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 .
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 1-45 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 “distal probe tip disposed at or near the distal end”. The term “at or near” is considered indefinite as it is not clear whether the probe tip is disposed at the distal end or near the distal end. It is suggested claim language provide further clarity with respect to this configuration. The dependent claims do not provide additional clarity and therefore stand rejected under 112(b).
Claims 4, 8, 9, 24, and 25 recite various ranges for depths (claims 4, 24, 25) and ranges for angular offset (claims 8, 9). The language “greater than about”, “such as up to about”, “no more than about”, “about” is considered indefinite and lacks clarity with respect to the exact range for the various dimensions as claimed. It is suggested claim language provide further clarity with respect to these ranges.
Claim 5 uses the term “optionally” which is considered indefinite and not clear what is meant by “in a manner that reduces effects of rotation of the probe tip”. It is suggested claim language replace this language with structural limitation to positively recite the reduction in the effects of rotation of the probe tip on the measured spectra.
Claim 6 recites the language “an illumination fiber extending…to the probe tip and configured to, the illumination fiber defining an illumination axis”. It is not clear what is meant by “illumination fiber…configured to , the illumination fiber defining…” It is not clear if the claim language was intended to recite “illumination fiber…configured to defining an illumination axis”. It is suggested claim language provide further clarity with respect to this language.
Claims 13-15 recite the language “substantially adjacent” and “spaced apart” which are considered indefinite and lacks clarity as to what degree the detection fibers are adjacent or spaced art from the illumination fiber. It is suggested the language provide additional clarity with respect to this language.
Claim 25 recites “a tissue characterization system” and claim 28, dependent on claim 25, recites “system as in any one of claims 3-5 or 23-24”. Since claim 28 is dependent on claim 25, it is not clear how the multiple dependency goes back to claims 3-5 which are dependent on claim 1. Claim 25 also does not provide any further details of the “tissue characterization system”. It is suggested claims 25 and 28 be modified to provide accurate dependencies and adequately define the “tissue characterization system”. The dependent claims stand rejected under 112(b) due to lack of additional clarity.
Claim Objections
Claims 3, 20, 21, 23, and 28 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. It is suggested claim dependencies be modified to reflect proper dependencies. See MPEP § 608.01(n).
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) 1-4, 6-15, 23, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takeuchi et al. (2019/0223706).
With respect to claims 1 and 6 Takeuchi et al. teach of a tissue characterization probe 100, 1200 (fig. 1, 12) comprising an elongate member [fig. 1A] with a proximal end (fig. 1A) and distal end (fig. 1A) [0033-0036] with the proximal end and a distal end extending along an optical axis [0033]. Takeuchi et al. teach of a plurality of distal probe tips disposed at or near the distal end of the elongate member or to form a multi-arm arrangement (fig 1A) with a plurality of illumination fibers 1103 (fig. 11) or illumination fiber 110 (fig 1A, 0033-0036) with flexible tips [0074] and a plurality of detection fibers 101-108 (fig. 1A) extending partially through the elongate member, each detection fiber extending to a respective probe tip of the multi-arm arrangement such that each probe tip includes at least one detection fiber (fig. 1A). Takeuchi et al. teach of the first set of detection fibers 421, 422 (fig. 4C, 4D) on the same detection line (Rd1) is substantially disposed along a first detection line (fig. 4c, 4d), the first detection line being orthogonal to the illumination axis [0050-0052] and a second set of detection fibers 421, 422 (fig. 4C, 4D) on the same detection line is substantially disposed along a second detection line Rd3 (fig. 4C, 4D), the second detection line being orthogonal to the illumination axis and being transverse to the first detection line (fig. 4c, 4D, 0050-0052).
With respect to claims 2 and 7, Takeuchi et al. teach of the probe being configured to be introduced through a central lumen or inner sheath 112 and extending beyond the tip of the catheter or sheath [0054, 0058, fig. 6].
With respect to claims 3 and 23, Takeuchi et al. teach of a tissue characterization system or SEE endoscopic system [0032] with a tissue characterization probe (as described above for rejection of claim 1), a light source [0032] coupled to illumination fiber 110 [0033, 0034] and one or more spectrometers operatively coupled to the detection fibers [0034, 0036] or light source 1202, spectrometer and illumination fiber 1205 [0075, fig. 12].
With respect to claim 8, Takeuchi et al. teach of the detection fiber to be radially offset from its respective detection line by no more than about 30 degrees (fig. 4D, (rd1, Rd1), [0052]).
With respect to claim 9, Takeuchi et al. teach of the detection lines crossing each other at the illumination axis to form a transverse angle range (fig. 4c, [0052]).
With respect to claim 10, Takeuchi et al. teach of the first and second detection lines to be orthogonal (fig. 4C, (rd1, rd3), [0052]).
With respect to claims 11 and 12, Takeuchi et al. teach of the first and second set of detection fibers to include two detection fibers (fig. 4c, D).
With respect to claim 13, Takeuchi et al. teach of the detection fibers 421, 422 to be substantially adjacent the illumination fiber (fig. 4C,D).
With respect to claims 14 and 15, Takeuchi et al. teach of the detection fibers being spaced apart from the illumination fiber and spaced apart from each other (fig. 4C,D).
With respect to claims 4 and 24, Takeuchi et al. teach of probe being configured to characterize tissue at various depths (fig. 2, 3, 0037-0039).
Takeuchi et al. do not teach of all the claimed elements in a single embodiment. It would have therefore been obvious to combine the elements from the various embodiments to improve the collection efficiency, improve view in a forward direction with increased field-of-view angle and used for in-vivo with small size without requiring complex and invasive procedures for obtaining image data [Takeuchi, 0077].
Claim(s) 5 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takeuchi et al. in view of Tearney et al. (2008/0262359). Takeuchi et al. do not explicitly teach of the use of system to characterize cardiac tissues. In a related field of endeavor Tearney et al. teach of a tissue characterization probe (fig. 10-12, [0067-0073]) that may be used to characterize cardiac tissues [0067-0073]. Takeuchi et al. do not explicitly teach of the multi-arm arrangement. Tearney et al. teach of a multi-arm tissue characterization probe or miniature optical imaging probes with multiple waveguide arrangements [0086, 0087, fig. 11]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Tearney et al. to modify Takeuchi et al. for better diagnostic and improved detection of vulnerable plaque [Tearney, 0015].
Claim(s) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takeuchi et al. in view of Perry et al. (2021/0052261). With respect to claims 16 and 17, Takeuchi et al. teach of the band 910 rotated relative to the inner sheath 112 so as to bend (twist) the fibers around the tip of the sheath at a predetermined angle [0068]. Takeuchi et al. also teach of a drive cable consisting of one or more wires to transfer the rotation from the motor at the proximal end holds the illumination fiber and distal optics inside where the plurality of detection fibers are attached to the central tube 1102 or inner sheath except for the very tip with a locking band 1108 attached [0073]. Takeuchi et al. do not explicitly teach of the support wire in the claimed configuration or shape. In a related field of endeavor Perry et al. teach of a tissue probe that includes a support wire shaft extending at least partially through the elongate member to the probe tip and configured to form a bend in the distal end of the probe tip where the wire may have a rectangular cross-sectional shape [0172]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching Perry et al. to modify Takeuchi et al. to provide desired structural integrity and control and stiffness to navigate the tissue structure.
Claim(s) 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takeuchi et al. in view of Gmeiner et al. (2018/0344130). Takeuchi et al. teach of the use of a line scan camera [0076] but do not explicitly teach of the localization assembly comprising one of the localization components to provide information for the localization of the distal tip. In a related field of endeavor Gmeiner et al. teach of flexible endoscope comprising multiple optical fibers/bundles each coupled to an integrated multi-lens array at a distal end and multiple cameras at a proximal end [0131]. Gmeiner et al. teach of a tracking system 213 to tack a probe with micro-optical surgical probe with pre-operative imaging data captured via optical scopes 204 or cameras [0142]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Gmeiner et al. to modify Takeuchi et al. to provide enhanced or complementary inner-cavity imaging, localization, characterization and/or mapping [Gmeiner, 0142].
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takeuchi et al. Takeuchi et al. teach of a method of characterizing tissue using a tissue characterization system with a tissue characterization probe 100, 1200 (fig. 1, 12) comprising an elongate member [fig. 1A] with a proximal end (fig. 1A) and distal end (fig. 1A) [0033-0036] with the proximal end and a distal end extending along an optical axis [0033]. Takeuchi et al. teach of a plurality of distal probe tips disposed at or near the distal end of the elongate member or to form a multi-arm arrangement (fig 1A) with a plurality of illumination fibers 1103 (fig. 11) or illumination fiber 110 (fig 1A, 0033-0036) with flexible tips [0074] and a plurality of detection fibers 101-108 (fig. 1A) extending partially through the elongate member, each detection fiber extending to a respective probe tip of the multi-arm arrangement such that each probe tip includes at least one detection fiber (fig. 1A). Takeuchi et al. teach of the first set of detection fibers 421, 422 (fig. 4C, 4D) on the same detection line (Rd1) is substantially disposed along a first detection line (fig. 4c, 4d), the first detection line being orthogonal to the illumination axis [0050-0052] and a second set of detection fibers 421, 422 (fig. 4C, 4D) on the same detection line is substantially disposed along a second detection line Rd3 (fig. 4C, 4D), the second detection line being orthogonal to the illumination axis and being transverse to the first detection line (fig. 4c, 4D, 0050-0052). Takeuchi et al. teach of probe being configured to characterize tissue at various depths (fig. 2, 3, 0037-0039) and resolving the spectra in order to characterize the targeted tissue.
With respect to claim 28, Takeuchi et al. teach of a tissue characterization system or SEE endoscopic system [0032] with a tissue characterization probe (as described above for rejection of claim 1), a light source [0032] coupled to illumination fiber 110 [0033, 0034] and one or more spectrometers operatively coupled to the detection fibers [0034, 0036] or light source 1202, spectrometer and illumination fiber 1205 [0075, fig. 12].
Takeuchi et al. do not teach of all the claimed elements in a single embodiment. It would have therefore been obvious to combine the elements from the various embodiments to improve the collection efficiency, improve view in a forward direction with increased field-of-view angle and used for in-vivo with small size without requiring complex and invasive procedures for obtaining image data [Takeuchi, 0077].
Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takeuchi et al. in view of Tearney et al. (2008/0262359). Takeuchi et al. do not explicitly teach of the use of system to characterize cardiac tissues. In a related field of endeavor Tearney et al. teach of a tissue characterization probe (fig. 10-12, [0067-0073]) that may be used to characterize cardiac tissues [0067-0073]. Tearney et al. also teach of the targeted anatomical location to be a blood-filled beating heart [0110, 0113]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Tearney et al. to modify Takeuchi et al. for better diagnostic and improved detection of vulnerable plaque [Tearney, 0015].
Claim(s) 29-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takeuchi et al. in view of Rosell Ferrer et al. (2019/0110710). Takeuchi et al. do not teach of a generating a three-dimensional map of tissue microstructure or a fibrosis map or the spatial distribution of the constituents of the targeted tissue within the heart. In a related field of endeavor Rosell Ferrer et al. teach of a system and method to assess infarcted myocardial tissue where an electrocatheter probe is placed various locations to assess cardiac tissue at the various locations [0099]. Rosell Ferrer et al. therefore teach of characterizing tissue at multiple target locations and obtaining one or more data points of the characterized tissue, determine location of the probe tip within the anatomical working space, associating each data point with corresponding determined location with the working space, and generating a map based on the data points and the corresponding locations such as a fibrosis map (0113, 0118, claim 52). It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Rosell Ferrer et al. to modify Takeuchi et al. for more improved characterization of tissue structures with increased accuracy [Rosell Ferrer et al., 0017-0020].
Claim(s) 34-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takeuchi et al. in view of Maier-Hein et al. (2022/0008157).
With respect to claims 34-38, Takeuchi et al. do not teach of utilizing unsupervised machine learning technique. In a related field of endeavor Maier-Hein et al. teach of a system and method of generating augmented images of tissue of a patient undergoing open surgery wherein each augmented image associates at least one tissue parameter with a region or pixel of the image of the tissue by estimating a spectral composition of light illuminating the region of interest, obtaining multispectral images of the region of interest, applying machine learning to the multispectral images (see abstract). Maier-Hein et al. teach of unsupervised machine learning [0088, 0359] that includes cluster analysis [0369]. Maier-Hein et al. teach of using principal component analysis [0286] measuring similarity from at least the first and second principal components of the spectra [0286, 0354] based on Euclidean distance [0259, 0301]. With respect to claims 39-41, Takeuchi et al. do not teach of a supervised machine learning technique such as a convolutional neural network CNN. Maier-Hein et al. teach of the classifier based on convolution neural network where the CNN is trained and tested using data from a set of prior measurements of scattering in tissues [0048, 0049, 0245, 0246, 0257]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Maier-Hein et al. to modify Takeuchi et al. to allow for a very precise estimation of the spectral composition of the illumination and allowing to reliably predict tissue parameters under various and illuminating conditions [Maier-Hein et al., 0044].
Claim(s) 42-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takeuchi et al. in view of Maier-Hein et al. and further in view of Khosousi et al. (2020/0205745). The previous references do not explicitly teach of the claimed parameter ranges. In a related field of endeavor Khosousi et al. teach of a method and system to configure and use neural networks in characterizing physiological system where the batch size is within the claimed range of 50 to 300 (Table 1, 2), learning rate of the CNN varies from 0.001 to 0.015 (Table 1, 2), the filter size varies from 5 to 40 (Table 1, 2) [0123, 0124]. Khosousi et al. teach of the CNN being trained with reduced sampling [0032, 0086, 0105]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Khosousi et al. to modify the previous teachings for more improved detection, diagnostics, and treatment of various diseases and conditions [0131] and improve signal quality with respect to probe placement [Khosousi, 0106].
Conclusion
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BR
/BAISAKHI ROY/Primary Examiner, Art Unit 3797
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