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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-8, and 10, drawn to a composition of Salvia Plebia and Scutellariae Radix compound acne cream in the reply filed on December 13, 2025 is acknowledged. Applicants’ election of restriction requirement of Group 1, claim(s) 1-8, and 10 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 13, 2025.
Claims 1-8, and 10 are currently under examination.
The examiner has required restriction between a composition and process claims. Where applicant elects claims directed to the composition, and a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the composition claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between composition claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, Applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The priority date is November 23, 2020.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on July 19, 2023 is being considered by the examiner. The signed IDS forms are attached with the instant office action.
Drawings
The drawings were received on July 19, 2023. These drawings are acceptable.
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.
Claim1-8 and 10 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.
In claims 1-8, the phrase, “characterized in that” is unclear. What characteristic is being claimed? Does the cream have the components recited or a characteristic of the components? It is unclear what characterized in that is referring to for the compound acne cream. Clarificataion is requested.
Claims dependent on a rejected claim are rejected for failing to cure the indefiniteness.
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.
Claims 1-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et. al. (CN 101112418 A) in view of CHO (KR 102100333 B1).
The instant claims are drawn to a compound acne cream, which comprises a Scutellariae extract, a Salvia Plebia extract and adjuvants, the adjuvants include water phase adjuvants, which are mixture of glycerol, water and triethanolamine; and oil phase adjuvants which are mixture of stearic acid, Vaseline, lanoline, glyceryl monostearate, and cetyl alcohol. Furthermore, the extract of Salvia Plebia and Scutellariae are obtained from extraction by ethanol (claims 1+).
The instant claim is distinguished over Zhang ‘418, however, in that the reference does not recite in a singular preferred embodiment (does not anticipate under 35 USC 102), the Salvia Plebia extract in the composition. Zhang et al. teaches “A partially used drug composition of curing acne contains bezoar, baikal skullcap root (Scutellariae Radix as in instant claim) extractive, honeysuckle extractive and matrix (Abstract [line 1]). Additionally, Zhang teaches the steps taken for extracting of Scutellariae, “said scutellaria extract is prepared as follows: taking radix scutellariae, adding in boiling water to decoct for two times, each time for 1 hours, combining the decoctions, filtering, concentrating the filtrate by adding sulphuric acid to regulate pH value to 2, standing, filtering and taking precipitate, after washing with proper ethanol, drying to obtain the product. (Description [technical field; para 003; line 5-9])”. Although Zhang ‘418 does not explicitly recite extraction by ethanol, however, use of ethanol as part of preparation of extraction as taught by Zhang, it would have been obvious variant for one of ordinary skilled in the art to have extracted the plant materials thereby. The final eluted product with what the reference teaches would not be different than the instant claim.
The adjuvants of water phase and oil phase as in instant claim 2 are taught by Zhang et al., because Zhang ‘418 teaches, “the medicine ointment of the invention preparation prescription of stearyl alcohol Vaseline, glycerol, radix scutellariae extract, distilled water…ointment medicine prepared by the invention prescription: glyceryl stearate, stearic acid, Vaseline, lanoline, triethanolamine scutellaria extract and honeysucke (Technical field [para 6-10])”.
The instant claims 3 and 4 recites that the amount of extracts of Scutellariae and Salvia Plebia are same. Zhang ‘418 further teaches the amount of extract of Scutellarie and honey suckle are used in same quantity as well “scutellaria extract 6 g, and 6 g of honeysuckle extract (Technical field [para 6-10])”. The use of same quantity of extract as in instant claim and taught by reference, the outcome would not be different (as instantly claimed, would have remained obvious in view of the cited reference).
Although the cited reference does not explicitly teach application of compound acne cream, comprising of Salvia Plebia, Scutellariae, and water and oil phase adjuvants, the reference does teach the preparation of the drug composition for curing acne.
Zhang does not recite Salvia Plebia, as in instant (claims 1+), however, Cho ‘333 teaches that the “mixed extract of Salvia plebia, Polygala tenuifolia and Aloe Barbadensis an external preparation for skin, a cosmetic (para 000-001)”. Cho ‘333 teaches “the composition of the present invention includes various nutrients, vitamins, electrolytes, flavoring agents, coloring agents, pectic acid and salts thereof, alginic acid and salts thereof, organic acids, protective colloidal thickeners, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols (para 0042).” The cited reference teaches the ointment application externally to the skin.
It would have been obvious to a person having ordinary skill in the art at the time of the instant applications effective filing date to have provided extracts of Salvia Plebia and Scutellariae to prepare an acne cream composition, because Zhang et al. and Cho teach providing the same Salvia Plebia and Scutellariae extracts for preparation of acne cream and application thereof.
"It 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." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
One would have had a reasonable expectation of success to achieve the composition of compound acne cream, because the cited references teach providing the same Salvia Plebia and Scutellariae extract for preparation of acne cream and application thereof, and because, success merely requires preparing the composition thereof, especially in the absence of the criticality of some undisclosed features, or unexpected results.
Zhang and Cho are relied upon for the reasons discussed above. If not expressly taught by Zhang and Cho, based upon the overall beneficial teaching provided by this reference with respect (in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable extracts, application to the area of the skin, and amounts, proportions and ranges thereof in which to perform and providing of a compositions for the treatment of acne), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effectively filled. As evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are presently allowed.
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/ALPA NILESH AMIN/ Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655