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 .
Priority
This application, filed 02/02/2024 is a National Stage entry of PCT/CN2022/111265, International Filing Date: 08/09/2022. PCT/CN2022/111265 claims foreign priority to 202110915843.4, filed 08/10/2021.
Status of Claims
Claims 1-5, 8-9, 12-21, and 23-25 are pending as of the response filed on 4/16/26. Claims 6-7, 10-11, and 22 have been canceled.
Applicant's election with traverse of invention I, claims 1-5, 8-9, 13-21, and 24 in the reply filed on 4/16/26 is acknowledged. The traversal is on the ground(s) that the shared technical feature between inventions I and II as claimed makes a contribution over Kaiser, US 20050142124 A1 because Kaiser fails to disclose or suggest the dose relationship between the zinc containing compound and the selenium containing compound as recited in claim 1. Applicants have further argued therefore inventions I and II possess unity, and each of the claims should be examined together without undue burden on the examiner. This is not found persuasive because although Applicants’ arguments have been considered with respect to Kaiser, the claimed composition, including the recited parts by weight ranges for each of the components would have been encompassed by Serfontein, WO 2004107881 A1, publ. 12/15/2004. Serfontein, as discussed below teaches an exemplary composition comprising selenium-based compounds, including selenomethionine at a dose range between 50-1000 mg; sodium selenite at a dose range between 50-600 mg; L-cysteine (glutathione precursor) at a dose of 50-2000 mg; N-acetyl cysteine (NAC; glutathione precursor) at a dose of 50-3000 mg; and zinc in an amount between 5-60 mg., as well as vitamin C from 50-3000 mg. (p. 25, line 24-p. 26). Therefore, the shared technical feature, a composition comprising a selenium compound from 5-50 parts by weight, a glutathione precursor from 200-1200 parts by weight, and a zinc compound from 20-105 parts by weight doesn’t constitute a special technical feature as it would have been prima facie obvious in view of Serfontein, and unity of invention is lacking.
The requirement is still deemed proper and is therefore made FINAL.
Applicants have requested potential rejoinder of claims 12 and 23 if the restriction is maintained, and have referred to MPEP 706.02(n). The examiner agrees that the withdrawn claims will be considered for rejoinder in the event that claims drawn to the elected invention are found allowable, provided the withdrawn claims depend on or otherwise include all the limitations of the allowed product claims.
Claims 12 and 23 are 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. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/16/26.
Claims 1-5, 8-9, 13-21, and 24-25 were examined. Claims 1-3, 5, 8-9, 14-21, and 24-25 are rejected. Claims 4 and 13 are objected to.
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 1-3, 5, 8-9, 15-17, and 24-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) a composition comprising a mixture of components that occur naturally or as found in naturally occurring products. This judicial exception is not integrated into a practical application because glutathione precursors, selenium, and zinc compounds are present in naturally occurring, and the parts by weight ranges for each component as recited in the claims don’t appear to impart significantly distinct properties to the composition compared to the naturally occurring products. Naturally occurring products are judicial exceptions that are not patentable. See MPEP 2106.064(I): Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not end the eligibility analysis, because claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection.
See Sharma et. al., Sensors Intl., vol. 3, p. 100182, publ. 6/3/2022; in particular, see the 1st para of Intro, where it is stated that ZnO is a naturally occurring chemical. It is also well-known in the art that cysteine and N-acetylcysteine, precursors of glutathione, are naturally occurring amino acids, and numerous selenium containing compounds, such as selenomethionine, are also naturally occurring; see “DL-selenomethionine”, PubChem, publ. 9/16/2004; and L-selenium-methylselenocysteine, also known in the art as methylselenocysteine (“Methylselenocysteine”, Wikipedia). While it is noted the claims recite each component in parts by weight ranges, these ranges don’t appear to impart markedly different characteristics to the composition compared to the naturally occurring products. See MPEP 2106.04(b): Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature. The courts have often described these exceptions using other terms, including "physical phenomena," "scientific principles", "natural laws," and "products of nature." As such, the claims appear to be drawn to a mixture of naturally occurring compounds that do not have markedly different characteristics compared to the compounds as they are found in nature, and are patent ineligible.
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.
Claim(s) 1-3, 5, 8-9, 14-16, and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Serfontein, WO 2004107881 A1, publ. 12/16/2004.
Serfontein teaches nutritional compositions for the prophylaxis or treatment of infections, particularly HIV, and for enhancement of immunity comprised of selenium in synergistic combinations with biologically absorbable sources of glutathione, alkalinity enhancing components, a sulfur compound, and an anti-mutagenic compound (title & abstract; p. 1, lines 6-9; p. 6, line 21-p. 7, line 6). Serfontein teaches an exemplary composition comprising selenium-based compounds, including selenomethionine at a dose range between 50-1000 mg; sodium selenite at a dose range between 50-600 mg; L-cysteine (glutathione precursor) at a dose of 50-2000 mg; N-acetyl cysteine (NAC; glutathione precursor) at a dose of 50-3000 mg; and zinc in an amount between 5-60 mg., as well as vitamin C from 50-3000 mg. (p. 25, line 24-p. 26). Therefore, Serfontein teaches a composition comprising a selenium-based compound, a glutathione precursor, and a zinc containing compound, wherein the selenium based compound, e.g., sodium selenite is present between 50-600 parts by weight, or selenomethionine from 50 to 1000 parts by weight; the glutathione precursor compound, e.g., NAC is present from 50 to 3000 parts by weight; and the zinc containing compound is present from 5 to 60 parts by weight, all which overlap with the claimed ranges. Serfontein further teaches zinc oxide as a zinc-containing compound (p. 41, line 44; p. 42, line 18). The composition is taught to be in various dosage forms, such as liquids, syrups, powders, pills, tablets, or capsules (p. 27, lines 8-10; p. 43, lines 13-14), wherein tablets further comprise a disintegrant (p. 49, line 43), and a flavoring (p. 51, line 37). Therefore, the claimed composition would have been prima facie obvious in view of the teachings of Serfontein before the effective filing date of the claims, and one of ordinary skill in the art would have applied the teachings of Serfontein to arrive at the claimed composition and have had a reasonable expectation of success.
Claim(s) 1-3, 5, 8-9, 15-21, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ockerman, US 20140161878 A1, publ. 6/12/2014.
Ockerman teaches a multi-nutrient supplement comprising vitamins, minerals, trace elements, antioxidants, amino acids, probiotics, and other components to treat diseases associated with oxidative stress (title & abstract; para [0003]). Ockerman teaches an exemplary composition comprising a selenium compound from .0001-10 mg. (from .0001 to 10 parts by weight), a zinc compound from .001-50 mg. (from .001 to 50 parts by weight); dried blueberry powder from .0001-2000 mg. (e.g. blueberry essence, from .0001 to 2000 parts by weight); and vitamins such as vitamin A from .01-10 mg. (from .01 to 10 parts by weight) (p. 3, table 1). Ockerman further teaches the composition to include N-acetyl cysteine (NAC, a glutathione precursor) in an amount of 400 mg. (para [0056]), or alternatively L-cysteine (glutathione precursor) in the same amount as NAC (para [0027], [0071]). In addition to the amounts of compounds taught above, Ockerman teaches it is understood to those skilled in the art that other amounts of compounds may be beneficial (para [0031]). Ockerman teaches selenium compounds to include selenomethionine, and zinc compounds to include zinc lactate (para [0025]). Ockerman teaches the supplement in the form of tablets or capsules, and teaches the tablets to comprise pharmaceutically acceptable excipients such as microcrystalline cellulose (e.g. filler), magnesium stearate (e.g., lubricant), silicon dioxide (e.g., glidant), shellac, talcum powder, isomaltose, and mannitol (para [0039]). Therefore, the claimed composition would have been prima facie obvious in view of the teachings of Ockerman before the effective filing date of the claims, and one of ordinary skill in the art would have applied the teachings of Ockerman to arrive at the claimed composition and have had a reasonable expectation of success.
Regarding instant claim 20, Ockerman teaches as discussed above, including tablet dosage forms, and teaches the tablets to comprise pharmaceutically acceptable excipients such as microcrystalline cellulose (e.g. filler), magnesium stearate (e.g., lubricant), silicon dioxide (e.g., glidant), shellac, talcum powder, isomaltose, and mannitol. Therefore, it would have been prima facie obvious to have prepared the tablet dosage form comprising tableting a mixed powder of the glutathione precursor (NAC or L-cysteine), the zinc containing compound (zinc lactate), the selenium containing compound (selenomethionine) with the blueberry flavoring powder, the lubricant (magnesium stearate), the glidant (silicon dioxide), and the filler (microcrystalline cellulose). Furthermore, it is noted claim 20 is drawn to a composition, not a process of preparation, and therefore this claim is drawn to a product-by-process. See MPEP 2113(I): "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). As Ockerman teaches tablet formulations as claimed, and there is no evidence of record to show the process recited in this claim results in a different tablet formulation than that taught by Ockerman, this claim is not distinct from Ockerman.
Regarding instant claim 21, “or the capsule formulation is prepared by the following preparation method:…”, it is noted that Ockerman teaches the compositions as described above in the form of tablets or capsules. Moreover, claim 21 is drawn to a formulation, not a process of preparation, therefore, this claim is drawn to a product by process. See MPEP 2113(I): "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). As Ockerman teaches capsule formulations as claimed, and there is no evidence of record to show the process recited in this claim results in a different capsule formulation than that taught by Ockerman, this claim is not distinct from Ockerman.
Regarding instant claim 25, although Ockerman explicitly teaches NAC or L-cysteine in an amount of 400 mg., or 400 parts by weight, Ockerman further teaches the amounts of compounds can be adjusted to optimize benefit. Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have adjusted the amount of NAC or L-cysteine in the composition and have arrived at 450 parts by weight by routine experimentation, in the absence of evidence showing the criticality of this amount; see MPEP 2144.05(II): Generally, 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).
Claim Objections
Claims 4 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627
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