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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on November 24, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claims 2, 3, 15, 16, 19, 24, and 25 are objected to because of the following informalities:
Regarding claims 2 and 3, the claim should be amended to recite “the recombinant adenovirus particle” in line 2 to keep claim terminology consistent.
Regarding claim 15, the claim should be amended to recite “the head portion” and “the stem portion” since these limitations were previously introduced in claim 14.
Regarding claim 16, the claim should be amended to recite “the plurality of microneedles” since the plurality is already introduced n claim 1.
Regarding claim 19, the claim should be amended to recite “…at a tip of the plurality of microneedle” in line 3 to provide antecedent basis for the claim terminology and to keep claim language consistent.
Regarding claim 24, the claim should be amended to recite “the [[microneedle]] head of the microneedles” to keep claim terminology consistent.
Regarding claim 25, the claim should be amended to recite “wherein the stem [[is]] comprises” to correct for grammar.
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.
Claims 6, 7, 9, 14-16, 19, 25, 26, and 32 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 claim 6, the claim is dependent on a cancelled claim. For examination purposes, the claim is examined as if depending on claim 1.
Regarding claim 6, there is a lack of antecedent basis for “the microneedle” in line 1. It is unclear if this limitation is intended to mean “the microneedle device” or “the plurality of microneedles”. For examination, the second interpretation was used.
Regarding claim 14, there is a lack of antecedent basis in the terms “the top portion” and “the bottom portion” in line 5. It is unclear if these limitations should be amended to recite “a top” and “a bottom” or if they should be interpreted to mean “the head portion” and “the stem portion”. The examiner notes that the specification provides no guidance on how to interpret this limitation, As best understood by the examiner, for examination purposes, the second interpretation was used.
Regarding claim 15, the claim recites that the head portion is attached to the stem portion. Using the interpretation set forth above for claim 14, the intermediate portion is defined as being between the head portion and stem portion. As such, it is unclear how the head portion and stem portion can be attached while also having an intermediate portion between the two.
Regarding claim 19, there is a lack of antecedent basis in “the adenovirus particles” in line 2. This claim is dependent on claim 1 which is drawn to “a recombinant adenovirus particle” which is understood to be a singular particle.
Regarding claim 25, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 32, there is a lack of antecedent basis in the limitation “the Adenovirus” in line 2. It is unclear if this limitation should read “an adenovirus” or if it should be read “the recombinant adenovirus particle”. For examination purposes, the second interpretation was used.
Claims 7, 9, 16, and 26 are also rejected by virtue of being dependent on a claim above.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 14-17, and 19-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ozdoganlar (US 20180119077).
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).
Regarding claim 14, Ozdoganlar discloses the plurality of microneedles have a shape that comprises a first cross-sectional dimension at a head portion distal to the backing layer (see below, see dotted line within designated head portion), a second cross-sectional dimension at a stem portion proximal to the backing layer (see below, see dotted line within designated stem portion), and a third cross-sectional dimension at an intermediate portion located between the top portion and the bottom portion having a cross-sectional dimension greater than the first and second cross-sectional dimensions (see dotted line between designated head and stem portions).
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Regarding claim 15, Ozdoganlar discloses the plurality of microneedles comprise a stem portion adjacent or proximal to the backing layer (see above), and a head portion attached to the stem portion distal to the backing layer (see above), the microneedles having a barbed or undercut profile in which the head portion having a cross section adjacent to the stem is larger than a cross section of the stem adjacent to the head (fig. 6 shows that the stem tapers towards a smaller diameter towards the backing layer so to form an undercut profile).
Regarding claim 16, 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, 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, Ozdoganlar discloses the plurality microneedles have a layered structure with the adenovirus particles located substantially at the tip of the microneedles (paragraph 80 discloses multi-layered microneedles with the rAAV particles being loaded in the tip).
Regarding claim 20, 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, Ozdoganlar discloses the plurality of microneedles have a filleted base (see “Fillet radius” in fig. 6).
Regarding claim 22, Ozdoganlar discloses the plurality of microneedles comprise a stem (see below), a head (see below, a filleted base (“Fillet radius” in fig. 6), and at least one undercut feature (the angle between the head and the stem is the “undercut feature”).
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Regarding claim 23, 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, Ozdoganlar discloses the at least one undercut feature is directly below the microneedle head (see annotated figure above for claim 22).
Regarding claim 25, Ozdoganlar 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”).
Regarding claim 26, 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).
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, 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, 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, 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).
Conclusion
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).
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/COURTNEY B FREDRICKSON/ Primary Examiner, Art Unit 3783