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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 26 December 2025. As directed by the amendment: claims 1-4, 6-10, and 12 have been amended, claims 5, 11, 13, and 14 are cancelled, and claims 15-20 have been newly added. Claims 1-4, 6-10, 12, and 15-20 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the previous claim objections, which are accordingly withdrawn.
The amendments to the claims are sufficient to overcome the previous rejections under 35 U.S.C. 112(b), which are accordingly withdrawn.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent Application Publication No. US 2008/0208344 to Kilpela et al. (hereinafter, “Kilpela”) have been fully considered but they are not persuasive. As to claim 1, Applicant contends that Kilpela does not disclose a distal retention plate having a distal part comprising a non-round lumen or a proximal retention plate having a proximal part comprising a non-round lumen. Examiner respectfully submits that the lumen of the distal part is non-round because the space between 2360’s is non-round at the inner surfaces of 2360a,b and at the cut through areas between 2360a and 2360b; and the lumen of the proximal part is non-round because the lumen through the upper right plate of 2320 (the proximal part) comprises a cutaway portion of a circle, so that the lumen as a whole is non-round, particularly at the side of the lumen that is opposite the plate, since that side is either flat or can have any amorphous shape to complete the negative space of the lumen.
Applicant further contends that Kilpela fails to disclose an elongated shaft having a non-round cross-section that mates with the non-round lumen of the distal part and the non-round lumen of the proximal part. Examiner respectfully submits that the elongated shaft has a non-round cross-section at the arms 2356a,b, to fit into the non-round lumen 2362, FIG. 97.
As to claim 12, Applicant contends that Kilpela’s arms 2356a,b are for insertion into a throughbore 2326 and therefore Kilpela fails to disclose a proximal retention plate that is fixedly secured to the elongated shaft. Examiner respectfully submits that the proximal retention plate is fixedly secured to the elongated shaft once the whole device is locked together in a final fixation position.
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.
Claims 12 and 17-20 are rejected under 35 U.S.C. 112(a) 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.
As to claim 12, the limitations that the proximal part of the proximal retention plate has a lumen extending proximally into the proximal part, and the proximal retention plate is fixedly secured to the elongated shaft, are not supported by the specification as originally filed. The specification recites these features in different embodiments. The embodiment shown in FIG. 4 describes the proximal part of the proximal retention plate has a lumen extending proximally into the proximal part, while the embodiment shown in FIGS. 1-3 describes the proximal retention plate may be fixedly secured to the elongated shaft. The features in the different embodiments are not described or shown as interchangeable, and the elongated shaft being received in a lumen of the proximal part of the proximal retention plate would result in them not being fixedly secured to each other.
As to claim 18, the limitation that the proximal retention plate comprises at least one opening for receiving a screw is described in a different embodiment (FIG. 3), than the embodiment described in claim 12 (FIG. 4; the proximal and distal parts each comprise a lumen). The features in the different embodiments are not described or shown as interchangeable.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6-9, 12, 15, 17, and 19 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent Application Publication No. US 2008/0208344 to Kilpela et al. (hereinafter, “Kilpela”).
As to claim 1, Kilpela discloses a device for securing a first vertebral body to a second vertebral body (superior and inferior vertebral bodies shown for example in FIG. 1) (¶8, 9, 131), shown in FIGS. 96-103, wherein the first vertebral body and the second vertebral body are separated by a gap (between adjacent spinous processes), the device comprising: a distal retention plate (2308) having a distal part (2360a,b) extending proximally therefrom (¶267-269), FIG. 96, the distal part comprising a proximal end (free ends of 2360’s) having a non-round lumen (space between 2360’s; the lumen is non-round at the inner surfaces of 2360a,b and at the cut through areas between 2360a and 2360b) extending distally into the distal part, FIG. 96; a proximal retention plate (lower left plate of 2320 in FIG. 96) having a proximal part (upper right plate of 2320 in FIG. 96) extending distally therefrom, FIG. 97, the proximal part comprising a distal end (distal face of upper right plate of 2320) having a non-round lumen (cutout through upper right plate of 2320; the lumen is non-round because of the cutaway portion) extending proximally into the proximal part, FIG. 97; an elongated shaft (2306) having a non-round cross-section (at 2356a,b) that mates with the non-round lumen of the distal part and the non-round lumen of the proximal part (since the non-round transverse cross-section part of the elongated shaft telescopes or slides into and through the lumens in the distal and proximal parts; the elongated shaft non-round cross-section mates or fits together with the lumens by passing therethrough, as part of the whole device).
As to claim 2, Kilpela discloses the device of claim 1 wherein the distal and proximal retention plates are configured to be rotated (the distal retention plate is rotated relative to the proximal retention plate, ¶268, FIGS. 98-99; and both the distal and proximal retention plates are fully capable of being rotated, along with rotation of and as part of the entire device, after insertion into the gap, for positional adjustment), FIGS. 98-99.
As to claim 3, Kilpela discloses the device of claim 1 wherein the distal part and the proximal part are secured to the elongated shaft in telescoping and non-rotating relation to one another (the elongated shaft telescopes or slides into and through the distal part, shown in the progression of FIGS. 99-102, and is in non-rotating relation because of their complementary shapes so that when one is rotated, the other is caused to rotate as well, ¶268-269; and the elongated shaft telescopes or slides into and through the proximal part, FIG. 102, and is in non-rotating relation once the aperture in the wing of 2330 locks onto the protrusion on 2320, FIGS. 97-100 and 102).
As to claim 4, Kilpela discloses the device of claim 1 wherein rotation of the proximal retention plate effects conjoint rotation of the distal retention plate (once the whole device is locked together when the elongated shaft is snapped into the distal retention plate and the aperture in the wing of 2330 locks onto the protrusion on 2320; rotating the whole device by rotating the proximal retention plate would effect conjoint rotation of the whole device including the distal retention plate).
As to claim 6, Kilpela discloses the device of claim 1 wherein the distal part, the proximal part, and the elongated shaft have a combined length configured to enable the proximal and distal retention plates to extend beyond the first and second vertebral bodies (the length of the device as a whole, including the distal part, proximal part, and elongated shaft when connected to each other, enables the proximal and distal retention plates to extend beyond respective sides of the spinous processes of first and second vertebral bodies).
As to claim 7, Kilpela discloses the device of claim 2 wherein the device comprises an unrotated position of repose (FIG. 98) and an infinite plurality of rotated positions relative to said unrotated position of repose (any of an infinite plurality of positions micro-adjusted from the position in FIG. 98 to and including the position in FIG. 100; the rotated positions may also be of the device when rotated together as a whole).
As to claim 8, Kilpela discloses the device of claim 7, further comprising: said unrotated position of repose configured to align said device with said gap prior to insertion and during insertion of said device into said gap (¶265 as to another embodiment but that also describes the embodiment of FIGS. 96-103; in the unrotated compact position of repose, the device is aligned or in correct relative position with the gap in order to be able to be passed therethrough); said device being in one of said plurality of rotated positions (FIG. 100) after said distal retention plate has exited said gap on a distal side of said gap, but prior to said proximal retention plate entering said gap (because the plates are meant to remain on opposite sides of the gap); said device when in said one of said plurality of rotated positions preventing distal-to-proximal or proximal-to-distal displacement of said distal and proximal retention plates into said gap (due to the relative size of the plates and the gap); and said distal retention plate, when the device is in said one of said plurality of rotated positions cooperating with said proximal retention plate to hold said first and second vertebral bodies in a stable relationship to one another.
As to claim 9, Kilpela discloses the device of claim 8, further comprising: a telescoping relation enabling retraction of the distal part relative to the elongated shaft, FIGS. 99-100 and 102, and said proximal part relative to the elongated shaft, FIGS. 99-100, whereby to enable the proximal and distal retention plates to positively engage the first and second vertebral bodies, shown for example in FIG. 7.
As to claim 15, Kilpela discloses the device of claim 1 wherein a distal end (distal faces of 2364a,b) of the elongated shaft is configured to be slidably received in the non-round lumen of the distal part of the distal retention plate (the distal end, comprising the distal faces of 2364a,b, is slidably received in and through the non-round lumen of the distal part during assembly) and a proximal end (proximal faces of 2364a,b) of the elongated shaft is configured to be slidably received in the non-round lumen of the proximal part of the proximal retention plate (the proximal end, comprising the proximal faces of 2364a,b, is slidably received in and through the lumen of the proximal part during assembly, FIGS. 102-103), whereby to provide a longitudinally adjustable distance between the distal retention plate and the proximal retention plate (distance between the plates is shown decreasing from the position of FIG. 99 to the position of FIG. 100).
As to claim 12, Kilpela discloses a device for insertion into a gap between two bony elements (between superior and inferior adjacent spinous processes, shown for example in FIG. 1) (¶8, 9, 131), shown in FIGs. 96-103, the device comprising: a distal retention plate (2308) having a distal part (2360a,b) extending proximally therefrom (¶267-269), FIG. 96, the distal part comprising a proximal end (free ends of 2360’s) having a lumen (space between 2360’s) extending distally into the distal part, FIG. 96; a proximal retention plate (lower left plate of 2320 in FIG. 96) having a proximal part (upper right plate of 2320 in FIG. 96) extending distally therefrom, FIG. 97, the proximal part comprising a distal end (distal face of upper right plate of 2320) having a lumen (cutout through upper right plate of 2320) extending proximally into the proximal part, FIG. 97; and an elongated shaft (2306) connecting the distal retention plate to the proximal retention plate (as parts of the connected whole device), wherein the proximal retention plate is fixedly secured to the elongated shaft such that rotation of the proximal retention plate effects conjoint rotation of the distal retention plate (once the whole device is locked together, so that the proximal retention plate is fixedly secured to the elongated shaft, when the elongated shaft is snapped into the distal retention plate and the aperture in the wing of 2330 locks onto the protrusion on 2320; rotating the whole device by rotating the proximal retention plate would effect conjoint rotation of the whole device including the distal retention plate).
As to claim 17, Kilpela discloses the device of claim 12 wherein the distal retention plate and the proximal retention plate are telescopically interconnected to one another, from the position of FIG. 99 to the position of FIG. 100.
As to claim 19, Kilpela discloses the device of claim 12 wherein the distal part and the proximal part receive the elongated shaft (at least during assembly, and when assembled in FIG. 102).
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.
Claims 1-4, 6, 7, 12, and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2008/0161818 to Kloss et al. (hereinafter, “Kloss”).
As to claim 1, Kloss discloses a device for securing a first vertebral body to a second vertebral body (superior and inferior vertebral bodies), FIG. 5, wherein the first vertebral body and the second vertebral body are separated by a gap (between adjacent spinous processes), the device comprising: a distal retention plate (portion of 1A with chamfered edges, further from 1B) having a distal part (portion of 1A that is closer to 1B and that extends proximally from the portion of 1A with chamfered edges) extending proximally therefrom, the distal part comprising a proximal end; a proximal retention plate (portion of 1B with chamfered edges, further from 1A) having a proximal part (portion of 1B that is closer to 1A and that extends distally from the portion of 1B with chamfered edges) extending distally therefrom, the proximal part comprising a distal end (end of 1B closest to 1A) having a non-round lumen extending proximally into the proximal part (par. [0101]; the lumen is non-round because it is complementary to the non-round elongated shaft 3, which has a cross-section that is extended or elongated in one direction and thus not round); an elongated shaft (3) having a non-round cross-section (non-round because it is extended or elongated in one direction) that mates with the non-round lumen of the proximal part, FIG. 5.
As to claim 2, Kloss discloses the device of claim 1 wherein the distal and proximal retention plates are configured to be rotated (the distal and proximal retention plates are fully capable of being rotated, along with rotation of and as part of the entire device).
As to claim 3, Kloss discloses the device of claim 1 wherein the proximal part is secured to the elongated shaft in telescoping and non-rotating relation to one another (par. [0101], FIG. 5.
As to claim 4, Kloss discloses the device of claim 1 wherein rotation of the proximal retention plate effects conjoint rotation of the distal retention plate (rotation of the proximal retention plate effects conjoint rotation of the distal retention plate because they are non-rotatable relative to each other).
As to claim 6, Kloss discloses the device of claim 1 wherein the distal part, the proximal part, and the elongated shaft have a combined length configured to enable the proximal and distal retention plates to extend beyond the first and second vertebral bodies (the length of the device as a whole, including the distal part, proximal part, and elongated shaft when connected to each other, enables the proximal and distal retention plates to extend beyond respective sides of the spinous processes of first and second vertebral bodies).
As to claim 7, Kloss discloses the device of claim 2 wherein the device comprises an unrotated position of repose and an infinite plurality of rotated positions relative to said unrotated position of repose (any position, such as that shown in FIG. 6, may be interpreted as an unrotated position of repose, and the device as a whole can be rotated into an infinite plurality of rotated positions relative to said unrotated position of repose).
As to claim 15, Kloss discloses the device of claim 1 wherein a proximal end of the elongated shaft is configured to be slidably received in the non-round lumen of the proximal part of the proximal retention plate (par. [0101]), whereby to provide a longitudinally adjustable distance between the distal retention plate and the proximal retention plate, FIG. 5.
Kloss is silent as to the distal part comprising a proximal end having a non-round lumen extending distally into the distal part; the non-round cross-section of the elongated shaft mates with the non-round lumen of the distal part (claim 1); wherein the distal part is secured to the elongated shaft in telescoping and non-rotating relation to one another (claim 3); wherein a distal end of the elongated shaft is configured to be slidably received in the non-round lumen of the distal part of the distal retention plate (claim 15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to separate the distal part from the elongated shaft and to secure them in telescoping and non-rotating relation to one another, since constructing a formerly integral structure in various elements involves only routine skill in the art, and Kloss contemplates that the elongated shaft (3) is not fixedly connected to the distal part (portion of 1A) (par. [0101]). The modification would result in both the proximal and distal retention plates being slidably connected to the elongated shaft, therefore providing greater flexibility to the expansion of the device. Either or both of the plates can be translated relative to the elongated shaft and relative to the other plate, so that the practitioner is given the flexibility to manipulate either of the plates based on accessibility in the particular patient body. Another screw (4) would be provided to lock the distal retention plate and the distal part relative to the elongated shaft once the desired distraction has been achieved (par. [0102]). To achieve this modification, the proximal end of the distal part would have a non-round lumen extending distally into the distal part complementary to the non-round cross-section of the elongated shaft, so that the non-round cross-section of the elongated shaft mates with the non-round lumen of the distal part to allow relative sliding when a distal end of the elongated shaft is configured to be slidably received in the non-round lumen of the distal part of the distal retention plate. Both the distal part and the proximal part are thus secured to the elongated shaft in telescoping and non-rotating relation to one another due to the complementary non-round features.
As to claim 16, Kloss is silent as to wherein the non-round lumens and the non-round cross-section are octagonal.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the non-round lumens and the non-round cross-section octagonal, since this is one of various shapes that would allow relative translational movement without relative rotation, as required by Kloss. A person having ordinary skill in the art would find this shape obvious for the purpose of allowing relative translational movement while preventing relative rotation.
As to claim 12, Kloss discloses a device for insertion into a gap between two bony elements (space between adjacent spinous processes), the device comprising: a distal retention plate (portion of 1A with chamfered edges, further from 1B) having a distal part (portion of 1A that is closer to 1B and that extends proximally from the portion of 1A with chamfered edges) extending proximally therefrom, the distal part comprising a proximal end; a proximal retention plate (portion of 1B with chamfered edges, further from 1A) having a proximal part (portion of 1B that is closer to 1A and that extends distally from the portion of 1B with chamfered edges) extending distally therefrom, the proximal part comprising a distal end (end of 1B closest to 1A) having a lumen extending proximally into the proximal part (par. [0101]); and an elongated shaft (3) connecting the distal retention plate to the proximal retention plate, FIG. 5, wherein the proximal retention plate is fixedly secured to the elongated shaft (via screw 4, par. [0102]) such that rotation of the proximal retention plate effects conjoint rotation of the distal retention plate (rotation of the proximal retention plate effects conjoint rotation of the distal retention plate because they are non-rotatable relative to each other).
As to claim 17, Kloss discloses the device of claim 12 wherein the distal retention plate and the proximal retention plate are telescopically interconnected to one another (via 3, par. [0101]).
As to claim 18, Kloss discloses the device of claim 12 wherein the proximal retention plate (which comprises the proximal part) comprises at least one opening for receiving a screw (4) (par. [0102]).
As to claim 19, Kloss discloses the device of claim 12 wherein the proximal part receives the elongated shaft, FIG. 5.
Kloss is silent as to the distal part comprising a proximal end having a lumen extending distally into the distal part (claim 12); wherein the distal part receives the elongated shaft (claim 19).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to separate the distal part from the elongated shaft and to secure them in telescoping and non-rotating relation to one another, since constructing a formerly integral structure in various elements involves only routine skill in the art, and Kloss contemplates that the elongated shaft (3) is not fixedly connected to the distal part (portion of 1A) (par. [0101]). The modification would result in both the proximal and distal retention plates being slidably connected to the elongated shaft, therefore providing greater flexibility to the expansion of the device. Either or both of the plates can be translated relative to the elongated shaft and relative to the other plate, so that the practitioner is given the flexibility to manipulate either of the plates based on accessibility in the particular patient body. Another screw (4) would be provided to lock the distal retention plate and the distal part relative to the elongated shaft once the desired distraction has been achieved (par. [0102]). To achieve this modification, the proximal end of the distal part would have a lumen extending distally into the distal part complementary to the cross-section of the elongated shaft, so that the cross-section of the elongated shaft mates with the lumen of the distal part to allow relative sliding when the distal part receives the elongated shaft. Both the distal part and the proximal part are thus secured to the elongated shaft in telescoping and non-rotating relation to one another due to the complementary non-round features.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kilpela in view of U.S. Patent Application Publication No. US 2014/0324103 to Levieux et al. (hereinafter, “Levieux”).
Kilpela discloses the claimed invention except for further comprising a roughened inboard surface formed on each of said distal and proximal retention plates (claim 10); wherein at least one of the distal retention plate and the proximal retention plate comprises a roughened inboard surface (claim 20).
Levieux teaches a spinal implant comprising a roughened inboard surface formed on the faces of the plates that contact bone for more secure gripping of adjacent bone to inhibit migration of the implant (¶43, 104).
Accordingly, at the time the invention was filed, it would have been obvious to a person having ordinary skill in the art to provide a roughened inboard surface formed on each of said distal and proximal retention plates of Kilpela’s device, since the inboard surfaces of the plates are bone contacting, and roughening these surfaces would allow for more secure gripping of adjacent bone and inhibiting undesirable migration of the implant, as taught by Levieux. The elongate shafts would be made of an appropriate length to accommodate the roughening in the unrotated position of repose.
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, 2, 4, 15, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 10,463,504. 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 lies in the fact that the patent claims include more elements and are thus more specific. 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.
Instant Application Claim 1
U.S. Patent No. 10,463,504
1. A device for securing a first vertebral body to a second vertebral body, wherein the first vertebral body and the second vertebral body are separated by a gap, the device comprising:
a distal retention plate having a distal part extending proximally therefrom, the distal part comprising a proximal end having a non-round lumen extending distally into the distal part;
a proximal retention plate having a proximal part extending distally therefrom, the proximal part comprising a distal end having a non-round lumen extending proximally into the proximal part;
an elongated shaft having a non-round cross-section that mates with the non-round lumen of the distal part and the non-round lumen of the proximal part.
2. The device of claim 1 wherein the distal and proximal retention plates are configured to be rotated.
4. The device of claim 1 wherein rotation of the proximal retention plate effects conjoint rotation of the distal retention plate.
15. The device of claim 1 wherein a distal end of the elongated shaft is configured to be slidably received in the non-round lumen of the distal part of the distal retention plate and a proximal end of the elongated shaft is configured to be slidably received in the non-round lumen of the proximal part of the proximal retention plate, whereby to provide a longitudinally adjustable distance between the distal retention plate and the proximal retention plate.
16. The device of claim 1 wherein the non-round lumens and the non-round cross-section are octagonal.
Claim 1. a spinal fusion implant
for fusing two adjacent, spaced-apart vertebral bodies
1. a distal retention plate
3. a distal retention plate shaft member (“distal part”) mounted to the distal retention plate
6. the distal retention plate shaft member comprises octagonal lumen
1. a proximal retention plate
3. a proximal retention plate shaft member (“proximal part”) mounted to the proximal retention plate
6. the proximal retention plate shaft member comprises octagonal lumen
4. an elongated base (“an elongated shaft”) connecting the distal retention plate shaft member to the proximal retention plate shaft member
5. the elongated base comprises a non-round cross section
6. the non-round cross section is octagonal, and further wherein the distal retention plate shaft member and the proximal retention plate shaft member comprise octagonal lumens
1. rotation of said proximal retention plate effects conjoint rotation of said distal retention plate
1. rotation of said proximal retention plate effects conjoint rotation of said distal retention plate
4. an elongated base connecting the distal retention plate shaft member to the proximal retention plate shaft member
5. the elongated base comprises a non-round cross section
6. the non-round cross section is octagonal, and further wherein the distal retention plate shaft member and the proximal retention plate shaft member comprise octagonal lumens
2. the elongated member is configured to be selectively telescoped between a longitudinally-extended configuration and a longitudinally-retracted configuration, whereby to move the distal retention plate and the proximal retention plate closer together
6. the non-round cross section is octagonal, and further wherein the distal retention plate shaft member and the proximal retention plate shaft member comprise octagonal lumens
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775