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 .
Drawings
The drawings were received on 11 December 2025. These drawings are acceptable.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a compliance member…configured to deform” in claims 1, 34 and 35 and corresponding dependent claims and “an indicator element configured to emit” in claims 34 and 35 and corresponding dependent claims.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
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.
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.
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.
Claim(s) 1, 4, 20, 21, 23 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blom et al (2016/0206842) in view of Culver et al (6,487,428) and further in view of Lundahl (5,125,925) and still further in view of Crozier et al (2019/0192224).
Regarding claim 1, Blom et al disclose an optical sensor system for detecting a tissue type in a surgical procedure, the optical sensor system comprising:
an excitation source configured to selectively emit excitation light (light is directed via the optical fiber to the crystal – [0141]);
a probe (surgical instrument 10 – [0098]) comprising:
at least one fiber coupled to the excitation source (light is directed via the optical fiber to the crystal and partially reflected back into the fiber – [0141]);
a compliance member coupled to the at least one fiber (balloon 546 – fig.18), the compliance member being configured to deform in response to engagement by a surgical tool (the balloon catheter 514 also has a tube 548 for the introduction of an inflating fluid into, and exhaust fluid from – [0147]), wherein a portion of the at least one fiber is disposed inside the compliance member (lumen 560 – fig.18); and
an indicator element configured to emit light in response to receiving an indicator signal (a light source such as, for example, a light emitting diode (LED) 30 – [0100]); and
a spectrometer coupled to the at least one fiber ([0141]).
Blom et al fail to explicitly disclose at least one fiber coupled to the excitation source and configured to illuminate target tissue with the excitation light and collect light from target tissue; a compliance member being at least partially translucent, a spectrometer configured to generate a signal based on the collected light from the target tissue; and a controller operatively connected to the spectrometer and configured to determine a tissue characteristic based on the signal and generate the indicator signal based on the determined tissue characteristic.
However, Culver et al teach in the same medical field of endeavor, at least one fiber coupled to an excitation source and configured to illuminate target tissue with an excitation light and collect light from target tissue (light source into patient via an optical fiber 36 and light detector 34 via an optical detector fiber 38 – col.5, ll.44-52); a module coupled to the at least one fiber and configured to generate a signal based on the collected light from the target tissue; and a controller operatively connected to the module and configured to determine a tissue characteristic based on the signal and generate the indicator signal based on the determined tissue characteristic (a programmed algorithm electronic unit 52 that interprets the information in the signals representative of the light received by light detectors…and outputs warning…an audible and/or visible warning mechanism – col.6, l.65-col.7, l.5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the at least one fiber and indicator element as well as the spectrometer of Blom et al with at least one fiber to excite and collect light from target tissue and an optical detection module coupled to the at least one fiber to generate a signal based on the collected light and generate the indicator signal based on the determined tissue characteristic as it would provide a warning to the user in response to the detected target tissue information.
Blom et al as modified by Culver et al fail to explicitly disclose a compliance member being at least partially translucent.
However, Lundahl teaches in the same medical field of endeavor, a compliance member being at least partially translucent (a catheter has a translucent balloon - abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the compliance member of Blom et al as modified by Culver et al with being at least partially translucent as it would provide light which passes through it to be diffused.
Blom et al as modified by Culver et al and Lundahl fail to explicitly disclose wherein the indicator element is an indicator fiber configured to emit light in response to receiving an indicator signal.
However, Crozier et al teach in the same medical field of endeavor, an indicator fiber configured to emit light in response to receiving an indicator signal (the indicator can be an LED, a fiber-optic, or a laser – [0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the indicator element which may be an LED of Blom et al as modified by Culver et al and Lundahl with an indicator fiber of Crozier et al as it would provide a well-known and conventional functional alternative to an LED to provide a visual indication.
Regarding claim 4, Blom et al disclose wherein the compliance member includes a projection extending from an outer surface of the compliance member and sized to be disposed at least partially within a lumen of a suction tool (the balloon catheter 514 also includes a tube 548 for the introduction of an inflating fluid into, and exhaust of inflating fluid from, the balloon 546 – [0147]).
Regarding claim 20, Blom et al disclose wherein the excitation source is further defined as a first excitation source ([0017]), the optical sensor system further comprising a second excitation source, an indicator fiber coupled to the second excitation source, the second excitation source configured to emit light in response to the indicator signal (indicator 20 includes a light source such as, for example, a light emitting diode (LED) 30, and other electrical circuitry 32 operable to energize the LED – [0100]), but fail to explicitly disclose the indicator fiber of claim 1 is coupled to the second excitation source.
However, Crozier et al teach in the same medical field of endeavor, disclose the indicator fiber of claim 1 is coupled to the second excitation source (the indicator can be an LED, a fiber-optic, or a laser – [0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the indicator element which may be an LED of Blom et al as modified by Culver et al and Lundahl with an indicator fiber coupled to a second excitation source of Crozier et al as it would provide a well-known and conventional functional alternative to an LED to provide a visual indication.
Regarding claim 21, Bloom et al disclose wherein the compliance member defines a lumen sized to allow a portion of the surgical tool to be placed therethrough (the balloon catheter 514 has a lumen 560 – [0149]).
Regarding claim 23, Blom et al as modified by Culver et al and Lundahl disclose the invention as claimed and discussed above. Blom et al further disclose wherein second excitation source is operable in different states, the different states including at least one of an on state, an off state, a first flashing state in which light is emitted at a first frequency, a second flashing state in which light is emitted at a second frequency different than the first flashing state ([0122];[0179]).
Regarding claim 25, Blom et al as modified by Culver et al and Lundahl disclose the invention as claimed and discussed above, but fail to explicitly disclose the compliance member defines a sphere shape; and the compliance member includes a first hemisphere and a second hemisphere, a portion of the at least one fiber being disposed entirely within at least one of the first hemisphere and the second hemisphere.
However, Lundahl et al further teach in the same medical field of endeavor, a compliance member defines a sphere shape; and the compliance member includes a first hemisphere and a second hemisphere, a portion of an at least one fiber being disposed entirely within at least one of the first hemisphere and the second hemisphere (an optical sensing fiber is affixed to or within the balloon wall material – abstract; a catheter which has a balloon on its end which forms a sphere or other uniform shape when inflated – col.3, ll.5-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the balloon and optical fiber through a balloon of Blom et al as modified by Culver et al with the explicit disclosure of a sphere shape and at least one fiber being disposed entirely within at least one of the first hemisphere and the second hemisphere of a sphere shape of Lundahl et al as it would provide irradiation with uniform illumination.
Claim(s) 6, 8-10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blom et al (2016/0206842) in view of Culver et al (6,487,428) and further in view of Lundahl (5,125,925) and still further in view of Crozier et al (2019/0192224)as applied to claim 1 above, and further in view of Ryan et al (2007/0078500).
Regarding claims 6 and 8, Blom et al disclose wherein the probe further comprises: a jacket enclosing at least a portion of the at least one fiber (balloon catheter 514 includes a sheath 540 – [0147]). Blom et al as modified by Culver et al and Lundahl fail to explicitly disclose a carrier coupled to the jacket and configured to assume different shapes, wherein the carrier is a wire coupled to the jacket between a first portion of the jacket and a second portion of the jacket, and a third portion of the jacket between the first portion and the second portion of the jacket is configured to assume the shape of the carrier.
However, Ryan et al teach in the same medical field of endeavor, a carrier coupled to a jacket and configured to assume different shapes, wherein the carrier is a wire coupled to the jacket between a first portion of the jacket and a second portion of the jacket, and a third portion of the jacket between the first portion and the second portion of the jacket is configured to assume the shape of the carrier (a guidewire sheath 131 with guidewire 145 – [0194]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the jacket of Blom et al with a carrier that is a wire located within the jacket and configured to assume the shape of the carrier as it would provide a well-known and conventional guidewire structure to navigate the instrument into the patient.
Regarding claim 9, Blom et al disclose wherein the probe includes a gripping element coupled to the jacket and being located proximal to the compliance member (retainer 516 – fig.15).
Regarding claim 10, Blom et al disclose wherein the gripping element includes at least one of: a fastener configured to attach to a portion of a patient in order to prevent movement of the probe from a desired position; and a tab for engagement by the surgical tool for guiding the compliance member into a desired position (a moveable retainer 516 that is positionable lengthwise on the balloon to resist movement of the balloon catheter during surgery – [0151]; fig.15).
Regarding claim 13, Blom et al disclose wherein the probe further comprises an anchor coupled to the at least one fiber or jacket and configured to anchor at least a portion of the at least one fiber or jacket to a position, the position being located outside of a patient (516 - fig.14).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blom et al (2016/0206842) in view of Culver et al (6,487,428) and further in view of Lundahl (5,125,925) and still further in view of Crozier et al (2019/0192224) as applied to claim 1 above, and further in view of Bierhoff (2014/0236024).
Regarding claim 17, Blom et al as modified by Culver et al, Lundahl and Crozier et al disclose the invention as claimed and discussed above, but fail to explicitly disclose the probe is configured to illuminate the tissue with the excitation light in a first mode or in a second mode; and in the first mode, the at least one fiber illuminates the tissue with a diffused excitation light and in the second mode, the at least one fiber illuminates the tissue with a focused excitation light.
However, Bierhoff et al teach in the same medical field of endeavor, a probe is configured to illuminate a tissue with an excitation light in a first mode or in a second mode; and in the first mode, the at least one fiber illuminates the tissue with a diffused excitation light and in the second mode, the at least one fiber illuminates the tissue with a focused excitation light (combine fluorescence measurements with diffuse reflectance measurements by providing at least one of a fiber switch…with focusing optics, and wherein said one of said at least two optical fibers conveys excitation light for measuring fluorescence and light for diffuse reflectance – claim 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the illumination of tissue with excitation light by a probe of Blom et al as modified by Culver et al, Lundahl and Crozier et al with a first mode of diffused excitation light and a second mode of focused excitation light as it would provide tailoring the type of data collected based on user preference.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blom et al (2016/0206842) in view of Culver et al (6,487,428) and further in view of Lundahl (5,125,925) and still further in view of Crozier et al (2019/0192224)as applied to claim 1 above, and further in view of Stigall et al (2014/0276028).
Regarding claim 19, Blom et al as modified by Culver et al, Lundahl and Crozier et al disclose the invention as claimed and discussed above, but fail to explicitly disclose the compliance member comprises a radiopaque material.
However, Stigall et al teach in the same medical field of endeavor, wherein a compliance member comprises a radiopaque material ([0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the compliance member of Blom et al as modified by Culver et al, Lundahl and Crozier et al with a radiopaque material of Stigall et al as it would provide tracking of the balloon within a patient.
Allowable Subject Matter
Claims 34-37 are allowed.
Claims 18, 28 and 30 are 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4, 6, 8-10, 13, 17, 19-21, 23 and 25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ROCHELLE DEANNA TURCHEN whose telephone number is (571)270-7104. The examiner can normally be reached Mon - Fri 6:30-2:30.
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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797