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
Claims 10-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 15, 2026.
Applicant’s election without traverse of Set 1 Species i and Set 2 Species vii in the reply filed on June 15, 2026 is acknowledged.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 31. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 115, 935, 49. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-9 and 13-19 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.
The term “fine” in claims 1 and 6 is a relative term which renders the claim indefinite. The term “fine” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the shape of the needle-shaped projections is rendered indefinite.
Claim 8 recites “one vertically penetrating discharge hole” claim 9 recites “a plurality of vertically penetrating discharge holes. Claim 1 recites “a plate in which a vertically penetrating discharge hole is formed” it is not clear if the recitations in claims 8 and 9 refer to the same or different holes than in claim 1. For the purposes of the rejection, it is taken to be the same.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-9, 13, and 14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Evjensvold et al. (US 2023/0173193 A1).
With regard to claim 1, Evjensvold et al. teach a needle-shaped projection-including part, which is configured to inject a liquid to a target object, the needle-shaped projection-including part comprising: a plate in which a vertically penetrating discharge hole is formed (Fig. 11 member 123 holes surrounding 115 in the upper surface); one or a plurality of fine needle-shaped projections that project from one face of the plate (Fig. 11 members 115); and a lip portion that is formed at an outer edge portion of the one face of the plate (Fig. 11 member 125), wherein in response to the liquid being discharged through the discharge hole, the liquid spreads in a space defined by the target object, the lip portion, and the one face of the plate, and the liquid enters the target object through holes formed by the one or plurality of needle-shaped projections ([0091], [0095], as fluid flows into the needles it is spreading into the space through the needles and into the target object).
With regard to claim 2, see Fig. 11.
With regard to claim 3, 4, 13, and 14, see Fig. 11 members 122, see Reference Figure 1 below.
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With regard to claim 7, the needle-shaped projection-including part is usable, with the needle-shaped projection-including part being mounted in a syringe barrel ([0091], 142 is inserted into a syringe, Fig. 6B, 12A); the needle-shaped projection-including part includes an attaching frame into which the plate is to be fitted (Figs. 1 and 11, frame generally formed by 116 and 118); the attaching frame is provided with an attaching barrel that is open so that a front barrel portion of a front end of the syringe barrel is fitted (Fig. 6b attaching barrel 142); and in response to pushing of a piston inserted into the syringe barrel, the liquid is expelled from the attaching barrel and discharged through the discharge hole ([0091], [0092]).
With regard to claims 8 and 9, see Fig. 1 at least one hole is aligned with 142 with additional holes out from the center. See Fig. 11, as the plate and frame are two separate pieces there is necessarily a gap, however small, between the components as they are not adhered together. As fluid flows into the needles it is spreading into the space through the needles and into the target object ([0091], [0092], [0095]).
With regard to claim 6, Evjensvold et al. teach a needle-shaped projection-including part, which is configured to inject a liquid to a target object, the needle-shaped projection-including part comprising: a plate (Fig. 11 member 118); one or a plurality of base portions that project from one face of the plate (Fig. 11 member 123); one or a plurality of fine needle-shaped projections that project from a front- end face of each of the one or plurality of base portions (Fig. 11 members 115); and a lip portion that is formed at an outer edge portion of the front-end face of the base portion (Fig. 11 member 125), wherein the plate and the one or plurality of base portions have a discharge hole that vertically penetrates from another face of the plate to the front-end face of the base portion (Fig. 11 holes aligned with 115), and in response to the liquid being discharged through the discharge hole, the liquid spreads in a space defined by the target object, the lip portion, and the front-end face of the base portion, and the liquid enters the target object through holes formed by the one or plurality of needle-shaped projections ([0091], [0095], as fluid flows into the needles it is spreading into the space through the needles and into the target object).
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.
Claim(s) 5 and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evjensvold et al. (US 2023/0173193 A1) as applied to claims 1-4, 13, and 14 above, and further in view of Asai et al. (US 2017/0239457 A1).
With regard to claims 5 and 15-19, Evjensvold et al. teach a device substantially as claimed. Evjensvold et al. do not disclose the shape of the projections. However, Asai et al. teach a plurality of projections for injection attached to a syringe which may be equivalently conical or polygonal ([0047]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a needle as shaped in Evjensvold et al. as in Asai et al. as Asai et al. teach such shapes are equivalently effective for insertion into the skin for delivering an injected substance. This would yield the same predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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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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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
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