Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restriction
Applicant's election with traverse of Group I, claims 1-12 in the Reply filed on 12/22/2025 is acknowledged.
Applicant argues the inventions have a common buffer composition and there is no search burden or other rationale for the present election. Due to applicant’s certain persuasive arguments, the restriction requirement drawn to Group II-III has been withdrawn while maintaining the restriction requirement drawn to Group IV. As a result, claims 23-27 directed to a method have been withdrawn from further consideration.
Claims 1-22 are now being examined on the merits to which the following grounds of rejections are applicable.
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, or 365(c) is acknowledged.
Information Disclosure Statement
The two (2) information disclosure statements (IDS) submitted on 01/16/2024 were filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statements have been considered by the examiner, and signed and initialed copies are enclosed herewith.
Claim Objections
Claims 2, 13, and 17 are objected to a minor informality.
Each of claims 2, 13, and 17 are not written in a proper Markush-type claim format where the Markush-type claim should recite alternatives in a format such as "selected or chosen from the group consisting of A, B, and C." Alternatively, “selected or chosen from A, B or C” can be used. (see MPEP 2111.03 –II and 2117 and MPEP 2173.05(h)).
Each of claims 2, 13 and 17 recites “wherein alkyl” in line , but which would be better to write “wherein the alkyl”.
Appropriate correction is requested.
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 3 and 13-22 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.
Each of claims 3, 13 and 17 recites parentheses “poly(meth)acrylates (including both acrylates and methacrylates)”. That is, it is unclear whether the limitation in parentheses is meant to be limitation in the claims or whether it is only suggestions/examples. In this context, please see “parenthetical expressions are not permissible which do not contribute to clearness or exactness in stating Applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125).
The remaining claims are also rejected due to the rejection of base claims 13 and 17.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-5, 8-10 and 17-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rolf et al. (WO2003/063817A1).
Applicant claims the below claims 1 and 17 filed on 10/11/2023:
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Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02); and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
Rolf teaches an adhesive patch comprising a flexible backing which reads on the flexible outer layer, a cosmetic formulation containing cosmetic agent, skin absorption enhancer and solvent or skin protectant (e.g., topical moisturizer or skin conditioner (e.g., claim 1 of prior art) in which the cosmetic agent and skin absorption enhancer reads on the claimed optional ingredient such as skin protective agent, a pressure sensitive adhesive such as polyisobutylene, rubber, silicone based pressure sensitive adhesive, polystyrene-polybutadiene-polystyrene, polystyrene-polyisoprene-polystyrene, polystyrene-poly(ethylene-butylene)-polystyrene block polymers which reads on the claimed water insoluble adhesive, and a polymer such as polyacrylic acid which reads on the claimed non-neutralized polymeric acid, and sodium polyacrylate which may read on the claimed partially-neutralized polymeric acid because according to instant clams 6-7, the partially neutralized degree includes between about 50-about 100%, and thus the claimed partially neutralized polymeric acid embraces fully neutralized polymeric acid, and mixtures thereof (e.g., claims 1 and 44 of prior art) in which the mixture consists of polymeric acid having – COOH acid and sodium polyacrylate having – COONa base, and when they are mixed together, buffering would arise, accordingly, the mixture of Rolf reads on the claimed buffered composition. That is, Rolf teaches a composition comprising water insoluble adhesive, a buffered composition and skin protective agent or active agent of instant claim 1. Although Rolf does not expressly disclose “wound dressing” of instant claim 17, Rolf disclose adhesive patch comprising the said composition and a flexible backing layer and thus, the patch reads on the claimed wound dressing (instant claims 1-3, 5, 10, 17, 19 and 20); Rolf further teaches polycellulose fibers, polyester fibers, polyurethane fibers, polyolefin fibers, polyamide fibers, cotton fibers, copolyester fibers, or any mixture thereof (claims 3 and 60 of prior art) which reads on the claimed fiber (instant claims 4 and 18); Rolf further teaches the sodium polyacrylate is used in an amount of about 1.0%-about 20% (claim 47 of prior art), and but although Roth teaches the amount of partially neutralized sodium polyacrylate, mixture of polyacrylic acid and its sodium polyacrylate would be used in that amount due to the same function and therefore, the amount would overlap the instant range of about 10 to about 32%, in the absence of criticality evidence to the contrary, and also the ratio of non-neutralized polyacrylic acid to partially neutralized polymeric acid of instant claim 8 would be optimized depending on the intended purpose and relationship with other ingredient, in the absence of criticality evidence to the contrary. In this context, MPEP 2144.05 (II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (instant claims 8-9).
In light of the foregoing, instant claims 1-5, 8-10 and 17-20 are obvious over Rolf.
Claims 6-7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rolf et al. (WO2003/063817A1) in view of Bracht (US6,689,379B1 – IDS of 01/16/2024).
However, Rolf does not expressly teach the degree of neutralization of instant claims 6-7. The deficiencies are cured by Bracht.
Bracht discloses a transdermal patch comprising high degree (70%-100%) of neutralized polyacrylic acid or its salt wherein the neutralization degree impacts on permeation rate of active substance and high neutralization degree of the acid or its salt leads to high permeation rate (see Fig. 5 and its explanation on col. 9), and the degree 70-100% overlaps the instant range of between about 50% and about 100% including about 75% of instant claims 6-7. MPEP 2144.05 states that [I]n 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) (instant claims 6-7).
It would have been obvious to further define the degree of neutralization of Rolf with high degree of Bracht in order to obtain high permeation rate of active ingredient, as taught by Bracht.
In light of the foregoing, instant claims 6-7 are obvious over Rolf in view of Bracht.
Claims 13-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rolf et al. (WO2003/063817A1) in view of Ahmad et al. et al. (WO2007/092289A2, IDS of 01/16/2024).
Applicant claims the below claim 13 filed on 10/11/2023:
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However, Rolf does not expressly teach an ostomy skin barrier wherein the polymeric acids are dispersed as particles in the adhesives of instant claim 13. The deficiency is cured by Ahmed.
Ahmed discloses ostomy pad comprising a pouch, a liquid permeable layer, hot melt superabsorbent polymer composition (claim 1 of prior art) comprising superabsorbent polymer particles such as sodium polyacrylates such as AQUA KEEP series, olefinically unsaturated carboxylic acids and acid anhydrides (bridge paragraph pages 9-10 and page 11) and thermoplastic polymer, and further pressure-adhesive composition such as styrene block copolymer (page 19, last para. and claims 1-2 of prior art) wherein the superabsorbent polymer particles are dispersed in the adhesive (e.g., Fig. 3); and the ostomy pad can be used to absorb exudates from the body and in particular stomas and the surface of the skin surrounding a stoma (page 1, lines 10-11).
It would have been obvious to modify the composition of Rolf with ostomy pad of Ahmed in order to provide protective barriers on wounded skin area because the composition of Rolf can be used in hydrating skin (e.g., claim 117 of prior art) and thus, it can be applied onto skin area in order to help hydrate and maintain moisture in the skin around the stoma by forming a protective layer.
Rolf teaches the polycellulose fibers, polyester fibers, polyurethane fibers, polyolefin fibers, polyamide fibers, cotton fibers, copolyester fibers, or any mixture thereof (claims 3 and 60 of prior art) which reads on the claimed fiber (instant claim 14).
In light of the foregoing, instant claims 13-14 are obvious over Rolf in view of Ahmad.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined 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 made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of patent no. 9,422,463B2
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims set require a buffered composition comprising non-neutralized polyacrylic acid and partially neutralized polyacrylic acid, a polyisobutylene (PIB) adhesive, polymer fibers and overlapping amounts thereof. The difference between them is that patent ‘463 further requires conditional limitation and however such conditional clause may not be excluded in the instant invention using “comprising” language.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘463 subject matter.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of patent no. 9,763,833B2
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims set require a buffered composition comprising non-neutralized polyacrylic acid and partially neutralized polyacrylic acid, a water insoluble adhesive including PIB and styrene block copolymer, polymer fibers and overlapping amounts thereof. The difference between them is that patent ‘833 further recites buffered activity of both acids, and however such property of patent ‘833 would be implicit because instant claims use the same ingredients.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘833 subject matter.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of patent no. 10,434,015B2
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims set require a buffered composition comprising non-neutralized polyacrylic acid and partially neutralized polyacrylic acid as water insoluble adhesive, additional adhesive, polymer fibers and overlapping amounts thereof. The difference between them is that patent ‘015 further recites the extents of the fluid absorption and pH buffering, and however such property of patent ‘015 would be implicit because instant claims use the same ingredients.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘015 subject matter.
Claims 13-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of patent no. 10,470,936B2
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims set require an ostomy skin barrier and a wound dressing, each comprising a buffered composition comprising non-neutralized polyacrylic acid and partially neutralized polyacrylic acid as water insoluble adhesive, additional adhesive, polymer fibers and overlapping amounts thereof. The difference between them is that patent ‘936 further recites high Mw of polymeric buffer composition. However, since the claimed invention recites “comprising,” introduction of the additional feature, Mw of polymeric acids is not excluded.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘936 subject matter.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of patent no. 11,147,716B2
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims set require a buffered composition comprising non-neutralized polyacrylic acid and partially neutralized polyacrylic acid as water insoluble adhesive, additional adhesive, polymer fibers and overlapping amounts thereof. The difference between them is that patent ‘716 further recites an absorptive capacity properties. However, since the claimed invention recites “comprising,” introduction of the additional properties is not excluded, and the instant invention requires the same composition and thus such properties would also be implicit.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘716 subject matter.
Claims 13-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of patent no. 11,304,854B2
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims set require an ostomy skin barrier and a wound dressing, each comprising a buffered composition comprising non-neutralized polyacrylic acid and partially neutralized polyacrylic acid as a first adhesive, polymer fibers and overlapping amounts thereof. The difference between them is that patent ‘854 further recites hydrocolloid. However, since the claimed invention recites “comprising,” introduction of the additional feature hydrocolloid is not excluded.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘854 subject matter.
Claims 13-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of patent no. 11,304,855B2
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims set require an ostomy skin barrier and a wound dressing, each comprising a buffered composition comprising non-neutralized polyacrylic acid and partially neutralized polyacrylic acid, adhesives, polymer fibers and overlapping amounts thereof. The difference between them is that patent ‘855 further recites second adhesive comprising PIB, SIS copolymer, pectin and CMC. Since the claimed invention recites “comprising,” introduction of the additional feature such as second adhesive is not excluded.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘855 subject matter.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of patent no. 11,819,389B2
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims set require a buffered composition comprising non-neutralized polymeric acid and partially neutralized polymeric acid as a water insoluble adhesive, and species of the polymeric acids, additional adhesive, polymer fibers and overlapping amounts thereof. The difference between them is that instant claims require optional active ingredient and since optional ingredient embraces its absence, instant claims 1, 13 and 17 are obvious from patent ‘389.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘389 subject matter.
Claims 13-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of patent no. 11,826,235B2
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims set require an ostomy skin barrier and a wound dressing, each comprising a buffered composition comprising non-neutralized polyacrylic acid and partially neutralized polyacrylic acid, adhesives, polymer fibers and overlapping amounts thereof. The difference between them is that patent ‘235 further recites second adhesive comprising hydrocolloid, but since the claimed invention recites “comprising,” introduction of the additional feature such as hydrocolloid is not excluded.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘235 subject matter.
Claims 13-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending application no. 18/381,401
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims set require an ostomy skin barrier and a wound dressing, each comprising a buffered composition comprising non-neutralized polyacrylic acid and partially neutralized polyacrylic acid, first/second adhesives, and polymer fibers. The difference between them is that copending ‘401 further recites second adhesive comprising hydrocolloid, but since the claimed invention recites “comprising,” introduction of additional feature such as hydrocolloid is not excluded.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending ‘401 subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613