DETAILED ACTION
Applicant’s amendments and remarks, filed February 8, 2026, are fully acknowledged by the Examiner. Currently, claims 1, 6, 8-10, 12, 15, 16, 21, 28-32, 37, 41-43, 45 and 52 are pending with claims 2-5, 7, 11, 13, 14, 17-20, 22-27, 33-36, 38-40, 44, 46-51 and 53-59 cancelled, claims 1, 6, 8-10, 12, 15, 16, 21 and 28-32 withdrawn, and claims 41-43, 45 and 52 amended. The following is a complete response to the February 8, 2026 communication.
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 of Group III (claims 37, 41-43, 45 and 52) in the reply filed on February 8, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claim 1, 6, 8-10, 12, 15, 16, 21, 28-32 are withdrawn from consideration as directed toward non-elected Groups I and II.
Specification
The disclosure is objected to because of the following informalities: The heading of “EXEPLARY EMBODIMENTS” is misspelled in line 30 on page 16 of the clean copy of the Specification. This should read “EXEMPLARY EMBODIMENTS”.
Appropriate correction is required.
Claim Objections
Claims 37 and 42-43 are objected to because of the following informalities:
Regarding claim 37, the Examiner respectfully suggests that Applicant amend the recitation in line 6 of claim 37 that reads “a plurality of said electrodes” to read as “a plurality of said plurality of electrodes”.
Regarding claims 37 and 42-43, the Examiner respectfully requests that Applicant amend each recitation of “probes” in claims 37 and 42-43 to read as “interstitial probes” to maintain naming consistency throughout the claims.
Appropriate correction is required.
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 37, 41-43, 45 and 52 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 37, the claim recites “a plurality of electrodes” in line 2, then further requires “at least one of said of plurality of probes including a plurality of said electrodes” in line 6. The Examiner is of the position that the current language of the claim renders the scope of the claim as indefinite because it is unclear if the “a plurality of said electrodes” requires a plurality of the prior recited “a plurality of electrodes” or is directed towards different electrodes than the previously recited “a plurality of electrodes”. The Examiner respectfully suggests Applicant amend line 6 of claim 37 to read as “an at least one of said[[ of]] plurality of probes including a plurality of said plurality of electrodes” to correct the issue. Claims 41-43, 45 and 52 are rejected due to their dependency on claim 37. Appropriate correction is required
Regarding claim 42, the claim recites method-like language regarding the use of the system in an apparatus claim. Specifically, claim 42 recites “wherein the plurality of probes are introduced into the volume of tissue in mostly parallel directions”. The Examiner is of the position that the scope of claim 42 is indefinite because it is unclear if infringement of the claim would occur when a system with a plurality of probes capable of being inserted as claimed is provided, or only once the plurality of probes are inserted into the volume of tissue as claimed. See MPEP 2173.05(p)II. The Examiner respectfully suggests Application utilize language such as “wherein the plurality of probes are configured to be introduced into the volume of tissue in mostly parallel directions” to overcome the issue. Appropriate correction is required.
Regarding claim 42, the claim recites the limitation of “mostly parallel direction” therein. The term “mostly” recited therein is being interpreted a relative term which renders the claim indefinite. The term “mostly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The Examiner further notes that the instant disclosure, at most, includes three substantial reiterations of the claim terminology that provide no additional insight as to what direction or directions are encompassed other than parallel by the claim requirement of “mostly parallel”. Appropriate correction is required.
Regarding claim 43, the claim recites method-like language regarding the use of the system in an apparatus claim. Specifically, claim 43 recites “wherein the plurality of probes is inserted transperennially”. The Examiner is of the position that the scope of claim 43 is indefinite because it is unclear if infringement of the claim would occur when a system with a plurality of probes capable of being inserted as claimed is provided, or only once the plurality of probes are inserted transperennially as claimed. See MPEP 2173.05(p)II. The Examiner respectfully suggests Application utilize language such as “wherein the plurality of probes are configured to be inserted transperennially” to overcome the issue. Appropriate correction is required.
Regarding claim 43, the claim sets forth the term of “transperennially” therein. MPEP 2173.05(a)I sets forth that “[t]he meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." In re Packard, 751 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014). In the instant case, the Examiner is unable to find a clear meaning to the at-issue claim term of “transperennially”. This term is not clearly defined by its usage in the instant disclosure, where such is only substantially reiterated in the manner in which it is used in claim 43. Further the Examiner has failed to find any other use of the term in patent prior art, and has only found a limited amount of non-patent literature that include this term. This non-patent literature, however, only utilizes the term in a similar matter as the instant disclosure and, thereby, fails to provide for a clear and unambiguous meaning for the term.
Given that the term of “transperennially” cannot be adequately defined, the Examiner is of the position that the scope of claim 43 is indefinite. It is the Examiner’s best estimation that the at-issue term is intended to be “transperineally” which would have an accepted meaning of being inserted through the perineum. The Examiner will be interpreting the at-issue limitation to be “transperineally” for the purpose of examination. Appropriate correction is required.
Regarding claim 52, the claim recites “wherein reaction of the tissue to ablating energy is used for diagnostic purposes”. The Examiner is first of the position that the scope of claim 52 is indefinite because it is unclear how the claimed “tissue reaction” and “ablating energy” is related to any of the structure and the functionality associated with each respective structure in claim 37. Parent claim 37 fails to provide any manner of implicit or explicit basis for “a reaction of tissue” or “ablating energy”. Thus, claim 52 is considered by the Examiner as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01.
The Examiner further finds the scope of claim 52 as indefinite because the language set forth therein reads as method-like language in an apparatus claim. The Examiner is further of the position that the scope of claim 52 is indefinite because it would be unclear if infringement of the claim would occur when a system capable of using a tissue reaction to ablating energy for diagnostic purpose is provided, or only once the system is actually performing the diagnostic purposes as claimed. See MPEP 2173.05(p)II. Appropriate correction is required.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 37, 41-43, 45 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez et al. (US Pat. Pub. 2019/0336757 A1) further in view of Azure (WO 2009/036471 A1).
Regarding claim 37, Rodriguez provides for a system (see figures 1-3 and 15 displaying a system) comprising:
a plurality of electrodes (two electrodes at 600 as in figure 15),
a plurality of interstitial probes configured for positioning said plurality of electrodes within a volume of tissue (each 604 as in figure 15) wherein each of said plurality of probes provided with at least one of said plurality of electrodes (each of 604 includes one of 600) and
a control unit in communication with the probes (generator 12 with controller 24), the control unit programmed to deliver signals at a plurality of frequencies between various groups of said plurality of electrodes (see [0402] providing for the delivery of energy “over a range of interrogation frequencies”) and calculate a characteristic of an interaction between the signals and the tissue at the plurality of frequencies and at a plurality of locations (see [0248] and [0402] providing for the determination of properties of the tissue based on the sensing circuitry 31 feedback relative to the electrodes).
While Rodriguez contemplates various electrode arrangements including ones having two, four and six electrodes, Rodriguez fails to specifically contemplate that at least one of said of plurality of probes includes a plurality of said electrodes. Azure discloses a similar device for applying energy to the body and specifically contemplates the interchangeable use of a single electrode on a probe like that in Rodriguez (see figure 8A with 152) or with a plurality of electrodes on a probe (see figure 8B with regions 156 and 158). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a plurality of electrodes on at least one of the probes of Rodriguez in view of the teaching in Azure. Such would provide for the ability to select desired ablation patterns between the probes while also allowing for tailored and/or larger ablations to be performed by a single probe.
Regarding claim 41, Rodriguez provides that the control unit is configured to control positioning of the plurality of probes, plurality of electrodes, or both (see [0278] providing for “used as commands for a robot to move the applicator to a target site”).
Regarding claim 42, Rodriguez provides that the proves are capable of being introduced in mostly parallel directions (see figure 15 with each 600 being substantially parallel; see also [0335]).
Regarding claim 43, Rodriguez provides that the plurality of probes are capable of being inserted transperineally (604 are capable of being inserted as claimed; see the rejection of claim 43 under 35 U.S.C. 112(b) above addressing the instant claim interpretation).
Regarding claim 45, Rodriguez provides that the control unit is further configured to perform a comparison between the characteristics detected at each of said plurality of locations (via the feedback and detection by the controller at the location of each 600 in view of the functionality in [0402] and [0403]).
Regarding claim 52, Rodriguez provides that the system is capable of using the reaction of the tissue to ablating energy for diagnostic purposes (see [0361] providing for the use of data from the sensing circuitry 31 to a diagnostic model).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794