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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/4/26 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite “…wherein the distal end member does not form ana conductor used to establish electrical contact with a nonmetallic part of a circuit. The disclosure as originally filed states “the distal end member being a sharp member and made of metal” (page 5 of specification) and “Any known metal used in drug solution injection needles can be used as the metal constituting the distal end member 10, with examples including stainless steel, NiTi, β titanium, and platinum iridium” (page 11 of specification). While it may be possible to perform procedures where the distal end member is not used as an electrode, it seems inaccurate to say that the distal end member does not form any electrode. In other words, it appears that because the distal end member is formed of metal, the distal end member is capable of being used as an electrode depending on how the drug solution injection needle is used. Therefore, it cannot be said for sure that the claim contains subject matter which was described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The examiner recommends amending the claim to clarify electrical connections of the drug solution injection needle (i.e. what the metal tube/electrode is connected to that allows it serve as an electrode, and how the distal end member is electrically isolated from specific components of the drug solution injection needle).
Claims 2-7 are rejected as they depend from claim 1.
Response to Arguments
Applicant’s Remarks submitted 1/15/26 have been considered. While the examiner agrees with the Remarks concerning the previous prior art rejections, the amendments have resulted in the rejection under 35 U.S.C. 112(a) above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783
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