaxanthin extract and at least one probiotic extract, wherein the at least one probiotic extract is selected from the group consisting of a lipoteichoic acid and a peptidoglycan, in some embodiments, further comprising a method for treating an RNA virus infection (influenza A virus, SARS-CoV-2), the method comprising administering an effective concentration of a nutritional composition consisting of an astaxanthin extract and at least one probiotic extract, and the at least one probiotic extract is selected from the group consisting of a lipoteichoic acid and a peptidoglycan.
Talukdar, et al., teaches the potential of natural astaxanthin in alleviating the risk of cytokine storm in COVID-19. Talukdar, et al. teaches natural astaxanthin has a clinically proven safety profile and has antioxidant, anti-inflammatory, and immunomodulatory properties (Abstract; page 4) (broadly teaching instant claims 1-15). Talukdar, et al. teaches astaxanthin as an orally bioavailable dietary supplement and administered orally in doses ranging from 4mg to 100 mg/day, with no adverse side effects (see page 13) (broadly teaching instant clams 6-15). Talukdar, et al teaches the pleiotropic protective effects of astaxanthin owing to its potent antioxidant, anti-inflammatory and immunomodulatory actions may support its potential adjunctive use in alleviating and management of cytokine storms and associated risks in COVID-19 patients (see page 4) (broadly teaching instant claims 1-15). Moreover, Talukdar, et al. teaches astaxanthin may act against viral infection by modulating sirtuins, which are known to regulate cellular pathways required through the viral life cycle, including modulating host and viral gene expression of influenza A virus titers (see page 9) (as required in instant claim 8).
Talukdar, et al., is silent as to the nutritional composition consisting of astaxanthin and at least one probiotic extract (i.e. lipoteichoic acid, peptidoglycan) (instant claims 1-15); the effective concentration of the astaxanthin extract, lipoteichoic acid and/or peptidoglycan in the nutritional composition (instant claims 2-4; 13-15); the nutritional composition is capable as an RNA-dependent RNA polymerase (RdRp) inhibitor (instant claim 7); the nutritional composition is capable of inhibiting binding of a SARS-CoV-2 spike protein to ACE2 (instant claim 10); and the nutritional composition is capable of inhibiting an activity of a main protease and/or the papain-like protease of the SARS-CoV-2 (instant claims 11-12).
However, Nayebi, et al. teaches probiotic supplementation as a prospective approach for treatment of COVID-19. Nayebi, et al. teaches that probiotics directly counteract SARS-CoV in the gastrointestinal and respiratory tracts and suppress severe immune responses including precenting cytokine storms to inhibit pathologic inflammatory conditions in the body via modulation of immune responses (Abstract; FIGs. 1-2) (broadly teaching instant claims 1-15). Naybei, et al. teaches commensal bacteria (e.g. probiotics) also regulate Treg cells, innate lymphocytes, and TH cells and greatly affect mucosal immunity and that the immune-modulating activity can be used for therapeutic purposes in COVID-19 (see page 168). Nayebi, et al. teaches probiotics contain immune stimulants such as lipoteichoic acid and peptidoglycan (see page 168) (as required in the instant claims 1-15). Nayebi, et al. further teaches a potential strategy for the prevention and treatment of COVID-19 is through improving the composition of the intestinal flora and its metabolites and that some specific intestinal microorganisms that can reduce intestinal ACE2 expression have also been identified as potential targets for protecting against SARS-CoV-2 (page 170) (as required in the instant claim 10). Nayebi, et al. teaches thus, based on their antiviral and respiratory activities, using probiotics might be an adjuvant therapy to reduce burden and severity of SARS-CoV (Abstract).
It would have been obvious to one of person of ordinary skill in the art at
the time of the instant invention effective filing to have combined astaxanthin as taught by Talukdar, et al. with at least one probiotic (e.g. lipoteichoic acid, peptidoglycan) as taught by Nayebi, et al. as a nutritional composition and/or for treating an RNA virus infection (e.g. SARS-CoV-2 and/or inhibit binding of SARS-CoV-2 to ACE2). A person of ordinary skill in the art would have been motivated to use a composition comprising astaxanthin and at least one probiotic, particularly wherein astaxanthin and the probiotics were known in the art for their immunomodulatory activity and for treating RNA virus infection (i.e. SARS-CoV-2, influenza A virus).
A person of ordinary skill in the art would have been motivated to combine and use a nutritional composition comprising astaxanthin and at least one probiotic, as instantly claimed. Thus, it would have been obvious to a person of ordinary skill in the art to combine the teachings of the references to arrive at the instantly claimed invention(s) with a reasonable expectation of success.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Talukdar, et al., “Potential of natural astaxanthin in alleviating the risk of cytokine storm in COVID-19”, Biomedicine & Pharmacotherapy, Vol. 132, 2020 and Nayebi, et al., “Probiotic supplementation: A prospective approach in the treatment of COVID-19”, Nutr Health. 2022, Vol. 28(2) 163-175, in further view of Karpiński, et al., “In silico studies of selected xanthophylls as potential candidates against SARS-CoV-2 targeting main protease (Mpro) and papain-like protease (PLpro)”, Herba Polonica. 67. 1-8. 10.2478/hepo-2021-0009, (2021).
The claims and teachings of the instant references are of record.
The references are silent as to the effective concentration of the astaxanthin extract, lipoteichoic acid and/or peptidoglycan in the nutritional composition (instant claims 2-4; 13-15); the nutritional composition is capable as an RNA-dependent RNA polymerase (RdRp) inhibitor (instant claim 7); and the nutritional composition is capable of inhibiting an activity of a main protease and/or the papain-like protease of the SARS-CoV-2 (instant claims 11-12).
Karpiński, et al., teaches xanthophylls (i.e. astaxanthin) as potential inhibitors of SARS-CoV-2 main protease (Mpro) and papain-like protease (PLpro) (see whole document) (as required in the instant claims 11-12).
It would have been obvious to one of person of ordinary skill in the art at
the time of the instant invention effective filing to have combined astaxanthin as taught by Talukdar, et al. with at least one probiotic (e.g. lipoteichoic acid, peptidoglycan) as taught by Nayebi, et al. as a nutritional composition and/or for treating an RNA virus infection (e.g. SARS-CoV-2 and/or inhibit binding of SARS-CoV-2 to ACE2). It would have been further obvious to a person of ordinary skill in the art that the method for treating the RNA virus infection, wherein the nutritional composition is capable of inhibiting an activity of SARS-CoV-2 main protease (Mpro) and papain-like protease (PLpro) as taught by Karpiński, et al. A person of ordinary skill in the art would have been motivated to use a composition comprising astaxanthin and at least one probiotic, wherein the nutritional composition is capable of inhibiting an activity of SARS-CoV-2 main protease (Mpro) and papain-like protease (PLpro), particularly where astaxanthin was known in the art to inhibit main protease (Mpro) and papain-like protease (PLpro) of SARS-CoV-2.
A person of ordinary skill in the art would have been motivated to combine and use a nutritional composition comprising astaxanthin and at least one probiotic to inhibit main protease (Mpro) and papain-like protease (PLpro) of SARS-CoV-2, as instantly claimed. Thus, it would have been obvious to a person of ordinary skill in the art to combine the teachings of the references to arrive at the instantly claimed invention(s) with a reasonable expectation of success.
Claim(s) 2-4, 7 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Talukdar, et al., “Potential of natural astaxanthin in alleviating the risk of cytokine storm in COVID-19”, Biomedicine & Pharmacotherapy, Vol. 132, 2020, Nayebi, et al., “Probiotic supplementation: A prospective approach in the treatment of COVID-19”, Nutr Health. 2022, Vol. 28(2) 163-175, Karpiński, et al., “In silico studies of selected xanthophylls as potential candidates against SARS-CoV-2 targeting main protease (Mpro) and papain-like protease (PLpro)”, Herba Polonica. 67. 1-8. 10.2478/hepo-2021-0009, (2021), in further view of Ali, et al., “In silico screening of the effectiveness of natural compounds from algae as SARS-CoV-2 inhibitors: molecular docking, ADMT profile and molecular dynamic studies.”, Journal of Biomolecular Structure and Dynamics, 41(7), 3129–3144 (2022) (Abstract only).
The claims and teachings of the instant references are of record.
The references are silent as to the effective concentration of the astaxanthin extract, lipoteichoic acid and/or peptidoglycan in the nutritional composition (instant claims 2-4; 13-15) and the nutritional composition is capable as an RNA-dependent RNA polymerase (RdRp) inhibitor (instant claim 7).
Ali, et al. teaches natural compounds found in algae (e.g. astaxanthin) interact with SARS-CoV-2 target proteins including main protease and RNA-dependent-RNA polymerase activity (RdRp) (Abstract) (as required in the instant claim 7).
It would have been obvious to one of person of ordinary skill in the art at
the time of the instant invention effective filing to have combined astaxanthin as taught by Talukdar, et al. with at least one probiotic (e.g. lipoteichoic acid, peptidoglycan) as taught by Nayebi, et al. as a nutritional composition and/or for treating an RNA virus infection (e.g. SARS-CoV-2 and/or inhibit binding of SARS-CoV-2 to ACE2). It would have been further obvious to a person of ordinary skill in the art that the method for treating the RNA virus infection, wherein the nutritional composition is capable of inhibiting an activity of SARS-CoV-2 main protease (Mpro) and papain-like protease (PLpro) and/or RNA-dependent-RNA polymerase activity (RdRp) as taught by Karpiński, et al. and Ali, et al. A person of ordinary skill in the art would have been motivated to use a composition comprising astaxanthin and at least one probiotic, wherein the nutritional composition is capable of inhibiting an activity of SARS-CoV-2 main protease (Mpro) and papain-like protease (PLpro) and/or RNA-dependent-RNA polymerase activity (RdRp), particularly where astaxanthin was known in the art to inhibit main protease (Mpro) and papain-like protease (PLpro) and/or RNA-dependent-RNA polymerase activity (RdRp) of SARS-CoV-2.
A person of ordinary skill in the art would have been motivated to combine and use a nutritional composition comprising astaxanthin and at least one probiotic to inhibit main protease (Mpro) and papain-like protease (PLpro) and/or RNA-dependent-RNA polymerase activity (RdRp) of SARS-CoV-2, as instantly claimed. Thus, it would have been obvious to a person of ordinary skill in the art to combine the teachings of the references to arrive at the instantly claimed invention(s) with a reasonable expectation of success.
The references is/are relied upon for the reasons discussed above. If not expressly taught by the references, based on the overall beneficial teaching provided by the references with respect to the ingredients of the composition(s) and/or method(s) of making and/or using disclosed therein, the adjustments of particular conventional working conditions (E.g. the percent by weight of each ingredient in the claimed compositions, i.e. the effective concentration of the astaxanthin extract, lipoteichoic acid and/or peptidoglycan in the nutritional composition (claims 2-4; 13-15)) in which to perform such method is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Thus, absent some demonstration of unexpected results or criticality from the claimed parameters, this optimization would have been obvious before the effective filing date of applicant’s claimed invention.
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 filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within recited processes), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are currently allowed.
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/V.G.V./Examiner, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655