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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19), Species 1b, and Species 2a in the reply filed on 05/06/2026 is acknowledged. Claims 1-5 and 7-19 read on the elected invention and species. Claims 1-27 are presently pending, with claims 6 and 20-27 withdrawn from consideration. Claims 1-5 and 7-19 are examined below.
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 11 and 19 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.
The term “approximately” in claim 11 is a relative term which renders the claim indefinite. The term “approximately” 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. The degree to which the length can be approximately 10 cm is unclear. Appropriate correction is required.
Claim 19 recites the limitation "the axial sheath" in third line of the claim. There is insufficient antecedent basis for this limitation in the claim.
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) 1, 5, 7, 9-13 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang et al. (US 2017/0188793 A1) in view of Cho (US 2022/0304558 A1) in view of Lent et al. (US 2022/0280245 A1).
Regarding claim 1, Ouyang discloses a portable endoscopic system with a single-use cannula comprising: a single-use cannula (104; Fig. 1; par. [0066]); wherein said cannula has: an imaging module (par. [0064]) at its distal end configured to produce image data for a field of view; a permanently built-in, hollow injection needle inside the cannula (par. [0041]; 114; Fig. 1) that has a distal end configured to move between an extended position in which it extend distally (par. [0041] – protruded position) and a retracted position (par. [0041] – retracted position); cannula ports and at proximal (132; par. [0070]) and distal portions of the cannula (616/618; par. [0070]; Fig. 6A), respectively, and one or more internal channels (416/418; par. [0070]) coupling the cannula ports for fluid flow (par. [0070]); a syringe port (174; Fig. 1; par. [0084]) at the proximal portion of the cannula, coupled for fluid flow to a proximal end of the injection needle (par. [0062]); a syringe body (170; par. [0067]; Fig. 1) coupled with the injection needle (114; par. [0062]) and configured to move the needle axially between said retracted and extended positions thereof (par. [0072]; Figs. 5A-5B); and a needle position lock (520/534; par. [0075]-[0076]; Figs. 5A-5B) configured to selectively lock the injection needle against axial motion.
However, Ouyang does not specifically disclose the endoscopic system comprising: a single-use access sheath, comprising: a single-use, tubular access sheath that has open proximal and distal ends; wherein said sheath has: sheath ports at its proximal and distal portions, respectively; a back-flow restrictor at its proximal end configured to resist proximal fluid flow from said space between the cannula and the sheath; and a funnel-shaped entrance into its open proximal end. Cho teaches an analogous endoscopic system comprising a cannula (50/54; par. [0040]; Fig. 8) and a single-use access sheath (1; Figs. 1 and 8; par. [0030]), comprising: a single-use, tubular access sheath (1) that has open proximal and distal ends (Fig. 3); wherein said sheath has: sheath ports at its proximal (224; par. [0032]; Fig. 4) and distal (12; par. [0031]; Fig. 8) portions, respectively; a back-flow restrictor at its proximal end (31/34/223/225.226; par. [0036]; Fig. 3) configured to resist proximal fluid flow from a space between the cannula (50/54) and the sheath (1); and a funnel-shaped entrance into its open proximal end (Figs. 3-4). It would have been obvious to one having ordinary skill in the art to include the single-use access sheath of Cho with the single-use cannula of Ouyang in order to maintain a clear surgical field during surgery by irrigating the surgical site with the single-use access sheath of Cho, thereby improving the surgeon’s ability to visualize the surgical site. Such modification provides a system configuration wherein the single-use cannula (104) has a distal portion releasably sliding axially in said sheath to a working position in the sheath in which a distal end of the cannula is at a distal end of but inside the sheath (Cho: Fig. 8) and a proximal portion of the cannula extends proximally from the sheath (Cho: Fig. 8); wherein the outer diameter of the cannula portion that is in the sheath is sufficiently smaller than the inner diameter of the surrounding sheath to leave space for axial fluid flow (Cho: Fig. 8) and further includes an imaged region distal from the sheath (Cho: Fig. 8).
However, modified Ouyang does not disclose that the sheath includes physical markings at its distal end arranged at selected angularly spaced positions. Lent teaches providing physical markings (14/12; Figs. 4 and 6; par. [0067]) at the distal end of a sheath (10; Figs. 4 and 6) at selected angularly arranged spaced positions in order to allow the surgeon to orient the needle and to accurately place the needle at the injection location (par. [0065]-[0067]). It would have been obvious to one having ordinary skill in the art to provide physical marks on the sheath in order to allow the surgeon to orient the needle and to accurately place the needle at the injection location, as taught by Lent.
Regarding claim 5, Ouyang in view of Cho in view of Lent disclose the endoscopic system of claim 1, further including an aspiration source (Cho: of 33; par. [0036]) and an aspiration tube (Cho: 333; par. [0036]; Fig. 3) operatively coupling the aspiration source and said sheath port at said proximal portion of the sheath (Cho: Fig. 3), and a flow regulator (Cho: 332; par. [0036]; Fig. 3) operatively coupled with said aspiration tube (Cho: 333) to selectively close said aspiration tube partly or completely.
Regarding claim 7, Ouyang in view of Cho in view of Lent disclose the endoscopic system of claim 3, in which said flow regulator (Cho: 332) comprises a hand operated stopcock (Cho: Fig. 3).
Regarding claim 9, Ouyang in view of Cho in view of Lent disclose the endoscopic system of claim 1, further comprising a reusable portion (102; Fig. 1; par. [0065]) to which said cannula (120/104) mounts releasably (par. [0069]) and which comprises a display [150; Fig. 1; par. [0080]) operatively coupled with said imaging module to display images taken with the imaging module (par. [0080]), and a handle (140; par. [0065]; Fig. 1) on which the display (150) is mounted.
Regarding claim 10, Ouyang in view of Cho in view of Lent disclose the endoscopic system of claim 1, in which a distal end of said injection needle (114) is offset from a central axis of said cannula (120/104; Fig. 1) and said cannula is configured to rotate in said access sheath which the sheath remains stationary relative to space of to a patient (capable of rotating when cannula is uncoupled from sheath), wherein the needle points to different injection sites for different angular positions of the cannula relative to the sheath (when cannula is rotated).
Regarding claim 11, Ouyang in view of Cho in view of Lent disclose the endoscopic system of claim 1, but does not specifically disclose in which the portion of the access sheath between the funnel-shaped proximal end and the distal end thereof is approximately 10 cm. At the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to make the portion of the access sheath between the funnel-shaped proximal end and the distal end thereof Ouyang approximately 10 cm because Applicant has not disclosed that the approximate 10 cm spacing provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Ouyang’s system, and applicant’s invention, to perform equally well with either the spacing of Ouyang or the claimed approximate 10 cm spacing because both spacing dimensions would perform the same function of coupling the cannula. Therefore, it would have been prima facie obvious to modify Ouyang to obtain the invention as specified in claim 11 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Ouyang.
Regarding claim 12, Ouyang in view of Cho in view of Lent disclose the endoscopic system of claim 1, but does not specifically disclose in which the cannula portion that is in the access sheath is no longer than 11.5 cm. At the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to make the cannula portion that is in the access sheath of Ouyang no longer than 11.5 cm because Applicant has not disclosed that the less than 11.5 cm length provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Ouyang’s system, and applicant’s invention, to perform equally well with either the length of Ouyang or the claimed no longer than 11.5 cm length because both dimensions would perform the same function of covering the cannula. Therefore, it would have been prima facie obvious to modify Ouyang to obtain the invention as specified in claim 12 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Ouyang.
Regarding claim 13, Ouyang discloses a portable endoscopic system with a single-use cannula comprising: a single-use cannula (104; Fig. 1; par. [0066]); wherein said cannula has: an imaging module (par. [0064]) at its distal end configured to produce image data for a field of view; a hollow injection needle inside the cannula (par. [0041]; 114; Fig. 1) that has a distal end configured to move between an extended position in which it extend distally (par. [0041] – protruded position) and a retracted position (par. [0041] – retracted position); cannula ports and at proximal (132; par. [0070]) and distal portions of the cannula (616/618; par. [0070]; Fig. 6A), respectively, and one or more internal channels (416/418; par. [0070]) coupling the cannula ports for fluid flow (par. [0070]); a syringe port (174; Fig. 1; par. [0084]) at the proximal portion of the cannula, coupled for fluid flow to a proximal end of the injection needle (par. [0062]); and a needle position lock (520/534; par. [0075]-[0076]; Figs. 5A-5B) configured to selectively lock the injection needle against axial motion.
However, Ouyang does not specifically disclose the endoscopic system comprising: a single-use access sheath, comprising: a single-use, tubular access sheath that has open proximal and distal ends; wherein said sheath has: sheath ports at its proximal and distal portions, respectively. Cho teaches an analogous endoscopic system comprising a cannula (50/54; par. [0040]; Fig. 8) and a single-use access sheath (1; Figs. 1 and 8; par. [0030]), comprising: a single-use, tubular access sheath (1) that has open proximal and distal ends (Fig. 3); wherein said sheath has: sheath ports at its proximal (224; par. [0032]; Fig. 4) and distal (12; par. [0031]; Fig. 8) portions, respectively. It would have been obvious to one having ordinary skill in the art to include the single-use access sheath of Cho with the single-use cannula of Ouyang in order to maintain a clear surgical field during surgery by irrigating the surgical site with the single-use access sheath of Cho, thereby improving the surgeon’s ability to visualize the surgical site. Such modification provides a system configuration wherein the single-use cannula (104) has a distal portion releasably sliding axially in said sheath to a working position in which a distal end of the cannula is at a distal end of but inside the sheath (Cho: Fig. 8) and a proximal portion of the cannula extends proximally from the sheath (Cho: Fig. 8); wherein the outer diameter of the cannula portion that is in the sheath is sufficiently smaller than the inner diameter of the surrounding sheath to leave space for axial fluid flow (Cho: Fig. 8) and further includes an imaged region distal from the sheath (Cho: Fig. 8).
However, modified Ouyang does not disclose that the sheath includes physical markings at its distal end arranged at selected angularly spaced positions. Lent teaches providing physical markings (14/12; Figs. 4 and 6; par. [0067]) at the distal end of a sheath (10; Figs. 4 and 6) at selected angularly arranged spaced positions in order to allow the surgeon to orient the needle and to accurately place the needle at the injection location (par. [0065]-[0067]). It would have been obvious to one having ordinary skill in the art to provide physical marks on the sheath in order to allow the surgeon to orient the needle and to accurately place the needle at the injection location, as taught by Lent.
Regarding claim 17, Ouyang in view of Cho in view of Lent disclose the endoscopic system of claim 13, further including a syringe body a syringe body (170; par. [0067]; Fig. 1) that connects a proximal end of said injection needle (114; par. [0062]) and configured for manual operation to move the needle axially between said retracted and extended positions (par. [0072]; Figs. 5A-5B).
Regarding claim 18, Ouyang in view of Cho in view of Lent disclose the endoscopic system of claim 13, in which said cannula is configured to rotate relative to the access sheath (capable of rotating when cannula is uncoupled from sheath).
Regarding claim 19, Ouyang in view of Cho in view of Lent disclose the endoscopic system of claim 13, in which a distal end of said injection needle (114) is offset from a central axis of said cannula (120/104; Fig. 1) and the cannula is configured to rotation in the axial sheath (capable of rotating when cannula is uncoupled from sheath), whereby different angular positions of the cannula relative to the sheath cause the distal end of the needle to point at different injection sites (when cannula is rotated).
Allowable Subject Matter
Claims 2-4, 8 and 14-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claims 2-4 and 14-16, the prior art of record does not disclose, or otherwise render obvious, the endoscopic system wherein the open distal end of the sheath has a radially inwardly facing surface that is made of or is covered with a material characterized by low light reflectivity to thereby prevent or at least significantly reduce artifacts in images from said imaging module due to light reflected by said radially inwardly facing surface of the sheath, in combination with the other elements of the claim.
Regarding claim 8, the prior art of record does not disclose, or otherwise render obvious, the endoscopic system wherein the sheath further includes a tubular cap body at said open proximal end of the sheath and a lid hinged to the cap body to selectively close the cap body or open the cap body for passage therethrough of said cannula, in combination with the other elements of the claim.
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
7/23/26
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