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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-9) in the reply filed on June 29, 2026 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (note that claims 10-20 are not eligible for rejoinder as they do not include the inner slides as recited in claim 1 – claim 20 was amended to include one or more inner slides, not two inner slides, and does not include the structure of the inner slides as recited in claim 1), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 29, 2026.
Claims 1-9 have been examined.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 121 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosures of the prior-filed applications, Application Nos. 17/886,833 and 63/233,046, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed applications fail to provide support for the deflectable prong comprising an attachment point configured to engage protrusions or recesses in the housing of the bone anchor as recited in claim 1. Accordingly, none of claims 1-9 have been awarded priority to the prior-filed applications.
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: the deflectable prong comprising an attachment point configured to engage protrusions or recesses in the housing of the bone anchor as recited in claim 1.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first and second extensions of the bone anchor housing each comprising a protrusion (claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: “a vertebrae” should be “a vertebra” (line 2) as “vertebra” is the singular form and “vertebrae” is the plural form. 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.
Claims 1-9 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. Claim 1 recites “a deflectable prong…comprising an attachment point configured to engage the protrusion or recess in the housing” (lines 14-16). However, previously, claim 1 recites that “each of the first and second extensions comprise a protrusion or recess” (lines 8-9), indicating that there are two protrusions or two recesses wherein one is in each extension. It is unclear how a single deflectable prong is capable of engaging protrusions/recesses in both the first and second extensions. Instead, Applicant’s disclosure includes four deflectable prongs 23A-23D, each of which comprises a single retainer 80A-80D, respectively, wherein each retainer 80A-80D is positioned within a respective socket 224 of housing 204 (see Figs. 18 and 23, for example). Claims 2-9 are rejected because they depend from claim 1. For examination purposes, the Examiner is interpreting claim 1 as reciting “first and second deflectable arms and first and second deflectable prongs at the distal portion, the first deflectable prong comprising an attachment point configured to engage the protrusion or recess in the first extension of the housing and the second deflectable prong comprising an attachment point configured to engage the protrusion or recess in the second extension of the housing” (lines 14-17).
Claims 1-9 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. Claim 1 recites “the housing of a bone anchor” (lines 16-17). However, claim 1 previously recites a bone anchor (line 2) and thus it is unclear whether the recitation in lines 16-17 is intended to refer to an additional bone anchor. Claims 2-9 are rejected because they depend from claim 1. In order to overcome this rejection, Applicant should either delete “a bone anchor” or recite “the bone anchor” (lines 16-17).
Claim 3 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 3 recites that “the first and second deflectable arms and the first through fourth deflectable prongs include the attachment points” (lines 3-4). However, claim 1 recites “a deflectable prong…comprising an attachment point configured to engage the protrusion or recess in the housing” (lines 14-16). Thus, per claim 1, there is a single deflectable prong having a single attachment point. Because claim 2 indicates that the deflectable prong comprises first through fourth deflectable prongs, it is understood that each of the first through fourth deflectable prongs includes an attachment point. However, neither claim 1 nor claim 2 indicate that the deflectable arms include an attachment point. Furthermore, claim 1 only recites a single protrusion or recess per extension of the housing (see “each of the first and second extensions comprise a protrusion or recess” in lines 8-9). Six attachment points (one each for the four deflectable prongs and one each for the two deflectable arms) would necessitate a total of six protrusions or recesses, or three per extension of the housing. The Examiner suggests amending claim 3 (a) to indicate that each deflectable arm includes an attachment point and (b) such that the number of recesses is in agreement with the number of attachment points.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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 1-9 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). Claim 1 recites “a bone anchor comprising a threaded fastener engaging a vertebrae of a spinal column” (line 2). Such a recitation encompasses a human organism and therefore claim 1 is unpatentable. Claims 2-9 depend from claim 1 and are therefore also unpatentable. In order to overcome this rejection, the Examiner suggests amending claim 1 to recite “a bone anchor comprising a threaded fastener configured to engage a vertebrae of a spinal column” (line 2).
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 and 4-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of U.S. Patent No. 12,167,876 B2 in view of Lindner (US 2019/0142471 A1). Claim 2 of the application corresponds to claim 1 of the patent and claims 4-6 of the application correspond to claims 3-5, respectively, of the patent. The difference between the claims of the patent and those of the application is that claim 2 of the application includes a bone anchor (see claim 1), whereas claim 1 of the patent does not. Lindner teaches a system comprising: a bone anchor (sleeve 13 and shank 38) comprising a threaded fastener (shank 38) engaging a vertebrae of a spinal column and a rod housing (sleeve 13) comprising a base portion (portion below U-shaped channel as shown in Fig. 11A), an aperture (opening through which head 39 of shank 38 extends as shown in Fig. 11A), and first and second extensions (separated by U-shaped channel as shown in Fig. 11A) defining therebetween a channel (U-shaped channel as shown in Fig. 11A) configured to receive an elongated fixation element and upper portions of the first and second extensions being threaded (see Fig. 11A) to receive a set screw to retain the elongated fixation element in the channel, the rod housing rotatably engaging a head (head 39) of the threaded fastener to position the first and second extensions in different positions, wherein each of the first and second extensions comprise a protrusion or recess (indentations 46); and an extender tower (coupling unit 1, sleeve 2, and tappet 3) comprising prongs (pins 36), each prong comprising an attachment point (ends of pins 36) configured to engage a respective recess in the housing of the bone anchor to secure the extender tower to the bone anchor (see Fig. 12 and para. 0071), wherein the bone anchor is used to provide for stabilization of a spine suffering from a variety of conditions (see para. 0003). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of claim 1 of the patent by providing a bone anchor as taught by Lindner in order to provide means for stabilizing a spine suffering from a variety of conditions.
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
Prosecution Insights