DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 1 is 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 1 recites the limitation "the inferior spinous process or sacrum" in line 7. There is insufficient antecedent basis for this limitation in the claim as the claim does not previously recite that the band is configured to be coupled with the sacrum.
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 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 1 is rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Fielding et al. (US 2005/0216017 A1).
Fielding discloses a spinal treatment system comprising: a constraint device (band 20) comprising an upper tether portion (adjacent end 24b) and a lower tether portion (adjacent end 24a), the constraint device configured to be disposed around a superior surface of a superior spinous process (see Fig. 2 inset) superior to a prosthesis adapted to be coupled with a spinal segment (see Fig. 2 inset) in a spine and around an inferior surface of an inferior spinous process (see Fig. 2 inset) that is part of superior region of the spinal segment, wherein the upper tether portion is configured to be coupled with the superior spinous process and the lower tether portion is configured to be coupled with the inferior spinous process or sacrum of the spinal segment, to restrict flexion of the spinal segment supradjacent to the spinal segment (see text of Fig. 2) (Figs. 2-3C). Note that the limitations “configured to be disposed around a superior surface of a superior spinous process superior to a prosthesis adapted to be coupled with a spinal segment in a spine and around an inferior surface of an inferior spinous process that is part of superior region of the spinal segment,” “configured to be coupled with the superior spinous process,” and “configured to be coupled with the inferior spinous process or sacrum of the spinal segment” are intended use statements. As shown in Fig. 2, band 20 is capable of being used such that it extends around the spinous processes as claimed and therefore capable of being used with a prosthesis coupled with the spinal segment as claimed.
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 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,167,874 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the patent discloses a spinal treatment system comprising: a constraint device (see col. 16, l. 33) comprising an upper tether portion (see col. 16, l. 34) and a lower tether portion (see col. 16, l. 35), the constraint device configured to be disposed around a superior surface of a superior spinous process superior to a prosthesis adapted to be coupled with a spinal segment in a spine and around an inferior surface of an inferior spinous process that is part of superior region of the spinal segment (see col. 16, ll. 37-44), wherein the upper tether portion is configured to be coupled with the superior spinous process and the lower tether portion is configured to be coupled with the inferior spinous process or sacrum of the spinal segment (see col. 16, ll. 41-44), to restrict flexion of the spinal segment supradjacent to the spinal segment (see col. 16, ll. 44-46).
The difference between claim 1 of the application and claim 1 of the patent is that claim 1 of the patent includes additional elements not present in claim 1 of the application. Thus, the invention of claim 1 of the patent is in effect a species of the generic invention of claim 1 of the application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Because claim 1 of the application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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