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 . 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.
Election/Restriction
This application contains claims directed to the following patentably distinct species: Species I, two movable jaws with hemispherical surfaces facing perpendicular to the longitudinal axis of the device, figures 5A-6; Species II, a foot, figures 10-11B and Species III, jaws with one stationary hemispherical surface and one substantially planar movable surface, figures 12-13.
The species are independent or distinct because the claims to the different species recite the mutually exclusive characteristics of such species. Clearly Species I (e.g. claim 29), Species II (e.g. claim 31) and Species III (e.g. claim 30) recite mutually exclusive features of the different species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 21-25 are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter; and/or
the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Stephen DiLorenzo on 23 July 2026 a provisional election was made without traverse to prosecute the invention of Species III, claims 21-28, 30 and 32-39. Affirmation of this election must be made by applicant in replying to this Office action. Claims 29, 31 and 40 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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.
Claims 21-25, 27, 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Sobotka (US 2015/0051594) in view of Eder (US 2008/0172052).
Regarding claim 21-25, 27 and 32-36, Sobotka discloses a method for treating PCOS (abstract) that includes the steps of positioning an end effector of an electrosurgical device (fig. 1) to contact tissue containing ovarian nerves and applying energy to disrupt neural function in the nerves ([0036]). Note that the end effector (110) being shown as a black box at least suggests a wide range of end effector configurations are contemplated (see also the discussion in [0070]). Sobotka further discloses a temperature of less than 45°C during the procedure ([0041]) and treating tissue to a depth of 3mm ([0082], see also [0053]), where the tissue in question includes the ovarian arteries and veins and tissue along with the suspensory ligament ([0036]). While Sobotka discloses a wide range of energy ablation modalities are contemplated, including RF energy in both monopolar and bipolar forms ([0035], [0040]), there is no specific disclosure of using alternating bipolar electrodes on an end effector that includes first and second movable jaws. Eder discloses an electrosurgical device for heating tissue with pivotable jaws (fig. 2) two, planar tissue contacting surfaces (302, 304) including a plurality of bipolar electrodes (310, [0039]) and teaches a recognized benefit of this configuration concentrates the energy between the electrodes and limits the effects on adjacent tissue ([0016]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill to modify the method of Sobotka to use any commonly known type of medical heating device, including a heating device with actuatable jaws and sets of bipolar electrode pairs such as taught by Eder, that would produce the predictable result of allowing a user to treat tissue in a particular manner.
Claims 26 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Sobotka and Eder, further in view of Arya (US 2014/0074091).
Regarding claim 26, the method of Sobotka as modified does not disclose the exact pressure applied by the end effector to tissue. However, a wide range of pressures are commonly known the art for grasping tissue, including less than 2 kg/cm2 as taught by Arya (abstract). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the method of Sobotka to include applying any pressure commonly known to be useful for treating tissue, including less than 2 kg/cm such as taught by Arya, that would produce the predictable result of treating tissue in a desired manner.
Claims 28, 30, 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Sobotka and Eder, further in view of Artale (US 2009/0036881).
Regarding claims 28, 30, 38 and 39, the method of Sobotka as modified includes one planar surface (as discussed above, fig. 2 of Eder) but does not include another contact surface being a hemispherical surface. However, hemispherical surfaces are common in the art. Artale discloses an electrosurgical device with two jaws, and teaches that the jaws can have a flat or hemispherical surfaces (facing either inward toward tissue or outward away from tissue, [0045]). Therefore, before the application was filed, it would have been obvious to provide at least one of the contact surfaces of Sobotka with a hemispherical surface such as taught by Artale, that would produce the predictable result of allowing a user to grasp tissue within the jaws, including with the hemispherical shape and the planar shape moved together to accomplish the grasping, for allowing a user to treat tissue in a desired manner. It is noted that Sobotka as modified discloses at least one jaw moving relative to the other to open and close on tissue (compare figs. 5a-b of Eder).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding another teaching that a hemispherical portion can be provided to one or both jaws, see claim 10 of US 5,797,958 to Yoon. Regarding another teaching that grasping pressure for forceps can be under 2km/cm2, see paragraph [0181] of US 2020/0107894 to Wallace.
Recognizing that the elected species as shown in figures 12 and 13 is not strongly represented in the claims, and therefore in the interest of compact prosecution, the following references are also cited as relevant to those figures: Regarding forceps jaws perpendicular to the longitudinal axis of the device where the proximal jaw is static and the distal jaw is movable, see figures 2A-B of US 2004/0068274 to Hooven. Regarding a tissue heating device with a distal-facing hemispherical surface against which tissue is pulled by an adjustable arm, see figures 2A-3 of US 2010/0160905 to Shadduck. Regarding the use of a generally concave shape to guide tissue into contact with electrodes on a distal end of a device, see figure 10 of US 6,015,406 to Goble. Regarding a planar arm used to pull tissue against a distal face, see fig. 13 of US 5,906,628 to Miyawaki. Regarding a device with a distal facing set of individually addressable electrode pairs, see figures 11-13 of US 2006/0161151 to Privitera.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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