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 Objections
Claim 2 is objected to because of the following informalities:
Claim 2, lines 1-2 recites “the water soluble polymer” and should recite “the water soluble polymers”.
Appropriate correction is required.
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.
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.
Claims 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Rowley (US 2021/0000754) in view of Kawarama et al. (US 2009/0043236) and Morikane et al. (US 2021/0401767).
Regarding claim 1, Rowley discloses a microneedle patch (Figure 1), comprising:
a backing (Figure 1, 110);
an adhesive layer (130) provided on a main surface of the backing (the main surface is the lower surface of 110 that is not visible in figure 1); and
a microneedle array (claim 18 describes microneedles, i.e. a microneedle array in the embossed release liner 120), at least a part of the microneedle array being positioned within the adhesive layer (paragraph 25 describes the adhesive matrix 130 absorbs into the embossed release liner 120), wherein
the adhesive layer comprises a water-soluble polymer (paragraph 28 describes polyacrylic acid, a water-soluble polymer) and water (paragraph 25).
Rowley is silent on the adhesive layer comprises 11 to 20% by mass in total of water soluble polymers, 3.5 to 7% by mass of sodium carboxymethylcellulose, 2% by mass or more and less than 5% by mass of a partially-neutralized polyacrylate, 0.22 to 1% by mass of a crosslinking agent, and
a loss tangent of the adhesive layer under measurement conditions of an environmental temperature of 25°C and a frequency of 1 Hz is 0.20 to 0.41.
Kawarama teaches a loss tangent of the adhesive layer (Table 1) under measurement conditions of an environmental temperature of 25 C (Table 1 shows a wide range of temperatures and a line at 25.12 °C) and a frequency of 1 Hz (paragraph 21 describes the frequency as 6,2832 rad/s, which is 1 Hz) is 0.20 to 0.41 (The table 1 loss tangent value that corresponds to 25.12 °C is 0.294 and the loss tangent value that corresponds to 19.11 °C is 0.337, so the loss tangent at exactly 25 °C would be slightly larger than 0.294 and less than 0.337).
Therefore it would have been obvious to modify Rowley’s invention to include a loss tangent of the adhesive layer under measurement conditions of an environmental temperature of 25 C and a frequency of 1 Hz is 0.20 to 0.41 in order to provide a gentle enough adhesion to the skin to avoid excessive pain and improved water resistance as suggested and taught by Kawarama in paragraphs 9-11.
Rowley in view of Kawarama are silent on the adhesive layer comprises 11 to 20% by mass in total of water soluble polymers, 3.5 to 7% by mass of sodium carboxymethylcellulose, 2% by mass or more and less than 5% by mass of a partially-neutralized polyacrylate, 0.22 to 1% by mass of a crosslinking agent.
Morikane teaches the adhesive layer comprises 11 to 20% by mass in total of water soluble polymers (paragraph 10 describes the adhesive having 3 to 15% of polyacrylic acid and/or partially neutralized product thereof or a salt thereof and paragraph 15 describes the adhesive having 1 to 10% of carboxyvinyl polymer and/or carboxymethylcellulose or a salt thereof and 1 to 10% of polyvinyl alcohol, and paragraph 26 describes the water comprising 70-85 percent of the solution, leaving 15 to 30 percent for water soluble polymers; there are various permutations within these parameters that give a total water soluble polymer mass of 11 to 20%), 3.5 to 7% by mass of sodium carboxymethylcellulose (paragraph 15 describes the adhesive having 1 to 10% of carboxyvinyl polymer and/or carboxymethylcellulose or a salt thereof and paragraph 60 describes sodium carboxymethylcellulose), 2% by mass or more and less than 5% by mass of a partially-neutralized polyacrylate (paragraph 10 describes the adhesive having 3 to 15% of polyacrylic acid and/or partially neutralized product thereof or a salt thereof), 0.22 to 1% by mass of a crosslinking agent (paragraph 10 describes the adhesive having .05 to .3% cross-linking agents).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Rowley in view of Kawarama’s invention to include the adhesive layer comprises 11 to 20% by mass in total of water soluble polymers, 3.5 to 7% by mass of sodium carboxymethylcellulose, 2% by mass or more and less than 5% by mass of a partially-neutralized polyacrylate, 0.22 to 1% by mass of a crosslinking agent in order to provide improved drug absorbency while maintaining adhesion in the patch as suggested and taught by Morikane in paragraph 6.
Regarding claim 2, Rowley in view of Kawarama and Morikane teach the invention as claimed and described above. Rowley further teaches wherein the water-soluble polymer comprises a polyacrylic acid (paragraph 25 describes polyacrylic acid).
Regarding claim 3, Rowley in view of Kawarama and Morikane teach the invention as claimed and described above. Rowley further teaches wherein the adhesive layer further comprises a polyhydric alcohol (paragraph 27 describes the adhesive layer including glycerin, a polyhydric alcohol).
Regarding claim 4, Rowley in view of Kawarama and Morikane teach the invention as claimed and described above. Rowley further teaches wherein the polyhydric alcohol is glycerin (paragraph 27 describes the adhesive layer including glycerin).
Regarding claim 5, Rowley in view of Kawarama and Morikane teach the invention as claimed and described above. Kawarama further teaches wherein the loss tangent is 0.202 to 0.404 (The table 1 loss tangent value that corresponds to 25.12 °C is 0.294 and the loss tangent value that corresponds to 19.11 °C is 0.337, so the loss tangent at exactly 25 °C would be slightly larger than 0.294 and less than 0.337).
Regarding claim 7, Rowley discloses a microneedle patch (Figure 1), comprising:
a backing (Figure 1, 110);
an adhesive layer (130) provided on a main surface of the backing (the main surface is the lower surface of 110 that is not visible in figure 1); and
a microneedle array (claim 18 describes microneedles, i.e. a microneedle array in the embossed release liner 120), at least a part of the microneedle array being positioned within the adhesive layer (paragraph 25 describes the adhesive matrix 130 absorbs into the embossed release liner 120), wherein
the adhesive layer comprises a water-soluble polymer (paragraph 28 describes polyacrylic acid, a water-soluble polymer) and water (paragraph 25).
Rowley is silent on the adhesive layer comprises 11 to 20% by mass in total of water-soluble polymers, 0.5% by mass or more and less than 3.5% by mass of sodium carboxymethylcellulose, 1% by mass or more and less than 5% by mass of a partially-neutralized polyacrylate, 0.18 to 0.7% by mass of a crosslinking agent, and
a loss tangent of the adhesive layer under measurement conditions of an environmental temperature of 25°C and a frequency of 1 Hz is 0.20 to 0.41.
Kawarama teaches a loss tangent of the adhesive layer (Table 1) under measurement conditions of an environmental temperature of 25 C (Table 1 shows a wide range of temperatures and a line at 25.12 °C) and a frequency of 1 Hz (paragraph 21 describes the frequency as 6,2832 rad/s, which is 1 Hz) is 0.20 to 0.41 (The table 1 loss tangent value that corresponds to 25.12 °C is 0.294 and the loss tangent value that corresponds to 19.11 °C is 0.337, so the loss tangent at exactly 25 °C would be slightly larger than 0.294 and less than 0.337).
Therefore it would have been obvious to modify Rowley’s invention to include a loss tangent of the adhesive layer under measurement conditions of an environmental temperature of 25 C and a frequency of 1 Hz is 0.20 to 0.41 in order to provide a gentle enough adhesion to the skin to avoid excessive pain and improved water resistance as suggested and taught by Kawarama in paragraphs 9-11.
Morikane teaches the adhesive layer comprises 11 to 20% by mass in total of water-soluble polymers (paragraph 10 describes the adhesive having 3 to 15% of polyacrylic acid and/or partially neutralized product thereof or a salt thereof and paragraph 15 describes the adhesive having 1 to 10% of carboxyvinyl polymer and/or carboxymethylcellulose or a salt thereof and 1 to 10% of polyvinyl alcohol, and paragraph 26 describes the water comprising 70-85 percent of the solution, leaving 15 to 30 percent for water soluble polymers; there are various permutations within these parameters that give a total water soluble polymer mass of 11 to 20%), 0.5% by mass or more and less than 3.5% by mass of sodium carboxymethylcellulose (paragraph 15 describes the adhesive having 1 to 10% of carboxyvinyl polymer and/or carboxymethylcellulose or a salt thereof), 1% by mass or more and less than 5% by mass of a partially-neutralized polyacrylate (paragraph 10 describes the adhesive having 3 to 15% of polyacrylic acid and/or partially neutralized product thereof or a salt thereof and paragraph 60 describes sodium carboxymethylcellulose), 0.18 to 0.7% by mass of a crosslinking agent (paragraph 10 describes the adhesive having .05 to .3% cross-linking agents).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Rowley in view of Kawarama’s invention to include the adhesive layer comprises 11 to 20% by mass in total of water-soluble polymers, 0.5% by mass or more and less than 3.5% by mass of sodium carboxymethylcellulose, 1% by mass or more and less than 5% by mass of a partially-neutralized polyacrylate, 0.18 to 0.7% by mass of a crosslinking agent in order to provide improved drug absorbency while maintaining adhesion in the patch as suggested and taught by Morikane in paragraph 6.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rowley (US 2021/0000754) in view of Kawarama et al. (US 2009/0043236), Morikane et al. (US 2021/0401767) and Hu et al. (US 2024/0100042).
Regarding claim 6, Rowley discloses a microneedle patch (Figure 1), comprising:
a backing (Figure 1, 110);
an adhesive layer (130) provided on a main surface of the backing (the main surface is the lower surface of 110 that is not visible in figure 1); and
a microneedle array (claim 18 describes microneedles, i.e. a microneedle array in the embossed release liner 120), at least a part of the microneedle array being positioned within the adhesive layer (paragraph 25 describes the adhesive matrix 130 absorbs into the embossed release liner 120), wherein
the adhesive layer comprises a water-soluble polymer (paragraph 28 describes polyacrylic acid, a water-soluble polymer) and water (paragraph 25).
Rowley is silent on the adhesive layer comprises 11 to 20% by mass in total of water-soluble polymers, 0.5% by mass or more and less than 3.5% by mass of sodium carboxymethylcellulose, 1% by mass or more and less than 5% by mass of a partially-neutralized polyacrylate, 1 to 9% by mass of a crosslinking agent, and
a loss tangent of the adhesive layer under measurement conditions of an environmental temperature of 25°C and a frequency of 1 Hz is 0.20 to 0.41.
Kawarama teaches a loss tangent of the adhesive layer (Table 1) under measurement conditions of an environmental temperature of 25 C (Table 1 shows a wide range of temperatures and a line at 25.12 °C) and a frequency of 1 Hz (paragraph 21 describes the frequency as 6,2832 rad/s, which is 1 Hz) is 0.20 to 0.41 (The table 1 loss tangent value that corresponds to 25.12 °C is 0.294 and the loss tangent value that corresponds to 19.11 °C is 0.337, so the loss tangent at exactly 25 °C would be slightly larger than 0.294 and less than 0.337).
Therefore it would have been obvious to modify Rowley’s invention to include a loss tangent of the adhesive layer under measurement conditions of an environmental temperature of 25 C and a frequency of 1 Hz is 0.20 to 0.41 in order to provide a gentle enough adhesion to the skin to avoid excessive pain and improved water resistance as suggested and taught by Kawarama in paragraphs 9-11.
Morikane teaches the adhesive layer comprises 11 to 20% by mass in total of water-soluble polymer (paragraph 10 describes the adhesive having 3 to 15% of polyacrylic acid and/or partially neutralized product thereof or a salt thereof and paragraph 15 describes the adhesive having 1 to 10% of carboxyvinyl polymer and/or carboxymethylcellulose or a salt thereof and 1 to 10% of polyvinyl alcohol, and paragraph 26 describes the water comprising 70-85 percent of the solution, leaving 15 to 30 percent for water soluble polymers; there are various permutations within these parameters that give a total water soluble polymer mass of 11 to 20%)s, 0.5% by mass or more and less than 3.5% by mass of sodium carboxymethylcellulose (paragraph 15 describes the adhesive having 1 to 10% of carboxyvinyl polymer and/or carboxymethylcellulose or a salt thereof and paragraph 60 describes sodium carboxymethylcellulose), 1% by mass or more and less than 5% by mass of a partially-neutralized polyacrylate (paragraph 10 describes the adhesive having 3 to 15% of polyacrylic acid and/or partially neutralized product thereof or a salt thereof), and a crosslinking agent (paragraph 10 describes the adhesive a cross-linking agent).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Rowley in view of Kawarama’s invention to include the adhesive layer comprises 11 to 20% by mass in total of water-soluble polymers, 0.5% by mass or more and less than 3.5% by mass of sodium carboxymethylcellulose, 1% by mass or more and less than 5% by mass of a partially-neutralized polyacrylate, a crosslinking agent in order to provide improved drug absorbency while maintaining adhesion in the patch as suggested and taught by Morikane in paragraph 6.
Rowley in view of Kawarama and Morikane are silent on 1 to 9% by mass of a crosslinking agent.
Hu teaches 1 to 9% by mass of a crosslinking agent (paragraph 7 describes 2% of a cross-linking agent).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Rowley in view of Kawarama and Morikane’s invention to include 1 to 9% by mass of a crosslinking agent in order to provide a stable mixture for the patch as suggested and taught by Hu in paragraph 39.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7 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.
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.
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/KATHERYN A MALATEK/ Primary Examiner, Art Unit 3741
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