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 .
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. The limitation from claim 5, “wherein the pedicle screw comprises at least two additional fenestrations positioned along the cylindrical body”, is not presented in any of the figures of 3/24/2025. Furthermore, the Specification does not appear to provide support for this limitation in combination with other required elements of claim 5 (i.e., “an internal divider fluidly separating a first chamber comprising the first fenestration and a second chamber comprising the second fenestration, wherein the internal divider is configured to ensure bone cement introduced into the first chamber only exits out of the first fenestration and bone cement introduced into the second chamber only exits out of the second fenestration”). This 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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 5 recites “wherein the pedicle screw comprises at least two additional fenestrations positioned along the cylindrical body”. Support for the embodiment of claim 1 (from which claim 5 is dependent from) is found in paragraph 73 of the Specification figure 14 of the Drawings. A careful review of these sections only appears to only show support for “first” and “second” fenestrations 1408 and 1409. The embodiment described in figure 13 shows additional fenestrations but this figure and accompanying text (paragraphs 69-72) do not provide support for the other required limitations of claim 5 (e.g., “an internal divider fluidly separating a first chamber comprising the first fenestration and a second chamber comprising the second fenestration, wherein the internal divider is configured to ensure bone cement introduced into the first chamber only exits out of the first fenestration and bone cement introduced into the second chamber only exits out of the second fenestration”). Note that the embodiment of figure 15 is similar to that of figure 13 in that, while providing support for more fenestrations, this embodiment also does not contain the internal divider and chambers as required in claim 5. As best understood, claim 5 appears to be a mixed combination of the embodiments depicted in figures 13 and 14 without any corresponding text within the Specification to support this combination.
EXAMINER’S COMMENT
There does not appear to be any overlapping subject matter requiring a Double Patenting rejection with regard to US Patents 11839414 and 12059181 or Application 18/756733 at this time.
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(s) 1-3, 6, 7, 13-15, 17 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-24 of U.S. Patent No. 12274477 in view of Poulos (US 9326801).
With respect to claim 1, Hyman (US Patent 12274477) teaches a pedicle screw for use in a spine stabilization procedure (see claims 18-24), the pedicle screw comprising: a threaded portion positioned along at least a part of the cylindrical body (see para. 18-24, note that a screw contains threads); a first fenestration positioned along the cylindrical body (see claims 18-24); a second fenestration positioned along the cylindrical body (see claims 18-24); and an internal divider fluidly separating a first chamber comprising the first fenestration and a second chamber comprising the second fenestration (see claims 18-24), wherein the internal divider is configured to ensure bone cement introduced into the first chamber only exits out of the first fenestration and bone cement introduced into the second chamber only exits out of the second fenestration (see claims 18-24).
As for claim 2, Hyman (US Patent 12274477) teaches the pedicle screw of claim 1, wherein the internal divider includes an internal cannulation that is configured to receive a wire passing through the pedicle screw (see claim 19).
As for claim 3, Hyman (US Patent 12274477) teaches the pedicle screw of claim 2, wherein internal cannulation is fluidly separated from the first chamber and the second chamber (see claim 19).
As for claim 13, Hyman (US Patent 12274477) teaches the kit for performing a spine stabilization procedure (see claims 19-20), the kit comprising: a balloon-tipped cannula having an expandable balloon enclosed by an expandable metal mesh (see claims 19-20), the balloon-tipped cannula configured to pass through a working sleeve and to expand the expandable balloon and expandable metal mesh within a surgical site (see claims 19-20); and a pedicle screw as in claim 1 to be inserted into the surgical site (see claims 19-20); and an injection system (claims 19-20) configured to supply bone cement to the surgical site through of at least one fenestration or cannulation of the pedicle screw when the pedicle screw is positioned within the injection site (claims 19-20).
As for claim 14, Hyman (US Patent 12274477) teaches the kit of claim 13 further comprising: an injection system configured to supply bone cement to the surgical site through at least one of the first fenestration and the second fenestration of the pedicle screw when the pedicle screw is positioned within the injection site (see claims 19-20).
As for claim 15, Hyman (US Patent 12274477) teaches the kit of claim 13, wherein the injection system comprises a bone cement cannula configured to be inserted through a cannulated screwdriver (see claim 20).
As for claim 18, Hyman (US Patent 12274477) teaches the kit of claim 13 further comprising an inflation device configured to apply an expansion pressure to the balloon-tipped cannula (see claims 19-20).
Hyman does not appear to teach the pedicle screw comprising a cylindrical body and a drill coupling member positioned at a first end of the cylindrical body (claim 1); wherein the pedicle screw is threaded along the entire length of the cylindrical body (claim 6); wherein the drill coupling comprises a hexalobular socket (claim 7); a source of bone cement (claim 17).
Poulos, also drawn to fillable pedicle screws, teaches pedicle screw (1) comprising a cylindrical body (see fig. 4 below) and a drill coupling member (17) positioned at a first end of the cylindrical body (see fig. 4 below); wherein the pedicle screw is threaded along the entire length of the cylindrical body (see fig. 2); wherein the drill coupling comprises a hexalobular socket (see fig. 4 below); and a source of bone cement (see fig. 25-26) in order to provide a known pedicle screw body configuration that will allow easy and stable receipt of a driving tool and bone cement (see col. 7 lines 54-63 and abstract).
PNG
media_image1.png
388
526
media_image1.png
Greyscale
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hyman with the pedicle screw comprising a cylindrical body and a drill coupling member positioned at a first end of the cylindrical body, and a source of bone cement, in view of Poulos, in order to provide a known pedicle screw body configuration that will allow easy and stable receipt of a driving tool and bone cement.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Sawa (US 20100106199).
With respect to claim 1, Sawa discloses a pedicle screw (11) for use in a spine stabilization procedure (see para. 4 and interpretations in annotated fig. 1 and 1A below), the pedicle screw comprising: a cylindrical body (see fig. 1 and 1A below); a threaded portion positioned along at least a part of the cylindrical body (see fig. 1 and 1A below); a drill coupling member (33) positioned at a first end of the cylindrical body (see para. 18 and also fig. 1 and 1A below); a first fenestration (e.g., 14 or 16) positioned along the cylindrical body (see fig. 1 and fig. 1A below); a second fenestration (e.g., 16 or 16, see fig. 1 and 1A below) positioned along the cylindrical body; and an internal divider (e.g., space in head between 18 and 12 or 12, see fig. 1 and 1A below) fluidly separating a first chamber (e.g., 12 or 18, see fig. 1 and 1A below) comprising the first fenestration and a second chamber (e.g., 18 or 18, see fig. 1 and 1A below) comprising the second fenestration, wherein the internal divider is configured to ensure bone cement introduced into the first chamber only exits out of the first fenestration (see fig. 1 and 1A below) and bone cement introduced into the second chamber only exits out of the second fenestration (see fig. 1 and 1A below and note that this device is capable of performing this function if one so desires).
PNG
media_image2.png
591
996
media_image2.png
Greyscale
PNG
media_image3.png
487
729
media_image3.png
Greyscale
As for claim 2, Sawa further discloses the pedicle screw of claim 1, wherein the internal divider includes an internal cannulation that is configured to receive a wire passing through the pedicle screw (see para. 20).
As for claim 3, Sawa further discloses the pedicle screw of claim 2, wherein internal cannulation is fluidly separated from the first chamber and the second chamber (see fig. 1A above).
As for claim 4, Sawa further discloses the pedicle screw of claim 1, wherein the first fenestration and the second fenestration are positioned at a same axial position on opposite sides of the cylindrical body (see fig. 1A above).
As for claim 5, Sawa further discloses the pedicle screw of claim 1, wherein the pedicle screw comprises at least two additional fenestrations (e.g., 14 or 16, respectively) positioned along the cylindrical body (see fig. 1 and 1A above).
As for claim 6, Sawa further discloses the pedicle screw of claim 1, wherein the pedicle screw is threaded along the entire length of the cylindrical body (see fig. 1 and 1A above).
As for claim 7, Sawa further discloses the pedicle screw of claim 1, wherein the drill coupling comprises a hexalobular socket (see para. 18).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 8, 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sasso (US 20040225292) in view of Teisen (US 20090125028).
With respect to claim 8, Sasso teaches a pedicle screw (10) for use in a spine stabilization procedure (see fig. 5 below), the pedicle screw comprising: a cylindrical body (see fig. 5 below); a threaded portion positioned along at least a part of the cylindrical body (see fig. 5 below); a drill coupling member (44) positioned at a first end of the cylindrical body; a first fenestration (e.g., any of 32) positioned along the cylindrical body (see fig. 5 below, also note para. 25 which states that fenestration openings 32 may be disposed along the entire length of the bone engaging portion 12).
PNG
media_image4.png
466
904
media_image4.png
Greyscale
While Saaso teaches the use of bone cement (88) through the fenestrations (32) for the creation of a cement bone anchor (mantle M) about the threaded shank (20) to enhance engagement of the screw to the vertebra (see para. 46 and also fig. 5 above), Sasso does not teach an expandable balloon attached to the cylindrical body and covering the first fenestration, wherein the expandable balloon is configured to expand when bone cement exits the first fenestration.
Teisen, also drawn to pedicle screws anchored with bone cement (see abstract), teaches a hybrid implant incorporating a balloon to any location on the screw (see fig. 1a, 1b, 7a, 7b), specifically, an expandable balloon (e.g., 40) attached to the cylindrical body (see fig. 1b), wherein the expandable balloon is configured to expand when bone cement is inserted therethrough (see para. 30) in order to provide the same function of using bone cement for better anchoring/ fixation of the screw to bone, while providing the additional benefit of increased targeted anchoring with use of the combination of the bone cement and balloon to contain and direct this anchoring (see para. 3 and 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Sasso to include an expandable balloon attached to the cylindrical body and covering the first fenestration, wherein the expandable balloon is configured to expand when bone cement exits the first fenestration, in view of Teisen, in order to provide the same function of using bone cement for better anchoring/ fixation of the screw to bone, while providing the additional benefit of increased targeted anchoring with use of the combination of the bone cement and balloon to contain and direct this anchoring.
As for claim 11, Sasso, as modified by Teisen, further teaches the pedicle screw of claim 8, wherein the pedicle screw comprises at least one additional fenestration positioned along the cylindrical body (see fig. 5 above).
As for claim 12, Sasso, as modified by Teisen, further teaches the pedicle screw of claim 8, wherein the drill coupling comprises a hexalobular socket (see para. 28).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sasso (US 20040225292) and Teisen (US 20090125028), as applied to claim 8 above, in view of Spedden (US 20100125240).
As for claim 9, Sasso, as modified by Teisen, does teach the use of a variety of balloon materials (see para. 40 of Teisen), including polymers, but does not appear to teach wherein the expandable balloon is dissolvable.
Spedden, also drawn to balloons (i.e., plugs) used with bone screws (see para. 131) teaches a variety balloon materials including material that is dissolvable (see para. 131) in order to provide a known polymer material that is not only biocompatible but also biodegradable in order to provide better integration of the implant to the bone as using a specific material to impart a certain functional result is a well-known practice in the art (see para. 131).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Sasso, as modified by Teisen, wherein the expandable balloon is dissolvable, in view of Spedden, as a matter of engineering design choice, in order to provide better integration of the implant to the bone as using a specific material to impart a certain functional result is a well-known practice in the art.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sasso (US 20040225292) and Teisen (US 20090125028), as applied to claim 8 above, in view of Lovoi (US 20090209803).
As for claim 10, Sasso, as modified by Teisen, does not appear to teach the connector between the pedicle screw and balloon, specifically, wherein the expandable balloon is connected to the pedicle screw through one or more O-ring seals.
Lovoi, also drawn to surgical balloons (see abstract), teaches the use of one or more O-ring seals (see para. 32) between two elements in order to provide a conventional sealing mechanical connector that can be used for fluid control between the elements (see para. 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Sasso, as modified by Teisen, wherein the expandable balloon is connected to the pedicle screw through one or more O-ring seals, in view of Lovoi, in order to provide a conventional sealing mechanical connector that can be used for fluid control between the elements.
Claim(s) 13-15, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sawa (US 20100106199), as applied to claim 1 above, in view of Teisen (US 20090125028).
As for claims 13-15, 17 and 18, Sawa further teaches a kit (see fig. 2) including a pedicle screw as in claim 1 to be inserted into the surgical site (see fig. 1 above); and an injection system (e.g., 19) configured to supply bone cement to the surgical site through of at least one fenestration or cannulation of the pedicle screw when the pedicle screw is positioned within the injection site (see fig. 2); an injection system (e.g., at 21) configured to supply bone cement to the surgical site through at least one of the first fenestration and the second fenestration of the pedicle screw when the pedicle screw is positioned within the injection site (see fig. 2, para. 16-17); wherein the injection system comprises a bone cement cannula (e.g., syringe) configured to be inserted through a cannulated screwdriver (see fig. 2, para. 16-17 and note that this device is capable of performing this function and that the cannulated screwdriver is not positively recited); further comprising a source of bone cement (e.g., at 21 and/or syringe, see para. 16-17).
Sawa does not teach the kit comprising: a balloon-tipped cannula having an expandable balloon enclosed by an expandable metal mesh, the balloon-tipped cannula configured to pass through a working sleeve and to expand the expandable balloon and expandable metal mesh within a surgical site; further comprising an inflation device configured to apply an expansion pressure to the balloon-tipped cannula.
Teisen, also drawn to pedicle screws anchored to bone using bone cement, teaches the use of a balloon-tipped cannula having an expandable balloon (see para. 36) enclosed by an expandable metal mesh (40) (see para. 30, 36), the balloon-tipped cannula configured to pass through a working sleeve and to expand the expandable balloon and expandable metal mesh within a surgical site (see para. 30, 36- note that this device is capable of performing this function if one so desires and the working channel is not positively recited); further comprising an inflation device configured to apply an expansion pressure to the balloon-tipped cannula (see para. 36) in order to provide a known expansion mechanism that will expand a desired cavity or compact the bone into which the screw is affixed (see para. 30, 36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Sawa to include a balloon-tipped cannula having an expandable balloon enclosed by an expandable metal mesh, the balloon-tipped cannula configured to pass through a working sleeve and to expand the expandable balloon and expandable metal mesh within a surgical site; further comprising an inflation device configured to apply an expansion pressure to the balloon-tipped cannula, in view of Teisen, in order to provide a known expansion mechanism that will expand a desired cavity or compact the bone into which the screw is affixed.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sawa (US 20100106199) and Teisen (US 20090125028), as applied to claim 13 above, in view of Sweeny (US 20050015060).
As for claim 16, Sawa, as modified by Teisen, does not appear to teach further comprising one or more additional pedicle screws, wherein each pedicle screw has a different axial length.
Sweeny, also drawn to kits for delivering fluids to bone through screws, teaches the kit comprising one or more additional similar elements (e.g., 2300, 2310) of different axial length (see para. 65) in order to provide adaptation for different sized configurations based one the procedure (see para. 65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Sawa, as modified by Teisen, with the kit further comprising one or more additional pedicle screws, wherein each pedicle screw has a different axial length, in view of Sweeny, as providing similar elements in a variety of sizes in order to provide adaptation for different sized configurations based one the procedure, is a well-known feature of kits in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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, please contact the examiner’s supervisor, Eduardo Robert, 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.
/TARA ROSE E CARTER/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
Prosecution Insights