DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 10/08/2025.
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 .
Status of Claims
Claim(s) 1-4, 9, 21, 23-24, 27, 33-36, 42-45, 50, 57, and 59-62 is/are pending in the application.
Claim(s) 24, 27, 33-36, 42-45, 50, and 57 is/are withdrawn from consideration.
Claim(s) 1-4, 9, 21, 23, and 59-62 is/are examined on the merits.
Response to Arguments
Applicant’s arguments filed on 10/08/2025 have been fully considered but are moot because the independent claim(s) has/have been amended and the new ground of rejection does not rely on the same combination references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim(s) 1-4, 9, 21, 23, and 60-62 is/are rejected under 35 U.S.C 103 as being unpatentable over Lin (US PGPUB 20190030223) in view of Elder (US PGPUB 20210001019) and Eriksson (US PGPUB 20150119857).
Regarding claim 1, Lin discloses a method of reducing edema at a target site on a subject (reducing edema and treat edema at a wound bed 213: ¶0102, 0167-0168 and, 0172), comprising:
identifying a target site exhibiting edema on the subject (¶0167);
securing a treatment device to a periphery of the target site (wound therapy apparatus 200: ¶0015, 0102, and 0182), the treatment device (200) comprising:
a chamber defining a treatment space (a wound interface 215 defining an enclosed space 217: ¶0102 and Fig. 6A), the chamber configured to conform to the shape of the periphery (¶0103), the chamber having a sealing portion at a base (adhesive 290 at a base 220: ¶0104 and Fig. 6A);
applying a negative pressure to the treatment space of the treatment device (¶0004 and 0167); and
maintaining the negative pressure in the treatment space for a duration of time sufficient to reduce edema at the target site (¶0167-0170).
Lin further discloses the target site (the wound bed) comprising a localized region of tissue that has lost skin and been affected by hostile factors, resulting in, for example, cellular abnormalities such as swelling, inflammation, degradation, infection, or cell death or unhealed wound (¶0003), but does not specifically disclose the target site comprising tissue exhibiting non-procedural edema or tissue surrounding a closed incision wound resulting from an elective procedure, a skin graft procedure, or a surgical procedure. Lin also discloses using NPWT to treat edema by withdrawing exudate from the wound (¶0167-0168).
In the same field of endeavor, negative pressure wound therapy, Elder discloses negative pressure wound therapy systems and methods for assisting in the closure and healing of wounds by reducing tissue edema (Abstract, ¶0004, and 0029). Elder further discloses/suggests wounds that can be used in the NPWT systems are incisional wounds resulting from skin grafts or surgery (¶0027 and 0029).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of reducing edema of Lin in view of Elder by selecting tissue surrounding a closed incision wound resulting from a skin graft procedure or a surgical procedure as the target site, motivated by the desires to treat edema and accelerate healing time, as suggested in ¶0027 and 0029 of Elder.
Lin/Elder does not disclose the chamber being fabricated from a substantially impermeable material and an inner surface of the chamber including a plurality of surface patterns.
In the same field of endeavor, negative pressure wound therapy, Eriksson discloses a treatment device 20 to a periphery of a target site 30 (¶0052 and Figs. 1-2) and a method of reducing edema at a target site on a subject (¶0003, 0006, and Figs. 1-2). Eriksson further discloses the treatment device (20) comprising a chamber defining a treatment space (a chamber 20 defining a treatment space 24: ¶0052 and Figs. 1-2) and the chamber being fabricated from a substantially impermeable material (¶0065: any appropriate medical grade material that has flexibility, conformability, gas impermeability, and liquid impermeability) for the benefits of providing a chamber that can retain shape, function, and effectiveness of raised structures under desired ranges of negative pressure, and introduce therapeutic agents to the wound (¶0052 and 0065). Eriksson also discloses an inner surface of the chamber including a plurality of surface patterns (interior surfaces of the chamber wall may be configured with structures 40 that are engineered on the surfaces: ¶0062; Figs. 1-2, and 6) for the benefit of ensuring that negative pressure established within the chamber space is evenly distributed and maintained throughout such space (¶0063).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the treatment device of Lin/Elder in view of Eriksson by making the chamber from an impermeable material and incorporating a plurality of surface patterns on an inner surface of the chamber, in order to provide a chamber that can retain shape, function, and effectiveness of raised structures under desired ranges of negative pressure, and introduce therapeutic agents to the wound and ensure that negative pressure established within the chamber space is evenly distributed and maintained throughout such space, as suggested in ¶0052, 0063, and 0065 of Eriksson 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). Thus, the treatment device of Lin/Elder in view of Eriksson is capable of applying a negative pressure to the treatment space of the treatment device to allow the plurality of surface patterns to directly contact the target site and create pathways configured to evenly distribute the negative pressure in the treatment space and Lin/Elder in view of Eriksson discloses a method of applying a negative pressure to the treatment space of the treatment device to allow the plurality of surface patterns to directly contact the target site and create pathways configured to evenly distribute the negative pressure in the treatment space.
Regarding claim 2, Lin further discloses the target site comprises a wound site (¶0003, 0102, and Figs. 6A-B).
Regarding claim 3, Lin further discloses the treatment device reduces edema in a tissue surrounding the wound site (¶0167-0170).
Regarding claim 4, Lin does not disclose the target site is associated with a breast of the subject; however, Lin further discloses the chamber (the wound interface 215) has geometric shapes to adapt various shaped wounds on various regions of the body (¶0103). Thus, the target site of Lin/Elder/Eriksson can be associated with a breast of the subject.
Regarding claim 9, Lin further discloses the target site is associated with a lower leg, a foot. an arm, a hand, a chest or an abdomen of the subject; however, Lin further discloses the chamber (the wound interface 215) has geometric shapes to adapt various shaped wounds on various regions of the body (¶0103). Thus, the target site of Lin/Elder/Eriksson can be associated with a lower leg, a foot. an arm, a hand, a chest or an abdomen of the subject.
Regarding claim 21, Lin/Elder does not disclose debriding the target site prior to the securing of the treatment device.
Eriksson further discloses/suggests debriding the target site prior to the securing of the treatment device (¶0009 and claim 19) for the benefit of facilitating wound healing (¶0009).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Lin/Elder/Eriksson in view of Eriksson by incorporating a method step of debriding the target site prior to the securing of the treatment device, in order to facilitate wound healing, as suggested in ¶0009 of Eriksson.
Regarding claim 23, Lin/Elder/Eriksson discloses the chamber being fabricated from a substantially impermeable material which is advantageous for introducing therapeutic agents to the wound (see rejection of claim 1 above). The treatment device of Lin/Elder/Eriksson is capable of being introduced therapeutic agents to the wound and; thus, Lin/Elder/Eriksson further discloses applying a therapeutic agent to the target site.
Regarding claim 60, Lin further discloses interstitial fluid in the tissue surrounding the wound site is reduced (¶0167-0168: the treatment device collects fluid from wound; thus, the interstitial fluid in the tissue surrounding the wound site will be reduced).
Regarding claim 61, Lin further discloses the treatment device remains in place for up to about four to seven days or longer before being replaced or removed (¶0167-0173).
Regarding claim 62, Lin further discloses the target site exhibiting edema is associated with healthy tissue of the subject (¶0003 and 0167-0173).
Claim(s) 59 is/are rejected under 35 U.S.C 103 as being unpatentable over Lin (US PGPUB 20190030223) in view of Elder (US PGPUB 20210001019) and Eriksson (US PGPUB 20150119857), as applied to claim 1 above, and further in view of Daich (US PGPUB 20180344534).
Regarding claim 59, Lin/Elder/Eriksson does not disclose the nonprocedural edema is associated with diabetic joint swelling, swelling during pregnancy or lymphedema.In the same field of endeavor, negative pressure wound therapy, Daich discloses negative pressure wound therapy systems and methods for treating wounds (Abstract). Daich further discloses/suggests the NPWT system can be used to reduce lymphedema (¶0063) for the benefit of providing enhanced quality of life and healing benefits to patients (¶0063).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the treatment device of Lin/Elder/Eriksson in view of Daich by using the treatment device for lymphedema, in order to enhanced quality of life and healing benefits to patients, as suggested in ¶0063 of Daich.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached on (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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/NHU Q. TRAN/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781