Prosecution Insights
Last updated: April 17, 2026
Application No. 18/034,660

COMPOSITION CONTAINING 5-AMINOLEVULINIC ACID HYDROCHLORIDE

Non-Final OA §103§112
Filed
Apr 28, 2023
Examiner
MOREAU, NASHARA LOUISE
Art Unit
1655
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
unknown
OA Round
1 (Non-Final)
Grant Probability
Favorable
1-2
OA Rounds
2y 1m
To Grant

Examiner Intelligence

Grants only 0% of cases
0%
Career Allow Rate
0 granted / 0 resolved
-60.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Fast prosecutor
2y 1m
Avg Prosecution
24 currently pending
Career history
24
Total Applications
across all art units

Statute-Specific Performance

§101
12.5%
-27.5% vs TC avg
§103
43.8%
+3.8% vs TC avg
§102
15.6%
-24.4% vs TC avg
§112
27.1%
-12.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 0 resolved cases

Office Action

§103 §112
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 Applicant’s election with traverse of Group I, claims 1-2 in the reply filed on February 12, 2026 is acknowledged. The traversal is on the ground(s) that the features in the independent claims (claims 1 and 3) overlap in scope and are obvious variants. This is not found persuasive because as demonstrated through claims 1 and 3 itself, the compositions are different in terms of ingredients within both of the compositions. Each ingredient within the compositions of claims 1 and 3 have vastly different origins as well as functions (e.g. Indole-3-Acetic Acid or IAA is known for being used for plant development), in addition, due to the ingredients having different functions, it could alter how the finished composition can be utilized. Thus, applicant’s argument is not persuasive. Claims 3-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-2 are examined on the merits. 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 2 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 2 is indefinite because it is unclear what “balance” means; the specification does not list the exact meaning of the phrase. It is unclear if “balance” refers to a specific amount of mineral water that should be added to the composition or if “balance” refers to how much mineral water should be added, bringing the total composition weight percentage to 100% after all of the other ingredients have been included. Thus, the metes and bounds of the claim are unclear. Claim 2 is also indefinite because the use of “consisting” in line 1 is unclear. “Consisting” is not a traditional transitional phrase. “Consisting of” is a transitional phrase that indicates that any unrecited elements are excluded (see MPEP section 2111.03). It is unclear if the use of “consisting” in claim 2 is intending to limit the claim to exclude unrecited elements or if this is a typographical error which was intended to read “comprising.” For the sake of examination, the claim will be interpreted as “comprising” since this is the broadest reasonable interpretation and because applicant’s specification does not specifically describe an embodiment stating that the composition is “consisting of” the claimed ingredients. However, clarification is needed. 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) 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Soler (WO 2018141988 A1), Lee Chung (KR 20130049995 A– English translation provided), Sim Young (KR 101634786 B1 – English translation provided), Klaveness (WO 2009136179 A1), Kim Tae (KR 101722181 B1 – English translation provided), Walther (WO 2012175742 A2), Lange (WO 2019170238 A1), Wang (CN 110292547 A – English translation provided), Hillebrand (WO 2019108715 A1), Ella-Louise (U.K. Pub. No. GB 2563283 A), Prunel (WO 2014108846 A2). Regarding claims 1 and 2, Soler teaches a cosmetic composition that comprises the hydrochloride salt of ALA ([e.g. 5-aminolevulinic acid hydrochloride]) (page 6). Soler teaches medical conditions of the skin that may be prevented and/or treated with the compositions according to the present invention include acne vulgaris (e.g. acne) (page 11). Soler does not teach a cosmetic composition that contains the remainder of the ingredients (as claimed within the present invention) in the same composition and in weight percentages such as fermented black codonopsis extract, cordyceps extract, krill oil, polydeoxyribonucleotide sodium, propylene glycol, hyaluronidase, l-carnitine, caffeine, organum vulgare leaf oil, ascorbic acid (vitamin C), allantoin, cetyl alcohol and mineral water. Lee Chung teaches a cosmetic composition that contains 0.001-80 wt% of fermented Codonopsis lanceolata extract (abstract). Lee Chung teaches that the deodeok ([another name for C. lanceolata]) fermented extract of the present invention has a significant effect on other skin diseases such as acne (page 12). Sim Young teaches a cosmetic composition that contains 1-10 wt% of Cordyceps militaris extract (abstract). Sim Young teaches that the cosmetic composition examples helped to improve anti-inflammation (acne) (page 8 under ‘Test Example 5’ and table 4). Klaveness teaches a cosmetic composition that contains krill oil (page 7, paragraph 23). Klaveness teaches that the compositions of the invention [that] provide benefit include acne (page 21, paragraph 0017). Kim Tae teaches a cosmetic composition that comprises 0.1-5 wt% of PDRN (abstract). Kim Tae teaches PDRN has been developed as a skin-improving cosmetic product with various functions such as [treating] acne (page 2 under ‘Background Art’). Walther teaches a composition that can comprise hyaluronidase (page 29). Walther teaches a cosmetic composition as described hereinbefore for use in reducing or minimizing scar tissue [as a result of acne] (page 26). Lange teaches a cosmetic composition that can comprise l-carnitine (page 24, paragraph 0075). Lange teaches that the cosmetic composition may contain anti-acne agents (page 7, paragraph 0030). Wang teaches a cosmetic composition that comprises caffeine (abstract). Wang teaches a cosmetic composition that comprises propylene glycol (page 3). Wang teaches a cosmetic composition that is capable of relieving skin damage (such as acne) (page 2, under ‘Background’). Hillebrand teaches a cosmetic composition that can comprise oregano oil (page 19, paragraph 0069, line 7). Hillebrand teaches examples of skin conditions that may be reduced, slowed, and/or prevented via the topical composition such as acne (page 3, paragraph 0020). Ella-Louise teaches a cosmetic composition (e.g. a cream) that contains vitamin C (pages 25-26, table 8). Ella-Louise teaches a cream preparing kit for anti-acne (claims 12 and 13). Prunel teaches a cosmetic composition that contains allantoin (page 18, paragraph 6). Prunel teaches an emulsion-type composition that contains cetyl alcohol (page 22, example 3). Prunel teaches a cosmetic composition that can contain mineral water (page 15, line 17). Prunel teaches a cosmetic composition dedicated to the treatment of acne-prone skin (page 4, paragraph 0010-0012). The cosmetic composition as taught by Soler can be modified to include the fermented black C. lanceolata (C. lanceolata is a naturally dark plant) extract as taught by Lee Chung, C. militaris extract as taught by Sim Young, krill oil as taught by Klaveness, PDRN (e.g. polydeoxyribonucleotide sodium) as taught by Kim Tae, hyaluronidase as taught by Walther, l-carnitine as taught by Lange, caffeine and propylene glycol as taught by Wang, oregano oil (e.g. origanum vulgare leaf oil) as taught by Hillebrand, vitamin C as taught by Ella-Louise, allantoin, cetyl alcohol and mineral water as taught by Prunel that can be used within a cosmetic composition, for example, to treat acne as discussed within the specification of the current invention (page 1). Some of the references do not specifically teach adding the ingredients together in the amounts claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “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).” The references teach the use of each of the ingredients in a cosmetic composition. Varying the concentration of ingredients within a cosmetic composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention. In addition, these references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that treat acne. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from them having been used individually in the prior art. Based on the disclosure by these references that these substances are used in compositions to treat acne, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to treat acne. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET. 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 U 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. NASHARA L MOREAU Examiner, Art Unit 1655 /SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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Prosecution Timeline

Apr 28, 2023
Application Filed
Mar 19, 2026
Non-Final Rejection — §103, §112 (current)

Precedent Cases

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MANUFACTURING METHOD FOR COMPOSITION PROMOTING BONE DENSITY ENHANCEMENT
2y 5m to grant Granted Feb 10, 2026
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Prosecution Projections

1-2
Expected OA Rounds
Grant Probability
2y 1m
Median Time to Grant
Low
PTA Risk
Based on 0 resolved cases by this examiner. Grant probability derived from career allow rate.

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