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 of Claims
The amendments and arguments filed 11 December 2025 are acknowledged and have been fully considered. Claims 1, 3, 5-12, 21-22, 24, 26, 28, 31, 33, and 36 are currently pending. Claim 1 is amended; claims 2, 4, 13-20, 23, 25, 27, 29-30, 32, 34-35, and 37-48 are cancelled; claims 5-9 are withdrawn; no claims are new.
Claims 1, 3, 10-12, 21-22, 24, 26, 28, 31, 33, and 36 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. In particular, the rejection of claims under 35 U.S.C. is withdrawn in view of Applicant’s amendment to the claims. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 1 is objected to because of the following informalities:
“a strontium nitrate” should read “strontium nitrate”
“chlorogenic acid and its salts” indicates that the composition comprises chlorogenic acid and every salt of chlorogenic acid. This limitation should read “chlorogenic acid or a salt thereof.”
Appropriate correction is required.
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.
Claims 1, 3, 10-12, 21-22, 24, 26, 28, 31, 33, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Hahn et al. (US 7,404,967; of record) in view of Moser et al. (US 2007/0104676; of record).
Claim 1 is drawn to a composition for treating pain, pruritus, irritation, and inflammation comprising:
strontium nitrate; and
chlorogenic acid.
Claims 3 and 10 are drawn to the composition of claim 1 wherein the composition further comprises a synergistic agent comprising citric acid.
Hahn et al. teach topical compositions for treating skin irritation (Title) including the composition of Example 6 (Col. 31) comprising strontium nitrate and citric acid.
Hahn et al. do not teach the composition comprising chlorogenic acid.
However, Hahn et al. teach the compositions further comprising an antioxidant (Col. 17 lines 55-58). Moser et al. also teach cosmetic compositions for reducing skin irritation (Abstract), further teaching citric acid and chlorogenic acid as suitable antioxidants for use in compositions for reducing skin irritation (Par. [0089]).
And as discussed in MPEP 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
In the instant case, citric acid and chlorogenic acid are both taught in the prior art to be useful for the same purpose as an antioxidant suitable for use in compositions for reducing skin irritation. As such, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Hahn et al. to include chlorogenic acid. It would have been obvious to combine citric acid and chlorogenic acid to obtain a composition with further use as an antioxidant in the strontium composition of Hahn et al., with a reasonable expectation of success.
Based on all of the foregoing, claims 1, 3, and 10 are rejected as prima facie obvious.
Claim 11 is drawn to the composition of claim 3, further comprising at least one enhancing agent, more specifically a moisturizer (claim 12).
Hahn et al. further teach in Example 6 (Col. 31) the composition comprising glycerin (i.e., glycerol), reading on a moisturizer as disclosed in par. [013] of the instant specification.
As such, claims 11-12 are rejected as prima facie obvious.
Claim 21 is drawn to the composition of claim 3, wherein the composition is formulated as a topical.
Hahn et al. teach the composition of Example 6 as a facial cleanser (i.e., a topical composition).
As such, claim 21 is rejected as prima facie obvious.
Claims 22, 24, 26, 28, 31, 33, and 36 are intended use claims and do not impose further structural limitation to the compositions of claims 1 and 3.
As the composition of Hahn et al. is capable of being administered to a subject in need thereof, it reads on the claims (see MPEP 2111.02(II)).
As such, claims 22, 24, 26, 28, 31, 33, and 36 are rejected as prima facie obvious.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hahn et al. and Moser et al. as applied to claims 1, 3, 10-12, 21-22, 24, 26, 28, 31, 33, and 36 above, and further in view of Gupta (US 2006/0110415; of record).
The teachings of Hahn et al. and Moser et al. have been set forth above.
Claim 11 is drawn to the composition of claim 3, further comprising at least one enhancing agent, more specifically colloidal oatmeal (Claim 12, Applicant’s elected species).
Hahn et al. and Moser et al. do not teach the composition comprising colloidal oatmeal.
However, Hahn et al. teach the composition comprising glycerin.
Gupta teaches topical compositions for the delivery of cosmetic and pharmaceutical ingredients (Abstract). Gupta further teaches the topical compositions comprising humectants (i.e., moisturizers) including colloidal oatmeal and glycerin.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Hahn et al. to include colloidal oatmeal in the place of glycerin. It would have been obvious to substitute one known humectant suitable for use in topical compositions for the delivery of cosmetic and pharmaceutical ingredients for another, with a reasonable expectation of success.
As such, claims 11-12 are rejected as prima facie obvious.
Response to Arguments
Applicant's arguments filed 11 December 2025 have been fully considered but they are not persuasive.
Applicant argues on pg. 4-5 that the inclusion of chlorogenic acid in the composition of Hahn et al. would require undue experimentation, citing Wyeth and Cordis Corp. v. Abbott Laboratories, 720 F.3d 1380 (Fed. Cir. 2013).
This argument is not persuasive. The discussion of undue experimentation in Wyeth is not relevant to the rejection of claims under 35 U.S.C. 103 as Wyeth is only cited in the MPEP regarding the Enablement Requirement of 35 U.S.C. 112(a), see MPEP 2164.01(a) final paragraph and MPEP 2164.08 second paragraph.
Nevertheless, substitution of chlorogenic acid for an antioxidant in the composition of Hahn et al. is well within what would be considered routine experimentation for one of ordinary skill in the art as Hahn et al. teach that the compositions can comprise antioxidants (Col. 17 lines 55-58) and chlorogenic acid is taught to be a suitable antioxidant to be included in compositions for reducing skin irritations as taught by Moser et al. (Abstract and Par. [0089]). As such, the substitution would not be considered undue experimentation.
Applicant argues on pg. 5-6 of the remarks that one of ordinary skill in the art would not rely on Moser et al. for using chlorogenic acid as an agent for blocking the biochemical pathways for pain, itch or irritation as Moser et al. teach chlorogenic acid as an antioxidant and antioxidants as anti-aging agents; further arguing that Moser et al. teach away from using chlorogenic acid because one of ordinary skill in the art would be looking for compounds impacting the biochemical pain and inflammation pathways.
This argument is not persuasive. Regardless of what Moser et al. teaches anti-oxidants to be useful for, Moser et al. teach chlorogenic acid as an antioxidant suitable for use in compositions useful for treating skin irritation (Par. [0089]). Further, Hahn et al. teach that the strontium compositions can comprise an antioxidant (Col. 17 lines 55-58). And as discussed in MPEP 2141(I), "[I]n Sakraida v. AG Pro, Inc., the Court derived . . . the conclusion that when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious." As the combination of a known antioxidant with a known composition that can comprise an antioxidant would yield what one of ordinary skill in the art would predict, the combination of Hahn et al. and Moser et al. is obvious.
Regarding Applicant’s argument that Moser et al. teaches away from the use of chlorogenic acid, as discussed in MPEP 2145(X)(D)(1), "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) ("a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed."). As there is nothing in Moser et al. that criticizes, discredits, or otherwise discourages the combination of chlorogenic acid with the strontium compositions of Hahn et al., there is no teaching away.
Applicant argues on pg. 6 of the Remarks that the combination of Moser et al. with Hahn et al. relies on impermissible hindsight.
As discussed in MPEP 2145(X)(A), , "[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). As the compositions of Hahn et al. and the use of chlorogenic acid as an antioxidant in compositions for treating skin irritation were both known in the prior art before the effective filing date of the claimed invention, the reconstruction is proper.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paul Hoerner whose telephone number is (571)270-0259. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
Prosecution Insights