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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/14/26 has been entered.
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 at proximal ends thereof and over an entire length from the proximal ends to the distal ends thereof (See examiner annotated Fig. 5 below. It is noted that the distance between adjacent needle members increases in a proximal to distal direction, wherein a distance measured between two adjacent needle members at the proximal ends where each needle member originates is marginal, and the distance therebetween increases as each needle member tapers towards its distal-most tip thereof.), and wherein each of the needle members is dimensioned to have a thickness that does not destroy 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]).
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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); wherein the needle members are arranged with a distance therebetween at proximal ends thereof and over an entire length from the proximal ends to the distal ends thereof (See examiner annotated Fig. 5 above. It is noted that the distance between adjacent needle members increases in a proximal to distal direction, wherein a distance measured between two adjacent needle members at the proximal ends where each needle member originates is marginal, and the distance therebetween increases as each needle member tapers towards its distal-most tip thereof.), wherein each of the needle members is dimensioned to have a thickness that does not destroy 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 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 in the RCE on 05/14/26, have overcome the objection to claim 1.
In regards to Applicant’s arguments, filed in the RCE on 05/14/26, with respect to the rejection of claims 1-3 & 6-7 as anticipated by Smith et al. and the Applicant’s contention that 1) the spikes are not arranged with a distance therebetween at proximal ends thereof and over an entire length from the proximal ends to the distal ends thereof: As seen in the office action above and the examiner annotated Fig. 5, two adjacent needle members 27 include a distance therebetween. The sharpened tip of each needle member defines the distal end thereof and the base portion of each needle member defines the proximal end thereof. The distance between two adjacent needle members increases in a proximal to distal direction based on the distally tapering shape of each needle member 27, wherein the distance measured between two adjacent needle members at the proximal ends where each needle member originates and is adjacent to the other is marginal, and the distance therebetween increases as each needle member tapers towards its distal-most tip thereof. It is not clear from the drawings or spec of Smith et al. as to whether the proximal ends of two adjacent needle members are directly interconnected or are spaced marginally apart, but either way, a distance remains therebetween even if the distance = 0. Therefore, Smith et al. discloses the claimed invention as stated in the newly amended claims as stated in the office action above, and the argument as presented by the Applicant has been fully considered but is not persuasive.
In regards to Applicant’s arguments, filed in the RCE on 05/14/26, with respect to the rejection of claims 1-3 & 6-7 as anticipated by Smith et al. and the Applicant’s contention that 2) “a peripheral edge of a hole formed in the endplate of the vertebra by one spike 27 overlaps with a peripheral edge of a hole formed in the endplate of the vertebra by a spike 27 adjacent to the one spike, thereby increasing the risk of destroying the endplate”: It is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Smith et al. states in Paragraphs [0030, 0033-0034, 0043-0044, 0050-0053]) that (“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. This promotes bleeding of the vertebral endplates and facilitates bone growth and implant incorporation in interbody fusion procedures.” Thus, the thickness of each needle member of Smith et al. is fully and structurally capable of perforating an endplate such that it does not destroy the endplate as stated in the newly amended claim. The Applicant’s argument has been fully considered but is not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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
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