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 .
Response to Amendment
The amendment filed 12/29/2025 has been entered. In the present application, claims 1-7 have been canceled. Claims 17-20 are newly added. Claim 8 has been amended. Claims 8-20 are pending and examined below.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the independent claim has been amended with new limitations. Independent claim 8 has been amended with the newly added statement stating, “wherein a circumference of the handle at the gripping section decreases from the manipulation section toward the transition section at least along a majority of a length of the gripping section.”
Such newly added limitations change the scope of the claims, renders the previous rejection identified in the non-final office action dated 09/29/2025 moot, and requires a new ground of rejection. As such the previous rejections identified in the non-final office action 09/29/2025 have been withdrawn. A new ground of rejection is presented below.
Please see section 35 U.S.C. §102 and 35 U.S.C. §103 below for further explanation.
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 8 is 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.
Regarding Claim 8, the phrase “at least along a majority of a length” in line 22, which includes the term ‘majority’ and is the term ‘majority’ a relative term which renders the claim indefinite. The term “majority” 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. It is unclear whether the term majority within the limitation “…the gripping section decreases from the manipulation section toward the transition section at least along a majority of a length of the gripping section” requires the ‘length’ to be the entire exterior surface of the gripping section or merely a specific section of the gripping section having a specific length. Also, it is unclear whether the term majority equates to slightly over half (i.e. 50.5%, 51%, or 52%) the entire exterior surface or specific length of the gripping section; or whether the term majority equates to significantly more, (i.e. 75%, 80%, 99%) than half of the entire exterior surface or specific length of the gripping section. It is suggested to amend the limitation to state language similar to, but not limited to, “where in a circumference of the handle at the gripping section decreases from the manipulation section toward the transition section
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.
Claims 8-13 and 18-20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Altshuler et al. (US11617858) hereinafter Altshuler.
Regarding Claim 8, Altshuler discloses an endoscope (Fig. 1b catheter assembly 30b) comprising:
an insertion cord (Fig. 1b steerable catheter 34), the endoscope (Fig. 1b catheter assembly 30b) including a longitudinal center axis (see annotated Fig. 1b) that passes through the insertion cord (Fig. 1b steerable catheter 34) in an unbent state of the insertion cord (Fig. 1b steerable catheter 34); and
a handle (Fig. 1b steering handle 32b) including a manipulation section (see annotated Fig. 1b),
a transition section (see annotated Fig. 1b), and
a gripping section (see annotated Fig. 1b) between the manipulation section (see annotated Fig. 1b) and the transition section (see annotated Fig. 1b),
wherein the insertion cord (Fig. 1b steerable catheter 34) extends from the transition section (see annotated Fig. 1b),
wherein the gripping section (see annotated Fig. 1b) comprises a back surface area (see annotated Fig. 1b) inclined at a first forward angle (see annotated Fig. 1b) greater than zero and a front surface area (see annotated Fig. 1b) inclined at a second forward angle (see annotated Fig. 1b) greater than the first forward angle (see annotated Fig. 1b),
wherein the manipulation section (see annotated Fig. 1b) protrudes forwardly from the front surface area (see annotated Fig. 1b) and includes a lower surface (see annotated Fig. 1b) adjacent the front surface area (see annotated Fig. 1b), the front surface area (see annotated Fig. 1b) being opposite the back surface area (see annotated Fig. 1b),
wherein a front-back plane (see annotated Fig. 1b) passes through the front surface area (see annotated Fig. 1b), the back surface area (see annotated Fig. 1b), and the longitudinal center axis (see annotated Fig. 1b),
wherein a left-right plane (see annotated Fig. 1b) orthogonal to the front-back plane (see annotated Fig. 1b) passes through the longitudinal center axis (see annotated Fig. 1b), and
wherein the first forward angle (see annotated Fig. 1b) and the second forward angle (see annotated Fig. 1b) are relative to the left-right plane;
wherein a circumference (see annotated Fig. 2) of the handle (Fig. 1b-2 steering handle 32b) at the gripping section (see annotated Figs. 1b-2) decreases from the manipulation section (see annotated Figs. 1b-2) toward the transition section (see annotated Figs. 1b-2) at least along a majority of a length (Examiner’s note: Here Examiner is interpreting length to mean the entirety of the gripping section.) of the gripping section(see annotated Figs. 1b-2).
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Regarding Claim 9, Altshuler discloses the endoscope of claim 8, wherein the first forward angle is between 100 and 200 ([0036] “The bulkhead 132 intersects the forward side 54 of the body portion 48 at a junction point 139 located at the mid-plane 52 of the handle 32 (FIGS. 6A and 6B). An exterior surface of the bulkhead 132 may be centered about a bulkhead plane 140 that extends in the forward and distal directions 62 and 67 relative to a reference vector 141 that extends normal to the junction point 139 in the forward direction 62, the reference vector 141 being coplanar with the mid-plane 52. The bulkhead plane 140 thereby defines a slope angle θ relative to the reference vector 141, the slope angle θ extending distal to the reference vector 141. In some embodiments, the slope angle θ is within a range of 10 degrees to 60 degrees inclusive; in some embodiments, the slope angle θ is within a range of 15 degrees to 50 degrees inclusive; in some embodiments, the slope angle θ is within a range of 20 degrees to 40 degrees inclusive”).
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Regarding Claim 10, Altshuler discloses the endoscope of claim 9, wherein the first forward angle is 140([0036] “The bulkhead 132 intersects the forward side 54 of the body portion 48 at a junction point 139 located at the mid-plane 52 of the handle 32 (FIGS. 6A and 6B). An exterior surface of the bulkhead 132 may be centered about a bulkhead plane 140 that extends in the forward and distal directions 62 and 67 relative to a reference vector 141 that extends normal to the junction point 139 in the forward direction 62, the reference vector 141 being coplanar with the mid-plane 52. The bulkhead plane 140 thereby defines a slope angle θ relative to the reference vector 141, the slope angle θ extending distal to the reference vector 141. In some embodiments, the slope angle θ is within a range of 10 degrees to 60 degrees inclusive; in some embodiments, the slope angle θ is within a range of 15 degrees to 50 degrees inclusive; in some embodiments, the slope angle θ is within a range of 20 degrees to 40 degrees inclusive”).
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Regarding Claim 11, Altshuler discloses the endoscope of claim 8, wherein said front surface area (see annotated Fig. 1b) comprises a saddle shape (see annotated Fig. 1b near arrow identifying the front surface area).
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Regarding Claim 12, Altshuler discloses the endoscope of claim 11, wherein said back surface area (see annotated Fig. 1b) comprises a flat surface (see annotated Fig. 1b).
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Regarding Claim 13, Altshuler discloses the endoscope of claim 8, wherein said back surface area (see annotated Fig. 1b) comprises a flat surface (see annotated Fig. 1b).
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Regarding Claim 18, Altshuler discloses the endoscope of claim 8, wherein the circumference (see annotated Fig. 2) of the gripping section (see annotated Fig. 2) decreases from the manipulation section (see annotated Fig. 2) toward the transition section (see annotated Fig. 2) in a continuous manner (Examiner is interpreting “continuous manner” to be a smooth surface. Here Altshuler shows a smooth surface in Fig. 2).
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Regarding Claim 19, Altshuler discloses the endoscope of claim 8, wherein the handle (Fig. 1b steering handle 32b) comprises a transition step (see annotated Fig. 2) between the gripping section (see annotated Fig. 2) and the transition section (see annotated Fig. 2), and wherein the transition step (see annotated Fig. 2) comprises a convex inflection and a concave inflection (see annotated Fig. 2) proximal of the convex inflection (see annotated Fig. 2).
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Regarding Claim 20, Altshuler discloses the endoscope of claim 8, wherein the handle (Fig. 1b steering handle 32b) comprises a transition step (see annotated Fig. 2) between the gripping section (see annotated Fig. 2) and the transition section (see annotated Fig. 2), and wherein the circumference (see annotated Fig. 2) of the handle decreases abruptly (Examiner is interpret the phrase “decreases abruptly at the transition step’, to mean the decrease stops at the transition step.) at the transition step (see annotated Fig. 2).
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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.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Altshuler in view of Fanenbruck et al. (US2018/0303318) hereinafter Fanenbruck.
Regarding Claim 14, Altshuler discloses the endoscope of claim 8, but is silent at explicitly teaching wherein a length of the back surface area measured at an intersection of the front-back plane and the back surface area is at least 100 mm.
However Fanenbruck, in the same field of endeavor, teaches wherein a length of the back surface area measured at an intersection of the front-back plane and the back surface area is at least 100 mm (Fanenbruck – [0011] The handle of the endoscopic probe according to the invention can have a diameter of 18 to 38 mm, in particular of 24 to 32 mm. Moreover, the grip portion and the front end can together have a length in the range of 100 to 120 mm, in particular in the range of 105 to 115 mm. With these dimensions, it is compact enough to allow the endoscopic probe to be used together with a surgical microscope, without there being any appreciable risk of the handle colliding with the surgical microscope, but also large enough to be able to receive the necessary technical elements such as light source and sensor, but also a heat accumulator to prevent the handle from overheating at places, which would make handling uncomfortable or, in extreme cases, impossible. Moreover, the safe handling of an instrument with the described geometry likewise requires a grip or handle of the stated dimensions.).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Altshuler with the teachings of Fanenbruck to have wherein a length of the back surface area measured at an intersection of the front-back plane and the back surface area is at least 100 mm for the benefit of having the handle be compact “…but also large enough to be able to receive the necessary technical elements such as a light source and sensor” (Fanenbruck – [0011]).
Regarding Claim 15, Altshuler discloses the endoscope of claim 8, wherein the first forward angle is between 100 and 200 ([0036] “The bulkhead 132 intersects the forward side 54 of the body portion 48 at a junction point 139 located at the mid-plane 52 of the handle 32 (FIGS. 6A and 6B). An exterior surface of the bulkhead 132 may be centered about a bulkhead plane 140 that extends in the forward and distal directions 62 and 67 relative to a reference vector 141 that extends normal to the junction point 139 in the forward direction 62, the reference vector 141 being coplanar with the mid-plane 52. The bulkhead plane 140 thereby defines a slope angle θ relative to the reference vector 141, the slope angle θ extending distal to the reference vector 141. In some embodiments, the slope angle θ is within a range of 10 degrees to 60 degrees inclusive; in some embodiments, the slope angle θ is within a range of 15 degrees to 50 degrees inclusive; in some embodiments, the slope angle θ is within a range of 20 degrees to 40 degrees inclusive”). , wherein said front surface area (see annotated Fig. 1b) comprises a saddle shape, wherein said back surface area (see annotated Fig. 1b) comprises a flat surface (see annotated Fig. 1b).
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Altshuler is silent at explicitly teaching wherein a length of the back surface area measured at an intersection of the front-back plane and the back surface area is at least 100 mm.
However Fanenbruck, in the same field of endeavor, teaches wherein a length of the back surface area measured at an intersection of the front-back plane and the back surface area is at least 100 mm (Fanenbruck – [0011] The handle of the endoscopic probe according to the invention can have a diameter of 18 to 38 mm, in particular of 24 to 32 mm. Moreover, the grip portion and the front end can together have a length in the range of 100 to 120 mm, in particular in the range of 105 to 115 mm. With these dimensions, it is compact enough to allow the endoscopic probe to be used together with a surgical microscope, without there being any appreciable risk of the handle colliding with the surgical microscope, but also large enough to be able to receive the necessary technical elements such as light source and sensor, but also a heat accumulator to prevent the handle from overheating at places, which would make handling uncomfortable or, in extreme cases, impossible. Moreover, the safe handling of an instrument with the described geometry likewise requires a grip or handle of the stated dimensions.).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Altshuler with the teachings of Fanenbruck to have wherein a length of the back surface area measured at an intersection of the front-back plane and the back surface area is at least 100 mm for the benefit of having the handle be compact “…but also large enough to be able to receive the necessary technical elements such as a light source and sensor” (Fanenbruck – [0011]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over William Roskopf (US2008/0177142) hereinafter Roskopf, in view of Altshuler.
Regarding Claim 16, Roskopf discloses a visualization system (Fig. 1 endoscope video imaging system 10) comprising: the endoscope (Fig. 1 imaging endoscope 20); and a display device (Fig. 1 display 176).
Roskopf is silent as to explicitly disclose the endoscope of claim 8.
However Altshuler, in the same field of endeavor, teaches the endoscope of claim 8 (see claim 8 above under section 35 U.S.C. §102).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Roskopf in view of Altshuler to create an endoscope as disclosed in claim 8 above with the endoscope of Roskopf for the benefit of creating a steering handle for an endoscope that resolves the problem of hand fatigue of an operator (Altshuler – [col. 1 lines 20-43]).
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Altshuler in view of Uchida et al. (WO2020070775A1) hereinafter Uchida, [ US12181656 is used for English Translation].
Regarding Claim 17, Altshuler discloses the endoscope of claim 8, wherein the manipulation section (Altshuler – see annotated Fig. 2) comprises a front surface and two control buttons (Altshuler – buttons 126) protruding from the front surface (Altshuler – see annotated Fig. 2) but is silent as explicitly discloses wherein two steering control knobs on a right side, an umbilical connection protrusion on a left side, the front-back plane traversing the two control buttons, and wherein the two steering control knobs, the umbilical connection protrusion and the two control buttons, are sized and positioned to enable an operator to control the handle and manipulate the two steering control knobs and the two control buttons with one hand.
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However Uchida, in the same field of endeavor teach, wherein two steering control knobs (Uchida - Fig. 1 knobs 11, 12, 13) on a right side (Uchida - Fig. 1 surface 6ca), an umbilical connection protrusion (Uchida - Fig. 1 cord fixing portion 80) on a left side (Uchida - Fig. 1 surface 6cb), the front-back plane (Uchida - Fig. 1 plane near surface 6cc)traversing the two control buttons (Uchida – Fig. 1 buttons 35-37), and wherein the two steering control knobs(Uchida - Fig. 1 knobs 11, 12, 13), the umbilical connection protrusion(Uchida - Fig. 1 cord fixing portion 80) and the two control buttons (Uchida – Fig. 1 buttons 35-37), are sized and positioned to enable an operator to control the handle and manipulate the two steering control knobs and the two control buttons with one hand (see Fig. 2).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Altshuler with the teachings of Uchida to include wherein two steering control knobs on a right side, an umbilical connection protrusion on a left side, the front-back plane traversing the two control buttons, and wherein the two steering control knobs, the umbilical connection protrusion and the two control buttons, are sized and positioned to enable an operator to control the handle and manipulate the two steering control knobs and the two control buttons with one hand for the benefit of having a handle have a configuration with “..a weight balance is excellent when the operator grasps the operation portion…without reducing the operability of the knobs and levers…” (Uchida – col. 5 line 60 -col. 8 line 61]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN E MONAHAN whose telephone number is (571)272-7330. The examiner can normally be reached Monday - Friday, 8am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN ELIZABETH MONAHAN/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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