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 .
Claim Interpretation
Many of the pending claims include recitations that fall under the category of recitations of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed and these types of recitations don’t always provide the claims with the distinguishing factors necessary to overcome or distinguish from the prior art.
It should be noted a recitation of intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. However, if a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. It is well established that a recitation with respect to the manner in which an apparatus is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963).
Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such prior art reference, regardless of whether the prior art reference explicitly discusses such capacity for performing the recited function. In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, Applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Cir. 1990); In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 138 (Fed. Cir. 1986); In re Ludtke, 441 F.2d at 664, 169 USPQ at 566 (CCPA 1971).
A recitation with respect to the manner in which an apparatus is intended to be employed does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Yanush, 477 F.2d 958, 177 USPQ 705 (CCPA 1973); In re Finsterwalder, 436 F.2d 1028, 168 USPQ 530 (CCPA 1971); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963); Ex parte Masham, 2 USPQ2d 1647 (BdPatApp & Inter 1987).
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 1-16 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 1 recites the limitation "the optical fiber" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “an optical fiber cable” in line 2. In order to provide an initial examination and search, the examiner interprets the recitation of “the optical fiber” in line 5 of claim 1 as “the optical fiber cable.”
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 27 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Varol (U.S. Patent Application Publication 2022/0273366).
Regarding claim 27, Varol discloses a fiber/fibre, catheter system used for ablation comprising:
positioning a temperature probe within a target tissue structure (“interstitial,” see abstract, [0006], [0008]-[0011], and [0046]);
performing laser ablation of the target tissue structure (see for example [0097] and 2300 in figure 24),
measuring the intra-procedure tissue temperature of the target tissue structure during laser ablation of the target tissue structure (see [0062]); and
determining a thermal damage estimate based on the measured intra-procedure tissue
temperature of the target tissue structure ([0070], and [0102]).
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.
Claims 1-7, and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Varol (U.S. Patent Application Publication 2022/0273366) in view of Mauer et al. (U.S. Patent Application Publication 2016/0018269) in view of Trusty et al. (U.S. Patent Application Publication 2007/0179488).
Regarding claim 1, Varol discloses a fiber/fibre, catheter system used for ablation comprising:
a probe comprising an optical fiber cable (“laser fibre 2105, ” see [0084] and figures 29-301 and 2, and other alternate/equivalent counterparts in other embodiments);
a sensor coupled (“diamond” thermal mass 2180/2185, see [0101]-[0103] and figures 29-30, and other alternate/equivalent counterparts in other embodiments) to the probe to process received light; and
a catheter (comprising tubular elements: 1) “irrigation tube 2125,” 2) “optical diffuser 2115,”, 3) “fluid guide tube 2140,” and 4) “outer tube 2160,” see [0101]-[0103] and figures 29-30, and other alternate/equivalent counterparts in other embodiments), wherein the probe is selectively slidably disposed within the catheter (first see [0093] “irrigation tube 2125, jointly with the device for interstitial laser therapy 2110 (i.e. including the laser fibre 2105 and optical diffuser 2115), is pushed forward or pulled away from the distal end of the system with cooling fluid 2100, or the position of trocar 2170, or the catheter end, the ablation zone will correspondingly shorten or lengthen, respectively, along the longitudinal axis,” secondly see [0110] “optional embodiments” combinations, then finally see figures 29-30); and
wherein the sensor determines a tissue temperature (see [0101]-[0103]).
Varol fails disclose in this embodiment:
1) the diamond comprising a plurality of nanodiamonds,
2) the optical fiber cable configured to emit light and receive light,
3) the optical fiber is configured to interface with the nanodiamonds, and
4) the sensor determines a tissue temperature based on the received light that is emitted from the nanodiamonds.
Like Varol, Mauer et al. discloses a system/method of ablation (thermoablation) and sensing tissue temperature using diamond(s) (see [0070]) and teach using “one nanodiamond spin system comprising a plurality of diamond NV centers” (see [0030]) in order to 1) “allow for detection of temperature variations down to milli-Kelvin resolution, at nanometer length scales,” and 2) allow for a “biologically compatible approach” with “superior temperature sensitivity and reproducibility with a reduced measurement time” (see abstract for example).
Although Varol discloses the optical fiber/fibre can function as “multi-mode fibres” (see [0048], as noted above Varol fail to explicitly recite:
2) the optical fiber cable configured to emit light and receive light,
3) the optical fiber is configured to interface with the nanodiamonds, and
4) the sensor determines a tissue temperature based on the received light that is emitted from the nanodiamonds.
Like Varol, Trusty et al. discloses a laser system/method used for ablation using a system having a diffusion element, a fiber optic , and a diamond temperature sensor and teach providing the system with an optical fiber that both delivers laser light that experiences diffusion and receives reflected light from its scattering component (like “diamond powder”) in order to provide an known and workable manner of measuring tissue temperature for laser ablation systems (see [0026]-[0027] and figure 5).
It should be noted the additional teaching of Trusty et al. to the combination of Varol and Mauer et al. makes obvious:
2) the optical fiber cable configured to emit light and receive light,
3) the optical fiber is configured to interface with the nanodiamonds, and
4) the sensor determines a tissue temperature based on the received light that is emitted from the nanodiamonds.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Varol, as taught by Mauer et al., to provide the system with diamond thermal mass for temperature sensing in the form of nanodiamond in order to 1) “allow for detection of temperature variations down to milli-Kelvin resolution, at nanometer length scales,” and 2) allow for a “biologically compatible approach” with “superior temperature sensitivity and reproducibility with a reduced measurement time,” and as further taught by Trusty et al., to provide the system with the addition of A) the optical fiber cable configured to emit light and receive light, B) the optical fiber is configured to interface with the nanodiamonds, and C) the sensor determines a tissue temperature based on the received light that is emitted from the nanodiamonds in order to provide an known and workable manner of measuring tissue temperature for laser ablation systems.
Regarding claim 2, Varol in view of Mauer et al. in view of Trusty et al. disclose (or make obvious) the claimed invention, see Trusty et al. [0026]-[0027].
Regarding claim 3, Varol in view of Mauer et al. in view of Trusty et al. disclose (or make obvious) the claimed invention, see Varol [0093].
Regarding claim 4, Varol in view of Mauer et al. in view of Trusty et al. disclose (or make obvious) the claimed invention, see Mauer et al. abstract, and [0051] for example.
Regarding claims 5-7, Varol in view of Mauer et al. in view of Trusty et al. disclose (or make obvious) the claimed invention, see Mauer et al. [0046] for example. Additionally, claims 5-7 encompass recitations of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed and are treated as noted above.
Regarding claims 11-16, Varol in view of Mauer et al. in view of Trusty et al. disclose (or make obvious) the claimed invention. Additionally, claims 11-14 encompass recitations of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed and are treated as noted above.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Varol (U.S. Patent Application Publication 2022/0273366) in view of McCarthy et al. (U.S. Patent 8,954,161).
Regarding claim 17, Varol discloses a fiber/fibre, catheter system used for ablation comprising:
positioning a temperature probe adjacent to or within a target tissue structure (“interstitial,” see abstract, [0006], [0008]-[0011], and [0046]),
ablating the target tissue (see for example [0097] and 2300 in figure 24), and
determining a thermal damage estimate of the target tissue structure ([0070], and [0102]).
Varol fails to recite:
1) measuring the baseline tissue temperature adjacent or within the target tissue structure prior to initiation of the laser ablation procedure;
2) performing laser ablation of the target tissue structure based on the baseline tissue temperature.
Like Varol, McCarthy et al. disclose a system and method of ablating tissue and teach: 1) measuring the temperature (tissue temperature) prior to ablation (see col. 3:34-50 and col. 5:41 through col. 6:3), and 2) performing laser ablation of the target tissue structure based on the baseline tissue temperature (terminating or “cutting off flow of ablation energy,” (terminating or “cutting off flow of ablation energy” if the measure temperature is at or above the “cutoff temperature”, see col. 14:19-43) in order to provide safe operating parameters and avoid “potentially dire consequences,” (see col. 5:41 through col. 6:3).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Varol, as taught by McCarthy et al., to 1) measure the temperature (tissue temperature) prior to ablation, and 2) perform laser ablation of the target tissue structure based on the baseline tissue temperature (terminating or “cutting off flow of ablation energy” if the measure temperature is at or above the “cutoff temperature”) in order to provide safe operating parameters and avoid “potentially dire consequences.”
Claims 35-39, and 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Varol (U.S. Patent Application Publication 2022/0273366) in view of Mauer et al. (U.S. Patent Application Publication 2016/0018269) in view of Trusty et al. (U.S. Patent Application Publication 2007/0179488).
Regarding claim 35, Varol discloses a fiber/fibre, catheter system used for ablation comprising:
a laser ablation probe comprising:
a laser fiber (“laser fibre 2105, ” see [0084] and figures 29-301 and 2, and other alternate/equivalent counterparts in other embodiments) configured to emit laser energy to ablate tissue;
one or more optical fibers (“a plurality of optical fibres,” see [0047]) configured to emit light (laser light )
a sensor coupled (“diamond” thermal mass 2180/2185, see [0101]-[0103] and figures 29-30, and other alternate/equivalent counterparts in other embodiments) to the probe to process received light; and
a catheter (comprising tubular elements: 1) “irrigation tube 2125,” 2) “optical diffuser 2115,”, 3) “fluid guide tube 2140,” and 4) “outer tube 2160,” see [0101]-[0103] and figures 29-30, and other alternate/equivalent counterparts in other embodiments), wherein the probe is selectively slidably disposed within the catheter (first see [0093] “irrigation tube 2125, jointly with the device for interstitial laser therapy 2110 (i.e. including the laser fibre 2105 and optical diffuser 2115), is pushed forward or pulled away from the distal end of the system with cooling fluid 2100, or the position of trocar 2170, or the catheter end, the ablation zone will correspondingly shorten or lengthen, respectively, along the longitudinal axis,” secondly see [0110] “optional embodiments” combinations, then finally see figures 29-30); and
wherein the sensor determines a tissue temperature (see [0101]-[0103]).
Varol fails disclose in this embodiment:
1) the catheter comprising a plurality of nanodiamonds,
2) the optical fiber cable configured to emit light and receive light,
3) the nanodiamonds are configured to thermally couple with adjacent tissue and to indicate a measure of tissue temperature in response to light emitted from the one or more optical fibers.
Like Varol, Mauer et al. discloses a system/method of ablation (thermoablation) and sensing tissue temperature using diamond(s) (see [0070]) and teach using “one nanodiamond spin system comprising a plurality of diamond NV centers” (see [0030]) in order to 1) “allow for detection of temperature variations down to milli-Kelvin resolution, at nanometer length scales,” and 2) allow for a “biologically compatible approach” with “superior temperature sensitivity and reproducibility with a reduced measurement time” (see abstract for example).
Although Varol discloses the optical fiber/fibre can function as “multi-mode fibres” (see [0048], as noted above Varol fail to explicitly recite:
2) the optical fiber cable configured to emit light and receive light,
3) the optical fiber is configured to interface with the nanodiamonds, and
4) the sensor determines a tissue temperature based on the received light that is emitted from the nanodiamonds.
Like Varol, Trusty et al. discloses a laser system/method used for ablation using a system having a diffusion element, a fiber optic , and a diamond temperature sensor and teach providing the system with an optical fiber that both delivers laser light that experiences diffusion and receives reflected light from its scattering component (like “diamond powder”) in order to provide an known and workable manner of measuring tissue temperature for laser ablation systems (see [0026]-[0027] and figure 5).
It should be noted the additional teaching of Trusty et al. to the combination of Varol and Mauer et al. makes obvious:
2) the optical fiber cable configured to emit light and receive light,
3) the optical fiber is configured to interface with the nanodiamonds, and
4) the sensor determines a tissue temperature based on the received light that is emitted from the nanodiamonds.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Varol, as taught by Mauer et al., to provide the system with diamond thermal mass for temperature sensing in the form of nanodiamond in order to 1) “allow for detection of temperature variations down to milli-Kelvin resolution, at nanometer length scales,” and 2) allow for a “biologically compatible approach” with “superior temperature sensitivity and reproducibility with a reduced measurement time,” and as further taught by Trusty et al., to provide the system with the addition of A) the optical fiber cable configured to emit light and receive light, B) the optical fiber is configured to interface with the nanodiamonds, and C) the sensor determines a tissue temperature based on the received light that is emitted from the nanodiamonds in order to provide an known and workable manner of measuring tissue temperature for laser ablation systems.
The test for obviousness is what the combined teachings of the references would have suggested to one of ordinary skill in the art, and all teachings in the prior art must be considered to the extent that they are in analogous arts.
Here:
the teaching of Mauer et al. modifies the diamond temperature sensor disposed on or in the catheter of Valor to nanodiamonds of/in the catheter,
the teaching of Trusty et al. modifies the nanodiamonds of Valor in view of Mauer et al. to a catheter with nanodiamonds feeding a optical fiber with light/temperature information where the optical fiber both emits and receives light for temperature measurements.
This prior art combination makes obvious the recited:
1) the catheter comprising a plurality of nanodiamonds,
2) the optical fiber cable configured to emit light and receive light,
3) the nanodiamonds are configured to thermally couple with adjacent tissue and to indicate a measure of tissue temperature in response to light emitted from the one or more optical fibers.
Regarding claim 36, Varol in view of Mauer et al. in view of Trusty et al. disclose (or make obvious) the claimed invention, see Mauer et al. abstract, and [0051] for example.
Regarding claims 36-39 and 43-44, Varol in view of Mauer et al. in view of Trusty et al. disclose (or make obvious) the claimed invention. Claims 36-37, and 43-44 encompass recitations of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed and are treated as noted above.
Regarding claims 45-46, Varol in view of Mauer et al. in view of Trusty et al. disclose (or make obvious) the claimed invention, claims 45-46 encompass recitations of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed and are treated as noted above.
Regarding claim 47, Varol in view of Mauer et al. in view of Trusty et al. disclose (or make obvious) the claimed invention, see Varol [0011], and [0066] for example.
Regarding claim 48, Varol in view of Mauer et al. in view of Trusty et al. disclose (or make obvious) the claimed invention, see Varol [0070] for example. Additionally, claim 48 encompasses a recitation of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed and are treated as noted above.
Claims 49-54 are rejected under 35 U.S.C. 103 as being unpatentable over Varol (U.S. Patent Application Publication 2022/0273366) in view of Mauer et al. (U.S. Patent Application Publication 2016/0018269) in view of Trusty et al. (U.S. Patent Application Publication 2007/0179488).
Regarding claims 49-50, Varol discloses a fiber/fibre, catheter system used for ablation comprising:
a probe comprising an optical fiber cable (“laser fibre 2105, ” see [0084] and figures 29-301 and 2, and other alternate/equivalent counterparts in other embodiments);
a sensor coupled (“diamond” thermal mass 2180/2185, see [0101]-[0103] and figures 29-30, and other alternate/equivalent counterparts in other embodiments) to the probe to process received light; and
a catheter (comprising tubular elements: 1) “irrigation tube 2125,” 2) “optical diffuser 2115,”, 3) “fluid guide tube 2140,” and 4) “outer tube 2160,” see [0101]-[0103] and figures 29-30, and other alternate/equivalent counterparts in other embodiments), wherein the probe is selectively slidably disposed within the catheter (first see [0093] “irrigation tube 2125, jointly with the device for interstitial laser therapy 2110 (i.e. including the laser fibre 2105 and optical diffuser 2115), is pushed forward or pulled away from the distal end of the system with cooling fluid 2100, or the position of trocar 2170, or the catheter end, the ablation zone will correspondingly shorten or lengthen, respectively, along the longitudinal axis,” secondly see [0110] “optional embodiments” combinations, then finally see figures 29-30);
wherein the sensor determines a tissue temperature (see [0101]-[0103]); and
the laser ablation system comprising the catheter, probe, and fiber optic capture a temperature of the tissue while an image of the tissue is captured with an MRI system (see [0070]),
it should be further noted the recitation of the laser ablation system captures a temperature of the tissue while an image of the tissue is captured with an MRI system is a recitation of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed and are treated as noted above.
Varol fails disclose in this embodiment:
1) the diamond comprising a plurality of optical elements
2) where the plurality of optical elements are nanodiamonds,
3) the optical fiber cable configured to emit light and receive light,
4) the optical fiber is used to optically interact with the plurality of optical elements and thereby capture a temperature of the tissue.
Like Varol, Mauer et al. discloses a system/method of ablation (thermoablation) and sensing tissue temperature using diamond(s) (see [0070]) and teach using “one nanodiamond spin system comprising a plurality of diamond NV centers” (see [0030]) in order to 1) “allow for detection of temperature variations down to milli-Kelvin resolution, at nanometer length scales,” and 2) allow for a “biologically compatible approach” with “superior temperature sensitivity and reproducibility with a reduced measurement time” (see abstract for example).
Although Varol discloses the optical fiber/fibre can function as “multi-mode fibres” (see [0048], as noted above Varol fail to explicitly recite:
2) the optical fiber cable configured to emit light and receive light,
3) the optical fiber is configured to interface with the nanodiamonds, and
4) the sensor determines a tissue temperature based on the received light that is emitted from the nanodiamonds.
Like Varol, Trusty et al. discloses a laser system/method used for ablation using a system having a diffusion element, a fiber optic , and a diamond temperature sensor and teach providing the system with an optical fiber that both delivers laser light that experiences diffusion and receives reflected light from its scattering component (like “diamond powder”) in order to provide an known and workable manner of measuring tissue temperature for laser ablation systems (see [0026]-[0027] and figure 5).
It should be noted the additional teaching of Trusty et al. to the combination of Varol and Mauer et al. makes obvious:
3) the optical fiber cable configured to emit light and receive light,
4) the optical fiber is used to optically interact with the plurality of optical elements and thereby capture a temperature of the tissue.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Varol, as taught by Mauer et al., to provide the system with diamond thermal mass for temperature sensing in the form of nanodiamond in order to 1) “allow for detection of temperature variations down to milli-Kelvin resolution, at nanometer length scales,” and 2) allow for a “biologically compatible approach” with “superior temperature sensitivity and reproducibility with a reduced measurement time,” and as further taught by Trusty et al., to provide the system with the addition of A) the optical fiber cable configured to emit light and receive light, B) the optical fiber is configured to interface with the nanodiamonds, and C) the sensor determines a tissue temperature based on the received light that is emitted from the nanodiamonds in order to provide an known and workable manner of measuring tissue temperature for laser ablation systems.
Regarding claims 51-54, Varol in view of Mauer et al. in view of Trusty et al. disclose (or make obvious) the claimed invention, claims 51-54 encompass recitations of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed and are treated as noted above.
Allowable Subject Matter
Claims 18-26, 28-33, and 40-42 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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/AARON F ROANE/Primary Examiner, Art Unit 3792