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 Objections
Claim(s) 5 is/are objected to because of the following informalities:
Claim 5 does not end with a period, and is therefore missing proper punction.
Appropriate correction is required.
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.
Claim(s) 12 is/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.
Regarding claim 12, the phrase "optionally includes" in lines 1-2 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For the purpose of compact prosecution, claim 12 will be examined as requiring the burr, rasp or teeth, e.g. “a portion of the decortication tool includes a burr, a rasp or teeth”.
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.
Claim(s) 1-2, 7-11, 13 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-3, 5, 9 of U.S. Patent No. 11,871,968 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
1. A spinal joint access device for accessing a spinal joint via a posterior access approach, the device comprising a body having a proximal portion and a distal portion; and a chamfered or beveled end feature positioned at the distal portion of the body and configured for insertion at the spinal joint.
8. The access device of claim 1, wherein the spinal joint is a cervical facet joint.
1. A spinal fixation access and delivery system for accessing the cervical facet joint via a posterior access approach, the system comprising an access device comprising a body having a proximal portion and a distal portion; and a chamfered or beveled end feature positioned at the distal portion of the body and configured for insertion at the cervical facet joint, a guide device having access device engagement features; and a spinal fixation member, wherein the access device includes at least one guide device receiving feature complementary to or keyed to the engagement feature of the guide device, and the guide device comprises at least one spinal fixation member engagement feature, and the spinal fixation member includes at least one guide device receiving feature complementary to or keyed to the engagement feature of the guide device.
2. The access device of claim 1, wherein the chamfered or beveled end feature is offset from the body.
2. The system of claim 1 wherein the chamfered or beveled end feature of the access device is offset from the body.
7. The access device of claim 1, wherein the body is an elongated tubular body.
9. The system of claim 1, wherein the body is an elongated tubular body.
9. The access device of claim 1, wherein the device further comprises a stop adapted to abut an edge or posterior portion of the spinal joint.
3. The system of claim 1 wherein the chamfered or beveled end feature of the access device further includes a stop adapted to abut a posterior edge or posterior portion of the facet joint.
10. A spinal fixation access and delivery system for accessing the spinal joint via a posterior access approach, the system comprising: a spinal joint access device comprising: a body having a proximal portion and a distal portion; and a chamfered or beveled end feature positioned at the distal portion of the body and configured for insertion at the spinal joint.
13. The system of claim 10, wherein the spinal joint is a cervical facet joint.
1. A spinal fixation access and delivery system for accessing the cervical facet joint via a posterior access approach, the system comprising an access device comprising a body having a proximal portion and a distal portion; and a chamfered or beveled end feature positioned at the distal portion of the body and configured for insertion at the cervical facet joint, a guide device having access device engagement features; and a spinal fixation member, wherein the access device includes at least one guide device receiving feature complementary to or keyed to the engagement feature of the guide device, and the guide device comprises at least one spinal fixation member engagement feature, and the spinal fixation member includes at least one guide device receiving feature complementary to or keyed to the engagement feature of the guide device.
11. The system of claim 10 further comprising a decortication tool.
5. The system of claim 1 further comprising a decortication tool.
As is apparent from the table above, while Patent claim 1 discloses a system, the system includes all of the features of the access device in application claim 1, as well as additional limitations (e.g. a guide device and spinal fixation device) that are not in the application claims. And as is apparent from the table above, Patent claim 1 discloses all of the features of the system in application claim 10, as well as additional limitations (e.g. a guide device and spinal fixation device) that are not in the application claims.
Claim(s) 3-6 and 12 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 5 and 9 of U.S. Patent No. 11,871,968 B2 in view of Marik et al. (U.S. Pub. No. 2012/0277801 A1, hereinafter “Marik”).
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
3. The access device of claim 1, wherein the chamfered or beveled end feature is
positioned at an end of the distal portion.
4. The access device of claim 3, wherein the body is an elongated tubular body.
9. The system of claim 1, wherein the body is an elongated tubular body.
11. The system of claim 10 further comprising a decortication tool.
12. The system of claim 11, wherein a portion of the decortication tool optionally includes a burr, a rasp or teeth.
5. The system of claim 1 further comprising a decortication tool.
As is apparent from the table above, Patent claims 1 and 9 disclose all of the features of application claims 1 and 3-4, except regarding claim 3 that the chamfered or beveled end feature is positioned at an end of the distal portion.
Patent claims 1 and 5 disclose all of the features of application claims 1 and 11-12, except regarding claim 12, wherein a portion of the decortication tool optionally includes a burr, a rasp or teeth. Patent claim 1 further fails to disclose, regarding claim 5, wherein the body has a rectangular shaped cross section; regarding claim 6, wherein the proximal portion has a first height and a distal portion has a second height and the first height is greater than the second height.
Marik discloses a spinal joint access device (10, see Fig. 3) having a body having a proximal portion and a distal portion (see annotated Fig. 9 below); and a chamfered or beveled end feature (17) positioned at the distal portion of the body (see Fig. 9) and configured for insertion at the spinal joint (see para. [0036]), wherein the chamfered or beveled end feature is positioned at an end of the distal portion (see annotated Fig. 9 below); wherein the proximal portion has a first height and the distal portion has a second height (see annotated Fig. 9 below) and the first height is greater than the second height (see annotated Fig. 9 below); further comprising a decortication tool (11-12, see Fig. 9, see para. [0027] “cutting faces”); wherein a portion of the decortication tool (15) includes teeth optionally includes a burr, a rasp or teeth (15, see Fig. 9, see para. [0027] “rasp teeth”); wherein the body has a rectangular shaped cross section (see Fig. 9, note that a cross section of the body would be rectangular shaped); and in order to provide a self-distracting leading end and shape to permit the device to enter and push apart portions of the opposing vertebrae (see para. [0036]), in order to provide a stop to restrict advancement of the device into the joint (see para. [0035]), and in order to enable the decortication tool to cut tissue (see para. [0033]).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the chamfered or beveled end feature in the Patent claims to be positioned at the distal portion of the body, to modify the body in the Patent claims to have a first height at the proximal portion and a second height at the distal portion, where the first height is greater than the second height; and to modify the body in the Patent claims to have a rectangular shaped cross section in view of Marik in order to provide a self-distracting leading end and shape to permit the device to enter and push apart portions of the opposing vertebrae and to provide a stop to restrict advancement of the device into the joint. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify a portion of the decortication tool in the Patent claims to include a burr, a rasp or teeth in view of Marik in order to enable the decortication tool to cut tissue.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3, 5-6, 8-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marik et al. (U.S. Pub. No. 2012/0277801 A1, hereinafter “Marik”).
Marik discloses regarding claim 1, a spinal joint access device (10, see Fig. 3) for accessing a spinal joint (FJ) via a posterior access approach (see Fig. 3), the device comprising a body having a proximal portion and a distal portion (see annotated Fig. 9 below); and a chamfered or beveled end feature (17) positioned at the distal portion of the body (see Fig. 9) and configured for insertion at the spinal joint (see para. [0036]).
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Regarding claim 2, wherein the chamfered or beveled end feature is offset from the body (see annotated Fig. 9 above).
Regarding claim 3, wherein the chamfered or beveled end feature is
positioned at an end of the distal portion (see Fig. 9).
Regarding claim 5, wherein the body has a rectangular shaped cross section (see Fig. 9, note that a cross section of the body would be rectangular shaped).
Regarding claim 6, wherein the proximal portion has a first height and the distal portion has a second height (see annotated Fig. 9 above) and the first height is greater than the second height (see annotated Fig. 9 above).
Regarding claim 8, wherein the spinal joint is a cervical facet joint (see para. [0002]).
Regarding claim 9, wherein the device further comprises a stop (16) adapted to abut an edge or posterior portion of the spinal joint (see para. [0029]).
Marik discloses, regarding claim 10, a spinal fixation access and delivery system (10, see Fig. 3) for accessing the spinal joint (FJ) via a posterior access approach (see Fig. 3), the system comprising: a spinal joint access device (10) comprising: a body having a proximal portion and a distal portion (see annotated Fig. 9 above); and a chamfered or beveled end feature (17) positioned at the distal portion of the body and configured for insertion at the spinal joint (see Fig. 9, see para. [0036]).
Regarding claim 11, further comprising a decortication tool (11-12, see Fig. 9, see para. [0027] “cutting faces”).
Regarding claim 12, wherein a portion of the decortication tool optionally
includes a burr, a rasp or teeth (15, see Fig. 9, see para. [0027] “rasp teeth”).
Regarding claim 13, wherein the spinal joint is a cervical facet joint (see para. [0002]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marik, as applied to claims 1 and 3 above, and in view of Nelson et al. (U.S. Pub. No. 2011/0071527 A1, hereinafter “Nelson”).
Marik discloses all of the features of the claimed invention, as previously set forth above, except regarding claims 4 and 7, wherein the body is an elongated tubular body.
Nelson discloses a spinal joint access device (100, see Fig. 1A) a body (102, see Fig. 1A), wherein the body is an elongated tubular body (112, 148, see Fig. 3A) in order to provide a suction opening and suction pathway to funnel excised tissue (see para. [0037]) enabling removal of bone fragments or other tissues through the elongated body (see para. [0029]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the elongated body in Marik to be an elongated tubular body in view of Nelson in order to provide a suction opening and suction pathway to funnel excised tissue enabling removal of bone fragments or other tissues through the elongated body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
The following references disclose spinal joint access devices e.g. distractors / rasps:
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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/M.C.G/ Examiner, Art Unit 3773 /JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773