DETAILED ACTION
Note: 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
1. Claims 1-29 are pending and currently under consideration for patentability.
Priority
2. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on January 3, 2025, February 27, 2025 and November 14, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
4. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
5. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
(i) “a reactive gas generator”
(ii) “an application device”
(iii) “a neutralization device”
(iv) “a flow control device”
(v) “a covering device”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
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.
6. Claim(s) 1-3, 11, 13-15, 17-22 and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Golkowski et al. (US PGPUB 2019/0314535).
7. With regard to claims 1-2, 13-15, 19, 26 and 28-29, Golkowski discloses a device for the medical treatment wounds and/or dermatoses of humans and/or animals (abstract; Figs. 10-12; [0004]; [0009]; [0038]; [0047]; [0077]), comprising: a reactive gas generator (plasma generator, 30 in combination with vaporizer, 32) comprising a plasma source (32; [0015]; [0017]; [0120]; [0144-0145]) in the form of a piezoelectric transformer (Figs. 1B, 1C) for generating an atmospheric pressure plasma ([0015]; [0041]; [0120]; [0145]; [0223]; [0229]) designed for generating reactive gases ([0005]; [0012]; [0025]; [0036]; [0072]; [0141]; [0143]); and an application device (wound chamber, 105) formed as a wound dressing ([0266]) for applying the reactive gases in a treatment area (within 105 on patient’s arm, 106); wherein the application device (105) comprises a covering device (wound chamber body, 107; Fig. 12) for covering the treatment area (Fig. 10), wherein the covering device (107) comprises at least one inlet port (connector, 110) for introducing the reactive gases into the treatment area and at least one outlet port (connector, 111) for removing the reactive gases from the treatment area (Figs. 10, 12), and wherein the reaction gas generator (30, 32) is connected to at least one of the inlet ports (110) of the covering device (107) of the application device (105) using a tube (flexible hose, 103; [0267-0269]).
While Golkowski fails to explicitly disclose, within the embodiment relied upon in Figs. 10-12, that the application device is associated with a neutralization device for neutralizing the reactive gases to thereby reduce the concentration of the reactive gases outside the treatment area; wherein the neutralization device is arranged in the area of the outlet port, Golowski discloses alternate embodiments (Figs. 1-2 and 4-7) wherein an application device (chamber, 10) is associated with a neutralization device (free radical destroyer (FRD), 24) for neutralizing the reactive gases to thereby reduce the concentration of the reactive gases outside a treatment area (within 10; [0048]; [0123]); wherein the neutralization device (24) is arranged in the area of an outlet port (outlet conduit, 44; Figs. 1-2, 4-7; [0209-0210]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the wound treatment application device disclosed by Golkowski to be associated with a neutralization device, similar to that disclosed by Golkowski in alternate embodiments, in order to eliminate any remaining free radicals that may have exited the application device, as suggested by Golkowski in paragraph [0048].
Further, while Golkowski discloses that the neutralization device (24; as modified above) is associated with the outlet port (111; Figs. 10, 12), Golkowski fails to explicitly disclose that the neutralization device covers the outlet port.
However, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to relocate the neutralization device disclosed by Golkowski so that it is covering the outlet port, in order to immediately destroy any remaining free radicals from exiting the application device, as suggested by Golkowski in paragraph [0048]. Additionally, it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
8. With regard to claim 3, Golkoski discloses that the neutralization device (24) comprises activated charcoal ([0048]; [0210]).
9. With regard to claim 11, Golkowski discloses that the application device (105) comprises a flow control device (valve to control and regulate gas flow) for influencing a flow of the reactive gases ([0024]; [0046]; [0075]; [0152-0153]).
10. With regard to claim 17, while Golkowski fails to explicitly disclose, within the embodiment relied upon in Figs. 10-12, that the covering device is selected from the group consisting of a limb bag, sock, glove, vest, and trouser, Golowski discloses alternate embodiments (Figs. 14-15) that the covering device is a limb bag (105; [0270-0272]; best seen in Fig. 14).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the application device disclosed by Golkowski to be a limb bag, similar to that disclosed by Golkowski in alternate embodiments, in order to treat multiple wounds or larger wounds that may span an entire limb, while still maintaining a sealed chamber, as suggested by Golkowski in paragraph [0271].
11. With regard to claims 18 and 21, Gollkowski discloses that the covering device (107) can be fastened to skin (via flexible or resilient sealing material, 112) in the area of a fastening edge (edge, 109) of the covering device (107) encircling the treatment area (Fig. 12; [0268]); and wherein the fastening edge (109) preferably comprises a closure strip, an adhesive, a self-adhesive film, or combinations thereof (flexible or resilient sealing material, 112; ‘flexible cuffs, tape, straps, zippers, snaps, clips, buttons, and other mechanical implementations’; [0270]).
12. With regard to claim 20, Golkowski discloses that at least one of the outlet ports (111) of the covering device (107) is integrated in a connector for the tube (flexible hose, 104) and/or in the fastening edge (109; Figs. 10, 12); wherein the outlet port (111) is an additional tube lumen in the tube (104; [0268-0269]).
13. With regard to claims 22, Golkowski discloses that the covering device (107) is associated with a flap valve (‘duckbill valve’) that is fully capable of exerting counteraction against an exudate from a wound running out of an outlet port (111; [0191]; [0282]).
14. With regard to claim 27, while Golkowski discloses a treatment kit (Fig. 24; [0278-0279]), Golkowski is silent in regard to a treatment for fabricating the device of Claim 27 (see rejection above), comprising the application device (105) and the neutralization device (24).
However, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the application device and neutralization device disclosed by Golkowski in the form of a kit, in order to provide the application device and neutralization device in a single sterile and/or disinfected package for transportation and subsequent use, as suggested by Golkowski in paragraphs [0278-0279].
15. Claim(s) 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Golkowski, as applied to claim 1 above, in further view of Riskin (WO 98/10825; provided by applicant in IDS).
16. With regard to claims 4-5, while Golkowski discloses a tube (103) connecting the reactive gas generator (30, 32) to the application device (105; Figs. 10, 12), Golkowski is silent in regard to the application device comprising a nozzle device for generating a jet of the reactive gases that is directed towards the treatment area; and that the tube connects the reactive gas generator to the nozzle device.
Riskin discloses the use of ozone for the manufacture of gaseous medicaments (abstract; Fig. 2; page 3, lines 22-31), wherein a reactive gas generator (high potential terminal of a transformer or other high-voltage generator, 27) generates reactive gases; an application device (tubular housing, 20 in combination with cover, 22 and frusto-conical sleeve, 31) is provided for applying the reactive gases (Fig. 2); and wherein the application device (20, 22, 31) is associated with a neutralization device (highly absorbing annular filter, 24); wherein the application device (20, 22, 31) comprises a nozzle device (sharp point electrode, 25) for generating a jet of the reactive gases (see arrows in Fig. 2) that is directed towards the treatment area; and a tube (inner tube, 21) connects the reactive gas generator (27) to the nozzle device (25; page 10, paragraphs 1-4).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the application device disclosed by Golkowski to include a nozzle device connected to the reactive gas generator, similar to that disclosed by Riskin, in order to create a corona discharge of reactive gases toward the treatment area, as suggested by Riskin on page 10, paragraph 4.
17. With regard to claims 6 and 8, Golkowski is silent in regard to the neutralization device comprising a housing, wherein the housing encircles the jet of reactive gases; and wherein the housing widens funnel-like, in a direction of the treatment area.
However, Riskin discloses that the neutralization device (24) comprises a housing (20 and 31), wherein the housing (20, 31) encircles the jet of reactive gases (Fig. 2); and wherein the housing (20, 31) widens funnel-like (at frusto-conical sleeve, 31), in a direction of the treatment area (page 10, paragraphs 1-4).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the neutralization device disclosed by Golkowski to include a housing that widens in a funnel-like manner toward the treatment area, similar to that disclosed by Riskin, in order to filter air returned from the afflicted area and to permit clean air to reach the fan and electrode, as suggested by Riskin on page 8, paragraph 3.
18. With regard to claims 7 and 9-10, Golkowski is silent in regard to the housing comprising a plastic funnel with an outer boundary surface that is at least covered by the neutralization device; wherein the plastic funnel is penetrated by at least one port, wherein the port is covered by the neutralization device; and wherein the plastic funnel can be detachably mounted onto the nozzle device.
However, Riskin discloses that the housing (20, 31) comprises a plastic funnel (31) with an outer boundary surface (20) that is at least covered by the neutralization device (24; Fig. 2); wherein the plastic funnel (31) is penetrated by at least one port (21, which extends into 31; Fig. 2), wherein the port (21) is covered by the neutralization device (24; Fig. 2; page 10 paragraphs 1-4); and wherein the plastic funnel (31) is fully capable of being detachably mounted onto the nozzle device (25; via 20 and three to four arms, 35; Fig. 2; page 10 paragraph 3).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the neutralization housing disclosed by Golkowski in view of Riskin, to include a detachably mounted plastic funnel, similar to that disclosed by Riskin, in order to more easily direct the jet of reactive gases toward the treatment area, and allow for detachment and subsequent disposal of the funnel after each treatment, as suggested by Riskin on page 10, paragraph 3.
Further, while Golkowski discloses that the neutralization device (24) comprises activated charcoal ([0048]; [0210]); and Riskin discloses that the neutralization device (24) is a highly-absorbing annular filter (page 10, paragraph 1), Golkowski and Riskin fail to explicitly disclose that the housing of the neutralization device comprises a foam blended with activated charcoal.
Nonetheless, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the neutralization device housing disclosed by Golkowski in view of Riskin to comprise a foam blended with activated charcoal, since Riskin suggests that the annular filter be highly absorbing on page 10, paragraph 1, and foams are well-known in the art to be high absorbing structures. Further, Golkowski suggests the use of activated charcoal neutralization devices in paragraph [0048], in order to eliminate any remaining free radicals that may have exited the application device. Additionally, it is well-known in the art to utilize foam filters blended with numerous substances to serve numerous purposes, and one having ordinary skill in the art would have a reasonable expectation of success when blending activated charcoal with foam to form a neutralization filter as an obvious matter of design choice.
19. Claim(s) 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Golkowski, as applied to claims 1 and 13 above, in further view of Brownhill et al. (US PGPUB 2019/0290496).
20. With regard to claim 12, while Golkowski discloses that the covering device (107) has an open end (open bottom, 108) and a closed end (Fig. 12; [0268]), Golkowski is silent in regard to the covering device comprising a water vapor-permeable tubular film.
However, Brownhill discloses a sensor enabled wound monitoring and therapy device (wound dressing, 100; abstract; Fig. 2B; [0049-0051]), comprising a covering device (backing layer, 220) that employs a water vapor-permeable tubular film (‘polyurethane film’; [0063]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the covering device disclosed by Golkowski to include a water vapor-permeable tubular film, similar to that disclosed by Brownhill, in order to seal and protect the wound from external bacterial contamination and allow liquid from wound exudates to be transferred through the layer and evaporated from the film outer surface, as suggested by Brownhill in paragraph [0063]. Further, it is well-known in the art of wound coverings to utilize water vapor-permeable wound covers with a reasonable expectation of success in allowing evaporation of wound exudate to the outer surface of the wound cover.
21. With regard to claim 16, Golkowski is silent in regard to the application device comprising a distribution layer for distributing the reactive gases over a specified portion of the treatment area.
However, Brownhill discloses the use of a distribution layer (absorbent layer, 221) for distributing fluid over a specified portion of the treatment area ([0058]); and further suggests the application of ozone for wound healing ([0103]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the application device disclosed by Golkowski to include a distribution layer, similar to that disclosed by Brownhill, in order to aid in distribution of the applied reactive gases to the treatment area, as suggested by Brownhill in paragraph [0058]. Further, it is well-known in the art of wound coverings to utilize a distribution layer to provide treatment evenly across the surface of a wound.
22. Claim(s) 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Golkowski, as applied to claim 40 above, in further view of Langner (DE 10 2011 001 416 A1; provided by applicant in the IDS).
23. With regard to claims 23 and 25, while Golkowski discloses a covering device (107) that comprises a film-like adhesive layer (112; Fig. 12; [0268]; [0270]), which forms an outer boundary surface (at edge, 109) of the covering device (107) that faces away from the treatment area, and wherein the fastening edge (109) encircling the treatment area covers the adhesive layer (112), Golkowski is silent in regard to the covering device comprising a foam, a superabsorber, a fleece, or combinations thereof; wherein the fastening edge comprises a foam blended with activated charcoal.
However, Langner discloses a plasma treatment device (1) with flexible surface electrodes (2, 3; abstract; Figs. 1-3; [0001]; [0008]), comprising a covering device (ozone depleting layer, 7) and a wound contact layer (5), wherein the covering device (7) comprises a foam or superabsorber blended with activated charcoal (‘activated carbon containing tissue’; [0024]), and wherein the covering device (7) has a fastening edge (covering velcro, 6; [0025]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the covering device disclosed by Golkowski to include a foam blended with activated charcoal, similar to that disclosed by Langner, in order to absorb, or bind to, and collect depleted or decomposed plasma created during treatment, as suggested by Langner in paragraphs [0008] and [0027].
24. With regard to claim 24, while Golkowski discloses that the adhesive layer (112; Fig. 12) may be any suitable sealing mechanisms, which may include a flexible cuff, tape, Velcro®, straps, or other mechanical implementations ([0077]), Golkowski and Langner fail to explicitly disclose that the adhesive layer is gas permeable.
However, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the adhesive layer disclosed by Golkowski in view of Langner to be gas permeable, since gas permeable adhesives, such as venting tape, are well-known in the wound covering arts for venting and allowing the treatment area to breath - further, Golkowski provides motivation for the use of such adhesives in paragraph [0077] where any suitable sealing mechanism or mechanical implementation may be utilized, such as tape.
Conclusion
25. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nettesheim et al. (US PGPUB 2016/0287310) discloses an assembly for treating wounds.
Jones et al. (US PGPUB 2011/0288458) discloses an ambulatory negative pressure therapeutical compression device.
26. 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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