DETAILED ACTION
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 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2012/0283835 (Bentley ‘835) in view of U.S. Patent Application Publication No. 2010/0094425 (Bentley ‘425) and U.S. Patent Application Publication No. 2021/0282884 (Patel).
Regarding claim 21, Bentley ‘835 discloses a system (see Fig. 6) comprising: an anatomical shield (300/315/318) comprising: a retractor flap (300); an anchoring barb (315/318) coupled to the retractor flap and configured to secure the retractor flap to a biological tissue (see paragraphs [0059], [0062], and [0063]); and a tethering ribbon (320) extending from the retractor flap; and an applicator (350) comprising: a housing (350) defining a barb loading portal (368/internal space of housing 350) configured to receive the anchoring barb (315/318) of the anatomical shield (300).
Further regarding claim 21 and regarding claim 23, Bentley ‘835 discloses the delivery applicator includes an ejection rod and an actuator mechanism to deploy the anchoring barb and anatomical shield (see paragraph [0063]), but fails to describe these and other components in the applicator in detail. However, Bentley ‘425 discloses a tissue fixation device applicator (2010) comprising a housing (2050); a handle (2054) located on one end of the housing (located at proximal end), the handle configured to be gripped by a user's hand during operation of the applicator (see paragraph [0135]); a driver (2064) movably disposed within the housing, wherein actuation of the driver is configured to advance an anchoring barb from the housing to a biological tissue (see paragraph [0248]); and an actuator (2060) coupled to the driver (see paragraph [0246]), wherein the actuator is configured to cause, upon actuation of the actuator, forward movement of the driver and delivery of the anchoring barb into the biological tissue (see paragraph [0248]). Regarding claim 23, Bentley ‘425 discloses wherein the handle comprises a protrusion (2054) extending laterally from the housing (see Fig. 75A, e.g.), the protrusion having a curved profile conforming to a contour of a user's palm or fingers to facilitate a grip and prevent slippage during operation of the applicator (see Fig. 75A and paragraph [0135]), and wherein the handle is located between a barb loading portal (inside tubular shaft 2050) and the actuator (2060) (see Fig. 75A and paragraphs [0246]-[0248]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to make the applicator of Bentley ‘835 include a handle, driver, and actuator as suggested by Bentley ‘425, as Bentley ‘835 discloses using an ejection rod and actuator mechanism to deploy the anchoring barb (see Bentley ‘835, paragraph [0063]), and Bentley ‘425 discloses an applicator that uses a handle, an ejection rod driver, and actuator to deploy anchoring barbs into biological tissue (see Bentley ‘425, paragraph [0248]). Further, the inclusion of the handle accommodates a surgeon’s hand for easier handling of the device during use (see Bentley ‘425, paragraph [0135]).
Further regarding claim 21, Bentley ‘835 fails to disclose the shield retractor flap being configured to protect a patient's dura during an interbody procedure, the anchoring barb attached to and extending from a distal end of the retractor flap, and the tethering ribbon extending longitudinally from a proximal end of the retractor flap and attached to the retractor flap so as to facilitate repositioning of the retractor flap after the retractor flap is secured to the biological tissue by the anchoring barb. However, Patel discloses an anatomical shield (200) configured to protect a patient’s dura during an interbody procedure (see Abstract and paragraph [0042]), an anchor (214) of the shield attached to and extending from a distal end of a retractor flap (210) of the shield (see Fig. 2A), and a tethering ribbon (212) extending longitudinally from a proximal end of the retractor flap (see Fig. 2A; tethering ribbon and anchor extend longitudinally from opposite sides of flap 210) and attached to the retractor flap so as to facilitate repositioning of the retractor flap after the retractor flap is secured to the biological tissue by the anchor (see paragraph [0043]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to use the system of Bentley ‘835 in conjunction with a shield configured to protect a patient’s dura as disclosed by Patel in order to allow a single applicator to install both a dura shield and anchoring barbs for anchoring the dura shield in soft tissue (i.e., applying the benefits of the applicator system of Bentley ‘835 with the dura shield of Patel).
Regarding claim 22, Bentley ‘835 discloses wherein the applicator further comprises a tip (365) configured to penetrate the biological tissue (see paragraph [0061]).
Regarding claim 24, Bentley ‘835 discloses wherein the housing comprises a tapered end proximate to a tip (365) (see marked-up Fig. 6 below).
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Claims 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Bentley ‘835 in view of Bentley ‘425 and Patel, and further in view of U.S. Patent Application Publication No. 2011/0172682 (Brady).
Regarding claims 25 and 26, Bentley ‘425 discloses a barb tail clearance channel (368) located within the housing and configured to accommodate a tail portion of the anatomical shield upon an advancement of the anatomical shield through the housing by the driver (see Fig. 6). Bentley ‘425 fails to suggest wherein the housing further comprises a cannula aligned with the barb loading portal, wherein the cannula is configured to guide the anatomical shield from the barb loading portal to a distal end of the cannula (claim 25); and further comprising: a needle disposed within the cannula and configured to extend beyond the distal end of the cannula to penetrate the biological tissue (claim 26). However, Brady discloses an implant delivery tool (600) that comprises a housing (612) that comprises a cannula (620) aligned with a portal in which an anchor (650) is loaded, wherein the cannula is configured to guide a implant (650/654) from the barb loading portal to a distal end of the cannula (see paragraph [0128]); and further comprising: a needle (628) disposed within the cannula and configured to extend beyond the distal end of the cannula to penetrate biological tissue (see paragraph [0152]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the applicator to include a housing, cannula, and needle configured as suggested by Brady as such a modification merely involves substituting one known implant delivery applicator configuration for deploying a tissue anchor in a patient for another known implant delivery applicator configuration for deploying a tissue anchor without any unpredictable results. Additionally, allowing the tissue piercing needle to be stored in a cannula prior to deployment protects the patient from being accidentally punctured by the needle.
Claims 27, 29-32, 34-40 are rejected under 35 U.S.C. 103 as being unpatentable over Bentley ‘835 in view of Patel.
Regarding claim 27 Bentley ‘835 discloses a system (see Fig. 6) comprising: an anatomical shield (300/315/318) comprising: a retractor flap (300); and an anchoring barb (315/318) coupled to the retractor flap and configured to secure the retractor flap to a biological tissue (see paragraphs [0059], [0062], and [0063]); and a tethering ribbon (320) extending from the retractor flap; and an applicator (350) comprising an actuator (actuator mechanism, see paragraph [0062]) and configured to: receive, via a portal (355) of the applicator, the anchoring barb (see Fig. 6 and paragraphs [0059]-[0063]); and deploy the anchoring barb into the biological tissue, wherein the actuator is configured to cause, upon actuation of the actuator, forward movement and delivery of the anchoring barb into the biological tissue (see paragraphs [0059]-[0063]).
Further regarding claim 27, Bentley ‘835 fails to disclose the shield retractor flap being configured to protect a patient's dura during an interbody procedure, the anchoring barb attached to and extending from a distal end of the retractor flap, and the tethering ribbon extending longitudinally from a proximal end of the retractor flap and attached to the retractor flap so as to facilitate repositioning of the retractor flap after the retractor flap is secured to the biological tissue by the anchoring barb. However, Patel discloses an anatomical shield (200) configured to protect a patient’s dura during an interbody procedure (see Abstract and paragraph [0042]), an anchor (214) of the shield attached to and extending from a distal end of a retractor flap (210) of the shield (see Fig. 2A), and a tethering ribbon (212) extending longitudinally from a proximal end of the retractor flap (see Fig. 2A; tethering ribbon and anchor extend longitudinally from opposite sides of flap 210) and attached to the retractor flap so as to facilitate repositioning of the retractor flap after the retractor flap is secured to the biological tissue by the anchor (see paragraph [0043]).
Regarding claim 30, Patel discloses wherein the retractor flap is non-rigid (see paragraph [0005] and [0038]; neoprene, e.g.). Alternatively, it would have been obvious to have the retractor flap be non-rigid as Patel suggests any material providing padding, including plastics, rubbers, sponges and neoprene, may be used (see paragraph [0038]), and non-rigid plastics, rubbers, sponges, and neoprene are suitable for providing padding.
Further regarding claims 27 and 30, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to use the system of Bentley ‘835 in conjunction with a shield configured to protect a patient’s dura as disclosed by Patel in order to allow a single applicator to install both a dura shield and anchoring barbs for anchoring the dura shield in soft tissue (i.e., applying the benefits of the applicator system of Bentley ‘835 with the dura shield of Patel).
Regarding claim 29, Bentley ‘835 discloses wherein the applicator comprises: a tip (365) configured to create an initial penetration into the biological tissue, and cause the anchoring barb to be subsequently guided through the tip and into the biological tissue (see paragraphs [0061] and [0063]).
Regarding claim 31, Bentley ‘835 discloses wherein the anchoring barb comprises a T-shape configuration (barbs can be T-anchors; see Fig. 5C and paragraphs [0050] and [0054]).
Regarding claim 32, Bentley ‘935 discloses wherein a cross portion of the T-shape provides a surface to abut against one side of the biological tissue and a tail portion of the T-shape extending through and corresponding in length to a thickness of the biological tissue, such that upon deployment, the anchoring barb is secured in place relative to the biological tissue without extending beyond the thickness of the biological tissue (see marked-up Fig. 5C above).
Regarding claim 34, Bentley ’835 discloses wherein the tethering ribbon has a length to facilitate manipulation or positioning of the anchoring barb during deployment (see paragraphs [0060] and [0062]). Bentley ‘835 fails to disclose the length being between 30 to 50 cm. However, it would have been obvious to have the length be within this recited range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, there is no evidence in the record that the recited length has criticality. See In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Regarding claim 35, Bentley ‘835 discloses wherein the tethering ribbon comprises a tethering hole (loop 35; see paragraphs [0046], [0061], and [0063]).
Regarding claim 36, Bentley ‘835 discloses a method (see paragraphs [0059]-[0063]) for delivering an anatomical shield (300) into a biological tissue (202), the method comprising: receiving an anchoring barb (315/318) of the anatomical shield into a portal (interior of housing 355) defined by a housing (355) of an applicator (350); wherein the anatomical shield comprises a retractor flap (300) and a tethering ribbon (320) extending longitudinally from the retractor flap; and an anchoring barb (315/318) coupled to the retractor flap and configured to secure the retractor flap to a biological tissue (see paragraphs [0059], [0062], and [0063]); puncturing a hole into the biological tissue at a desired location on the biological tissue by advancing a tip (350) of the applicator into the biological tissue (see paragraph [0063]); and actuating an actuator (actuator mechanism, see paragraphs [0062] and [0063]) coupled to a driver (ejection rod, see paragraph [0063]) movably disposed within the housing, to cause forward movement of the driver and drive the anatomical shield through the hole to anchor the anatomical shield within the biological tissue (see paragraph [0063]).
Further regarding claim 36 and regarding claim 40, Bentley ‘835 fails to disclose using the tethering ribbon to reposition the retractor flap after the anatomical shield is anchored within the biological tissue (claim 36); and wherein the retractor flap is configured to protect a patient’s dura during an interbody procedure. However, Patel discloses an anatomical shield (200) configured to protect a patient’s dura during an interbody procedure (see Abstract and paragraph [0042]), an anchor (214) of the shield attached to and extending from a distal end of a retractor flap (210) of the shield (see Fig. 2A), and a tethering ribbon (212) extending longitudinally from a proximal end of the retractor flap (see Fig. 2A; tethering ribbon and anchor extend longitudinally from opposite sides of flap 210) attached to the retractor flap, wherein a method of using the anatomical shield includes using the tethering ribbon to reposition the retractor flap after the anatomical shield is anchored within the biological tissue (see paragraph [0043]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to use the system of Bentley ‘835 in conjunction with a shield configured to protect a patient’s dura as disclosed by Patel in order to allow a single applicator to install both a dura shield and anchoring barbs for anchoring the dura shield in soft tissue (i.e., applying the benefits of the applicator system of Bentley ‘835 with the dura shield of Patel).
Regarding claim 37, Bentley ‘835 discloses further comprising: after the actuating the actuator, withdrawing the tip from the biological tissue while leaving the anatomical shield in place (see paragraph [0063]).
Regarding claim 38, Bentley ‘835 fails to disclose wherein the anatomical shield is delivered during an interbody procedure comprising at least one of: Transforaminal Lumbar Interbody Fusion, wherein the anatomical shield is deployed to protect dura mater or nerve roots while accessing disc space; Anterior Lumbar Interbody Fusion, wherein the anatomical shield is deployed to protect blood vessels; Lateral Lumbar Interbody Fusion wherein the anatomical shield is deployed to protect muscle or femoral nerve; anterior cervical discectomy and fusion, wherein the anatomical shield is deployed to protect esophagus, trachea, carotid artery, or venous network; corpectomy or vertebral column resection (VCR), wherein the anatomical shield is deployed to protect lung tissue when navigating through a thoracic cavity; pedicle subtraction osteotomy or VCR performed from a posterior, wherein the anatomical shield is deployed to protect dura mater or blood vessels; or spine surgery, neurosurgery, or general orthopedic surgery, wherein the anatomical shield is deployed to protect nerve tissue or blood vessels. However, Patel discloses a method that includes delivering an anatomical shield (200) during an interbody procedure comprising at least one of or spine surgery, neurosurgery, or general orthopedic surgery (see paragraph [0033]), [0040], and [0044]; spine surgery), wherein the anatomical shield is deployed to protect nerve tissue or blood vessels (see paragraphs [0033], [0042], [0046] and Abstract). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to use the system of Bentley ‘835 as part of method configured to deliver a shield to protect a patient’s dura as part of a spine surgery procedure as disclosed by Patent in order to allow a single applicator to install both a dura shield and anchoring barbs for anchoring the dura shield in soft tissue (i.e., applying the benefits of the applicator system of Bentley ‘835 with the dura shield of Patel).
Regarding claim 39, Bentley ‘935 discloses wherein the anchoring barb comprises a T-shape configuration (barbs can be T-anchors; see Fig. 5C and paragraphs [0050] and [0054]), wherein a cross portion of the T-shape provides a surface to abut against one side of the biological tissue and a tail portion of the T-shape extending through and corresponding in length to a thickness of the biological tissue, such that upon deployment, the anchoring barb is secured in place relative to the biological tissue without extending beyond the thickness of the biological tissue (see marked-up Fig. 5C below).
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Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Bentley ‘835 in view of Patel, and further in view of Bentley ‘425.
Regarding claim 28, Bentley ‘835 discloses the delivery applicator includes an ejection rod and an actuator mechanism to deploy the anchoring barb and anatomical shield (see paragraph [0063]), but fails to describe these and other components in the applicator in detail. However, Bentley ‘425 discloses a tissue fixation device applicator (2010) comprising a handle (2054) configured to be gripped by a user's hand during operation of the applicator (see paragraph [0135]); a driver (2064) configured to advance an anchoring barb from a portal to a biological tissue (see paragraph [0248]); wherein an actuator (2060) is coupled to the driver (see paragraph [0246]), wherein actuating the actuator is config cause the driver to move forward and deliver the anchoring barb into the biological tissue (see paragraph [0248]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to make the applicator of Bentley ‘835 to include a handle, driver, and actuator as suggested by Bentley ‘425, as Bentley ‘835 discloses using an ejection rod and actuator mechanism to deploy the anchoring barb (see Bentley ‘835, paragraph [0063]), and Bentley ‘425 discloses an applicator that uses a handle, an ejection rod driver, and actuator to deploy anchoring barbs into biological tissue (see Bentley ‘425, paragraph [0248]). Further, the inclusion of the handle accommodates a surgeon’s hand for easier handling of the device during use (see Bentley ‘425, paragraph [0135]).
Response to Arguments
Applicant’s arguments with respect to claims 21-32 and 34-40 have been considered but are moot in view of the new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 9:00 a.m. - 5:00 p.m. EST. 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, Eduardo Robert, can be reached on 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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