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 .
Priority
The present application is a National Stage entry of International application PCT/US23/21888 filed 05/11/2023, which claims the benefit of Provisional US application 63340663 filed 05/11/2022.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 10/24/2025, in the matter of Application N° 18/864,389. Said documents have been entered on the record. The Examiner further acknowledges the following:
Claims 1, 3, 5, 7, 9-11, 13-14, 18, 22, 25, 30, 34, 36, 41-42, 44, 49, and 51 are pending.
Claims 1, 3, 5, 7, 9-11, 13-14, 18, 22, 25, 30, 34, 36, 41-42, 44, 49, and 51 are presented for examination and rejected as set forth below.
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, 3, 5, 7, 9-11, 13-14, 18, 22, 25, 30, 34, 36, 41-42, 44, and 49 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature or natural phenomenon without significantly more.
Claims 1, 3, 5, 7, 9-11, 13-14, 18, 22, 25, 30, 34, 36, 41-42, 44, and 49 recite a composition that mixes various plant extracts. Because the mixture does not exist naturally in nature, the individual component plant extracts are considered. There is no evidence within the specification that the compositions recited in claims 1, 3, 5, 7, 9-11, 13-14, 18, 22, 25, 30, 34, 36, 41-42, 44, and 49 contain markedly different characteristics from their naturally-occurring counterparts. Therefore, the instant claims recite a product of nature. Note, claim 51 relates to a method and is not rejected under this section.
Extracts: While extraction of the compounds with a solvent would separate a portion of the animal matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the animal material. There is no evidence or reason to expect that any new compounds are formed during extraction. Furthermore, the balance of omega-3-fatty acids are understood to reflect the mixture of the animal source (i.e., Martinsen (US20170360846A1) describes the need to develop oil ratios different from the natural sources, but does not clarify how that distinction is determined or how the non-natural material is consistently produced [0013], whereby adding different ingredients to supplement the naturally-procured material is an obvious variation [0013]).
Additives: For claims introducing additional actives and additives in various amounts, the Art of the 103 rejection teaches it is well-understood, routine, and conventional in the field to combine the claimed extracts with cosmetic actives and/or additives for topical compositions. The addition of natural or synthetic additives to the natural extract composition does not necessarily mean a change in the structure, function, or other properties of the extracts in any marked way in comparison with the closest naturally occurring counterpart.
No Structure: There is no structural feature claimed that would modify release of an active (e.g., a solution, oil, and/or lotion could be simple conventional formulations comprising the active dissolved in carrier).
No Functional Change: There is no functional change to the active, that is induced by other ingredients. For example, while vitamin D and melatonin have antioxidant functionality, it has not been clearly demonstrated by objective data, if they generally improve stability and/or efficacy of compositions comprising omega-3 fatty acid ingredients.
This judicial exception is not integrated into a practical application because the instantly amended claims do not introduce any additional limitations which transform or improve on the judicial exceptions recited in claims 1, 3, 5, 7, 9-11, 13-14, 18, 22, 25, 30, 34, 36, 41-42, 44, and 49 and do not do anything beyond generally linking the use of the judicial exception to a particular technological environment.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because compositions comprising the instantly claimed ingredients, are well-understood as possessing routine, and conventional activity. The Examiner refers Applicant to the Art of the 103 rejection for the naturally-occurring origin and natural function of the instant ingredients (e.g., omega-3 fatty acids, vitamin D, melatonin, beta-glucan, etc.), that are conventionally included in topical cosmetics, as related to this 101 rejection. The presented data do not support anything other than a combination of the effects of the individual components that is observed when they are combined in the instant compositions. Claims 1, 3, 5, 7, 9-11, 13-14, 18, 22, 25, 30, 34, 36, 41-42, 44, and 49 are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. §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 1, 3, 5, 7, 9-11, 13-14, 18, 22, 25, 30, 34, 36, 41-42, 44, 49, and 51 are 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.
Claims 1, 3, 5, 9-10, 13-14, 17, and 42-44 recite the term “about” to describe numerical ranges, which is indefinite. The definition of the term “about” in the Specification definition on pg 8 is indefinite, whereby Applicant defines “about” to mean “approximately, in the region of, roughly, or around. When the term "about" is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth.” Thus, there is no defined way to modify a numerical range, in terms of the word “about”. Thus, the claim ranges are examined as if the term “about” is not present.
Note that all other claims that depend from claim 1 are also rejected.
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.
Claims 1, 3, 5, 7, 9-10, 25, 34, 36, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Martinsen (US20170360846A1), and in further view of Klein (US6168799B1) and Making Cosmetics (2017).
Applicant’s claims are directed to a topical formulation comprising: about 2 to about 25% by weight of an omega-3 fatty acid component comprising eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or a combination thereof; about 0.01 to about 1% by weight of melatonin; about 0.005 to about 1% by weight of vitamin D3; beta-glucan, and at least one topical carrier comprising water, wherein the topical formulation comprises about 60 to about 85% by weight of the water. The dependent claims further incorporate amount and/or ingredient limitations. Claim 51 is a method of treatment.
Martinsen teaches topical composition that can be in transdermal/transmucosal form [0018] that provides cosmetic and/or medical treatment of skin conditions such as burns and wounds [0062].
Regarding claims 1, 3, 5, and 7: Martinsen teaches topical formulations [0009, 0023] that contains eicosapentaenoic acid to docosahexaenoic acid ratio (DHA:EPA) form purified fish oil [0006-0007], ranging from 2:1 to 1:2, preferably 1:1 [0017], in a 15-35 wt% (Martinsen – claim 1), melatonin (Martinsen – claim 1(g)), and vitamin D (Martinsen – claim 1(b)).
Martinsen teaches melatonin as an antioxidant and/or active ingredient to adjust sleep/wake cycles in amounts of 0.1-100 mg [0053-0054, 0057]. Martinsen teaches vitamin D as an antioxidant in 15-500 mg/g oil (i.e., 1.5 wt% to 50 wt%) [0050, 0057]. Thus, the content container of 1-20 mL (i.e., thus, a maximum diluent/carrier in a container of about 1-20 g oil (d=0.7-0.9 g/mL) and/or water (d=1 g/mL)) [0065], in combination with the amounts/concentrations of melatonin and vitamin D, make obvious the instant concentrations of melatonin and vitamin D3 of claim 1, by encompassing those amounts. With regard to the numerical range, note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)). Furthermore, the concentration of active oils and/or antioxidants (i.e., result-effective variables, whereby the fish oil has positive clinical effects [0004], melatonin and antioxidants such as vitamin D limit oxidation [0044, 0050]) can be routinely optimized via addition of carriers and/or diluents [0059], whereby the skilled artisan would recognize that the amounts of each are result-effective variables are suitable for clinical treatment and/or preservation against oxidation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where 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).
Regarding claim 25: Martinsen further teaches incorporation of Vitamin A (Martinsen – claim 1(c)).
Regarding claim 34: Martinsen teaches creams, etc. [0061].
Regarding claim 36: Martinsen teaches addition ingredients such as glycerin, hyaluronic acids, etc. [0057].
Regarding claim 51: Martinsen teaches a method of administering a composition to individuals with burns/wounds to improve the skin condition (reads on “treating or preventing a dermatological condition…”) [0062]. Furthermore, Martinsen teaches topical skin, eye rectal, and vaginal delivery (Martinsen – claim 6, [0061]), and further teaches eye, skin, vaginal, sleep, and pain conditions [0002, 0053, 0062] via transdermal and/or transmucosal delivery [0060].
In summary, Martinsen teaches a topical composition comprising omega-3 fatty acids (e.g., EPA and/or DHA in combination), melatonin, and vitamin D3, and topical cream formulations incorporating carriers and/or diluents, for a method of improving skin. However, Martinsen does not teach the beta-glucan and amount (instant claims 1, and 9-10), and the explicit amount of water (instant claim 1), and the explicit amount of the antioxidant melatonin and/or vitamin D (instant claims 1 and 10).
Klein teaches beta-glucan topical compositions (e.g., creams or gels) that contain beta-glucan in 0.5-15 wt% (reads on instant claims 1, and 9-10, by encompassing the values) (abstract) with water from 50-100 wt% (reads on instant claim 1) (col 5, top table). With regard to the numerical range, note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)). Klein teaches beta-glucan in this amount provides healing treatment of burns and wounds and scarring (abstract).
Making Cosmetics teaches typical composition amounts, including preservatives (i.e., an antioxidant is a type of preservative) in 0.1-10 wt% (pg 2, face cream), active agents in 1-10 wt% (pg 2, face cream), and 55-75 wt% water (reads on amounts of instant claim 1, via functionality taught by Martinsen and by overlapping the instant amounts). Furthermore, antioxidants are taught in bath oils 1-3 wt% and creams 1-2 wt% (pg 2 and 4) and vitamins (with antioxidant functionality) are taught in creams at 0.1-1 wt% (pg 5). Thus, Making Cosmetics provides a teaching of explicit concentrations for active agents, preservatives, antioxidants, and water in cosmetic cream formulations, (in which cream formulations are disclosed in Martinsen and Klein).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Martinsen’s composition by adding the beta-glucan in 0.5-15 wt% as taught by Klein, because Klein teaches beta-glucan in this amount provides healing treatment of burns and wounds and scarring (abstract). This aligns with Martinsen’s objective of a topical medicament (Martinsen – claim 6) that treats burns and wounds [0062]. Furthermore, Martinsen teaches compositions that are “ideal for medical multipurpose use in combination with foods, drugs, topical creams, and ointments because predictable physiological and medical benefits may be consistently obtained with these compositions” [0023].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Martinsen’s composition by specifying the preservative, active, and water amounts, that Making Cosmetics teaches for face creams, because Martinsen teaches topical cream formulations [0061] that are attainable by adding various carriers and/or diluents [0059] to the active oil [0013], melatonin (antioxidant [0054]), and vitamin D (antioxidant [0054]), whereby Making Cosmetics teaches typical composition amounts, including preservatives in 0.1-10 wt% (pg 2, face cream), active agents in 1-10 wt% (pg 2, face cream), and 55-75 wt% water (reads on amounts of instant claims 1 and 10, via functionality taught by Martinsen).
Claims 1, 3, 5, 7, 9-11, 13-14, 18, 22, 25, 30, 34, 36, 41-42, 44, 49, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Martinsen (US20170360846A1), Klein (US6168799B1), and Making Cosmetics (2017), as applied to claims 1, 3, 5, 7, 9-10, 25, 34, 36, and 51 above, and in further view of Dermalogica Pro UK (2018), Zhou (US6103240A), Sung (Nutrients, 2020), Baillo (US20200345686A1), and Strait (Araza, 2020).
As discussed above, Martinsen, Klein, and Making Cosmetics teach the broader topical formulation of the instant claim set, including ingredient amounts, cream formulations, and a method of application with respect to various users. However, they do not teach the additional ingredients such as gamma linoleic acid (GLA), borage oil, a cannabinoid, ferulic acid, a medium chain fatty acid, mogrosides, licorice root, and an additional biological active agent (instant claims 11, 13-14, 18, 22, 30, 41-42, 44, 49).
Dermalogica Pro UK teaches common ingredients used in cosmetic/medical topical formulations including GLA (reads on instant claim 11) (pg 11 and 105; reinforces the barrier lipid layer; consider as an active agent), borage oil (reads on instant claims 13-14) (pg 11 and 105, high in GLA that also promotes intact epidermal lipid bilayers; considered as an active agent), ferulic acid (reads on instant claim 22) (pg 107, antioxidant and UV light absorber), licorice root (reads on instant claims 41-42) (pg 107, inhibits melanin biosynthesis and scavenges free radicals), and biological active agent (reads on instant claim 49) (pg 112, i.e., zinc gluconate inhibits the enzyme alpha reductase and scavenges free radicals, and reads on inhibitor of enzyme). The listed ingredients all have a role in skin health and/or antioxidant (i.e., scavenging free radicals) function, which parallels Martinsen’s objective of treating conditions with damaged skin [0062], that also incorporates vitamins and melatonin to scavenge free radicals as antioxidants [0049, 0053].
Zhou teaches compositions that contain mogrosides that function as preservatives in 0.1-99 wt% (reads on instant claims 41 and 44) (Zhou – claim 1). Additionally, Sung teaches compositions that contain mogrosides that function as topical active agents that resolve atopic dermatitis (abstract; pg 5, ‘3. Results’) with activity at low levels of 0-100 ug/mL (i.e., 0-0.01 wt%) (pg 10, figure 7).
Baillo teaches cannabinoid 0.01-5 wt% [0075] topical compositions for treating skin for pain (i.e., Martinsen teaches topical treatment for burns and wounds, which are associated with pain, and the fish oil of Martinsen also treats pain [0002]) (reads on instant claim 18) (Baillo – claim 3). Baillo also teaches capric acid [0121] (i.e., a medium chain fatty acid per instant claim 30). Furthermore, Strait teaches capric acid and caprylic acid which are good antioxidants and disinfectants that help to prevent infections, soften and smooth the skin, retain moisture and alleviate the signs of aging (pg 3).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Martinsen, Klein, and Making Cosmetics by adding the additional ingredients taught by the Art, because all additional ingredients taught above have important roles (e.g., active, preservative, antioxidant, etc.) in topical skin composition for improving skin, whereby the instant amounts are made particularly obvious by Making Cosmetics, in formulations such as creams, which aligns with the goals and compositions of Martinsen and Klein, whereby they generally allow incorporation of additives and antioxidants, and especially ingredients that benefit the skin, in the form of topical cream formulations.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 5, 7, 9-11, 13-14, 18, 22, 25, 30, 34, 36, 41-42, 44, 49, and 51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1, 9, 18, 22, 25, 29-30, 34-35, 43, 45, 51-53, 56, 58-60, 62-64, 67, and 70 of copending Application No. 18/035,690 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because all claim sets teach compositions comprising omega-3 fatty acids, melatonin, vitamin D3, and beta-glucan. From the Examiner perspective, there appears no patentably significant difference in both claim sets.
However, any missed aspects are found in the 103 rejection based on similar rationale.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 5, 7, 9-11, 13-14, 18, 22, 25, 30, 34, 36, 41-42, 44, 49, and 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Klein (US6168799B1), Dermalogica Pro UK (2012), Zhou (US6103240A), Sung (Nutrients, 2020), Baillo (US20200345686A1), and Making Cosmetics (2017):
claims 1-12 of Patent No. US10722542B2
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets teach topical compositions comprising omega-3 fatty acids, melatonin, and vitamin D3. However, the instant claim set does not teach beta-glucan and additional ingredients for topical formulations.
This is remedied by the additionally listed art, who teach beta-glucan and additional ingredients for topical formulations. One of ordinary skill in the art would have been motivated to modify the teachings of patent ‘542 because the additional ingredients taught by the Art all have some capacity to stabilize topical cosmetic formulations and/or improve skin (see 103 rejection above for rationale), whereby the claim set of patent ‘542 is directed to topical cosmetic/medical compositions for topical skin delivery.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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, Ali Soroush can be reached on 571-272-9925. 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.
/R.P./Examiner, Art Unit 1614 06/15/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
Prosecution Insights