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.
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 11 and 14 are objected to because of the following informalities: In claim 11, line 2, -that- should be inserted after “view”; In claim 14, line 4, “lights” should be replaced with -light-. 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 16-20 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 16 recites the limitation "a diameter" in line 2. The antecedent basis for this limitation is confusing, since it has already been recited. Appropriate correction is required.
Claim 18 is found to be indefinite because Examiner is unsure of what is meant by the limitation “change between a first field of view a the second field of view”. This renders the scope of the claim unclear. Appropriate correction is required.
Claim 19 recites the limitation "a diameter" in line 8. The antecedent basis for this limitation is confusing, since it has already been recited. 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 § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7, 15-16, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Casscells, U.S. 6,214,001 (hereinafter Casscells).
Regarding claim 1, Casscells discloses (note figs. 1A, 5A, and 6A-B) a medical device comprising: an outer shaft (114) having a lumen, a proximal portion and an distal tip portion (distal portion of ‘114’ that only partially encloses ‘142’) with an ‘enlarged dimension’ relative to a diameter (e.g., an inner diameter) of the proximal portion (it should also be noted that this distal tip portion appears to extend distally beyond the cylindrical portion of ‘114’ by a distance that is greater than the diameter of the proximal portion); and a cutter (142) configured to remove the tissue, wherein the cutter is at least partially received by the distal tip portion and has an enlarged dimension relative to the diameter of the proximal portion of the outer shaft (see fig. 5A).
Regarding claim 2, Casscells discloses (see above) a medical device wherein the cutter is configured to provide the medical device with a positive approach angle to the tissue with an outer surface or one or more edges of the cutter forming an acute inclined angle with an outer surface of the outer shaft (see fig. 5A), wherein the cutter is rotatable relative to the outer shaft and includes a first side with an electrode (any of the four bifurcated pair of 626’s in fig. 6B) necessarily having a radius of curvature, wherein the electrode is configured to provide radiofrequency energy to the tissue (see fig. 3B), and a second side (composed of the remaining three bifurcated pairs of 626’s in fig. 6B) with one or more features for mechanically cutting the tissue, wherein the one or more features include a plurality of resection ‘teeth’ (any two adjacent bifurcated pairs of 626’s of the remaining three in fig. 6B) along a first edge of the second side and a ‘blade’ (either ‘626’ in last remaining bifurcated pair of 626’s in fig. 6B) necessarily having a radius of curvature along a second opposing edge of the second side.
Regarding claim 3, Casscells discloses (see above) a medical device wherein the cutter forms an opening to the lumen (recessed gap between 626’s in fig. 6B; also see fig 5A), wherein the opening has a maximum dimension that is smaller than a cross-sectional area of the lumen.
Regarding claim 4, Casscells discloses (see above) a medical device wherein the outer shaft at the distal tip portion has a hemispherical dish shape (see figs. 1A and 5A).
Regarding claim 5, Casscells discloses (see above) a medical device wherein the cutter necessarily has a radius of curvature along substantially an entirety of an outer surface thereof (see figs. 5A and 6A-B).
Regarding claim 6, Casscells discloses (see above) a medical device wherein the cutter necessarily has a ‘truncated spheroid shape’ along an outer surface thereof (see figs. 5A and 6A-B).
Regarding claim 7, Casscells discloses (see above) a medical device wherein the cutter is nested in and captured by the distal tip portion such that the cutter is substantially prevented from proximal-distal movement relative to the distal tip portion of the outer shaft (see figs. 1A and 5A).
Regarding claim 15, Casscells discloses (note figs. 1A, 5A, and 6A-B) a medical device comprising: an outer shaft (114) having a lumen, a proximal portion and a distal tip portion (distal portion of ‘114’ that only partially encloses ‘142’) with a ‘hemispherical dish shape’ (see figs. 1A and 5A) that has a ‘dimension’ that is enlarged relative to a diameter (e.g., an inner diameter) of the proximal portion (it should also be noted that this distal tip portion appears to extend distally beyond the cylindrical portion of ‘114’ by a distance that is greater than the diameter of the proximal portion); and a cutter (142) configured to remove the tissue, wherein the cutter is at least partially nested in the distal tip portion and captured by the distal tip portion such that the cutter is substantially prevented from proximal-distal movement relative to the distal tip portion of the outer shaft (see figs. 1A and 5A).
Regarding claim 16, Casscells discloses (see above) a medical device wherein the cutter has an enlarged dimension relative to a diameter of the proximal portion of the outer shaft (see fig. 5A), wherein the cutter is configured to provide the medical device with a positive approach angle to the tissue with an outer surface or one or more edges of the cutter forming an acute inclined angle with an outer surface of the outer shaft (see fig. 5A), wherein the cutter is rotatable relative to the outer shaft and includes a first side with an electrode (any of the four bifurcated pair of 626’s in fig. 6B) necessarily having a radius of curvature, wherein the electrode is configured to provide radiofrequency energy to the tissue (see fig. 3B), and a second side (composed of the remaining three bifurcated pairs of 626’s in fig. 6B) with one or more features for mechanically cutting the tissue, wherein the one or more features include a plurality of resection ‘teeth’ (any two adjacent bifurcated pairs of 626’s of the remaining three in fig. 6B) along a first edge of the second side and a ‘blade’ (either ‘626’ in last remaining bifurcated pair of 626’s in fig. 6B) necessarily having a radius of curvature along a second opposing edge of the second side, wherein the cutter forms an opening to the lumen (recessed gap between 626’s in fig. 6B; also see fig 5A), wherein the opening has a maximum dimension that is smaller than a cross-sectional area of the lumen.
Regarding claim 19, Casscells discloses (note figs. 1A, 5A, and 6A-B) a medical device comprising: an outer shaft (114) having a lumen, a proximal portion and a distal tip portion (distal portion of ‘114’ that only partially encloses ‘142’) with an enlarged ‘dimension’ relative to a diameter (e.g., an inner diameter) of the proximal portion (it should also be noted that this distal tip portion appears to extend distally beyond the cylindrical portion of ‘114’ by a distance that is greater than the diameter of the proximal portion); and a cutter (142) configured to remove the tissue, wherein the cutter is at least partially received by the distal tip portion and is configured to provide the medical device with a positive approach angle to the tissue with an outer surface or one or more edges of the cutter forming an acute inclined angle with an outer surface of the outer shaft (see fig. 5A), wherein the cutter has an enlarged dimension relative to a diameter of the proximal portion of the outer shaft (see fig. 5A).
Regarding claim 20, Casscells discloses (see above) a medical device wherein the cutter is rotatable relative to the outer shaft and includes a first side with an electrode (any of the four bifurcated pair of 626’s in fig. 6B) necessarily having a radius of curvature, wherein the electrode is configured to provide radiofrequency energy to the tissue (see fig. 3B), and a second side (composed of the remaining three bifurcated pairs of 626’s in fig. 6B) with one or more features for mechanically cutting the tissue, wherein the one or more features include a plurality of resection ‘teeth’ (any two adjacent bifurcated pairs of 626’s of the remaining three in fig. 6B) along a first edge of the second side and a ‘blade’ (either ‘626’ in last remaining bifurcated pair of 626’s in fig. 6B) necessarily having a radius of curvature along a second opposing edge of the second side, wherein the cutter forms an opening to the lumen (recessed gap between 626’s in fig. 6B; also see fig 5A), wherein the opening has a maximum dimension that is smaller than a cross-sectional area of the lumen, wherein the cutter necessarily has a radius of curvature along substantially an entirety of an outer surface thereof (see figs. 5A and 6A-B), wherein the cutter necessarily has a ‘truncated spheroid shape’ along the outer surface thereof (see figs. 5A and 6A-B).
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) 8-10 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Casscells in view of Davis, U.S. 10,945,758 (hereinafter Davis).
Regarding claims 8-10 and 17, Casscells discloses (see above) a medical device comprising an outer shaft and a cutter. However, Casscells fails to explicitly disclose that the medical device further comprises a first camera coupled to the proximal portion of the outer shaft and a second camera coupled to the distal tip portion, wherein at least one of the cameras includes a light source. Davis teaches (note fig. 2) a similar device comprising a first camera (18) coupled to a proximal portion of an outer shaft and a second camera (note “[camera] disposed at a distal end of the tip of the device” - col. 3, line 53) coupled to a distal tip portion, wherein at least one of the cameras includes a light source (19), and wherein these cameras communicate with a display (note col. 4, line 23). It is well known in the art that this configuration, which enables visualization, would result in increased safety and efficiency. 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 Casscells to comprise a first camera coupled to the proximal portion of the outer shaft and a second camera coupled to the distal tip portion, wherein at least one of the cameras includes a light source, and wherein these cameras communicate with the display (as taught by Davis), in order to enable visualization and increase safety and efficiency. It should be noted that the cameras in this modified device would necessarily have the claimed fields of view.
Claim(s) 11-14 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Casscells in view of Davis as applied to claims 8-10 and 17 above, and further in view of Whitman, U.S. 2006/0020213 (hereinafter Whitman).
Regarding claims 11-14 and 18, Casscells in view of Davis teaches (see above) a medical device comprising an outer shaft, cutter, cameras, light source, and display. However, this combination of references fails to expressly teach cameras that are offset relative to a longitudinal axis, wherein each of the cameras includes a light source, and wherein a controller is configured to communicate with these components to activate the light sources in sequence and display a composite based on the fields of view. Whitman teaches (note abstract) a similar device comprising cameras that are offset relative to a longitudinal axis (note fig. 10), wherein each of the cameras includes a light source (not abstract), and wherein a controller is configured to communicate with these components to activate the light sources in sequence and display a composite based on the fields of view (note abstract; paragraphs 142 and 144). It is well known in the art that this configuration, which enhances visualization, would result in increased safety and efficiency. 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 Casscells to comprise cameras that are offset relative to a longitudinal axis, wherein each of the cameras includes a light source, and wherein a controller is configured to communicate with these components to activate the light sources in sequence and display a composite based on the fields of view (as taught by Whitman), in order to enhance visualization and increase safety and efficiency. It should be noted that the claim language describing how the change between the fields of view is determined (found in claims 13 and 18) has not been positively recited, and therefore these limitations are not required by the current language.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2005/0165420 (Cha).
U.S. 6,007,533 (Casscells).
U.S. 6,610,059 (West).
U.S. 9,381,022 (Bradley).
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
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