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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 7, 2026 has been entered.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mcure (KR 10-1227062).
With regard to claim 1, Mcure teaches a sequential injection module for injecting a gas and a drug into a skin of a user through a single injection needle, the sequential injection module comprising: a gas inlet having a shape extending horizontally along a Cartesian X axis and configured to receive the gas into a first chamber therein (Fig. 3 12a extends in three dimensions including along an X axis as shown in Reference Figure 1 below, Pg. 9 of the translation); a drug inlet having a shape extending vertically and configured to receive the drug into a second chamber therein (Fig. 3 12b extends in three dimensions including along a Y axis as shown in Reference Figure 1 below, Pg. 9 of the translation); an outlet having a shape extending vertically and configured to discharge either the gas or the drug to the single injection needle through a third chamber therein (Pg. 3 member 10 extends in three dimensions including along a Y axis as shown in Reference Figure 1 below); and a flow control unit configured to form: (a) a gas flow path communicating from the first chamber to the third chamber upon movement toward the second chamber by pressure of the gas supplied to the first chamber; and (b) a drug flow path communicating from the second chamber to the third chamber upon movement toward the first chamber by pressure of the drug supplied to the second chamber, the flow control unit being capable of horizontal movement by each of the gas and the drug between the first chamber, the second chamber, and the third chamber (Fig. 3 members 14a and 14b control flow between the chambers, Pgs. 9 and 10); wherein the gas inlet and the drug inlet are configured within the injection module to be generally perpendicular to each other (as indicated by the axes in Reference Figure 1, as the structures are three-dimensional they each have an axis which is perpendicular to the other).
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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) 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mcure (KR 10-1227062) as applied to claim 1 above, and further in view of Pelmulder et al. (US 4,712,583).
With regard to claims 4 and 6, Mcure teaches a device substantially as claimed but does not disclose the material. However, Pelmulder et al. teach a valve for flow control in a medical device made of silicone with a hardness of 30-70 Shore A selected for desired design considerations (Col. 6 lines 16-24). 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 silicone material with a hardness as claimed in Mcure as Pelmulder et al. teach such to be an art effective material and that materials are selected based on design considerations.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mcure (KR 10-1227062) as applied to claim 1 above, and further in view of Bayer (JP 2019-530544).
With regard to claim 5, Mcure teaches a device substantially as claimed but does not specifically disclose the channel controller is formed in an H shape. However, Bayer teaches using an H shaped reciprocal valve to control flow from two inputs to one output which increases the drag coefficient and equivalently using a single valve or two separate valves (Fig. 11, Fig. 25, see translation [0081]). 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 an H shaped valve in Mcure as Bayer teaches such to be an art equivalent means which is beneficial for increasing the drag coefficient and would yield the same predictable result.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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. The claims have been amended to introduce Cartesian axes, as the structures are three-dimensional, they necessarily extend in all three Cartesian coordinates. The claims generally recite shapes. The structures themselves are not recited as having axes in particular extents, for example a longitudinal axis, and a relative relationship between specific axes or planes of specific structures is not claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. KR 10-1685660 cited on the IDS July 22, 2022 shows a gas inlet (connected to 400 Fig. 2) and drug inlet (connected to 600 Fig. 2) which extend in perpendicular directions.
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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