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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/007426, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The provisional application fails to provide support for the angle between the proximal flared portion and the outer surface of the stem. The claims are examined with an effective filing date of 4/8/2021.
Response to Amendment
This office action is responsive to the amendment filed on May 13, 2026. As directed by the amendment: claims 1-3, 6, 7, 16, 17, 19-21, 23-25, and 32 have been amended and claims 14, 15, and 22 have been cancelled. Thus, claims 1-4, 6, 7, 9, 12, 16, 17, 19-21, 23-26, 32, 33, and 35 are presently pending in this application with claims 33 and 35 presently withdrawn.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed January 13, 2026.
Response to Arguments
Applicant’s arguments, filed May 13, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive, specifically in regards to the prior art not teaching or disclosing the claimed proximal flared portion. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
Claim Objections
Claims 1, 16, 19, 21, 23, 25, and 26 are objected to because of the following informalities:
Regarding claim 1, the claim should be amended to recite “the stem portion” in lines 11 and 15 to keep claim terminology consistent.
Regarding claim 16, the claim should be amended to recite “the plurality of microneedles” since the microneedles were already introduced in claim 1.
Regarding claim 19, the claim should be amended to recite “the plurality of microneedles” in line 1 to correct for grammar.
Regarding claim 19, the claim should be amended to recite “the distal tip portion” in line 3 to keep claim terminology consistent.
Regarding claim 21, the claim should be amended to recite “the stem portions” in line 2 to keep claim terminology consistent.
Regarding claim 23, the claim should be amended to recite “the recombinant adenovirus particle[[s]] is” to keep claim terminology consistent and since claim 1 recites only a singular particle.
Regarding claim 25, the claim should be amended to recite “the stem portion” in line 1 to keep claim terminology consistent.
Regarding claim 26, the claim should be amended to recite “the stem portion” in line 2 to keep claim terminology consistent.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 19 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 19, the claim has been amended to recite that the particle is substantially located at the [distal] tip portion of the microneedles. The originally filed disclosure does not provide sufficient support for such amendment. While paragraph 30 (of the published application) discloses that the particle is located substantially at the tip of the microneedles, paragraph 126 discloses that the tip is an area of the microneedle that extends from a base portion in a narrowing matter. This disclosure indicates that “the tip” in this context is synonymous with the head of the microneedle (25 in fig. 1A) and not, more specifically, the distal tip portion, which is merely a portion of the head. It is recommended to amend the claim to recite that the particle is located substantially at the head of the microneedle.
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 23-26 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.
Regarding claims 23-25, the claim is dependent on a cancelled claim. For examination purposes, the claim is examined as if depending on claim 1.
Claim 24 recites the limitation "the at least one undercut feature" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 is also rejected by virtue of being dependent on claim 25.
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.
Claim(s) 1 16, 17, 19-21, 23, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ozdoganlar (US 2018011907) in view of Chan (US 20070293815).
Regarding claim 1, Ozdoganlar discloses a microneedle device (fig. 6), comprising:
a backing layer (“backing layer” in fig. 6); and
a plurality of microneedles extending from the backing layer (fig. 6 shows two microneedles extending from the “backing layer”), and comprising a dissolvable (aqueous-soluble) and/or bioerodible matrix comprising trehalose (paragraph 10 discloses the microneedle arrays are “dissolvable”; paragraph 11 and 78 discloses that the microneedles can comprise trehalose), and a recombinant adenovirus particle comprising a gene for expressing a polypeptide or RNA (paragraph 32 discloses that the microneedle array can comprise a nucleic acid contained in a recombinant virus particle; paragraph 37 discloses an adenovirus gene encoding virus-associated RNA);
a head spaced from the backing layer, the head comprising a distal tip portion having a first diameter and a proximal flared portion having a second diameter, the second diameter being larger than the first diameter (see below); wherein
a stem portion arranged between the proximal flared portion of the head and the backing layer, wherein a distal portion of the stem immediately adjacent to the proximal flared portion of the head has a third diameter (see below), and wherein
the microneedles comprise a barbed or undercut profile in which the third diameter is smaller than the second diameter (see below; fig. 6 shows an undercut profile in which the stem continuously tapers to a smaller diameter closer to the backing layer).
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Ozdoganlar further discloses that the microneedles can have “any shape or configuration useful for dermal administration” (paragraph 53), However, Ozdoganlar does not teach or disclose an angle defined by a proximally facing surface of the proximal flared portion of the head and an outer surface of the stem is about 20° to about 100°.
Chan is directed towards a microneedle (microblade 102 in fig. 3) comprising a head having a distal tip portion (tip 104 in fig. 3) and a proximal flared portion (points 106 and 108 in fig. 3), a stem portion (sides 110 and 112 in fig. 3 form the stem portion). Chan further discloses that the microneedles comprise a barbed or undercut profile in which a third diameter is smaller than a second diameter (see below), such that an angle defined by a proximally facing surface of the proximal flared portion of the head and an outer surface of the stem is about 20° to about 100° (see below; fig. 3 discloses a 90° angle).
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Since Ozdoganlar discloses the microneedles can be any shape (paragraph 53), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the shape of the head and stem of the microneedle so that an angle defined by a proximally facing surface of the proximal flared portion of the head and an outer surface of the stem is about 90°, as taught by Chan, since Chan teaches that this is a known shape useful for piercing the stratum corneum (paragraph 15).
Regarding claim 16, in the device of modified Ozdoganlar, Ozdoganlar discloses a plurality of microneedles comprise a plurality of layers of one or more dissolvable or bioerodible, biocompatible material (paragraph 60 discloses “one or more additional layers”).
Regarding claim 17, in the device of modified Ozdoganlar, Ozdoganlar discloses the plurality of microneedles further comprise carboxymethyl cellulose (paragraph 78 discloses the microneedles can comprise CMC as well as trehalose).
Regarding claim 19, in the device of modified Ozdoganlar, Ozdoganlar discloses the plurality microneedles have a layered structure with the recombinant adenovirus particle located substantially at the tip portion of the microneedles (paragraph 80 discloses multi-layered microneedles with the rAAV particles being loaded in the tip).
Regarding claim 20, in the device of modified Ozdoganlar, Ozdoganlar discloses the plurality of microneedles each have a length of 1 mm or less (Table 2 discloses a height of 100 um which is equated to 0.1mm).
Regarding claim 21, in the device of modified Ozdoganlar, Ozdoganlar discloses the plurality of microneedles have a filleted base (see “Fillet radius” in fig. 6).
Regarding claim 23, in the device of modified Ozdoganlar, Ozdoganlar discloses the plurality of microneedles comprise the recombinant adenovirus particles located substantially in the head of the microneedles (paragraph 76 discloses a “tip loaded” microneedle array).
Regarding claim 24, in the device of modified Ozdoganlar, Chan discloses the at least one undercut feature is directly below the microneedle head (fig. 3 shows the smaller stem of the microneedle relative to the arrowhead shape of the head forms the undercut feature; the examiner notes that the shape of Chan is substantially similar to Applicant’s shape in fig. 2A/B which are disclosed to have “undercut features” in paragraph 173 of the published application).
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.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ozdoganlar in view of Chan, as applied to claim 1 above, and further in view of Wu (US 20020031527).
Regarding claims 2 and 3, Ozdoganlar discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the recombinant adenovirus in the microneedle device retains viability for at least one month at 4°C [claim 2] or the number of infectious units (IU) of the recombinant adenovirus in the microneedle decreases by less than 50%, 40%, 30%, or 25% on storage for one month at 4°C [claim 3].
Wu is directed towards an adenovirus composition which has an infectivity between 60-100% compared to starting infectivity when the composition is stored for six months at 4°C (paragraph 10). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of Ozdoganlar so that the recombinant adenovirus retains viability and the number of infectious units (IU) of the recombinant adenovirus in the microneedle decreases by less than 50%, 40%, 30%, or 25% on storage for one month at 4°C, as taught by Wu, in order to render the device storage stable (paragraph 10).
Claim(s) 4, 6, 7, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ozdoganlar in view of Chan, as applied to claim 1 above, and further in view of Falo (US 20180304062).
Regarding claims 4 and 5, Ozdoganlar discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the gene expresses an immunogen [claim 4] and the microneedle further comprise a compound or composition having immune stimulant or adjuvant effect [claim 5].
Falo is directed towards a similar microneedle device (fig. 30 shows an equivalently formed microneedle to Ozdoganlar) which is intended for drug delivery (paragraph 3) and which comprises a recombinant adenovirus particle (paragraph 128) which expresses an immunogen (paragraph 131 expressing genes which induce an immune response which is aligned with Applicant’s definition of “immunogen” set forth in paragraph 85 of the Specification). Falo further teaches that the microneedle further comprises a compound or composition having immune stimulant or adjuvant effect (paragraph 63). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the microneedle device to be used for drug delivery to produce an immune response by modifying the gene to express and immunogen and to further include a compound/composition having immune stimulant or adjuvant effect, as taught by Falo. This modification would enable the microneedle of Ozdoganlar to employ co-delivery of different agents for polyfunctional drug delivery (paragraph 63).
Regarding claim 7, in the modified device of Ozdoganlar, Falo discloses the compound or composition having immune stimulant or adjuvant effect is double stranded RNA (paragraph 244).
Regarding claim 9, in the modified device of Ozdoganlar, Falo discloses the compound or composition having immune stimulant or adjuvant effect is Poly(I:C) or Poly-ICLC (paragraph 244).
Claim(s) 12 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ozdoganlar in view of Chan, as applied to claim 1 above, and further in view of Massie (US 20020051966).
Regarding claim 12, Ozdoganlar discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the gene expresses an antisense RNA or an RNAi reagent.
Massie is directed towards a recombinant adenovirus vector which expresses an antisense RNA (paragraph 60). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of Ozdoganlar so that the gene expresses an antisense RNA or an RNAi reagent. This modification would enable the microneedle device of Ozdoganlar to be used in gene therapy and vaccination (paragraph 60).
Regarding claim 32, Ozdoganlar discloses all of the claimed limitation set forth in claim 1, as discussed above, but does not teach or disclose the Adenovirus is an Ad5 vector for expression of a transgene.
Massie is directed towards recombinant adenovirus compositions (paragraph 57) in which the Adenovirus is an Ad5 vector for expression of a transgene (paragraphs 6 and 56). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the recombinant adenovirus particle to be an ad5 vector for expression of a transgene, as taught by Massie, since Massie teaches that this type of vector has been studied most intensively and has been used in gene transfer processes for decades (paragraph 6).
Claim(s) 25 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ozdoganlar in view of Chan, as applied to claim 1 above, and further in view of Gill (US 20080213461).
Regarding claim 25, modified Ozdoganlar teaches all of the claimed limitations set forth in claim 1, as discussed above. Ozdoganlar further discloses the stem comprises a dissolvable or bioerodible material (paragraph 80 discloses the needle base, equated to the stem, is made from a “fast dissolving material”) which can dissolve within seconds (paragraph 80).
However, modified Ozdoganlar does not explicitly teach or disclose the material dissolves in less than 30 seconds, less than 20 seconds, less than 10 seconds, or less than 5 seconds in water.
Gill teaches a microneedle which is made from a material which dissolves less than 30 seconds in water (paragraph 108 discloses 10-20 seconds; paragraph 170 discloses using water to dissolve the material). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the material so it dissolves in less than 30 seconds in water, as taught by Gill, in order to rapidly deliver the therapeutic materials to the patient.
Regarding claim 26, in the device of modified Ozdoganlar, Ozdoganlar discloses the dissolvable or bioerodible material of the stem comprises carboxymethyl cellulose (paragraph 62 discloses the base material for the microneedle can be CMC).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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