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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/18/2026 has been entered.
Response to Amendment
In response to the amendment filed on 3/18/2026, no claims have been cancelled, no claims have been newly added, thus claims 1-20 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 1, 13 and 18 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.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 7-8, 10, 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170246410 Levitan.
Regarding claim 1, Levitan discloses a system for performing a medical procedure within a patient (abstract, paragraph 3), said system comprising:
a flexible elongate member (112, Fig. 1h, 1j-k, paragraph 20, 23) insertable to a target site within the patient (abstract, paragraph 20, 23); and
a movable device (100, Fig. 1h) movable with respect to said flexible elongate member (112) (paragraph 20-21, 23, 29);
wherein said movable device (100) includes a reconfigurable proximal portion (104, Fig. 1h) which is bendable by a user to hook around a proximal portion of said flexible elongate member (112) (paragraph 29, Fig. 1h) or another proximal component of said system to hold said movable device in a selected position with respect to at least the proximal portion of said flexible elongate member (paragraph 29).
Regarding claim 2, Levitan discloses the limitations of claim 1, and further discloses wherein said reconfigurable proximal portion is configurable with respect to said flexible elongate member to maintain a selected position of said movable device with respect to the proximal portion of said flexible elongate member (paragraph 29).
Regarding claim 3, Levitan discloses the limitations of claim 1, and further discloses wherein said movable device is axially or rotationally movable with respect to said flexible elongate member (paragraph 20-21, 23, 29), and bendable to hook around a proximal portion of said flexible elongate member to be held in place axially or rotationally with respect to said flexible elongate member (paragraph 29).
Regarding claim 7, Levitan discloses the limitations of claim 1, and further discloses wherein said movable device includes an operable component (108, Fig. 1a, 1g-i) on a distal end thereof configured to engage tissue (paragraph 25), wherein when the tissue is engaged by said operable component, the tissue engaged by the operable component exerts a distally-directed force on said movable device (paragraph 9, 25, the operable component 108 engages tracheal rings and the tracheal rings exert an opposite reactive force in order to provide tactile feedback of when the operable component engages the tracheal rings).
Regarding claim 8, Levitan discloses the limitations of claim 7, wherein said bendable reconfigurable proximal portion of said movable device, when hooked around a proximal portion of said flexible elongate member or another proximal component of said system (paragraph 29, Fig. 1h), resists the distally-directed force exerted by the tissue to maintain said movable device with respect to said flexible elongate member and against the distally-directed force exerted thereon by tissue engaged by said movable device (paragraph 29, the bendable reconfigurable portion is capable of performing this limitation when the bendable reconfigurable portion is bent down hard enough around the proximal portion of the flexible elongate member essentially clamping it down around the flexible elongate member to resist the distally-directed force exerted by the tissue).
Regarding claim 10, Levitan discloses the limitations of claim 1, and further discloses wherein said reconfigurable proximal portion is adjacent a user-engageable portion (handle 114, Fig. 1h, paragraph 29) of said movable device.
Regarding claim 13, Levitan discloses a system for performing a medical procedure within a patient (abstract, paragraph 3), said system comprising:
a movable device (100, Fig. 1h) movable with respect to another component (112, 1h, 1j-k) (paragraph 20-21, 23, 29) of said system;
wherein said movable device (100) comprises:
a reconfigurable proximal portion (104, Fig. 1h) which is bendable by a user to hook around a proximal portion of at least said another component (112) (paragraph 29, Fig. 1h) of said system to hold said movable device in a selected position with respect to at least said another component of said system (paragraph 29); and
an operable component (108, Fig. 1a, 1g-i) comprising a tissue engagement element (paragraph 25).
Claim Rejections - 35 USC § 103
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.
Claims 1-11, 13, 18 are rejected under 35 U.S.C. 103 as being unpatentable over US 20070142849 A1 Ewers et al. (hereinafter Ewers) in view of Levitan.
Regarding claim 1, Ewers discloses a system for performing a medical procedure within a patient, said system comprising:
a flexible elongate member (12, Fig. 1-3b, 15a-16) insertable to a target site within the patient (paragraph 38); and
a movable device (34, Fig. 1-12, 14c, 15b, 16) movable with respect to said flexible elongate member (paragraph 52);
wherein said movable device includes a reconfigurable proximal portion (58, Fig. 5, paragraph 57, reconfigurable proximal portion 58 may be removable depending upon the desired ergonomics and surgical situation, therefore is reconfigurable).
Ewers is silent on wherein the reconfigurable proximal portion is bendable by a user to hook around a proximal portion of said flexible elongate member or another proximal component of said system to hold said movable device in a selected position with respect to at least the proximal portion of said flexible elongate member.
However, Levitan teaches a system for performing a medical procedure within a patient (abstract, paragraph 3) that comprises a flexible elongate member (112, Fig. 1h, 1j-k, paragraph 20, 23), a movable device (100, Fig. 1h) movable with respect to said flexible elongate member (112) (paragraph 20-21, 23, 29), and wherein said movable device (100) includes a reconfigurable proximal portion (104, Fig. 1h) which is bendable by a user to hook around a proximal portion of said flexible elongate member (112) (paragraph 29, Fig. 1h) or another proximal component of said system to hold said movable device in a selected position with respect to at least the proximal portion of said flexible elongate member (paragraph 29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ewers with the teachings of Levitan in order to fix the position of the moveable device on the flexible elongate member and keep them from sliding off from each other as disclosed by Levitan (paragraph 29).
Regarding claim 2, the combination of Ewers and Levitan teaches the limitations of claim 1, and Levitan teaches wherein said reconfigurable proximal portion is configurable with respect to said flexible elongate member to maintain a selected position of said movable device with respect to the proximal portion of said flexible elongate member (paragraph 29).
Regarding claim 3, the combination of Ewers and Levitan teaches the limitations of claim 1, and Levitan teaches wherein said movable device is axially or rotationally movable with respect to said flexible elongate member (paragraph 20-21, 23, 29), and bendable to hook around a proximal portion of said flexible elongate member to be held in place axially or rotationally with respect to said flexible elongate member (paragraph 29).
Regarding claim 4, the combination of Ewers and Levitan teaches the limitations of claim 1, and Ewers further discloses wherein said flexible elongate member is a medical scope (paragraph 37-38).
Regarding claim 5, the combination of Ewers and Levitan teaches the limitations of claim 4, and Ewers further discloses further comprising an auxiliary flexible tubular elongate member (80, Fig. 13a-16) extendable along said medical scope and defining a lumen (86, Fig. 13a-13b) through which said movable device is movable (paragraph 64-67).
Regarding claim 6, the combination of Ewers and Levitan teaches the limitations of claim 4, and Ewers further discloses wherein said movable device is movable through a working channel (28, Fig. 1-3b) defined through said medical scope (paragraph 40).
Regarding claim 7, the combination of Ewers and Levitan teaches the limitations of claim 1, and Ewers further discloses wherein said movable device includes an operable component (32, Fig. 1-12, 13c-16) on a distal end thereof configured to engage tissue (paragraph 40, 46, 51), wherein when the tissue is engaged by said operable component, the tissue engaged by the operable component exerts a distally-directed force on said movable device (as seen in Fig. 2a-2c, as tissue F is engaged by the operable component and the movable device is pulled proximally, tissue F exerts an opposite reactive force that is applied distally to the movable device).
Regarding claim 8, the combination of Ewers and Levitan teaches the limitations of claim 7, and Levitan teaches wherein said bendable reconfigurable proximal portion of said movable device, when hooked around a proximal portion of said flexible elongate member or another proximal component of said system (paragraph 29, Fig. 1h), resists the distally-directed force exerted by the tissue to maintain said movable device with respect to said flexible elongate member and against the distally-directed force exerted thereon by tissue engaged by said movable device (paragraph 29, the bendable reconfigurable portion is capable of performing this limitation when the bendable reconfigurable portion is bent down hard enough around the proximal portion of the flexible elongate member essentially clamping it down around the flexible elongate member to resist the distally-directed force exerted by the tissue).
Regarding claim 9, the combination of Ewers and Levitan teaches the limitations of claim 7, and Ewers further discloses wherein said operable component is a helical tissue engagement element (abstract, paragraph 40, 51).
Regarding claim 10, the combination of Ewers and Levitan teaches the limitations of claim 1, and Ewers further discloses wherein said reconfigurable proximal portion is adjacent a user-engageable portion (handle 52, Fig. 4a-5, paragraph 11, 55).
Regarding claim 11, the combination of Ewers and Levitan teaches the limitations of claim 1, and Ewers further discloses further comprising an additional device (16, Fig. 1-2b) operable with said movable device (paragraph 36, 40, 42).
Regarding claim 13, Ewers discloses a system for performing a medical procedure within a patient, said system comprising:
a movable device (34, Fig. 1-12, 14c, 15b, 16) movable with respect to another component (12, Fig. 1-3b, 15a-16) of said system (paragraph 38, 52);
wherein said movable device comprises:
a reconfigurable proximal portion (58, Fig. 5, paragraph 57, reconfigurable proximal portion 58 may be removable depending upon the desired ergonomics and surgical situation, therefore is reconfigurable); and
an operable component (32, Fig. 1-12, 13c-16) comprising a tissue engagement element (paragraph 40, 46, 51).
Ewers is silent on wherein the reconfigurable proximal portion is bendable by a user to hook around a proximal portion of at least said another component of said system to hold said movable device in a selected position with respect to at least said another component of said system.
However, Levitan teaches a system for performing a medical procedure within a patient (abstract, paragraph 3) that comprises a movable device (100, Fig. 1h) movable with respect to another component (112, 1h, 1j-k) (paragraph 20-21, 23, 29) of said system, and wherein said movable device (100) comprises a reconfigurable proximal portion (104, Fig. 1h) which is bendable by a user to hook around a proximal portion of at least said another component (112) (paragraph 29, Fig. 1h) of said system to hold said movable device in a selected position with respect to at least said another component of said system (paragraph 29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ewers with the teachings of Levitan in order to fix the position of the moveable device on the said another component and keep them from sliding off from each other as disclosed by Levitan (paragraph 29).
Regarding claim 18, Ewers discloses a method of operating a system configured to perform a procedure within a patient (paragraph 7-16, 45-52), said method comprising:
moving a first device (34, Fig. 1-12, 14c, 15b, 16) with respect to a component (16, Fig. 1-2b) of the system (paragraph 36, 40, 42, 46).
Ewers discloses a reconfigurable proximal portion (58, Fig. 5, paragraph 57, reconfigurable proximal portion 58 may be removable depending upon the desired ergonomics and surgical situation, therefore is reconfigurable) of the first device, but is silent on bending the reconfigurable proximal portion of the first device to hook around a proximal portion of the component of the system to maintain the position of the first device in a selected position.
However, Levitan teaches a system for performing a medical procedure within a patient (abstract, paragraph 3) that comprises a first device (100, Fig. 1h) movable with respect to a component (112, 1h, 1j-k) (paragraph 20-21, 23, 29) of the system, and wherein said first device (100) comprises a reconfigurable proximal portion (104, Fig. 1h) which is bendable by a user to hook around a proximal portion of the component (112) (paragraph 29, Fig. 1h) of the system to maintain the position of first device in a selected position (paragraph 29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ewers with the teachings of Levitan in order to fix the position of the first device on a component of the system and keep them from sliding off from each other as disclosed by Levitan (paragraph 29).
Claim 12 is rejected under 35 U.S.C. 103 as being obvious over Ewers in view of Levitan as applied to claim 11 above, and further in view of US 20120150200 A1 Mitelberg.
Regarding claim 12, the combination of Ewers and Levitan teaches the limitations of claim 11, and Ewers further discloses wherein said movable device comprise a tissue-engagement element (32, Fig. 1-12, 13c-16, abstract, paragraph 40, 46, 51).
The combination is silent on wherein said additional device is a suturing device.
However, Mitelberg teaches a similar system for performing a medical procedure within a patient wherein the system comprises a suturing device (20, Fig. 1-5, 24-42, paragraph 194, 202-204).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Ewers with Levitan with the teachings of Mitelberg to achieve wherein said additional device is a suturing device in order to apply sutures to targeted tissues and provide better securement of the tissues.
Claim 14 is rejected under 35 U.S.C. 103 as being obvious over Ewers in view Levitan as applied to claim 13 as above, and further in view of US 20040215230 A1 Frazier et al. (hereinafter Frazier).
Regarding claim 14, the combination of Ewers and Levitan teaches the limitations of claim 13, and Ewers further discloses wherein said tissue engagement element comprises a helical tissue-engaging element (abstract, paragraph 40, 51).
The combination is silent on wherein the helical tissue-engaging element is formed from a laser-cut tube.
However, Frazier teaches a tissue anchoring system that comprises a helical tissue-engaging element (422, Fig. 25-26, paragraph 143-145) at a distal end of a rotatable torque rod (340), wherein the helical tissue-engaging element is formed from a laser-cut tube (paragraph 143).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Ewers with Levitan with the teachings of Frazier to achieve wherein the helical tissue-engaging element is formed from a laser-cut tube, in order to provide more precise and accurate cuts during machining of the helical tissue-engaging element.
Furthermore, although the combination of references does not disclose “the helical tissue-engaging element is formed from a laser-cut tube”, it is noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.
Therefore, given that the combination of Ewers, Levitan and Frazier meets the requirements of the claimed structure, the helical tissue-engaging element clearly meet the requirements of present claim 14.
Claim 15-17 are rejected under 35 U.S.C. 103 as being obvious over Ewers in view of Levitan as applied to claim 13 above, and further in view of Mitelberg.
Regarding claim 15, the combination of Ewers and Levitan teaches the limitations of claim 13.
The combination is silent on wherein said movable device comprises a flexible control wire, at least a proximal portion thereof forming said reconfigurable proximal portion of said movable device.
However, Mitelberg teaches a similar system for performing a medical procedure within a patient wherein the system comprises a movable first device (26, Fig. 2, 14-15) comprising a flexible control wire (1036, Fig. 101a-103b, paragraph 237-239) that extends to a proximal end (1037) that is mounted to a rotatable knob (1016).
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 modification of Ewers with Levitan with the teachings of Mitelberg to achieve wherein said movable device comprises a flexible control wire, at least a proximal portion thereof forming said reconfigurable proximal portion of said movable device, in order to provide better stability and control of the movable device.
Regarding claim 16, the combination of Ewers, Levitan and Mitelberg teaches the limitations of claim 15, and Mitelberg further teaches wherein an operable component (1018, Fig. 100, 101b, 102b, 103b) comprises a tissue-engagement element (helix coils of operable component 1018 engages tissue) coupled to a distal end (1046) of said flexible control wire (paragraph 237-239).
Regarding claim 17, the combination of Ewers and Levitan teaches the limitations of claim 13, and Ewers further discloses further comprising an endoscope (paragraph 37-38).
The combination is silent on a suturing device operatively associated with said endoscope, said movable device being movable with respect to said suturing device to draw tissue proximally into a path of a needle of said suturing device.
However, Mitelberg teaches a similar system for performing a medical procedure within a patient wherein the system comprises a suturing device (20, Fig. 1-5, 24-42, paragraph 194, 202-204) operatively associated with an endoscope (12, Fig. 1-2, paragraph 194), a tissue engagement element (42) at the end of a movable first device (26) that is advanced into tissue, and retracted to draw the tissue in the path of the suturing device (paragraph 202, 204).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Ewers with Levitan with the teachings of Mitelberg to achieve a suturing device operatively associated with said endoscope, said movable device being movable with respect to said suturing device to draw tissue proximally into a path of a needle of said suturing device, in order to apply sutures to targeted tissues and provide better securement of the tissues.
Claim 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ewers in view of Levitan as applied to claim 18 above, and further in view of Mitelberg.
Regarding claim 19, the combination of Ewers and Levitan teaches the limitations of claim 18, and the combination further discloses wherein: the first device is a tissue engagement element (Ewers: paragraph 40, 51); moving the first device further comprises advancing the tissue engagement element into tissue, and retracting the tissue engagement element to draw the tissue (Ewers: paragraph 40, 46, 51); and reconfiguring the reconfigurable proximal portion of the first device includes engaging the reconfigurable portion with respect to a component of the system to maintain the position of the first device (Levitan: paragraph 29).
The combination is silent on the component is a suturing device; the advancing of the tissue engagement element into tissue, and retracting the tissue engagement element to draw the tissue in the path of the suturing device; and to maintain the position of the first device to maintain tissue in the path of the suturing device.
However, Mitelberg teaches a similar method of operating a system for performing a medical procedure within a patient (paragraph 194, 202-204) wherein the system comprises a suturing device (20, Fig. 1-5, 24-42, paragraph 194, 202-204), a tissue engagement element (42) at the end of a movable first device (26) that is advanced into tissue, and retracted to draw the tissue in the path of the suturing device (paragraph 202, 204), and to maintain the position of the first device to maintain tissue in the path of the suturing device (paragraph 202, 204).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Ewers with Levitan with the teachings of Mitelberg to achieve wherein the component is a suturing device; the advancing of the tissue engagement element into tissue, and retracting the tissue engagement element to draw the tissue in the path of the suturing device; and to maintain the position of the first device to maintain tissue in the path of the suturing device, in order to apply sutures to targeted tissues and provide better securement of the tissues.
Regarding claim 20, the combination of Ewers, Levitan and Mitelberg teaches the limitations of claim 19, and Levitan teaches further comprising reconfiguring the reconfigurable proximal portion of the first device to release the first device from its position engaged with a component of the system (the reconfigurable proximal portion 104 can be unbent to release the first device from the component of the system in order to manipulate the first device and remove it from the component and/or the patient).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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, Jackie Ho can be reached at 571-272-4696. 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.
/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
Prosecution Insights