DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/20/26 has been entered.
Response to Arguments
Applicant’s arguments, filed 4/20/26 with respect to the rejection(s) of claim(s) 1-20 under 35 USC 103 have been fully considered and are persuasive.
Cappiello et al. discloses a multi-actuated trigger 6208 for advancing tube 6804 a first actuation of the trigger advances the tube a fixed distance with respect to the elongate body 6801 and a second actuation of the trigger deploys the needle further than the leading end (figures 69-71) the distances may be controlled by changing the dimensions of the device. Examiner notes stopping before it contacts the body tissue is functional language and the device may be configured to perform this function depending upon the placement of distance from tissue. However, Cappiello et al. is an intrauterine device inserted that uses a tube based insertion mechanism and fails to disclose a needle assembly and scoped needle start position for advancing a needle for piercing through tissue, but instead is designed against perforation (paragraph 0219). Therefore, it would not be obvious to one having ordinary skill in the art to modify the needle assembly of Cheng et al. with the trigger assembly of Cappiello et al., as they are directed toward incompatible devices for different procedures and Cappiello et al. does not comprise a needle that pierces through tissue with the second trigger actuation or at all.
Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made under 35 USC 101 as discussed below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 discloses “advances the needle…stopping before it contacts body tissue” on lines 10-11. Examiner notes this language should be “advances the needle…configured for stopping before it contacts body tissue”.
Claim 1 discloses “deploys the needle further beyond the leading end and through the body tissue” on lines 13-14. Examiner notes this language should be “deploys the needle further beyond the leading end and configured to go through the body tissue”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/ Examiner, Art Unit 3771
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