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 .
Claims 1-9,23-27 are under examination.
Restriction/Election
Applicant’s election without traverse of Group I (Claims 1-9,23-27) in the reply filed on September 26, 2025 is acknowledged. Applicant canceled non-elected Groups II-IV (Claims 10-22). Election was made without traverse in the reply filed on September 26, 2025. Claims 10-20, and 22 are still withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-IV, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 26, 2025. The restriction requirement made by examiner is not going to be withdrawn even though the withdrawn claims are canceled because MPEP 821.04(b) recites, “If applicant cancels all the claims directed to a nonelected process invention before rejoinder occurs, the examiner should not withdraw the restriction requirement. This will preserve applicant’s rights under 35 U.S.C. 121.” In this case, the withdrawn claims are process claims.
Claim Objections
Claims 3-4 are objected to because of the following informalities: Claims 3-4 were originally drafted to present multiple species of outer microneedle components (Claim 3) and cytocompatible hydrogel-based material (Claim 4). Both claims 3 and 4 have been limited to one species; however, the claims still have language indicating multiple choices. In claim 3, “a material selected from the group:” needs to be removed.” In claim 4, “the group comprising:” needs to be removed. Appropriate correction is required.
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.
Claim 5 is 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 5 uses the terminology “less than about.” This term is indefinite because the term less than means the amount must be less than a stated value. However, the term “about” means that the amount can be less than or greater than a stated value. Because of this discrepancy, the claim is indefinite and the metes and bounds cannot be adequately determined. For purposes of examination, the examiner will interpret less than about to mean just less than.
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.
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 1-6,9,25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Desimone (US 20180064920) in view of Akbari (US 20180355121)
Desimone teaches a delivery device for the localized delivery of live cells (Desimone, Paragraph 66—stem cells) to living tissue comprising: a base substrate layer having a plurality of microneedles extending away from the surface of the base substrate layer (Abstract, FIG 4A, FIG 4B,FIG5A), wherein the plurality of microneedles are formed from an outer hardened shell comprising a biodegradable or dissolvable polymer (Paragraph 152 of Desimone), and wherein the plurality of microneedles are detachable from the base substrate layer (Paragraph 18 of Desimone) as in instant Claim 1.
Desimone teaches a cell (Paragraph 66) carrier device which has a biodegradable or dissolvable polymer (PGLA—as taught in paragraph 152) in the outer hardened portion of microneedles. Desimone fails to teach that its microneedles contain an inner region with a cytocompatible hydrogel-based material mixed with live cells. Akbari teaches a cell carrier device with an outer biodegradable/dissolvable moiety and an inner hydrogel component (Paragraphs 3,7,57, and 77 of Akbari). It would have been obvious for an artisan of ordinary skill in the art to have included the inner hydrogel component mentioned in Akbari. An artisan would have been motivated to have used the hydrogel component taught by Akbari because it is able to support cellular viability and proliferation of cells (Paragraph 57 of Akbari) as in instant Claim 1.
Dependent Claims taught by Desimone
Desimone teaches wherein the plurality of microneedles comprise sharpened tips (Paragraph 141, Figure 4A, Figure 4B, and Figure 5A of Desimone) as in instant Claim 2. Desimone teaches wherein the outer hardened shell of the plurality of microneedles is formed from a material selected from the group comprising: poly(lactic-co-glycolic) acid (PLGA) (Paragraph 152 of Desimone) as in instant Claim 3. Desimone teaches wherein the plurality of microneedles have a length of less than 1.5 mm (Paragraphs 78 and 80) as in instant Claim 5. Desimone teaches wherein the plurality of microneedles have a length within the range of about 10 µm to about 1,500 µm (Paragraph 78 and 80) as in instant Claim 6. Desimone teaches wherein the plurality of microneedles are disposed in an array on the base substrate layer (FIG 4A, FIG 4B,FIG5A) as in instant Claim 9. Desimone teaches wherein the live cells comprise stem cells (Paragraph 66) as in instant Claim 27.
Dependent Claims taught by Akbari
Akbari teaches wherein the cytocompatible hydrogel-based material is selected from crosslinked gelatin methacryloyl (GelMA) hydrogel (Paragraph 77) as in instant Claim 4. Akbari teaches wherein the cytocompatible hydrogel-based material comprises crosslinked gelatin methacryloyl (GelMA) hydrogel (Paragraph 77) having a stiffness between from 1kPa to 1MPa (Paragraph 57) as in instant Claims 25-26.
Desimone teaches a microneedle delivery device used for delivering live cells into living tissue. Desimone does not teach that the cells are surrounded by a cytocompatible hydrogel material in the inner region of the microneedles. However, an artisan would have been strongly motivated to have included such a cytocompatible hydrogel capable of surrounding the cells in the microneedles in order to support proliferation and viability of those cells. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cell culture, and cell carrier devices. Therefore, the level of ordinary skill in this art is high.
Claims 1-9,23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Desimone (US 20180064920) in view of Akbari (US 20180355121) and Jung (WO 2018093218)
Desimone and Akbari apply as above to claims 1-6,9,25-27. Desimone and Akbari does not teach that the base substrate layer comprises a flexible substrate has an adhesive material, an adhesive layer, or glue applied to attach the microneedles. Jung teaches a flexible substrate that has an adhesive layer ( Page 6 (Paragraph 55), Page 7, and Page 9 (Paragraph 95)). Paragraph 95 on page 9 states that the needles can be easily detached from the adhesive layer so the time for administration to the subject can be reduced; this indicates that the adhesive layer is composed of weak bonds. It would have been obvious to an artisan of ordinary skill at the time of effective filing to have attached the needles of Desimone with the flexible substrate having an adhesive layer taught in Akbari. An artisan would have been motivated to have used Akbari’s flexible substrate having an adhesive layer in order to successfully attach the base substrate layer to needles and then being able to quickly remove those needles from the base substrate layer (Page 6 (Paragraph 55), Page 7, and Page 9(Paragraph 95)). Desimone teaches that the needles can be broken off its base substrate layer. Jung teaches an alternative method of needle release involving an adhesive layer that can easily release the needles. An artisan would have been motivated to have used Jung’s adhesive layer because it can quickly release needles without breakage, thus providing a better release mechanism for the microneedles. Because the needles can be successfully attached to a flexible substrate with an adhesive layer and undergo a speedy efficient release, there would have been a high expectation for success (Pages 6-7 and Page 9 (Paragraph 95) as taught by Jung) as in instant Claims 7-8,23-24.
Desimone teaches a microneedle delivery device used for delivering live cells into living tissue. Desimone does not teach that the cells are surrounded by a cytocompatible hydrogel material in the inner region of the microneedles. However, an artisan would have been strongly motivated to have included such a cytocompatible hydrogel capable of surrounding the cells in the microneedles in order to support proliferation and viability of those cells. An artisan would have been motivated to have used Jung’s adhesive layer because it can quickly release needles without breakage, thus providing a better release mechanism for the microneedles. Because the needles can be successfully attached to a flexible substrate with an adhesive layer and undergo a speedy efficient release, there would have been a high expectation for success. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cell culture, and cell carrier devices. Therefore, the level of ordinary skill in this art is high.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638