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 4-6, 11-16 and 20 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 4, line 4, “the second lateral size” is unclear and requires correction.
Claim 11, lines 3-4, “the plurality of arced anchoring members” lacks antecedent basis.
Claim 11, line 9, “the shaft” lacks antecedent basis.
Claim 20, line 1, “the anchoring member” lacks proper antecedent basis. The antecedent from claims 19 and 18 is in the plural. If there is an intended distinction between “the plurality of anchoring members, including the anchoring member” (claim 17), that distinction is further unclear.
Dependent claims include the limitations of their respective parent claim(s) and are therefore also rejected.
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.
Claims 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chataigner et al. (2015/0209089).
Regarding claim 17, Chataigner et al. disclose an implant system (e.g., Figs. 2A and 25A) comprising:
an implant body 2 (Fig. 2A) comprising:
an implant bore configured to receive an anchoring member 1 (Figs. 2A); and
a tool interface 26 (Fig. 2B; para. 0120), wherein the anchoring member comprises:
a head 17 comprising a surface, an anchor bore 14 extending into the surface, and a shoulder adjacent the head 17, wherein the surface is configured to receive a force to move the anchoring member 1 within the implant bore (Fig. 2A), the anchor bore is configured to receive a tool (Fig. 25A), and the shoulder is configured to engage a surface of the implant bore (Fig. 2A) to guide the anchoring member 1 within the implant bore (id.); and
a tool (Fig. 25A) comprising: an interface body configured to engage the installation tool interface (para. 0120); and
a tool bore (cf. Fig. 23C) configured to receive the anchoring member 1.
Regarding claim 18, the system includes a plurality of anchoring members 1 (e.g., Fig. 2A), including the anchoring member 1, wherein the tool further comprises:
a plurality of installation bores (Fig. 23C) configured to simultaneously receive a plurality of drive members 41 (Fig. 24C and para. 0164); and
the plurality of drive members 41 are configured to drive the plurality of anchoring members 1 while the installation tool is attached to the implant body 2 (id. and Fig. 25A).
Regarding claim 19, the plurality of drive members 41 are usable to simultaneously drive the plurality of anchoring members 1 into an adjacent bone (id.).
Regarding claim 20, the arced anchoring member 1 comprises a bone barb configured to inserted into the adjacent bone, wherein the bone barb defines a curved shaft (e.g., Fig. 2A) configured to translate within the tool bore (supra).
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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kloss (WO-2012010327-A1) in view of Mozeleski et al. (2015/0151171) and further in view of Shoshtaev (2018/0193164).
Regarding claim 1, Kloss discloses an implant (Fig. 1 and cf. Fig. 4) comprising:
a device (including porous and solid portions) having a front and a rear defined between first and second lateral sides (id.). It is noted that Kloss further teaches that the implant can be screwed into adjacent vertebral bodies (page 42, lines 18-28).
Kloss does not explicitly recite wherein each bore is configured to receive an anchoring member, and
wherein each anchoring member comprises:
a head at an end of a shaft, the head comprising a surface, a threaded bore extending into the surface, and a shoulder, wherein the surface is configured to receive a force to move the anchoring member within the bore, the threaded bore is configured to receive a tool, and the shoulder is configured to engage a surface of the bore to guide the anchoring member within the bore.
Mozeleski et al. disclose a plurality of arced bores 230/330, 240/340 (Figs. 2 and 3) (e.g., at least proximate the convex head of the anchor (“bone blade”); cf. Fig. 14) extending into a rear of an implant device 200/300; wherein each arced bore is configured to receive an arced anchoring member 410 (Fig. 7B). The anchoring member 410 comprises a head 412 at an end of a shaft 418, the head comprises a surface and a bore 413 (Fig. 6A) extending into the surface, and a shoulder adjacent thereto, the surface is solid and integral with the anchoring member 410 and therefore configured to receive a force to move the anchoring member within the bore, and the shoulder is configured to engage a surface of the bore to guide the anchoring member within the bore (Fig. 14).
Mozeleski et al. teach that providing such bores and anchors facilitates securely retaining the implant by engaging a vertebra in a different manner and orientation than a bone screw (para. 0074).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the implant of Kloss with a plurality of bores configured to receive an anchoring member, wherein each anchoring member comprises:
a head at an end of a shaft, the head comprising a surface, bore extending into the surface, and a shoulder, wherein the surface is configured to receive a force to move the anchoring member within the bore, the bore is configured to receive a tool, and the shoulder is configured to engage a surface of the bore to guide the anchoring member within the bore, in view of Mozeleski et al., to facilitate securely retaining the implant by engaging a vertebra in a different manner and orientation than a bone screw.
Shoshtaev further teaches that drive features of an orthopedic device can optionally be provided with numerous configurations, including a thread, to facilitate engagement with an instrument (para. 0025).
It would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide a thread within the bore (e.g., within the base thereof) of the anchoring member, in view of Shoshtaev, to optionally provide a threaded connection to facilitate engagement with an instrument.
Regarding claim 2, the device of the combination (supra) includes a porous portion (Kloss, Fig. 1) and a solid portion (having windows on the lateral sides) surrounding the porous portion (id. and cf. Fig. 4; page 18, lines 26-31).
Regarding claim 3, the porous portion of the device of the combination (supra) comprises a plurality of hexagonal-shaped pores (Kloss, page 13, lines 4-16).
Regarding claim 4, the device of the combination (supra) further comprises a first lateral side and a second lateral side, wherein the first lateral side includes a first lateral window (Kloss, Fig. 4) extending through the first lateral side and the second lateral side includes a second lateral window extending through the second lateral side (id.).
Regarding claim 5, the first lateral window of the device of the combination (supra) enables visualization of a cavity (Kloss, Fig. 1) of the device through the first lateral window (Kloss, Fig. 1 and cf. Fig. 4), and wherein the second lateral window enables visualization of the cavity through the second lateral window (id.).
Regarding claim 6, the first lateral window of the device of the combination (supra) comprises a plurality of first lateral windows (Kloss, Fig. 4) and the second lateral window comprises a plurality of second lateral windows (id.).
Regarding claim 7, Mozeleski et al. disclose an anchoring member retention component 500 (Figs. 6A and 10A-10D), wherein the implant device includes an aperture 360 (Fig. 9) configured to receive the anchoring member retention component such that the anchoring member retention component locks the arced anchoring member in place and prevents backing out of the arced anchoring member (Fig. 6A; para. 0077).
It would have been further obvious to a person having ordinary skill in the art before the effective filing date to further configure the implant of the combination of Kloss, Mozeleski et al. and Shoshtaev (supra) with an anchoring member retention component, wherein the implant device includes an aperture configured to receive the anchoring member retention component such that the anchoring member retention component prevents backing out of the arced anchoring member, also in view of Mozeleski et al., to prevent the anchoring members from backing out and to facilitate secure retention of the implant in the desired location.
Regarding claim 8, the anchoring member retention component 500 of the combination (supra) is a cam screw having a head 520, a threaded shaft (Mozeleski et al., para. 0079), a flat annular tip, and a shoulder (e.g., the fillet adjacent the head 520; Fig. 10D).
Regarding claim 9, the cam screw 500 is movable between a first position, enabling insertion and removal of one of the anchoring members 410, and a second position, preventing back out of one of the anchoring members 410 (Mozeleski et al., para. 0077).
Regarding claim 10, the arced anchoring members comprise a bone barb (Mozeleski et al., para. 0077, i.e., “bone blade”).
Regarding claim 11, Kloss discloses an implant (Fig. 1 and cf. Fig. 4) comprising:
a plurality of anchoring members (page 42, lines 18-28);
wherein the device includes a porous portion (Fig. 1 and cf. Fig. 4) and a solid portion (having windows on the lateral sides; id.) at least partially surrounding the porous portion (Figs. 1 and 4; page 18, lines 26-31), the solid portion having a higher density than the porous portion (page 18, lines 26-31). It is noted that Kloss shows and defines the solid outer portion having a higher density than the porous central portion by showing the solid portion having a thicker structure than the porous central portion (see, e.g., Figs. 1, 3A, 3B and 4). Kloss also defines porosity as the volume of material relative to the whole volume of the implant (page 18, lines 26-31). Therefore, the density of the outer solid portion shown by Kloss is higher than that of the porous central portion.
Kloss does not explicitly recite the plurality of anchor bores; and each of the anchoring members comprising a head at an end of the shaft, the head comprising a surface, a threaded bore extending into the surface, and a shoulder, wherein the surface is configured to receive a force to move the anchoring member within one of the anchor bores, the threaded bore is configured to receive a tool, and the shoulder is configured to engage a surface of the anchor bore to guide the anchoring member within the anchor bore.
Mozeleski et al. disclose a plurality of arced bores 230/330, 240/340 (Figs. 2 and 3) (e.g., at least proximate the convex head of the anchor (“bone blade”); cf. Fig. 14) extending into a rear of an implant device 200/300; wherein each arced bore is configured to receive an arced anchoring member 410 (Fig. 7B). The anchoring member 410 comprises a head 412 at an end of a shaft 418, the head comprises a surface and a bore 413 (Fig. 6A) extending into the surface, and a shoulder adjacent thereto, the surface is solid and integral with the anchoring member 410 and therefore configured to receive a force to move the anchoring member within the bore, and the shoulder is configured to engage a surface of the bore to guide the anchoring member within the bore (Fig. 14).
Mozeleski et al. teach that providing such bores and anchors facilitates securely retaining the implant by engaging a vertebra in a different manner and orientation than a bone screw (para. 0074).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the implant of Kloss with a plurality of bores configured to receive an anchoring member, wherein each anchoring member comprises: a head at an end of a shaft, the head comprising a surface, bore extending into the surface, and a shoulder, wherein the surface is configured to receive a force to move the anchoring member within the bore, the bore is configured to receive a tool, and the shoulder is configured to engage a surface of the bore to guide the anchoring member within the bore, in view of Mozeleski et al., to facilitate securely retaining the implant by engaging a vertebra in a different manner and orientation than a bone screw.
Shoshtaev further teaches that drive features of an orthopedic device can optionally be provided with numerous configurations, including a thread, to facilitate engagement with an instrument (para. 0025).
It would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide a thread within the bore (e.g., within the base thereof) of the anchoring member, in view of Shoshtaev, to optionally provide a threaded connection to facilitate engagement with an instrument.
Regarding claim 12, the device of the combination (supra) further comprises a first lateral side and a second lateral side, the first lateral side comprises a first lateral window (Kloss, Fig. 4) extending through the solid portion and the second lateral side comprises a second lateral window (id.) extending through the solid portion, and wherein the device is a single integral piece (Kloss, page 28, lines 20-30).
Regarding claim 13, the first lateral window of the device of the combination (supra) enables visualization of a cavity (Kloss, Fig. 1) of the device through the first lateral window (id. and cf. Fig. 4), and wherein the second lateral window enables visualization of the cavity through the second lateral window (id.).
Regarding claim 14, the first lateral window of the device of the combination (supra) comprises a plurality of first lateral windows and the second lateral window comprises a plurality of second lateral windows (Kloss, Fig. 4).
Regarding claim 15, Mozeleski et al. disclose an anchoring member retention component 500 (Figs. 6A and 10A-10D) comprising a cam screw having a head 520, a threaded shaft (Mozeleski et al., para. 0079), a flat annular tip, and a shoulder (e.g., the fillet adjacent the head 520; Fig. 10D), wherein the implant device includes an aperture 360 (Fig. 9) configured to receive the anchoring member retention component such that the anchoring member retention component locks the arced anchoring member in place and prevents backing out of the arced anchoring member (Fig. 6A; para. 0077).
It would have been further obvious to a person having ordinary skill in the art before the effective filing date to further configure the implant of the combination (supra) with an anchoring member retention component comprising a cam screw having a head, a threaded shaft, a flat annular tip, and a shoulder, wherein the implant device includes an aperture configured to receive the anchoring member retention component such that the anchoring member retention component prevents backing out of the arced anchoring member, also in view of Mozeleski et al., to prevent the anchoring members from backing out and to facilitate secure retention of the implant in the desired location.
Regarding claim 16, the cam screw 500 of the device of the combination (supra) is movable between a first position, enabling insertion and removal of one of the anchoring members 410, and a second position, preventing back out of one of the anchoring members 410 (Mozeleski et al., para. 0077).
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,414,860.
Although the claims at issue are not identical, they are not patentably distinct from each other because the differences amount to minor changes in the arrangement and phraseology of the claim limitations. The only substantive 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., the bore being angled, the anchoring member being arced and having a surface that is flat and a shoulder that is rounded, and regarding the device described in claims 1 and 11, further characterizing the device as an interbody device, and describing the lateral sides and central cavity of the device). 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 1, patent claim 1 discloses an implant comprising:
a device having a front, a rear, and a plurality of bores extending into the rear of the device;
wherein each bore is configured to receive an anchoring member, and
wherein each anchoring member comprises:
a head at an end of a shaft, the head comprising a surface, a threaded bore extending into the surface, and a shoulder, wherein the surface is configured to receive a force to move the anchoring member within the bore, the threaded bore is configured to receive a tool, and the shoulder is configured to engage a surface of the bore to guide the anchoring member within the bore.
Regarding independent application claim 11, patent claim 11 discloses an implant comprising:
a plurality of anchoring members; and
a device having a plurality of anchor bores each configured to receive one of the plurality of arced anchoring members;
wherein the device includes a porous portion and a solid portion at least partially surrounding the porous portion, the solid portion having a higher density than the porous portion, and wherein each anchoring member comprises:
a head at an end of the shaft, the head comprising a surface, a threaded bore extending into the surface, and a shoulder, wherein the surface is configured to receive a force to move the anchoring member within one of the anchor bores, the threaded bore is configured to receive a tool, and the shoulder is configured to engage a surface of the anchor bore to guide the anchoring member within the anchor bore.
Regarding independent application claim 17, patent claim 17 discloses an implant system comprising:
an implant body comprising:
an implant bore configured to receive an anchoring member; and
a tool interface, wherein the anchoring member comprises:
a head comprising a surface, an anchor bore extending into the surface, and a shoulder, wherein the surface is configured to receive a force to move the anchoring member within the implant bore, the anchor bore is configured to receive a tool, and the shoulder is configured to engage a surface of the implant bore to guide the anchoring member within the implant bore;
and a tool comprising:
an interface body configured to engage the tool interface; and a tool bore configured to receive the anchoring member.
The dependent application claims are mapped to the patent claims as set forth in the table below:
Appl. 19/316248
Pat. 12,414,860
1
1
2
2
3
6
4
3
5
4
6
5
7
7
8
8
9
9
10
10
11
11
12
12
13
13
14
14
15
15
16
16
17
17
18
18
19
19
20
20
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
In particular, Predick et al. (2017/0239053) teaches an anchoring member with a threaded bore in head 14 (Fig. 3; para. 0025).
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