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 .
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.
Election/Restrictions
Applicant’s election without traverse of 5/10/2026 in the reply filed on Group I, claims 1-7 is acknowledged.
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 1-3, 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Fischel-Ghodsian (US Patent No. 5,455043) in view of Ito et al. (JP2017-226188, see machine translated version).
Regarding claim 1, Fischel-Ghodsian teaches a controlled release device (sustained release body) (col. 3, lines 30-35) comprising a reservoir layer (substrate) containing a vaporizable active ingredient (col. 3, lines 50-55, 65-67, col. 4, lines 1-5, 10-20), the reservoir layer (substrate) having a structure for releasing a vaporized gas of the active ingredient (col. 3, lines 50-55, 65-67, col. 4, lines 1-5, 10-20, 60-66); and a diffusion rate limiting membrane layer directly formed on a first surface that is one end surface of both end surfaces of the reservoir layer (substrate) (col. 4, lines 10-20, col. 5, lines 2-15), the diffusion rate limiting membrane layer being configured to receive the vaporized gas of the active ingredient from the first surface of the reservoir layer (substrate) and sustainedly release the vaporized gas (col. 4, lines 10-20, col. 5, lines 2-15).
Fischel-Ghodsian fail to teach wherein the diffusion rate limiting membrane layer is a vapor deposition polymerization film. However, Ito et al. teach a sustained release body (paragraph [0001]) comprising a vaporizable active ingredient (paragraph [0012]) and a vapor deposited polymerized film (paragraphs [0012], [0013]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to use the vapor deposited polymerized film of Ito et al. on the substrate of Fischel-Ghodsian in order to suppress the occurrence of delamination and eliminate the use of adhesive (Ito et al., paragraphs [0013], [0014]).
Regarding claim 2, Fischel-Ghodsian teaches wherein the body comprises a barrier layer formed on a second surface opposite to the first surface, the second surface being another end surface of the both end surfaces of the substrate in the thickness direction (col. 5, lines 10-15, col. 6, lines 28-32), the barrier layer being configured to block the vaporized gas of the active ingredient from the second surface of the substrate (col. 5, lines 10-15, col. 6, lines 28-32).
Regarding claim 3, Fischel-Ghodsian teaches wherein the reservoir layer (substrate) is made of porous material (col. 5, lines 14-25).
Regarding claim 5, Fischel-Ghodsian teaches wherein the reservoir layer (substrate) is made of a polymer having a non-crystalline portion (col. 5, lines 15-25).
Regarding claim 6, Fischel-Ghodsian does not disclose wherein the vapor deposition polymerization film has a lower gas permeability than the substrate. However, Ito et al. teach a sustained release body (paragraph [0001]) comprising a vaporizable active ingredient (paragraph [0012]) and a vapor deposited polymerized film (paragraphs [0012], [0013]).
Ito et al. do not disclose wherein the vapor deposition polymerization film has a lower gas permeability than the substrate. However, where in the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges in permeability involve only routine skill in the art, absence a showing of criticality. MPEP 2144.05 II. One would have been motivated to modify the gas permeability of the vapor deposition polymerization film of Ito et al. in order to stably release only the necessary amount of vaporizable substance (Ito et al., paragraph [0013]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to use the vapor deposited polymerized film of Ito et al. on the substrate of Fischel-Ghodsian in order to suppress the occurrence of delamination and eliminate the use of adhesive (Ito et al., paragraphs [0013], [0014]).
Regarding claim 7, Fischel-Ghodsian fails to teach wherein the vapor deposition polymerization film has a thickness in a range of 1 µm or more and 900 µm or less. However, Ito et al. teach a sustained release body (paragraph [0001]) comprising a vaporizable active ingredient (paragraph [0012]) and a vapor deposited polymerized film (paragraphs [0012], [0013]).
Ito et al. do not disclose wherein the vapor deposition polymerization film has a thickness in a range of 1 µm or more and 900 µm or less. However, Ito et al. teach wherein the thickness of the vapor deposition polymerization film is determined appropriately, taking into account the amount of vaporized substance released to the outside of the film per unit time, the type and amount of vaporized substance and other factors (paragraphs [0029], [0030]). Where in the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges in thickness involve only routine skill in the art, absence a showing of criticality. MPEP 2144.05 II. One would have been motivated to modify the thickness of the vapor deposition polymerization film of Ito et al. taking into account the amount of vaporized substance released to the outside of the film per unit time and the type and amount of vaporized substance (paragraphs [0029], [0030]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to use the vapor deposited polymerized film of Ito et al. on the substrate of Fischel-Ghodsian in order to suppress the occurrence of delamination and eliminate the use of adhesive (Ito et al., paragraphs [0013], [0014]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fischel-Ghodsian (US Patent No. 5,455043) in view of Ito et al. (JP2017-226188, see machine translated version), in further view of Nakade et al. (JP05-339102, see machine translated version).
Fischel-Ghodsian and Ito et al. are relied upon as disclosed above.
Regarding 4, Fischel-Ghodsian fails to teach wherein the porous material has a structure of continuous open cell. However, Nakade et al. teach a laminate comprising a substrate containing a volatile active ingredient (paragraph [0007]), wherein the substrate is made of a porous material (paragraph [0007]), wherein the porous material has a structure of continuous open cell (paragraph [0007]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to use an open cell structure as that of Nakade et al. as the substrate of Fischel-Ghodsian in order to gradually release volatile active ingredients into the air (Nakade et al., paragraph [0006]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHINESSA GOLDEN whose telephone number is (571)270-5543. The examiner can normally be reached on Monday - Friday; 8:00 - 4:00 EST.
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/Chinessa T. Golden/Primary Examiner, Art Unit 1788 5/28/2026
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