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 .
Status
Applicant’s response dated 19 September 2025 to the previous Office action dated 05 August 2025 is acknowledged. Pursuant to amendments therein, claims 1-5, 7-10, 12-14, 18, 20-23, and 25-29 are pending in the application.
Priority
Applicant has claimed the benefit of foreign priority, but the claim is to a domestic U.S. provisional application rather than to a foreign application. Correction is required.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-5, 7, 20-23, 25, and 28-29) in the reply filed on 19 September 2025 is acknowledged.
Claims 8-10, 12-14, 18, and 26-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 September 2025.
Claims 1-5, 7, 20-23, 25, and 28-29 are under current consideration.
Claim Rejections - 35 USC § 112
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 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites the limitation "the capsule" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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, 7, 20, 23, and 28-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon/product without significantly more.
The claim(s) 1 and 20 recite(s) a composition comprising the naturally occurring products vitamin C, zinc, vitamin D3, elderberry fruit extract, ginger root extract, and an excipient, each of which are natural products and thus are not markedly different from their naturally occurring counterparts because they are identical to their naturally occurring counterparts, or they are extracts thereof which are considered natural products as extracted or essential oils are not transformed from natural products such that they have new properties as for example discussed in In re Bhagat, 726 Fed. Appx. 772 (Fed. Cir. 2018). The term “excipient” encompasses natural products such as water or silicon dioxide, each of which are natural products and thus are not markedly different from their naturally occurring counterparts because they are identical to their naturally occurring counterparts.
This judicial exception is not integrated into a practical application because mere mixtures of natural products remain patent ineligible. See, e.g., Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) (mere mixtures of different bacterial species are patent ineligible).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed properties of immune support, neutralization of free radicals, suppression of cough, and stimulation of expectoration of mucous are all properties of the individual natural products, rather than arising from the mixture thereof, as noted by applicant in the instant specification at for example paragraphs [0022], [0025], [0036].
Claims 2-3 merely recite particular varieties of elderberry and ginger, each of which are natural products and thus are not markedly different from their naturally occurring counterparts because they are identical to their naturally occurring counterparts. Moreover, they are not integrated into a practical application or include additional elements that are sufficient to amount to significantly more than the judicial exception for reasons discussed above regarding claims 1 and 20.
Claims 4, 7, and 28-29 merely recite amounts of the individual natural products, which is not sufficient to render the claims patent eligible. See, e.g., Ex parte Burgos, decision of the Patent Trial and Appeal Board dated 03 January 2017, Patent Application No. 13/076,117, pages 6-9, affirmed at 711 Fed.Appx. 646 (Fed. Cir. 2018) (a mixture of naturally occurring compounds is not rendered patent eligible under 35 U.S.C. 101 merely by claiming relative amounts or concentrations of the compounds in the mixture; noting that patent ineligible claims in Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) recited relative amounts of bacterial species in a mixture). Furthermore, the recited zinc oxide is a natural product and thus is not markedly different from its naturally occurring counterpart because it is identical to its naturally occurring counterparts. Moreover, the claims are not integrated into a practical application or include additional elements that are sufficient to amount to significantly more than the judicial exception for reasons discussed above regarding claims 1 and 20.
Claim 5 merely recites an excipient such as silicon dioxide, which is a natural product and thus not markedly different from its naturally occurring counterpart because it is identical to its naturally occurring counterpart. Moreover, the claim is not integrated into a practical application or include additional elements that are sufficient to amount to significantly more than the judicial exception for reasons discussed above regarding claims 1 and 20.
Claim 23 merely recites that the extracts are mixed and slugged (i.e., mixed) together, which would thereby simply produce a mixture, which does not render the claim patent eligible for reasons discussed above regarding claims 1 and 20. Moreover, the claim is not integrated into a practical application or include additional elements that are sufficient to amount to significantly more than the judicial exception for reasons discussed above regarding claims 1 and 20.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prescott ("7 in 1 immune support booster supplement with elderberry, vitamin C and zinc 50 mg, vitamin D 5000 IU, turmeric curcumin & ginger, echinacea - immunity for adults kids, immune defense (120 capsules) $25.12", 08 December 2020, pages 1-6; of record).
Regarding claims 1 and 20, Prescott discloses capsules for immune defense (title) containing vitamin C, zinc, vitamin D3, elderberry extract, and ginger (page 2), which reads on the claimed composition for immune support comprising vitamin C, zinc, vitamin D3, elderberry fruit extract, ginger root extract, and at least one excipient, in that the capsule wall material of Prescott is an excipient. Further regarding the claimed recitation of “for immune support”, such is a statement of intended use of the claimed composition/product requiring no additional structure/elements.
Further regarding claims 1 and 20, regarding the recitation of the composition being effective to neutralize free radicals and to suppress cough and to stimulate the expectoration of mucous, such properties are presumed inherent in the capsules of Prescott as discussed above per MPEP 2112(V) and 2112.01(I) given that such capsules of Prescott and the claimed composition are at least substantially identical and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II). Moreover, Prescott discloses that the pills provide daily antioxidant support (page 2), which reads on the claimed composition being effective to neutralize free radicals.
Claim(s) 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prescott as evidenced by Wagner-Salvini (US 2020/0352206 A1; published 12 November 2020).
Regarding claim 2 as it refers to claim 1, Prescott discloses capsules for immune defense (title) containing vitamin C, zinc, vitamin D3, elderberry extract, and ginger (page 2), which reads on the claimed composition for immune support comprising vitamin C, zinc, vitamin D3, elderberry fruit extract, ginger root extract, and at least one excipient, in that the capsule wall material of Prescott is an excipient. Further regarding the claimed recitation of “for immune support”, such is a statement of intended use of the claimed composition/product requiring no additional structure/elements.
Further regarding claim 2 as it refers to claim 1, regarding the recitation of the composition being effective to neutralize free radicals and to suppress cough and to stimulate the expectoration of mucous, such properties are presumed inherent in the capsules of Prescott as discussed above per MPEP 2112(V) and 2112.01(I) given that such capsules of Prescott and the claimed composition are at least substantially identical and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II). Moreover, Prescott discloses that the pills provide daily antioxidant support (page 2), which reads on the claimed composition being effective to neutralize free radicals.
Further regarding claim 2, Prescott discloses that the elderberry is Sambucus elderberry and the elderberry extract is black elderberry extract (page 2), and black elderberry is also known as Sambucus nigra as evidenced by Wagner-Salvini at paragraph [0225], which reads on the claimed elderberry being Sambucus nigra.
Claim(s) 3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prescott as evidenced by Hawkins (US 2009/0186012 A1; published 23 July 2009).
Regarding claim 3 as it refers to claim 1, Prescott discloses capsules for immune defense (title) containing vitamin C, zinc, vitamin D3, elderberry extract, and ginger (page 2), which reads on the claimed composition for immune support comprising vitamin C, zinc, vitamin D3, elderberry fruit extract, ginger root extract, and at least one excipient, in that the capsule wall material of Prescott is an excipient. Further regarding the claimed recitation of “for immune support”, such is a statement of intended use of the claimed composition/product requiring no additional structure/elements.
Further regarding claim 3 as it refers to claim 1, regarding the recitation of the composition being effective to neutralize free radicals and to suppress cough and to stimulate the expectoration of mucous, such properties are presumed inherent in the capsules of Prescott as discussed above per MPEP 2112(V) and 2112.01(I) given that such capsules of Prescott and the claimed composition are at least substantially identical and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II). Moreover, Prescott discloses that the pills provide daily antioxidant support (page 2), which reads on the claimed composition being effective to neutralize free radicals.
Further regarding claim 3, Prescott discloses that the capsule includes ginger (page 2), and ginger is also known as Zingiber officinale as evidenced by Hawkins at Abstract, which reads on the claimed ginger being Zingiber officinale.
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.
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) 4-5, 7, and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prescott in view of Alam (US 2005/0249820 A1; published 10 November 2005).
Regarding claims 4, 7, and 28-29 as they refer to claim 1, Prescott discloses capsules for immune defense (title) containing vitamin C, zinc, vitamin D3, elderberry extract, and ginger (page 2), which reads on the claimed composition for immune support comprising vitamin C, zinc, vitamin D3, elderberry fruit extract, ginger root extract, and at least one excipient, in that the capsule wall material of Prescott is an excipient. Further regarding the claimed recitation of “for immune support”, such is a statement of intended use of the claimed composition/product requiring no additional structure/elements.
Further regarding claims 4, 7, and 28-29 as they refer to claim 1, regarding the recitation of the composition being effective to neutralize free radicals and to suppress cough and to stimulate the expectoration of mucous, such properties are presumed inherent in the capsules of Prescott as discussed above per MPEP 2112(V) and 2112.01(I) given that such capsules of Prescott and the claimed composition are at least substantially identical and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II). Moreover, Prescott discloses that the pills provide daily antioxidant support (page 2), which reads on the claimed composition being effective to neutralize free radicals.
Regarding claims 4, 7, and 28-29, although Prescott discloses zinc, Prescott does not disclose such zinc as zinc oxide as in claims 4, 7, and 28-29.
Alam discloses a nutritional supplement (title) in the form of capsules (abstract) wherein zinc oxide is a preferred source of zinc (paragraph [0025]) wherein the nutritional supplement may contain vitamins, minerals, and herbal and botanical extracts (paragraph [0042]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Prescott and Alam by using the zinc oxide of Alam as the source of zinc in the capsule of Prescott, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use a source of zinc therein that was known to be a preferred source of zinc in capsule supplements as suggested by Alam.
Further regarding claims 4, 7, and 28-29, although Prescott does not disclose such claimed amounts and percentages, Prescott does disclose that the vitamins C (i.e., ascorbic acid) and D an elderberry provide antioxidant support, and the zinc and ginger provides antioxidant and immune support (page 2). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize antioxidant and immune support by varying the amounts and percentages of vitamin C (i.e., ascorbic acid), vitamin D3, zinc oxide (i.e., source of zinc per Alam), elderberry fruit extract, and ginger root extract actives in the capsules of Prescott through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that each of such ingredients is taught by Prescott to provide antioxidant and immune support.
Regarding claim 5, although Prescott does not disclose a specific excipient as claimed, Alam discloses that a nutritional supplement may contain pharmaceutically-acceptable inactive ingredients such as silicon dioxide (paragraph [0023]), which reads on the claimed silicon dioxide excipient.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include silicon dioxide as suggested by Alam in the capsule of Prescott in view of Alam as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to include therein a known pharmaceutically-acceptable inactive ingredient used in supplement capsules as suggested by Alam.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prescott in view of Moscoso Del Prado et al. (WO 2021/260093 A1; published 30 December 2021; priority to 24 June 2020).
Regarding claims 21-22 as they refer to claim 20, Prescott discloses capsules for immune defense (title) containing vitamin C, zinc, vitamin D3, elderberry extract, and ginger (page 2), which reads on the claimed composition for immune support comprising vitamin C, zinc, vitamin D3, elderberry fruit extract, ginger root extract, and at least one excipient, in that the capsule wall material of Prescott is an excipient. Further regarding the claimed recitation of “for immune support”, such is a statement of intended use of the claimed composition/product requiring no additional structure/elements.
Further regarding claims 21-22 as they refer to claim 20, regarding the recitation of the composition being effective to neutralize free radicals and to suppress cough and to stimulate the expectoration of mucous, such properties are presumed inherent in the capsules of Prescott as discussed above per MPEP 2112(V) and 2112.01(I) given that such capsules of Prescott and the claimed composition are at least substantially identical and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II). Moreover, Prescott discloses that the pills provide daily antioxidant support (page 2), which reads on the claimed composition being effective to neutralize free radicals.
Regarding claims 21-22, although Prescott discloses capsules, Prescott does not disclose such capsules as non-vegetable-based or bovine-sourced gelatin as in claims 21-22.
Moscoso Del Prado et al. discloses capsules for food and health supplements (abstract) wherein capsules can preferably be bovine gelatin capsules (page 7 lines 14-25), which reads on the claimed non-vegetable-based or bovine-sourced gelatin capsule.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Prescott and Moscoso Del Prado et al. by using the bovine gelatin capsules of Moscoso Del Prado et al. as the capsule of Prescott, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use a capsule therein that was known to be a preferred capsule for food and health supplements as suggested by Moscoso Del Prado et al.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prescott in view of Small et al. (Journal of Pharmaceutical Sciences, Vol. 66, No. 4, April 1977, pages 504-509).
Regarding claim 23 as it refers to claim 20, Prescott discloses capsules for immune defense (title) containing vitamin C, zinc, vitamin D3, elderberry extract, and ginger (page 2), which reads on the claimed composition for immune support comprising vitamin C, zinc, vitamin D3, elderberry fruit extract, ginger root extract, and at least one excipient, in that the capsule wall material of Prescott is an excipient. Further regarding the claimed recitation of “for immune support”, such is a statement of intended use of the claimed composition/product requiring no additional structure/elements.
Further regarding claim 23 as it refers to claim 20, regarding the recitation of the composition being effective to neutralize free radicals and to suppress cough and to stimulate the expectoration of mucous, such properties are presumed inherent in the capsules of Prescott as discussed above per MPEP 2112(V) and 2112.01(I) given that such capsules of Prescott and the claimed composition are at least substantially identical and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II). Moreover, Prescott discloses that the pills provide daily antioxidant support (page 2), which reads on the claimed composition being effective to neutralize free radicals.
Regarding claim 23, Prescott does not disclose mixing and slugging as in claim 23.
Small et al. discloses an automatic capsule filling machine (title) wherein ingredients are mixed in a blender (page 507 first full paragraph) and wherein powder is compressed into slugs then ejected into capsules (page 504 all including abstract, pages 508-509).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Prescott and Small et al. by mixing and slugging as per Small et al. the ingredients of Prescott then filling into capsules using the capsule filling machine of Small et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to automate the capsule filling process as suggested by Small et al.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prescott in view of Cherukuri (US 2007/0212417 A1; published 13 September 2007).
Regarding claim 25 as it refers to claim 20, Prescott discloses capsules for immune defense (title) containing vitamin C, zinc, vitamin D3, elderberry extract, and ginger (page 2), which reads on the claimed composition for immune support comprising vitamin C, zinc, vitamin D3, elderberry fruit extract, ginger root extract, and at least one excipient, in that the capsule wall material of Prescott is an excipient. Further regarding the claimed recitation of “for immune support”, such is a statement of intended use of the claimed composition/product requiring no additional structure/elements.
Further regarding claim 25 as it refers to claim 20, regarding the recitation of the composition being effective to neutralize free radicals and to suppress cough and to stimulate the expectoration of mucous, such properties are presumed inherent in the capsules of Prescott as discussed above per MPEP 2112(V) and 2112.01(I) given that such capsules of Prescott and the claimed composition are at least substantially identical and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II). Moreover, Prescott discloses that the pills provide daily antioxidant support (page 2), which reads on the claimed composition being effective to neutralize free radicals.
Regarding claim 25, although Prescott discloses vitamin C, Prescott does not disclose such vitamin C as granular as in claim 25.
Cherukuri discloses granules comprising nutritional supplements of vitamins, minerals, and herbals (claim 18) including vitamin C (claim 19) wherein the ingredients can be compressed then filled into a capsule (paragraph [0054]) wherein the granules are free-flowing and non-stick to permit high volume manufacture of capsules (paragraph [0044]), which reads on the claimed vitamin C in a granular form.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Prescott and Cherukuri by using the granular form of ingredients, such as vitamin C, of Cherukuri as the form of ingredients such as vitamin C in the capsules of Prescott, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to permit high volume manufacture of capsules as suggested by Cherukuri.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617