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
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected process of assembly, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 28th,2026.
During a telephone conversation with Christopher J. Mckenna on September 22nd,2026 a provisional election was made without traverse to prosecute the invention of Species I, claims 1-6. Affirmation of this election was be made during the call and resulted in claims 7-12 being withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-6 are being examined in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 2 recites “the medical delivery application system”, line 8 recites “the wearable drug delivery device” and line 11 recites “the second backing side”. There is insufficient antecedent basis for this limitation in the claim.
Claim 3, line 7 recites “the adhesive platform bridges” and “the temporary backing bridges”. There is insufficient antecedent basis for this limitation in the claim.
Appropriate action is required.
All remaining claims are also rejected as they depend from rejected independent claims.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 20220104773 A1, herein, Lee), in view of Huang et al. (US 12635946 B2, herein, Huang).
Regarding claim 1, Lee discloses a medical device application system (system 100 – Fig.1) for positioning a medical device on a user (“the present systems and methods for securing a continuous analyte sensor to a host”, see para [0110]), the medical delivery application system comprising:
an adhesive platform (cushioning layer 326 of multilayer adhesive pad 322 – Fig.10) operable to be coupled to the medical device, the adhesive platform comprising a first platform surface (undersurface 348 of cushioning layer 326 – Fig.10) and a second platform surface (exposed portion 346 of the cushioning layer 326 – Fig.11);
a temporary backing (inner liner 324 – Fig.10) detachably connected to the first platform surface of the adhesive platform (“the undersurface 348 (FIG. 10) of the cushioning layer 326 secures the cushioning layer 326 to the inner liner 324”, see para [0208]), wherein the second platform surface of the adhesive platform is configured to interface with the wearable drug delivery device (medicament delivery pump 2 – Fig.1)(“the sensor electronics unit housing 352 is secured to the exposed portion 346 of the cushioning layer 326”, see para [00208]).
Lee does not appear to expressly disclose a first temporary backing wing extending from a first backing side of the temporary backing and a second temporary backing wing extending from a second side of the temporary backing, wherein the second backing side extends from the opposite side as the first backing side.
Huang teaches a first temporary backing wing (see annotated Fig.20A) extending from a first backing side of the temporary backing (backing 111 – Fig.20A) and a second temporary backing wing (see annotated Fig.20A) extending from a second side of the temporary backing, wherein the second backing side extends from the opposite side as the first backing side.
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It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the disclosure of Lee to include a first and second temporary backing wings as taught by Huang to further increase “the adhesion strength of the physiological parameter detection device 21 on the skin surface” (Huang Col.6 lines 38-40).
Regarding claim 2, Lee discloses the medical device application system (system 100 – Fig.1) of claim 1, further comprising a temporary backing tab (protruding tab 336 – Fig.10) extending from the temporary backing (“an edge of the inner liner 324 includes a protruding tab 336 that provides a convenient location for the host to grasp”, see para [0202]).
Regarding claim 3, Lee discloses the medical device application system (system 100 – Fig.1) of claim 1, wherein the adhesive platform (cushioning layer 326 – Fig.10), as recited above.
Lee does not appear to expressly disclose wherein the adhesive platform further comprises:
a first platform bridge extending from a first platform side of the temporary backing, and a second platform bridge extending from a second platform side of the temporary backing, wherein the second side is opposite the first side, and
the adhesive platform bridges are paired with the temporary backing bridges.
Huang teaches wherein the adhesive platform further comprises:
a first platform bridge (see annotated Fig.20A) extending from a first platform side of the temporary backing, and a second platform bridge (see annotated Fig.20A) extending from a second platform side of the temporary backing (backing 111 – Fig.20A), wherein the second side is opposite the first side, and
the adhesive platform bridges are paired with the temporary backing bridges.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the disclosure of Lee to include a first and second platform bridges as taught by Huang to further increase “the adhesion strength of the physiological parameter detection device 21 on the skin surface” (Huang Col.6 lines 38-40).
Regarding claim 4, Lee discloses the medical device application system (system 100 – Fig.1) of claim 1, wherein the medical device is a drug delivery device (“system 100 can also include other devices and/or sensors, such as a medicament delivery pump 2”, see para [0118], Fig.1).
Regarding claim 5, Lee discloses the medical device application system (system 100 – Fig.1) of claim 1, wherein the medical device is an analyte sensor (“an adhesive pad system is provided for securing a continuous analyte sensor assembly to skin of a host”, see para [0008]).
Regarding claim 6, Lee discloses the medical device application system (system 100 – Fig.1) of claim 1, wherein the adhesive platform is configured to adhere to skin of the user (“wherein the undersurface of the adhesive pad includes an adhesive material configured to adhere the adhesive pad to the skin of the host”, see para [0008]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAGWA M ABU-DAYEH whose telephone number is (571)270-0389. The examiner can normally be reached 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.A./Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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