DETAILED ACTION
Note: The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
1. Claims 26-45 are pending and currently under consideration for patentability.
Claims 1-25 are canceled as of the December 3, 2025 preliminary amendment.
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 April 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.
Claim Objections
4. Claim 40 is objected to because of the following informalities:
In line 2 of claim 40, the term “configure to” should read as ---configured to---.
Appropriate correction is required.
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 –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
5. Claim(s) 26-34, 36, 37 and 41-43 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Blott et al. (US PGPUB 2006/0155260 A1).
6. With regard to claim 26, Blott discloses a wound-vacuum system (apparatus for aspirating, irrigating and/or cleansing wounds, 1; abstract; Figs. 17, 18a, 27) comprising: a dressing (conformable wound dressing, 2) configured to be positioned proximate to a wound (5; Fig. 27), wherein the dressing (2) comprises a top surface (surface of circular backing layer, 342 facing away from wound, 5) opposite a bottom surface (surface of membrane, 361 facing wound, 5), the bottom surface facing the wound when the dressing (2) is positioned proximate to the wound (5; Figs. 18a, 27); a housing (boss, 351) configured to be coupled to the top surface (of 342) of the dressing (2; [0601-0602]; [0620]; [0133]; [0156]; [0228]); first tubing (outlet pipe, 347) and second tubing (inlet pipe, 346) configured to be coupled to the housing (351; Fig. 18a; [0602]); a suction system (‘vacuum pump assembly’ including tank, 911; Fig. 27) configured to be coupled to the housing (351) via the first tubing (347), wherein the suction system comprises a vacuum-producing device (vacuum pump, 918) configured to generate negative pressure to remove exudate from the wound through the first tubing ([0633]; [0640]; [0642]); and an irrigation system (‘peristaltic pump, acting on the fluid supply tube 7’; including fluid reservoir, 12) configured to be coupled to the housing (351) via the second tubing (346), wherein the irrigation system is configured to distribute fluid to the wound through the second tubing ([0631-0633]).
7. With regard to claim 27, Blott discloses that the housing (351) is configured to be coupled to a central location (‘mounted centrally’) along the top surface (of 342) of the dressing (2; [0620]; Fig. 18a).
8. With regard to claims 28-32, Blott discloses that the system further comprises a sponge (wound filler, 364; Fig. 18a) comprising a foam ([0166]; [0184]; [0609]; [0622]; [0630]), configured to be positioned against the wound (5) such that the sponge (364) is between the wound (5) and the bottom surface (of 361) of the dressing (2; Fig. 18a; [0607]; [0609]; [0618]; [0620]); wherein the sponge (364) extends between a first rounded end and a second rounded end (‘inverted frustoconical’; [0548]; ‘inverted generally hemispherical’; [0557]; between circular backing layer, 342 and circular membrane, 361); wherein the sponge (364) comprises a wound-facing surface and a plurality of fluid channels (‘open-cell foam with pores that may form such bores, channels, conduits, passages and/or spaces through the wound filler’) defined along the wound-facing surface ([0184]); and wherein the dressing (2) is configured to completely cover the sponge (via 342) when the sponge (364) is positioned against the wound (5; Fig. 18a; [0617]).
9. With regard to claim 33, Blott discloses that the suction system and the irrigation system are configured to operate at the same time ([0009]; [0039]; [0520-0522]; [0631-0645]; Fig. 27).
10. With regard to claim 34, Blott discloses that the dressing (2) is at least partially transparent (‘backing layer… of a transparent or translucent material’; [0103]).
11. With regard to claims 36 and 43, Blott discloses that the first tubing (347) and the second tubing (346) are configured to be suspended at least partially above the dressing (2; Figs. 1, 27; [0620]); wherein the first tubing (347) and the second tubing (346) are configured to extend parallel relative to each other outward from the housing (351; Figs. 1, 27; [0620]; [0633-0645]).
12. With regard to claim 37, Blott discloses that the first tubing (347) and the second tubing (347) are configured to be coupled to a channel of the housing (351), the channel defined at a central location the housing (351; [0133]; [0602]; [0620]; Fig. 18a).
13. With regard to claim 41, Blott discloses that the system (1) further comprises at least one collection unit (tank, 911 and waste bag, 915) configured to receive the exudate removed from the wound by the suction system (1; Fig. 21; [0633-0645]).
14. With regard to claim 42, Blott discloses that the dressing (2) comprises a preformed shape configured to match a geometry of the wound without requiring the dressing to be cut to size (Figs. 18a, 27; [0082]; [0158-0159]; [0165]; [0167]; [0608]).
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).
15. Claims 35, 38-40, 44 and 45 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Blott in view of Vogel (US PGPUB 2007/0032763 A1).
16. With regard to claim 35, while Blott discloses that the dressing (2) has a generally round, and in particularly circular sealing periphery ([0124]; [0599]; [0617]; Figs. 1, 27); and that the housing (351) projects distally (outwardly from the wound) around each relevant tube (346, 347; [0133]), Blott fails to explicitly disclose that the housing has a circular cross- section.
However, within the same field of endeavor, Vogel discloses a wound irrigating device pressure monitoring and control system (100; abstract; Figs. 1 and 5A) comprising: a dressing (wound dressing, 123) configured to be positioned proximate a wound ([0026]; a housing (self-adhesive dressing connector, 515) configured to be coupled to the top surface (over hole, 530) of the wound dressing (123; Fig. 5A; [0048]); and a multi-lumen tubing (512) coupled to the housing (515); wherein the housing has a circular cross-section (Fig. 5A).
Therefore, it would have been obvious to one having ordinary skill in the art before the invention was made to have modified the housing disclosed by Blott to have a circular cross-section, similar to that disclosed by Vogel, in order to utilize a housing formed as an annular adhesive ring to be positioned in alignment over the centrally located hole in the drape, as suggested by Vogel in paragraph [0048], forming a proper seal around the hole with a reasonable expectation of success.
17. With regard to claims 38-40, while Blott suggests the use of valves, regulators (919) or other control devices ([0052]; [0441]; [0642]; [0644]) which communicate with the suction and irrigation system, as well as a tank sensor (921) and dressing sensor (922) to measure pressures at the wound (5) and tank (911; Fig. 27), Blott is silent in regard to the system further comprising a central processing unit configured to communicate with at least one of the dressing, the suction system, and the irrigation system; wherein the central processing unit is configured to measure negative pressure generated by the vacuum-producing device of the suction system; and wherein the central processing unit is configured to activate an alarm representing a change in operation of at least one of the suction system and the irrigation system, the alarm comprising a visual indicator.
However, Vogel discloses the use of a central processing unit (microcontroller, 101; Figs. 1, 5A-5C) configured to communicate with at least one of the dressing (123), a suction system (at least the vacuum pump, 105), and an irrigation system ([0009]; [0026]); wherein the central processing unit (101) is configured to measure negative pressure (‘vacuum pressure signal’) generated by the vacuum-producing device (105) of the suction system (via vacuum-pressure sensor, 109; [0028-0030]); and wherein the central processing unit (101) is configured to activate an alarm (‘indicate alarm conditions’) representing a change in operation of at least one of the suction system and the irrigation system, the alarm comprising a visual indicator (LEDs, 163; [0026]; [0030-0033]; [0038]; [0046]).
Therefore, it would have been obvious to one having ordinary skill in the art before the invention was made to have modified the system disclosed by Blott to include a CPU, similar to that disclosed by Vogel, in order to accurately measure system pressures and provide alarm indications when pressures are outside of target ranges for proper wound therapy, for a user or practitioner to visibly recognize alarm conditions, indicating issues, such as dressing leaks or full canisters, that need to be immediately resolved in order to continue proper wound therapy, as suggested by Vogel in paragraph [0046].
18. With regard to claim 44, Blott discloses a wound-vacuum system (apparatus for aspirating, irrigating and/or cleansing wounds, 1; abstract; Figs. 17, 18a, 27) comprising: a dressing (conformable wound dressing, 2) configured to be positioned proximate to a wound (5; Fig. 27), wherein the dressing (2) comprises a top surface (surface of circular backing layer, 342 facing away from wound, 5) opposite a bottom surface (surface of membrane, 361 facing wound, 5), the bottom surface facing the wound when the dressing (2) is positioned proximate to the wound (5; Figs. 18a, 27), wherein the dressing (2) is at least partially transparent (‘backing layer… of a transparent or translucent material’; [0103]); a housing (boss, 351) configured to be coupled to a central location (of 342) of the dressing (2) over the wound (5; [0601-0602]; [0620]; [0133]; [0156]; [0228]), the housing (351) comprising a channel defined at a central location of the housing (351; [0133]; [0602]; [0620]; Fig. 18a); first tubing (outlet pipe, 347) and second tubing (inlet pipe, 346) configured to be coupled to the channel of the housing (351; Fig. 18a; [0602]), wherein the first tubing (347) and the second tubing (346) are configured to be suspended at least partially above the dressing (2; Figs. 1, 27; [0620]); a suction system (‘vacuum pump assembly’ including tank, 911; Fig. 27) configured to be coupled to the housing (351) via the first tubing (347), wherein the suction system comprises a vacuum-producing device (vacuum pump, 918) configured to generate negative pressure to remove exudate from the wound through the first tubing ([0633]; [0640]; [0642]); and an irrigation system (‘peristaltic pump, acting on the fluid supply tube 7’; including fluid reservoir, 12) configured to be coupled to the housing (351) via the second tubing (346), wherein the irrigation system is configured to distribute fluid to the wound through the second tubing ([0631-0633]).
While Blott suggests the use of valves, regulators (919) or other control devices ([0052]; [0441]; [0642]; [0644]) which communicate with the suction and irrigation system, as well as a tank sensor (921) and dressing sensor (922) to measure pressures at the wound (5) and tank (911; Fig. 27), Blott is silent in regard to the system further comprising a central processing unit configured to communicate with at least one of the dressing, the suction system, and the irrigation system.
However, Vogel discloses the use of a central processing unit (microcontroller, 101; Figs. 1, 5A-5C) configured to communicate with at least one of a dressing (123), a suction system (at least the vacuum pump, 105), and an irrigation system ([0009]; [0026-0033]; [0038]; [0046]).
Therefore, it would have been obvious to one having ordinary skill in the art before the invention was made to have modified the system disclosed by Blott to include a CPU, similar to that disclosed by Vogel, in order to accurately measure system pressures and provide alarm indications when pressures are outside of target ranges for proper wound therapy, for a user or practitioner to visibly recognize alarm conditions, indicating issues, such as dressing leaks or full canisters, that need to be immediately resolved in order to continue proper wound therapy, as suggested by Vogel in paragraph [0046].
19. With regard to claim 45, Blott discloses that the system further comprises a sponge (wound filler, 364; Fig. 18a) comprising a foam ([0166]; [0184]; [0609]; [0622]; [0630]), configured to be received against the wound (5) such that the sponge (364) is between the wound (5) and the bottom surface (of 361) of the dressing (2; Fig. 18a; [0607]; [0609]; [0618]; [0620]); wherein the sponge (364) comprises a wound-facing surface and a plurality of fluid channels (‘open-cell foam with pores that may form such bores, channels, conduits, passages and/or spaces through the wound filler’) defined along the wound-facing surface ([0184]; [0617]).
Conclusion
20. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bybordi et al. (US PGPUB 2004/0054338) discloses a closed wound drainage system.
Svedman et al. (US 5,176,663) discloses a dressing having a pad.
Lockwood et al. (US PGPUB 2002/0161346) discloses a vacuum therapy and cleansing dressing.
Henley et al. (US PGPUB 2002/0183702) discloses a wound treatment apparatus.
21. 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..
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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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