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 .
Response to Amendment
The amendments filed on 03/09/2026 has been entered. Claims 26-37 are pending is application. Claims 1-25 are cancelled. Claim 26 is amended.
Response to Arguments
Applicant’s arguments with respect to amended claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Though the same prior art reference is re-used herein, amended claims 26 required a change in the grounds of rejection relying on additional prior art as detailed below in the prior art rejection. More specifically, the claim amendment “subsequently applying a medicament containment device forming a containment reservoir about the subject’s nail” further changes the scope of the claimed invention. The prior art of Peters teaches the claimed invention of amended claim 26, the rejection of the amended claim 26 is further addressed in the rejection below.
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.
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) 26-36 are rejected under 35 U.S.C. 103 as being unpatentable over Peters (Publication No. WO 2006/084910 A2).
Regarding claim 26, Peters teaches a method of treating a nail condition responsive to nitric oxide (NO) therapy in a subject (Abstract; Page 12, lines 12-30), comprising: applying a therapeutically effective amount of a nitric oxide releasing substance (NORS) to the subject’s nail (NO releasing substance is applied to the toe using the side of tape 20 that is facing the toe; Page 17, line 34 to Page 18, line 9); and applying a medicament containment device forming a containment reservoir about the subject’s nail (tape 20 is applied by wrapping around the toe to treat the nail and has a reservoir/space on the tape’s side facing the toe to hold NO for treatment; Figure 2; Page 17, line 34 to Page 18, line 9).
The embodiment of Figure 2 of Peters does not teach applying the therapeutically effective amount of the nitric oxide releasing substance (NORS) to the subject’s nail and subsequently applying the medicament containment device.
However, another embodiment of Peters teaches applying the therapeutically effective amount of the nitric oxide releasing substance (NORS) to the subject’s nail and subsequently applying the medicament containment device (NORS is in gel form and is first applied onto the nail of the patient, then a patch is applied onto the skin of the user, on top of the applied gel; Column 20, line 26 to Column 21, line 8).
Peters is considered to be analogous to the claimed invention because they are in the same field of NO treatment devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Figure 2 of Peters to incorporate the teachings of the alternative embodiment of Peters and have the method and components of the patch and the NO releasing substance in gel form, of the alternative embodiment of Peters, as the method of treatment of the embodiment of Figure 2. This allows for the substance to penetrate pockets and corners in the skin for closer elution of NO on the treatment area (Peters; Page 21, lines 6-8).
Regarding claim 27, Peters teaches the method of claim 26. Peters further teaches wherein the nail condition is a nail infection (Abstract; Claim 1; Page 12, lines 12-30).
Regarding claim 28, Peters teaches the method of claim 27. Peters further teaches wherein the nail condition comprises onychomycosis, green nail syndrome, or a combination thereof (Abstract; Claim 1).
Regarding claim 29, Peters teaches the method of claim 26. Peters further teaches wherein the medicament containment device is applied via an adhesive (tape 20 is applied onto the skin – inherent that tape has adhesive; Figure 2; Page 17, line 34 to Page 18, line 9).
Regarding claim 30, Peters teaches the method of claim 26. Peters further teaches wherein the medicament containment device is applied by wrapping the device about a portion of a body part of a subject (tape 20 is wrapped around the toe of the foot; Figure 2).
Regarding claim 31, Peters teaches the method of claim 26. Peters further discloses wherein the body part is a hand, a foot, an arm, a leg, a torso, a phalange, a penis, a nipple, a head, a neck, or a combination thereof (tape 20 is wrapped around the toe of the foot; Figure 2).
Regarding claim 32, Peters teaches the method of claim 26. Peters does not expressly teach wherein the containment reservoir has a volume of from about 0.1 ml to about 20 ml.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the containment reservoir to have a volume of about 0.1 ml to about 20 ml since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04(IV)(A)). In the instant case, the containment reservoir would not operate differently with the claimed volume since the containment reservoir is constructed with similar components and structure (see disclosed above) and is intended to contain nitric oxide releasing substance for nitric oxide treatment to the skin. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the volume is “about” the given ranges (specification; pg. 23, lines 19-26).
Regarding claim 33, Peters teaches the method of claim 26. Peters further teaches wherein the NORS is introduced in an inactive state (NO releasing substance is inactive when applied on skin and activates when in contact with liquid; Page 18, lines 6-9).
Regarding claim 34, Peters teaches the method of claim 26. Peters further teaches wherein the NORS is prepared and activated as the medicament containment device is applied to the subject’s nail (NORS is in gel form and is activated when in contact with a water soaked patch, as it is applied to the subject; Page 20, line 26 to Page 21, line 6).
Regarding claim 35, Peters teaches the method of claim 33. Peters further teaches wherein the NORS is introduced as a gel (NORS is in inactive gel form; Page 20, line 26 to Page 21, line 6).
Regarding claim 36, Peters teaches the method of claim 26. Peters further teaches wherein the NORS is formulated to release from about 10 ppm NO to about 5000 ppm NO (NO PPM between 0.001 to 5000 ppm; Page 21, lines 9-24).
Claim(s) 37 is rejected under 35 U.S.C. 103 as being unpatentable over Peters (Publication No. WO 2006/084910 A2) in view of Squires et al. (Publication No. US 2019/0046681 A1).
Regarding claim 37, Peters teaches the method of claim 26. Peters further teaches wherein the time of release can be controlled based on the materials and polymers used in the device (Page 21, lines 25-29). Peters does not expressly teach wherein the NORS is formulated to release NO for a period of from about 30 minutes to about 12 hours.
However, Squires teaches wherein the NORS is formulated to release NO for a period of from about 30 minutes to about 12 hours (Paragraph 0111 – “matrix may be left in place for a time period ranging from about 30 minutes to about 10 days, or any time period therebetween, and then removed” and Paragraph 0083 – “the delivery of the therapeutic gas can be selectively controlled such that the therapeutic gas can be delivered or transported continuously over a time period of up to about 10 days, such as a time period of up to about 7 days, such as a time period of up to about 5 days”, meaning that the period of the release can be between about 30 minutes to about 12 hours, if desired).
Peters and Squires are considered to be analogous to the claimed invention because they are in the same field of NO treatment devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peters to incorporate the teachings of Squires and have the method of the duration of releasing NO of Squires in the method of treatment of Peters. This allows for the user to selectively place the device onto the treatment site for a longer or shorter amount of time, if desired (Squires; Paragraph 0083 and 0111). Furthermore, Figure 4 of Peters displays the capabilities of the duration of NO that can be released by the nitrogen oxide releasing substances, spanning to 1 or 2 days, thus fully capable of releasing NO between about 30 minutes to about 12 hours.
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 KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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