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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/10/2026 has been entered.
Response to Amendment
Applicant has amended claims 1, 9, 12, and 15, and added claims 16-19.
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 5-7 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.
Claims 5-7 are indefinite due to improper antecedent basis causing a lack of clarity in each of the respective claims. Claim 1, which claims 5-7 are each dependent on, requires “the distal-most upper end point being positioned lower than a maximum radius region of the second region”. However, claims 5-7 each recite “a maximum radius region of the second region”. It is unclear if these are all meant to be the same maximum radius region as the maximum radius region established in claim 1, or if these are meant to be different regions, especially due to them being established as new claim limitations where each recitation is drawn to a region as opposed to the region.
For the purposes of compact prosecution, Examiner has understood the claims to each be referring to maximum radius regions which are different than the maximum radius region of claim 1.
Examiner also notes that the alternative interpretation of the indefinite limitations (which would be that the maximum radius region of claims 5-7 is the same as the maximum radius region of claim 1) would not appear to be supported for claim 7 as it does not appear that an embodiment is disclosed which requires both the support wings configuration of claim 1 and of claim 7.
Claim Rejections - 35 USC § 102
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) 1-3, 5-8, 11-13, 15, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Amir (US 20150209563, henceforth Amir).
Regarding claim 1, Amir discloses a microstructure comprising: a base film (substrate 514b and base 510b make up the claimed base film, fig. 5B); and a plurality of microneedles (microneedle 500, fig. 5B, is the chosen embodiment and is a part of a plurality of microneedles as shown in fig. 6A) disposed on one surface of the base film (see figs. 5B and 6A), wherein each of the plurality of microneedles comprises: a needle body (the parts of microneedle 500 which are not flaps 522 or part of the base 810b are the claimed needle body) having: a first region (the bottom most surface of composition 524, fig. 5B) coupled to the base film (see fig. 5B); a second region (leakage stopper 504B, fig. 5B) extending from the first region (see fig. 5B, leakage stopper 504B extends distally upwards from the first region) and gradually increasing in width as a distance from the first region increases (see fig. 5B, the rounded conical shape provides for such an increasing width); and a third region (sharp tip section 502B, fig. 5B) extending from the second region (see fig. 5B) and gradually decreasing in width as a distance from the second region increases (see fig. 5B, the conical tip provides for such a decreasing width); and a plurality of support wings (longitudinal flaps 522, fig. 5B) disposed around the needle body (see fig. 5B), and connecting an outer surface of the needle body and the base film (see fig. 5B), wherein each of the plurality of support wings is coupled to the needle body between the first region and the second region (see fig. 5B, flaps 522 are coupled to the needle body between the regions where they touch composition 524 as shown), and has a thickness thinner than a thickness of the needle body (see fig. 5B), wherein a distal end of each of the plurality of support wings is a distal-most upper end point coupled to the outer surface of the needle body (see fig. 5B), the distal-most upper end point being positioned lower than a maximum radius region of the second region (see fig. 5B, the distal most upper end point of flaps 522 is lower than the point at which the second region and third region intersect which is a maximum radius region of the second region as claimed), and wherein an outer surface of each of the plurality of support wings is not directly connected to an outer surface of the third region (see fig. 5B, there is no direct connection between flaps 522 and section 502B, only intermediate connection via section 504B).
Regarding claim 2, Amir discloses the microstructure of claim 1 wherein the plurality of support wings are disposed symmetrically about a longitudinal axis passing through a center of the needle body (see fig. 5B).
Regarding claim 3, Amir discloses the microstructure of claim 1 wherein each of the plurality of support wings gradually decreases in thickness in a direction extending radially away from a center of the needle body (see fig. 5B, flaps 522 decreasing in radial thickness in a radial outward direction as the thickness is measured from a first point below the distal-most upper end point of flap 522 to a second point at the distal-most upper end point of flap 522).
Regarding claim 5, Amir discloses the microstructure of claim 1 wherein a connection region at which each of the plurality of support wings and the base film are connected has a radial end located radially inward of a maximum radius region of the second region in a plan view (see fig. 5B, the radial outermost edge of flaps 522 at the interface with base 510b is radially inward of a maximum radius region of the second region which is the interface between the second region and the third region).
Regarding claim 6, Amir discloses the microstructure of claim 1 wherein a connection region at which each of the plurality of support wings and the base film are connected has a radial end located at a position corresponding to a maximum radius region of the second region in a plan view (see fig. 5B, the radial outermost edge of flaps 522 at the interface with base 510b is radially equidistant from the central axis of the needle body with a maximum radius region of the second region which is the region at which the distal-most upper end point of flaps 522 terminates into the second region).
Regarding claim 7, Amir discloses the microstructure of claim 1 wherein a connection region at which each of the plurality of support wings and the base film are connected has a radial end located radially outward of a maximum radius region of the second region in a plan view (see fig. 5B, the radial outermost edge of flaps 522 at the interface with base 510b is radially outward from the central axis of the needle body to a maximum radius region of the second region which is the lower most end of the second region shown interfacing with composition 524 in fig. 5b).
Regarding claim 8, Amir discloses the microstructure of claim 1 wherein the needle body further comprises a fillet at an intersection between the second region and the third region (see fig. 5B, there is an angled intersection between sharp tip section 502b and leakage stopper 504b; this is a fillet because Merriam Webster defines a fillet to be “a strip that gives a rounded appearance to such a junction” where the junction is where two surfaces meet, and the meeting of surfaces shown in fig. 5B is curved and rounded) to connect the second region and the third region, the fillet having a curved outer circumferential surface (see fig. 5B, the outer circumferential surface is curved where it goes around the conically shaped needle body).
Regarding claim 11, Amir discloses the microstructure of claim 1 wherein the plurality of support wings includes: a first support wing located on a first lateral side of the needle body (see fig. 5B, the first flap 522 is on the left in the provided perspective); and a second support wing located on a second lateral side of the needle body (see fig. 5B, the second flap 522 is on the right in the provided perspective), the second lateral side being opposite the first lateral side (see fig. 5B, the left and right sides are opposite), wherein the first support wing and the second support wing have different thicknesses (see fig. 5B, the thickness of the first support wing at the distal-most upper end is thinner than the second support wing where it interfaces with base 510 at its lower end).
Regarding claim 12, Amir discloses the microstructure of claim 1 wherein each of the plurality of support wings gradually increases in thickness in a direction from the distal-most upper end point toward a lower end of each of the plurality of support wings directly adjacent to the base film (see fig. 5B, the flaps 522 gradually increase in thickness as measured moving downwards from the distal-most upper end point as they interface with leakage stopper 504 until they reach their full, consistent thickness measured from the central axis of the needle body radially outwards).
Regarding claim 13, Amir discloses the microstructure of claim 1 wherein the third region gradually decreases in the width to taper into a sharp tip at a distal end point thereof (see fig. 5B and [0191]).
Regarding claim 15, Amir discloses the microstructure of claim 1 wherein a height of the second region is equivalent to a height of the third region (see annotated fig. 5A below).
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Annotated fig. 5A from Amir
Regarding claim 18, Amir discloses the microstructure of claim 1 wherein regions of the outer surface of needle body between adjacent support wings of the plurality of support wings is exposed (see fig. 5B, portions of the second region and the space between the first region and second region at composition 524 are exposed), the exposed regions defining a convexly curved surface (see fig. 5B, the regions are curved as claimed especially at the interface between the second region and composition 524).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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.
Allowable Subject Matter
Claims 9, 10, 14, 16-17, and 19 allowed.
The following is an examiner’s statement of reasons for allowance: The prior art does not disclose or render obvious in combination the claimed microstructure having support wings in the arrangement as claimed. Particularly, the prior art does not contain the support wings having a distal-most upper end point located at a distal end point of the third region as claimed which extends downward and wherein at each height below the upper end point at which each of the support wings is present, a radially outermost portion of the support wing is located radially outward of an outermost surface of the needle body at a corresponding height.
There is prior art which discloses support wings which extend from a distal most point of a needle body to a film, such as Dalton et al. (US 20040049150), especially at fig. 7 and [0020]. However, this prior art does not disclose the three regions of the needle body as claimed. There is also prior art which discloses needle bodies having the three regions as claimed, such as Falo et al. (US 20160271381) at fig. 30, Baek (US 20170368321, previously made of record) at fig. 4d, Jung et al. (US 20150224293) at fig. 7, and Falo et al. (US 20110098651, previously made of record) at fig. 21. However, this prior art does not disclose the support wings as claimed. Further, it does not appear that any combinations of these prior art references would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application, particularly because the microstructures which include the support wings are made by molding (see Garstein et al., US 20040164454, at figs. 44-45, [0006], and [0095] and see Dalton [0016] and fig. 7) and are configured to make insertion of the microstructure into the skin easier (see Dalton [0020] and see Baek [0075]), however these support wings would not be combinable with the needle bodies of other prior art references since those references rely on different manufacturing processes than those used to make the support wings, and the different processes are not compatible with one another.
Additionally, there are alternative teachings in the prior art which disclose support wings which do not extend from the distalmost end of the needle body as in the claimed configuration as in Desimone et al. (US 20180064920, previously made of record in the IDS filed 05/19/2023) at fig. 6A and [0144] and see the rejection relied upon in the previous Office Action or do extend proximally from the distalmost end but do not extend to the base film as in Devoe et al. (US 20090099537, previously made of record) at fig. 6. These support wings also do not appear to have been obviously combinable to render the claimed invention.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL J MARRISON/ Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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