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 1, claims 1-23 in the reply filed on 2 January 2026 is acknowledged. Claims 24-45 are withdrawn from further consideration.
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 11 and 22-23 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.
Regarding claim 11, the claim recites “the said inner rod” which lacks antecedent basis.
Regarding claim 22, there is insufficient limitation for the limitation of “the said sensed pressure”.
Regarding claim 23, there is insufficient antecedent basis for “the handheld tool and its controller unit”.
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) 1-5, 8-10 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2012/0289985 to Motai et al. (Motai hereinafter) in view of US Pre-Grant Publication 2012/0071812 to Mitelberg et al. (Mitelberg).
Regarding claim 1, Motai teaches two nested needles (10, see Fig. 13B and discussion thereof) having sharp tips for performing concentric cuts (paragraph 70, as utilized with the embodiment of Fig. 13B) spaced by 90 degrees to complete a 360 degree bore followed by extraction of the cut tissue (paragraph 70, “recovers the excised tissue”). Motai is silent to an inner plunger and implant. Mitelberg teaches another tissue penetrating device (40) generally, and particularly teaches a plunger (416) which is guided as a catheter (with 6) as well as teaching deployment of a pair of forceps (72) to squeeze an area of tissue which may be an implant (414). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to form the needles of Motai as forceps in order to implant an implant and remove a biopsy sample.
Regarding claims 2-4, the examiner notes that the catheter of Motai is guidable by ultrasound, and that an apparatus claim is defined by what the apparatus is, rather than how it is used. Since guidance by ultrasound is a functional limitation which does not require any particular structure as part of the catheter, the examiner holds that these claims are obvious over Motai as modified in view of Mitelberg.
Regarding claim 5, the catheter of Motai is guidable by at least one of the enumerated technologies and is therefore capable of performing this limitation.
Regarding claim 8, the catheter of Motai is capable of excising at least scar tissue (paragraph 116 describes the range of tissues recoverable).
Regarding claim 9, Motai teaches rotation of an amount at least including 90 degrees in order to complete the bore (paragraph 70).
Regarding claim 10, Motai teaches biopsy (paragraph 116).
Regarding claim 12, Mitelberg teaches means for firmly holding an implant (e.g. 414) and its placement at a desired position via activation of the forceps (72). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to modify the needles of Motai with these structures in order to allow for implantation of devices in target tissues.
Regarding claim 13, Motai is silent to independent operation of the needles. Mitelberg teaches independent operation (Figs. 8A-8E) of forceps (72) and an inner needle (74) to allow for separate functions thereof. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide the needles of Motai as independently operable in order to allow their use to be altered in situ.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Motai in view of Mitelberg as applied to claim 1 above, and further in view of US Pre-Grant Publication 2011/0146387 to Ohman et al. (Ohman).
Regarding claim 6, the previously applied references teach the limitations of claim 1 from which claim 6 depends, but do not teach a biosensor as the implant. Ohman teaches another medical system generally, and particularly teaches that biosensor implants are known for the treatment of diabetes (paragraph 64). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a biosensor as the implant in Motai in order to facilitate treatment of diabetes.
Regarding claim 7, the previously applied references teach the limitations of claim 1 from which claim 6 depends, but do not teach the use of an RF tag as the implant. Ohman teaches that such tags (paragraph 64) are known, and those of skill are generally aware of their conventional use as label devices. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use an implant in the form of an RF tag as taught by Ohman in order to provide a labeling function.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Motai in view of Mitelberg as applied to claim 1 above, and further in view of CN 212592362 to Qu et al. (Qu hereinafter, copy and machine translation attached).
Regarding claim 11, the previously applied references teach the limitations of claim 1 from which claim 6 depends, but do not teach the use of a pressure sensor. Qu teaches another set of forceps generally and particularly teaches a pressure sensor (210) mounted on an inner rod (115) thereof. Qu teaches that this allows for display of current pressure being applied. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a pressure sensor as taught by Qu to the forceps of Mitelberg in the apparatus of Motai in order to display pressure being applied.
Claim(s) 14-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Motai in view of Mitelberg as applied to claim 13 above, and further in view of U.S. Patent 5,084,060 to Freund et al. (Freund).
Regarding claim 14, as discussed above, Motai is modified to include inner and outer needles as taught by Mitelberg but the references are silent to a handheld tool equipped with a flat panel display. Freund teaches another catheter apparatus generally, and particularly teaches a handheld device (12) for controlling action of a catheter (16) as well as a flat panel display (70) for displaying the state of the tool. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a handheld device and flat panel display as taught by Freund to the apparatus of Motai in order to control the apparatus and display its state.
Regarding claim 15, Motai is silent to display of relative position. However, Mitelberg teaches such display (32) for informing a user of the relative position of the elements thereof. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to display the relative position of Motai using the display of Freund in order to inform the user of that position as taught by Mitelberg.
Regarding claim 16, in adapting the display of Freund for use with the apparatus of Motai, it would have been obvious to provide an image of the forceps, at least in schematic form, in order to display the information conveyed by the markings (32) of Mitelberg.
Regarding claim 17, Freund teaches manual operation (using 72).
Regarding claim 18, Freund teaches that manual operation is enabled by a foot pedal system (72) independent of the distal device.
Regarding claim 19, Mitelberg teaches a series of actuation steps that alter the shape of the forceps (e.g. Figs. 7A-7C).
Regarding claim 20, Mitelberg teaches controllable implant placement (i.e. of 414).
Regarding claim 21, various controls are known in the art as equally apt for controlling various operations. In particular, the examiner takes Official Notice that smart rotary dials with press-activation are known in the art, based on their commercial availability prior to the effective filing of this application. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use such a smart dial either in addition to or in place of one of the controls of Motai or Freund as the mere substitution of one known control element for another according to known methods and achieving predictable results.
Regarding claim 22, as best understood by the examiner, a sensed pressure, such as atmospheric pressure, will oppose dial deflection.
Regarding claim 23, Freund teaches reuse of the controller and handheld tool inasmuch as these elements are not described as disposable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 29 April 2026
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