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/EP2023/025071 filed 02/16/2023, which claims the benefit of Foreign application EP22020066.1 filed 02/18/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 08/19/2024, in the matter of Application N° 18/839,487. Said documents have been entered on the record. The Examiner further acknowledges the following:
Claims 1-12 are pending.
Claims 1-12 are presented for examination and rejected as set forth below.
Claim Objections
Claims 7-8 are objected to because of the following informalities: (1) Claims 7 and 8 both repeat the term “genistein” in each claim; (2) Claim 8 alternates with commas and periods in the numbering used in the chemical nomenclature naming convention, and overall, the spacing for the chemical names is sporadic and should be cleaned up. Appropriate correction is required.
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 1-11 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 1-11 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 1-11 contain markedly different characteristics from their naturally-occurring counterparts (i.e., a basic understanding of the term “composition” is a simple mixture). Therefore, the instant claims recite a product of nature. Because claim 12 is a method claim, the rejection does not apply.
Extracts: While extraction of the compounds with a solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material. There is no evidence or reason to expect that any new compounds are formed during extraction. Furthermore, 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. Thus, the Ophiopogon japonica extract (instant claims 1-3, ceramides (instant claims 4-5), isoflavones (instant claims 6-8), vitamin B such as niacinamide (instant claims 9-11), are all naturally occurring, and there is no indication that they are modified to have markedly different characteristics.
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 1-11 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. Balaraman (US20150297652A1) states that plant extracts and natural ingredients derived from plants are being more commonly used in skin care products for different medicinal and nutritional properties [0003-0017, 0042], including Ophiopogon japonicus (abstract) and ceramide [0049]; isoflavones such as genistein (reads on claims 7-8), etc., that may be derived from additional herbal ingredients such as Punica granatum (reads on claim 6) [0045]; niacinamide and nicotinamide (reads on vitamin B of instant claims 9-11) [0045]. 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 1-11 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 1-11 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 1-11 should use proper form to establish antecedent basis (i.e., the independent claim should start with “A composition”, and subsequent dependent claims use “the composition” when referring back to the composition). See 608.01(i) and 2173.05(e). In this case, claim 1 specifically does not start with “A” (although method claim 12 does start with “A”). Thus, the claims are indefinite on the basis of improper antecedent basis.
Claim 10 recites exemplary language in the form of “including non-vasodilating esters”, that is indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05(d). For examination purposes, the examples provided by the exemplary language are not considered limitations of the claim, and the broadest reasonable interpretation is used.
Claim 9 recites a “vitamin B derivative”, which is indefinite because it is unclear how far one can deviate from the listed parent compounds (i.e., the term “derivative” itself does not provide structure) and yet still remain within the metes and bounds of the invention claimed. Note that the indefiniteness of “vitamin B derivative” is resolved by defined species lists of dependent claims 10-11.
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, 6-9, and 11-12, are rejected under 35 U.S.C. 103 as being unpatentable over Balaraman (US20150297652A1).
Applicant’s claims are directed to a cosmetic composition suitable for use in application to menopausal skin comprising extract of Ophiopogon Japonicus and at least one ceramide (as stated in instant claim 1). Independent claim 12 is a method of applying the composition of claim 1.
The “suitable for use in application to menopausal skin” is an intended use that does not have weight in terms of patentability of a composition (instant claims 1-11). It is further noted that method claim 12 treats any “skin” by application of the composition (i.e., no user population limitation).
Furthermore, the term “derived” of claim 6 is interpreted to imply originates from, and does not mean “chemically-modified”. For instant claim 9, the claims are read such that either “vitamin B” or a “vitamin B derivative” meets the limitation of the claim. The term “including” of claim 10 is considered to have the same meaning as “comprising”. Note that the Art recognizes nicotinic acid, niacin, nicotinamide, niacinamide, and/or nicotinamide as various form of vitamin B3.
Balaraman teaches a composition for treating skin disorders (abstract), including issues of neoplasms, infections, disorders of inflammation, proliferation, autoimmunity, hypersensitivity, pruritus, photodamage or photoaging, wound healing, angiogenesis, hair, nails, odor or hyperhidrosis, and pigmentation [0042].
Regarding claim 1: Balaraman teaches a topical skin composition (abstract, [0019]), comprising Ophiopogon japonicus (abstract, Balaraman – claim 1) and ceramide [0049]. When Balaraman discusses the plant species as a whole [002-0017], Balaraman teaches a preparation method that includes extraction of the plants into plant extract ingredients that have beneficial properties [0005-0006, 0012], including Ophiopogon japonicus that enters the heart, lung and stomach channels and nourishes the yin of the stomach, spleen, heart and lungs and clears heat and quiets irritability [0017]. The amount of composition ingredients (e.g., plant extracts and/or ceramides) are reasonably about 0.1 to about 100% of the weight of a given unit dosage form [0061], with an example of 2 wt% active ingredient Ophiopogon japonicus in Composition 1 [0078].
Regarding claims 6-8: Balaram teaches incorporation of isoflavones such as genistein (reads on claims 7-8), etc., that may be derived from additional herbal ingredients such as Punica granatum (reads on claim 6) [0045] in amounts described above.
Regarding claims 9 and 11: Balaram teaches incorporation of niacinamide and nicotinamide (reads on vitamin B of instant claims 9-11) [0045] in amounts described above.
Regarding claim 12: Balaram teaches a method of topically applying the composition to skin to treat a skin disease or disorder (Balaram - claim 18).
In summary, Balaram teaches the elements and desirability for the limitations of the instant claims, and thus, their obviousness. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Thus, Balaraman teaches the combination of art-known elements (i.e., therapeutic extracts, isoflavones, vitamin B in a topical formulation) according to their disclosed beneficial properties with the resultant product nothing more than one would expect from their combination (i.e., improvement of skin).
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Balaraman (US20150297652A1), as applied to claims 1, 6-9, and 11-12, and in further view of Yao (CN112754978A – machine translation provided; published 2021-05-07), An (Biochemical and Biophysical Research Communications, 2020), and Allen (2009).
As discussed above, Balaram teaches topical compositions, comprising Ophiopogon japonicus (abstract) and ceramide [0049]. However, Balaram does not teach root part of the Ophiopogon japonicus plant (instant claim 2), Ophiopogon D (instant claim 3), or the specific ceramides (instant claims 4-5), or the vitamin B derivatives (instant claim 10).
Yao teaches a topical skin composition using root extract (reads on instant claim 2) of the Ophiopogon japonicus plant [n0008, n0021], that also comprises various ceramides such as ceramide 1, ceramide 3 and ceramide 6 (reads on instant claims 4-5) [n0012] , for moisturizing soothing, repairing skin [n0008] (whereby Balaram teaches compositions that treat skin disorders (abstract, [0042])). Furthermore, Yao teaches it is important to specify ratios and selection of specific ceramides [n0012], because they can work synergistically with Ophiopogon japonicus extract to provide skin repair and moisturizing, etc.[n0008]. Yao additionally teaches incorporation of B vitamins via a lysate that are beneficial to skin care [n0027].
An teaches ophiopogonin D (i.e., a steroidal glycoside from Radix Ophiopogon japonicus plant) that when applied topically produces beneficial results in dermatitis models in mice (pg 41, ‘section 2.3’), that has applicability to dermatitis in children and adults (abstract).
Allen teaches nicotinic acid esters (including myristyl nicotinate) (reads on instant claim 10), as prodrugs, that are preferred over nicotinic acid (aka, niacin or vitamin B3) for transdermal delivery, because the ester prodrug form allows for long release of the active ingredient (pg 1).
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 teachings of Balaram to use the root portion of the Ophiopogon japonicus plant (that also comprises ophiopogonin D) as taught by Yao, because Balaram teaches incorporation of Ophiopogon japonicus plant generally for topical use for skin disorders [0042], and by nourishing yin and quieting irritability [0017]. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Thus, Furthermore, An demonstrates ophiopogonin D (i.e., a steroidal glycoside from Radix Ophiopogon japonicus plant) provides beneficial effects when topically applied in dermatitis models (abstract).
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 teachings of Balaram to incorporate the specific ceramides taught by Yao, because Balaram generally teaches incorporation of emollients such as ceramides [0049]. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Thus, the specified ceramides of Yao would provide the emollient effect as taught by Balaram. Furthermore, Yao teaches it important to specify ratios and selection of specific ceramides [n0012], because they can work synergistically with Ophiopogon japonicus extract [n0008].
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 teachings of Balaram to select the nicotinic acid ester form of vitamin B3, as taught by Allen, because Allen teaches nicotinic acid esters (including myristyl nicotinate), as prodrugs, that are preferred over nicotinic acid (aka, niacin or vitamin B3) for transdermal delivery, because the ester prodrug form allows for long release of the active ingredient (pg 1), Balaram is directed to a topical skin composition (abstract, [0019]) to treat skin disorders (abstract).
Claims 1-2, 4-9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over James (US20200069543A1).
James teaches topical skin cosmetic compositions and a method of application (abstract, [0017-0018]) to treat skin that is inflamed, dry, dull, and/or scaly [0007-0008].
Regarding claims 1-2: James teaches a cosmetic composition, comprising extracts of Ophiopogon (e.g. Ophiopogon japonicas) (James – claim 1), as a skin-barrier enhancing agent [0099], and ceramides (James – claim 1), that can be obtained from the root [0075]. Notably, James teaches combinations of skin-barrier agents such as Ophiopogon japonicas extracts and ceramides [0098] for skin balancing compositions [0096-0098], skin improvement compositions [0163-0164], or intensive moisture products (James – claim 6). James provides Example 3 [0294-0297] that combines as Ophiopogon japonicas root extract (3 wt%) and a sphingosine [0135-0143] (i.e., 0.1 wt% sphinganine) that led to positive skin balancing results [0296].
Regarding claims 4-5: James teaches ceramides 1, 2, 3, and 6 [0136].
Regarding claims 6-8: James teaches isoflavones such as genistein, etc. [0072], that may be obtained from extracts of Punica granatum, etc. [0076].
Regarding claims 9: James teaches incorporation of vitamin B1 to vitamin B12 (reads on vitamin B3) [0204].
Regarding claim 12: James teaches a method of applying the composition to skin on a regular basis (James – claims 13 and 15).
In summary, James teaches the elements and desirability for the limitations of the instant claims, and thus, their obviousness. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Thus, James teaches the combination of art-known elements according to their disclosed beneficial properties with the resultant product nothing more than one would expect from their combination.
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 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Yao (CN112754978A – machine translation provided; published 2021-05-07):
claims 1-17 of copending Application No. 18/839,501 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because all claim sets teach topical compositions based on Ophiopogon japonicas extract. The copending application differs only significantly by not including the ceramides of the instant application.
This is remedied by Yao, who teaches a topical skin composition using root extract of the Ophiopogon japonicus plant [n0008, n0021], that also comprises various ceramides such as ceramides 1-10 (reads on instant claims 4-5) [n0012], for moisturizing soothing, repairing skin [n0008]. One of ordinary skill in the art would have been motivated to modify the teachings of the copending Application because the ceramides of Yao, allow moisturizing soothing, repairing skin [n0008]. Furthermore, Yao teaches it important to specify ratios and selection of specific ceramides [n0012], because they can work synergistically with Ophiopogon japonicus extract [n0008].
This is a provisional nonstatutory double patenting rejection.
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).
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/R.P./Examiner, Art Unit 1614 06/15/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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