DETAILED ACTION
This Office Action is in response to the amendment filed December 2, 2025. Claims 42 and 56 have been amended. Claims 47, 60 and 61 have been cancelled. Claims 42-46 and 48-59 are pending in the instant application.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
The drawings were received on December 2, 2025. These drawings are approved by the examiner.
Response to Amendment
In response to the amendment, the objections to the drawings and the specification have been withdrawn. In response to the amendment, the 102(a) rejection of claims 42, 46, 56, 57 and 60, the 103 rejection of clam 43 and the double patenting rejections of claims 42, 44-45, 56, 58, 59 have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of U.S. Patent No. 4,926,850.
Terminal Disclaimer
The terminal disclaimer filed on December 2, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 8,604,265, U.S. Patent No. 9,492,325 and U.S. Patent No. 10,765,783 has been reviewed and is NOT accepted.
The terminal disclaimer does not comply with 37 CFR 1.321 because:
The applications/patents being disclaimed have not been identified.
Claim Rejections - 35 USC § 102
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.
Claim(s) 48-52 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Patent No. 4,926,850 (“Lott et al.”).
Regarding claim 48, Lott et al. discloses a wound dressing that anticipates Applicants’ presently claimed invention. More specifically Lott et al. discloses a covering for forming a sealed space over a tissue site, the covering (constituted by a backing sheet 10) comprising: a film (see col. 2, lines 28-31 which discloses the dressing or bandage comprises a vapor permeable plastic film) having a first portion (a periphery comprising adhesive 12, see Figs. 1-4), and a second portion (non-adhesive window 14, see Figs. 1-4 and col. 2, lines 33-35); an adhesive (adhesive 12, see col. 2, lines 32-33) disposed on the first portion of the film (see Figs. 1-4 and col. 2, lines 33-35); and the second portion of the film being free of the adhesive (the window is non-adhesive, see col. 2, lines 33-35) and configured to permit evaporation of water vapor through the second portion (the dressing is a vapor permeable plastic film).
As regards claim 54, Lott et al. discloses the dressing of claim 48, wherein the
second portion comprises a membrane (constituted by the film which reads on the claimed membrane since Applicants' specification does not provide a special definition of "membrane" to distinguish a membrane from a film).
Regarding claim 50, Lott et al. discloses the covering of claim 48, wherein the first portion comprises a periphery of the film (note the rejection of claim 48 above).
Regarding claim 51, Lott et al. discloses the covering of claim 48, wherein the second portion comprises a center of the film (note the disclosure of the central portion of the backing sheet 10 is not coated with the adhesive thus forming a non-adhesive window 14, see col. 2, lines 33-35).
Regarding claim 52, Lott et al. discloses the covering of claim 48, wherein the first portion comprises a periphery of the film (note the rejection of claim 48 above, and the second portion comprises a center of the film (note the disclosure of the central portion of the backing sheet 10 is not coated with the adhesive thus forming a non-adhesive window 14, see col. 2, lines 33-35).
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 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).
Claim 53 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lott et al. in view of U.S. Patent No. 9,302,033 ("Riesinger").
Regarding claim 53, Lott et al. discloses the covering of claim 48, except that the covering further comprises a one-way valve coupled to the film, the one-way valve permitting fluid flow from the sealed space through the covering.
Riesinger, however, teaches it is known to provide a dressing (100) with a one- way valve (12) in order to allow flow through of air and if excess wound secretions (see col. 14, lines 60-62). In view of Riesinger, it would have been obvious to one having ordinary skill in the art to add a one-way valve to the film of Lott et al. in order to allow flow through of air and if excess wound secretions.
Claims 54 and 55 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lott et al. in view of U.S. Patent No. 8,114,126 (“Heaton et al.”).
As regards claims 54 and 55, Lott et al. discloses the dressing of claim 48, except that the dressing further comprises a pressure-regulating valve coupled to the film, the pressure-regulating valve permitting fluid flow into the sealed space through the film, and wherein the pressure-regulating valve permits fluid flow into the sealed space in response to a maximum reduced pressure in the sealed space.
However, Heaton et al. teaches it is known to provide a wound dressing (100) with a pressure regulating valve (154) in order to regulate pressure in the dressing (col. 5, line 50-col. 6, line 10).
In view of Heaton et al., it would have been obvious to one having ordinary skill in the art to modify the dressing of Lott et al. with the addition of a pressure regulating valve in order to regulate the pressure in the dressing.
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 48-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-7 of U.S. Patent No. 10,765,783 (the ‘783 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the same structural elements are disclosed in each.
Regarding claim 48, lines 1-8 of the ‘783 patent discloses a covering for forming a sealed space over a tissue site, the covering comprising: a film having a periphery and a center; an adhesive disposed on the periphery of the film; and the center of the film being free of the adhesive and configured to permit evaporation of water vapor through the second portion. The difference between instant claim 48 and claim 1 of the ‘783 patent does not recite the film has a first portion and second portion; however, one having ordinary skill in the art would understand that the periphery and the center of the film represents first and second portions, respectively.
Regarding claim 49, claim 4 of the ‘783 patent discloses the covering of claim 48, wherein the second portion comprises a membrane (see claim 4).
Regarding claim 50, claim 1 of the ‘783 patent discloses the covering of claim 48, wherein the first portion comprises a periphery of the film (note the rejection of claim 48 above).
Regarding claim 51, claim 1 of the ‘783 patent discloses the covering of claim 48, wherein the second portion comprises a center of the film (note the rejection of claim 48 above).
Regarding claim 52, claim 1 of the ‘783 patent discloses covering of claim 48, wherein the first portion comprises a periphery of the film, and the second portion comprises a center of the film (note the rejection of claim 48 above).
Regarding claim 53, claim 5 of the ‘783 patent discloses the covering of claim 48, further comprising a one-way valve coupled to the film, the one-way valve permitting fluid flow from the sealed space through the covering (see claim 5).
Regarding claim 54, claim 6 of the ‘783 patent discloses the covering of claim 48, further comprising a pressure-regulating valve coupled to the film, the pressure-regulating valve permitting fluid flow into the sealed space through the film (see claim 6).
Regarding claim 55, claim 7 of the ‘783 patent discloses covering of claim 54, wherein the pressure-regulating valve permits fluid flow into the sealed space in response to a maximum reduced pressure in the sealed space.
Allowable Subject Matter
Claims 42-46 and 56-59 are allowed.
The closest prior art is that of Hartwell. With respect to claim 42, Hartwell, however, fails to teach or fairly suggest to one alone or in combination, an evaporative window disposed over the absorbent layer; and a liquid-impermeable, vapor-permeable membrane covering the evaporative window, in combination with the other recited elements of claim 42.
With respect to claim 56, Hartwell further fails to teach or fairly suggest to one alone or in combination the dressing is configured to process between 110% and 160% of the saturation capacity, in combination with the other recited features of claim 56.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIM M LEWIS whose telephone number is (571)272-4796. The examiner can normally be reached Monday -Friday 5:30 am -11:30 am.
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/KIM M LEWIS/Primary Examiner, Art Unit 3786