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 .
Terminal Disclaimer
The terminal disclaimer filed on March 23, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent 11,903,637 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 13-17 and 21 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 13 recites “the stop mechanism is configured to prevent said penetrating tip from extending beyond a selected distance from the outer surface of the wall” in lines 9-10, which 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 16 recites “a stop mechanism is configured to prevent penetration of the penetrating tip beyond a selected distance from the outer surface of the organ” in lines 13-14, which 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.
Paragraph 0055 states that it may be desirable to provide the penetrating element with a stop mechanism to prevent the penetrating element from extending significantly beyond adventitial surface of the bladder, so as to prevent the penetrating element from injuring nearby tissue, however the specification fails to clearly define what is meant by “the penetrating element”. The penetrating element is not defined as a penetrating tip of a cannula or an elongate shaft as claimed. Paragraph 0055 states that 220 could be a stiletto-type puncture penetration catheter and also states that that the electrode tips penetrate the adventitia. Furthermore, the specification fails to provide support for “a selected distance from the outer surface of the wall or organ”. Therefore, the specification as originally filed fails to provide support for the stop mechanism configured to prevent said penetrating tip from extending beyond a selected distance from the outer surface of the wall/organ with respective to the newly amended recitation of “a penetrating tip”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 13 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sachs et al (WO/2013/016590) in view of Moss et al (2011/0238057).
Referring to claim 13, Sachs et al teaches a device for treating a condition in a patient with ablative energy, said device comprising: at least one ablative element (62) comprising a penetrating electrode configured to pierce an outer tissue surface of an organ within a patient and capable of delivering ablative energy to adventitia of an organ; and a cannula (60) with a stop mechanism (61 with aperture), the cannula is configured to extend luminally into the organ and the stop mechanism is (61 with aperture) is configured to prevent extending beyond a selected distance from the outer surface of the wall (page 12, lines 16-22; page 16, lines 10-13; page 24, lines 3-16; page 32, lines 11-16 and page 50, lines 9-17; page 51, lines 3-30; Figures 10A-11B). The amended claim language is a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Sachs et al fails to expressly teach a cannula with a penetrating tip. Moss et al teaches an analogous device for treating a patient comprising a cannula (9) with a penetrating tip (23) configured to penetrate through an outer surface of a wall of the organ from within the organ (paragraph 0078; Figures 3-6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula, as taught by Sachs et al, to have a penetrating tip, as taught by Moss et al in order to pierce tissue (paragraph 0078).
Moss et al teaches a stop mechanism (index marker) configured to prevent said penetrating tip from extending beyond a selected distance from the outer surface of the wall (paragraphs 0078-0079; Figures 1-6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stop mechanism, as taught by Sachs et al, be configured to prevent said penetrating tip from extending beyond a selected distance from the outer surface of the wall, as taught by Moss et al in order gauge the depth of deployment (paragraph 0079).
Referring to claim 15, Sachs et al teaches wherein said at least one ablative element comprises two or more electrodes in an array, with at least one electrode having a tip configured to penetrate tissue (page 24, lines 3-16; page 32, lines 11-16 and page 50, lines 9-17; Figures 10A-11B).
Referring to claim 16, Sachs et al teaches a device for treating a condition in a patient, said device comprising: an ablative device comprising an elongate shaft (42 in Figure 8; shown in Figures 10 and 11 but not labeled) (page 19, line 29 through page 20, line 7), a deployable electrode array (51 in Figure 8 and 62 in Figures 10 and 11) disposed proximate an end of said elongate shaft, wherein: said ablative device is advanceable with the deployable electrode array in a laterally contracted state through an organ in a human body to a treatment site on an outer surface of the organ, and the deployable electrode array is expandable to move the electrode array laterally away from said elongate shaft to be positioned to be brought into contact with tissue at the treatment site (page 12, lines 16-22; page 16, lines 10-13; page 24, lines 3-16; page 32, lines 11-16 and page 50, lines 9-17; page 51, lines 3-30; Figures 8, 10A-11B); and a stop mechanism (61 with aperture) to prevent penetration beyond a selected distance from the outer surface of the organ (page 12, lines 16-22; page 16, lines 10-13; page 24, lines 3-16; page 32, lines 11-16 and page 50, lines 9-17; page 51, lines 3-30; Figures 8, 10A-11B). The amended claim language is a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Sachs et al fails to expressly teach a penetrating tip at a distal end of the elongate shaft. Moss et al teaches an analogous device for treating a patient comprising an ablative device with an elongate shaft with a penetrating tip (23) configured to penetrate through an outer surface of the organ from within the organ (paragraph 0078; Figures 3-6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ablative device with an elongate shaft, as taught by Sachs et al, to have a penetrating tip, as taught by Moss et al in order to pierce tissue (paragraph 0078).
Moss et al teaches a stop mechanism (index marker) configured to prevent said penetrating tip from extending beyond a selected distance from the outer surface of the organ (paragraphs 0078-0079; Figures 1-6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stop mechanism, as taught by Sachs et al, be configured to prevent said penetrating tip from extending beyond a selected distance from the outer surface of the organ, as taught by Moss et al in order gauge the depth of deployment (paragraph 0079).
Referring to claim 17, Sachs et al teaches wherein each electrode of the deployable electrode array is deployed on a shape memory element (page 38, lines 18-23).
Allowable Subject Matter
Claims 1-12 are allowed. Claims 14 and 21 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA M GOOD whose telephone number is (571)270-7480. The examiner can normally be reached Mon to Wed, 7am to 3pm.
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/SAMANTHA M GOOD/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794