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 .
DETAILED ACTION
Claims 1-2, 4, 9-10, 12, 14 and 19-28 are pending. Claims 19-28 are withdrawn.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/30/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 07/30/2025 is acknowledged and has been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in para. [0229]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 9 is objected to because of the following informalities: K. marxianus should be replaced by the full name the first time it appears. Applicant may consider replacing “K. marxianus” with “Kluyveromyces marxianus”. Appropriate correction is required.
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 1-2, 4, 9, 12 and 14 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.
Claim 1 recites “for topical application and is in the form of suppository”. The claim is indefinite because suppositories are not used topically but are inserted into a body cavity.
Claim 9 recites “a. K. marxianus; b. at least one probiotic microorganism” in lines 2 and 3. Kluyveromyces marxianus is a probiotic yeast (specification [0237]). The claim is indefinite because it is unclear if Kluyveromyces marxianus fulfills the requirement for at least one probiotic microorganism or if the claim requires an additional probiotic microorganism. Applicant may consider amending the claim to recite “at least one probiotic bacterium” in order to obviate the rejection.
Claims 2, 4, 12 and 14 depend from claims 1 and 9 respectively and are also rejected.
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 9-10, 12 and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception of laws of nature, natural phenomena, and products of nature (a nature-based product) without significantly more.
Claims 9-10, 12 and 14 recite a composition (Step 1: YES) comprising K. marxianus, glycerol, and one probiotic microorganism. Claim 10 recites probiotic microorganism is selected from the group consisting of: Lactobacillus, Propionibacterium, Lactococcus, and Leuconostoc, which are all products of nature. Applicant discloses K. marxianus, Lactobacillus, Lactococcus, Propionibacterium, and Leuconostoc are naturally found in probiotic yogurt such as kefir ([0237]). WebMD (WebMD, Glycerol, Overview, Uses, Side Effects, Precautions, Interactions, Dosing and Reviews, 2025, webmd.com/vitamins/ai/ingredientmono-4/glycerol, of record in Office Correspondence mailed on 04/30/2025) reports glycerol is a naturally occurring alcohol in form of liquid (page 2 “Overview”). Claim 12 recites the mixture is suspended in milk, which is a natural product. Claim 14 recites the mixture is kefir. Nourish kefir (Nourish kefir, where do kefir grains come from?, 2023, of record in Office Correspondence mailed on 08/02/2025) reports that kefir grains are naturally occurring in nature (first para.). There is no markedly different characteristic of the recited products compared to their naturally occurring counterpart in its natural state (same structure or form, same biological and chemical properties), and combining them into the recited composition does not change any of their natural characteristics individually or in combination. The claimed product lacks markedly different characteristics and is a product of nature (Step 2A prong 1: YES). This judicial exception is not integrated into a practical application because formulating these natural products into a composition or food product by simply mixing multiple naturally-occurring components is nothing more than an attempt to generally link the product of nature to a particular technological environment (Step 2A prong 2: NO). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B: NO).
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 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Harendza-Harinxma (US 4,847,283, published 07/1989) in view of Salucci (Journal of dermatological science 80.1 (2015): 61-68) and Fragopoulou (Journal of agricultural and food chemistry 55.1 (2007): 80-89), and as evidenced by Desitin (Desitin Maximum Strength Paste, 2025) and EFSA (EFSA Journal 15.3 (2017): e04720, of record in Office Correspondence mailed on 04/30/2025).
The term “consisting essentially of” is construed as equivalent to “comprising”.
Regarding claims 1 and 4, Harendza-Harinxma teaches an ointment composition of 1% tryptophol in Desitin (column 12 lines 23-25). Evidentiary reference Desitin reports that the ointment comprises glycerin (page 1 “Inactive ingredients”). Evidentiary reference EFSA reports glycerin and glycerol are the same (page 10 last para.). Harendza-Harinxma does not teach tyrosol.
However, Salucci teaches that tyrosol protects cells from apoptotic cell death and suggests using it as biological ingredient in topical preparations (Abstract). Salucci teaches using 5 µM tyrosol (page 62 right column first para.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Harendza-Harinxma by adding tyrosol, as suggested by Salucci, and by optimizing the ratio of tryptophol and tyrosol. One of ordinary skill in the art would be motivated to do so in order to form a safe and effective composition to protect the skin. MPEP §2144.06(I) states that “[i]t 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.” Since Harendza-Harinxma and Salucci teach a desire to form a composition with skin protection effect, there is a reasonable expectation of success.
Harendza-Harinxma and Salucci do not teach tryptophol is tryptophol acetate and tyrosol is tyrosol acetate, specifically.
However, Fragopoulou teaches tyrosol acetate and acetylated phenolic compounds are found in nature (Abstract, page 80 right column, para. 2). Fragopoulou teaches acetylated phenolics have the same or higher biological activity compared with the one of the initial phenolic compounds (Abstract, page 86 right column para. 2). Fragopoulou teaches acetyl group improves the cell permeability of phenolic compounds and provides biological activity (page 81 right column para. 4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition taught by Harendza-Harinxma by adding acetyl group to tryptophol and tyrosol, as suggested by Fragopoulou, to make tryptophol acetate and tyrosol acetate. One of ordinary skill in the art would be motivated to do so in order to increase tryptophol and tyrosyl’s cell permeability and improve their biological activity. Since Harendza-Harinxma teaches a desire to form an anti-inflammatory composition comprising a phenolic compound, and Fragopoulou teaches a desire to increase the cell permeability and biological activity of phenolic compounds to be used in pharmaceuticals, there is a reasonable expectation of success.
Regarding claim 2, Applicant discloses tryptophol acetate has a MW of 203 g/mol (FIG. 7A, [042]). Harendza-Harinxma teaches 1% of tryptophol which corresponds to 49 mM tryptophol acetate.
Claims 9-10, 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lin (Australian Journal of Dairy Technology 54.1 (1999): 14, of record in Office Correspondence mailed on 10/25/2024) in view of EFSA, and as evidenced by Romanin (Beneficial microbes 7.1 (2016): 83-93, of record in Office Correspondence mailed on 10/25/2024).
Regarding claims 9 and 12, Lin teaches a fermented milk, kefir, comprising K. marxianus and teaches inoculating the milk with 5% K. marxianus (page 15 para. “Characterization of the LAB and yeast isolates”, Figure 2). Evidentiary reference Romanin reports Kluyveromyces marxianus is a probiotic yeast microorganism (Title).
Lin does not teach the mixture comprises glycerol.
However, EFSA teaches glycerol is used as a food additive, has low acute toxicity, is used as a sweetener, and is used in milk (Title, Abstract, page 3 para. 7, Table 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Lin by adding glycerol to the composition, as suggested by EFSA. One of ordinary skill in the art would be motivated to do so in order to sweeten the composition. Since Lin teaches a desire to form a healthy milk composition, and since EFSA teaches glycerol addition to milk products, there is a reasonable expectation of success.
The limitation wherein said composition is formulated for topical application is a recitation of intended use. The limitation does not add any compositional or structural limitations to the claimed composition and, thus, it is not considered to contribute to the patentability of the claimed composition. See MPEP 2111.02.
Regarding claim 10, Lin teaches kefiran comprises lactic acid such as Lactobacillus and Leuconostoc ( page 14 “Summary).
Regarding claim 14, Lin teaches a mixture of kefiran which comprises lactic acid bacteria and yeasts such as K. marxianus (Summary, page 16 para. “Identification of yeasts”) used to ferment milk.
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 1-2 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12 and 15 of copending Application No. 17/922,790 in view of Hejna (Renewable and Sustainable Energy Reviews 66 (2016): 449-475, of record in Office correspondence mailed on 04/30/2025).
Regarding instant claims 1-2 and 4, copending claim 1 recites composition comprising a Tryptophol acetate and a Tyrosol acetate in a ratio ranging from 4:1 (w/w) to 1:4 (w/w). Copending claim 12 recites the composition is a pharmaceutical composition or a nutraceutical composition. Copending claim 15 recites wherein said Tryptophol acetate and Tyrosol acetate are present in said composition in a molar ratio of 1:1 (w:/w). Copending claims 1, 12 and 15 do not recite glycerol.
However, Hejna teaches glycerol is used in pharmaceutical compositions to form syrups and creams (para. “Introduction”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in copending claims 1, 12 and 15 by adding glycerol as suggested by Hejna. One of ordinary skill in the art would be motivated to do so in order to formulate the composition as a cream. Copending claims 1, 12 and 15 do not recite the claimed concentration. However, one of ordinary skill in the art would be motivated to optimize the concentration of the compounds in order to form a safe and effective composition.
The limitation wherein said composition is formulated for topical application is a recitation of intended use. The limitation does not add any compositional or structural limitations to the claimed composition and, thus, it is not considered to contribute to the patentability of the claimed composition. See MPEP 2111.02.
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7-17 of copending Application No. 17/534,483 in view of Hejna.
Regarding instant claims 1-2 and 4, copending claims 1 and 7-16 recite a composition consisting of a tryptophol acetate and tyrosol acetate and a least one pharmaceutically acceptable carrier wherein said tryptophol acetate and tyrosol acetate are in a ratio of 10:1-1:10. Copending claim 2 recites wherein said tryptophol acetate and tyrosol acetate are each present at a concentration of at least 1 µM within said composition. Copending claim 3 recites wherein said Tryptophol acetate is at a concentration of at least 0.1 µM within said composition. Copending claim 4 recites wherein said tryptophol acetate and tyrosol acetate are in a w/w ratio ranging from 2:1 (w/w)-1:2 (w/w). Copending claims 1-4 and 7-16 do not recite glycerol.
However, Hejna teaches glycerol is used in pharmaceutical compositions to form syrups and creams (para. “Introduction”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in copending claims 1-4 and 7-16 by adding glycerol as suggested by Hejna. One of ordinary skill in the art would be motivated to do so in order to formulate the composition as a cream.
Regarding instant claim 9, copending claim 17 recites a composition consisting of tryptophol acetate, tyrosol acetate, Kluyveromyces marxianus, at least one probiotic microorganism, and at least one pharmaceutically acceptable carrier. Copending claim 17 does not recite the claimed concentration of at least 3% K. marxianus. However, one of ordinary skill in the art would be motivated to optimize the concentration of the microorganism in order to form a safe and effective probiotic composition.
The limitation wherein said composition is formulated for topical application is a recitation of intended use. The limitation does not add any compositional or structural limitations to the claimed composition and, thus, it is not considered to contribute to the patentability of the claimed composition. See MPEP 2111.02.
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4, 9-10, 12 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9, 16-17, 23-26 of copending Application No. 18/258,560 in view of Hejna.
Regarding instant claim 1, copending claim 1 recites a composition comprising a Tryptophol derivative, a 4- Ethyl-Phenol derivative, or a combination thereof. Copending claim 16 recites “wherein said composition is a pharmaceutical composition or a nutraceutical composition”. Copending claim 17 recites “composition comprising a Tryptophol derivative, a 4-Ethyl-Phenol derivative, or a combination thereof, a microorganism mixture and an acceptable carrier”. Copending claim 9 recites “wherein said Tryptophol derivative is Tryptophol acetate, wherein said 4-Ethyl-Phenol derivative is Tyrosol acetate, or combination thereof”. Copending claim 26 recites the mixture is suspended in a medium (i.e., in solution). Copending claims 1, 9, 16-17 and 26 do not recite glycerol.
However, Hejna teaches glycerol is used in pharmaceutical compositions to form creams (para. “Introduction”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in copending claims 1, 9, 16-17 and 26 by adding glycerol as suggested by Hejna. One of ordinary skill in the art would be motivated to do so in order to administer the composition as a cream.
Regarding instant claim 2, copending claim 8 recites wherein said composition comprises any one of said Tryptophol derivative and said 4-Ethyl-Phenol derivative in a concentration ranging from 1 µM to 100 µM.
Regarding instant claim 4, copending claims 1, 9, 16-17 and 26 do not recite ratio ranging from 2:1 (w/w)- 1:2 (w/w). However, one of ordinary skill in the art would be motivated to optimize the ratio of the tryptophol acetate and tyrosol acetate in order to form a safe and effective composition.
Regarding instant claim 9, copending claim 17 recites composition comprising a Tryptophol derivative, a 4-Ethyl-Phenol derivative, or a combination thereof, a microorganism mixture and an acceptable carrier. Copending claim 23 recites wherein said microorganism mixture comprises Kluyveromyces marxianus and at least one probiotic microorganism, and wherein said microorganism mixture comprises at least 3% K. marxianus.
Regarding instant claim 10, copending claim 25 recites probiotic bacterium is selected form the group consisting of Lactobacillus, Propionibacterium, Lactococcus, and Leuconostoc.
Regarding instant claims 12 and 14, copending claim 28 recites the mixture is kefir (i.e., fermented milk).
Response to Arguments
Applicant's arguments filed 07/30/2025 have been fully considered but they are not persuasive.
Applicant argues that reference claim 1 of copending application 17/534,483 relates to an oral composition, which is completely different from the claimed topical composition and argues one skilled in the art would not have consider, based on reference claim 1 and Hejna, to use the composition as a topical composition, by the use of glycerol as a pharmaceutically carrier.
In response to the argument, Hejna teaches glycerol is used in pharmaceutical compositions to form creams (i.e., topical application). In addition, the limitation wherein said composition is formulated for topical application is a recitation of intended use. The limitation does not add any compositional or structural limitations to the claimed composition and, thus, it is not considered to contribute to the patentability of the claimed composition. See MPEP 2111.02.
Applicant argues that the claimed composition is for topical administration and that Spinnler does not teach, nor suggests a composition for topical administration.
In response to the argument, newly referenced prior art Harendza-Harinxma teaches an ointment composition of 1% tryptophol in Desitin which comprises glycerol as discussed above, and teaches the composition is used topically to heal a skin sore (column 12 lines 23-25). Prior art Salucci suggests using tyrosol as biological ingredient in topical preparations in order to protects cells (Abstract). Since both Harendza-Harinxma and Salucci teach tyrosol and tryptophol have a protective effect on the skin and can be used topically, there is a reasonable expectation of success to combine these teachings.
Applicant argues claim 9 relates to a composition wherein the pharmaceutically acceptable carrier consists essentially of glycerol and wherein the composition is for topical administration.
In response to the argument, consisting essentially of is construed as equivalent to comprising. Claim 9 recites a composition of a microorganism mixture comprising, which does not exclude the presence of other components. The limitation for topical administration does not add any compositional or structural limitations to the claimed composition and, thus, it is not considered to contribute to the patentability of the claimed composition. See MPEP 2111.02.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657