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 Arguments
The previous objection of claims 3 and 9 due to minor informalities has been withdrawn in light of applicant’s amendments made 7/09/2026.
The previous rejection of claim(s) 12 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 12 on 7/09/2026.
The rejection of claims 1-4 and 12-13 under 35 U.S.C. 102(a)(1) as being anticipated by Malla (US 2011/0270293 A1) has been withdrawn in light of applicant’s amendment made 7/09/2026. Specifically, Malla does not teach the first and second winged structures protruding from a distal portion of the instrument shaft, wherein the first winged structure and the second winged structure circumferentially spiral about the instrument shaft along its longitudinal axis.
Applicant’s arguments with respect to claims 1-4 and 7-13 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference Eisner et al. (US 2017/0319776 A1) teaches said limitation.
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.
Claims 4 and 15 are 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.
Claim 4 recites “an interior of the instrument shaft further comprising a second instrument channel separate from the first instrument channel” in lines 3-4. Support for this limitation can be found in Figs. 13A-13B and paragraph [0092] in which “the instrument shaft 1320 is structured to accommodate two separate instruments, a first instrument or cable wire through instrument channel 1322, and a second instrument through instrument channel 1324. The instruments can be removably coupled to or integrated into each respective channel.” Claim 4 ultimately depends from claim 1 which recites “wherein the first winged structure and the second winged structure circumferentially spiral about the instrument shaft along its longitudinal length” in lines 13-14. Support for this limitation can be found in Figs. 14A-14B and paragraph [0093]. Thus, claim 4 combines features of different embodiments (that of Figs. 13A-13B and 14A-14B). Paragraph [0095] of the specification recites “It should be appreciated that all combinations of the foregoing concepts (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein. In particular, all combinations of claimed subject matter appearing at the end of this disclosure are contemplated as being part of the inventive subject matter disclosed herein.”
However, the combination of embodiments found in claim 4 is mutually inconsistent with the specification. For example, with respect to claim 4 i.e., Figs. 13A-13B, the instrument shaft 1320 is structured to accommodate two separate instruments, a first instrument or cable wire through instrument channel 1322, and a second instrument through instrument channel 1324. Specifically, the instrument shaft is not cylindrical and instead is shaped like two cylindrical structures integral with one another. Such a shape is not compatible with the embodiment of claim 1, i.e., Figs. 14A-14B, which requires the first winged structure and the second winged structure to circumferentially spiral about a cylindrical instrument shaft along its longitudinal length. Putting the spirals of Figs. 14A-14B on the non cylindrical instrument shaft along its longitudinal length would require substantially redesign and reconstruction of the winged structures as they would need to vary widths along the non-cylindrical shaft in order to maintain separate fluid channels. Accordingly, the specification does not 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 both the first winged structure and the second winged structure circumferentially spiraling about the instrument shaft along its longitudinal length and an interior of the instrument shaft further comprising a second instrument channel separate from the first instrument channel.
Claim 15 is rejected based on its dependency to rejected claim 4.
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) 1-3 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eisner et al. (US 2017/0319776 A1).
Regarding claim 1, Eisner discloses a single portal surgical apparatus (vacuum tube 1704; Figs. 24A-24B), comprising: a cannula (second elongate lumen 1706) to couple to a fluid source (fluid irrigation source; [0175]) such that fluid flows from the fluid source through a proximal opening of the cannula (as the fluid irrigation source can be a syringe connected through any suitable connection such as a needle that is in fluid communication with the peripheral passageways 1744, which are bounded by a proximal opening of the second elongate lumen 1706; [0175]); an instrument shaft (first elongate lumen 1740) longitudinally extending within the cannula (Figs. 24A-24B), an outer surface of the instrument shaft (1740) comprising circumferentially spaced first and second winged structures (any two ridges between passageways 1744; Fig. 24B; [0177]) protruding from and longitudinally extending along a distal portion of the instrument shaft (as each ridge protrudes towards second elongate lumen 1706 and extends along the length of the first elongate lumen 1740; [0177]), the first winged structure (ridge) in continuous, touching relation with a first surface of an inner wall of the cannula (1706) along a first location (along the length of the first elongate lumen 1740; Figs. 24A-24B; [0174]; [0177]), and the second winged structure (other ridge) in continuous, touching relation with a second surface of the inner wall of the cannula (1706) along a second location (along the length of the first elongate lumen 1740; Figs. 24A-24B; [0174]; [0177]) such that an interior of the cannula (1706) is partitioned into at least two fluid channels (peripheral passageways 1744) having boundaries defined by at least the first location and the second location (Fig. 24B); and a first tool (navigation mechanism 106 e.g., a guidewire and/or another device e.g., a ureteroscope 134, another viewing instrument, etc.; [0175]) distally extending from the instrument shaft, wherein the first winged structure and the second winged structure circumferentially spiral about the instrument shaft (1740) along its longitudinal length (as the ridges form a series of helical ridges that extend the length of the first elongate lumen 1740; [0177]).
Regarding claim 2, Eisner discloses wherein: an interior of the instrument shaft (1740) comprises a first instrument channel (first passageway 1742) longitudinally extending along the instrument shaft (Figs. 24A-24B); and the first tool (106 and/or 134) distally extends from a distal end of the first instrument channel ([0175]).
Regarding claim 3, Eisner discloses a cable wire (as 106 is a guidewire i.e., a cable wire; [0100]) coupled (integrally coupled) to proximal end of the first tool (106), the cable wire running through the first instrument channel (1742) to a proximal end of the single portal surgical apparatus ([0175]).
Regarding claim 9, Eisner discloses wherein: the outer surface of the instrument shaft (1740) further comprises a third winged structure (any third ridge) protruding from and longitudinally extending along the distal portion of the instrument shaft (1740; Fig. 24B), the third winged structure in continuous, touching relation with a third surface of the inner wall of the cannula (1706) along a third location (Fig. 24B), and the third winged structure circumferentially spaced with the first and second winged structures (Fig. 24B); the at least two fluid channels (1744) comprise three or more fluid channels (Fig. 24B); and the interior of the cannula (1706) is partitioned into the three or more fluid channels (1744) having boundaries defined by at least the first location, the second location, and the third location (Fig. 24B).
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.
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.
Claim(s) 4 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eisner et al. (US 2017/0319776 A1).
Regarding claim 4, Eisner discloses a second tool (other of 106 or 134) distally extending from the instrument shaft ([0175]), but fails to explicitly disclose: an interior of the instrument shaft further comprises a second instrument channel separate from the first instrument channel; and the second tool distally extends from a distal end of the second instrument channel.
However, Eisner teaches an alternative embodiment (Figs. 14A, 14B) with an interior of an instrument shaft comprising a first instrument channel (fist passageway 742), a second instrument channel (second passageway 744) and a plurality of fluid channels (peripheral passageways 746) surrounding the instrument channels (Figs. 14A, 14B), wherein the first instrument channel (742) and the second instrument channel (744) can be configured to accommodate first and second tools from their distal ends (navigation mechanism 106 (e.g., a guidewire) and/or another device (e.g., ureteroscope 134, another viewing instrument, etc.); [0134]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the instrument shaft of Eisner to include first and second instrument channels in the interior thereof as taught by Eisner in order to keep the guidewire in place while the ureteroscope or other viewing instrument is inserted into the patient without the two interfering.
Regarding claim 15, Eisner modified discloses wherein a respective instrument (106, 134, etc.) can be removably coupled (via user manipulation) into each of the first instrument channel (744) and the second instrument channel (742).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eisner et al. (US 2017/0319776 A1) in view of Truckai et al. (US 11,707,190 B1).
Regarding claims 10-11, Eisner fails to disclose a light source to transmit light to an anatomical site during surgery; and an image sensor to image the anatomical site during surgery, wherein: the image sensor is integrated into the cannula and the cannula comprises a channel via which the light transmitted by the light source travels; or a distal end of the cannula comprises the light source.
However, Truckai teaches an apparatus (Fig. 6) comprising a cannula (endoscope 150), an instrument shaft (outer sleeve 245) within the cannula, and a third cannula (inner sleeve 244) within the instrument shaft (Fig. 6) where the third cannula (244) rotates relative to the instrument shaft to resect tissue (column 6, lines 1-9), similar to that of Malla. Truckai further teaches the cannula (150) comprises a channel (channel in which 164a and 164b are located) via which a light source (LEDs 164a, 164b) is transmitted and an image sensor (image sensor 162; Fig. 4; column 4, lines 31-38) integrated into the cannula (Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula of Eisner to include a light source and image sensor as taught by Truckai in order to illuminate the surgical site as well as provide the user with images to improve positioning and sight of the treatment area.
Claim(s) 1-2, 7-8 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucklick (US 2007/0010823 A1) in view of Eisner et al. (US 2017/0319776 A1).
Regarding claim 1, Kucklick discloses a single portal surgical apparatus (arthroscopic shaver 1), comprising: a cannula (inflow/outflow sheath 9) to couple to a fluid source (fluid source; Fig. 1) such that fluid flows from the fluid source through a proximal opening of the cannula (at irrigation line 12); an instrument shaft (insertion tube 5) longitudinally extending within the cannula (Fig. 2; [0007]), an outer surface (outer wall 15) of the instrument shaft (5) comprising circumferentially spaced first and second winged structures (longitudinal webs 14) protruding from and longitudinally extending along a distal portion of the instrument shaft (Fig. 2), the first winged structure in continuous touching relation with a first surface of an inner wall of the cannula along a first location, and the second winged structure in continuous, touching relation with a second surface of the inner wall of the cannula along a second location such that an interior of the cannula is partitioned into at least two fluid channels (outer lumens 16) having boundaries defined by at least the first location and the second location (as the webs 14 establish fluid tight seals between 14 and 9; [0008]); and a first tool (cutting element 6) distally extending from the instrument shaft (Fig. 1; [0007]).
Kucklick fails to disclose wherein the first winged structure and the second winged structure circumferentially spiral about the instrument shaft along its longitudinal length.
However, Eisner teaches a single portal surgical apparatus (vacuum tube 1704; Figs. 24A-24B), comprising: a cannula (second elongate lumen 1706) to couple to a fluid source (fluid irrigation source; [0175]) such that fluid flows from the fluid source through a proximal opening of the cannula (as the fluid irrigation source can be a syringe connected through any suitable connection such as a needle that is in fluid communication with the peripheral passageways 1744, which are bounded by a proximal opening of the second elongate lumen 1706; [0175]); an instrument shaft (first elongate lumen 1740) longitudinally extending within the cannula (Figs. 24A-24B), an outer surface of the instrument shaft (1740) comprising circumferentially spaced first and second winged structures (any two ridges between passageways 1744; Fig. 24B; [0177]) protruding from and longitudinally extending along a distal portion of the instrument shaft (as each ridge protrudes towards second elongate lumen 1706 and extends along the length of the first elongate lumen 1740; [0177]), the first winged structure (ridge) in continuous, touching relation with a first surface of an inner wall of the cannula (1706) along a first location (along the length of the first elongate lumen 1740; Figs. 24A-24B; [0174]; [0177]), and the second winged structure (other ridge) in continuous, touching relation with a second surface of the inner wall of the cannula (1706) along a second location (along the length of the first elongate lumen 1740; Figs. 24A-24B; [0174]; [0177]) such that an interior of the cannula (1706) is partitioned into at least two fluid channels (peripheral passageways 1744) having boundaries defined by at least the first location and the second location (Fig. 24B); and a first tool (navigation mechanism 106 e.g., a guidewire and/or another device e.g., a ureteroscope 134, another viewing instrument, etc.; [0175]) distally extending from the instrument shaft, wherein the first winged structure and the second winged structure circumferentially spiral about the instrument shaft (1740) along its longitudinal length (as the ridges form a series of helical ridges that extend the length of the first elongate lumen 1740; [0177]). Eisner teaches each winged structure (ridge) can be configured to extend along the length of the instrument shaft (1740) with any suitable shape ([0177]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second winged structures of Kucklick to circumferentially spiral about the instrument shaft along its longitudinal length as taught by Eisner as a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed winged structure was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 2, Kucklick modified discloses the invention as claimed above, and Kucklick further discloses wherein: an interior of the instrument shaft (5) comprises a first instrument channel (lumen through 5, 15; Fig. 2) longitudinally extending along the instrument shaft (Fig. 2); and the first tool (6) distally extends from a distal end of the first instrument channel (Fig. 1; [0007]).
Regarding claim 7, Kucklick modified discloses the invention as claimed above, and Kucklick further discloses wherein: the at least two fluid channels (16) comprise a first fluid channel and a second fluid channel (on opposing sides of 14; Fig. 2); the fluid entering the proximal opening of the cannula is to flow through the first fluid channel and exit at a distal end of the cannula (via a fluid source; [0008]); and the second fluid channel is configured to suction the fluid or tissue (via a vacuum source; [0008]).
Regarding claim 8, Kucklick modified discloses the invention as claimed above, and Kucklick further discloses wherein: the second fluid channel is coupled to a suction line proximal to the cannula (9; Fig. 1).
Regarding claim 12, Kucklick modified discloses the invention as claimed above, and Kucklick further discloses a handle (handle 2) proximal to and coupled to the cannula (9) and the instrument shaft (5; Fig. 1), the handle (2) comprising a control (at least power cord 3/power source) configured to be actuated to drive the first tool (via motor; [0007]).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucklick (US 2007/0010823 A1) in view of Eisner et al. (US 2017/0319776 A1), as applied to claim 1, and further in view of Truckai et al. (US 11,707,190 B1).
Regarding claims 10-11, Kucklick modified fails to disclose a light source to transmit light to an anatomical site during surgery; and an image sensor to image the anatomical site during surgery, wherein: the image sensor is integrated into the cannula and the cannula comprises a channel via which the light transmitted by the light source travels; or a distal end of the cannula comprises the light source.
However, Truckai teaches an apparatus (Fig. 6) comprising a cannula (endoscope 150), an instrument shaft (outer sleeve 245) within the cannula, and a third cannula (inner sleeve 244) within the instrument shaft (Fig. 6) where the third cannula (244) rotates relative to the instrument shaft to resect tissue (column 6, lines 1-9), similar to that of Malla. Truckai further teaches the cannula (150) comprises a channel (channel in which 164a and 164b are located) via which a light source (LEDs 164a, 164b) is transmitted and an image sensor (image sensor 162; Fig. 4; column 4, lines 31-38) integrated into the cannula (Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula of modified Kucklick to include a light source and image sensor as taught by Truckai in order to illuminate the surgical site as well as provide the user with images to improve positioning and sight of the treatment area.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucklick (US 2007/0010823 A1) in view of Eisner et al. (US 2017/0319776 A1), as applied to claim 12 above, and further in view of Malla et al. (US 2011/0270293 A1).
Regarding claim 13, Kucklick modified discloses the invention as claimed above, and Kucklick further discloses a connector (coupling 13) distal to the handle (2), but fails to explicitly disclose the connector configured to removably couple a proximal end of the instrument shaft to the handle.
However, Malla teaches a single portal surgical apparatus (surgical tissue cutting instrument 10; Figs. 1-8), comprising: a cannula (sleeve 86) to couple to a fluid source (source of irrigation fluid; [0034) such that fluid flows from the fluid source through a proximal opening of the cannula (through irrigation passage 68 into exit opening 72 of sleeve 86; Fig. 2; [0034]); an instrument shaft (elongate tubular outer member 14) longitudinally extending within the cannula (Figs. 1-3), an outer surface of the instrument shaft (14) comprising circumferentially spaced first and second structures (outer surfaces of 14 between side walls 80a; Fig. 8) longitudinally extending along a distal portion of the instrument shaft (Figs. 6, 8), the first structure in continuous, touching relation with a first surface of an inner wall of the cannula (86) along a first location (location to the left of 75a, 75b; Fig. 8), and the second structure in continuous, touching relation with a second surface of the inner wall along a second location (location to the right of 75a, 75b; Fig. 8) such that an interior of the cannula (86) is partitioned into at least two fluid channels (irrigation passages 74a, 74b; [0035]) having boundaries defined by at least the first location and the second location (Fig. 8); and a first tool (cutting element 42) distally extending from the instrument shaft (14; Fig. 6). Malla teaches a handle (handpiece 18) proximal to and coupled to the cannula (86) and the instrument shaft (14; Figs. 1-2), the handle comprising a control (motor) configured to be actuated to move the first instrument ([0042]), and a connector (boot 57) distal to the handle (Figs. 1-3), the connector (57) configured to removably couple a proximal end of the instrument shaft (14) to the handle (via locking portions 50, 51; [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector of modified Kucklick to removable coupled a proximal end of the instrument shaft to the handle in order to easily replace and/or sterilize shafts between uses without disposing the entire apparatus.
Allowable Subject Matter
Claim 14 is 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Merritt et al. (US 2023/0241302 A1) is noted for teaching spiral channels. Kucklick (US 8,870,748 B2) is noted for teaching ribs holding projections.
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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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