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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/21/2026 has been entered.
Response to Amendment
Amendments to claims 1, 7 of 8/6/2025 acknowledged and entered.
New claims 10, 11 of 1/21/2026 acknowledged and entered.
Response to Arguments
Applicant's arguments filed 1/21/2026 have been fully considered but they are not persuasive.
Regarding p. 13, para. 1, applicant alleges that examiner relies upon Daum to teach a surgical device and an endoscope in the same citation. Examiner’s intention with the citation was to demonstrate that the insertion portion, which would have a diameter equal or marginally less than the trocar, would have a diameter than falls within the range as taught by Daum. This argument will be further supported by Sato in the outgoing rejection.
Regarding p. 13, para. 3-4, applicant argues that Ellman does not teach an endoscope with length 260-270mm, and that Sato, Teitelbaum, Bae, and Daum do not cure these deficiencies. Examiner is not in accordance, as Tietelbaum teaches a flexible shaft 144 with length of 250-300mm. The flexible shaft supports a bore, which acts as the punch of the instant application. Examiner posits that application of a bore at a depth beyond the endoscope would create undue harm to the patient, hence the combination of Tietelbaum and Ellman as applied to claim 1 would necessitate a device of length 250-300mm, which contains the claimed range.
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, 5-8, 10, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ellman (US20230039562 A1) in view of Sato (US 20090259104 A1) and Teitelbaum (US 20050033292 A1) and Daum (US 6120517 A).
Regarding Claim 1, Ellman teaches a surgical instrument set for single port spinal surgery, comprising:
a punch (fig. 13, 14, element 40) configured to form a treatment hole in a skin above a surgery target part ([0038]);
surgical device (fig. 1, 5, element 200), wherein the surgical device has a tubular shape and is insertable into the treatment hole according to the punch to secure a surgery space ([0039-0041] teach the process of forming and dilating the hole before insertion of surgical device);
an endoscope (fig. 9, element 228) comprising an insertion portion (fig. 9, element 260, 262) having a rod shape, which is inserted into the surgical device ([0036] recites that optical cannula 228 can be inserted into the sheath 200),
in which a guide hole (fig. 9, element 262) having a tubular shape is opened ([0035]),
and comprising an image-capturing portion (fig. 9, element 260 [0035] recites the optical channel for passing a camera to image the site); and
a surgical instrument inserted into the guide hole to perform surgery on the surgery target part ([0035] teaches the insertion of surgery instruments through the working channel).
wherein the insertion portion comprises:
an abstergent supply portion (fig. 9, element 274) configured to supply an abstergent to one end of the insertion portion ([0035] discloses that cleaning solution such as saline may be injected through port 274);
and an abstergent discharge portion (fig. 9, element 264) configured to discharge the supplied abstergent ([0035] discloses that the solution flows through the optical channel to end 264).
Ellman does not explicitly teach the device wherein
The surgical device is configured to receive the punch,
an endoscope to be inserted into the surgical device after removal of the punch from the surgical device
the image capturing portion is configured to take images of the surgery target part during a surgical procedure;
wherein the guide hole, the abstergent supply portion, the abstergent discharge portion, and the image-capturing portion are separated from each other in the insertion portion;
wherein the image-capturing portion is positioned between the abstergent supply portion and the abstergent discharge portion; and
wherein the abstergent supply portion, the abstergent discharge portion, and the image capturing portion are configured to enable viewing of the surgery target part during performance of the surgical procedure,
wherein the punch has a length in a range of 200 mm to 300 mm which is an entire length from a fore end to the other end of the punch, and wherein the punch has a diameter in a range of 5 mm to 6.75 mm;
wherein the surgical device has a diameter in a range of 6 mm to 7 mm, and the diameter of the surgical device is greater than the diameter of the punch;
wherein the surgical device has a length in a range of 165 mm to 175 mm from a fore end to a distal end of the surgical device, and the length of the surgical device is less than the length of the punch; and
wherein the insertion portion has an outer diameter in the range of 5.5 mm to 6.1 mm;
and the endoscope outer diameter is substantially equal to the surgical device inner diameter;
wherein the endoscope has a length in a range of 260 mm to 270 mm.
However, Teitelbaum teaches the device wherein
The surgical device (fig. 30, element 916, [0118]) is configured to receive the punch (fig. 29, element 914, [0117-118], working sheath 916 is inserted over the bone drill 914, which is then removed),
an elongate device to be inserted into the surgical device after removal of the punch from the surgical device ([0144], laser catheter may be pushed through an introducer into the channel f figs. 28-30)
wherein the punch has a length in a range of 200 mm to 300 mm which is an entire length from a fore end to the other end of the punch (fig. 5, element 144, [0062], the flexible shaft 144 has an axial length of 250-300mm), and wherein the punch has a diameter in a range of 5 mm to 6.75 mm (fig. 5, element 130, [0057], the flexible drilling tip 130 is preferably between 3-5mm in diameter);
wherein the endoscope has a length in a range of 260 mm to 270 mm ([0062], flexible shaft 144 has an axial length of 250 mm to 300 mm).
However, Sato teaches the device wherein the elongate device is an endoscope,
the image capturing portion (fig. 3, element 21) is configured to take images of the surgery target part during a surgical procedure ([0039]);
wherein the guide hole (fig. 3, element 25, [0043]), the abstergent supply portion ([0041], water feeder, not illustrated), the abstergent discharge portion (fig. 3, element 23a, [0040-41]), and the image-capturing portion (fig. 3, element 21) are separated from each other in the insertion portion (fig. 3 shows distinct separation, fig. 2 shows separation of channels);
wherein the image-capturing portion is positioned between the abstergent supply portion and the abstergent discharge portion (fig. 2, element 21/23, camera element 21 being recessed into the distal end and water nozzle 23 extending past the distal end); and
wherein the abstergent supply portion, the abstergent discharge portion, and the image capturing portion are configured to enable viewing of the surgery target part during performance of the surgical procedure ([0039]);
and the endoscope outer diameter is substantially equal to the surgical device inner diameter ([0112], inner diameter of second protrusion 15g is set to be substantially equal to the outer diameter of the insertion portion 11 of the endoscope).
However, Daum teaches wherein the surgical device has a diameter in a range of 6 mm to 7 mm (col. 6, ln. 7-19, trocar from 5-10mm in diameter, 50-250mm in length), and the diameter of the surgical device is greater than the diameter of the punch;
wherein the surgical device has a length in a range of 165 mm to 175 mm from a fore end to a distal end of the surgical device (col. 6, ln. 7-19, trocar from 5-10mm in diameter, 50-250mm in length), and the length of the surgical device is less than the length of the punch; and
wherein the insertion portion has an outer diameter in the range of 5.5 mm to 6.1 mm (col. 6, ln. 7-19, trocar from 5-10mm in diameter, 50-250mm in length).
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 procedure of Ellman to include inserting a guide over the punch before removal as taught in Teitelbaum in order to protect tissue and musculature near the surgical site (Teitelbaum [0117]).
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 endoscope of Ellman to include separate fluid and imaging channels as taught in Sato in order to use the fluid conduit to clean the imager (Sato [0040-41]).
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 endoscope of Ellman to include a trocar of the specified dimensions as taught in Daum in order to prepare for a biopsy procedure (Daum col. 6, ln. 7-19).
Regarding Claim 5, Ellman in view of Sato, Teitelbaum, and Daum teaches the surgical instrument set of claim 1,
Further, Ellman teaches the device wherein the surgical device has one cross section including an inclined surface (fig. 5, element 202; [0031] discloses that the sheath terminates in a beveled tip).
Regarding Claim 6, Ellman in view of Sato, Teitelbaum, and Daum teaches the surgical instrument set of claim 1,
Further, Ellman teaches the device wherein the surgical instrument is at least one of a forceps, an ultrasonic instrument, and a laser instrument ([0042] discloses that forceps may be inserted into the working channel).
Regarding Claim 7, Ellman teaches a method of using a surgical instrument set for single port spinal surgery, comprising:
an operation of forming a treatment hole in the skin above a surgery target part using a punch (fig. 13, 14, element 40; [0039-0041] teach formation and dilation of a hole);
an operation of securing a surgery space by inserting a surgical device (fig. 1, 5, element 200) having a tubular shape into the treatment hole along the punch ([0039-0041]);
an operation of removing the punch (100) from the surgical device ([0039-41]);
an operation of inserting an endoscope (fig. 9, element 228) including an insertion portion (fig. 9, element 260, 262) in which a guide hole (fig. 9, element 262) is formed and which comprises an image-capturing portion into the surgical device (fig. 9, element 260; [0036] recites that optical cannula 228 can be inserted into the sheath 200; [0035] recites the optical channel for passing a camera to image the site);
after the operation of inserting the endoscope including the insertion portion in which the guide hole is formed and which comprises the image-capturing portion into the surgical device, a view of the image-capturing portion is secured by cleaning the surgery target part using an abstergent supply portion (fig. 9, element 274) and an abstergent discharge portion (fig. 9, element 264) which are provided in the insertion portion to supply or suction an abstergent ([0035] discloses that the solution flows through the optical channel to end 264 and suction can be provided via the same port 274),
and an operation of performing surgery on the surgery target part by inserting the surgical instrument into the guide hole ([0035] teaches the insertion of surgery instruments through the working channel).
Ellman does not explicitly teach the device wherein
An endoscope is inserted after the punch is removed from the surgical device
the guide hole, the abstergent supply portion, the abstergent discharge portion, and the image-capturing portion are separated from each other in the insertion portion and
wherein the image-capturing portion is positioned between the abstergent supply portion and the abstergent discharge portion;
wherein the punch has a length in a range of 200 mm to 300 mm which is an entire length from a fore end to the other end of the punch, and wherein the punch has a diameter in a range of 5 mm to 6.75 mm;
wherein the surgical device has a diameter in a range of 6 mm to 7 mm, and the diameter of the surgical device is greater than the diameter of the punch;
wherein the surgical device has a length in a range of 165 mm to 175 mm from a fore end to a distal end of the surgical device, and the length of the surgical device is less than the length of the punch; and
wherein the insertion portion has an outer diameter in the range of 5.5 mm to 6.1 mm;
and the endoscope outer diameter is substantially equal to the surgical device inner diameter;
wherein the endoscope has a length in a range of 260 mm to 270 mm.
However, Teitelbaum teaches An endoscope is inserted after the punch is removed from the surgical device (fig. 29, element 914, [0117-118], working sheath 916 is inserted over the bone drill 914, which is then removed, [0144], laser catheter may be pushed through an introducer into the channel f figs. 28-30).
wherein the punch has a length in a range of 200 mm to 300 mm which is an entire length from a fore end to the other end of the punch (fig. 5, element 144, [0062], the flexible shaft 144 has an axial length of 250-300mm), and wherein the punch has a diameter in a range of 5 mm to 6.75 mm (fig. 5, element 130, [0057], the flexible drilling tip 130 is preferably between 3-5mm in diameter);
wherein the endoscope has a length in a range of 260 mm to 270 mm ([0062], flexible shaft 144 has an axial length of 250 mm to 300 mm).
However, Sato teaches the device wherein the guide hole (fig. 3, element 25, [0043]), the abstergent supply portion ([0041], water feeder, not illustrated), the abstergent discharge portion (fig. 3, element 23a, [0040-41]), and the image-capturing portion (fig. 3, element 21) are separated from each other in the insertion portion (fig. 3 shows distinct separation, fig. 2 shows separation of channels) and
wherein the image-capturing portion is positioned between the abstergent supply portion and the abstergent discharge portion (fig. 2, element 21/23, camera element 21 being recessed into the distal end and water nozzle 23 extending past the distal end);
and the endoscope outer diameter is substantially equal to the surgical device inner diameter ([0112], inner diameter of second protrusion 15g is set to be substantially equal to the outer diameter of the insertion portion 11 of the endoscope).
However, Daum teaches wherein the surgical device has a diameter in a range of 6 mm to 7 mm (col. 6, ln. 7-19, trocar from 5-10mm in diameter, 50-250mm in length), and the diameter of the surgical device is greater than the diameter of the punch;
wherein the surgical device has a length in a range of 165 mm to 175 mm from a fore end to a distal end of the surgical device (col. 6, ln. 7-19, trocar from 5-10mm in diameter, 50-250mm in length), and the length of the surgical device is less than the length of the punch; and
wherein the insertion portion has an outer diameter in the range of 5.5 mm to 6.1 mm (col. 6, ln. 7-19, trocar from 5-10mm in diameter, 50-250mm in length).
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 procedure of Ellman to include inserting a guide over the punch before removal as taught in Teitelbaum in order to protect tissue and musculature near the surgical site (Teitelbaum [0117]).
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 endoscope of Ellman to include separate fluid and imaging channels as taught in Sato in order to use the fluid conduit to clean the imager (Sato [0040-41]).
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 endoscope of Ellman to include a trocar of the specified dimensions as taught in Daum in order to prepare for a biopsy procedure (Daum col. 6, ln. 7-19).
Regarding Claim 8, Ellman in view of Sato, Teitelbaum, and Daum teaches the method of claim 7,
Further, Ellman teaches the device wherein at least one of a forceps configured to grip or remove the surgery target part, an ultrasonic instrument, and a laser instrument is used in the operation of performing of the surgery on the surgery target part by inserting the surgical instrument into the guide hole ([0035] teaches the insertion of forceps specifically through the working channel).
Regarding claim 10, Ellman in view of Sato, Tietelbaum, and Daum teaches The surgical instrument set of claim 1,
Further, Sato teaches wherein the endoscope further comprises a handle portion, which comprises:
a first operation button configured to open or close paths of the abstergent supply portion and the abstergent discharge portion (fig. 1, element 12b, [0042], air/water feed button 12b for feeding air and water); or
a second operation button configured to allow the image-capturing portion to start, finish, temporarily stop, or record image-capturing to allow a practitioner to manipulate the endoscope by a first hand without using a second hand which is holding the surgical instrument.
Regarding claim 11, Ellman in view of Sato, Tietelbaum, and Daum teaches The surgical instrument set of claim 7,
Further, Sato teaches wherein the endoscope further comprises a handle portion, which comprises:
a first operation button configured to open or close paths of the abstergent supply portion and the abstergent discharge portion (fig. 1, element 12b, [0042], air/water feed button 12b for feeding air and water); or
a second operation button configured to allow the image-capturing portion to start, finish, temporarily stop, or record image-capturing to allow a practitioner to manipulate the endoscope by a first hand without using a second hand which is holding the surgical instrument.
Claim(s) 3, 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ellman in view of Sato, Tietelbaum, and Daum as applied to claim 1 in further view of Bae (KR 20120068563 A).
Regarding Claim 3, Ellman in view of Sato, Teitelbaum, and Daum teaches the surgical instrument set of claim 1,
wherein the surgical instrument is a forceps ([0035 discloses a surgery instrument that is specifically generic forceps known in the art]),
Ellman in view of Sato does not explicitly teach an instrument set wherein the forceps comprises:
a rod portion inserted into the guide hole;
a pincer portion provided on one end of the rod portion and configured to grip the surgery target part;
and a manipulation portion provided on the other end of the rod portion and configured to manipulate the pincer portion,
and wherein only the rod portion and the pincer portion are inserted into the guide hole.
However, Bae teaches an instrument set wherein the forceps (fig. 1, element 4, 10) comprises:
a rod portion (fig. 1, element 2) inserted into the guide hole (p. 2, para. 12);
a pincer portion (fig. 1, element 4) provided on one end of the rod portion and configured to grip the surgery target part (p. 2, para. 13);
and a manipulation portion (fig. 1, element 6) provided on the other end of the rod portion and configured to manipulate the pincer portion (p. 2, para. 11),
and wherein only the rod portion and the pincer portion are inserted into the guide hole (p. 3, para. 2).
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 substituted the generic forceps of Ellman for the forceps of Bae in order to coagulate lesions and diseased tissue in operation (Bae p. 2, para. 7).
Regarding Claim 4, Ellman in view of Sato, Teitelbaum, and Daum and Bae teach the surgical instrument set of claim 3.
Bae further teaches the set wherein the rod portion has a tubular shape (p. 2, para. 11),
wherein the pincer portion comprises a second pincer fixed to one end of the rod portion and a first pincer hinge-connected (fig. 1, element 8) to the one end of the rod portion (p. 3, para. 12),
wherein the rod portion further comprises a transfer portion therein which has one end connected to the first pincer and the other end connected to the manipulation portion (p. 2, para. 14 teaches connection cables and wires running through the rod to connect the handle and forceps),
and wherein the transfer portion is moved forward or backward by manipulating the manipulation portion (p. 2, para. 14 teaches connection cables and wires running through the rod to connect the handle and forceps controlled via actuation of the handle).
Conclusion
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 on 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TIMOTHY TUAN LUU/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795