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 .
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) 1-3, 5-6, 9-11, 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. (KR 20190114815 A, hereafter “Cho) in view of Ross (US 20120220980 A1, hereafter “Ross”).
Regarding claim 1, Cho discloses a prefilled patch (figs. 6 and 7) comprising: an adhesive layer (140) configured to be attached to skin (page 5 lines 2-3, page 10 lines 2-5); a capsule (160) which is provided on the adhesive layer (see fig. 7) and in which an active ingredient or a drug is stored (page 10 lines 31-34, page 11 lines 4-10).
However, Cho fails to disclose a handle connected to a discharge hole formed in the capsule, wherein the handle is separated from the capsule by a user to open the discharge hole.
a handle connected to a discharge hole formed in the capsule, wherein the handle is separated from the capsule by a user to open the discharge hole.
Ross teaches a similar device in the same endeavor with a handle (110 with tab 171) connected to a discharge hole (porous membrane 108 has multiple holes/passageways to connect the reservoir above, para. [0040, 0041]) formed in the capsule, wherein the handle is separated from the capsule by a user to open the discharge hole (para. [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patch of Cho and incorporate the handle of Ross to prevent premature leakage of the drug compound into the microneedles (para. [0031, 0056]).
Regarding claim 2, the combination of Cho and Ross discloses the patch of claim 1. Cho further discloses wherein the capsule (160) is provided on a surface of the adhesive layer (140) while being disposed closer to the skin than the adhesive layer (figs. 6 and 7), and has a planar area smaller than a planar area formed by the adhesive layer (fig. 7).
Regarding claim 3, the combination of Cho and Ross discloses the patch of claim 1. However, Cho fails to disclose wherein a first longitudinal end of the handle blocks the discharge hole formed in the capsule, and a second longitudinal end of the handle is exposed to outside of the adhesive layer.
Ross teaches wherein a first longitudinal end of the handle (110) blocks the discharge hole (porous membrane 108 has multiple holes/passageways to connect the reservoir above, para. [0040, 0041]) formed in the capsule, and a second longitudinal end (tab 171) of the handle (110) is exposed to outside of the adhesive layer (104, figs. 1 and 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patch of Cho and incorporate the handle of Ross to prevent premature leakage of the drug compound into the microneedles (para. [0031, 0056]).
Regarding claim 5, the combination of Cho and Ross discloses the patch of claim 2. Cho further discloses a microneedle (100) provided by being attached to the adhesive layer (140) with a planar area that is larger than the planar area formed by the capsule (160) and smaller than the planar area formed by the adhesive layer (140, fig. 7).
Regarding claim 6, the combination of Cho and Ross discloses the patch of claim 5. Cho further discloses wherein the microneedle (100) comprises: a substrate portion (110) configured to be attached to the adhesive layer (140); a plurality of carrying holes (120) formed in the substrate portion (110); and an insertion needle (130) provided to protrude from a portion of the substrate portion that partitions the carrying holes, and configured to be inserted into the skin (page 4 line 35 – page 5 line 3, page 5 line 35 page 6 line 4).
Regarding claim 9, the combination of Cho and Ross discloses the patch of claim 6. Cho further discloses wherein the microneedle (100) further comprises: a carrying groove (133) that provides a path for the active ingredient or the drug discharged (page 6 lines 5-19), wherein the carrying groove is formed extending from a portion of the area formed by the substrate portion toward an end of the insertion needle (fig. 5, page 6 lines 5-19).
However, Cho fails to disclose a discharge hole to flow through.
Ross discloses a discharge hole to flow through via a porous membrane 108 that has multiple holes/passageways to connect the reservoir above (para. [0040, 0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patch of Cho and incorporate the membrane of Ross to control fluid flow and prevent premature leakage of the drug compound into the microneedles (para. [0031, 0040, 0056]).
Regarding claim 10, the combination of Cho and Ross discloses the patch of claim 9. Cho further discloses wherein the microneedle further comprises: a slit groove (134) that guides the active ingredient or the drug loaded in the carrying groove to the end of the insertion needle (page 7 lines 4-10).
Regarding claim 11, the combination of Cho and Ross discloses the patch of claim 6. Cho further discloses wherein the substrate portion and the insertion needle of the microneedle are made of a bioresorbable metal, and the bioresorbable metal contains at least one of magnesium, calcium, zinc, and iron (column 8 lines 16-23).
Regarding claim 14, Cho discloses a prefilled patch (figs. 6 and 7) comprising: an adhesive layer (140) configured to be attached to skin (page 5 lines 2-3, page 10 lines 2-5); a capsule (160) which is provided on the adhesive layer (see fig. 7) and in which an active ingredient or a drug is stored (page 10 lines 31-34, page 11 lines 4-10).
However, Cho fails to disclose a handle integrally connected with the capsule, wherein when the handle is pulled by a user, the capsule is cut so that the active ingredient or the drug is discharged.
Ross teaches a handle (110) integrally connected with the capsule (110 is lightly bonded to the membrane above, para. [0056]), wherein when the handle (110) is pulled by a user, the capsule is cut so that the active ingredient or the drug is discharged (the bond between 110 and the above membrane is broken, para. [0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patch of Cho and incorporate the handle of Ross to prevent premature leakage of the drug compound into the microneedles (para. [0031, 0056]).
Regarding claim 15, the combination of Cho and Ross discloses the patch of claim 14. However, Cho fails to disclose wherein a first longitudinal end of the handle is integrally connected to the capsule, and a second longitudinal end of the handle is exposed to outside of the adhesive layer.
Ross teaches wherein a first longitudinal end of the handle (110) is integrally connected to the capsule (para. [0056]), and a second longitudinal end (171) of the handle is exposed to outside of the adhesive layer (104, figs. 1 and 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patch of Cho and incorporate the handle of Ross to prevent premature leakage of the drug compound into the microneedles (para. [0031, 0056]).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho (KR 20190114815 A) in view of Ross (US 20120220980 A1), and in further view of Quan et al. (US 20150335870 A1).
Regarding claim 12, the combination of Cho and Ross discloses the patch of claim 1. However, the combination fails to disclose a release paper attached to a peripheral area of the adhesive layer.
Quan teaches a similar device in the same endeavor with a release paper (12) attached to a peripheral area of the adhesive layer (13, fig. 1, para. [0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patch of Cho and incorporate the release paper of Quan to protect the adhesive.
Regarding claim 13, the combination of Cho, Ross, and Quan discloses the patch of claim 12. However, the combination of Cho and Ross fails to disclose wherein the release paper is provided as a pair and is attached to the peripheral area of the adhesive layer, wherein one and the other of the pair of the release papers are moved in different directions to be separated from the adhesive layer, and one of the release papers is attached to the handle.
Quan teaches wherein the release paper (12) is provided as a pair and is attached to the peripheral area of the adhesive layer (figs. 1(a) and 1(b)), wherein one and the other of the pair of the release papers are moved in different directions to be separated from the adhesive layer (para. [0043], see directional lines on example in fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patch of Cho and incorporate the release paper of Quan to protect the adhesive and cover the handle until it is ready to be used.
Allowable Subject Matter
Claims 4, 7-8, and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: there is no art alone or in combination that discloses wherein the handle is branched to correspond with each discharge hole, wherein the discharge hole corresponds to any one of the carrying holes, and wherein the handle has a guide area to guide the movement of the handle. Further, no art could be found that discloses a perforated line in a portion of the capsule directly connected to a first longitudinal end of the handle.
The combination of Cho and Ross teaches a patch with a removable tab connected to an inner layer to allow the drug to entre into the microneedles when the tab is pulled out. However, the tab is connected to a sheet layer, rather than an elongated or branched structure that directly corresponds with a hole. It would not have been obvious to modify the sheet of Ross to only cover certain parts without changing the operation and structure of the references. Without a reference to rely on, it would not have been obvious to make such a change.
In regards to claim 16, although Quan teaches perforated lines for their release liners, it would not have been obvious to modify the patch of Cho and Ross to have a perforated line where the handle meets the capsule without a reference that has a structure where the perforated line is in that claimed position. Making such a modification would involve hindsight and without support, it would not have been on obvious modification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 5 March 2026
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