DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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. 120 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 disclosure of the prior-filed application, Application No. 14/039,660, fails 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 application fails to provide support for installing a plate such that the plate contacts a rib as recited in claim 1. As such, none of the pending claims are supported by the aforementioned prior-filed application.
The disclosure of the prior-filed application, Application No. 17/932,472, fails 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 application fails to provide support for engaging the plate to the posterior portion of the rib using a fastening element as recited in claim 5 and for the opening being elongate to allow for movement of the coupling element as recited in claim 9. As such, neither claim 5 nor claim 9 are supported by the aforementioned prior-filed application.
Thus, the effective filing date of claims 1-4 and 6-8 is the filing date of Application No. 14/930,800, which is November 3, 2015. The effective filing date of claims 5 and 9 is the filing date of the present application, which is December 11, 2024.
Applicant states that this application is a continuation or divisional application of prior-filed Application No. 17/932,472. 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: engaging the plate to the posterior portion of the rib using a fastening element as recited in claim 5 and the opening being elongate to allow for movement of the coupling element as recited in claim 9.
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 fastening element (claim 5) and the plate coupled to the rib (claim 7) 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 9 is objected to because of the following informalities: the word “elongates” should be “elongated.” 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 5 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. It is unclear how the plate is engaged with the rib via a fastening element as the specification fails to recite the use of such a fastening element. Thus, the scope of “fastening element” is unclear. Instead, the specification merely recites that the plate can be coupled to the ribs or contact the ribs without coupling (see para. 0069).
Claim 9 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. There is no indication in the specification that the opening is elongated to allow for movement of the coupling element. Per the specification, the coupling element is either nut 710 (see para. 0069 and Fig. 26) or sleeve 712 (see para. 0070 and Fig. 27). Fig. 26 shows and para. 0069 describes opening 708 as being elongated. However, Fig. 26 does not show nut 710 extending into opening 708. Furthermore, para. 0069 states that the opening can be elongated to allow for movement of shank 706 of screw 702, not to allow for movement of nut 710. Thus, para. 0069 provides support for the opening being elongated to allow for movement of the bone fastener, not the coupling element as recited in claim 9. Neither Fig. 27 nor para. 0070 describe the opening as being elongated.
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 –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 5 and 9 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Zhang et al. (US 2024/0090925 A1). Note that the text of claim 1 is included below because, though claim 1 itself is not being rejected using Zhang, claims 5 and 9 necessarily include the limitations of claim 1.
Zhang discloses a method of adjusting the curvature of the spine without fusion, the method comprising:
installing a plate (plate 2805), wherein the plate includes an opening (see Fig. 29A inset) and contacts a posterior portion of a rib (see Fig. 30A inset);
installing a bone fastener (see Fig. 28 inset) into a pedicle of a vertebra (see Fig. 30A inset), the bone fastener extending through the opening in the plate (see Figs. 28 and 30A-B);
installing a coupling element (see Fig. 28 inset) on the bone fastener to couple the bone fastener to the plate, wherein rotation of the coupling element results in pulling of the bone fastener causing derotation of the vertebra (see Figs. 30A-B) (Figs. 28-30B; paras. 0071-0075).
Claim 5. Zhang discloses engaging the plate to the posterior portion of the rib using a fastening element (medial rib hook 2810) (Figs. 28-30B; paras. 0071-0075).
Claim 9. Zhang discloses wherein the opening of the plate is elongated (see Fig. 29A) to allow for movement of the coupling element (Figs. 28-30B; paras. 0071-0075).
[AltContent: textbox (Coupling Element)][AltContent: textbox (Bone Fastener)]
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[AltContent: connector][AltContent: textbox (Opening)]
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[AltContent: connector][AltContent: textbox (Posterior Portion of Rib)][AltContent: connector][AltContent: textbox (Pedicle of Vertebra)]
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 1-9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McCarthy et al. (US 2015/0190174 A1) in view of Bardaji Pascual (US 2011/0166612 A1).
Claim 1. McCarthy discloses a method of adjusting the curvature of the spine without fusion, the method comprising:
installing a plate (plate 16), wherein the plate includes an opening (passageway 34) and contacts a posterior portion of a rib (rib R2);
installing a bone fastener (fastener received in passageway 34 – see para. 0040) into a pedicle of a vertebra (see Fig. 5), the bone fastener extending through the opening in the plate (see para. 0040) (Figs. 1-3 and 5; paras. 0023-0039).
Claim 5. McCarthy discloses engaging the plate to the posterior portion of the rib using a fastening element (hooks 24 and 26) (see Fig. 5) (Figs. 1-3 and 5; paras. 0023-0039).
Claim 7. McCarthy discloses wherein installing a plate comprises coupling the plate to the posterior portion of the rib (via hooks 24 and 26) (see Fig. 5) (Figs. 1-3 and 5; paras. 0023-0039).
Claim 8. McCarthy discloses wherein installing a plate comprises installing the plate such that the plate contacts the posterior portion of the rib without coupling thereto (see para. 0039, which states that hooks 24 and 26 are disengaged from the rib) (Figs. 1-3 and 5; paras. 0023-0039).
Claim 9. McCarthy discloses wherein the opening of the plate is elongated (in the direction that passageway 34 extends through plate 16) (Figs. 1-3 and 5; paras. 0023-0039).
McCarthy fails to disclose installing a coupling element on the bone fastener to couple the bone fastener to the plate, wherein rotation of the coupling element results in pulling of the bone fastener causing derotation of the vertebra (claim 1), wherein the coupling element is a nut having a bore with threading and the bone fastener includes complementary threading to threadingly receive the nut (claim 2), wherein the coupling element is a sleeve having a bore with threading and the bone fastener includes complementary threading to threadingly receive the sleeve (claim 3), wherein the bone fastener includes a first threaded portion for being threaded into the pedicle and includes a second threaded portion for receiving the coupling element (claim 4), wherein installing a plate comprises installing the plate such that the plate contacts a posterior portion of a rib on a left side and a right side of a patient (claim 6), and wherein the elongated opening allows for movement of the coupling element (claim 9).
Bardaji Pascual teaches a method of moving a rib relative to a bone structure, the method comprising: installing a plate (device 1) to a bone structure (sternum 12), wherein the plate includes an opening (hole 4); installing a bone fastener (screw 9a) onto the bone structure, the bone fastener extending through the opening in the plate; installing a coupling element (nut 9b) on the bone fastener to couple the bone fastener to the plate, wherein rotation of the coupling element results in pulling of the bone fastener causing movement of the bone fastener relative to the rib (rib 14) (Figs. 2a-2b; para. 0040); wherein the coupling element is a nut (nut 9b) having a bore with threading and the bone fastener includes complementary threading (see Fig. 3 inset) to threadingly receive the nut (see para. 0042); wherein the coupling element is a sleeve (nut 9b) having a bore with threading and the bone fastener includes complementary threading (see Fig. 3 inset) to threadingly receive the sleeve (see para. 0042); wherein the bone fastener includes a first threaded portion (see Fig. 3 inset) for being threaded into the bone structure and includes a second threaded portion (see Fig. 3 inset) for receiving the coupling element (see para. 0042); wherein installing a plate comprises installing the plate such that the plate contacts a posterior portion of a rib (rib 14) on a left side and a right side of a patient (see Figs. 2a-2b); wherein the use of such a bone fastener and coupling element simplifies movement of the bone structure (see para. 0012) (Figs. 1a-3; paras. 0012 and 0032-0042).
[AltContent: textbox (First Threaded Portion)][AltContent: textbox (Complementary Threading/
Second Threaded Portion)]
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 method of McCarthy to include installing a coupling element on the bone fastener to couple the bone fastener to the plate, wherein rotation of the coupling element results in pulling of the bone fastener causing derotation of the vertebra (claim 1), wherein the coupling element is a nut having a bore with threading and the bone fastener includes complementary threading to threadingly receive the nut (claim 2), wherein the coupling element is a sleeve having a bore with threading and the bone fastener includes complementary threading to threadingly receive the sleeve (claim 3), wherein the bone fastener includes a first threaded portion for being threaded into the pedicle and includes a second threaded portion for receiving the coupling element (claim 4), wherein installing a plate comprises installing the plate such that the plate contacts a posterior portion of a rib on a left side and a right side of a patient (claim 6), as suggested by Bardaji Pascual, in order to simplify attachment of the plate and derotation of the vertebra. In view of such a modification, the elongated opening would allow for movement of the coupling element (claim 9).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kono (US 2019/0262040 A1) teaches the use of a comparable plate construct (see Figs. 1-3).
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.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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