DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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) 1-20 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Dankowicz et al. (US 2005/0262911), herein referred to as Dankowicz.
Regarding claim 1, Dankowicz discloses a spinal rod (element “R”) (figure 2) for a patient’s spine (¶39), the spinal rod (element “R”) having a plurality of bend points (elements 100) along a length of the spinal rod (¶42 and figures 1A, 1B), wherein the plurality of bend points (elements 100) are determined by (considered product-by-process): (a) obtaining data for a plurality of locations relative to the patient's spine; (b) generating a bend curve between at least two of the plurality of bend points along the length of the spinal rod, wherein the bend curve is based on the data for the plurality of locations and wherein the bend curve is adapted to: address abnormalities in alignment of the patient's spine, straighten abnormalities in alignment of the patient's spine, alter abnormalities in alignment of the patient's spine create a deformity in the patient's spine, lessen a deformity in the patient's spine, eliminate deformities in the patient's spine, impose changes in alignment of the patient's spine, add stress to the patient's spine, or reduce stress to the patient's spine; and (c) generating bending instructions for bends to be performed on the spinal rod (the Examiner notes that such steps are considered product-by-process).
Regarding claim 2, Dankowicz discloses wherein the spinal rod (element “R”) is for engagement (considered functional) to a plurality of pedicle screws (¶104) engaged within the patient's spine, each of the plurality of pedicle screws (¶104) having an engagement portion (¶104) for engagement with the spinal rod (element “R”), and wherein the plurality of bend points (elements 100) are further determined by (considered product-by-process) developing a curve function to approximate a desired location of each of the plurality of pedicle screws along the length.
Regarding claim 3, Dankowicz discloses wherein the plurality of bend points (elements 100) are further determined by (considered product-by-process) calculating a location of the spinal rod shaped according to the curve function at the desired location of each of the plurality of pedicle screws.
Regarding claim 4, Dankowicz discloses wherein the plurality of bend points (elements 100) are further determined by (considered product-by-process) calculating an error based on a difference in the calculated location of the spinal rod and the desired location of each of the plurality of pedicle screws and determining if the error exceeds a tolerance range.
Regarding claims 5, 6, Dankowicz discloses wherein the plurality of bend points (elements 100) are further determined by (considered product-by-process) eliminating bend points when the calculated error exceeds the tolerance range, wherein calculating the error comprises applying a least mean squares approach over all of the desired locations of each of the plurality of pedicle screws.
Regarding claims 7, 8, Dankowicz discloses wherein generating the bend curve includes generating a plurality of bend curves, and wherein each of the plurality of bend curves are in different non-coplanar planes, wherein generating the bend curve includes generating a plurality of bend curves, wherein at least two of the plurality of bend curves occur in planes orthogonal to one another (considered product-by-process).
Regarding claim 9, Dankowicz discloses a spinal rod (element “R”) (figure 2) for a patient's spine (¶39), the spinal rod (element “R”) having a length (figure 2) having one or more curves (¶42 and figures 1A, 1B) between a first end of the spinal rod (¶42 and figures 1A, 1B) and a second end of the spinal rod (¶42 and figures 1A, 1B), wherein the spinal rod (element “R”) is formed by (considered product-by-process): determining data representing a plurality of locations along the patient's spine; developing a curve function based on at least two of the plurality of locations along the patient's spine; generating a bend curve according to the curve function and having at least two bend points (elements 100) along the length of the spinal rod (¶42 and figures 1A, 1B), wherein the bend curve is based on the data representing the plurality of locations along the patient's spine, and wherein the bend curve is adapted to address abnormalities in alignment of the patient's spine, straighten abnormalities in alignment of the patient's spine, alter abnormalities in alignment of the patient's spine, create deformities in the patient's spine, lessen deformities in the patient's spine, eliminate deformities in the patient's spine, impose changes in alignment of the patient's spine, add stresses to the patient's spine, or reduce stresses to the patient's spine; generating bending instructions for bends to be performed on the spinal rod; and bending the spinal rod according to the bend instructions using a bending tool (the Examiner notes that such steps are considered product-by-process).
Regarding claim 10, Dankowicz discloses wherein the plurality of bend points (elements 100) are further determined by (considered product-by-process) calculating an error based on a difference between a calculated location of the spinal rod and a desired location of each of a plurality of pedicle screws and determining if such error exceeds a tolerance range.
Regarding claim 11, Dankowicz discloses wherein the plurality of bend points (elements 100) are further determined by (considered product-by-process) eliminating bend points when a calculated error exceeds the tolerance range.
Regarding claim 12, Dankowicz discloses wherein the spinal rod (element “R”) is configured to (i.e. capable of) be received in a channel of a head portion of one or more of the plurality of pedicle screws (¶104), and wherein the plurality of bend points (elements 100) are further determined by (considered product-by-process) determining a tolerance range based on a maximum angle through which the head portion may pivot relative to a bony structure of the patient's spine.
Regarding claim 13, Dankowicz discloses wherein the plurality of locations are based on anatomical points that must be avoided by the spinal rod when the spinal rod is engaged with the plurality of pedicle screws (considered product-by-process).
Regarding claim 14, Dankowicz discloses wherein the plurality of bend points (elements 100) are further determined by (considered product-by-process) applying a smoothing function to the curve function.
Regarding claim 15, Dankowicz discloses a spinal rod (element “R”) (figure 2) customized for a patient's spine (¶39), the spinal rod (element “R”) having a plurality of curves (¶42 and figures 1A, 1B) along a length of the spinal rod (¶42 and figures 1A, 1B), wherein the plurality of curves (¶42 and figures 1A, 1B) are determined by (considered product-by-process): generating the plurality of curves based on a desired location of at least one pedicle screw in the patient's spine, and wherein the plurality of curves are adapted to alter alignment of the patient's spine; and generating bending instructions for bends to be performed on the spinal rod by a bending tool to achieve the plurality of curves (the Examiner notes that such steps are considered product-by-process).
Regarding claim 16, Dankowicz discloses wherein generating the plurality of curves is based on digitized data of a location of the at least one pedicle screw (considered product-by-process).
Regarding claim 17, Dankowicz discloses wherein the plurality of curves are further determined by (considered product-by-process) developing a curve function to approximate the desired location of each of the at least one pedicle screw.
Regarding claim 18, Dankowicz discloses wherein the plurality of curves are further determined by (considered product-by-process) calculating a location of the spinal rod shaped according to the curve function at the desired location of the at least one pedicle screw.
Regarding claim 19, Dankowicz discloses wherein the plurality of curves are further determined by (considered product-by-process) calculating an error based on a difference in the calculated location of the spinal rod and the desired location of each of the at least one pedicle screw and determining if such error exceeds a tolerance range.
Regarding claim 20, Dankowicz discloses wherein the plurality of curves are further determined by (considered product-by-process) applying a smoothing function to the curve function.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,931,795. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims.
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775
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