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 .
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 38-43 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.
Regarding Claim 38, the limitation “wherein the antimicrobial agent is applied to the wound contact layer step a)” is unclear. It is unclear if the antimicrobial agent is intended to be applied to the wound contact layer before, during, or after step a). For the purpose of compact prosecution, this limitation is interpreted as the antimicrobial agent is applied to the wound contact layer after step a, based on ¶ [0131] of the published application. Claims 39-43 are also rejected based on their dependency on Claim 38.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 38 and 40-43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Collyer et al (GB 2290031).
Regarding Claim 38, Collyer discloses a method of manufacturing a wound dressing (pg. 6 lines 3-19, pg. 11 lines 8-10, pg. 14 line 16 – pg. 15 line 8), the method comprising the steps of:
compressing a wound contact layer (3, Fig. 1; pg. 6 lines 3-6);
attaching the wound contact layer (3, Fig. 1) to an absorption layer (1, Fig. 1) using an adhesive (pg. 6 lines 7-10);
applying at least one antimicrobial agent to the wound contact layer (3, Fig. 1), wherein the antimicrobial agent is applied to the wound contact layer (3, Fig. 1) after step a) (pg. 6 lines 14-19, pg. 11 lines 8-10 “the resulting laminate is cut to give individual dressings which may be impregnated with medicaments”, pg. 14 line 16 – pg. 15 line 8).
Regarding Claim 40, Collyer discloses the antimicrobial agent is applied to the wound contact layer (3, Fig. 1) as a solution (pg. 14 line 16 – pg. 15 line 8).
Regarding Claim 41, Collyer discloses the step of drying the wound dressing (pg. 15 lines 4-8).
Regarding Claim 42, Collyer discloses the step of attaching a backing layer (2, Fig. 1) to the absorption layer (1, Fig. 1) using an adhesive (pg. 4 lines 13-21).
Regarding Claim 43, Collyer discloses attaching an adhesion means (combination of backing layer 2 and associated adhesive, pg. 4 lines 13-21) to the wound contact layer (3, Fig. 1; the backing layer/associated adhesive are attached to the wound contact layer via the absorption layer), the adhesion means (backing layer 2 and associated adhesive, Fig. 1) comprising an adhesive (pg. 4 lines 13-21) bonded to a carrier layer (backing layer 2, Fig. 1; pg. 4 lines 13-21).
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.
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.
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collyer et al (GB 2290031) in view of Collinson et al (US 2016/0144084) further in view of Carty (US 2016/0038629).
Regarding Claim 39, Collyer is silent whether the adhesive comprises an acrylic powder, wherein the powder is scattered onto a surface of the wound contact layer and/or the absorption layer and the wound contact layer and the absorption layer are then laminated.
Collinson teaches a wound dressing, thus being in the same field of endeavor, which uses a hot melt adhesive powder sprinkled over an ADL prior to heat lamination to bond the ADL to the absorption layer (¶ [0145]). This ensures the ADL and the absorption layer are securely bonded to one another.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Collyer to include scattering an adhesive powder onto a surface of the wound contact layer prior to heat laminating the would contact layer and absorption layer, as taught by Collinson, to ensure the layers are securely bonded to one another (as motivated by Collinson ¶ [0145]). This is further motivated by Collyer, who indicates the wound-contacting layer can be attached to the absorption layer with heat bonding as well as with adhesives (pg. 7-10).
Collyer/Collinson is silent whether the adhesive powder comprises an acrylic powder.
Carty teaches an adhesive composition usable for adhering medical articles such as wound dressings to a patient’s skin (¶ [0074]), where the adhesive composition is an acrylic hot melt adhesive (¶ [0026]).
Therefore, it would have been obvious to substitute the hot melt adhesive of Collyer/Collinson for the acrylic hot melt adhesive of Carty, as Carty indicates that acrylic hot melt adhesives can be utilized in medical devices such as wound dressings (as motivated by Carty ¶ [0074]), and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 38-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17 of U.S. Patent No. 12,090,028. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims include all the limitations of the pending claims as well as additional limitations. As such, the patented claims are narrower in scope than the pending claims, and can be considered the species to the pending claim’s genus. Since it has been held that the species anticipates the genus, the patented claims anticipate the pending claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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