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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. PCT/US21/59376 and 63/115,737, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The prior filed Application Nos. PCT/US21/59376 and 63/115,737 fail to provide adequate support or enablement for the wave spring arranged about an outer surface of the anvil as required by claims 8, a wave spring arranged about the outer surface of the anvil, as required by claim 17, and a wave spring at least partially circumscribing an outer surface of the anvil, as required by claim 20. Therefore claims 8, 17 and 20 are not entitled to the benefit of the prior-filed Application Nos. PCT/US21/59376 and 63/115,737; and have instead been given the effective filing date of Application No. 17/560471, 12/23/2021.
Claim Objections
Claim(s) 20 is/are objected to because of the following informalities:
Claim 20 recites the limitation “a retaning ring” in line 10 instead of “a retaining ring” in order to have the proper spelling.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “the cap having a distal surface not extending past the distal end of the housing” in lines 9-10, which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification fails to explicitly disclose that a distal surface of the cap does not extend past the distal of the housing, and the drawings show the cap extending around and past the distal end of the housing (see Fig. 1B) or do not show the relationship of the distal surface of the cap to the distal end of the housing when assembled (see Fig. 16).
Claim 9 recites the limitation “the cap having a distal surface coplanar with the distal end of the housing” in lines 9-10, which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification fails to explicitly disclose that a distal surface of the cap is coplanar with the distal of the housing, and the drawings show the cap extending around and past the distal end of the housing (see Fig. 1B) or do not show the relationship of the distal surface of the cap to the distal end of the housing when assembled (see Fig. 16).
Claim 20 recites the limitation “the cap forming a retaining ring receiving portion and having a distal surface not extending past the distal end of the housing” in lines 10-11, which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification fails to explicitly disclose that a distal surface of the cap does not extend past the distal of the housing, and the drawings show the cap extending around and past the distal end of the housing (see Fig. 1B) or do not show the relationship of the distal surface of the cap to the distal end of the housing when assembled (see Fig. 16).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4-5, 8-11, 13-14, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann et al. (U.S. Pub. No. 2015/0196337 A1, hereinafter “Biedermann”) and in view of Ahn et al. (U.S. Pub. No. 2006/0247631 A1, hereinafter “Ahn”).
Biedermann discloses, regarding claim 1, a pedicle screw assembly (see Fig. 24), comprising: a bone screw (1) having a head (3) and a shank (2); and a head assembly (5”, 6”, 7”, 10) comprising: a housing (5”) having a proximal end (5a) and a distal end (5b); an anvil (10) disposed within the housing such that the anvil is translatable and inhibited from rotating relative to the housing (via spring 7” and pins 11a-b, see paras. [0091]-[0093]); a spring (7”) at least partially circumscribing an outer surface (e.g. outer surface of 106) of the anvil and entirely disposed within the housing (see Fig. 35); and a retaining ring (6”), the retaining ring being transitionable between an expanded configuration in which the retaining ring is sized to receive the head of the bone screw (see Fig. 36) and a compressed configuration in which the retaining ring prevents the head of the bone screw from passing distally through the retaining ring (see Fig. 39).
Regarding claim 4, wherein the head of the bone screw is spherical (see Fig. 24).
Regarding claim 5, wherein the retaining ring is formed of resilient material (see para. [0083]).
Regarding claim 8, wherein the spring is a wave spring arranged about the outer surface of the anvil (see Figs. 28-29).
Biedermann discloses, regarding claim 9, a spinal fixation kit (see Fig. 24), comprising: a bone screw (1) having a head (3) and a shank (2); and a head assembly (5”, 6”, 7”, 10) comprising: a housing (5”) having a proximal end (5a) and a distal end (5b), the housing defining a throughbore (54) extending between the proximal end and the distal end of the housing (see Fig. 6); an anvil (10) disposed within the throughbore (see Fig. 35), wherein the housing is configured to receive the bone screw and allow the housing to move about multiple axes relative to the bone screw (see Fig. 36, see para. [0012]).
Regarding claim 10, further comprising: a spinal rod (100); and a set screw (9) for securing the spinal rod to the housing (see Fig. 38).
Regarding claim 13, wherein the head of the bone screw is spherical (see Fig. 24).
Regarding claim 14, wherein the head assembly further comprises a spring (7”) at least partially circumscribing an outer surface of the anvil (e.g. outer surface of 106) and entirely disposed within the throughbore (see Fig. 35).
Regarding claim 17, wherein the spring is a wave spring arranged about the outer surface of the anvil (see Figs. 28-29).
Regarding claim 18, wherein the head assembly further comprises a retaining ring (6”), the retaining ring being transitionable between an expanded configuration in which the retaining ring is sized to receive the head of the bone screw (see Fig. 36) and a compressed configuration in which the retaining ring prevents the head of the bone screw from passing distally through the retaining ring (see Fig. 39).
Regarding claim 19, wherein the retaining ring is formed of resilient material (see para. [0083]).
Biedermann discloses, regarding claim 20, a pedicle screw assembly (see Fig. 24), comprising: a bone screw (1) having a head (3) and a shank (2); and a head assembly (5”, 6”, 7”, 10) comprising: a housing (5”) having a proximal end (5a) and a distal end (5b), the housing defining a throughbore (54) extending along a longitudinal axis (C) of the housing and between the proximal and distal ends (see Fig. 35); an anvil (10) disposed within the housing such that the anvil is translatable and inhibited from rotating relative to the housing (via spring 7” and pins 11a-b, see paras. [0091]-[0093]; a wave spring (7”) at least partially circumscribing an outer surface of the anvil (e.g. outer surface of 106) and entirely disposed within the housing (see Fig. 35); and a retaining ring (6”) formed of a resilient material (see para. [0083]), the retaining ring being transitionable between an expanded configuration in which the retaining ring is sized to receive the head of the bone screw (see Fig. 36) and a compressed configuration in which the retaining ring prevents the head of the bone screw from passing distally through the retaining ring (see Fig. 39).
Biedermann fails to disclose, regarding claim 1, wherein the assembly comprises a cap coupled to the housing, the cap having a distal surface not extending past the distal end of the housing; and wherein the retaining ring is held within the housing by the cap; regarding claim 2, wherein the cap is threadably connected to the housing; regarding claim 9, wherein the kit comprises a cap coupled to the housing, the cap having a distal surface coplanar with the distal end of the housing; regarding claim 11, wherein the cap is threadably connected to the housing; regarding claim 18, wherein the retaining ring is held within the housing by the cap; and regarding claim 20, a cap threadably coupled to the housing, the cap forming a retaining ring receiving portion and having a distal surface not extending past the distal end of the housing and wherein the retaining ring is held within the housing by the cap.
Ahn discloses a pedicle screw assembly (100, see Figs. 2-3) with housing (110), wherein a cap (150) is threadably coupled to the housing (see Fig. 2, see para. [0032]), the cap having a distal surface not extending past the distal end of the housing (see annotated Fig. 2 below), the cap having a distal surface coplanar with the distal end of the housing (see annotated Fig. 2 below) in order to enable the housing to receive the screw head through the bottom opening (see para. [0039]), providing a more miniatures screw assembly (see para. [0008]) while preventing the screw head to be separated from the housing (see paras. [0008] and [0039]).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the housing in Biedermann to have a cap threadably coupled to the distal end of the housing, the cap having a distal surface not extending past the distal end of the housing, the cap having a distal surface coplanar with the distal end of the housing in view of Ahn in order to enable the housing to receive the screw head through the bottom opening, providing a more miniatures screw assembly while preventing the screw head to be separated from the housing.
Claim(s) 3, 6-7, 12 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann in view of Ahn, as applied to claims 1, 9, 14 above and in further view of Hammill, SR et al. (U.S. Pub. No. 2010/0125302 A1, hereinafter “Hammill”).
Biedermann in view of Ahn discloses all of the features of the claimed invention, as previously set forth above. Biedermann in view of Ahn further discloses, regarding claims 6 and 15, wherein the spring at least partially circumscribing an outer surface of the anvil (e.g. outer surface of 106, see Fig. 35), and regarding claims 7 and 16, wherein the spring extends from a distal end of the anvil (see Fig. 35); however fails to explicitly disclose, regarding claims 6-7 and 15-16, wherein the spring is a leaf spring and regarding claims 3 and 12, wherein the cap is press fit to the housing.
Hammill discloses a pedicle screw assembly (see Fig. 5) with a housing (31) and a cap (33), and a spring (102), wherein the spring is a leaf spring (see para. [0101]) in order to provide a resilient type member suitable for displacing the anvil (see para. [0101]) and the cap and the housing are coupled with a press fit (see para. [0099]) in order to provide a technique for securely attaching the housing and cap while preventing dislodgement after assembly (see para. [0101]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the spring in Biedermann in view of Ahn to be a leaf spring in further view of Hammill in order to a resilient type member suitable for displacing the anvil and to modify the cap and housing in Biedermann in view of Ahn to be connected by a press fit in further view of Hammill in order to provide a technique for securely attaching the housing and cap while preventing dislodgement after assembly.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at (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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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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