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 Objections
Claims 2-3, 15-16, 18, and 20-21 are objected to because of the following informalities:
In claim 2, line 1, “wherein the portion of the tool bends” should read “wherein the portion of the tool is configured to bend.” The suggested amendment would improve clarity by specifying that the recited limitation pertains to the functional capability of the claimed apparatus to bend in the recited direction, rather than reciting an affirmative step of bending the portion of the tool.
In claim 3, line 1, “wherein the portion of the tool resists bending” should read “wherein the portion of the tool is configured to resist bending.” The suggested amendment would improve clarity by specifying that the recited limitation pertains to the functional capability of the claimed apparatus to resist bending in the recited direction, rather than reciting an affirmative step of resisting the bending of the portion of the tool.
In claim 15, line 1, “wherein the imaging device is bent away” should read “wherein the imaging device is configured to be bent away.” The suggested amendment would improve clarity by specifying that the recited limitation pertains to the functional capability of the claimed imaging device to bend in the recited direction, rather than reciting an affirmative step of bending of the imaging device.
In claim 15, line 2, “wherein the portion of the tool is bent away” should read “wherein the portion of the tool is configured to be bent away.” The suggested amendment would improve clarity by specifying that the recited limitation pertains to the functional capability of the claimed apparatus to bend in the recited direction, rather than reciting an affirmative step of bending of the portion of the tool.
In claim 16, line 1, “claim 15 wherein” should read “claim 15, wherein”
In claim 18, line 2, “20mm mm” should read “20 mm”
In claims 20-21, line 1, “claim 19 wherein” should read “claim 19, wherein”
Appropriate correction is required.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 is:
“an imaging device configured to generate image data having a field of view” in claims 1 and 19 as described in Para. [0023] of Applicant’s specification.
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 § 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.
Claim 21 is 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.
The term “vulnerable tissue” in claim 21 is a relative term which renders the claim indefinite. The term “vulnerable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification does identify examples of vulnerable tissue, such as vasculature or pleural tissue, the specification does not provide an objective standard for determining whether other tissue is considered “vulnerable.” Therefore, it is unclear which tissues fall within the scope of “vulnerable tissue.” For the purposes of examination, “vulnerable tissue” is being examined as “tissue.”
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)(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.
(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.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1-2, 4, 9-11, 13-14, and 17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Appl. Publ. No. 2022/0361743 A1 to Chan et al. (“Chan”).
Regarding claim 1, Chan discloses an apparatus (imaging apparatus 100; Fig. 6A, paragraph 0145) comprising:
an imaging probe (an elongate catheter body 102; Fig. 6A, paragraph 0092) including:
a channel extending through the imaging probe (a second catheter lumen 106 … or passage extending through the catheter body 102; Fig. 6A, paragraph 0092) and terminating at an opening (the catheter outlet port 118 can be in fluid communication with the second catheter lumen 106; Fig. 6A, paragraph 0104); and
an imaging device (the imaging component 110 can comprise an imaging sensor 111; Fig. 6A, paragraph 0099) configured to generate image data having a field of view (a field of view 122 of the imaging component 110; Fig. 6A, paragraph 0106); and
a tool (a guidewire 112 or another minimally-invasive surgical tool; Fig. 6A, paragraph 0093) configured to slidably extend within the channel (the second catheter lumen 106 can be configured to house or contain at least part of a guidewire 112; Fig. 6A, paragraph 0099), wherein a portion of the tool is flexible (the guidewire 112 can be a steerable guidewire; Fig. 6A, paragraph 0102), has a bent, and bends away from the imaging device when the portion of the tool is extended distally of the opening (the portion of the guidewire 112 extending distilling of the port 118 is bent away from the imaging sensor 111; Fig. 6A).
Regarding claim 2, Chan discloses the apparatus according to claim 1. Chan further discloses wherein the portion of the tool bends in a direction that results in a distal tip of the tool being within the field of view of the imaging device (the catheter outlet port 118 can be aligned or overlap with at least one of the one or more light transmittable windows 120 such that the guidewire 112 is within the field of view 122 of imaging component 110 within the first catheter lumen 104 when the guidewire 112 exists the second catheter lumen 106 through the catheter outlet port 118; Fig. 6A, paragraph 0106).
Regarding claim 4, Chan discloses the apparatus according to claim 1. Chan further discloses wherein the field of view increases as distance from the imaging device increases (the field of view 122 of the imaging component 110 increases as distance from the imaging component 110 increases; Fig. 6A).
Regarding claim 9, Chan discloses the apparatus according to claim 1. Chan further discloses wherein the tool is constrained to prevent rotation of the tool within the channel (the guiding needle 700 may have a tendency to rotatably torque or whip to an angular orientation that is different than the desired orientation by the user. In some further variations, the guiding needle 700 may be provided with a non-circular outer perimeter … along its catheter body or a distal portion thereof, with a complementary interfit in the second catheter lumen 106 or catheter outlet port 118, to help maintain the guiding needle 700 within a predictable angular orientation range; Fig. 7C, paragraph 0163).
Regarding claim 10, Chan discloses the apparatus according to claims 1 and 9. Chan further discloses wherein each of the tool and the channel has a cross- sectional shape that is asymmetrical in orthogonal dimensions (the guiding needle 700 may be provided with a non-circular outer perimeter, e.g. an oval, square, rectangular, triangle, trapezoidal, or other polygonal shape along its catheter body or a distal portion thereof; paragraph 0163)(Figs. 9C to 9N depict various alternate configurations of the first and second lumens, including different sizes, shapes, orientations, and positions; Fig. 9C-9F, paragraph 0168-0169).
Regarding claim 11, Chan discloses the apparatus according to claims 1 and 9-10. Chan further discloses wherein a cross-sectional shape of the channel is oval and a cross-sectional shape of the tool is oval (the guiding needle 700 may be provided with a non-circular outer perimeter, e.g. an oval, square, rectangular, triangle, trapezoidal, or other polygonal shape along its catheter body or a distal portion thereof; paragraph 0163)(the guiding needle and/or an outer sheath of an imaging apparatus spinning inside the outer sheath may have a partially or completely complementary shape and size of the lumen in which it resides; Fig. 9F, paragraph 0168-0169).
Regarding claim 13, Chan discloses the apparatus according to claims 1 and 9-10. Chan further discloses wherein a cross-sectional shape of the channel is D- shaped and a cross-sectional shape of the tool is D-shaped (the guiding needle and/or an outer sheath of an imaging apparatus spinning inside the outer sheath may have a partially or completely complementary shape and size of the lumen in which it resides; Fig. 9D, paragraph 0168-0169).
Regarding claim 14, Chan discloses the apparatus according to claim 1. Chan further discloses wherein a cross-sectional shape of the channel is different from a cross-sectional shape of the tool (Figs. 9C to 9N depict various alternate configurations of the first and second lumens, including different sizes, shapes, orientations, and positions; Fig. 9C-9F, paragraph 0168).
Regarding claim 17, Chan discloses the apparatus according to claim 1. Chan further discloses wherein the tool is a tissue piercing tool including a beveled tip (the needle tip 706 may be a beveled needle tip with a beveled face that may be orientated either in parallel or orthogonal to the longitudinal axis of the catheter body 102. An orthogonal bevel face may facilitate penetration of the needle tip 706 into the adjacent tissue, while a parallel bevel face may facilitate blunt dissection through adjacent tissue; Fig. 7A, paragraph 0162) and the tool is rotationally constrained relative to the channel (the guiding needle 700 may have a tendency to rotatably torque or whip to an angular orientation that is different than the desired orientation by the user. In some further variations, the guiding needle 700 may be provided with a non-circular outer perimeter … along its catheter body or a distal portion thereof, with a complementary interfit in the second catheter lumen 106 or catheter outlet port 118, to help maintain the guiding needle 700 within a predictable angular orientation range; Fig. 7C, paragraph 0163).
Claims 1 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Appl. Publ. No. 2019/0350648 A1 to Owens et al. (“Owens”).
Regarding claim 1, Owens discloses an apparatus (imaging component 100; Fig. 1A, paragraph 0086) comprising:
an imaging probe (an imaging shaft 103; Fig. 1A, paragraph 0086) including:
a channel extending through the imaging probe (the imaging shaft may comprise a proximal end and a distal end with a cavity 105 extending across the length of the shaft from the proximal end towards the distal end; Fig. 1A, paragraph 0086) and terminating at an opening (distal opening of cavity 105; Fig. 1C); and
an imaging device (the distal end of the imaging component may comprise an imaging transducer 107; Fig. 1C, paragraph 0097) configured to generate image data having a field of view (the ultrasound transducers may be aligned radially and/or axially to image multiple views simultaneously; Fig. 1A, paragraph 0099); and
a tool (a tissue collector instrument 210; Fig. 2A, paragraph 0102) configured to slidably extend within the channel (a distal end of the imaging component with a tissue collector instrument 210 disposed within the shaft 105 of the imaging component 100; Fig. 2A, paragraph 0102), wherein a portion of the tool is flexible, has a bent shape, and bends away from the imaging device when the portion of the tool is extended distally of the opening (the shaft of tissue collector 211 may be made of a pliable and/or flexible material such that it may be deflected by the imaging transducer and/or an angled portion within the cavity of the shaft; Fig. 2A, paragraph 0103).
Regarding claim 15, Owens discloses the apparatus according to claim 1. Owens further discloses wherein the imaging device is bent away from a longitudinal axis of the channel in a first direction (the imaging transducer may be configured to deflect relative to the longitudinal axis of the shaft of the imaging component; Fig. 4, paragraph 0099) and the portion of the tool is bent away from the longitudinal axis of the channel in a second direction opposite to the first direction (the distal end of the cavity of the imaging component may comprise a portion angled axially relative to the shaft, such that a distal end of an instrument may be deflected upward as it is pushed out the distal end of the cavity; Fig. 2A, paragraph 0103).
Claims 19-22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Appl. Publ. No. 2023/0148848 A1 to Gono et al. (“Gono”).
Regarding claim 19, Gono discloses a system (medical system 10; Fig. 3, paragraph 0074) comprising:
an imaging probe (endoscope 100; Fig. 3, paragraph 0074) including a channel extending through the imaging probe (a treatment tool channel for allowing the treatment tool 400 to pass through from the insertion opening 190 to the opening of the distal end section 130 is provided inside the insertion section 110; Fig. 3, paragraph 0076) and terminating at an opening (an opening 131 of a treatment tool channel; Fig. 6, paragraph 0155) and an imaging device configured to generate image data having a field of view (camera 132; Fig. 6, paragraph 0155); and
a tool configured to slidably extend within the channel (a treatment tool channel for allowing the treatment tool 400 to pass through from the insertion opening 190 to the opening of the distal end section 130 is provided inside the insertion section 110; Fig. 6, paragraph 0076), wherein a portion of the tool is flexible, has a bent shape, and bends away from the imaging device when the portion of the tool is extended distally of the opening (the treatment tool 400 includes … a bending movement section 403 capable of bending movement; Figs. 18-19, paragraph 0157); and
a control system comprising one or more processors (control device 600 includes a drive control device 200 … and a video control device 500; Fig. 3, paragraphs 0077 and 0220) configured to:
deploy the portion of the tool distally of the opening and into the field of view (drive control unit 200 controls the … treatment tool motion; Fig. 6, paragraphs 0094, 0145, and 0165); and
receive the image data including the portion of the tool in the field of view (the video control device 500 receives an image signal from a camera provided at the distal end section 130 of the endoscope 100; Fig. 3, paragraph 0077).
Regarding claim 20, Gono discloses the system according to claim 19. Gono further discloses wherein the control system is further configured to evaluate the image data to determine a position of the tool with respect to a target tissue in the field of view (the drive controller 260 performs automatic control of the endoscope or the treatment tool based on the endoscope image from the image acquisition device 270; Fig. 14, paragraph 0145).
Regarding claim 21, Gono discloses the system according to claim 19. Gono further discloses wherein the control system is further configured to evaluate the image data to determine a position of the tool with respect to a vulnerable tissue in the field of view (when the endoscope or the treatment tool is about to contact an organ, the drive control device 200 causes intervention of the automatic control during the manual operation so as to cause the medical instrument to perform an avoiding action; paragraph 0085) (the control device 200 may predict the contact by a process of recognition of the image and the operation information; paragraph 0107). Gono discloses a control system that evaluates image data to determine the position of the tool with respect to vulnerable tissue such as the intestinal wall of the duodenum and avoid contact between the tool and the vulnerable tissue (paragraph 0102).
Regarding claim 22, Gono discloses the system according to claim 19. Gono further discloses wherein deploying the portion of the tool includes causing the tool to bend in a direction that results in a distal tip of the tool being within the field of view (the drive controller 260 performs automatic control of the endoscope or the treatment tool based on the endoscope image from the image acquisition device 270; Fig. 14, paragraph 0145). Gono discloses a step of aiming the imaging device such that the papillary portion appears in the center of the field of view (paragraph 0067), and subsequently, a step of delivering the treatment tool out of the opening of the treatment tool channel and into the opening of the common duct (paragraph 0068). As the opening of the common duct is located in the papillary portion of the duodenum, it is understood that the treatment tool is within the field of view of the imaging device.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chan.
Regarding claim 12, Chan discloses the apparatus according to claims 1 and 9-10. Chan further discloses wherein a cross-sectional shape of the channel is oval (Figs. 9C to 9N depict various alternate configurations of the first and second lumens, including different sizes, shapes, orientation, and positions; Fig. 9F, paragraph 0168). However, Chan does not explicitly disclose wherein a cross-sectional shape of the tool is D-shaped, but Chan does disclose wherein the treatment tool has a non-circular cross-sectional shape (paragraph 0163). It is noted, that there is no significant difference between the plurality of non-circular shapes disclosed by Chan and a D-shape. Further, D-shaped tools were well known in the art at the time the invention was made (as evidenced by Chan, see Fig. 9D). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the apparatus of Chan to have a tool with a D-shaped cross-section, as such modification would involve a mere change in configuration. It has been held that a change in configuration of shape of a device is obvious, absent persuasive evidence that a particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 18, Chan discloses the apparatus according to claim 1. However, Chan does not explicitly disclose wherein the imaging probe has an outer width between approximately 3.0 and 20 mm and the tool has an outer width between approximately 1.0 and 3.5 mm.
While the reference does not explicitly disclose the specific outer width of the imaging probe and tool, it would have been obvious to one of ordinary skill in the art at the time of the invention to change the outer width of the imaging probe and tool, since such a modification would have involved a mere change in the size (or dimension) of a component. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). It is well known in the art that many design parameters are taken into consideration when determining the outer width of the imaging probe and tool.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Owens.
Regarding claim 18, Owens discloses the apparatus according to claim 1. However, Owens does not explicitly disclose wherein a bend angle between the imaging device and the tool is between 20 and 80 degrees.
Owens however, discloses wherein the imaging device can be deflected by less than 45 degrees and additionally or alternatively, for example, … less than 90 degree, … less than 15 degrees. As such, the change the bend angle between the imaging device and the tool are disclosed to be a result effective variable in that the bend angle between the imaging device and the tool is dependent on actuation of the deflection lever (paragraph 0999) and the angle of the distal end of the channel (paragraph 0100). Therefore it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to change the bend angle between the imaging device and the tool to be between 20 and 80 degrees as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, Applicant places no criticality on the range claimed, indicating that “in some examples, the bend angle 122 may be between approximately 20 and 80 degrees” (paragraph 0028 of Applicant’s specification).
Claims 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Chan in view of U.S. Patent Appl. Publ. No. 2017/0143317 A1 to Hoffman (“Hoffman”).
Regarding claim 3, Chan discloses the apparatus according to claim 1. However, Chan does not explicitly disclose wherein the portion of the tool resists bending in a direction that results in a distal tip of the tool being outside of an imaging plane of the field of view.
Hoffman teaches wherein the portion of the tool resists bending in a direction that results in a distal tip of the tool being outside of an imaging plane of the field of view (arranged in this manner, the flexibility of the needle wall 300 along the region of increased flexibility 302 will be asymmetrically flexible so as to permit increased bending or flexibility in one direction or plane while being less flexible in another direction; Fig. 3F, paragraphs 0054-0055). Hoffman teaches that modifying a needle by limiting flexibility in one direction helps to maintain alignment between the needle and imaging device (paragraph 0055).
Hoffman is considered to be analogous to the claimed invention because it is in the same field of imaging probes with a channel configured to receive a tool. It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the needle of Chan to incorporate the teachings of Hoffman such that the tool resists bending in one direction. Doing so would help to maintain alignment between the needle and imaging device, as recognized by Hoffman.
Regarding claim 7, Chan discloses the apparatus according to claim 1. However, Chan does not explicitly disclose wherein the bent shape of the tool is formed by surface features on the portion of the tool.
Hoffman teaches wherein the bent shape of the tool is formed by surface features on the portion of the tool (cuts 304 can be positioned along only one side of the needle wall 300; Fig. 3F, paragraph 0054). Hoffman teaches that cuts in the needle wall help to enhance flexibility (paragraph 0057).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the needle of Chan to incorporate the teachings of Hoffman by adding cuts on the outer wall. Doing so would help to enhance flexibility of the tool, as recognized by Hoffman.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Chan in view of U.S. Patent Appl. Publ. No. 2016/0278809 A1 to Sato (“Sato”).
Regarding claim 6, Chan discloses the apparatus according to claim 1. However, Chan does not explicitly disclose wherein the bent shape of the tool is formed of a flexible, shape memory material.
Sato teaches wherein the bent shape of the tool is formed of a flexible, shape memory material (the needle tube 34 is formed of a shape memory alloy which can be restored to a predetermined shape; Fig. 10, paragraph 0073).
Sato is considered to be analogous to the claimed invention because it is in the same field of imaging probes with a channel configured to receive a tool. It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the needle of Chan to incorporate the teachings of Sato by forming the needle of a flexible, shape memory material. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Appl. Publ. No. 2007/0232922 A1 to Kohno teaches an ultrasound endoscope with a biopsy channel for insertion of an instrument into the endoscope as described in the abstract and following descriptive text.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET.
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/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
