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 .
Information Disclosure Statement
The information disclosure statement filed 06/30/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. The Examiner notes that copies of most of the Foreign and Non-Patent Documents listed on the IDS of 06/30/2025 were provided in parent application 18/308,624. However, a copy of Foreign Patent Document Number 11 (JP 2022-547662) was not provided in parent applications 17/768,865 or 18/308,624, nor was it provided in the current application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Dependent claim 8 recites, “further comprising adjusting a pad of the clamp from a first position to a second position where the pad is in contact with the endoscope in the second position”. However, amended independent claim 7, from when claim 8 depends, recites, in pertinent part, “adjusting a pad of the clamp from a first position in which the pad does not contact the endoscope when positioned in the receiving area to a second position where the pad is in contact with the endoscope in the second position”. The specification, as originally filed, does not disclose the clamp comprising two separate pads that are adjusted from a first position to a second position. Accordingly, the claim fails to comply with the written description requirement.
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 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. Dependent claim 8 recites, “further comprising adjusting a pad of the clamp from a first position to a second position where the pad is in contact with the endoscope in the second position”. However, amended independent claim 7, from when claim 8 depends, recites, in pertinent part, “adjusting a pad of the clamp from a first position in which the pad does not contact the endoscope when positioned in the receiving area to a second position where the pad is in contact with the endoscope in the second position”. It is not clear if there are two separate pads on the clamp that are adjusted, or if there is only one pad and the subject of dependent claim 8 does not further limit the subject matter of claim 7. Accordingly, the claim is rendered indefinite.
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.
Claim(s) 1-4, 6-11 and 13-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gupta et al. (US 2018/0078115 A1).
Regarding claim 1, Gupta discloses a method of reversibly restraining an elongate medical device (50; par. [0042]), comprising: positioning an elongate medical device in a holder of a clamp (500; par. [0042]; Figs. 14-15); wherein the holder comprising a first sidewall (512; par. [0049]; Fig. 7) and a second sidewall (513; par. [0049]; Fig. 7) defining a receiving area (523A of 513; Fig. 7); actuating at least one of the first sidewall (512) or the second sidewall of the holder to at least a clamped configuration (moving 512 to a closed position; par. [0049]) to exert a positioned in the receiving area (523A disposed on 513; Fig. 7) such that the elongate medical device is neither axially nor rotationally translatable (par. [0042] and [0049]); and adjusting a pad (520 disposed on 512; Figs. 7, 14 and 15) of the clamp from a first position (Fig. 14) in which the pad (520 disposed on 512; Figs. 7, 14 and 15) does not contact the elongate medical device (50) when positioned in the receiving area (523A disposed on 513; Fig. 7) to a second position (Fig. 15) where the pad (520 disposed on 512; Figs. 7, 14 and 15) is in contact with the elongate medical device (50) in the second position (Fig. 15), wherein the pad (520 disposed on 512; Figs. 7, 14 and 15) is located opposite the receiving area (523A disposed on 513; Figs. 7 and 15)
Regarding claim 2, Gupta discloses the method of claim 1, further comprising: transitioning the holder between a first configuration (Fig. 14) in which a first sidewall (512) is configured to set apart from the elongate medical device (50) and the clamped configuration (Fig. 15) in which the first sidewall (512) and a second sidewall (513) are configured to clamp the elongate medical device (50; par. [0049]); and moving the elongate medical device axially and rotationally in the holder in the first configuration (Fig. 14; par. [0049]).
Regarding claim 3, Gupta discloses the method of claim 2, further comprising coupling the clamp (500) to an arm (400; par. [0042] and [0045]) extending horizontally from a column (300; par. [0042] and [0044]), which extends vertically from a base (200; par. [0042]-[0043]).
Regarding claim 4, Gupta discloses the method of claim 2, wherein actuating [[the]] at least one of the first sidewall (512) or the second sidewall of the holder comprises actuating the holder to a plurality of configurations between the first configuration and the clamped configuration (Figs. 14-15; configurations between the first open configuration shown in Fig. 14 and the clamped configuration show in Fig. 15), wherein a force exerted by the holder is adjustable to restrict one or both of: an axial movement or a rotational movement of the elongate medical device (par. [0049]).
Regarding claim 6, Gupta discloses the method of claim 1, further comprising applying a circumferential force to an outer diameter of the elongate medical device (50) positioned therein by [[a]] the first sidewall (512) holder and [[a]] the second sidewall (513)
Regarding claim 7, Gupta discloses a method of reversibly restraining an endoscope (50; par. [0004] and [0042]), comprising: positioning an endoscope in a holder of a clamp (500; par. [0042]; Figs. 14-15 wherein the holder comprising a first sidewall (512; par. [0049]; Fig. 7) and a second sidewall (513; par. [0049]; Fig. 7) defining a receiving area (523A of 513; Fig. 7); actuating one or more sidewalls (512) of the holder to at least to a clamped configuration (moving 512 to a closed position; par. [0049]) to exert a force on the endoscope (par. [0053]-[0055]; Figs. 14 and 15); adjusting a pad (520 disposed on 512; Figs. 7, 14 and 15) of the clamp from a first position (Fig. 14) in which the pad (520 disposed on 512; Figs. 7, 14 and 15) does not contact the endoscope (50) when positioned in the receiving area (523A disposed on 513; Fig. 7) to a second position (Fig. 15) where the pad (520 disposed on 512; Figs. 7, 14 and 15) is in contact with the endoscope (50) in the second position (Fig. 15), wherein the pad (520 disposed on 512; Figs. 7, 14 and 15) is located opposite the receiving area (523A disposed on 513; Figs. 7 and 15) and receiving feedback through at least one of: a ball detent mechanism (515; Figs. 14-15; par. [0049] – ball portion of 515 located on 512 engages with detent of 515 located on 513), or a piezoelectric mechanism, to indicate when the holder is locked into a position of desired force on the endoscope.
Regarding claim 8, Gupta discloses the method of claim 7, further comprising adjusting a pad (520 disposed on 512; Figs. 7, 14 and 15) of the clamp from a first position (Fig. 14) to a second position (Fig. 15) where the pad (520 disposed on 512; Figs. 7, 14 and 15) is in contact with the endoscope (50) in the second position (Fig. 15).
Regarding claim 9, Gupta discloses the method of claim 8, wherein, in the second position (Fig. 15), the endoscope is axially and rotationally restrained (par. [0042] and [0049]).
Regarding claim 10, Gupta discloses the method of claim 7, further comprising coupling the clamp (500) to an arm (400; par. [0042] and [0045]) extending horizontally from a column (300; par. [0042] and [0044]), which extends vertically from a base (200; par. [0042]-[0043]).
Regarding claim 11, Gupta discloses the method of claim 7, wherein actuating the one or more sidewalls of the holder comprises actuating the holder to a plurality of configurations between a first configuration and a second configuration (Figs. 14-15; configurations between the first configuration shown in Fig. 14 and the second configuration show in Fig. 15), wherein a force exerted by the holder is adjustable to restrict one or both of: an axial movement or a rotational movement of the elongate medical device (par. [0049]).
Regarding claim 13, Gupta discloses the method of claim 7, further comprising applying a circumferential force to an outer diameter of the endoscope (50) positioned therein by a first sidewall (512) of the one or more sidewalls of the holder and a second sidewall of (513) the one or more sidewalls of the holder (par. [0053]-[0055]).
Regarding claim 14, Gupta discloses the method of claim 3, further comprising translating the arm (400) vertically along the column (300; par. [0044]) and horizontally relative to the column (when coupling 400 to 300).
Regarding claim 15, Gupta discloses the method of claim 3, further comprising pivoting the clamp (500) relative to the arm (400; when coupling 500 to 400).
Regarding claim 16, Gupta discloses the method of claim 3, wherein the column (300) is pivotally coupled to the base (200; par. [0044]; Figs. 4, 19 and 23).
Regarding claim 17, Gupta discloses the method of claim 16, wherein the column (300) is configured to pivot relative to the base (200) in 10° increments (par. [0044]).
Regarding claim 18, Gupta discloses the method of claim 10, further comprising translating the arm (400) vertically along the column (300; par. [0044]) and horizontally relative to the column (when coupling 400 to 300).
Regarding claim 19, Gupta discloses the method of claim 10, further comprising pivoting the clamp relative to the arm (500) relative to the arm (400; when coupling 500 to 400).
Regarding claim 20, Gupta discloses the method of claim 310 wherein the column (300) is pivotally coupled to the base (200; par. [0044]; Figs. 4, 19 and 23).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 5 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gupta, as applied to the claims above, in view of Putman (US 5,441,042).
Regarding claim 5, Gupta discloses the method of claim 1, but does not specifically disclose it further comprising positioning a surgical drape over the clamp. Putman teaches an analogous clamp wherein a surgical drape (82; Figs. 1-2) is positioned over the clamp (108; col. 7, ll. 10-2 and col. 11, ll. 3-7) to maintain a sterile environment during a surgical procedure. It would have been obvious to one having ordinary skill in the art to position the surgical drape over the clamp of Gupta thereby maintaining a sterile environment during a surgical procedure, as taught by Putman.
Regarding claim 12, Gupta discloses the method of claim 7, but does not specifically disclose it further comprising positioning a surgical drape over the clamp. Putman teaches an analogous clamp wherein a surgical drape (82; Figs. 1-2) is positioned over the clamp (108; col. 7, ll. 10-2 and col. 11, ll. 3-7) to maintain a sterile environment during a surgical procedure. It would have been obvious to one having ordinary skill in the art to position the surgical drape over the clamp of Gupta thereby maintaining a sterile environment during a surgical procedure, as taught by Putman.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYNAE E BOLER whose telephone number is (571)270-3620. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 9/5/26
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