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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/10/2026 has been entered.
Status of Claims
Receipt of Remarks/Amendments filed on 03/10/2026 is acknowledged. Claims 1 and 4 are amended and claims 2 and 7-8 are canceled. Claim 9 is new. Claims 1, 3-6, and 9 are currently pending and are examined on the merits herein.
Priority
The instant application filed 05/26/2023, claims benefit to Provisional Application No. 63/349,299, filed 06/06/2022.
Terminal Disclaimer
The terminal disclaimer, filed on 03/10/2026, is acknowledged and has been approved.
Withdrawn Objections/Rejections
Claim 1 was objected to because informalities. Applicant’s amendments to claim 1 have overcome the objection and the objection is withdrawn.
Claims 1 and 3-6 were rejected under 35 U.S.C. 112(b) as being indefinite. Applicant’s amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claims 1 and 3-6 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/534,140. Applicant’s filing of a terminal disclaimer has overcome the rejection and the rejection is withdrawn.
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.
1. Claims 1 and 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Shyur, Lie-Fen, et al. (US 2010/0317603 A1, 12/16/2010, on record), hereinafter US’603 in view of Shyur, Lie-Fen, et al. (US 2019/0060388 A1, 12/16/2010, on record), hereinafter US’388.
US’603 discloses a method of treating an inflammatory disorder in a subject, the method comprising administering to a subject in need thereof an effective amount of an extract prepared from Crassocephalum rabens, wherein the extract is prepared by solvent extraction (claim 1). Such a method reads on administering a composition containing an effective amount of a Crassocephalum rabens extract to an individual as recited in claim 1.
The extract can be prepared by mixing a C. rabens plant with a solvent, such as methanol or ethanol, in room temperature for 1 to 3 days ([0020]). Thus, US’603 teaches ethyl alcohol (i.e., ethanol) as an extraction solvent, as recited in claim 1.
The extract comprises 1,2-di-O-α-linolenoyl-3-O-β-galactopyranosyl-sn-glycerol (dLGG) ([0015]; [0019]-[0020]; claim 3), which reads on the dLGG of claim 1.
The C. rabens bioactive fraction can contain the marker substance (dLGG) in a range from 15 to 90% (e.g., 15-60%) of the weight of a preparation ([0021]), which converts roughly to 150-900 mg/mL. Such a range encompasses the instantly claimed dLGG concentration of 218.05 mg/mL as recited in claim 1.
Regarding claims 3-5, the composition of US’603 which contains the C. rabens extract may be a food or nutritional supplement. It may further be in the form of capsules ([0024]; [0038])).
Regarding claims 4 and 9, the effective doses of the extract will vary, as recognized by those skilled in the art, depending on the types of diseases treated, route of administration, excipient usage, etc. ([0028]). Generally, the dosage will vary with the age, weight, sex, condition, and extent of a condition in a subject, and the intended purpose. The dosage can be determined by one of skill in the art without undue experimentation. The dosage can be adjusted in the event of any counter indications, tolerance, or similar conditions. Those of skill in the art can readily evaluate such factors and, based on this information, determine the particular effective concentration of a composition of the present invention to be used for an intended purpose ([0043]). Regarding a cosmetic composition, the applied amount, the frequency of application, and the period of use vary widely depending upon the active levels of a given composition and the level of regulation desired. Typically, the composition can be applied once per day ([0055]).
In a specific example, mice were treated with the CREa8 subfraction (i.e., dLGG enriched C. rabens extract) at a dose of 10 mg/kg ([0077]). A dose of 10 mg/kg in a 20 g mouse converts to 0.712 mg/kg in a 60 kg human ([0078]), which is around 43 mg total per administration for a 60 kg human.
Regarding claim 6, US’603 specifically teaches a cosmetic composition comprising a dermatologically acceptable carrier and the active compound or extract ([0044]). The cosmetic composition is topically applied to the skin in a safe and effective amount ([0055]), thereby reading on a skincare product for external use. The cosmetic composition is useful for regulating or improving skin condition, including regulating visible or tactile wrinkles or discontinuities in skin texture or color, more especially those associated with skin inflammation, ageing, or other internal factors (e.g., biochemical changes from within the skin) or external factors (e.g., ultraviolet radiation, environmental pollution, wind, heat, low humidity, harsh surfactants, and abrasives) ([0053]). The cosmetic composition also provides visible improvement in skin condition essentially immediately following application of the composition to the skin. Such immediate improvement involves covering or masking skin imperfections such as textural discontinuities (including those associated with skin inflammation or aging, e.g., enlarged pores), or providing a more even skin tone or color ([0056]).
The teachings of US’603 differ from that of the instant invention in that US’603 does not explicitly teach 95% ethyl alcohol as the extraction solvent nor a dLGG concentration of 218.05 mg/mL as recited in claim 1. US’603 also does not explicitly teach an administration dosage of 100-200 mg/day in capsules as recited in claim 4, nor the more specific dosage of 180 mg/day as recited in claim 9.
US’388 discloses a method comprising administering a composition comprising an effective amount of a galactolipids-enriched plant extract or at least one purified object, wherein the galactolipids-enriched plant extract is extracted from Crassocephalum rabens S. Moore (CR) via solvent extraction (claim 1). The galactolipids-enriched plant extract is extracted from a plant sample by using a lower alcohol such as methanol or ethanol ([0010]-[0012]; claim 4). Specifically, the plant extracts are prepared from CR by extracting 15 kg of fresh whole plant with 2-3 times weight of 95% ethanol at room temperature ([0068]), which reads on the 95% ethyl alcohol of claim 1. The purified object (i.e., the enriched galactolipid) is 1,2,di-O-α-linolenoyl-3-O-β-galactopyranosyl-sn-glycerol (dLGG) ([0011]; claim 2).
Regarding the use of 95% ethyl alcohol as the extraction solvent in claim 1, it would have been prima facie obvious to use the 95% ethanol of US’388 to generate the C. rabens extract of US’603 since 95% ethanol is a known and routine extraction solvent in the art. It would have been obvious to one skilled in the art to select 95% ethanol as the extraction solvent since it is known and effective for extracting C. rabens and would predictably generate the desired dLGG-containing extract. One of ordinary skill in the art would have had a reasonable expectation of success in using 95% ethanol since US’603 teaches ethanol extraction and US’388 teaches 95% ethanol for providing dLGG-enriched C. rabens extracts. It would have been further obvious to use the combined extract of US’603 and US’388 in the product forms of instant claims 3-6 since these are known and routine administration forms for C.rabens extract as taught by US’603 above. One skilled in the art could have combined these elements by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding the concentration of dLGG in the C. rabens extract as recited in claim 1, it is discussed above that US’603 teaches the C. rabens bioactive fraction (i.e., extract) to contain dLGG in a range that encompasses the instantly claimed dLGG concentration of 218.05 mg/mL. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. One of ordinary skill in the art could have achieved such a concentration by adjusting the extraction method, as is known and routine in the art. As such, a skilled artisan would have reached the instantly claimed dLGG concentration through no more than routine experimentation, using the concentrations of US’603 as guidance and the ethanol extraction method of US’388. 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).
Regarding the recitation of “for improving a skin condition by functioning as a COL1A1, COL1A2, and ELN gene expression promoter” in claim 1, this is no more than the recitation of an intended use. Similarly, the recitation of “a skin structure related gene regulation composition” does no more than define the intended use of the instantly claimed composition. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. As outlined above, the prior art teaches all of the structural limitations of the claim (i.e., administering an effective amount of the instantly claimed C. rabens extract), meaning the method of the prior art is inherently capable of performing the recited intended use.
Similar to intended use, the recitations regarding the specific properties or outcomes of the method impart no structural limitations into the claims which differentiate them from the prior art. Such recitations simply recite properties which are inherent to the instantly claimed method. The combination of US’603 and US’388 teaches all of the structural limitations of the claims as discussed above. Since the method made obvious by US’603 and US’388 is identical to the claimed method it must necessarily have the characteristics claimed as an inherent property (i.e., the ability to increase the content of collagen or elastin in the skin, decrease pore number/size, and increase the expression of specific genes). It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Additionally, the inflammatory disorder treated by the method of US’603 is further defined as a skin disorder (claim 2), meaning it would have been obvious to use the composition and method of US’603 in skin-related applications.
Regarding the dosage of claims 4 and 9, it would have been obvious to one of ordinary skill in the art to optimize the dosage of the C. rabens extract in a capsule based on the teachings of US’603 before the effective filing date of the claimed invention. Effective dose is a results effective parameter and US’603 describes the various factors that influence it. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B). It would have been obvious to one of ordinary skill in the art to optimize the dosage of the C. rabens extract to reach the dosage of 100-200 mg/day as recited in claim 4, specifically 180 mg/day as recited in claim 9, in order to produce a nutritional supplement with the desired effect. Additionally, US’603 teaches an embodiment in mice that converts to a 43 mg dose per administration in a 60 kg person. It is well within the abilities of an ordinary artisan to optimize such a dosage depending on the desired effect of the treatment method, the rate of administration, the weight of the person etc. As such, one of ordinary skill in the art would have arrived at the instantly claimed dosages through no more than routine experimentation. 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). One of ordinary skill in the art would have had a reasonable expectation of success in optimizing the dose since US’603 sets out the various factors that influence effective dose.
Response to Arguments
Applicant's arguments filed 03/10/2026 have been fully considered but they are not persuasive:
Applicant argues against the rejection under 35 USC 103, asserting that A) the specific extract of the present application demonstrates unexpected gene regulation, a technical effect not disclosed by the prior art. Applicant also argues that B) the specific dLGG concentration of 218.05 mg/mL is non-obvious and critical for the claimed gene-promoting efficacy. Lastly, Applicant asserts that C) the optimization of the specific dosage claimed (i.e., 180 mg/day) results in significantly superior results compared to existing treatments like hyaluronic acid, which constitutes “unexpected results”.
In response to Applicant’s argument of unexpected results, an affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. See In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). In this case, Applicant has not provided a comparison to the closest prior art to sufficiently show unexpected results. Applicant claims unexpected gene regulation, however, every structural element of the instantly claimed method is made obvious by the prior art above. As such, the instantly claimed properties are considered inherent to the method made obvious by the prior art. The prior art is not required to disclose such a technical effect in order for it to be considered inherent nor has the Applicant provided any evidence to the contrary. Secondly, if Applicant wishes to argue the criticality of the instantly claimed dLGG concentration, comparative evidence between a composition having the broader dLGG concentration taught in US’603 compared to the specific dLGG concentration claimed must be provided. Lastly, Applicant claims that the instantly claimed dosages result in unexpectedly superior results compared to existing treatments like hyaluronic acid. However, treatment with hyaluronic acid is not considered the closest prior art given the teachings of US’603 and US’388 above.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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, Sue X Liu can be reached at (571)272-5539. 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.
/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616