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 .
DETAILED ACTION
Status of Claims
The amendments and arguments filed on 08/06/2025 are acknowledged and have been fully considered. Claims 1 and 4-15 are now pending. Claims 2-3 are canceled; claims 1 and 4-5 are amended; claims 7-14 are withdrawn; claim 15 is new.
Claims 1, 4-6, and 15 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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 15 is 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.
Claim 15 depends from claim 2, which is cancelled. As such, one with ordinary skill in the art would not be able to understand the metes and bounds of the claim, thus it is indefinite. For purposes of search and consideration, the claim is understood to read “The wound dressing or other wound contact medium according to claim 1”.
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 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over EP 2995287 A1 (Flach, 2016).
In regards to claims 1 and 5-6, Flach teaches a medical dressing comprising acetylsalicylic acid (see Flach, claims 1 and 12). The wound dressing does not comprise any peroxide compounds, as Flach does not teach any. Further, the medical dressing is taught to have two chemical compounds, wherein the first chemical compound and the second chemical compound may independently be selected from antimicrobial compounds such as acetylsalicylic acid (see Flach, paragraphs 0031-0032). It is taught that the composition has a coating comprising the second chemical compound (see Flach, paragraph 0010). The coating is taught to be polyvinylpyrrolidone (PVP) or polyvinyl alcohol (PVA) (see Flach, paragraph 0067), which are taught to be polymeric materials in the instant specification as filed (see page 3, paragraph 5 of the specification as filed). The coating is taught to be a plurality of particles (see Flach, paragraph 0016). Using the teachings of Flach, one with ordinary skill in the art would be able to easily envisage polyvinylpyrrolidone particles comprising a chemical compound, such as acetylsalicylic acid (i.e., the acetylsalicylic acid would be encapsulated by the PVP in the coating).
Further, in regards to the limitation about the polymeric polymers which are produced by a thermally induced phase separation process, a product-by-process claim drawn to a composition directed towards the wound dressing or other wound contact medium, the patentability of a product does not depend on its method of production. Flach teaches the instantly claimed composition. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by- process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. Flach teaches the composition as instantly claimed, thus the burden shifts to the applicant to come forward with evidence showing that the process of making the composition as instantly claimed produces a materially different product than the medical dressing of Flach.
In regards to claim 4, it is taught that the coating comprising the second chemical compound on at least a portion of the skin-facing surface of the adhesive layer may comprise a plurality of particles of the second chemical compound distributed on at least a portion of the skin-facing surface, wherein a first portion of each particle may penetrate into the adhesive layer whilst a second portion of the particle may protrude out from the adhesive layer (see Flach, paragraph 0017).
Flach does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Flach with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
Claims 1, 4-6, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over EP 2995324 A1 (Flach, 2016; referred to as Flach 324 herein).
In regards to claims 1 and 5-6, Flach 324 teaches a medical dressing comprising acetylsalicylic acid (see Flach 324, claims 1 and 10). The wound dressing does not comprise any peroxide compounds, as Flach 324 does not teach any. Further, the medical dressing is taught to have two chemical compounds, the first chemical compound and the second chemical compound may independently be selected from a group of antimicrobial compounds such as acetylsalicylic acid (see Flach 324, paragraphs 0029-0031). It is taught that the composition has a coating comprising the second chemical compound (see Flach 324, paragraph 0010). The coating is taught to be polyvinylpyrrolidone (PVP) or polyvinyl alcohol (PVA) (see Flach 324, paragraph 0066), which are taught to be polymeric materials in the instant specification as filed (see page 3, paragraph 5 of the specification as filed). The coating is taught to be a plurality of particles (see Flach 324, paragraph 0014). Using the teachings of Flach 324, one with ordinary skill in the art would be able to easily envisage PVP or PVA particles comprising a chemical compound, such as acetylsalicylic acid (i.e., the acetylsalicylic acid would be encapsulated by the PVP/PVA in the coating).
Further, in regards to the limitation about the polymeric polymers which are produced by a thermally induced phase separation process, a product-by-process claim drawn to a composition directed towards the wound dressing or other wound contact medium, the patentability of a product does not depend on its method of production. Flach 324 teaches the instantly claimed composition. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by- process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. Flach 324 teaches the composition as instantly claimed, thus the burden shifts to the applicant to come forward with evidence showing that the process of making the composition as instantly claimed produces a materially different product than the medical dressing of Flach 324.
In regards to claims 4 and 15, it is taught that the coating comprising the second chemical compound on at least a portion of the skin-facing surface of the adhesive layer may comprise a plurality of particles of the second chemical compound distributed on at least a portion of the skin-facing surface, wherein a first portion of each particle may penetrate into the adhesive layer whilst a second portion of the particle may protrude out from the adhesive layer (see Flach 324, paragraph 0015). Further it is taught that the first chemical copund is bound to the structure or internal surface of the substrate, using for example, carboxymethyl cellulose (i.e., a linking group) (see Flach 324, paragraph 0062-0063). Though, it is worth noting that the first chemical compound is not taught to be in the form of particles, it is taught that the first chemical compound is encapsulated within PVA or PVP (see Flach 324, paragraph 0066). Further, the first chemical compound and the second chemical compound may independently be selected from a group of antimicrobial compounds such as acetylsalicylic acid (see Flach 324, paragraphs 0029-0031). As such, it would be within the purview of one with ordinary skill in the art to envisage a product wherein the second chemical encapsulated by PVP or PVA in the form of particles is chemically attached to the substrate as well or wherein the first chemical is in the form of particles as the make-up of the chemical/coating would be the same for both the first and second chemicals.
Flach 324 does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Flach 324 with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
Response to Arguments
Applicant's arguments filed 08/06/2025 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regards to applicant’s arguments that the art does not teach polymeric particles produced by TIPS, it is noted that the limitation about the polymeric polymers which are produced by a thermally induced phase separation process is a product-by-process claim limitation, and as such the patentability of a product does not depend on its method of production. Both Flach and Flach 324 teach the instantly claimed composition. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by- process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. Both Flach and Flach 324 teach the composition as instantly claimed, thus the burden shifts to the applicant to come forward with evidence showing that the process of making the composition as instantly claimed produces a materially different product than the medical dressing of Flach and Flach 324.
Applicant argues that the TIPS process of the instant claims has minimized solvent residues which can affect the safety and efficacy of the resulting particle, however this is not enough to establish a nonobvious difference between the instant invention and the teachings of the art as they are not materially different products. Said another way, applicant’s listed benefits are taught as benefits of using the TIPS process, but it does not show evidence that the final product is materially different than what is taught in the art. As such, the claims remain obvious over Flach and Flach 324.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611