DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election of “applying a light to the dye through other tissue: in the reply filed on 9/26/22024 is acknowledged; election is based on the claim amendment, removing “living” as a modifier of tissue from the claims. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election without traverse of:
(i-b) a method of disinfecting a wound in tissue;
(ii-b) tissue, not including tooth tissue;
(iii-b) outside a clinical environment; and
(iv-e) the dye is applied to a bandage and is wetted via a liquid applied not including bodily fluid.
in the reply filed on 5/13/2025 is acknowledged.
Claims 41-47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/13/2025.
Priority
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, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/199,267, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The Examiner’s review of the ‘267 application failed to identify written description type support of the instant independent claims 32 and 38; no language disinfecting a wound was identified. Furthermore, regarding current claims, the “living tissue” limitation and multiple tissues (first, living) (claims 32, 38) was also not found Accordingly, the effective filing date of claims 32, 38 and claims dependent therefrom, corresponds to the filing date of 16/693,422, filed 11/25/2019.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 32, 36, 38-39 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As previously discussed, the claimed method of disinfecting a wound does not have written description type support in the original specification, and introduces New Matter. The language of a first tissue and “living” tissue also does not have support in the original specification, and introduces New Matter.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 38-39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aspiroz et al. (“Photodynamic Therapy With Methylene Blue for Skin Ulcers Infected With Pseudomanas aeruginosa and Fusarium spp.” 2017; Actas Dermosifliogr.; 108(6):e45-e48).
Aspiroz teaches photodynamic therapy (PDT) is a therapeutic modality with significant antimicrobial activity; PDT with methylene blue (a dye) as the photosensitizer led to clinical and microbiological cure with no significant adverse effects; PDT with methylene blue is a valid option for the management of superinfected chronic ulcers, reducing the use of antibiotics and the induction of resistance (abstract).
Ulcers on the legs of patients are depicted in the figures. In case 1, PDT was applied with 1% MB solution (wetted dye; a liquid dye), rinsing away of any excess MB and irradiation with the Aktilite lamp (applying light to the dye through the tissue). After 3 weeks with 2 weekly sessions, she continued with PDT with daylight at home (Applicant elected applying light outside of a clinical environment). Complete healing of the lesion (wound) was achieved after 6 months of treatment (e46, 8th paragraph).
Regarding the dye generating a reactive oxygen species, the same steps recited in claim 38 are taught by Aspiroz. Accordingly, the recited function, generating a reactive oxygen species, is taken to be characteristic of the same steps required by the method.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Regarding disinfecting a wound in tissue, antimicrobial effects of PDT have been known for more than 100 years; the advantages of antimicrobial PDT (aPDT) include the possibility to use in mixed infections, and can serve as a complement to conventional antimicrobial agents (e46, 2nd paragraph). Improvements that may result from a decrease or disappearance of the microbial load is discussed (e46, 5th paragraph), taken to read on disinfection a wound in the tissue, anticipating the claims.
Regarding the amended applying a light through a firs tissue to the living tissue, such that the dye generates a reactive oxygen species in the living tissue, inspection of the figures depicts the wound (ulcer) set in “living tissue” is construed to be characteristic of treating the ulcerous wounds, having first tissue (ulcerous portion) surrounded by living tissue. Application of the MB solution to the wound is construed to characteristically include application of the dye to the living tissue, and the light applied is construed to pass through first tissue, and into the living tissue surrounding the wound, resulting in the ROS species.
Applicant argues:
About the meaning of ulcer, an open sore, with dead tissue and shedded tissue; that ulcers form with the surface cells become inflamed, die and are shed, and may be linked to cancer. Applicant alleges that somehow, Aspiroz fails to disclose applying a photosensitive dye to living tissue, and applying a light to the dye through a first tissue, to the living tissue, as recited in amended claim 38.
This is not persuasive. As pointed out above, a first and living tissue are not disclosed in the original specification, and introduce new matter. The disclosure clearly intends treating of a wound, which the ulcers of Aspiroz are clearly. The pictures of ulcers match ulcers surrounded by living tissue, and application to the ulcer tissue (a first tissue) and into surrounding living tissue is construed to be characteristic of the application of MB solution to the ulcer tissue. Application of the light satisfies through first tissue, and light applied to the surrounding living tissue, or through the ulcer to living tissue below is construed to satisfy step (b). absent evidence to the contrary.
Application of MB and light to the ulcer, including dead cells, is not excluded from the claimed method.
Claim Rejections - 35 USC § 103
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.
Claim(s) 32, 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aspiroz et al. (“Photodynamic Therapy With Methylene Blue for Skin Ulcers Infected With Pseudomanas aeruginosa and Fusarium spp.” 2017; Actas Dermosifliogr.; 108(6):e45-e48).
The teachings of Aspiroz are set forth above. Regarding claim 32, the step of wetting the methylene blue (dye) is not explicitly taught, although the MB was applied to the tissue wound in the form of a solution. The skilled artisan would have recognized that application of dry (e.g., powder) of MB to the tissue, with subsequent wetting with saline or water, in the same amounts that correspond to the 1% MB solution would have been an alternate, obvious technique to deliver the same MB solution to the wound. Thus, substitution of application of dye, followed by wetting would have been obvious, to achieve the same benefit to the wound as is reported by Aspiroz. The motivation would have been to utilize an alternative technique to deliver the dye to the wound.
This rationale is consistent with KSR Rationale (D) Applying a known technique (application of dry/powdered MB dye, followed by wetting, in place of application of 1% MB solution) to a known method (that taught by Aspiroz) ready for improvement to yield predictable results (healing of the ulcerous wounds as a result of MB application with PDT would have been predicted).
The application of MB to “living tissue” is construed to be part of applying to the full wounds of Aspiroz, or at least during the healing process. Application of the light through the ulcer (first) tissue, would also be characteristic of the dye generating ROS in living tissue, supporting and surrounding the ulcer, absent a showing to the contrary, which is not shown by simply arguing that ulcers involve dead, necrotic tissue. Such tissue still reads on a first tissue, and the ulcers being surrounded and supported by living tissue is shown in photographs of the ulcers undergoing healing.
Conclusion
No claim is allowed.
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 TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614