DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
1. Claims 1-50 are pending and currently under consideration for patentability.
Applicant’s multiple attempts to file a preliminary amendment (8/8/2022, 1/4/2023 and 4/11/2023) failed due to compliance with 37 CFR 1.121 requiring a status identifier be used for all claims since the original claim set was filed.
Priority
2. 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
3. The information disclosure statements (IDS) submitted on August 8, 2022, March 4, 2024 and August 1, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
4. Claims are objected to because of the following informalities:
Claim number “50” is missing and is incorrectly listed as claim number “40” on the last page of the pending claims. For the purpose of examination, this second recitation of claim 40 will be considered as claim 50.
Claims 4-50 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only, and cannot depend from any other multiple dependent claims. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Appropriate correction is required.
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.
5. Claims 1-3 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 1, the phrases "such as" and “preferably” render the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 2 and 3 are rejected for ultimately depending from rejected independent claim 1.
Additionally, while not being treated on the merits (as noted above), claims 4, 10, 12, 13, 20, 34 and 36, utilize the phrases "such as" and “preferably,” which would render the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Accordingly, applicant’s response to the instant Office action should also address the issues to these claims, to avoid a potential 35 U.S.C. 112(b) rejection.
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.
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.
6. Claim(s) 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Kloeppels et al. (US PGPUB 2013/0226062 A1) in view of Maher et al. (WO 2019/226540 A1).
7. With regard to claim 1, Kloeppels describes a sheet material (cushion bandage, 10) useable for wound care devices (abstract; Figs. 1A, 1B; ), said sheet material comprising; a cover layer (base textile 14 woven of 21 and 22) formed from a woven or knit fabric comprised of fibers ([0011]; [0022]) such that the sheet material (10) is stretchable and has an elastic memory (Fig. 1A; [0031]; elastic; [0032]; [0026-0029]); said cover layer (14) including a plurality of fibers (cushion layer, 16 formed of threads, 18/20 in pile/looped regions, 19/23) extending from a bottom surface (two-sides, 12) thereof (Fig. 1A; [0011]; [0022]; [0031]; [0009]; [0016]); a binder ("coatings for fixing and stabilizing the base structure, but also the fibers and/or threads for the cushion layer") adjacent said bottom surface of said cover layer (14), said fibers extending into said binder, whereby said binder adheres to said fibers along lengths of said fibers ([0024]); and bottom layer of a first adhesive (14 formed as two-dimensional tape, 13 having an inherent adhesive bottom layer; [0031]; [0009]); said binder being an adhesive ("coatings for fixing and stabilizing… the fibers and/or threads for the cushion layer”; [0024]).
However, Kloeppels fails to explicitly discloses a bottom layer of gel adhesive, such as a silicone gel (preferably a heavy coat weight silicone gel) or a hydrogel; wherein said binder is an adhesive which will bond to said gel adhesive to securely adhere said gel adhesive to said cover layer.
Maher discloses a wound care device (101) having fluid transfer and adhesive properties (abstract; Figs. 1A, 1B) comprising: a cover layer (occlusive film layer, 130) formed from a woven or knit fabric comprised of fibers (page 7, line 6 – page 8, line 14); a fluid acquisition layer (120) extending adjacent from a bottom surface of the cover layer (130); and an apertured trilaminate adhesive layer (102; Fig. 3B) formed of an upper binder adhesive layer (102a) comprised of an acrylate adhesive (page 11, lines 6-18), and a lower silicone gel adhesive layer (102c; page 3, lines 4-10); wherein said binder will bond to said silicone gel adhesive to securely adhere said silicone gel adhesive to said cover layer (103; page 18, lines 1-16; page 19, lines 16-21).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sheet material disclosed by Kloeppels to include a bottom layer of gel adhesive which bonded to the binder, similar to that disclosed by Maher, in order to utilize well-known, biocompatible, gel adhesive, skin-contact layers, which aid in preventing the wound care device from detrimentally sticking to the wound – further promoting and improving the healing process, as suggested by Maher on at least Page 3, lines 4-7.
8. With regard to claim 2, Kloeppels in view of Maher disclose the sheet material of claim 1, as seen above.
However, Kloeppels is silent in regard to a release liner removably adhered to said gel adhesive.
Maher discloses a release liner removably adhered to said gel adhesive.
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sheet material disclosed by Kloeppels in view of Maher to include a release liner, similar to that disclosed by Maher, in order to utilize well-known means of protecting the silicone gel adhesive prior to use, as suggested by Maher at least from Page 13, lines 31 to Page 14, line 6.
9. Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kloeppels in view of Maher, as applied to claims 1 and 2 above, and further in view of Rodzewicz et al. (US PGPUB 2018/0008476 A1).
10. With regard to claim 3, Kloeppels in view of Maher disclose the sheet material of claims 1-2, as seen above.
Further, while Kloeppels discloses a cloth like woven textile ([0011]), Kloeppels and Maher fail to explicitly disclose that the sheet material (10) is gas and vapor permeable.
Rodzewicz discloses a medical dressing (abstract; Figs. 1a, 1b), comprising a cover layer (backing layer, 101), fluid acquisition, wicking and absorption layers (113, 114, 115), and a skin-safe adhesive such as silicone gel adhesive and acrylate adhesives ([0111-0112]); wherein it is suggested that the medical dressing is gas and vapor permeable ([0106]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sheet material disclosed by Kloeppels in view of Maher to be gas and vapor permeable, similar to that disclosed by Rodzewicz, in order to allow for the sheet material to be breathable and facilitate wound healing, such that moisture and heat can evaporate from the sheet material during use, as suggested by Rodzewicz in paragraph [0106].
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kazala, Jr. et al. (US PGPUB 2016/0015569 A1) discloses anisotropic drapes and systems.
Auguste et al. (US PGPUB 2014/0142526 A1) discloses hydrocellular absorbent dressings.
Riesinger (US PGPUB 2012/0179127) discloses a wound care article and convex insert.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/ANDREW J MENSH/Primary Examiner, Art Unit 3781