DETAILED ACTION
This action is in response to papers filed on 11/03/2025. Claims 1, and 5-14 of X. Zhou et al., 17597462 (01/06/2022) are pending examination on the merits: claim 1 is currently amended, claims 2-4 are cancelled, claims 5-12, and 13 are previously withdrawn, and claim 14 is newly added. Claim 1 and 14 are rejected.
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
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/CN2020/116033, filed on September 18, 2020, which claims priority to Chinese Application No. CN201910846541.9, filed on September 4, 2019.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. § 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/03/2025 has been entered.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
In a response filed on 11/18/2024 and in accordance with 37 CFR 1.499, applicant elected Group I, claims 1-4, drawn to a transdermal permeation enhancing composition, to which the claims must be restricted. Group II, claims 5-13, drawn to compositions comprising timolol as an active ingredient, are hereby withdrawn.
MPEP 818.01 discloses that Election in reply to a requirement for restriction may be made either with or without an accompanying traverse of the requirement. The absence of any statement indicating whether the requirement to restrict is traversed or the failure to provide reasons for traverse will be treated as an election without traverse. Therefore, Applicant’s response is treated as an election without traverse.
Withdrawn Rejections
The following rejections are withdrawn:
The rejection of claims 1-4 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant has amended claim 1 and canceled claims 2-4. Applicant’s Remarks at page 5.
The rejection of claims 2-4 under 35 U.S.C. 103 as being unpatentable over Duan Youhua., Chinese Application No. CN1271587A; November 1, 2000; (“Youhua”), as applied above to claim 1, in view of De Villiers, M. (2008). Ointment bases. Pract. Guide Contemp. Pharm. Pract., 3, 277-290 (“Villiers”) is withdrawn in view of Applicant’s cancelation of the claims. Applicant’s Remarks at page 7.
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 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Duan Youhua., Chinese Application No. CN1271587A; November 1, 2000; (“Youhua”) in view of Yadav et al., World Journal of Clinical Pharmacology, Microbiolog. World J. Clin. Pharmacol. Microbiol.Toxicol. Vol. 1 [1] May 2015; pp. 09-26, and De Villiers, M. (2008). Ointment bases. Pract. Guide Contemp. Pharm. Pract., 3, 277-290 (“Villiers”).
Regarding amended claim 1, the claim recites:
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Youhua teaches “an exterior-applied medicine in the form of powder or ointment...prepared...through mixing with vaseline and white wax.”, which is applied to the skin. See e.g., machine translation of abstract and claim 1. The wax is also selected from white beeswax (Youhua, claim 2).
Regarding the limitation, “wherein the composition is free of common penetration enhancers selected from the group consisting of propylene glycol, laurocapam, menthol, sodium tetradecyl sulfate, geraniol, anethole, and decyl methyl sulfoxide…”, while Youhua teaches the presence of five (5) Chinese-medicinal active materials in the ointment, Youhua discloses that said five ingredients are essentially mixed in with a base formulation consisting of Vaseline and white bees wax (Abstract). Considering that the ingredients are added to the base according to Youhua, and the base is described as consisting of Vaseline and white bees wax, it is inferred that said base is thus free of common penetration enhancers in general, and more specifically, common penetration enhancers selected from the group recited in the claim.
Instant claim 1 essentially claims this hydrocarbon base formulation, consisting of a mixture of Vaseline, white bees wax, and light liquid paraffin which would have been obvious to one of ordinary skill in the art at the time of filing as a base for the preparation for an ointment.
While Youhua does not expressly teach light liquid paraffin as part of the base formulation, to one of ordinary skill in the art, liquid paraffin is often used to adjust the desired consistency of the ointment. It is therefore not uncommon for an ointment base to further contain light liquid paraffin, based on desirability for an optimized performance and consistency as taught by Yadav.
Yadav teaches “The ointment base is that substance or part of an ointment, which serves as carrier or vehicle for the medicament. The nature of a base also controls its performance… The selection of ointment base is depending on the action desire nature of the medicament to be incorporated…” on pp. 10-11. Yadav teaches hydrocarbon bases, wherein constituents of the hydrocarbon bases include petrolatum or Vaseline which “… may be used alone or in combination with other agents as an ointment base…”, hard paraffin, which is “… used to harden or soften ointment bases…”, and liquid paraffin which is used along with hard paraffin “… to get desired consistency of the ointment…” (Yadav at page 11). Yadav also teaches beeswax as “… an ingredient of paraffin ointment. It is used as a stiffening agent in pastes and ointments…” at page 12. Yadav teaches that the claimed ingredients are substances extensively employed in pharmaceutical work as bases for preparation of ointments, and expressly teaches that the components are optimizable based on desirability.
As taught by Yadav, vaseline and liquid paraffin (i.e., mineral oil) are petrolatum bases, and the nature of a base controls its performance. Liquid paraffin as described by Yadav is often used along with hard paraffin “… to get desired consistency of the ointment…” at page 12, and beeswax essentially functions as similar to hard paraffin, where it is used as a stiffening agent in pastes and ointments.
As disclosed above, Youhua teaches a base formulation consisting of vaseline and white wax. In order to maintain the hydrocarbon base formulation for an ointment, and optimize its performance, one of ordinary skill would have been motivated to add liquid paraffin per Yadav’s teachings, to the vaseline (white petrolatum) and white wax petrolatum base already taught by Youhua. Per Yadav’s teachings, liquid paraffin is used to adjust consistency and influence performance.
This argument is underscored by Villier’s teachings. Villiers teaches a similar hydrocarbon standard base formulation of claim 1 for ointment comprising white 95% w/w Vaseline ((p. 286, Section 1. e. (2); also known as white petrolatum), and 5% w/w white beeswax (p. 287, Section 4. e., also referred to as White Wax) for ointments (p. 281, Table 23.2):
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Villiers teaches that for bases made of petrolatum, “If a stiffer base is desired, a portion of White Wax may be added” (p. 286, Section 1. d. (2)), showing that one ingredient can be combined or substituted for another based on desirability. Therefore, as it relates to the instant claim, to one of skill in the art, both vaseline and light liquid paraffin (i.e., mineral oil) are petrolatum bases, which can be combined based on the desirability as disclosed by Villiers Table 23.2 (p. 282):
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Villiers teaches various preparations where vaseline and light liquid paraffin (i.e., mineral oil) are used independently and in combination, based on desirability.
Consistent with this reasoning, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Youhua’s base to further include liquid paraffin, a component used to adjust the consistency of a formulation per Yadav’s teachings, of which light liquid paraffin is the refined grade. One of ordinary skill in the art would have been motivated to adjust a known hydrocarbon ointment base formulation, as part of a routine optimization designed to influence performance per Yadav’s teachings. Yadav’s teachings is further underscored by Villiers teachings describing the combination of Vaseline with liquid paraffin/mineral oil.
Furthermore, while Youhua in view of Yadav and Villiers teaches white Vaseline, white beeswax, and light liquid paraffin, as component of an ointment base, Youhua in view of Yadav and Villiers do not expressly disclose the three components in the claimed amounts per instant claims 1 and 14.
Instead, Youhua teaches that 500 g of white Vaseline (i.e., ~96 wt.% with respect to the oil base composition) and 20 g of white beeswax (see, claim 2 of Youhua) (i.e., ~ 3.85 wt.%) are used to prepare the ointment base (Abstract and claims 1-2). This is ratio is emphasized as typical and is also discussed by Villers teachings above. More specifically, the total weight of the composition taught by Youhua, including the 5 active ingredients, is about 630 mg (total: Flos Genkwa 20 g, Folium Hibisci Mutabilis 50 g, Squama Manis 20 g, Borneolum Syntheticum 10 g, red Plumbum peparatium 10 g, vaseline 500 g, and white bees wax 20 g). The total weight of the base composition only is 500 g of Vaseline plus 20 g of white beeswax. Therefore, the calculated weight percent of vaseline is equivalent to about 96% (500g/520g x 100) of the base composition, and the calculated weight percent of beeswax is about 3.85% (20g/520g x 100) of the base composition.
The amended claim discloses the amount of white vaseline present in the formulation as ranging from 77.5 wt.% to 79.5 wt.%, the amount of white beeswax 5 wt.%, and the light liquid paraffin at 15 wt.% to 17.5%.
For the white beeswax, the prior art teaches about 4 wt.%, while the claimed invention teaches 5 wt.% of white beeswax. However, according to MPEP § 2144.05(I), obviousness may be found where the claimed ranges do not overlap with the prior art but are merely close. Since the proportions are sufficiently similar, one skilled in the art would reasonably expect them to exhibit the same properties. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
For the white Vaseline, Youhua teaches about 96 wt.%, and about 4 wt.% for the white beeswax, which mirrors Villers hydrocarbon formulation and ratios discussed above. While the present claims recite about 77.5 wt.% to 79.5 wt.% for Vaseline, and for the light liquid paraffin 15 wt.% to 17.5 wt.%. Considering that Yadav teaches liquid paraffin as a component used to adjust consistency, it would have been obvious that the amount of Vaseline, being the major component of Youhua’s ointment formulation, would be primarily adjusted to optimize the consistency of the ointment and arrive at the weight percent per the claims based on desirability.
It is within the skill of an artisan to routinely optimize and formulate the claimed range or amount in order to arrive at the desired claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "where 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." See MPEP § 2144.05, "II. Optimization of Ranges". Moreover, it must be noted specifically that Applicant’s formulation exceeds 100 wt.%. The top end range of white vaseline is 79.5 wt.% + 5 wt.% of white beeswax + 17.5% of light liquid beeswax = 102 wt.%. Thus, the claimed range is inconsistent. Nonetheless, to one of ordinary skill in the art, since the adjustment is being made to Youhua’s formulation consisting of 96 wt.% of Vaseline, 4% white beeswax, using light liquid paraffin, it would have been obvious to adjust the consistency based on desirability and performance and arrive at the claimed range with reasonable expectation of success.
The prior art references therefore teach amounts that are close or falls within the scope of the claimed ranges, and as discussed above, it is within the skill of an artisan to routinely optimize and formulate the claimed range or amount in order to arrive at the desired claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "where 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." See MPEP § 2144.05, "II. Optimization of Ranges".
Regarding newly added claim 14, the claim is also rejected using the same rationale as applied to claim 1. The difference between claim 1 and claim 14 is the recitation of specific amounts as opposed to a range. For example, claim 14 claims 84.5 wt.% of white Vaseline, 5 wt.% white beeswax, and 10 wt.% light liquid paraffin, and wherein the composition of free of the claimed penetration enhancers. As applied above to claim 1, "where 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." See MPEP § 2144.05, "II. Optimization of Ranges". Furthermore, these ranges are outside the claimed range that Applicant argues is shows unexpected results of enhanced penetration and low skin irritation because it is free of penetration enhancers. The claimed amounts disclosed in claim 14 can be obtained through routine optimization, and according to MPEP § 2144.05(I), obviousness may be found where the claimed ranges do not overlap with the prior art but are merely close. Since the proportions are sufficiently similar, one skilled in the art would reasonably expect them to exhibit the same properties. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Claim 14 is therefore also obvious as is claim 1.
Applicant’s Arguments/Examiner’s Response
Applicant contends that claim 1 has been amended to be commensurate in scope with the experimental evidence of unexpected results related to enhanced transdermal penetration and low skin irritation. The amendment (in-part) recites, “A transdermal permeation enhancing composition, consisting of white vaseline, white beeswax, and light liquid paraffin, wherein the composition consists of 77.5 wt. % to 79.5 wt. % white vaseline, 5 wt. % white beeswax, and 15 wt. % to 17.5 wt. % light liquid paraffin...”. Applicant discusses two data points gathered from Examples 2 and 3 of the Specification.
While Applicant’s arguments are acknowledged, they are not found to be persuasive in view of the teachings of Youhua in view of Yadav and Villers for the reasons discussed above. As disclosed above, Youhua teaches a base formulation consisting of vaseline and white wax. Villers teaches that this combination is routine. In order to maintain the hydrocarbon base formulation for an ointment, and optimize its performance, one of ordinary skill would have therefore been motivated to add liquid paraffin per Yadav and Villiers teachings, to the vaseline (white petrolatum) and white wax petrolatum base already taught by Youhua. Per Yadav’s teachings, liquid paraffin is used to adjust consistency and influence performance, and per Villers teachings, this combination is routine in the preparation of hydrocarbon base ointment preparations.
Furthermore, even if Applicant has recognized another advantage, said advantage of the base formulation would flow naturally from following the suggestion of the prior art, and thus cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Lastly, Applicant’s argument that the ranges are now commensurate in scope is not fully the case considering that the high-end amount of light liquid paraffin, present in the formulation at 17.5 wt.%, is not tested as part of the range allegedly demonstrating unexpected results.
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100C). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F .2d 731,741,218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.). To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
As discussed above, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "where 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." See MPEP § 2144.05, "II. Optimization of Ranges". Additionally, obviousness does not require absolute predictability, but a reasonable expectation of success. See MPEP 2143.02.
Conclusion
No claims are allowed.
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/C A/Examiner, Art Unit 1622 December 15, 2025
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622