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/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-13, drawn to a method for performing a medical procedure, classified in A61B 2018/00642.
II. Claims 14-26, drawn to a system for performing a medical procedure, classified in A61B 18/1492.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus as claimed can be used to practice another and materially different process, such as a process that does not utilize feedback.
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 groupings have acquired a separate status in the art as shown by their different classification, their recognized divergent subject matter, and their differing 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.
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).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with Gabriel Azar on August 31, 2026 a provisional election was made without traverse to prosecute the invention of Group II, claims 14-26. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-13 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 14 and 20 are objected to because of the following informalities: In the last line of claim 14, -one or more of the- should be inserted before “electrodes”; In claim 20, line 4, -of the- should be inserted after “one or more”. 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 21-26 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.
Claims 21 (line 5), 22 (line 6), and 24 (line 7) recite the limitation "the external force". The antecedent basis for this limitation is confusing, because it’s unclear which “external force” is being referred to. Applicant is encouraged to insert -respective- before each occurrence of “external force”.
Claim 21 (line 6) recites the limitation "the internal probe forces". The antecedent basis for this limitation is confusing, because it’s unclear which “internal probe forces” are being referred to. Applicant is encouraged to insert -respective- before this limitation.
Claim 24 is found to be indefinite because it recites multiple limitations with insufficient or confusing antecedent basis. It appears as though this claim should be amended to depend from claim 22.
Claim 25 recites the limitation "the preset value". The antecedent basis for this limitation is confusing, because it’s unclear which “preset value” is being referred to (i.e., the original or the ‘further’). Appropriate correction is required.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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) 14-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sliwa, U.S. 2014/0276006 (hereinafter Sliwa) in view of Gutbrod, U.S. 2023/0105390 (hereinafter Gutbrod).
Regarding claims 14, 17, and 18, Sliwa discloses (note figs. 1A-B) a system comprising: a resilient probe (34), having a known spring constant (note paragraphs 32 and 37), for insertion into a body of a patient, the probe comprising a plurality of electrodes (note paragraph 29) and at least one position sensor (16/18) at respective locations along the probe; and a processor, configured to: record relative location coordinates of the at least one position sensor before and after deformation (note paragraph 40); compute a shape of the probe in a deformed state, in response to the recorded changes between the relative location coordinates (note paragraph 40); in response to the known spring constant of the probe and the computed shape of the probe in the deformed state, compute a respective force exerted by the tissue on the probe (note paragraph 40); and control a reception or application of electrical signals through the one or more of the electrodes from or to the tissue responsively to the computed respective force on the probe (note paragraph 80). However, Sliwa fails to explicitly disclose a system having a processor configured to record relative location coordinates of the electrodes and the at least one position sensor before and after deformation, wherein the recorded changes between the relative location coordinates of the electrodes and the at least one position sensor are used to compute the shape of the probe in the deformed state. Gutbrod teaches a relevant system having a processor configured to record relative location coordinates of electrodes (see ‘assembly of ablation electrodes’) and a position sensor (see ‘tracking electrode’ or ‘navigation sensor’) before and after deformation, wherein the recorded changes between the relative location coordinates of the electrodes and the position sensor are used to compute a shape of the probe in a deformed state (note paragraph 130; claim 1). It is well known in the art that these different deformation-tracking configurations (e.g., ultrasonic transmitter-receiver vs trackable electrodes) are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the system of Sliwa to comprise a processor configured to record relative location coordinates of the electrodes and the at least one position sensor before and after deformation, wherein the recorded changes between the relative location coordinates of the electrodes and the at least one position sensor are used to compute the shape of the probe in the deformed state. This is because this modification would have merely comprised a simple substitution of interchangeable deformation-tracking configurations in order to produce a predictable result (see MPEP 2143). It should be noted that the position sensor taught by Gutbrod could necessarily be described as either a ‘linear conductor’ (see tracking electrode ‘610’) or a ‘coil’ (see navigation sensor ‘620’).
Regarding claim 15, Sliwa discloses (see above) a system wherein the known spring constant necessarily comprises a ‘torsion’ spring constant.
Regarding claim 16, Sliwa discloses (see above) a system wherein in the unrestrained state only a force due to gravity acts on the probe (could necessarily be described in this manner).
Regarding claim 19, Sliwa discloses (see above) a system wherein while the probe is in the body and deformed by contact with the tissue, the processor is capable of recording changes in the relative location coordinates of one or more of the electrodes that are not in contact with the tissue. It should be noted that 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.
Allowable Subject Matter
Claim 20 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 21-26 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2009/0093806 (Govari).
U.S. 2017/0312420 (Harlev).
U.S. 2018/0085158 (Aeby).
U.S. 2011/0160556 (Govari).
CN 107789051.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
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