Prosecution Insights
Last updated: August 06, 2026
Application No. 18/458,248

Topical Hyperpigmentation Compositions and Method of Use

Non-Final OA §103
Filed
Aug 30, 2023
Priority
Aug 30, 2022 — provisional 63/373,891
Examiner
CAIN, JENNIFER LYNN
Art Unit
1655
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Allergan Sales, LLC
OA Round
1 (Non-Final)
41%
Grant Probability
Moderate
1-2
OA Rounds
5m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 41% of resolved cases
41%
Career Allowance Rate
21 granted / 51 resolved
-18.8% vs TC avg
Strong +68% interview lift
Without
With
+67.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
33 currently pending
Career history
100
Total Applications
across all art units

Statute-Specific Performance

§101
6.7%
-33.3% vs TC avg
§103
44.6%
+4.6% vs TC avg
§102
17.6%
-22.4% vs TC avg
§112
23.5%
-16.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 51 resolved cases

Office Action

§103
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 . Election/Restrictions Claims 26-30, 33, 34, 36, 37, and 47-50 are pending in the instant application. Applicant’s elections without traverse, of the species of Claims 26 and 37, in the reply filed on 12 June 2026, and Group I, Claims 24-46, in the reply filed 13 January 2026, are acknowledged. Claims 1-25, 31, 32, 35, and 38-46 are cancelled by applicant’s amendment. Claims 47-50 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 37 is amended. Claims 26-30, 33, 34, 36, and 37 are being examined on the merits. Specification The disclosure is objected to because scientific names should be written in italics with the genus name capitalized and the species name in lowercase throughout the document. For example, terms “nelumbo nucifera” and “Nelumbo Nucifera” on page 20 should read: --Nelumbo nucifera--. Appropriate correction is required. Claim Objections Claims 26-30, 33, 34, 36, and 37 are objected to because scientific names should be written in italics with the genus name capitalized and the species name in lowercase in Claims 26 and 36. Appropriate correction is required. All other claims depend directly or indirectly from rejected claims and are, therefore, also objected to for the reasons set forth above. Claim Rejections - 35 USC § 103 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 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 26-30, 33, 34, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Sawaki et al. (JP 2019156816 A, machine translation, 16 pages) in view of Cosmetic Ingredient Review (Vitis vinifera (Grape) Ingredients as Used in Cosmetics, 2012, 29 pages) and Khan et al. (Exp Thera Med, 2020, 3189-3196). The instant claims are as of record, drawn to a topical composition comprising bisbenzylisoquinoline alkaloids, tranexamic acid, niacinamide, phytic acid, resorcinol, grape flower cell extract, and water. Sawaki et al. teach external (topical) skin preparations comprising: bis-type alkaloids (bisbenzylisoquinoline alkaloids; pg. 9, para. 6; as required for instant Claim 26); 1-2 parts (pg. 12-13) tranexamic acid and derivatives thereof (pg. 9, para. 4; as required for instant Claim 26); nicotinic acid derivatives such as niacinamide (pg. 9, para. 6; as required for instant Claim 26); phytic acid (pg. 9, para. 2; as required for instant Claim 26); resorcinol (pg. 9, para. 4; as required for instant Claim 26); water (examples, pg. 11-15; as required for instant Claim 26); kojic acid and derivatives thereof (kojic dipalmitate; pg. 9, para. 5; as required for instant Claim 30); ascorbic acid and derivatives thereof (Vitamin C; pg. 9, para. 5; as required for instant Claim 30); lotus seed extract (Nelumbo nucifera germ extract; pg. 9, para. 7; as required for instant Claim 36); hyaluronic acid and its derivatives (sodium hyaluronate; pg. 8, para. 4-5; examples, pg. 12-13; as required for instant Claim 37); allantoin, chamomile extract, and aloe extract (anti-inflammatory agent; pg. 4, para. 2; instant specification pg. 8; as required for instant Claim 33); lactic acid, glycolic acid, citric acid (pg. 9, para. 3), malic acid (pg. 9, para. 5), and salicylic acid (pg. 9, para. 6; instant specification pg. 9; as required for instant Claim 34); and additional ingredients including fragrances and antioxidants as necessary (pg. 3, para. 1). Sawaki et al. do not teach wherein the composition comprises grape flower cell extract, the specific amounts of bisbenzylisoquinoline alkaloids or tranexamic acid, or specific bisbenzylisoquinoline alkaloids. Cosmetic Ingredient Review, however, teaches that extracts of grape flowers (e.g., any extract of grape flowers would necessarily comprise extracts of the cells thereof) is used in cosmetics as a skin conditioning agent, emollient, and fragrance ingredient (Cosmetic Ingredient Review, Table 1, pg. 11). Khan et al. teach that neferine, liensinine, and isoliensinine are major bisbenzylisoquinoline alkaloids derived from the seed embryo of the lotus plant (e.g., lotus seed extract would comprise both neferine and liensinine; Khan et al., Introduction, pg. 3189; as required for instant Claims 26-29 and 36). A topical cream comprising 0.1% neferine (0.0005-1.0 wt%; Khan et al., Materials and Methods, pg. 3190; as required for instant Claims 26 and 28) delayed skin wrinkle formation and reduced oxidative stress following UV irradiation (Khan et al., Abstract, pg. 3189). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to include the grape flower extract of Cosmetic Ingredient Review in the composition of Sawaki et al. and the specific bisbenzylisoquinoline alkaloids in the amount taught by Khan et al. and a skilled artisan would be motivated to do so because of the known effectiveness of the grape flower extract as a skin conditioning agent, emollient, and fragrance ingredient and topically applied 0.1% neferine for delaying of skin wrinkle formation and reducing oxidative stress. A skilled artisan could incorporate these ingredients into the composition of Sawaki et al. with a reasonable expectation of success because the composition comprises lotus seed extract and/or bisbenzylisoquinoline alkaloids, as well as fragrances. Additionally, a skilled artisan would know that the extract of lotus seed of Sawaki et al. would comprise its major components, liensinine and neferine, and would additionally be motivated to include liensinine at the same effective amount as neferine because they are both bisbenzylisoquinoline alkaloids. If not expressly taught by the prior art, based upon the overall beneficial teaching provided by this reference with respect to inclusion of bisbenzylisoquinoline alkaloids and tranexamic acid in the compositions disclosed therein, the adjustments of particular conventional working conditions (e.g., determining weight versus volume percentage of bisbenzylisoquinoline alkaloids (instant Claims 26-28 and 36); a specific weight percentage of liensinine (instant Claim 36 or weight percentage of tranexamic acid (instant Claim 26)) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Claims 26-30, 33, 34, 36, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Sawaki et al. (JP 2019156816 A, machine translation, 16 pages) in view of Cosmetic Ingredient Review (Vitis Vinifera (Grape) Ingredients as Used in Cosmetics, 2012, 29 pages) and Khan et al. (Exp Thera Med, 2020, 3189-3196) as applied to Claims 26-30, 33, 34, and 36 above, and further in view of INCI Decoder (2019, 4 pages; 2017a, 1 page; 2017b, 2 pages) and Selleck (Sclareolide, 2011, 1 page). The instant claims and teachings of Sawaki et al. in view Cosmetic Ingredient Review and Khan et al. Sawaki et al. in view Cosmetic Ingredient Review and Khan et al. do not teach wherein the composition further comprises sclareolide, hydroxyacetophenone, diethyl hexyl syringyldenemalonate, or xanthophyll. INCI Decoder teaches that diethylhexyl syringylidenemalonate (diethyl hexyl syringyldenemalonate) is a photostabilizer that protects products from color change; that hydroxyacetophenone is a preservative booster, antioxidant, and soothing agent; and that xanthophyll is an antioxidant, increases skin hydration and elasticity, and absorbs harmful blue light (see whole documents; as required for instant Claim 37). Selleck teaches that sclareolide is used as a fragrance in cosmetics (see whole document; as required for instant Claim 37). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to include the ingredients of INCI Decoder and Selleck in the composition as taught by Sawaki et al. in view Cosmetic Ingredient Review and Khan et al. A skilled artisan could reasonably expect to include known cosmetic ingredients in a topical composition and would be able to do so with a reasonable expectation of success because of their known positive properties as disclosed above. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary. Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Conclusion No claims are currently allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST. 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, Anand Desai can be reached at (571)272-0947. 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. /J.L.C./Examiner, Art Unit 1655 /AARON J KOSAR/Primary Examiner, Art Unit 1655
Read full office action

Prosecution Timeline

Aug 30, 2023
Application Filed
Jul 14, 2026
Non-Final Rejection mailed — §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
41%
Grant Probability
99%
With Interview (+67.5%)
3y 5m (~5m remaining)
Median Time to Grant
Low
PTA Risk
Based on 51 resolved cases by this examiner. Grant probability derived from career allowance rate.

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