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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5, line 3, “the inserter device body” lacks antecedent basis.
Claims depending from rejected claims include the limitations of their respective parent claim(s) and are therefore also rejected.
Claim Rejections - 35 USC § 101
Claim 19 is rejected under 35 U.S.C. 101 as claiming the same (identical) invention as that of claim 18 of prior U.S. Patent No. 10,219,841, as set forth above. This is a statutory double patenting rejection.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
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.
Claims 1, 2, 4-6 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kleiner et al. (2015/0148907; cited by Applicant).
Regarding claim 1, Kleiner et al. disclose a device, comprising:
a graft body 60 (Fig. 41) comprising a generally rectangular cross sectional area, a first end, and a second end, the graft body comprising a plurality of rows of teeth 61;
a head 64 extending from the first end of the graft body; and
an adaptor 92 extending from the second end, the adaptor being spaced apart from a last of the plurality of rows of teeth to form an inserter device groove (Fig. 41), the adaptor terminating with an inserter device interface 93, wherein the inserter device interface is configured to mate with an adaptor interface 96 of an inserter device 1 (Fig. 40), wherein the plurality of rows of teeth 61 are oriented so as to be capable of preventing migration or ejection of the graft body 60 when inserted, for example and if desired, into a pilot hole created in adjacent bone structures. It is noted that the sharp edges, described as “sawtooth-like ridges” (para. 0256) of the rows of teeth 61 are capable of engaging bone tissue, whether at the surface or at a drilled portion thereof.
Regarding claim 2, the graft body 60 (Fig. 41) comprises one or more apertures 67 that provide a pathway for bone growth through the graft body 60.
Regarding claim 4, the device interface 93 comprises a plurality of arcuate shaped sidewalls that form a protrusion (Fig. 41; e.g., both their lateral cross-sectional shape and their corners).
Regarding claim 5, the inserter device 1 comprises:
an inserter device body 2 (Fig. 40) having a first end and a second end; and
the first end comprising the adaptor interface 96, the adaptor interface comprising:
a plurality of resiliently biased tabs 97 that are spaced apart from one another so as to allow for independent movement (Fig. 41); and
wherein each of the plurality of resiliently biased tabs comprises a shape configured to engage the plurality of arcuate sidewalls (supra) of the inserter device interface 93 of the adaptor 92 (i.e., a groove to compliment the arcuate sidewalls and a detent to engage the spaced apart portion between the inserter device interface 93 and the graft body 60 (Fig. 41).
Regarding claim 6, the second end of the inserter device 1 comprises an annular stop (Fig. 40 and para. 0252).
Regarding claim 13, the head 64 is a blunt, tapered polygonal sided head (Fig. 41).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over (Kleiner et al. (2015/0148907; cited by Applicant) in view of Lynn et al. (2015/0045892).
Regarding claim 3, Kleiner discloses the claimed invention except for explicitly reciting a first portion of the plurality of rows of teeth being oriented in a first direction and a second portion of the plurality of rows of teeth being oriented in a second direction that is opposite of the first direction, the first portion of the plurality of rows of teeth being configured to remove bone as the graft body is inserted into the pilot hole, the second portion of the plurality of rows of teeth being configured to prevent retraction of the graft body from disengaging from the bone.
Lynn et al. disclose that a plurality of rows of teeth 40 of an implant 10 (Fig. 1A) can comprise a first portion of the plurality of rows of teeth being oriented in a first direction and a second portion of the plurality of rows of teeth being oriented in a second direction that is opposite of the first direction (paras. 0064-0066; cf. Fig. 3A). In addition, the first portion of the plurality of rows of teeth are shaped such that they are capable of removing bone as the graft body is inserted into the pilot hole (e.g., due to their sharp shape and orientation), and the second portion of the plurality of rows of teeth are configured to prevent retraction of the graft body from disengaging from the bone (para. 0066).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the graft body of Kleiner et al. with a first portion of the plurality of rows of teeth being oriented in a first direction and a second portion of the plurality of rows of teeth being oriented in a second direction that is opposite of the first direction, in view of Lynn et al., to enable the first portion of the plurality of rows of teeth to remove bone as the graft body is inserted into the pilot hole if desired, and to enable the second portion of the plurality of rows of teeth being to prevent retraction of the graft body from disengaging from the bone.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over (Kleiner et al. (2015/0148907; cited by Applicant) in view of Michelson (2002/0077641; cited by Applicant).
Regarding claims 7 and 8, Kleiner et al. disclose the claimed device except for a retraction guide that comprises a tubular retraction guide body having an inner sidewall surface, the retraction guide body having two prongs that are positionable in a space between two adjacent bone structures; and a drill bit that is configured to create a hemispherical groove on each of the two adjacent bone structures with one pass, wherein the hemispherical grooves form a spaced-apart aperture based on a joint space that exists between the two adjacent bone structures.
Michelson discloses a retraction guide 100, 140 (Figs. 1 and 6) that comprises a tubular retraction guide body, e.g., 106, the retraction guide body having two prongs 102 that are positionable in a space between two adjacent bone structures V; and
a drill bit, e.g., 250 (cf. Fig. 40) that is configured to create a hemispherical groove on each of the two adjacent bone structures V with one pass, wherein the hemispherical grooves form a spaced-apart aperture based on a joint space that exists between the two adjacent bone structures V. (para 0196).
The retraction guide and drill bit facilitate safe distraction of the vertebrae and preparation of the opposed vertebral surfaces (para. 0239) to enhance the stability of the implant and expedite fusion (para. 0067).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to provide the device of Kleiner et al. with retraction guide that comprises a tubular retraction guide body having an inner sidewall surface, the retraction guide body having two prongs that are positionable in a space between two adjacent bone structures; and a drill bit that is configured to create a hemispherical groove on each of the two adjacent bone structures with one pass, wherein the hemispherical grooves form a spaced-apart aperture based on a joint space that exists between the two adjacent bone structures, in view of Michelson, to facilitate safe distraction of the vertebrae and preparation of the opposed vertebral surfaces ) to enhance the stability of the implant and expedite fusion (para. 0067).
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over (Kleiner et al. (2015/0148907; cited by Applicant) in view of Michelson (2002/0077641; cited by Applicant), as applied above, and further in view of Mauldin et al. (2014/0276846; cited by Applicant).
Regarding claim 9, Michelson discloses using any of various tools, including a broach (i.e., reamer; para. 0196) to prepare the intervertebral space for an implant, but does not explicitly recite a broach comprising:
a broach body having a first end and a second end; a broach tip disposed on the first end of the broach body, the broach tip comprising a generally cylindrical head that is configured to insert within the spaced-apart aperture formed by the drill bit; and an incising member comprising a plurality of rectangular, circumferential cutting teeth positioned behind the generally cylindrical head, the plurality of rectangular circumferential cutting teeth incise out the hemispherical grooves to create an angular grooves, each with a vertex.
Mauldin et al. disclose a broach body, e.g., 800 (Fig. 8A and cf. Fig. 9A), having a first end and a second end (id.);
a broach tip 800 disposed on the first end of the broach body, the broach tip comprising a generally cylindrical head 804 that is capable of being inserted within a spaced-apart aperture between adjacent vertebrae formed by a drill bit; and
an incising member comprising a plurality of rectangular, circumferential cutting teeth 806 positioned behind the generally cylindrical head, the plurality of rectangular circumferential cutting teeth capable of incising out hemispherical grooves from the drill to create angular grooves, each with a vertex, if desired (para. 0048, disclosing a square cross-section, which is capable of being rotated to be a diamond shape, with a vertex extending into each adjacent vertebra). This broach configuration allows bone to be prepared for a matching implant (id.).
It would have been further obvious to a person having ordinary skill in the art before the effective filing date to configure the broach of Michelson in the device of the combination of Kleiner et al. and Michelson, to comprise a broach body having a first end and a second end; a broach tip disposed on the first end of the broach body, the broach tip comprising a generally cylindrical head that is configured to insert within the spaced-apart aperture formed by the drill bit; and an incising member comprising a plurality of rectangular, circumferential cutting teeth positioned behind the generally cylindrical head, the plurality of rectangular circumferential cutting teeth capable of incising out the hemispherical grooves created by the drill to create an angular grooves, each with a vertex, in view of Mauldin et al., to allow the vertebral bone to be prepared for a complimentary graft body implant inserted in a desired manner.
Regarding claim 10, the vertex of the disclosed (para. 0048) triangular cross section or rectangular cross section (rotated) is orthogonal to a surface of a bone structure.
Regarding claim 11, the plurality of rectangular (para. 0048), circumferential cutting teeth comprise an initial set of rectangular, circumferential cutting teeth that are proximate the broach tip (cf. Fig. 8A showing a triangular configuration), each of the initial set comprising four surfaces, wherein each corner of where the four surfaces meet comprise an arcuate chamfered edge (id.).
Regarding claim 12, each of the initial set increases in outer-peripheral area based on a distance from the broach tip (para. 0048 and cf. Fig. 8A).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,219,841. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims resides in the fact that the patent claims include more elements and are more specific (e.g., independent claim 1 further defines the rectangular cross sectional area, as well as further details of the pilot hole; independent claim 14 further defines the angular grooves as triangular). Thus, at least each element of the claims of the present application are disclosed in corresponding claims of the issued patent, as set forth below. Thus, the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claims 1-18 of the present application and the issued patent are mapped directly, as follows:
Appl. 18/138,500
Pat. 10,219,841
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Claim 19 is rejected under 35 U.S.C. 101, statutory double patenting, as discussed above.
Response to Arguments
Applicant's arguments filed 23 July 2025 have been fully considered but they are not persuasive.
First, it is noted that the corrections made to overcome the outstanding claim objections are acknowledged. The noted objections have been withdrawn.
The corrections to overcome the 35 U.S.C. 112 rejections have been considered. However, it is noted that the rejection of claims 5-12 is maintained because the issue pertaining to lack of antecedent basis in claim 5 has not been addressed. Claims 6-12 also remain rejected because they depend from claim 5. The remaining rejections under 35 U.S.C. 112 have been withdrawn.
It is respectfully noted that the remaining arguments under both 35 U.S.C. 102 and 35 U.S.C. 103 all depend on an incorrect characterization of Kleiner et al. (2015/0148907) and are not persuasive.
In the Remarks, pages 6-7, Applicant asserts that Kleiner discloses a cylindrical implant and cites Fig. 41 and paragraph 0256:
Kleiner discloses a cylindrical implant body with circumferential sawtooth-like ridges, as confirmed in paragraph [0256] describing a cylindrical body with ridges around the circumference and as illustrated in Figure 41 showing a rounded, tubular structure rather than a graft body with a generally rectangular cross- sectional area. This cylindrical configuration in Kleiner is fundamentally distinct from the claimed graft body, which features a rectangular shape enabling precise incising of angular grooves in adjacent bone structures such as those in a sacroiliac joint, as supported by Applicant's specification at paragraphs [0063]-[0066] and Figure 15 depicting the transformation of hemispherical grooves into angular ones via a rectangular profile.
However, this is not persuasive because paragraph 0256 does not at any point disclose a cylindrical implant body. Moreover, Fig. 41 clearly shows a graft body 60 having a generally rectangular cross-sectional area:
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Accordingly, the arguments are not persuasive and the rejections based on Kleiner under both 35 U.S.C. 102 and 35 U.S.C. 103 are maintained and made final.
The double patenting rejections, both statutory and non-statutory, have not been overcome by claim cancelation or a terminal disclaimer, and are accordingly maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773