DETAILED ACTION
Examiner Note: This is action is based upon the response dated 2/18/2026. The Applicant's arguments relating to the previous grounds of rejection are persuasive. Accordingly, the previous grounds of rejection have been withdrawn and new grounds of rejection are presented below. The new grounds of rejection were not necessitated by an amendment to the claims or an information disclosure statement; therefore, the current Office action is non-final.
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 .
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 14, 16, 17, 19-23 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.
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 14 recites the broad recitation 4 and 12% by weight, and the claim also recites 6 and 10% 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.
Claim 16 recites the broad recitation 50 to 60%, and the claim also recites 52 to 58% 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.
Claim 17 recites the broad recitation 750 g/mol and 1500 g/mol, and the claim also recites 800 g/mol and 1400 g/mol, 850 g/mol and 1300 g/mol, 900 g/mol and 1200 g/mol which are 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.
Claim 19 recites the broad recitation 30 to 50%, and the claim also recites 33 to 40% 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.
Claim 20 recites the broad recitation oil, and the claim also recites preferably a mineral oil, 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.
Claim 21 recites the broad recitation less than or equal to 25%, and the claim also recites 2 to 20%; 5 to 18%; 10 to 15% which are 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.
Claim 22 recites the broad recitation 0.01 and 20%, and the claim also recites 1 and 15% 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.
Claim 23 recites the broad recitation 50 μm to 1 mm, and the claim also recites 150 μm to 400 μm 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.
For the purpose of further examination, it is taken to mean in each claim above the broad ranges and been examined.
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.
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.
Claims 13-17, 23-24 rejected under 35 U.S.C. 103 as being unpatentable over Asmus (US20140228475, herein Asmus), in the view of Lam (US20090149567, herein Lam).
Regarding claims 13-17, Asmus teaches coating composition, comprising elastomer when formed as a coating are useful for protecting or treating skin [0010], the elastomer is selected from polyisobutylenes, and molecular weight range: 1400 to 1,000,000. [0013] overlaps the claimed range, and styrene copolymers [0013], SEBS [0022], wherein, the styrene-ethylene/butylene-styrene block copolymer (SEBS), reads on styrene—saturated olefin—styrene triblock copolymer. Asmus teaches the volatile liquid is at least 40% wt. of the total composition [0006], the elastomer in an elastomer phase is at least 35% wt. of the nonvolatile portion [0006], therefore, the elastomer range is at least 60%x35%=21%, overlaps the claimed range of polyisobutylene. It would have been obvious for a person of ordinary skill in the art to optimize and utilize the polyisobutylenes with molecular weight range: 1400 to 1,000,000 [0013] and preferentially select the lower molecular weight, as the lower molecular weight elastomer selection, leads to the optimal adhesion to skin [0021] as taught by Asmus, and apply the range of at least 21% polyisobutylene, into the composition formation, with a reasonable expectation of success, and can further enable the conformable coating to survive high elongation and have excellent adhesion and durability to the substrate, typically skin [0014] as taught by Asmus.
Asmus teaches other substances may be added to the liquid material or formulation for additional tackifiers for improved adhesion, [0031], which indicates the addition of the tackifier is optional and can be excluded, hence the concentration of tackifier is 0%, lies in the claimed range.
Asmus does not explicitly teach the SEBS range as claimed, however, Lam teaches adhesive composition for wound dressing [0068], comprising: tri-block copolymer [0034], in the range of 1-70% by weight [0048], overlaps the claimed range. Asmus and Lam are considered analogous art because they are reasonably pertinent to the problem faced by the inventor, that of polyisobutylene based skin protection adhesive composite formation, via tri-block copolymer selection. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add the adhesive composition for wound dressing [0068], with tri-block copolymer [0034], in the range of 1-70% by weight [0048], further apply into the composition formation process, because doing so would lead to the suitability of capable of forming a physically cross-linked matrix and apply in the tri-block copolymer into medical adhesive [0036], and further lead to pressure sensitive adhesive compositions suitable for various medical applications and especially suitable for use for adhesion to the skin [0002] as taught by Lam. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP § 2144.05.
Regarding claims 23, 24, Asmus teaches conformable coating provides a highly durable and resilient film useful for protecting and repairing surfaces such as skin and mucous membranes [0005] reads on dressing. Asmus and Lam teach the elastomeric matrix obtained from a composition according to claim 13, which is capable of forming the layer with specific thickness, therefore, the layer thickness is 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) MPEP 2144.07.
Claims 18-21 rejected under 35 U.S.C. 103 as being unpatentable over Asmus (US20140228475, herein Asmus), in the view of Lam (US20090149567, herein Lam).
Regarding claims 18-20, Asmus teaches coating composition, comprising elastomer when formed as a coating are useful for protecting or treating skin [0010], the elastomer is selected from polyisobutylenes, and molecular weight range: 1400 to 1,000,000. [0013] overlaps the claimed range, and styrene copolymers [0013], SEBS [0022], wherein, the styrene-ethylene/butylene-styrene block copolymer (SEBS), reads on styrene—saturated olefin—styrene triblock copolymer. Asmus teaches the volatile liquid is at least 40% wt. of the total composition [0006], the elastomer in an elastomer phase is at least 35% wt. of the nonvolatile portion [0006], therefore, the elastomer range is at least 60%x35%=21%, overlaps the claimed range of polyisobutylene. It would have been obvious for a person of ordinary skill in the art to optimize and utilize the polyisobutylenes with molecular weight range: 1400 to 1,000,000 [0013] and preferentially select the lower molecular weight, as the lower molecular weight elastomer selection, leads to the optimal adhesion to skin [0021] as taught by Asmus, and apply the range of at least 21% polyisobutylene, into the composition formation, with a reasonable expectation of success, and can further enable the conformable coating to survive high elongation and have excellent adhesion and durability to the substrate, typically skin [0014] as taught by Asmus.
Asmus teaches other substances may be added to the liquid material or formulation for additional tackifiers for improved adhesion, [0031], which indicates the addition of the tackifier is optional and can be excluded, hence the concentration of tackifier is 0%, lies in the claimed range.
Asmus does not explicitly teach the SEBS range as claimed, however, Lam teaches adhesive composition for wound dressing [0068], comprising: tri-block copolymer [0034], in the range of 1-70% by weight [0048], overlaps the claimed range. Asmus and Lam are considered analogous art because they are reasonably pertinent to the problem faced by the inventor, that of polyisobutylene based skin protection adhesive composite formation via tri-block copolymer selection. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add the adhesive composition for wound dressing [0068], with tri-block copolymer [0034], in the range of 1-70% by weight [0048], further apply into the composition formation process, because doing so would lead to the suitability of capable of forming a physically cross-linked matrix and apply in the tri-block copolymer into medical adhesive [0036], and further lead to pressure sensitive adhesive compositions suitable for various medical applications and especially suitable for use for adhesion to the skin [0002] as taught by Lam.
Asmus teaches plasticizer, mineral oil [0032], but does not explicitly teach the range as claimed, however, Lam teaches 0% to about 40% by weight plasticizer [0058], overlaps the claimed range, wherein, the plasticizer can be paraffin oil [0060] reads on the mineral oil. Asmus and Lam are considered analogous art because they are reasonably pertinent to the problem faced by the inventor, that of polyisobutylene based skin protection adhesive composite formation via plasticizer selection and inclusion. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add the 0% to about 40% by weight plasticizer [0058], further apply into the composition formation process, because doing so would increase flexibility, improve adhesion among different polymers included in the adhesive composition, and further lead to the pressure sensitive adhesive compositions suitable for various medical applications and especially suitable for use for adhesion to the skin [0002] as taught by Lam.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP § 2144.05.
Regarding claim 21, Asmus and Lam collectively teach the composition as set forth above in claim 18, Asmus is silent on the hydrocolloid particles and the range, however, Lam teaches hydrocolloid particles 5-60% by weight [0051] overlaps the claimed range. Asmus and Lam are considered analogous art because they are reasonably pertinent to the problem faced by the inventor, that of polyisobutylene based skin protection adhesive composite toward wound healing. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add the hydrocolloid particles 5-60% by weight [0051], further apply into the composition formation process, because doing so would improve moisture uptake and transmission [0050], further lead to the adhesive composition useful for wound dressings [0076], as taught by Lam.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP § 2144.05.
Claim 22 rejected under 35 U.S.C. 103 as being unpatentable over Asmus (US20140228475, herein Asmus), and Lam (US20090149567, herein Lam) as applied in claim 18, in the view of Meyer (US20200190310, herein Meyer).
Regarding claim 22, Asmus and Lam collectively teach the composition as set forth above in claim 18, Asmus is silent on the active substance(s) making it possible to induce or accelerate cicatrization or which can have a favorable role in the wound treatment, in an amount of between 0.01 and 20% by weight, preferably between 1 and 15% by weight, relative to the total weight of the composition. However, Meyer teaches non-steroidal anti-inflammatory drugs (NSAIDs), aspirin [0104] reads on the healing promoting substance, in the range of 0.01 to 20% by weight [0105] lies in the claimed range. Asmus and Meyer are considered to be analogous to the claimed invention because they are reasonably pertinent to the problem faced by the inventor, that of the poly(styrene-ethylene-butylene-styrene) block copolymers (abbreviated as SEBS)-based composition for wound dressing application. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Asmus to add the teachings of non-steroidal anti-inflammatory drugs (NSAIDs), aspirin [0104] and 0.01 to 20% by weight [0105] into the composition, because doing so would further lead to the effective wound healing [0097].
Response to Arguments
Applicant’s arguments, filed 2/18/2026, with respect to the rejection(s) of claim(s) 13 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Asmus (US20140228475, herein Asmus), and Lam (US20090149567, herein Lam).
In this case, the applicant’s arguments are directed toward the amendment of the claims, which has been addressed by the rejection set forth above.
In response to applicant's argument that Meyer is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
In this case, the rejection applied above, Meyer is relied upon merely for teaching the non-steroidal anti-inflammatory drugs (NSAIDs), aspirin [0104] reads on the healing promoting substance, and therefore one having ordinary skill in the art would be motivated to add the teachings of non-steroidal anti-inflammatory drugs (NSAIDs), aspirin [0104] and 0.01 to 20% by weight [0105] into the composition, because doing so would further lead to the effective wound healing [0097] as taught by Meyer. This motivation would not require the complete adoption of every teaching of Meyer with respect to the incorporation of said resin concentration, but would merely indicate to one having ordinary skill in the art that said active substance are suitable for their intended purpose. The incorporation therefore would have been obvious.
Hence, Meyer does not teach away the instant application specification.
In response to the “unexpected properties”, is not persuasive.
When Examples 1-15 [Instant App. US20220280683, P8, Table 1] are considered as a whole, they establish results associated with the ranges, respect to the claimed ranges provided for comparison.
Claim 13 is open to the content of 2.5 to 20% of a styrene—saturated olefin—styrene triblock copolymer. However, Examples 1-5, 7-9, 13 only show data for copolymer one single value of 6%. Hence, the Examples 1-5, 7-9, 13 are therefore insufficient to establish non-obviousness.
Whether 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. See MPEP 716.02(d).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zhen Liu whose telephone number is (703)756-4782. The examiner can normally be reached Monday-Friday 9:00 am - 5:00 pm.
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/Z.L./
Examiner, Art Unit 1767
/MARK EASHOO/ Supervisory Patent Examiner, Art Unit 1767
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