DETAILED ACTION
Note: The present application is being examined under the pre-AIA first to invent provisions.
This Office action is in response to communications filed on April 13, 2026.
Election/Restrictions
1. Applicant’s election without traverse of Group III, claims 27-32 in the reply filed on April 13, 2026 is acknowledged. Claims 13-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Status of Claims
1. Claims 27-46 are pending and currently under consideration for patentability.
Claims 1-12 were cancelled via preliminarily amendment on August 13, 2024.
Claims 13-26 are cancelled and claims 33-46 are newly added via amendment on April 13, 2026.
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 15, 2024, January 17, 2025, June 24, 2025 and October 2, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Double Patenting
4. 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.
5. Claims 27-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 8,447,375. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claims 1-20 contain additional limitations requiring a dressing system comprising: a sponge; a near infrared spectroscopy (NIRS) sensor positioned adjacent to the sponge for monitoring oxygenation levels of open tissue adjacent to the sponge; and a tube coupled to the sponge for removing fluid from the sponge, and is thus more specific, in effect making the invention of patented claims 1-20 a "species" of the "generic" invention of instant claims 27-46. It has been held that the generic invention is "anticipated" by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
6. Claim(s) 27-29 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Hu et al. (US PGPUB 2009/0259203 A1).
7. With regard to claim 27, Hu discloses a tensioning device (elongate support, 604; Figs. 6A, 6B, 6C) for use with a wound dressing (wound treatment device, 600; abstract; [0066-0067]), the tensioning device (604) comprising: a central shaft (cap structure, 628), the central shaft (628) configured to be positioned across a midline of a wound (wound edges, 634 and gap, 636), the central shaft (628) further configured to be flexible ([0066]); and a plurality of ribbons (one or more side flanges or flaps, 622) coupled to the central shaft (628) and extending away from either side of the central shaft (628; Figs. 6A-C; [0069]), each of the plurality of ribbons (622) configured to be attached to skin (at tissue contact surface, 624) at a perimeter of the wound (see wound edges, 634) and further configured to exert a force on the skin at the perimeter of the wound toward a center of the wound (see dashed line Fig. 6C; [0070-0071]).
8. With regard to claim 28, Hu discloses that the central shaft (628) comprises a plastic or polymer material ([0041]).
9. With regard to claim 29, Hu discloses that the plurality of ribbons (622) are spring-loaded so as to exert an inward force toward the center of the wound ([0071]; [0075]; Fig. 6C).
Claim Rejections - 35 USC § 103
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 for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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).
10. Claim 30 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hu.
11. With regard to claim 30, while Hu suggests that the plurality of ribbons (622) are attached to the central shaft (628; “same or different material”; [0069]; Figs. 6A-C), and appear fully capable of being forcibly detached from the central shaft (628), Hu fails to explicitly disclose that the plurality of ribbons are configured to be detachable from the central shaft.
Nonetheless, it would have been obvious to one having ordinary skill in the art prior to the invention being made to have modified the plurality of ribbons disclosed by Hu to be configured to detached from the central shaft, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlicnrnan, 168 USPQ 177, 179. Further, one having ordinary skill in the art would be motivated to provide detachable ribbons in order to allow for simple addition and/or replacement of ribbons if needed, with a reasonable expectation of success.
12. Claim 32 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hu in view of Wu et al. (US PGPUB 2011/0106026 A1).
13. With regard to claim 32, Hu is silent in regard to one or more pull tabs coupled to the plurality of ribbons and configured to be attached to the skin at the perimeter of the wound, wherein each ribbon of the plurality of ribbons comprises a first end attached to the central shaft and a second end coupled to the one or more pull tabs.
However, within the same field of endeavor, Wu disclose methods and devices for applying closed incision negative pressure wound therapy (abstract; Figs. 16A, 16B), but further discloses one or more pull tabs (1603) coupled to a plurality of ribbons (sealant layer 1602 may further comprise one or more stretch-limiting elements 1605) and configured to be attached to the skin at the perimeter of the wound (similar to that seen in Figs. 6A-B), wherein each ribbon of the plurality of ribbons (1602, 1605) comprises a first end attached to the central shaft (1601) and a second end coupled to the one or more pull tabs (1603; [0090]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the invention being made to have modified the second end of the plurality of ribbons disclosed by Hu to be coupled to one or more pull tabs, similar to that disclosed by Wu, in order to allow the user to grab or otherwise use the pull tabs to apply a pulling force to stretch the plurality of ribbons prior to application, as suggested by Wu in paragraph [0090].
Allowable Subject Matter
14. Claims 31 and 33-46 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). Namely, applicant must overcome the non-statutory double patenting rejection outlined above.
15. The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 31, the closest prior art of record fails to reasonably disclose or suggest, alone or in combination, the unique combination of claimed structure further comprising: a central crankshaft coupled to the plurality of ribbons, the central crankshaft configured to exert a force on the plurality of ribbons when the central crankshaft is rotated.
Regarding claim 33, the closest prior art of record fails to reasonably disclose or suggest, alone or in combination, the unique combination of claimed structure further comprising: a positive-pressure bladder configured to be positioned dorsally of the wound dressing. Blott et al. (US PGPUB 2008/0294127 A1) while disclosing a system similar to that being claimed, further discloses a positive-pressure bladder configured to be positioned underneath a wound dressing; however, there is no explicit reason/motivation to one having ordinary skill in the art to reposition the positive pressure bladder dorsally of the wound dressing, or to reasonably modify Hu to incorporate a positive pressure bladder, similar to that disclosed by Blott, dorsally of the wound dressing, as presently required by the claims.
Claims 34-43 are indicated as allowable for depending from claim 33.
Regarding claim 44, the closest prior art of record fails to reasonably disclose or suggest, alone or in combination, the unique combination of claimed structure further comprising: a bladder comprising: a flexible bottom portion; and a rigid top portion configured to minimize expansion of the bladder in a direction of the rigid top portion.
Claims 45-46 are indicated as allowable for depending from claim 44.
Conclusion
16. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lebner et al. (US PGPUB 2007/0038247) discloses a wound closure kit.
Rastegar et al. (US PGPUB 2008/0146982) discloses a shape and pressure adjustable dressing.
Fleischmann (US PGPUB 2008/0167593) discloses a wound treatment device.
Zamierowski (US 7,413,571) discloses a flexible medical closure screen.
Heaton et al. (US PGPUB 2010/0106188) discloses a modular reduced-pressure wound-closure system.
17. 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
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