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 Objections
Claim 1 is objected to because of the following informalities: In Line 14, the word –wherein-- should be added at the beginning of the line before the word “the”. Appropriate correction is required.
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.
Claim(s) 1-3 & 6-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (US PG Pub No. 2010/0152791).
Regarding Claim 1, Smith et al. discloses an endplate perforator (10, Figs. 1-21, Paragraphs [0029-0053]) comprising: a pipe (shaft 50, Fig. 2), an operation portion (handle assembly 16, Fig. 16) disposed at a rear end of the pipe (proximal end of 50, Fig. 1); a case (mounting portion 13, Fig. 2) disposed at a front end of the pipe (distal end of 50, Fig. 1), the case including an insertion surface (upper surface defined by 41, 24 & 45, Figs. 2, 4 & 10, Paragraph [0040]) configured to be placed parallel to an endplate of a vertebra (Paragraph [0040]); needle members (each spike 27 is a needle member, Figs. 3-4) housed in the case (Fig. 2) and configured to perforate the endplate of the vertebra (Paragraphs [0030-0034]); and a mechanism portion (actuation member 60 includes shaft 66 & coupling assembly 70, Figs. 6 & 11, Paragraphs [0038-0039]) configured to move the needle members in a direction (vertical direction) perpendicular to the insertion surface (“upwardly and downwardly”, Paragraphs [0042-0043]) in response to an operation of the operation portion (distal advancement of 60 with respect to 15, Paragraphs [0050-0053]) to cause the needle members to project (Fig. 3) or retract (Fig. 2) relative to the case (Paragraphs [0034, 0038-0042]), wherein each needle member is long enough to penetrate through the endplate of the vertebra (“The treatment portions 27, 29 include a plurality of pyramidally shaped spikes having a sharpened outer end to penetrate bone material of the vertebral endplate when deployed.”, “Treatment portions 27, 29 can at least partially penetrate, crush, or otherwise form openings in the bony material of the vertebral endplates when deployed.”, Paragraphs [0031, 0033, 0044]) and is configured such that movement of the needle members in a direction other than the directions perpendicular to the insertion surface is restricted (when in the undeployed/retracted position as seen in Fig. 2, unintentional further movement of the spikes 27 is restricted all together; and when in the full deployed/projecting position as seen in Fig. 3, unintentional further movement of the spikes is restricted all together via locking members 150 & 152, Paragraphs [0050-0053]), and wherein the needle members are arranged with a distance therebetween (See examiner annotated Fig. 5 below).
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Regarding Claim 2, Smith et al. discloses wherein the operation portion (16) includes: an operation member (140, Fig. 16) configured to rotate (clockwise or counterclockwise, Paragraph [0052]) relative to the pipe about an axis of the pipe (radially about the longitudinal central axis of 50); and an operation rod (148, Fig. 16) configured to move linearly in an axial direction of the pipe (horizontally along the longitudinal central axis of 50) in response to rotation of the operation member (Paragraph [0052]), and the mechanism portion (60/70) is configured to convert linear movement of the operation rod into movement of the needle members in a direction perpendicular to an insertion surface (“As shown in FIGS. 3 and 4, treatment members 26 are moved upwardly through the upper opening between flange members 20, 22 when moving to the deployed position, and treatment members 28 are moved downwardly through the lower opening between flange members 20, 22 when moving to the deployed position.”, Paragraph [0042]; “Referring to FIG. 21, knob 140 is rotatable relative to body 144 in a first direction such as, for example, counterclockwise, to axially and distally advance movable shaft 148 within fixed shaft 146. For example, movable shaft 148 can be provided with a threaded proximal end 168 that is threadingly engaged with knob 140 in body 144. The non-rotating, distal movement of movable shaft 148 distally advances actuating member 60 in mounting member 15, thus deploying treatment members 26, 28 from mounting portion 13. Rotation of knob 140 in the opposite direction moves movable shaft 148 and actuating member 60 proximally in the opposite direction to undeploy treatment members 26, 28 while maintaining mounting member 15 stationary.”, Paragraph [0053]).
Regarding Claim 3, Smith et al. discloses wherein the mechanism portion (60/70) includes a parallel link mechanism (Fig. 4) including: a first link (left-most 26, Fig. 4) on which the needle members are disposed; a second link (second from the left 26, Fig. 4) parallel to the first link and coupled to the operation rod (via 60/70, Figs. 2-5, Paragraph [0049]); a third link (left-most 28, Fig. 4) rotationally coupled to the first link and the second link (via pin 30, Figs. 2-3); and a fourth link (middle 28, Fig. 4) rotationally coupled to the first link and the second link (via pin 30, Figs. 2-3).
Regarding Claim 6, Smith et al. discloses a method of performing an interbody fusion (Paragraphs [0006, 0034]) using an endplate perforator (10, Figs. 1-21, Paragraphs [0029-0053]), wherein the endplate perforator includes: a pipe (shaft 50, Fig. 2), an operation portion (handle assembly 16, Fig. 16) disposed at a rear end of the pipe (proximal end of 50, Fig. 1); a case (mounting portion 13, Fig. 2) that is disposed at a front end of the pipe (distal end of 50, Fig. 1) and includes an insertion surface (horizontal upper surface defined by 41, 24 & 45, Figs. 2, 4 & 10, Paragraph [0040]); needle members (each spike 27 is a needle member, Figs. 3-4) housed in the case (Fig. 2) and configured to perforate an endplate of a vertebra (Paragraphs [0030-0034]); and a mechanism portion (actuation member 60 includes shaft 66 & coupling assembly 70, Figs. 6 & 11, Paragraphs [0038-0039]) configured to move the needle members in a direction (vertical direction) perpendicular to the insertion surface (“upwardly and downwardly”, Paragraphs [0042-0043]) in response to an operation of the operation portion (distal advancement of 60 with respect to 15, Paragraphs [0050-0053]) to cause the needle members to project (Fig. 3) or retract (Fig. 2) relative to the case (Paragraphs [0034, 0038-0042]), wherein each needle member is long enough to penetrate through the endplate of the vertebra (“The treatment portions 27, 29 include a plurality of pyramidally shaped spikes having a sharpened outer end to penetrate bone material of the vertebral endplate when deployed.”, “Treatment portions 27, 29 can at least partially penetrate, crush, or otherwise form openings in the bony material of the vertebral endplates when deployed.”, Paragraphs [0031, 0033, 0044]) and is configured such that movement of the needle members in a direction other than the directions perpendicular to the insertion surface is restricted (when in the undeployed/retracted position as seen in Fig. 2, unintentional further movement of the spikes 27 is restricted all together; and when in the full deployed/projecting position as seen in Fig. 3, unintentional further movement of the spikes is restricted all together via locking members 150 & 152, Paragraphs [0050-0053]), and wherein the needle members are arranged with a distance therebetween (See examiner annotated Fig. 5 above); and wherein the method includes: inserting the case into a space (“Treatment system 12 is positionable in a spinal disc space between adjacent endplates of a pair of opposing vertebrae.”, Paragraph [0030]) formed by dissecting intervertebral tissue (“skin and tissue are incised and retracted to expose the surgical site.”, Paragraph [0049]) such that the insertion surface is parallel to the endplate of the vertebra (“treatment system 12 is advanced to the desired location at the operative site. In the deployed position of FIGS. 3 and 4, treatment portions 27, 29 are moved transversely to longitudinal axis 11 and extend outwardly from mounting portion 13 to engage the adjacent bony structure to provide treatment thereto.” Paragraphs [0030, 0033-0034]); and perforating the endplate by projecting the needle member in a direction perpendicular to the insertion surface (“As shown in FIGS. 3 and 4, treatment members 26 are moved upwardly through the upper opening between flange members 20, 22 when moving to the deployed position, and treatment members 28 are moved downwardly through the lower opening between flange members 20, 22 when moving to the deployed position.” “The mounting arrangement between mounting portion 13 and treatment members 26, 28 facilitates the application of sufficient force to treatment members 26, 28 so that treatment portions 27, 29 can penetrate and/or crush the adjacent bony structure when deployed.” “Treatment portions 27, 29 can at least partially penetrate, crush, or otherwise form openings in the bony material of the vertebral endplates when deployed. This promotes bleeding of the vertebral endplates and facilitates bone growth and implant incorporation in interbody fusion procedures.”, Figs. 3-4, Paragraphs [0030, 0033-0034, 0043-0044, 0050-0053]).
Regarding Claim 7, Smith et al. discloses wherein the step of projecting the needle members in a direction perpendicular to the insertion surface includes rotating the operation portion (via knob 140, “Referring to FIG. 21, knob 140 is rotatable relative to body 144 in a first direction such as, for example, counterclockwise, to axially and distally advance movable shaft 148 within fixed shaft 146. For example, movable shaft 148 can be provided with a threaded proximal end 168 that is threadingly engaged with knob 140 in body 144. The non-rotating, distal movement of movable shaft 148 distally advances actuating member 60 in mounting member 15, thus deploying treatment members 26, 28 from mounting portion 13. Rotation of knob 140 in the opposite direction moves movable shaft 148 and actuating member 60 proximally in the opposite direction to undeploy treatment members 26, 28 while maintaining mounting member 15 stationary.”, Paragraphs [0050-0053]).
Allowable Subject Matter
Claims 4-5 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Smith et al. discloses the claimed invention as stated above, except wherein the mechanism portion includes a linear cam including: a cam plate that is coupled to the operation rod and includes a cam surface inclined with respect to a moving direction of the operation rod, a cam follower on which the needle member is disposed, the cam follower being in contact with the cam surface; and an urging member that urges the cam follower in a direction in which the needle member retracts into the case; and wherein the case includes a needle member housing hole that opens in the insertion surface and includes an inner surface including a first spiral groove, the needle member including a second spiral groove that meshes with the first spiral groove, and a spline shaft housing hole that opens in a proximal end surface of the needle member and extends in an axial direction of the needle member, and wherein the mechanism portion includes a bevel gear mechanism including: a driving bevel gear coupled to the operation rod to rotate integrally with the operation rod; a driven bevel gear meshing with the driving bevel gear; and a spline shaft that is coupled to the driven bevel gear to rotate integrally with the driven bevel gear and is fitted in the spline shaft housing hole. Furthermore, no art was found which could have been used to reasonably modify Smith et al. with the claimed features without destroying the invention.
Response to Arguments
Applicant’s amendments, filed 12/11/25, have overcome the objections to claims 6 & 7.
Applicant’s amendments, filed 12/11/25, have overcome the 112(b) rejection for Claim 2.
In regards to Applicant’s arguments, filed 12/11/25, with respect to the rejection of claims 1-3 & 6-7 as anticipated by Smith et al. and the Applicant’s contention that the treatment portions/spikes 27 are not long enough to penetrate the endplate of the vertebra and the treatment portions/spikes 27 are arranged without distances therebetween: As seen in the final office action above, each of the spikes 27 are provided in the device specifically for perforating the vertebral endplates, which is positively recited throughout, such as in Paragraphs [0031-0034, 0044]: “The treatment portions 27, 29 include a plurality of pyramidally shaped spikes having a sharpened outer end to penetrate bone material of the vertebral endplate when deployed.”, and “Treatment portions 27, 29 can at least partially penetrate, crush, or otherwise form openings in the bony material of the vertebral endplates when deployed.”. Furthermore, as seen in the examiner annotated Fig. 5 above, each spike 27 is spaced from an adjacent spike 27 by a distance therebetween, such as the distance between each tip thereof. The Applicant’s arguments have been fully considered but are not persuasive and Smith et al. discloses the claimed invention as stated above.
In regards to Applicant’s arguments, filed 12/11/25, with respect to Applicant’s contention that the treatment member 26 moves not only in a direction perpendicular to the endplate of the vertebra, but also in a direction other than the direction perpendicular to the endplate and thus the treatment portions 27 cannot perforate the endplate of the vertebra: As seen in the final office action above, Smith et al. discloses in various Paragraphs throughout, specifically in Paragraphs [0042-0043], that the treatment members 26 are moved upwardly and downwardly between the undeployed and deployed configuration, to advance the spikes 27 beyond the surfaces 41/45 and 43/46 prior to penetrating the adjacent endplates: “As shown in FIGS. 3 and 4, treatment members 26 are moved upwardly through the upper opening between flange members 20, 22 when moving to the deployed position, and treatment members 28 are moved downwardly through the lower opening between flange members 20, 22 when moving to the deployed position.” “The mounting arrangement between mounting portion 13 and treatment members 26, 28 facilitates the application of sufficient force to treatment members 26, 28 so that treatment portions 27, 29 can penetrate and/or crush the adjacent bony structure when deployed.” Paragraph [0034] further discloses that “It is further contemplated that treatment instrument 10 can be manipulated with treatment portions 27, 29 deployed to provide further endplate treatment.” Paragraphs [0050-0053] further describe the locking members 150 & 152 which allow the spikes 27 to be maintained in their undeployed/retracted or fully deployed/projecting configurations. Thus, regarding the claim limitation “wherein each of the needle members is long enough to penetrate through the endplate of the vertebra and is configured such that movement of the needle members in a direction other than the directions perpendicular to the insertion surface is restricted”: even though the treatment members 26 move distally relative to 20 & 22 via passages 110 & 108 while moving the members upwardly and downwardly, there is no movement of the spikes 27 in any direction, including a direction other than directions perpendicular to the insertion surface, when in the undeployed/retracted position as seen in Fig. 2, or when in the full deployed/projecting position as seen in Fig. 3. The Applicant’s arguments have been fully considered but are not persuasive and Smith et al. discloses the claimed invention as stated above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775