DETAILED ACTION
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 1-3, 6 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 and 13 of U.S. Patent No. 11285010.
Although the claims at issue 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 are 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.
All features of the pending claims are present in the patented claims defined with either identical or equivalent language. Features of the pending claims not explicitly recited in the patented claims would be readily obvious to one of ordinary skill in the art based on the application of the system of the patented claims.
Claims 4 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 and 13 of U.S. Patent No. 11285010 in view of Weikel et al. (US 20020177866 A1).
The patented claims disclose all elements of the claimed invention except for the profile of the distal portion to be different than (smaller) than a profile of the proximal portion.
Weikel et al. disclose varying the shape and size of the balloon to conform to the bone and allow for easier approach to the bone to be treated (para [0009]). Weikel et al. also disclose various balloon shapes wherein a profile of the distal portion is different than a profile of the proximal portion, for e.g. the distal portion has a smaller profile than a proximal portion of the balloon (Figs. 26 and 34).
It would have been obvious to one of ordinary skill in the art to have provided an implant in the patented claims with a shape wherein the distal end portion has a smaller profile than the proximal end portion to allow for easier approach to the facet joint.
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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1-7 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Pavlov et al. (US 20060064099).
Regarding claim 1, Pavlov et al. discloses insertion of a single piece cervical joint distraction device in the form of a screw 1 having a tapered distal portion (Fig. 2a) placed into interfacet space (Fig. 5) (paras [0011]-[0047]).
Pavlov et al. disclose the use of an access tool in the form of a trocar (Fig. 3 and para [0055]). The functional language “wherein the joint is covered by an articular capsule, and the access tool provides an access hole in the articular capsule” is met by Pavlov et al. because in order to gain access to the facet joint, the capsule of the facet joint must be entered.
Pavlov et al. also disclose a delivery tool in the form of a screwdriver 21 that has an elongated tubular body that is detachably coupled to a recess in the head of screw 1 and is detached from the device once the device is delivered or inserted into the facet joint (Fig. 5 and paras [0022] and [0057])
Regarding claims 4 and 5, Pavlov et al. screw has a distal portion (defined by the tapered tip) that has a smaller profile than the proximal portion (Figs. 2a and 2b).
Regarding the functional recitation “cervical joint distraction device,” implant 10a can be inserted into any facet joint at any level of the spine depending on a patient’s condition (Fig. 4 shows a facet joint).
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.
In the alternate, claims 1-7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carl et al. (US 8114158) in view of Weikel et al. (US 20020177866 A1).
Regarding claim 1, Carl et al. disclose a facet joint distraction system including: a hollow needle or access tool configured to access a facet joint so that facet repair may be performed percutaneously or via minimally invasive techniques (col. 4, lines 54-63).
Carl et al. disclose a joint distraction device in the form of an expandable member 268 (Fig. 12) wherein the expandable member can be inflated with a curable polymer, liquid, gas or other material wherein the expandable member may be adjusted after implanting by increasing or removing the inflation medium by accessing the member through a one-way valve (col. 6, lines 29-36).
Carl et al. disclose all elements of the claimed invention except for an explicit reference to a delivery tool that is an elongated, tubular body, the tool configured to deliver the joint distraction device into the facet joint.
Weikel et al. disclose a joint distraction device in the form of a balloon that may be disengaged, separated or detached from the delivery device (catheter) to remain in bone (para [0066]).
Regarding claims 4 and 5, Weikel et al. also disclose varying the shape and size of the balloon to conform and approach to the bone to be treated (para [0009]). Weikel et al. also disclose various balloon shapes wherein a profile of the distal portion is different than a profile of the proximal portion, for e.g. the distal portion has a smaller profile than a proximal portion of the balloon (Figs. 26 and 34).
It would have been recognized by one of ordinary skill in the art that applying the known technique of inserting an expandable implant/balloon at a target site in bone by inserting a catheter carrying the expandable implant/balloon and detaching the implant from the catheter, as taught by Weikel et al., to the Carl et al. system, would have yielded the predictable result of maintaining distraction by leaving the balloon-implant in bone.
Response to Arguments
Applicants’ arguments have been fully considered by the Examiner. Regarding the rejections under 35 U.S.C. 102(e) over Pavlov et al., the trocar is interpreted to be an access tool. The transitional phrase “comprising” does not preclude the presence of other elements.
Regarding the rejections under 35 USC 103(a) over Carl et al. (US 8114158) in view of Dutoit (US 2007/0093899 A1), new grounds of rejection have been made in this office action to address Applicant’s amendments to the claims.
Conclusion
Applicants’ 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 Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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August 27, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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