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 .
The Amendment filed 7/22/26 has been received, entered into the record, and carefully considered. The following information provided in the amendment affects the instant application by:
Claims 1-4, 6-7, 9, and 17 have been amended.
Claims 19-21 have been added.
Claims 10-13 have been canceled.
Remarks drawn to rejections of Office Action mailed 4/22/26 include:
Claim objections: which have been overcome by applicant’s amendments and have been withdrawn.
112 2nd paragraph rejections: which have been overcome in part by applicant’s amendments and have been withdrawn in part.
112 4th paragraph rejection: which has been overcome by applicant’s amendments and has been withdrawn.
101 rejection: which has been maintained for reasons of record.
102(a)(1) rejections: which have been maintained for reasons of record.
An action on the merits of claims 1-9 and 14-21 is contained herein below.
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.
The rejection of claim 3 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, is maintained for reasons of record.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation that component A) is present in an amount 0.05-18% by weight preferably 0.1-15% by weight, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Applicants amended the claim but he claim still has a broad and narrow range, and thus the rejection is maintained as proper.
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.
The rejection of claims 1-9 and 14-18 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more, is maintained for reasons of record. Newly added claims 19-21 are rejected herein additionally. The claim(s) recite(s) pharmaceutical compositions (compositions of matter) comprising the natural products polydatin, various diols (including naturally occurring glycerin and/or butylene glycol), and optionally resveratrol, antioxidants such as vitamin C and preservatives (such as benzyl alcohol). These compounds are all naturally occurring compounds. This judicial exception is not integrated into a practical application because the combination of active agents are all naturally occurring compounds, and thus the claims are drawn to a mixture of naturally occurring compounds. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the combination of natural products do not add significantly more to the exception. There is no indication that the present combinations result in the individual natural compounds having characteristics that are markedly different than the naturally occurring products. Likewise, the method claim recites a non-particular application step, which is merely instructions to apply the exception in a generic way. See MPEP 2106.04(d)(2). Further, the amount of the agents of the ingredients is not seen to contribute to an inventive concept.
Applicant’s arguments filed 7/22/26 have been considered but are not persuasive. Applicants argue that the component that comprises polydatin is preferably an extract in an isolated form and should not be construed as naturally occurring. However, this extract, which is extracted from Polygonum Cuspidatum, is seen to be naturally occurring as the extract is removed from the naturally occurring plants. Because the extract required solvent selection, etc. does not indicate the naturally occurring products have any markedly different characteristics compared to the naturally occurring counterparts. Applicants also state that the polyols are obtained from working human beings as extraction steps from animal and vegetable oils are required. However, as with the polydatin component, these compounds are also naturally occurring compounds which have not been shown to have any markedly different characteristics compared to the naturally occurring counterparts. As such, the rejection is maintained as proper.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The rejection of claim(s) 1-9 and 14-18 under 35 U.S.C. 102(a)(1) as being anticipated by “Pure Whitening Cream”, XP055858432, Nov. 2019 – document number 24 from applicant’s IDS filed 11/4/24 is maintained for reasons of record. Newly added claims 19-21 are additionally rejected herein.
“Pure Whitening Cream” is disclosed as a topical composition comprising butylene glycol (a C4 diol), glycerin (a C3 diol) and Polygonum Cuspidatum root extract for treating skin disorders. Polygonum Cuspidatum root extract is known to comprise both polydatin and resveratrol. The composition is in the form of a topical cream for application to the skin. The cream also contains aloe vera leaf extract, which is known to contain various vitamins such as vitamin C and additional antioxidants such as vitamins A and E. Likewise, the cream contains preservatives such as disodium EDTA. The composition is an anhydrous composition as it does not contain water. Regarding the amounts of the agents in the composition, since the Office does not have the facilities for preparing the claimed materials and comparing them with prior art inventions, the burden is on Applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 619 F.2d 67, 205 USPQ 594 (CCPA 1980).
Applicant’s arguments filed 7/22/26 have been considered but are not persuasive. Applicants argue that “it is noted that according to the present composition descripting based upon recitation of closed transition the content of the polyol component is 60 % by weight or more.” It is unclear as to what this means – the examiner notes that the compositions are not closed and use the open language of “comprising” so any additional agents can ben included therein.
Applicants also state: “Since neither reference discloses a composition comprising an amount of 60% by weight or more of polyols, the claimed composition is not disclosed. Regarding the relatively higher amount of the at least two polyols, neither reference discloses nor suggests a composition which comprises an amount of 60% by weight or more of the at least two specific polyols, has less than 2% by weight of water, and does not include an oily solvent”. It appears applicants are arguing limitations which are not in the claims. Applicants claims are not limited to compositions having 60% by weight or more of the at least two polyols. For example, component A is required to be present in an amount of from 0.01-20% by weight and the ratio of A to B is 0.001-0.3:1. Thus the amount of polyol portion B can be much lower than 60% as argued by applicants. Moreover, the composition of the art is seen to be anhydrous, contrary to applicants assertion. Moreover, applicants arguing that the art does not include an oily solvent is moot as this limitation is not in the claims.
The rejection of claim(s) 1-18 under 35 U.S.C. 102(a)(1) as being anticipated by “Brightening and Balancing Facial Serum” ; XP055858411, 11/2020, - document number 25 from applicant’s IDS filed 6/29/23 is maintained for reasons of record. Newly added claims 19-21 are additionally rejected herein.
“Brightening and Balancing Facial Serum” is disclosed as a highly concentrated non-water based product (anhydrous) for natural skin radiance (see description). The topical composition comprises butylene glycol (a C4 diol), pentylene glycol (a C5 diol) and Polygonum Cuspidatum root extract. Polygonum Cuspidatum root extract is known to comprise both polydatin and resveratrol. The composition is in the form of a liquid dropper for application to the skin. The composition also contains ascorbic acid (vitamin C). Likewise, the composition contains preservatives such as disodium EDTA. The composition is an anhydrous composition as it does not contain water. Regarding the amounts of the agents in the composition, since the Office does not have the facilities for preparing the claimed materials and comparing them with prior art inventions, the burden is on Applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 619 F.2d 67, 205 USPQ 594 (CCPA 1980).
An action on the merits of claims * is contained herein below. The text of those sections of Title 35, US Code which are not included in this action can be found in a prior Office action.
Applicant’s arguments filed 7/22/26 have been considered but are not persuasive. Applicants argue that “it is noted that according to the present composition descripting based upon recitation of closed transition the content of the polyol component is 60 % by weight or more.” It is unclear as to what this means – the examiner notes that the compositions are not closed and use the open language of “comprising” so any additional agents can ben included therein.
Applicants also state: “Since neither reference discloses a composition comprising an amount of 60% by weight or more of polyols, the claimed composition is not disclosed. Regarding the relatively higher amount of the at least two polyols, neither reference discloses nor suggests a composition which comprises an amount of 60% by weight or more of the at least two specific polyols, has less than 2% by weight of water, and does not include an oily solvent”. It appears applicants are arguing limitations which are not in the claims. Applicants claims are not limited to compositions having 60% by weight or more of the at least two polyols. For example, component A is required to be present in an amount of from 0.01-20% by weight and the ratio of A to B is 0.001-0.3:1. Thus the amount of polyol portion B can be much lower than 60% as argued by applicants. Moreover, the composition of the art is seen to be anhydrous, contrary to applicants assertion. Moreover, applicants arguing that the art does not include an oily solvent is moot as this limitation is not in the claims.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693
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