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 .
This Office Action is in response to the amendments dated December 11, 2025.
Claims 1-10 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 11,759,233 in view of Dejima (US PGPUB 2016/0175006 – “Dejima”). That is, Claim 1 shares the same features with Claim 1 of U.S. Patent No. 11,759,233, except for the features only found in instant Claim 1 of a camera configured to slide through the optical cannula; a lumen frame disposed in the optical cannula; and a light support slidingly engaged with the lumen frame such that the light support is movable along the lumen frame such that the light support is able to move in and out of an operative field, which are taught by Dejima, as described in detail below in the rejection of Claim 1 under 35 U.S.C. 103. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added these features, as taught by Dejima, in order to provide the user with the ability to visualize an endoscopic surgical target.
Furthermore, Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of copending Application No. 17/968,626 in view of Dejima. That is, Claim 1 shares the same features with Claim 1 of copending Application No. 17/968,626, except for the features of a lumen frame disposed in the optical cannula; and a light support slidingly engaged with the lumen frame such that the light support is movable along the lumen frame such that the light support is able to move in and out of an operative field, which are taught by Dejima, as described in detail below in the rejection of Claim 1 under 35 U.S.C. 103. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added these features, as taught by Dejima, in order to provide the user with the ability to illuminate an endoscopic surgical target.
This is a provisional nonstatutory double patenting rejection.
Applicant indicated in the December 11, 2025 response that Applicant will consider filing a terminal disclaimer(s) if all other rejections are withdrawn. As described below, Claims 1-10 remain rejected under 35 U.S.C. 103.
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 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”. 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 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Dejima (US PGPUB 2016/0175006 – “Dejima”) in view of Embry et al. (US PGPUB 2006/0047296 – “Embry”) and Watanabe (US PGPUB 2009/0080214 – “Watanabe”).
Regarding Claim 1, a first embodiment of Dejima discloses:
An intervertebral disc surgical system for use with an electrosurgical instrument having an elongated tubular member housing and an electrosurgical electrode for excising of or shrinking tissue (intended use, which describes no additional structural features), comprising:
at least one optical cannula (Dejima FIG. 1, endoscopic surgical device 10) configured with a working channel (Dejima FIG. 3, treatment tool insertion passage 308) and an optical channel (Dejima FIG. 3, endoscope insertion passage 306),
wherein the working channel and the optical channel are substantially cylindrical tubes positioned parallel to and abutting one another (Dejima FIG. 3, showing cylindrical/abutting passages 306 and 308), wherein the working channel is configured to receive the elongated tubular member housing of the electrosurgical instrument and the optical channel is configured to receive an optical scope (intended use, which describes no additional structural features), the optical cannula having an optical cannula operative end (Dejima FIG. 1, distal end of endoscopic surgical device 10) for entering an operative field of a patient;
an outer sheath (Dejima FIG. 1, overtube 300) having a lumen configured to receive the optical channel and the working channel (Dejima FIG. 4, lumen defined by interior of overtube body 320), wherein the outer sheath has a sheath operative end (Dejima FIG. 1, distal end of overtube 300) for entering an operative field;
a camera (Dejima FIG. 2, observation window 116; Dejima paragraph [0067], “image pick-up elements, such as a charge-coupled device (CCD) and a complementary metal-oxide semiconductor (CMOS), which are arranged at an image pick-up position of the objective lens, are disposed behind the observation window 116”) configured to slide through the optical cannula (Dejima FIGs. 25A and 25C, showing endoscope 100 sliding through the endoscopic surgical device 10 depicted in Dejima FIG. 1);
a lumen frame (Dejima FIG. 7, slider 400) disposed in the optical cannula (Dejima FIG. 1, endoscopic surgical device 10), wherein the lumen frame comprises a semi-circle shape that is not an entirely closed tube (Dejima FIG. 8, open semi-circle shape defined by an upper surface 404 and a lower surface 406);
a light support (Dejima FIG. 6, slider body 402 connected to insertion part 102 of endoscope 100) slidingly engaged with the lumen frame such that the light support is movable along the lumen frame (Dejima FIGs. 25A and 25C, showing slider body 402 moving along endoscope 100) such that the light support is able to move in and out of an operative field (Dejima FIGs. 25A and 25C, showing endoscope 100 moving axially within overtube body 320).
The first embodiment of Dejima presented above does not explicitly disclose the outer sheath having an oval shape.
However, a second embodiment of Dejima discloses the outer sheath having an oval shape (Dejima FIG. 16, elliptical shape of inner peripheral surface of overtube 300).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize the oval/elliptical overtube shown in Dejima FIG. 16 with the system disclosed by the first embodiment of Dejima. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of a system having a working channel capable of supporting an oval instrument, such as the slider 400 shown in Dejima FIG. 16.
Dejima does not explicitly disclose a dilator configured to slide over a guide wire and slide into the working channel, wherein the dilator includes a shaft extending along a length of the dilator, wherein the dilator further includes a tapered tip such that the tapered tip is positioned flush with the sheath operative end when the dilator is positioned in the outer sheath, wherein the dilator is oval in shape to match the oval shape of the outer sheath
Embry teaches a dilator (Embry FIG. 3, dilator tube 84) configured to slide over a guide wire (Embry FIG. 3, guide wire 80) and slide into the working channel (intended use, which describes no additional structural features), wherein the dilator includes a shaft (Embry FIG. 3, interior surface of dilator tube 84) extending along a length of the dilator, wherein the dilator further includes a tapered tip (Embry FIG. 3, tapered tip 86) such that the tapered tip is positioned flush with the sheath operative end when the dilator is positioned in the outer sheath (see Embry FIG. 3), wherein the dilator is oval in shape (Embry paragraph [0036], “dilator tubes can have different shaped cross sections, such as oval”) to match the oval shape of the outer sheath (Dejima FIG. 16, elliptical shape of inner peripheral surface of overtube 300).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Embry’s dilator with the system disclosed by Dejima. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a surgical system that is capable of creating an annulus within a disc during surgery.
Dejima in view of Embry does not explicitly teach an optical channel plug with a diameter sufficient to slide within the optical channel.
Watanabe teaches an optical channel plug (Watanabe FIG. 3, forceps plug 190) with a diameter sufficient to slide within the optical channel (Watanabe FIG. 3, insertion port 80; Watanabe paragraph [0090], “forceps plug 190 is completely fitted in the treatment device insertion port 80”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Watanabe’s forceps plug with the system taught by Dejima in view of Embry. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a system having an instrument port that is hermetically sealed when a treatment device is not inserted (see Watanabe paragraph [0088]).
Regarding Claim 4, Dejima in view of Embry and Watanabe teaches the features of Claim 1, as described above.
Dejima further discloses wherein the optical scope (Dejima FIG. 25C, insertion part 102 of endoscope 100) is movable within the light support to allow the optical scope to move in and out of an operative field independent of the light support (Dejima FIG. 25, showing insertion part 102 moving in and out of the operative field independent of slider body 402).
Claims 2-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Dejima (US PGPUB 2016/0175006 – “Dejima”) in view of Embry et al. (US PGPUB 2006/0047296 – “Embry”), Watanabe (US PGPUB 2009/0080214 – “Watanabe”) and Farr et al. (US PGPUB 2011/0028790 – “Farr”).
Regarding Claim 2, Dejima in view of Embry and Watanabe teaches the features of Claim 1, as described above.
Dejima in view of Embry and Watanabe does not explicitly teach:
a plurality of lights disposed on the light support; and
a controller interactive with the plurality of lights to illuminate different lights at different frequencies at different times.
Farr teaches:
a plurality of lights disposed on the light support (Farr FIG. 2a, illuminator 202; Farr paragraph [0044], ”LED sources in illumination module 202 can provide illumination in a wide range of the electromagnetic spectrum, from UV, to visible and IR, where the individual LED chips in 202 illuminator, each…can be independently controlled in time by software applications running in control unit 210”; Farr FIG. 4c, endoscopic device 400 including illuminator 202); and
a controller (Farr FIG. 4c, control unit 210) interactive with the plurality of lights to illuminate different lights at different frequencies at different times (Farr paragraph [0048], “With an endoscope equipped with a full range of LED wavelengths in illuminator 202, or a specific range of illumination wavelength, it is possible to obtain a full spectral images of the object by turning the various LEDs on and off at specified times by control unit 210”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Farr’s individually controlled LEDs with the system taught by Dejima in view of Embry and Watanabe. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a system that can selectively control the color/wavelength of illumination used by an endoscope for specific detection processes (see Farr paragraph [0048]).
Regarding Claim 3, Dejima in view of Embry, Watanabe, and Farr teaches the features of Claim 2, as described above.
Farr further teaches wherein at least one of the frequencies is ultraviolet and a second of the frequencies is visible (Farr paragraph [0044], ”LED sources in illumination module 202 can provide illumination in a wide range of the electromagnetic spectrum, from UV, to visible”).
Regarding Claim 5, Dejima in view of Embry, Watanabe, and Farr teaches the features of Claim 2, as described above.
Watanabe further teaches wherein the optical channel (Watanabe FIG. 2, channel 62) comprises a port (Watanabe FIG. 2, port 80) in fluid communication with the optical channel for evacuating or providing fluids to the optical channel (intended use, which describes no additional structural features).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Dejima (US PGPUB 2016/0175006 – “Dejima”) in view of Embry et al. (US PGPUB 2006/0047296 – “Embry”), Watanabe (US PGPUB 2009/0080214 – “Watanabe”), and Gazdzinski (US Patent 8,068,897 – “Gazdzinski”).
Regarding Claim 6, Dejima in view of Embry and Watanabe teaches the features of Claim 1, as described above.
Dejima further discloses:
a controller (Dejima Fig. 1 processor device 108),
a camera sensor located on the optical scope (Dejima FIG. 1, endoscope insertion part 102; Dejima paragraph [0066] – [0067], “endoscope insertion part 102 is provided with…image pick-up elements, such as a charge-coupled device (CCD)”); and
a light sensor located on the light support (Dejima FIG. 1, endoscope 100 having individual CCD pick-up elements in a camera; see Dejima paragraph [0067]).
Dejima in view of Embry and Watanabe does not explicitly teach wherein the light sensor and the camera sensor sense when the light sensor and the camera sensor are in proximity to each other.
Gazdzinski teaches wherein the light sensor and the camera sensor sense when the light sensor and the camera sensor are in proximity to each other (Gazdzinski FIG. 17, RFID reader 1750 and RFID tag 1702; Gazdzinski paragraph [0225], “bringing a RFID tag within proximity to an RFID sensor ("reader") 1750 which emanates a radio frequency wake-up field having a limited range. The RFID tag 1702 detects the presence of the wakeup field of the sensor 1750”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Gazdzinski’s proximity RFID’s with the light sensor and camera sensor in the system taught by Dejima in view of Embry and Watanabe. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a system that has components that are able to communicate and coordinate with one another (see Gazdzinski paragraph [0225]).
Regarding Claim 7, Dejima in view of Embry, Watanabe, and Gazdzinski teaches the features of Claim 6, as described above.
Gazdzinski teaches wherein the camera sensor and the light sensor are RFID sensors that sense when the camera sensor and the light sensor are in proximity to each other (Gazdzinski FIG. 17, RFID reader 1750 and RFID tag 1702; Gazdzinski paragraph [0225], “bringing a RFID tag within proximity to an RFID sensor ("reader") 1750 which emanates a radio frequency wake-up field having a limited range. The RFID tag 1702 detects the presence of the wakeup field of the sensor 1750”).
Claims 8, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Dejima (US PGPUB 2016/0175006 – “Dejima”) in view of Embry et al. (US PGPUB 2006/0047296 – “Embry”), Watanabe (US PGPUB 2009/0080214 – “Watanabe”), Gazdzinski (US Patent 8,068,897 – “Gazdzinski”). and Nakajima (US PGPUB 2017/0099421 – “Nakajima”).
Regarding Claim 8, Dejima in view of Embry, Watanabe, and Gazdzinski teaches the features of Claim 6, as described above.
Watanabe further teaches:
a plurality of lights (Watanabe FIG. 2, light guide bundle 94) disposed on the light support (Watanabe FIG. 2, illumination window 96).
Dejima in view of Embry, Watanabe, and Gazdzinski does not explicitly teach wherein the controller responds to the light sensor and camera sensor to adjust an illumination of the plurality of lights.
Nakajima teaches wherein the controller (Nakajima FIG. 1, controller 31; Nakajima paragraph [0029], “controller 31 that controls the optical scanning endoscope apparatus 10 overall”) responds to the light sensor (Nakajima FIG. 1, light amount detector 15) and camera sensor (Nakajima FIG. 1, photodetector for reception light 35 and signal processor 37) to adjust an illumination of the plurality of lights (Nakajima FIG. 1, light emission controller 32 and light source 33; Nakajima paragraph [0031], “the light emission controller 32 controls the light emission timing of the light source 33. In this embodiment, during one scan, the light emission controller 32 switches the wavelength of the R, G, or B illumination light from the light source 33 in a predetermined light emission order.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Nakajima’s light controller with the system taught by Dejima in view of Embry, Watanabe, and Gazdzinski. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result in order to provide a system that selectively controls the wavelength and order of different lights being provided according to diagnostic needs of the endoscopic procedure.
Regarding Claim 9, Dejima in view of Embry, Watanabe, Gazdzinski, and Nakajima teaches the features of Claim 8, as described above.
Nakajima further teaches wherein the controller responds to the light sensor and camera sensor to adjust a frequency of the plurality of lights (Nakajima paragraph [0031], “the light emission controller 32 controls the light emission timing of the light source 33. In this embodiment, during one scan, the light emission controller 32 switches the wavelength of the R, G, or B illumination light from the light source 33”).
Regarding Claim 10, Dejima in view of Embry, Watanabe, Gazdzinski, and Nakajima teaches the features of Claim 8, as described above.
Nakajima further teaches wherein the controller responds to the light sensor and camera sensor to adjust an order of illumination of the plurality of lights (Nakajima paragraph [0031], “the light emission controller 32 controls the light emission timing of the light source 33. In this embodiment, during one scan, the light emission controller 32 switches the wavelength of the R, G, or B illumination light from the light source 33 in a predetermined light emission order.”).
Response to Arguments
Applicant’s arguments, see page 5, filed December 11, 2025, with respect to the objections to Claims 5-10, have been fully considered and are persuasive, in view of the present amendments. The objections to Claims 5-10 have been withdrawn.
Applicant’s arguments, see pages 5-6, filed December 11, 2025, with respect to the objections to the drawings, have been fully considered and are persuasive, in view of the present amendments. The objections to the drawings have been withdrawn.
Applicant’s arguments, see pages 6-7, filed December 11, 2025, with respect to the rejection of Claim 7 under 35 U.S.C. 112(a), have been fully considered and are persuasive. The rejection of Claim 7 under 35 U.S.C. 112(a) has been withdrawn.
Applicant’s arguments, see page 7, filed December 11, 2025, with respect to the rejection of Claims 1, 3, 6, and 7 under 35 U.S.C. 112(b), have been fully considered and are persuasive. The rejections of Claims 1, 3, 6, and 7 under 35 U.S.C. 112(b) have been withdrawn.
Applicant’s remarks, see pages 7-8, filed December 11, 2025, with respect to the nonstatutory double patenting rejection of Claim 1, as described above, is maintained until a Terminal Disclaimer is filed.
Applicant’s arguments, see pages 8-9, filed December 11, 2025, with respect to the rejection of Claims 1-10 under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant asserts that Dejima fails to disclose wherein the lumen frame comprises a semi-circle shape that is not an entirely closed tube. However, as described above, Dejima FIG. 8 discloses an open semi-circle shape defined by an upper surface 404 and a lower surface 406. As such, the rejections of Claims 1-10 under 35 U.S.C. 103 are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
02/20/26