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 .
Status of Claims
As directed by the amendment filed on 9 February 2026: claim(s) 1 have been amended, claim(s) 8 has been cancelled. Thus, claims 1-7 and 9-20 are presently pending, with claims 10-20 previously withdrawn.
Response to Arguments
Applicant's arguments filed 9 February 2026 have been fully considered but they are not persuasive.
Regarding the argument that "in Zhang the medication is added to the patch after application, whereas claim 1 explicitly recites that the medication is sealed between the release liner and the cover, such that the medication is pre-sealed prior to application" on pg. 7 of Remarks, Zhang also discloses pre-sealing the medication prior to application (“An amount of drug-containing composition is dispensed into the open cavity of the cavity patch prior to adhesion of the patch to the skin” [0054]). Furthermore, it is noted that the features upon which applicant relies (i.e., the medication is pre-sealed prior to application) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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) 1-2, 7, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20060105029 A1) in view of Samour (US 4910020 A).
Regarding Claim 1, Zhang discloses an adhesive bandage system ("cavity patch"; see Abstract), comprising:
a first member ("wall 12" [0033]; FIG. 1), comprising:
an aperture ("open cavity 18" [0033]), and
an adhesive on a first side ("adhesive 14 is typically coated on the wall to effectuate adhesion between the ring structure of the wall and a skin surface" [0033]);
a second member ("absorbent mesh 16" [0034]; FIG. 1) at least partially spanning the aperture of the first member (see FIG. 1) and configured to allow medication to pass therethrough ("mesh material is used so that it does not close the open cavity" [0034]-[0035]);
a third member coupled to the second member ("wall 12" & “absorbent mesh 16” [0033-0035]; FIG. 1),
an aperture aligned with the second member ("open cavity 18" [0033]), the aperture configured to receive a medication therein ("the drug-containing composition is placed into the open cavity" [0033]), contacting the second member ([0035]); and
a cover ("impermeable cover 20" [0033]; FIG. 1) adhered to a top side of the third member ([0033]; FIG. 1), the cover sealing the aperture of the third member ("opening is configured to be closed by an impermeable cover 20" [0033]),
wherein the medication is sealed within the aperture of the first member and the aperture of the third member ("drug-containing composition is at least substantially sealed in the now closed open cavity by the impermeable cover 40, the patch wall 32 and the skin surface" [0037]).
Zhang fails to specify the first member and the third member being separate entities wherein a release liner removably coupled to the first side of the first member; the third member comprising: an adhesive on an underside for removably adhering to a top side of the first member; the medication is sealed between the release liner and the cover. However, Samour teaches a transdermal medication device (see Abstract) wherein the first member and the third member being separate entities (“lower member” & “upper member” col. 1 ln. 51-65; FIG. 1) wherein a release liner (“release sheet 20” col. 2 ln. 65; FIG. 2) removably coupled to the first side of the first member (“release sheet 20 underlies the adhesive coating 18” col. 2 ln. 65; “release sheet has been removed” col. 3 ln. 10; FIG. 2); the third member comprising: an adhesive on an underside for removably adhering to a top side of the first member (“upper member 24 has a reservoir 26 depending from the "Velcro" strip 28 which has filaments 30 cooperative with the filaments 16 to detachably secure the upper member 28 to the lower member 12” col. 3 ln. 1-4); the medication is sealed between the release liner and the cover (see FIG. 2). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Zhang according to the teachings of Samour to eliminate “the necessity of removal of the lower member from the body and giving rise to the major advantage of providing continuous medication to the same area of the skin while reducing trauma to that skin area” (col. 1 ln. 61-65).
Regarding Claim 2, Zhang discloses the second member comprises a transdermal patch comprising medication ("mesh 16" [0035]).
Regarding Claim 7, Zhang discloses the medication is lidocaine ("lidocaine" [0049]).
Regarding Claim 9, Zhang fails to specify the cover is removably adhered to the third member. However, the court has held that it would be obvious to make any claimed element separable "if it were considered desirable for any reason”. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). MPEP 2144.04 (V)(C). Therefore, it would have been obvious to modify the device of Zhang/Samour to improve the reusability and “to facilitate loading of a drug-containing composition into the cavity patch” (Zhang [0033]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. in view of Samour and further in view of Stockley et al. (US 20130345649 A1).
Regarding Claim 3, Zhang discloses the third member and the first member but fails to specify the third member further comprises a tab extending/that extends beyond the perimeter of the first member. However, Stockley teaches a dermal patch ([0091]; FIG. 1) wherein the third member (“top barrier layer 26” [0123]; FIG. 1) comprises a tab (“pull tab 28” [0123]; FIG. 1) extending/that extends beyond the perimeter of the first member (“bottom barrier layer 12, air regulation layer 24, and top barrier layer 26 are coextensive except for the presence of pull tab 28” [0123]; FIG. 1). Therefore, it would have been obvious to modify the device of Zhang/Samour as taught by Stockley to provide an easily graspable surface for relative manipulations of the layers ([0123]).
Claim(s) 4 & 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. in view of Samour and further in view of Yeung et al. (US 20190321234 A1).
Regarding Claims 4 & 5, Zhang discloses the first member and the aperture but fails to specify the first member further comprises a wound bandage coupled to the top side of the first member; wherein when the wound bandage is in a first position, the aperture of the first member is unobstructed, and when the wound bandage is in a second position, the aperture is at least partially covered by the wound bandage. However, Yeung teaches “an occlusive device or dressing that includes an access feature” ([0021]; FIG. 5B) wherein the first member 540 further comprises a wound bandage 560 coupled to the top side of the first member ([0043]; FIG. 5B); wherein when the wound bandage is in a first position, the aperture of the first member is unobstructed ([0045]; step 7 in FIG. 7), and when the wound bandage is in a second position, the aperture is at least partially covered by the wound bandage ([0045]; step 8 in FIG. 7). Therefore, it would have been obvious to modify the device of Zhang/Samour as taught by Yeung to provide a “safe and effective topical application of a composition containing an immunization enhancing pharmaceutical at or near (e.g. surrounding) a vaccine injection site” ([0028]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. in view of Samour and further in view of Shantha et al. (US 7883487 B2).
Regarding Claim 6, Zhang discloses the first member but fails to specify the first member further comprises a coupler configured to receive an intravenous catheter or needle. However, Shantha teaches “transdermal delivery devices that deliver a local anesthetic to an injection or lancing site” (col. 2 ln. 50-51) wherein the first member 10 further comprises a coupler (“resealable injection port 11” col. 5 ln. 27; FIG. 1) configured to receive an intravenous catheter or needle (“inserting a hypodermic needle into the injection port” col. 5 ln. 64-65; FIG. 2). Therefore, it would have been obvious to modify the device of Zhang/Samour as taught by Shantha to “maintain a sterile environment during injection and post-injection” (col. 2 ln. 67 – col. 3 ln. 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
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 Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
/REBECCA E EISENBERG/ Supervisory Patent Examiner, Art Unit 3781