DETAILED ACTION
Claims 1, 4, 8, 10-11, 17-18, 22, 27, 32-34, 36, 39, 44, 48-51, and 53 are pending and under consideration on the merits.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/8/24, 10/9/24, 11/14/24, and 4/11/25 was filed prior to the mailing date of a first Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
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, 4, 8, 10-11, 17-18, 22, 27, 32-34, 36, 39, 44, 48-51, and 53 are rejected under 35 U.S.C. 101.
Claims 1, 4, 8, 10-11, 17-18, 22, 27, 32-34, 36, 39, 44, 48-51, and 53 are drawn to compositions of matter, which are one of the four categories of statutory subject matter. Therefore, whether the claims lack utility is determined by whether the claims are directed to a judicial exception, and, if so, whether the claims include additional elements that are sufficient to amount to significantly more than the judicial exception, using the Step 2A Prong One, Step 2A Prong Two, and Step 2B analysis. See MPEP 2106.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon?
This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II), a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
Claim 1 is directed to an antiperspirant composition comprising an antiperspirant agent that comprises an optionally substituted benzenepropenoic acid, flavonoid, ester of gallic acid, ellagic acid, or mixtures thereof. The skilled artisan would recognize that substituted benzenepropenoic acid, flavonoids, esters of gallic acid, and ellagic acid are products of nature, and dependent claim 32 in fact makes it clear that the antiperspirant agent may be a product of nature by reciting that it is obtained from a natural extract that is cinnamon, black ginger, green tea, or saberry extract. Therefore, the present claims encompass compositions that contain only a mixture of naturally occurring components.
Since the claims read on mixtures of naturally-occurring components, the claim is ‘directed to’ a nature-based product. Since the claims recite a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is a plant in nature that comprises one of the antiperspirant agents recited by claim 1, such as the cinnamon, black ginger, tea tree, or saberry plants.
The Office notes that claim 1 fails to recite any additional elements that would change the structure, function or other characteristics of the individual natural components in any way.
Consequently, claim 1 recites a product of nature exception. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d)II.
Here, the language of claim 1 is limited to the recitation of the naturally occurring chemical compounds that comprise the antiperspirant agent, and fails to recite any additional elements relating to a practical application of the exception. Therefore, claim 1 is directed to the judicial exception.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. Here, claim 1 does not recite any additional elements beyond the structural elements and their properties as discussed above. Therefore, claim 1 does not include any additional element which would amount to ‘significantly more’ than the judicial exception itself and thus the claim as a whole does not amount to significantly more than the judicial exception.
Conclusion: Claim 1 which encompasses a composition that may comprise only a mixture of natural products, is not markedly different in structure or function as compared to the closest naturally-occurring counterpart. Subsequently, claim 1 is directed toward a judicial exception under 35 USC 101. Additionally, dependent claims 4, 8, 10-11, 17-18, 22, 27, 32-34, 36, 39, 44, 48-51, and 53 do not recite any further element which would be considered to provide ‘significantly more’ than the judicial exception.’ Consequently, claims 1, 4, 8, 10-11, 17-18, 22, 27, 32-34, 36, 39, 44, 48-51, and 53 prima facie lack utility under 35 USC 101.
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.
Claims 17-18, 27, 32, 36, and 44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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.
Claims 17-18 recite “ring A.” There is no antecedent basis for this limitation. Clarification is required. For the purpose of examination in view of the prior art, the Office has interpreted this limitation as referring to the aromatic ring on formula (I) of claim 4.
Claims 27, 32, 36, and 44 each recite “preferably,” which renders the metes and bounds of the claim unclear because it is unknown if the limitations following “preferably” are a required or optional limitation. The use of exemplary clam language can be indefinite due to the uncertainty whether the claimed narrower range is a real limitation. MPEP 2173.05(d). For the purpose of examination in view of the prior art, these claims have been given their broadest reasonable interpretation, which is that the narrower limitation is not a requirement.
The scope of claim 36 is indefinite for the additional reason that it depends from claim 35, which has been cancelled. Clarification is required. For the purpose of examination in view of the prior art, the Office has interpreted claim 36 as depending from claim 34.
The scope of claim 44 is indefinite for the additional reason that it depends from claim 38, which has been cancelled. Clarification is required. For the purpose of examination in view of the prior art, the Office has interpreted claim 44 as depending from claim 34.
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.
Claims 1, 4, 8, 10-11, 17-18, 22, 27, 32-34, 48-51, and 53 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Banowski et al. (US Pat. Pub. 2004/0234466)..
As to claims 1, 4, 8, 10-11, 17-18, 22, 27, 32-34, 48-51, and 53, Banowski discloses an antiperspirant composition comprising an antiperspirant (paragraph 106), and further comprising at least one beta-glucuronidase-inhibiting substance such as a flavonoid of claim 1 (paragraph 8) or gallic acid (paragraph 20), which may be in the form of its ester as recited by claims 1 and 11 (paragraph 8).
Regarding claims 10, 22, 27, 32, 34, and 48, the antiperspirant agent may be obtained from a natural extract such as green tea extract (paragraph 7) as recited by claims 32 and 34, and Banowski exemplifies a composition comprising green tea extract at paragraph 120. The skilled artisan would recognize that green tea extract contains ellagic acid (claim 10) and 2-flavonoids (claim 22) such as epigallocatechin gallate (claims 27 and 48), and Banowski expressly teaches that the green tea extract disclosed therein is one that comprises the catechols and gallic acid derivatives (paragraph 47), such that it will comprise the 2-flavonoids recited by these claims.
As to claims 8 and 17-18, Banowski exemplifies a composition comprising green tea extract in combination with caffeic acid (a benzenepropenoic acid of claims 1 and 4 as exemplified at paragraph 120, and which has two hydroxy substituents on the ring as recited by claims 17-18), and also teaches that the antiperspirant agent may be ferulic acid (paragraph 20), which has one hydroxy substituent and one methoxy (i.e., C1 alkoxy) substituent on the ring as recited by claims 17-18.
Regarding claim 33, the glucuronidase-inhibiting substance may be present in the amount of 0.1-10 wt%, which overlaps the recited range to such a large extent as to be anticipating (paragraph 21).
As to claim 49, the plant extract is present in the amount of 0.01 to 20 wt% (paragraph 35), which overlaps the recited range to such a large extent as to be anticipating.
As to claims 50-51, the composition further may comprise a topically acceptable carrier (paragraph 115) or be in the form of a cream or gel (paragraph 60).
Regarding claim 53, the composition may comprise a fragrance (paragraph 107).
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, 4, 8, 10-11, 17-18, 22, 27, 32-34, 36, 39, 44, 48-51, and 53 are rejected under 35 U.S.C. 103 as unpatentable over Banowski et al. (US Pat. Pub. 2004/0234466) in view of Unuofin et al. (Oxidative Medicine and Cellular Longevity (2020)).
The teachings of Banowski are relied upon as discussed above. Banowski further teaches that the composition further optionally may comprise an antioxidant, which Banowski teaches further inhibits odor by counteracting the oxidative decomposition of the components of perspiration, wherein the antioxidant may be a benzenepropenoic acid of claim 1 such as cinnamic acid (claim 8)(paragraph 109), which is also a compound of formula (I) of claim 4 wherein R1 through R4 is hydrogen, Banowski also further teaches that the antiperspirant agent may comprise antioxidant quercetin or polyphenol compounds (paragraphs 8 and 37), but Banowski does not further expressly disclose that the natural extract is black ginger extract comprising a flavan-4-one as recited by claims 32, 34 and 36, and while Banowski teaches that the composition may comprise cinnamic acid as recited by claim 44 as discussed above, it does not further expressly disclose that the source of the cinnamic acid is a cinnamon extract as recited by claims 32, 34, 39.
Unuofin is a review of the antioxidant effects and mechanisms of medicinal plants and their bioactive compounds (Title), and teaches that whole cinnamon extract contains polyphenol antioxidants (Table 1 at page 13) and that black ginger contains quercetin antioxidants (Table 2 at page 19).
As to claims 26, 32, 34, 36, 39, and 44, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Banowski composition by incorporating whole cinnamon and/or whole black ginger extract as additional antioxidants, because Banowski expressly teaches that antioxidants obtained from plant extracts including polyphenols and quercetin compounds are useful in the antiperspirant composition taught therein because they help to further inhibit odor by counteracting the oxidative decomposition of the components of perspiration, and Unuofin teaches that cinnamon contains polyphenols and that black ginger contains quercetin compounds, such that the skilled artisan reasonably would have expected that whole plant extracts of black ginger and cinnamon would provide useful odor inhibition properties to the Banowski composition. Such a modification is merely the combining of known elements according to known methods to achieve predictable results, which is prima facie obvious. MPEP 2143. The whole extracts of cinnamon will comprise 2-flavonoids of claim 39 including cinnamic acid of claim 44 and that of black ginger the flavan-4-ones of claim 36.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 4, 8, 10-11, 17-18, 22, 27, 32-34, 36, 39, 44, 48-51, and 53 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl. No. 18/955,716 and in view of Banowski et al. (US Pat. Pub. 2004/0234466) and/or Unuofin et al. (Oxidative Medicine and Cellular Longevity (2020)) where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a personal care composition comprising a benzenepropenoic acid of formula (I) such as cinnamic acid or from a cinnamon extract and which is present in the amount of 1.5-10 wt%, wherein the composition may comprise an antiperspirant or deodorant agent and a fragrance, and may comprise a topically acceptable carrier and be in the same forms recited by claim 51.
Although the reference claims do not recite that the benzenepropenoic acid comprises ellagic acid or an ester of gallic acid or is a 2-flavonoid such as epigallocatechin gallate or is obtained from black ginger extract comprising a flavan-4-one, it would have been prima facie obvious to incorporate these compounds and extract because Banowski and Unuofin teach that these compounds are antioxidants that are useful in antiperspirant personal care compositions.
Claims 1, 4, 8, 10-11, 17-18, 22, 27, 32-34, 36, 39, 44, 48-51, and 53 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl. No. 18/955,778, and in view of Banowski et al. (US Pat. Pub. 2004/0234466) and/or Unuofin et al. (Oxidative Medicine and Cellular Longevity (2020)) where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a personal care composition comprising a phytochemical such as a 2-flavonoid, ester of gallic acid, ellagic acid, or epigallocatechin gallate.
Although the reference claims do not recite that the benzenepropenoic acid comprises ellagic acid or an ester of gallic acid or is a 2-flavonoid such as epigallocatechin gallate or is obtained from cinnamon extract or black ginger extract comprising a flavan-4-one, it would have been prima facie obvious to incorporate these compounds and extract because Banowski and Unuofin teach that these compounds are antioxidants that are useful in antiperspirant personal care compositions.
Although the reference claims do not recite that the composition comprises a fragrance and a topically acceptable vehicle so as to form a cream or a gel, it would have been prima facie obvious to incorporate a fragrance as taught by Banowski to impart pleasant sensory qualities to the composition, and to formulate the composition as a cream or gel because Banowski teaches these as suitable forms for a personal care composition comprising a 2-flavonoid, ester of gallic acid, ellagic acid, or epigallocatechin gallate.
Although the reference claims do not recite the amount of the phytochemical, it would have been prima facie obvious to use amounts within the recited ranges because Banowski teaches such amounts as suitable for a personal care composition comprising the phytochemical active ingredients recited by the reference claims.
Claims 1, 4, 8, 10-11, 17-18, 22, 27, 32-34, 36, 39, 44, 48-51, and 53 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl. No. 19/249,134 and in view of Banowski et al. (US Pat. Pub. 2004/0234466) and/or Unuofin et al. (Oxidative Medicine and Cellular Longevity (2020)) where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a topical antiperspirant composition comprising a topically acceptable carrier and 1.5-25 wt% of an antiperspirant agent such as trans-cinnamic acid, the composition further comprising a fragrance and being in the form of a cream or a gel.
Although the reference claims do not recite that the benzenepropenoic acid comprises ellagic acid or an ester of gallic acid or is a 2-flavonoid such as epigallocatechin gallate or is obtained from black ginger extract comprising a flavan-4-one, it would have been prima facie obvious to incorporate these compounds and extract because Banowski and Unuofin teach that these compounds are antioxidants that are useful in antiperspirant personal care compositions.
Conclusion
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600