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
Amendments to claims 1, 2, 3, 8, 15, 21 of 4/2/2026 acknowledged and entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Information Disclosure Statement
The information disclosure statement filed 4/30/2024 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.
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.
Claim(s) 15, 18, 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by To (US 20120016260 A1).
Regarding claim 15, To teaches An endoscopy system comprising:
a surgical instrument that includes:
a proximal end portion (fig. 1, element 118, [0057], handle 118);
a distal end portion (fig. 1, element 102, [0057], tubular body 102);
at least one control cable (fig. 9, element 192, [0097], control members 192 may comprise wires) extending from the proximal end portion to the distal end portion; and
a tissue separator (fig. 3E, element 300, [0070], retractor assembly 300) coupled to the distal end portion, the tissue separator configured to engage sample tissue for collection under control of the at least one control cable
wherein the tissue separator is at least partially made from a material that allows light to pass through the tissue separator ([0005], retractor may comprise an optically transparent material)
an endoscope (fig. 12A, element 128, [0099], visualization channel 128) comprising an elongate bendable shaft that includes a first lumen in which the at least one control cable can be disposed;
a first light emitter ([0105], visualization channel 128 may include fiber optic strands to transmit light) at a distal region of the elongate bendable shaft and configured to project light distal to the distal end portion at a first wavelength; and
a viewing device at the distal region of the elongate bendable shaft and configured to view through the tissue separator (fig. 12a, element 128, [0099, 0095], visualization channel 128 may be used to deliver imaging devices).
Regarding claim 18, To teaches The endoscopy system of claim 15,
further comprising a second light emitter connected to the elongate body at the distal region of the elongate bendable shaft and configured to project light distal to the distal end portion at a second wavelength different from the first wavelength ([0105], one or more fiber optic strands).
Regarding claim 20, To teaches The endoscopy system of claim 15,
further comprising a light transmitting fiber extending through the elongate body bendable shaft to the first light emitter ([0105], one or more fiber optic strands).
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) 1-4, 6-10, 12-14, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over To in view of Kelleher (US 5760269 A).
Regarding claim 1, To teaches A surgical instrument comprising:
a proximal end portion (fig. 1, element 118, [0057], handle 118);
a distal end portion (fig. 1, element 102, [0057], tubular body 102);
at least one control cable (fig. 9, element 192, [0097], control members 192 may comprise wires) extending from the proximal end portion to the distal end portion; and
a tissue separator (fig. 3E, element 300, [0070], retractor assembly 300) coupled to the distal end portion, the tissue separator configured to engage sample tissue for collection under control of the at least one control cable;
wherein the tissue separator is at least partially made from a material that allows light to pass through the tissue separator ([0005], retractor may comprise an optically transparent material);
To does not explicitly teach the device configured for use in a working channel of an endoscope; and
wherein the tissue separator has a first outer diameter size that is larger than a second outer diameter size of the distal end portion such that the tissue separator cannot be withdrawn proximally through the working channel of the endoscope when the distal end portion is inserted therein.
However, Kelleher teaches the device configured for use in a working channel of an endoscope (fig. 26, element 174, col. 13, ln. 44-60, forceps channel 174); and
wherein the tissue separator has a first outer diameter size (fig. 26, element 54, jaws in an extended position are larger than the diameter of the distal end) that is larger than a second outer diameter size of the distal end portion such that the tissue separator cannot be withdrawn proximally through the working channel of the endoscope when the distal end portion is inserted therein (fig. 26, jaws in an open configuration are larger than the working channel of the endoscope).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of To to be used with an endoscope as taught in Kelleher in order to deflect the device without changing the field of view (Kelleher col. 13, ln. 44-60).
Regarding claim 2, To in view of Kelleher teaches An endoscopy system comprising the surgical instrument of claim 1
To teaches further comprising the endoscope, the endoscope comprising:
an elongate bendable shaft that includes a first lumen in which the at least one control cable can be disposed ([0097], control members 192 are slidable along the length of shaft 102 and are attached at distal end); and
a viewing device (fig. 12A, element 128, [0099], visualization channel 128) configured to view the tissue separator;
Further, Kelleher teaches wherein the tissue separator is positioned to obstruct the viewing device when the proximal end portion and the distal end portion are inserted in the working channel and the viewing device is positioned to view through the tissue separator (fig. 26, element B, col. 13, ln. 44-60, in position B, the tissue separator is positioned within and in a direction normal to the field of view of the endoscope).
Regarding claim 3, To in view of Kelleher teaches The surgical instrument of claim 1,
To in view of Kelleher does not explicitly teach wherein the tissue separator comprises a tissue removal device with magnification properties.
However, Yamaguchi teaches wherein the tissue separator comprises a tissue removal device with magnification properties (fig. 17, element 48a, [0062] zoom lens 48a is adjusted to control the magnification, while To teaches an optically transparent and adjustable component).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of To to include optical magnification properties as taught in Yamaguchi in order to selectively control the magnification set by the zoom lens (Yamaguchi [0062]).
Regarding claim 4, To in view of Kelleher teaches The surgical instrument of claim 1,
Further, To teaches wherein the tissue separator is fabricated from clear polycarbonate or glass ([0021], jaws of retractor may be formed of polycarbonate or glass).
Regarding claim 5, To in view of Kelleher teaches The surgical instrument of claim 1,
Further, To teaches wherein the tissue separator comprises an internal volume to store separated tissue (fig. 3c, element 136, [0071], working space 136).
Regarding claim 6, To in view of Kelleher teaches The surgical instrument of claim 1,
Further, To teaches wherein the tissue separator comprises an auger or a punch ([0128], retractor cannula device may be configured to house an auger).
Regarding claim 7, To in view of Kelleher teaches The surgical instrument of claim 1,
Further, To teaches wherein the tissue separator comprises forceps comprising:
a first jaw (fig. 5a, element 500, [0084], jaw(s) 500);
a plurality of teeth (fig. 5a, element 504, [0084], teeth 504) extending from the first jaw; and
a second jaw (fig. 5a, element 500) disposed opposite the first jaw;
wherein the first jaw is pivotable from a closed position engaged with the second jaw to an open position away from the second jaw (fig. 4d); and
wherein an internal storage volume is defined between the first jaw and the second jaw (fig. 3c, element 136, [0071], working space 136).
Regarding claim 8, To in view of Kelleher teaches The surgical instrument of claim 7,
To in view of Kelleher does not explicitly teach wherein the plurality of teeth are fabricated from a material that is florescent.
However, Tenger teaches wherein the plurality of teeth are fabricated from a material that is florescent (fig. 10, element 720, [0041], jaws 720 coated with a fluorescent material may be used).
Regarding claim 9, To in view of Kelleher teaches The surgical instrument of claim 7,
Further, To teaches wherein the forceps include a capacity enhancement feature configured to allow the forceps to hold multiple tissue samples (fig. 3c, element 136, [0071], working space 136, jaws are shaped like scoops to create an internal volume).
Regarding claim 10, To I view of Kelleher teaches The surgical instrument of claim 9,
Further, To teaches wherein the capacity enhancement feature comprises a tissue biasing device configured to immobilize a piece of tissue retained between the first and second jaws in the open position ([0084], tissue engaging teeth 504 may optimally engage tissue).
Regarding claim 12, To in view of Kelleher teaches The surgical instrument of claim 9,
Further, To teaches wherein the capacity enhancement feature comprises a capacity increasing feature configured to increase an internal volume of at least one of the first and second jaws (fig. 3c, element 136, [0071], working space 136, jaws are shaped like scoops to create an internal volume).
Regarding claim 13, To in view of Kelleher teaches The surgical instrument of claim 12,
Further, To teaches wherein the capacity increasing feature comprises at least one of the first jaw and the second jaw being configured to translate in a direction opposite the other of the first and second jaws at a hinge to increase the internal storage volume between the first and second jaws (fig. 4d, element 403/405, [0077], jaws rotate in direction of arrows 403/405).
Regarding claim 14, To in view of Kelleher teaches The surgical instrument of claim 12,
Further, To teaches wherein the capacity increasing feature comprises at least one of the first jaw and the second jaw being configured with a flexible wall to increase the internal storage volume between the first and second jaws ([0012], hinge for retractor may be composed of a living hinge with flexion).
Regarding claim 21, To teaches A method of collecting biological matter using a tissue retrieval device, comprising a shaft and a tissue collector attached to a distal end portion of the shaft, the method comprising:
inserting the endoscopes and the tissue retrieval device into anatomy of a patient, the tissue retrieval device comprising a proximal end portion (fig. 1, element 118, [0057], handle 118), and at least one control cable (fig. 9, element 192, [0097], control members 192 may comprise wires) extending from the proximal end portion to the distal end portion;
guiding a tissue collector (fig. 3E, element 300, [0070], retractor assembly 300) of the tissue retrieval device to a target tissue, the tissue collector configured to engage sample tissue for collection under control of the at least one control cable;
viewing the target tissue through the tissue collector with a viewing device of the tissue retrieval device, wherein the tissue collector is at least partially made of material that allows light to pass through the tissue collector ([0005], retractor may comprise an optically transparent material); and
collecting biological matter from the target tissue with the tissue retrieval device ([0067], retractor may be used to remove tissue).
To does not explicitly teach Inserting the shaft into a distal end of a working channel of an endoscope, wherein the tissue collector is larger than the working channel,
However, Kelleher teaches Inserting the shaft into a distal end of a working channel of an endoscope, wherein the tissue collector is larger than the working channel (fig. 26, jaws in an open configuration are larger than the working channel of the endoscope).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of To to be used with an endoscope as taught in Kelleher in order to deflect the device without changing the field of view (Kelleher col. 13, ln. 44-60).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over To in view of Kelleher as applied to claim 10 above, and further in view of Refai (US 20080033474 A1).
Regarding claim 11, To in view of Kelleher teaches The surgical instrument of claim 10,
Further, To teaches wherein the tissue biasing device comprises:
a needle array ([0084], tissue engaging teeth 504 may optimally engage tissue) located on the second jaw positioned to penetrate the sponge when the first and second jaws are in the closed position.
To in view of Kelleher does not explicitly teach a sponge located on the first jaw.
However, Refai teaches a sponge located on the first jaw ([0041], jaws configured to support sponges).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the jaw of To to support a sponge as taught in Refai in order to enable better grasping of the tissue through friction (Refai [0041]).
Claim(s) 16, 17, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over To as applied to claim 15, 18 above, and further in view of Butte (US 20210015350 A1).
Regarding claim 16, To teaches The endoscopy system of claim 15,
To does not explicitly teach the device wherein the first light emitter is configured to fluoresce a fluorophore.
However, Butte teaches the device wherein the first light emitter is configured to fluoresce a fluorophore ([0012], light source emits a wavelength absorbed by a fluorophore).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the jaw of To to use a fluorophore as taught in Butte in order to emit a narrowband light (Butte [0012]).
Regarding claim 17, To teaches The endoscopy system of claim 15,
To does not explicitly teach the device wherein the first light emitter comprises a laser and the first wavelength comprises 358 to 405 nanometers.
However, Butte teaches the device wherein the first light emitter comprises a laser and the first wavelength comprises 358 to 405 nanometers ([0013], narrowband light source may be 340nm to 400nm).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the jaw of To to use a fluorophore as taught in Butte in order to emit a narrowband light (Butte [0012]).
Regarding claim 19, To teaches The endoscopy system of claim 18,
To does not explicitly teach the device wherein the second light emitter comprises a light emitting diode and the second wavelength comprises 400 to 700 nanometers.
However, Butte teaches he device wherein the second light emitter comprises a light emitting diode and the second wavelength comprises 400 to 700 nanometers ([0013], narrowband wavelength can range from 400-700nm).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the jaw of To to use a fluorophore as taught in Butte in order to emit a narrowband light (Butte [0012]).
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 TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY TUAN LUU/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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