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 .
Foreign Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statements
Information Disclosure Statement (IDS) filed on 04/24/2023 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Claims Status
Applicant’s election without traverse of Group I and the species of glycolic acid (component 1), hydrogen peroxide (component 2) and rupintrivir (component 3) and drink solution form in the reply filed on 11/28/2025 is acknowledged.
Claims 6-7 and 20 and 27-34 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/28/2025.
Claims 1-5 and 8-12 are under current examination to the extent of the elected species of: glycolic acid, hydrogen peroxide, rupintrivir, and drink solution.
Sequence Requirements-Specification
This application contains sequence disclosure that is encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.821(a)(1) and (a)(2). This application fails to comply with the requirements of 37 C.F.R. §§ 1.821-1.825. Although the claims in the instant application are not drawn to specific sequences, the disclosure at page 31, lines 17-19 contains sequences that are encompassed by the sequence rules and requires a sequence identifier, e.g., SEQ ID No. Applicants cooperation is requested in checking the entire disclosure to ensure that the application is in sequence compliance.
Any questions regarding compliance with the sequence rules requirements specifically should be directed to the departments listed at the bottom of the Notice to Comply.
APPLICANT IS GIVEN THE TIME ALLOTED IN THIS OFFICE ACTION WITHIN WHICH TO COMPLY WITH THE SEQUENCE RULES, 37 C.R.F. §§ 1.821-1.825. Failure to comply with these requirements will result in ABANDONMENT of the application under 37 C.F.R. § 1.821(g). Extensions of time may be obtained by filing a petition accompanied by the extension fee under the provisions of 37 C.F.R. § 1.136. In no case may an applicant extend the period for response beyond the six-month statutory period. Direct the response to the undersigned. Applicant is requested to return a copy of the attached Notice to Comply with the response.
Claim Objections
Claim 3 is objected to because of the following informalities: For claim language consistency, claim 3 should recite and the hydrogen peroxide is presented in a concentration since hydrogen peroxide is defined in claim 1 as component 2.
Claim 10-11 are objected to because of the following informalities: For claim language consistency, claims 10-11 should recite the rupintrivir since claim 8 defines component 3 as rupintrivir.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 8 recites component 3 is rupintrivir, however claim 8 from which claim 9 depends already defines component 3 as rupintrivir. Accordingly, claim 9 does not further limit.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-5 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature, or natural phenomenon (Step 2A, Prong One). In the instant application, the claims recite the following limitations:
Claim 1 is directed to a composition with the intended use for neutralizing toxic effects of hydrogen peroxide in living cells or tissues comprising at least two components wherein component 1 is glycolic acid and component 2 is hydrogen peroxide.
Claims 2-5 recite the concentrations for the glycolic acid and/or hydrogen peroxide. Claim 12 recites in the form of a drink solution.
The claims are directed to a judicial exception such as a natural phenomenon (e.g., product of nature) as the only compositional requirement set forth in the instant claims is that the composition comprises a combination of naturally occurring ingredients.
Hydrogen peroxide is provided naturally by plant and animal cells, see Barnhardt (The Eco-Friendliness of Hydrogen Peroxide) at pages 1-2.
Glycolic acid is natural compound occurring in fruits, beets and sugarcane, see Medical News Today (Benefits of Glycolic Acid for the Skin), see page 2.
As noted above both glycolic acid and hydrogen peroxide are naturally occurring compounds.
Thus, the claims are directed to a composition of matter wherein the composition contains all naturally occurring ingredients.
MPEP 2106.04(c) states that the markedly different characteristics analysis is part of Step 2A Prong One: “Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. For instance, for the probiotic composition example, the mixture of Lactobacillus and milk should be analyzed for markedly different characteristics, rather than the Lactobacillus separately and the milk separately. See subsection II, below, for further guidance on the markedly different characteristic analysis.”
Further, from MPEP 2106.04(c): “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, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.”
The guidelines for performing the markedly different characteristics analysis, include (a) selecting the appropriate naturally occurring counterpart(s) to the nature-based product limitation, (b) identifying appropriate characteristics for analysis, and (c) evaluating characteristics to determine whether they are "markedly different".
Regarding (a), MPEP 2106.04(c) recites: “When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. For example, assume that applicant claims an inoculant comprising a mixture of bacteria from different species, e.g., some bacteria of species E and some bacteria of species F. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature); Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (although claimed as a pair, individual primer molecules were compared to corresponding segments of naturally occurring gene sequence); In re Bhagat, 726 Fed. Appx. 772, 778-79 (Fed. Cir. 2018) (non-precedential) (comparing claimed mixture of lipids with particular lipid profile to "naturally occurring lipid profiles of walnut oil and olive oil").”
In the instant case, the closest counterparts to the claimed mixture are the individual components of the mixture: a naturally occurring compound of glycolic acid and a naturally occurring compound of hydrogen peroxide.
Regarding (b), MPEP 2106.04(c) recites: “Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673 (unclaimed characteristics could not contribute to eligibility). Examiners can identify the characteristics possessed by the claimed product by looking at what is recited in the claim language and encompassed within the broadest reasonable interpretation of the nature-based product. In some claims, a characteristic may be explicitly recited.”
In the instant case, the preamble of claim 1 “for neutralizing the toxic effects of hydrogen peroxide in living cells” is an intended use of the positively recited composition. The intended use does not breathe life into the claim because the statement merely recites how Applicants intend to use the naturally occurring composition in the instant case, and the intended use does not affect or alter, add to or subtract anything from the body of the claim. Furthermore, the claim merely characterizes the benefit or natural result of administering a naturally occurring composition. Therefore, the intended use recited within at least instant claim 1 is not considered a claim limitation. Subsequently, the scope of claim 1 reads on a composition containing the naturally occurring ingredients in amounts listed for each ingredient for the dependent claims.
Regarding instant claim 12, a drink solution is inclusive of water, thus does not impart markedly different characteristics to the composition containing a mixture of natural ingredients.
Regarding (c), MPEP 2106.04(c)recites: “The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.
If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception. If there is a change in at least one characteristic as compared to the counterpart, and the change came about or was produced by the inventor’s efforts or influences, then the change will generally be considered a markedly different characteristic such that the claimed product is not a product of nature exception.”
A review of the instant disclosure does not indicate that the intended use for neutralizing the toxic effects of hydrogen peroxide requires any particular formulation of the different components, or that any particular amount or ratio of the hydrogen peroxide and glycolic acid components is required in order to achieve the desired outcome. Thus, it is reasonable to conclude that the intended use as recited in the claims does not confer any particular structural or compositional limitation on the instant claims. See MPEP 2111.02 regarding ‘intended use’ limitations.
Consequently, the claimed composition lacks markedly different characteristics and is a product of nature exception (Step 2A, Prong 1: YES)
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2).
The instant claims recite the additional element which indicates that the natural composition is “for neutralizing the toxicity of hydrogen peroxide in cells”. As noted above, this limitation is merely an intended use limitation and does not convey any discernable structural or composition limitations to the claimed product.
This judicial exception is not integrated into a practical application because there are no additional elements recited in the claims beyond the judicial exception. From MPEP 2106.04(d): “Because a judicial exception alone is not eligible subject matter, if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application.” (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B).
As noted above, there are no additional elements recited in the claims beyond the judicial exception, as the claim merely recites the intended use of the natural product and a judicial exception alone is not eligible subject matter (Step 2B: NO). The claims do not recite anything else, compositionally or structurally, which provides an inventive concept that departs from merely reciting a composition containing all naturally occurring components. The amounts recited in instant claims 2-5 do not appear to add significantly more than administering naturally occurring compounds. Therefore, simply combining natural compounds and adjusting the concentration of naturally occurring compounds does not provide significantly more than the judicial exception.
Therefore, the claims are not patent eligible subject matter under 35 USC § 101.
It is suggested to overcome this rejection that Applicants can amend the claims to include rupintrivir as this is a synthetic compound.
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(s) 1 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Howard Murad (United States Patent 6,296,880).
Murad teaches pharmaceuticals formulations containing hydrogen peroxide and glycolic acid, see Example 2, and claims 1 and 3-4.The formulation can contain a solution and elixir, see column 10, lines 23-24. Regarding the recitation “ for neutralizing the toxic effects of hydrogen peroxide, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, Murad meets the same structure claimed to solution forms comprising hydrogen peroxide and glycolic acid, thus is capable of performing the intended use.
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.
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.
Claims 1-5 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Howard Murad (United States Patent 6,296,880) in view of Zhenghong et al. (CN103565803A-published 2/2014).
Murad teaches pharmaceutical compositions comprising hydrogen peroxide and an acidic component inclusive of glycolic acid, see claim 1 and 4. The acidic component which includes glycolic acid can be present from about 0.1-8% by weight with hydrogen peroxide from 0.01-6% by weight and antimicrobial agent from 0.01-1.5% by weight, see column 3, lines 39-56. The antimicrobial agent is inclusive of antiviral agents, see column 3, lines 28-30, column 4, lines 52-55 and column 6, lines 50-68. Such antiviral agents include but are not limited to acyclovir, tamvir and penciclovir, see column 6, lines 63-65. Thus, Murad suggests that the antiviral agent is not limited. The formulations of Murad are taught as solutions and elixirs which meets the limitation of drink solution, see column 10, lines 21-23. The composition includes aqueous liquids such as water, see column 10, line 49, examples 1-14 and column 7, lines 53-58. A 0.01% by weight of glycolic acid is 0.01g of glycolic acid in 100g solution. The molar mass of glycolic acid is 76.05g/mol. Since the solutions include water, the density is about 1g/mL. Mass of glycolic acid= 1000g solution x 0.01/100=0.1g L. To concert mass to moles M=0.1g/L/76.05g/mol= about 0.0013149mol/L. Concentration in mM is 0.0013149mol/L x 1000 mmol/mol= 1.3149mM. An 8% by weight of glycolic acid is equivalent to 1052mM. Therefore, Murad suggests the range for glycolic acid of from 1.3149mM-1052mM which overlaps the instantly claimed amounts of from 0.1-20mM, from 9-11mM, 10mm. A 0.01% hydrogen peroxide is Molarity=0.1g/L /34.0147g/mol (note the molar mass of hydrogen peroxide is 34.0147g/mol)= 0.00294 mol/L. Converting M to mM 0.00294 Mx1000= 2.94mM. Thus a 0.01% hydrogen peroxide is equivalent to about 2.94mM. A 6% by weight hydrogen peroxide is equivalent to 1764mM. Thus, Murad suggests a range of hydrogen peroxide inclusive of from 2.94mM-1764mM which overlaps the clamed range of 10ppm-150mM, or 0.1-150mM. Thus, the amounts of the glycolic acid and hydrogen peroxide overlap and therefore render the instantly claimed amounts obvious. 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) . Furthermore, routes of administration are oral in the alternative to topical, see column 8, lines 39-41. Regarding the recitation “ for neutralizing the toxic effects of hydrogen peroxide, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, Murad meets the same structure claimed, solution forms comprising glycolic acid and hydrogen peroxide, thus is capable of performing the intended use.
Murad teaches that the composition may include antiviral agents from 0.01-1.5% by weight, however does not teach the antiviral agent of rupintrivir.
Zhenghong et al. teach rupintrivir formulations, see abstract. The composition is suitable for oral administration, see pages 2-3. Rupintrivir is advantageous as it can treat drug resistant viruses, see pages 3-4, 7 and 10. Rupintrivir is suitably used at 0.01-99% by weight a formulation, see page 7. The formulation can take solution form, see page 7.
It would have been prima facie obvious to substitute the antiviral agent of Murad for rupintrivir.
One of ordinary skill in the art would have been motivated to do so because rupintrivir is taught to be safe and effective against drug resistant viruses.
There would have been a reasonable expectation of success because Murad teaches the inclusion of antiviral agents which are not limited.
It would have been obvious to adjust the amount of the rupintrivir to obtain the desired antiviral activity as Zhenghong teaches suitable amounts for use are 0.01-99% by weight. Furthermore, Murad teaches that the antiviral agent can be present from 0.01-1.5% by weight. Thus, a 0.01% by weight rupintrivir (mw of 598.66g/mol) is about 0.167MM and a 1.5% rupintrivir is about 25.06mM in aqueous solutions. These amounts overlap and render obvious the range from 0.1-5mM of rupintrivir.
Regarding instant claim 11, the mM amount of hydrogen peroxide is inclusive of from 2.94mM-1764mM while the range of rupintrivir antiviral is suggested from 0.167-25.06mM. A 2.94mM hydrogen peroxide and 0.167mM of rupintrivir meets about a 17:1 molar ratio. Therefore, Murad in view of Zhenghong suggests overlapping molar ratios for hydrogen peroxide and rupintrivir antiviral agent.
Conclusion
Currently, no claims are allowed and claim 1-5 and 8-12 are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619