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 6, 7 and 9 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 6, lines 3-4, “the plurality of thread interruptions” lack antecedent basis. As best understood, and for purposes of examination, claim 6 will be treated as depending from claim 5, which provides antecedent basis.
Claim 7, line 2, “the one or more recesses” lacks antecedent basis. As best understood, and for purposes of examination, claim 7 will be treated as depending from claim 6, which provides antecedent basis.
Claim 9, line 1 “the proximal multi-lead thread region” lacks antecedent basis.
Claim 9, lines 2-3, “the proximal multi-lead thread region” lacks antecedent basis. As best understood, and for purposes of examination, claim 9 will be treated as depending from claim 3, which provides antecedent basis.
Appropriate correction is required.
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.
Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vaidya (2016/0157897).
Vaidya discloses a threaded implant ("implant") 8 adapted for pelvic stabilization (Fig. 3G; paras. 0045-0046), comprising:
a monolithic threaded elongate body (id.) having a distal end, a proximal end, and a length therebetween (id.), the elongate body sized and configured to be laterally implanted such that it extends across first and second SI joints of a subject (id.), and within a sacral corridor while avoiding sacral foramen (cf., e.g., Figs. 3D and 3D’).
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.
Claims 3-11, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Vaidya (2016/0157897) in view of Mesiwala et al. (2020/0268525).
Regarding claim 3, Vaidya discloses the claimed invention except for the monolithic threaded elongate body further comprising a plurality of threaded regions including, in a proximal to distal direction, a proximal multi-lead thread region adjacent the proximal end, a proximal single lead thread region, a central multi-lead thread region, a distal single lead thread region, and a distal multi-lead thread region adjacent the distal end, the plurality of threaded regions including a plurality of threads that are disposed about a shank.
Mesiwala et al. disclose a threaded elongate body comprising a plurality of threaded regions including, in a proximal to distal direction, a proximal multi-lead thread region adjacent the proximal end, a proximal single lead thread region, a central threaded region, a distal single lead thread region, and a distal multi-lead thread region adjacent the distal end, the plurality of threaded regions including a plurality of threads that are disposed about a shank, and interspersed with bone ingrowth features (see annotated Fig. 36A, below). Providing the plurality of threaded regions facilitates strong engagement with bone (e.g. paras. 0009, 0010 and 0012). Mesiwala et al. further teach that “the relative lengths and ratio may depend on wherein the implant regions are disposed after implantation, and the function that is needed from the different implant regions based on the adjacent tissue” (para. 0208).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the threaded implant of Vaidya with a plurality of threaded regions including, in a proximal to distal direction, a proximal multi-lead thread region adjacent the proximal end, a proximal single lead thread region, a central threaded region, a distal single lead thread region, and a distal multi-lead thread region adjacent the distal end, the plurality of threaded regions including a plurality of threads that are disposed about a shank, and interspersed with bone ingrowth features, in view of Mesiwala et al., to facilitate strong engagement with bone. It would have been further obvious to a person having ordinary skill in the art before the effective filing date to configure any desired region, such as the central threaded region, as a multi-lead thread region, to facilitate secure engagement with bone based on the function that is needed from the region and the adjacent tissue, e.g., bone of the sacrum.
Regarding claim 4, it would have been further obvious to provide each of the proximal single lead thread region, the central multi-lead thread region, and the distal single lead thread region of the threaded implant of the combination (supra) with a plurality of thread interruptions, e.g., the root of the thread being interrupted by ribs, recesses and lattice (annotated Fig. 36A, supra; paras. 0009, 0010, 0012, 0208), also in view of Mesiwala et al., to facilitate bone ingrowth and strong fixation with bone.
Regarding claim 5, it would have been further obvious to provide the shank of the threaded implant of the combination (supra) with an inner lumen and to include one or more raised support ribs extending along at least a portion of each of the plurality of threaded regions (e.g., the root thereof), also in view of Mesiwala et al. (annotated Fig. 36A, supra; paras. 0009, 0010, 0012, 0208), to facilitate bone ingrowth and strong fixation with bone.
Regarding claim 6, it would have been further obvious to provide one or more recesses extending along at least a portion of each of the plurality of threaded regions of the threaded implant of the combination (supra), each of the one or more recesses circumferentially adjacent to one of the one or more raised support ribs, and wherein the plurality of thread interruptions in each of the proximal single lead thread region, the central multi-lead thread region, and the distal single lead thread region are disposed at the one or more recesses, also in view of Mesiwala et al. (annotated Fig. 36A, supra; paras. 0009, 0010, 0012 0208), to facilitate bone ingrowth and strong fixation with bone.
Regarding claim 7, it would have been further obvious to provide a lattice disposed about the one or more support ribs of the threaded implant of the combination (supra) and the one or more recesses in at least a portion of each of the plurality of threaded regions, also in view of Mesiwala et al. (annotated Fig. 36A, supra; paras. 0009, 0010, 0012 0208), to facilitate bone ingrowth and strong fixation with bone.
Regarding claim 8, it would have been further obvious to provide the threaded implant of the combination (supra) with a plurality of distal cutting flutes adjacent the distal end, also in view of Mesiwala et al. (para. 0234; cf. Fig. 41B, ref. no. 4128), to facilitate purchase and insertion of the threaded implant into bone.
Regarding claim 9, it would have been further obvious to provide the proximal multi-lead thread region of the threaded implant of the combination (supra) with a first thread with a thread height that is greater than a thread height of a second thread in the proximal multi-lead thread region (annotated Fig. 36A, supra; paras. 0009, 0010, 0012 and 0208), also in view of Mesiwala et al., to facilitate strong fixation with bone. It would have been further obvious to configure either of the threads with a desired height as a matter of obvious design choice to achieve desired characteristics of insertion and purchase.
Regarding claim 10, the threaded implant of the combination (supra) discloses the claimed invention except for the length of the elongate body being explicitly from 140 mm to 180 mm and the diameter being from 8.3 mm to 9.0 mm. It is noted that the threaded implant of Vaidya spans the left SI joint, the sacrum and the right SI joint (Fig. 3G; paras. 0045-0046) as in the present invention and comprises a similar width (para. 0014).
It would have been further obvious to a person having ordinary skill in the art before the effective filing date to configure the threaded implant of the combination (supra) with any desired length of the elongate body, e.g., being from 140 mm to 180 mm, and with any desired diameter, e.g., being from 8.3 mm to 9.0 mm, this being within the approximate range of values based on the disclosed function (passing through both ilia and the sacrum) and based on the disclosure (supra), e.g., to provide a threaded implant that spans the requisite distance while providing sufficient diameter and strength. It is further noted 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.
Regarding claim 11, Vaidya does not disclose the claimed lengths of at least one of the thread regions. Mesiwala et al. teach that the thread regions have ranges of lengths that at least intersect the claimed ranges (see, e.g., paras. 0206-0208). In addition, Mesiwala et al. further teach that “the relative lengths and ratio may depend on wherein the implant regions are disposed after implantation, and the function that is needed from the different implant regions based on the adjacent tissue” (para. 0208). Those regions include the ilium, an SI joint, the sacrum, another SI joint, and the other ilium (Vaidya, Fig. 3G; paras. 0045-0046).
Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filing date to provide the threaded implant of the combination (supra) with at least one of the proximal multi-lead thread region with a desired length, e.g., from 10 mm to 40 mm, the proximal single lead thread region with a desired length, e.g., from 5 mm to 70 mm, the central multi-lead thread region with a desired length, e.g., from 10 mm to 80 mm, the distal single lead thread region with a desired length, e.g., from 5 mm to 70 mm, or the distal multi-lead thread region with a desired length, e.g., from 10 mm to 40 mm, in view of Mesiwala et al., to provide a desired level of fixation with bone based on where the implant regions are disposed after implantation (ilium, SI joint, sacrum, SI joint, ilium), and the function that is needed from the different implant regions (e.g., threads or interruptions for ingrowth) based on the adjacent tissue.
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 2-7, 10 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 5 of U.S. Patent No. 12,433,733.
Although the claims at issue are not identical, they are not patentably distinct from each other because the substantive difference between the application claims and the patent claims is that the patent claims include more elements and are more specific (e.g., including the dependent claim limitations of the present application in the independent claim of the patent). Thus, the invention of the patent claims is 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.
Regarding independent application claim 2, patent claim 4 (4/1) discloses a threaded implant ("implant") adapted for pelvic stabilization, comprising:
a monolithic threaded elongate body having a distal end, a proximal end, and a length therebetween, the elongate body sized and configured to be laterally implanted such that it extends across first and second SI joints of a subject, and within a sacral corridor while avoiding sacral foramen. It is noted that the clause following “configured to” is satisfied by the alternate phraseology of claim 4 describing a length of the elongate body being from 140 mm to 180 mm and having a diameter from 8.3 mm to 9.0 mm, which is specifically suited for extending across first and second SI joints, within a sacral corridor while avoiding sacral foramen.
The dependent claims are mapped as follows in the table below.
Claims 8 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 (4/1) of U.S. Patent No. 12,433,733, in view of Mesiwala et al. (2020/0268525).
Regarding claim 8, patent claim 4 (4/1) sets forth the claimed invention except for a plurality of distal cutting flutes adjacent the distal end.
Mesiwala et al. disclose an SI screw having a plurality of distal cutting flutes adjacent the distal end (para. 0234; cf. Fig. 41B, ref. no. 4128). The cutting flutes facilitate purchase and insertion of the screw into bone.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the threaded implant of patent claim 4 (4/1) with a plurality of distal cutting flutes adjacent the distal end, in view of Mesiwala et al., to facilitate purchase and insertion of the screw into bone.
Regarding application claim 9, patent claim 4 (4/1) sets forth the claimed invention except for the proximal multi-lead thread region including a first thread with a thread height that is greater than a thread height of a second thread in the proximal multi-lead thread region.
Mesiwala et al. show a proximal multi-lead thread region (e.g., about 3415 in Fig. 34A) including a first thread (e.g., more distal) with a thread height that is greater than a thread height of a second thread (e.g., more proximal) in the proximal multi-lead thread region (id.). This configuration facilitates purchase and insertion of the screw into bone.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the threaded implant of patent claim 4 (4/1) with a proximal multi-lead thread region including a first thread with a thread height that is greater than a thread height of a second thread in the proximal multi-lead thread region, in view of Mesiwala et al., to facilitate purchase and insertion of the screw into bone. It would have been further obvious to configure either of the threads with a desired height as a matter of obvious design choice to achieve desired characteristics of insertion and purchase.
The claims of the present application and the patent are mapped as follows:
Appl. 19/291,475
Pat. 12,433,733
1 (canceled)
N/A
2
4/1
3
4/1
4
4/1
5
4/1
6
4/1
7
4/1
8
v. Mesiwala et al.
9
v. Mesiwala et al.
10
4/1
11
5/4/1
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
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
Prosecution Insights