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 .
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) 1-3 and 8-11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mirza (US 2022/0354526 A1).
Regarding claim 1, Mirza discloses:
A carpal tunnel release device (see Fig. 1) comprising:
an outer cannula (cannula 6, see Fig. 5) comprising a body defining an interior longitudinal cavity (see Fig. 5 and Para. [0158]) and having a dorsal groove (slot 22, see Fig. 5) formed into the body surface (see Fig. 5 and Para. [0161]);
wherein the dorsal groove is adapted to receive the transverse carpal ligament of a patient when the device is positioned in said patient’s wrist proximate the carpal tunnel cavity (see Para. [0188]-[0189] mentioning wherein a ligament may be placed near or at slot (22) to be severed by a blade extending therethrough; the slot is therefore understood to be capable of and “adapted to” receive a portion of the transverse carpal ligament therein unless otherwise stated); and
an inner cannula (inner tube 48, see Fig. 5) insert designed to be inserted into the interior longitudinal cavity of the outer cannula (see Para. [0190]), said inner cannula insert including a blade projection (blade 24, see Fig. 5) adapted for cutting the transverse carpal ligament when said ligament is seated in the dorsal groove of the outer cannula (see Para. [0192] mentioning wherein the blade is actuated along slot (22) to cut the transverse carpal ligament).
Regarding claim 2, Mirza discloses the invention of claim 1, Mirza further discloses wherein the blade projection is fixed to a distal end of the inner cannula insert (see Fig. 7C showing a fixation assembly fixing the blade to the inner tube).
Regarding claim 3, Mirza discloses the invention of claim 1, Mirza further discloses wherein the blade projection comprises a retractable blade that can be deployed from a distal end of the inner cannula insert (see Para. [0169] and [0192]).
Regarding claim 8, Mirza discloses the invention of claim 1, Mirza further discloses, wherein the body of the outer cannula has an open proximal end providing access for the inner cannula insert into the interior longitudinal cavity and a closed distal end restricting the longitudinal movement of the inner cannula insert within the outer cannula (see Figs. 28A-28F; see also Para. [0190]).
Regarding claim 9, Mirza discloses the invention of claim 8, Mirza further discloses a probe positioned on the distal end of the outer cannula (distal end 26, see Figs. 4 and 28C; the claimed “probe” is disclosed to be a blunt feature at the distal end of the outer cannula and not a separate surgical instrument as evident by Para. [0041]-[0043] of the instant Specification and accompanying Figs. 13-15) for palpating the distal end of the transverse carpal ligament upon insertion of the device into the carpal canal of the patient (the distal end of the cannula is fully capable of being used to palpate the transverse carpal ligament during insertion to the target site).
Regarding claim 10, Mirza discloses the invention of claim 1, Mirza further discloses wherein the inner cannula insert further includes a longitudinally extending channel (see Para. [0018]).
Regarding claim 11, Mirza discloses the invention of claim 10, Mirza further discloses an arthroscope adapted to be inserted through the longitudinally extending channel in the inner cannula insert (arthroscope 14, see Fig. 5 and Para. [0018]).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mirza (US 2022/0354526 A1) in view of Seymour (US 2016/0157881 A1).
Regarding claim 4, Mirza discloses the invention of claim 1, Mirza discloses all of the limitations of the invention of claim 1.
However, Mirza does not expressly disclose wherein the body of the outer cannula includes an interior groove axially extending along the length of the interior longitudinal cavity of the outer cannula, and wherein the inner cannula insert includes an axially extending longitudinal projection adapted to fit into the internal groove of the outer cannula.
In the same field of endeavor, namely carpal tunnel treatment devices, Seymour teaches a carpal tunnel release device (see Fig. 1) comprising an outer tube (guide 10, see Fig. 4D) having a longitudinally-extending lumen (see Fig. 4D); and an inner tube (knife 770, see Fig. 9B) slidably received within the lumen of the outer tube (see Para. [0050]-[0051]), the inner tube comprising a blade at the distal end thereof (773, see Fig. 9B); wherein the longitudinally-extending lumen of the outer tube comprises a pair of axially-extending grooves along the length thereof (pin grooves 711 and 712, see Fig. 9A and Para. [0050]-[0052]) configured to mate with a pair of radially-extending projections position on the inner tube (pivot pins 713 and 714, see Fig. 9B and Para. [0050]-[0052]) to provide increased stability to the inner tube during advancement into the lumen of the outer tube (see Para. [0050]-[0052]).
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 slot of the outer cannula of Mirza to comprise at least one longitudinally-extending groove extending along the axial length thereof configured to receive a corresponding pin located along the exterior surface of the inner tube as taught and suggested by Seymore to, in this case, increase the stability between the two components as the inner tube is slid along the length of the slot of the outer cannula (see Seymour Para. [0050]-[0052]).
Claim(s) 5-7, 12-15 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mirza (US 2022/0354526 A1) in view of Hughes (US 2005/0261581 A1).
Regarding claim 5, Mirza discloses all of the limitations of the invention of claim 1.
However, Mirza does not expressly disclose an external guide removably attached to the outer cannula and projecting generally parallel to said outer cannula, wherein when said outer cannula is positioned in the patient’s wrist, the external guide is projected outside and over the patient’s wrist.
The problem to be solved by the external guide is to provide a depth guide to accurately gauge the location of the distal end of the device and/or the extent of deployment of the inner cannula within the outer cannula (see Para. [0014] and [0043]-[0044] of the instant Specification).
In solving the problem of providing a depth stop to accurately gauge the location of a distal end of the surgical device within a surgical site, Hughes teaches a surgical device (probe 100, see Fig. 2) having a distal end effector (cutter inserted through aperture 104, see Para. [0091]-[0092] and Fig. 2); wherein an external guide system (depth guidance assembly 400, see Fig. 5C) comprising a guide rail (404, see Fig. 5C) may be provided, wherein at the surgical device is inserted through a receiving aperture of the external guide system (see Figs. 5 and 5C) such that the external guide and surgical device extend parallel to one-another (see Fig. 5C) to allow a user to track the penetration depth of the surgical device within a target site based on the relative position between the surgical device and the guide rail (see Para. [0111]-[0112]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included a depth measurement device as taught disclosed by Hughes into the system of Mirza, the depth measurement device comprising a depth guide bar extending parallel to the device of Mirza to, in this case, allow a user to determine the location of the distal end of the outer cannula within a target site based on the relative location between the outer cannula and the depth guide, allowing a user to more accurately locate the distal end effector within a surgical site during use (see Hughes Para. [0111]-[0112]).
Regarding claim 6, the combination of Mirza and Hughes disclose the invention of claim 5, Mirza, as modified by Hughes, further discloses wherein the external guide includes at least one marking indicating the extent of deployment of the inner cannula insert when said inner cannula insert is inserted into the outer cannula (see Hughes Figs. 5 and 5C showing a plurality of depth marker indicia located along the length of the guide bar (404)).
Regarding claim 7, the combination of Mirza and Hughes disclose the invention of claim 6, Mirza, as modified by Hugues, further discloses wherein the at least one marking comprises a gradient scale provided on the external guide (see Figs. 5 and 5C showing the marking indicia positioned along the guide bar consists of a gradient scale).
Regarding claim 12, Mirza discloses:
A carpal tunnel release device (see Fig. 1) comprising:
an outer cannula (cannula 6, see Fig. 5) comprising a body defining an interior longitudinal cavity (see Fig. 5 and Para. [0158]) and having a dorsal groove (slot 22, see Fig. 5) formed into the body surface (see Fig. 5 and Para. [0161]);
wherein the dorsal groove is adapted to receive the transverse carpal ligament of a patient when the device is positioned in said patient’s wrist proximate the carpal tunnel cavity (see Para. [0188]-[0189] mentioning wherein a ligament may be placed near or at slot (22) to be severed by a blade extending therethrough; the slot is therefore understood to be capable of and “adapted to” receive a portion of the transverse carpal ligament therein unless otherwise stated); and
an inner cannula (inner tube 48, see Fig. 5) insert designed to be inserted into the interior longitudinal cavity of the outer cannula (see Para. [0190]), said inner cannula insert including a blade projection (blade 24, see Fig. 5) adapted for cutting the transverse carpal ligament when said ligament is seated in the dorsal groove of the outer cannula (see Para. [0192] mentioning wherein the blade is actuated along slot (22) to cut the transverse carpal ligament).
However, Mirza does not expressly disclose:
an external guide removably attached to the outer cannula and projecting in generally parallel alignment with said outer cannula;
wherein when said outer cannula is positioned in the patient’s wrist, the external guide is projected outside and over the patient’s wrist, wherein the external guide includes at least one marking facilitating determining the position of the dorsal groove within the patient’s wrist and/or the extent of deployment of the inner cannula insert within the outer cannula.
The problem to be solved by the external guide is to provide a depth guide to accurately gauge the location of the distal end of the device and/or the extent of deployment of the inner cannula within the outer cannula (see Para. [0014] and [0043]-[0044] of the instant Specification).
In solving the problem of providing a depth stop to accurately gauge the location of a distal end of the surgical device within a surgical site, Hughes teaches a surgical device (probe 100, see Fig. 2) having a distal end effector (cutter inserted through aperture 104, see Para. [0091]-[0092] and Fig. 2); wherein an external guide system (depth guidance assembly 400, see Fig. 5C) comprising a guide rail (404, see Fig. 5C) having depth marking indicia provided thereon (see Figs. 5 and 5C) may be provided, wherein at the surgical device is inserted through a receiving aperture of the external guide system (see Figs. 5 and 5C) such that the external guide and surgical device extend parallel to one-another (see Fig. 5C) to allow a user to track the penetration depth of the surgical device within a target site based on the relative position between the surgical device and the guide rail (see Para. [0111]-[0112]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included a depth measurement device as taught disclosed by Hughes into the system of Mirza, the depth measurement device comprising a depth guide bar extending parallel to the device of Mirza to, in this case, allow a user to determine the location of the distal end of the outer cannula within a target site based on the relative location between the outer cannula (disposed within the patient’s wrist) and the depth guide (positioned parallel to the surgical device and outside the patient’s wrist), allowing a user to more accurately locate the distal end effector within a surgical site during use (see Hughes Para. [0111]-[0112]), aided with depth marker indicia provided along the length of the guide bar.
Regarding claim 13, the combination of Mirza and Hughes disclose the invention of claim 12, Mirza, as modified by Hughes, further discloses wherein the at least one marking comprises a gradient scale provided on the external guide (see Hughes Figs. 5 and 5C showing a plurality of depth marker indicia located along the length of the guide bar (404)).
Regarding claim 14, the combination of Mirza and Hughes disclose the invention of claim 12, Mirza further discloses wherein the blade projection is fixed to a distal end of the inner cannula insert (see Fig. 7C showing a fixation assembly fixing the blade to the inner tube).
Regarding claim 15, the combination of Mirza and Hughes disclose the invention of claim 12, Mirza further discloses wherein the blade projection comprises a retractable blade that can be deployed from a distal end of the inner cannula insert (see Para. [0169] and [0192]).
Regarding claim 17, the combination of Mirza and Hughes disclose the invention of claim 12, Mirza further discloses wherein the body of the outer cannula has an open proximal end providing access for the inner cannula insert into the interior longitudinal cavity and a closed distal end restricting the longitudinal movement of the inner cannula insert within the outer cannula (see Figs. 28A-28F; see also Para. [0190]).
Regarding claim 18, the combination of Mirza and Hughes disclose the invention of claim 17, Mirza further discloses a probe positioned on the distal end of the outer cannula (distal end 26, see Figs. 4 and 28C; the claimed “probe” is disclosed to be a blunt feature at the distal end of the outer cannula and not a separate surgical instrument as evident by Para. [0041]-[0043] of the instant Specification and accompanying Figs. 13-15) for palpating the distal end of the transverse carpal ligament upon insertion of the device into the carpal canal of the patient (the distal end of the cannula is fully capable of being used to palpate the transverse carpal ligament during insertion to the target site).
Regarding claim 19, the combination of Mirza and Hughes discloses the invention of claim 12, Mirza further discloses wherein the inner cannula insert further includes a longitudinally extending channel (see Para. [0018]).
Regarding claim 20, the combination of Mirza and Hughes discloses the invention of claim 12, Mirza further discloses arthroscope adapted to be inserted through the longitudinally extending channel in the inner cannula insert (arthroscope 14, see Fig. 5 and Para. [0018]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mirza (US 2022/0354526 A1) in view of Hughes (US 2005/0261581 A1), further in view of Seymour (US 2016/0157881 A1).
Regarding claim 16, the combination of Mirza and Hughes disclose all of the limitations of the invention of claim 12.
However, none of either Mirza of Hughes expressly disclose wherein the body of the outer cannula includes an interior groove axially extending along the length of the interior longitudinal cavity of the outer cannula, and wherein the inner cannula insert includes an axially extending longitudinal projection adapted to fit into the internal groove of the outer cannula.
In the same field of endeavor, namely carpal tunnel treatment devices, Seymour teaches a carpal tunnel release device (see Fig. 1) comprising an outer tube (guide 10, see Fig. 4D) having a longitudinally-extending lumen (see Fig. 4D); and an inner tube (knife 770, see Fig. 9B) slidably received within the lumen of the outer tube (see Para. [0050]-[0051]), the inner tube comprising a blade at the distal end thereof (773, see Fig. 9B); wherein the longitudinally-extending lumen of the outer tube comprises a pair of axially-extending grooves along the length thereof (pin grooves 711 and 712, see Fig. 9A and Para. [0050]-[0052]) configured to mate with a pair of radially-extending projections position on the inner tube (pivot pins 713 and 714, see Fig. 9B and Para. [0050]-[0052]) to provide increased stability to the inner tube during advancement into the lumen of the outer tube (see Para. [0050]-[0052]).
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 slot of the outer cannula of Mirza to comprise at least one longitudinally-extending groove extending along the axial length thereof configured to receive a corresponding pin located along the exterior surface of the inner tube as taught and suggested by Seymore to, in this case, increase the stability between the two components as the inner tube is slid along the length of the slot of the outer cannula (see Seymour Para. [0050]-[0052]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s
disclosure. See the attached PTO-892 Notice of Reference Cited. Specifically, US 20210059654 A1 to Ryan, US 5281224 A to Faccioli, US 4596553 A to Lee, US 20220233270 A1 to Sauer and US 20200253621 A1 to Ramirez all disclose surgical devices comprising penetration depth guides for measuring and/or determining the location of a distal end effector within a target site. Additionally, US 2017/0252056 A1 to Garvey, US 2015/0320436 A1 to Agee, US 2007/0288043 A1 to Rehnke, US 2021/0386648 A1 to Mirza and US 2017/0273706 A1 to Mirza all disclose surgical cutting devices for treating carpal tunnel release.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771