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.
Terminal Disclaimer
The terminal disclaimer filed on November 3, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of the full statutory term of U.S. Patent No. 11,517,715 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 5 and 6 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.
Claim 5 is found to be indefinite because Examiner is unsure of it’s scope, since it contradicts newly-amended independent claim 1. Appropriate correction is required.
It should be noted that claim 6 has 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) 1-6 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaer, U.S. 5,882,333 (hereinafter Schaer) in view of Ostrovsky, U.S. 2017/0007803 (hereinafter Ostrovsky).
Regarding claims 1, 5, and 6, Schaer discloses (note figs. 1, 6, 15, and 17 – as best understood by Examiner) a medical probe comprising: a shaft (i.e., linear/proximal region of device in fig. 17) for navigation in a body, the shaft extending along a longitudinal axis and comprising a proximal end and a distal end; a handle (see fig. 1) disposed on the proximal end of the shaft; a flexible section (region of device that is distal to ‘shaft’ and includes distal end of ‘103’) disposed on the distal end of the shaft; a ‘spring’ (region of device that is distal to ‘flexible section’ and proximal to junction with ‘101’ – comprises a spring embedded in wall of device, see cross-sectional view in fig. 15) disposed on a distal end of the flexible section; a rigid distal tip (region of device that is distal to ‘spring’ and includes junction with ‘101’) disposed on a distal end of the spring; a first deflection mechanism comprising a first wire (103) attached to an inner surface of the flexible section (i.e., a surface within the interior of this region) and the handle, the first deflection mechanism configured to deflect the flexible section relative to the shaft; and a second deflection mechanism comprising a second wire (101) attached to an inner surface of the rigid distal tip (i.e., a surface within the interior of this region) and the handle, the second deflection mechanism configured to deflect the rigid distal tip relative to the flexible section; wherein the shaft, the flexible section, the spring, and the rigid distal tip form a hollow profile and the first wire and the second wire are each disposed within the hollow profile (note fig. 15). However, Schaer fails to explicitly disclose a probe having deflection mechanisms/wires that are both attached to an outer surface of the probe. Ostrovsky teaches (note fig. 3A) a similar device comprising multiple deflection mechanisms/wires (304), wherein these wires are attached to an outer surface of the probe. It is well known in the art that these different actuating configurations (i.e., internal vs external actuating/deflection mechanisms) 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 apparatus of Schaer (in view of Ostrovsky) to comprise deflection mechanisms/wires that are attached to an outer surface of the probe. This is because this modification would have merely comprised a simple substitution of interchangeable actuating configurations in order to produce a similar/predictable result (see MPEP 2143).
Regarding claim 2, Schaer discloses (see above) a medical probe wherein the second deflection mechanism deflects the rigid distal tip relative to the flexible section ‘via the spring’ (note fig. 17).
Regarding claim 3, Schaer discloses (see above) a medical probe further comprising a medical device comprising a plurality of electrodes configured to detect electrical-potential signals of a heart (note col. 1, line 9; col. 5, line 16).
Regarding claim 4, Schaer discloses (see above) a medical probe further comprising a medical device comprising a plurality of electrodes configured for ablation of tissue of a heart (note col. 1, line 9; col. 5, line 16).
Regarding claim 8, Schaer discloses (see above) a medical probe wherein the first wire is configured to deflect the flexible section in a first direction relative to the longitudinal axis, and wherein the second wire is configured to deflect the rigid distal tip in a second direction relative to the longitudinal axis, the second direction being different than the first direction (note fig. 17).
Regarding claim 9, Schaer discloses (see above) a medical probe wherein the flexible section is necessarily less flexible (since it is more proximal) than the spring (also note differences in curvature depicted in fig. 17).
Regarding claim 10, Schaer discloses (see above) a medical probe wherein the handle necessarily comprises a first device configured to apply a first force to the first wire to cause deflection of the flexible section, and wherein the handle comprises a second device configured to apply a second force to the second wire to cause deflection of the rigid distal tip (note col. 4, line 53; col. 6, line 15).
Claim(s) 1, 2, 5, 6, and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundquist, U.S. 5,195,968 (hereinafter Lundquist) in view of Ostrovsky.
Regarding claims 1, 5, and 6, Lundquist discloses (note figs. 20-24 – as best understood by Examiner) a medical probe comprising: a shaft (i.e., linear/proximal region of device in figs. 20-22) for navigation in a body, the shaft extending along a longitudinal axis and comprising a proximal end and a distal end; a handle (note fig. 20) disposed on the proximal end of the shaft; a flexible section (region of device that is distal to ‘shaft’ and includes distal end of ‘1480’) disposed on the distal end of the shaft; a spring (region of device that is distal to ‘flexible section’ and proximal to junction with ‘1470’ – includes lead spring ‘1640’; note col. 13, line 55 – col. 14, line 11) disposed on a distal end of the flexible section; a rigid distal tip (region of device that is distal to ‘spring’ and includes junction with ‘1470’) disposed on a distal end of the spring; a first deflection mechanism (1480) comprising a first wire attached to an inner surface of the flexible section (i.e., a surface within the interior of this region) and the handle, the first deflection mechanism configured to deflect the flexible section relative to the shaft; and a second deflection mechanism (1470) comprising a second wire attached to an inner surface of the rigid distal tip (i.e., a surface within the interior of this region) and the handle, the second deflection mechanism configured to deflect the rigid distal tip relative to the flexible section; wherein the shaft, the flexible section, the spring, and the rigid distal tip form a hollow profile and the first wire and the second wire are each disposed within the hollow profile (note figs. 20-21). However, Lundquist fails to explicitly disclose a probe having deflection mechanisms/wires that are both attached to an outer surface of the probe. Ostrovsky teaches (note fig. 3A) a similar device comprising multiple deflection mechanisms/wires (304), wherein these wires are attached to an outer surface of the probe. It is well known in the art that these different actuating configurations (i.e., internal vs external actuating/deflection mechanisms) 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 apparatus of Lundquist (in view of Ostrovsky) to comprise deflection mechanisms/wires that are attached to an outer surface of the probe. This is because this modification would have merely comprised a simple substitution of interchangeable actuating configurations in order to produce a similar/predictable result (see MPEP 2143).
Regarding claim 2, Lundquist discloses (see above) a medical probe wherein the second deflection mechanism deflects the rigid distal tip relative to the flexible section ‘via the spring’ (note fig. 21).
Regarding claim 8, Lundquist discloses (see above) a medical probe wherein the first wire is configured to deflect the flexible section in a first direction relative to the longitudinal axis, and wherein the second wire is configured to deflect the rigid distal tip in a second direction relative to the longitudinal axis, the second direction being different than the first direction (note fig. 21).
Regarding claim 9, Lundquist discloses (see above) a medical probe wherein the flexible section is less flexible (since it is more proximal) than the spring (also note differences in curvature depicted in fig. 21).
Regarding claim 10, Lundquist discloses (see above) a medical probe wherein the handle comprises a first device (1550) configured to apply a first force to the first wire to cause deflection of the flexible section, and wherein the handle comprises a second device (1540) configured to apply a second force to the second wire to cause deflection of the rigid distal tip.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundquist in view of Ostrovsky as applied to claims 1, 2, 5, 6, and 8-10 above, and further in view of Schaer.
Regarding claims 3-4, Lundquist discloses (see above) a medical probe further comprising an electrode thereon (note col. 13, line 55). However, Lundquist fails to explicitly disclose a probe comprising a plurality of electrodes thereon, wherein the electrodes are for detecting heart signals or ablating tissue. Schaer teaches (see above) a similar device comprising a plurality of electrodes thereon, wherein the electrodes are for detecting heart signals or ablating tissue (note col. 1, line 9; col. 5, line 16). It is well known in the art that this configuration (which utilizes multiple electrodes for multiple purposes) would result in increased efficiency and versatility. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the apparatus of Lundquist (in view of Schaer) to comprise a plurality of sensing/ablating electrodes thereon in order to increase efficiency and versatility.
Response to Arguments
Applicant's arguments filed November 3, 2025 have been fully considered but they are not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner asserts that the primary references already disclose deflection mechanisms that are attached to either a flexible section or a rigid distal tip (respectively), and that Ostrovsky is merely being relied upon for it’s teaching of a device having comparable deflection mechanisms that are attached to an outer surface of said device (not for the longitudinal attachment points of these deflection mechanisms).
In response to applicant's argument against the modification in view of Ostrovsky, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Regarding Applicant’s argument that Ostrovsky fails to expressly teach ‘deflection mechanisms that are attached to outer surfaces,’ Examiner respectfully disagrees. More specifically, Examiner maintains that Ostrovsky teaches these limitations, due to the breadth of the terms “attached” and “outer”. Furthermore, as can be seen in fig. 3B of Ostrovsky, the slots/openings in ‘308’ would enable this ‘outer surface’ interpretation.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). While Examiner acknowledges Applicant’s arguments concerning the modification of the base references, Examiner respectfully disagrees. As stated previously, Examiner maintains that that 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 apparatus of Schaer/Lundquist (in view of Ostrovsky) to comprise deflection mechanisms/wires that are attached to an outer surface of the probe, since this modification would have merely comprised a simple substitution of known actuating configurations in order to produce a similar/predictable result (which is an accepted rationale for supporting a conclusion of obviousness - see MPEP 2143). Therefore, Examiner asserts that the claims are still met in view of the cited references (as can be seen above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2009/0240110 (Miyawaki).
U.S. 2007/0156116 (Gonzalez).
THIS ACTION IS MADE FINAL. 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 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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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794