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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 50-59 in the reply filed on 01/29/2026 is acknowledged.
Claims 60-66 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/29/2026.
Response to Amendment
The amendment filed 01/29/2026 has been entered. Claims 1-49 and 67 are cancelled. Claims 50-66 remain pending in this application. Claims 60-66 are withdrawn.
Claim Objections
Claim 57 is objected to because of the following informalities:
Claim 57, ln. 2 should read ---a single polymeric sheet folded to [[fo1m]] form the first polymeric---
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.
Claim 59 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 59, ln. 3 recites “the second pressure-offloading layer comprises the polyurethane foam”. It is unclear whether “the polyurethane foam” recited in claim 59 is the same polyurethane foam recited in claim 50, from which claim 59 depends.
Claim Rejections - 35 USC § 102
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) 50-53, 56-57 and 59 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hartwell (Pub. No.: US 2016/0106892 A1).
Regarding claim 50, Hartwell discloses (fig. 3A-3C) an apparatus (fluidic connector 300) for managing fluid from a tissue site (abstract), comprising:
A sealed compartment formed by a first polymeric film (bottom layer 334) and a second polymeric film (top layer 332) (¶ 0093, ¶ 0096),
Wherein the sealed compartment comprises a first fluid pathway (characterized by pathway between bottom layer 334 and intermediate layer 333, fig. 3C, ¶ 0093); and
A first pressure-offloading layer (fluid distributing layer 355) adapted to be positioned adjacent the first polymeric film of the sealed compartment (fig. 3C, ¶ 0104), wherein the first pressure-offloading layer comprises a polyurethane foam (¶ 0104).
Regarding claim 51, Hartwell discloses wherein the sealed compartment further comprises a second fluid pathway (characterized by pathway between intermediate layer 333 and top layer 332, fig. 3C, ¶ 0093) adjacent the first fluid pathway (fig. 3C).
Regarding claim 52, Hartwell discloses wherein the first fluid pathway and the second fluid pathway are formed by a polymeric layer (intermediate layer 333, ¶ 0093) disposed between the first polymeric film and the second polymeric film (¶ 0093).
Regarding claim 53, Hartwell discloses wherein the first polymeric film, the second polymeric film, and the first pressure-offloading layer are welded together (the first polymeric film and the second polymeric film may be sealed by heat welding, ¶ 0096; the first pressure offloading layer can be welded to the first polymeric film, ¶ 0104).
Regarding claim 56, Hartwell discloses wherein the first polymeric film and the second polymeric film comprise polyurethane (¶ 0093).
Regarding claim 57, the claim limitation, “wherein the first polymeric film and the second polymeric film are formed from a single polymeric sheet folded to form the first polymeric film and the second polymeric film” is being treated as product-by-process.
When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP § 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “Even 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).
Hartwell discloses the invention substantially as claimed by Applicant but is silent to wherein the first polymeric film and the second polymeric film are formed from a single polymeric sheet folded to form the first polymeric film and the second polymeric film. This claim is interpreted as a product-by-process claim, since it claims an apparatus and describes the process used to make or construct the apparatus. In spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established (MPEP 2113).
Regarding claim 59, Hartwell discloses a second pressure-offloading layer (second spacer layer 344) adapted to be positioned adjacent the first polymeric film of the sealed compartment (fig. 3C, ¶ 0098), wherein the second pressure-offloading layer comprises the polyurethane foam (¶ 0099).
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) 54-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartwell, as applied to claim 51 above, and further in view of Melin et al. (Pub. No.: US 2016/0144085 A1).
Regarding claim 54, Hartwell fails to disclose wherein the first polymeric film comprises a first plurality of bubbles extending into the first fluid pathway of the sealed compartment.
Melin teaches (fig. 2-3, 7) an apparatus (fluid transport assembly 52) for managing fluid from a tissue site (¶ 0032) and thus in the same field of endeavor, comprising:
A sealed compartment formed by a first polymeric film (intermediate sheet 34) and a second polymeric film (bottom sheet 32) (¶ 0073, fig. 2), wherein the sealed compartment comprises a first fluid pathway (fluid conduits 38, ¶ 0078), wherein the first polymeric film comprises a first plurality of bubbles (see sealed chambers 28 surrounded by voids 36) extending into the first fluid pathway of the sealed compartment (fig. 2, ¶ 0077-¶ 0078), wherein the plurality of bubbles are configured to prevent clogging of the apparatus during use and a cushioning effect to contribute to a more comfortable therapy (¶ 0034).
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 first polymeric film of Hartwell such that it comprises a first plurality of bubbles extending into the first fluid pathway of the sealed compartment, as taught by Melin, in order to prevent clogging of the apparatus during use and a cushioning effect to contribute to a more comfortable therapy (Melin ¶ 0034).
Regarding claim 55, Hartwell fails to disclose wherein the second polymeric film comprises a second plurality of bubbles extending into the second fluid pathway of the sealed compartment.
Melin teaches (fig. 2-3, 7) an apparatus (fluid transport assembly 52) for managing fluid from a tissue site (¶ 0032) and thus in the same field of endeavor, comprising: a sealed compartment formed by a first polymeric film (bottom sheet 32) and a second polymeric film (intermediate sheet 34), wherein the sealed compartment comprises a second fluid pathway (fluid conduits 38, ¶ 0078), wherein the second polymeric film comprises a second plurality of bubbles (see sealed chambers 28 surrounded by voids 36) extending into the second fluid pathway of the sealed compartment (fig. 2, ¶ 0077-¶ 0078), wherein the plurality of bubbles are configured to prevent clogging of the apparatus during use and a cushioning effect to contribute to a more comfortable therapy (¶ 0034).
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 second polymeric film of Hartwell such that it comprises a second plurality of bubbles extending into the second fluid pathway of the sealed compartment, as taught by Melin, in order to prevent clogging of the apparatus during use and a cushioning effect to contribute to a more comfortable therapy (Melin ¶ 0034).
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartwell, as applied to claim 50 above, and further in view of Allen et al. (Pub. No.: US 2015/0141941 A1).
Regarding claim 58, Hartwell fails to disclose wherein the first pressure-offloading layer has a thickness between 2 mm and 8 mm.
Allen teaches (fig. 1B) an apparatus (suction adapter comprising bridge 211) for managing fluid from a tissues (abstract), and thus in the same field of endeavor, comprising:
A pressure-offloading layer (fluid passage 212), wherein the first pressure-offloading layer comprises a polyurethane foam (¶ 0128), wherein the pressure-offloading layer has a thickness between 1.5 mm and 6 mm (¶ 0129), which overlaps with the claimed range of between 2 mm and 8 mm, wherein the thickness of the first pressure-offloading layer is configured to permit greater patient comfort and provide greater kink resistance (¶ 0128-¶ 0129).
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 first-pressure offloading layer of Hartwell such that it has a thickness of between 2 mm and 8 mm, as taught by Allen, in order to configure the first pressure-offloading layer to permit greater patient comfort and provide greater kink resistance (Allen ¶ 0128-¶ 0129).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Locke et al. (Pub. No.: US 2017/0189236 A1) discloses an apparatus for managing fluid from a tissue site. Coulthard et al. (Pub. No.: US 2011/0230849 A1) discloses an apparatus for managing fluid from a tissue site.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEAGAN NGO/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781