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 without traverse of Group I (claims 1-14) and Species A (figures 1A-3B) in the reply filed on 1/8/2026 is acknowledged. Upon further review, examiner found that claims 8, 9 and 12-14 read over non-elected species B and C. Therefore, examiner withdraws claims 8, 9 and 12-14 from current examination. A call was made to attorney, Peter Sleman, on 1/16/2026 to notify regarding withdrawn claims and attorney acknowledged to examine claims 1-7, 10 and 11 only.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “200” has been used to designate both “skin” in figure 2B and “syringe” in figure 4. 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.
Specification
The disclosure is objected to because of the following informalities:
The reference character “200” has been used to refer to “syringe on page 6, line 27 and “skin” on page 4, line 19.
Appropriate correction is required.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Schmid (US 2018/0274962 A1) in view of Brown (US 5,569,212).
Regarding claim 1, Schmid discloses an injection device (figures 3 and 11) comprising:
a reservoir (hollow portion inside element 2 that contains element 1) for containing a medicament 1;
a needle 4a in communication with the reservoir and configured to deliver the medicament to a patient’s body;
at least two electrodes 6, 7 spaced apart from one another and disposed on opposing sides of the needle 4a; and
a capacitance-to-signal converter circuit 8 (paragraph 0105) configured to generate a signal and measure capacitance between the at least two electrodes.
Schmid is silent regarding a capacitance-to-signal converter circuit being a capacitance-to-digital converter circuit.
However, Brown teaches an apparatus for electrically determining injection doses comprising a signal converter circuit 28 wherein the signal converter circuit is signal-to-digital converter circuit 28 (column 2, lines 41-45, in order to store the results in digital memory unit, the results have to be converted into digital form) for the purpose of converting the measured results into a useful information (column 4, line 66, column 5, line 2, “electronic microprocessor”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the capacitance-to-signal converter circuit into the capacitance-to-digital converter circuit (“signal-to-digital converter circuit”) as taught by Brown for the purpose of converting the measured results into a useful information (column 4, line 66, column 5, line 2, “electronic microprocessor”).
Regarding claim 2, Schmid discloses wherein the at least two electrodes 6, 7 are flat (at least the small portion/section of elements 6 and 7 are flat when viewing elements 6 and 7 in figure 4).
Regarding claim 3, Schmid discloses wherein the at least two electrodes 6, 7 are arcuate (see figure 12).
Regarding claim 4, Schmid discloses wherein the at least two electrodes 6, 7 comprise an electrically conductive material (paragraph 0105, lines 3-13, elements 6 and 7 are made of metallic and are allowing generation of capacitance).
Regarding claim 5, Schmid discloses wherein the at least two electrodes 6, 7 are spaced from the needle 4a but does not explicitly disclose between 2 and 7 mm., as required by the claim. There is no evidence of record that establishes that changing the space would result in a difference in function of the Schmid injection device. Further, a person having ordinary skill in the art, being faced with modifying the space of Schmid would have a reasonable expectation of success in making such a modification and it appears that the injection device would function as intended being given the claimed space. Lastly, applicant has not disclosed that the claimed range solves any state problem, indicating that the space “may” be within the claimed range and therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Regarding claim 6, Schmid discloses wherein the at least two electrodes 6, 7 are not in physical contact (see figure 12) with the needle 4a.
Regarding claim 7, Schmid discloses wherein the at least two electrodes 6, 7 are spaced from each other by certain distance but does not explicitly disclose between 5 and 15 mm., as required by the claim. There is no evidence of record that establishes that changing the space would result in a difference in function of the Schmid injection device. Further, a person having ordinary skill in the art, being faced with modifying the space of Schmid would have a reasonable expectation of success in making such a modification and it appears that the injection device would function as intended being given the claimed space. Lastly, applicant has not disclosed that the claimed range solves any state problem, indicating that the space “may” be within the claimed range and therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Allowable Subject Matter
Claims 10 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Schmid (US 2018/0274962 A1) in view of Brown (US 5,569,212), is silent regarding the at least one barrel flange having an insulated conductive pad in electrical communication with the capacitance-to-digital converter circuit in combination with other claimed limitations of claim 10.
The closest prior art of record, Schmid (US 2018/0274962 A1) in view of Brown (US 5,569,212), is silent regarding the plunger flange having a central conductive pad in electrical communication with the capacitance-to-digital converter circuit in combination with other claimed limitations of claim 11.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783