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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-8, drawn to an end effector, classified in A61B18/1492.
II. Claims 9-17, drawn to a method of making an end effector, classified in A61B2017/00526.
III. Claims 18-20, drawn to a device for making an end effector, classified in B29C43/18.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the apparatus can be made without reference to a mold.
Inventions III and I are related as apparatus and product made. The inventions in this relationship are distinct if either or both of the following can be shown: (1) that the apparatus as claimed is not an obvious apparatus for making the product and the apparatus can be used for making a materially different product or (2) that the product as claimed can be made by another and materially different apparatus (MPEP § 806.05(g)). In this case the product can be made without reference to compression surfaces.
Inventions III and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the method can be practiced without reference to opposite, vertically movable compression surfaces.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
the inventions 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 an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve 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 restriction 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 upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions 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 inventions 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 invention.
During a telephone conversation with Korbin Blunck on 18 February 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-8. Affirmation of this election must be made by applicant in replying to this Office action. Claims 9-20 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 § 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 2-5 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 claims 2-5, claim 2 is worded in a manner that renders the claim indefinite. The claim recites that the flexible circuit further comprises a framework contiguous to the insulative material. The claim further recites that, alternatively, the framework is contiguous with a portion of the framework. It is unclear how an element can be contiguous with a portion of itself. Claims 3-5 depend from claim 2 and are therefore also indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Basu (US 2021/0077183).
Regarding claims 1 and 2, Basu discloses an end effector (fig. 2B) comprising a flexible circuit with a plurality of electrodes (232) disposed on an insulative material (252, fig. 5, see also [0055] regarding the electrode traces also being disposed on the insulative material). Any part of the electrode exposed to the ambient environment, that is, not covered by insulation, constitutes a “contact surface” by definition. Basu explicitly shows the insulative material is contiguous with the contact surfaces (fig. 5), although if the electrodes are disposed on the insulative material and have exposed surfaces, it is unclear in what scenario the exposed surfaces would not be contiguous with the insulative material. Basu further discloses a framework (250, fig. 5) contagious to the insulative material.
Regarding claims 3 and 4, each column (in the proximal-to-distal direction) of electrodes can be considered a flex circuit within the breath of the claim language (232, fig. 2B), resulting in four flex circuits, each having the characteristics described with respect to claims 1 and 2. The framework (250), spanning the array, also exists between the flex circuits.
Regarding claim 5, this is a product-by-process limitation: “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). The insulative material is formed around at least a portion of one of the flex circuits and/or the framework, such as, for example, when viewed from the angle shown in figure 2B.
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 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Voth (US 2021/0153932).
Regarding claim 6, the end effector of Basu does not disclose that a second flex circuit is disposed opposite the first flex circuit across the framework. However, placing electrodes as part of flex circuits on opposite sides of a framework is known in the art and there is no evidence that this configuration produces an unexpected result (within the meaning of MPEP 716.02(a)). Voth, for example, discloses a planar array of flex circuits with electrodes (274, fig. 7A) on opposite sides of a framework (276). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the at to modify the end effector of Basu to have any commonly known electrode configuration, including flex circuits with electrodes on opposite sides of the framework as taught by Voth, that would produce the predictable result of allowing a user to interact with tissue on either side of the end effector.
Regarding claims 7 and 8, Basu further discloses the contact surfaces are parallel to the outer surface of the insulative material which forms a contiguous, generally planar surface, such that the electrodes extend vertically and outwardly therefrom (232, fig. 5). Basu also teaches that the framework can be strips ([0054]) but does not specifically show that embodiment so that it is not clear what the relationship is between the insulative material and the strips (i.e. whether the strips are within a single mass of insulation). However, Basu does disclose sheets of insulation that extend between the various flex circuits (252/214 and 254-216, figs. 2B and 5), and it has been held that making elements integral is an obvious modification (MPEP 2144.04(V)(B)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the end effector of Basu to use any commonly known framework, including strips as taught by Basu, and to provide the sheets of insulation between the framework and the electrodes as integral elements (thus forming a single mass), that would produce the predictable result of a end effector that has desired mechanical and/or electrical properties useful for treating tissue according to the preferences of an operator. The claim language of “fused” is a product-by-process limitation as discussed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding another end effector which uses flex circuits on insulation strengthened with a framework inserted through a unitary insulation, see paragraphs [0048]-[0049] of US 2021/0015551 to Fuentes-Ortega. Regarding the use of strips to provide resiliency to a unitary element, where the strips can be on the inner surface, outer surface or embedded within the element, see paragraph [0041] of US 2018/0140807 to Herrera. Regarding other devices that use electrodes on an insulator on a framework, see figures 2-3 of US 2015/0025532 to Hanson and figure 28A-E of US 2014/0238176 to Huszar.
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