DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 15, 2026 has been entered.
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 and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9333086.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the only difference between the claims of the present application and the patented claims is that the patented claims include more elements and are thus more specific. Thus, the invention of the patented claims is in effect a “species” of the “generic” invention of the claims of the present application. 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 claims of the present application are anticipated by the patented claims, they are not patentably distinct from the patented claims.
Claims 2-7 and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 8512347.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the only difference between the claims of the present application and the patented claims is that the patented claims include more elements and are thus more specific. Thus, the invention of the patented claims is in effect a “species” of the “generic” invention of the claims of the present application. 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 claims of the present application are anticipated by the patented claims, they are not patentably distinct from the patented claims.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 2-12 and 13-18 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In claim 2, the recitation “…, the first surface is a superior articular facet joint engagement surface that abuts a superior articular surface of said facet joint” and the recitation “…, the second surface is an inferior articular facet joint engagement surface that abuts an inferior articular surface of said facet joint,” appears to positively recite a part of human. It is suggested that Applicant utilize language such as “…, the first surface is a superior articular facet joint engagement surface that is configured to abut a superior articular surface of said facet joint” and “…, the second surface is an inferior articular facet joint engagement surface that is configured to abut an inferior articular surface of said facet joint.”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 2-7 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Young et al. (US 6190414).
Regarding claim 2, Young et al. discloses a spinal implant which is capable of being placed in a facet joint, the implant including: a first portion or plate 158 including a first surface and a first plurality of openings 166 through the first surface, wherein upon implantation of said implant into said facet joint, the first surface is adapted to abut or capable of abutting a superior articular surface of the facet joint; and a second portion or plate 160 including a second surface and a second plurality of openings 166 through the second surface, wherein upon implantation of said implant into said facet joint, the second surface is adapted to abut or capable of abutting an inferior articular surface of the facet joint, wherein the first portion and the second portion are movably coupled together such that, upon implantation of the implant into said facet joint, the first portion and the second portion are able to move relative to one another to change a shape of the implant so that the implant conforms to a shape formed by the superior and inferior articular surfaces of the spinal joint or facet joint (Figs. 1-14, col. 4, lines 31-67 and cols. 5-7).
Regarding claims 3-6, wherein the first portion includes a first plurality of securement features or teeth 164 for engaging a superior surface or articular surface and securing the implant within the spinal or facet joint; and the second portion includes a second plurality of securement features or serrations or teeth164 for engaging an inferior articular surface or bone surface of a joint and securing the implant within the joint.
Regarding claim 7, prior to implantation and assembly, the implant is planar (Fig. 9).
Claim(s) 2-7 and 16-18 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Vaccaro (US 6102950).
Regarding claim 2, Vaccaro discloses a spinal implant (Fig. 2) which is capable of being placed in a facet joint, the implant including: a first portion or upper member 22 including a first surface and a first plurality of openings 26 through the first surface, wherein upon implantation of said implant into said facet joint, the first surface is adapted to abut or capable of abutting a superior articular surface of the facet joint; and a second portion or lower member 24 including a second surface and a second plurality of openings 26 through the second surface, wherein upon implantation of said implant into said facet joint, the second surface is adapted to abut or capable of abutting an inferior articular surface of the facet joint, wherein the first portion and the second portion are movably coupled together such that, upon implantation of the implant into said facet joint, the first portion and the second portion are able to move relative to one another to change a shape of the implant so that the implant conforms to a shape formed by the superior and inferior articular surfaces of the spinal joint or facet joint (Figs. 1-7, col. 5, lines 20-67, cols. 6-7 and col. 8, lines 1-64).
Regarding claims 3-6, wherein the first portion includes a first plurality of securement features or teeth 52 for engaging a superior surface or articular surface and securing the implant within the spinal or facet joint; and the second portion includes a second plurality of securement features or teeth 52 for engaging an inferior articular surface or bone surface of a joint and securing the implant within the joint (Figs. 1-7, col. 5, lines 20-67, cols. 6-7 and col. 8, lines 1-64).
Regarding claim 7, prior to implantation and assembly, the implant is planar (for e.g. Figs. 2, 4 and 7).
Regarding claim 16, Vaccaro discloses a spinal implant (Fig. 2) which is capable of being placed in a facet joint, the implant including: a first portion or upper member 22 including a first surface and a first plurality of openings 26 through the first surface, wherein upon implantation of said implant into said facet joint, the first surface is adapted to abut or capable of abutting a superior articular surface of the facet joint; and a second portion or lower member 24 including a second surface and a second plurality of openings 26 through the second surface, wherein upon implantation of said implant into said facet joint, the second surface is adapted to abut or capable of abutting an inferior articular surface of the facet joint, wherein the first portion and the second portion are movable relative to each other but are inseparably coupled to one another via a flexible web 60, upon implantation of the implant into said facet joint, the first portion and the second portion are able to move relative to one another by insertion of wedge 40 to change a shape of the implant so that the implant conforms to a shape formed by the superior and inferior articular surfaces of the spinal joint or facet joint (Figs. 1-7, col. 5, lines 20-67, cols. 6-7 and col. 8, lines 1-64).
Regarding claim 17, prior to implantation and assembly, the Vaccaro implant is planar (for e.g. Figs. 2, 4 and 7).
Regarding claim 18, Vaccaro discloses the upper member 22 and the lower member 24 to bite into each of the surfaces of a joint via teeth 52 (Figs. 1-7, col. 5, lines 20-67, cols. 6-7 and col. 8, lines 1-64).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 8-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Young et al. (US 6190414) in view of Carl et al. (US 20060036323 A1).
Regarding claims 8-12, Young et al. disclose all elements of the claimed invention (see previous discussion for claims 2-7). Young et al. also disclose the use of a delivery instrument (cannula 200 and applicator instrument 102, Figs. 12 and 13).
Regarding claims 13-15, Young et al. disclose changing the shape of implant such that the upper and lower engaging plates 158, 160 penetrate and engage the vertebral end plates to securely fix the implant within the intervertebral space (Fig. 13, col. 6, lines 59-67 and col. 7, lines 1-14).
Regarding claims 8-15, Young et al. disclose all elements of the claimed invention except for a method of treating a facet joint of a spine of a patient.
Carl et al. disclose the use of a stabilization device or distraction implant which applies a distraction force for treatment of a facet joint (Fig. 7 and para [0081]).
It would have been obvious to one of ordinary skill in the art to have utilized the Young et al. implant, as taught by Carl et al., to apply a distraction force to opposing surfaces of a facet joint, to enable distracting and positioning the facet joint for treatment of the facet joint.
The claimed method steps are rendered obvious by the above discussion.
Claims 8-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Vaccaro (US 6102950) in view of Carl et al. (US 20060036323 A1).
Vaccaro discloses all elements of the claimed invention (see previous discussion for claims 2 and 16). Vaccaro also discloses the use of a delivery instrument or driver tool T that releasably engages the implant and facilitates insertion of the implant into the facet joint (Fig. 1, col. 5, lines 20-67, cols. 6-7 and col. 8, lines 1-64 ).
Regarding claims 13-15, Vaccaro discloses the implant to have a first shape prior to implantation (Figs. 2 and 7) and a second shape after implantation (Fig. 1).
Regarding claims 8-15, Vaccaro discloses all elements of the claimed invention except for a method of treating a facet joint of a spine of a patient.
Carl et al. disclose the use of a stabilization device or distraction implant which applies a distraction force for treatment of a facet joint (Fig. 7 and para [0081]).
It would have been obvious to one of ordinary skill in the art to have utilized the Vaccaro implant, as taught by Carl et al., to apply a distraction force to opposing surfaces of a facet joint, to enable distracting and positioning the facet joint for treatment of the facet joint.
The claimed method steps are rendered obvious by the above discussion.
Response to Arguments
Applicant's arguments filed have been fully considered by the Examiner. New grounds of rejection have been made in this office action.
Regarding the rejections under 35 USC 102(b) over Young et al., Applicant’s arguments are not persuasive because they are directed to functional recitations “…wherein upon implantation……that abuts a superior articular surface of said facet joint” and “…wherein upon implantation….that abuts an inferior articulating surface of said facet joint,” which are capable of being performed by the Young et al. implant. Young et al. disclose an implant for fusion of adjacent bone structures which includes facet joint surfaces. Upon implantation of the Young et al. implant, the upper and lower bone engaging surfaces of the implant abut the bone surfaces that define the space or gap into which the implant is placed.
Regarding the rejections under 35 USC 102(b) over Vaccaro, Applicant’s arguments are not persuasive because they are directed to functional recitations “…wherein upon implantation……that abuts a superior articular surface of said facet joint” and “…wherein upon implantation….that abuts an inferior articulating surface of said facet joint,” which are capable of being performed by the Vaccaro implant. The first and second bone-engaging surfaces of the Vaccaro implant abut a superior articular surface and an inferior articular surface of a facet joint, respectively, when the Vaccaro implant is deployed in a facet joint. Applicant’s claim does not recite any specific structure to distinguish the claimed implant over the Vaccaro implant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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May 26, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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