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 remain objected to as failing to comply with 37 CFR 1.84(p)(4) because the following reference characters each designate different features of the invention:
Reference character “10” has been used to designate both a rod (i.e., member connecting pedicle screws; Fig. 1-11, 14 and 15) and a locking instrument (Fig. 12A).
Reference character “40” has been used to designate both a female coupler (Figs. 6-11, 14 and 15) and a sphere of a locking instrument (Fig. 12A).
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. 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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“driving feature” (i.e., a feature or means for driving) in claims 1 and 5.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. These are understood to include features such as a hexalobe or “any other driving feature”. . . “including one or more features along the rim of the head” (e.g., paras. 0052 and 0054), and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
Claims 5 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ritland (2003/0093078).
Regarding claim 5, Ritland discloses a coupling assembly (Figs. 1b and 30, and annotated Fig. 30, below) comprising:
a pedicle screw 10 comprising:
a threaded shaft 18; and
a head portion 20 comprising:
a driving feature (e.g., a surface of the head or a surface along the rim of the head)
capable of being driven by a tool (e.g., pliers or forceps), if desired;
an external bore-engaging surface (see annotated Fig. 30) defining an external diameter of the head portion 20; and
a proximally oriented screw bore 22 having a proximal portion defining an opening 24 (Figs. 1b and 30) having a continuous perimeter (Fig. 1b) with a first, narrower internal width w and a medial portion with a second, broader internal width W (see annotated Fig. 30) and
a member 202/200 (Fig. 31) adapted to extend between adjacent pedicle screws 10 (id.), the member comprising:
a female member 100 comprising a receiving bore 104 (Fig. 30) adapted to receive the head portion 20 of the pedicle screw 10. The receiving bore has a first inner diameter (i.e., d) and a second inner diameter (e.g., w, of opening 56; Fig. 26) that is smaller than the first inner diameter, wherein the first inner diameter d is smaller than the external diameter D of the head portion but still large enough to allow the bore to elastically deform to accommodate the head portion of the pedicle screw in a press-fit (Fig. 30, para. 0126).
Regarding claim 6, the continuous perimeter of the opening 24 is generally circular (Fig. 1b).
PNG
media_image1.png
310
534
media_image1.png
Greyscale
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 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) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (CA-2650223-A1) in view of Hayes et al. (2008/0097441).
Regarding claim 1, Kim discloses a coupling assembly (Fig. 35) comprising:
a first pedicle screw 922, 926, 932 comprising:
a threaded shaft 922; and
a head portion 926, 932 comprising:
a driving feature (e.g., a surface of the head portion or a surface along a rim of the head) capable of being driven by a tool (e.g., pliers or forceps), if desired; and
a proximally oriented bore (i.e., upper portion of 932); and
a member 946 adapted to extend between the first pedicle screw and a second pedicle screw (Fig. 35), the member comprising:
a first protrusion 942 adapted for insertion into the bore (supra) of the first pedicle screw, the protrusion having a protrusion diameter that is larger than a portion of the proximally oriented bore (Fig. 35).
Kim does not explicitly recite a cannula extending through the first protrusion, the cannula being configured to receive a component for guiding insertion of the first protrusion into the bore of the first pedicle screw.
Hayes et al. disclose a coupling assembly (Fig. 13A) and teach a cannula 246 extending through desired portions of the device (e.g., 200, 238; para. 0092), including a first protrusion 245, for guiding insertion of the first protrusion into a bore (central opening of 226) of a pedicle screw 222, 226 along a guidewire and facilitating installation of the assembly (Fig. 13A; para. 0092).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the coupling assembly of Kim with a cannula extending through the first protrusion, the cannula being configured to receive a component, i.e., a guidewire, for guiding insertion of the first protrusion into the bore of the first pedicle screw, in view of Hayes et al., to facilitate installation of the assembly.
Regarding claim 2, a distal end portion of the first protrusion 942 that is configured to be received within a distal end portion of the proximally oriented bore (upper portion of 932) and a distal end portion of the first protrusion comprise a contiguous surface (Fig. 35).
Regarding claim 3, the first protrusion 942 is integrally coupled to a first end portion of the member 946 (Fig. 35; para. 0232, discussing ball-shaped ends 942 and 944 of rod 946).
Regarding claim 4, the member 946 further comprises a second protrusion 944 that is integrally coupled to a second end portion of the member 946 (id.).
Double Patenting
Claims 5 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,514,616.
Regarding independent application claim 5, issued patent claim 11 discloses a coupling assembly comprising:
a pedicle screw comprising:
a threaded shaft; and
a head portion comprising:
a driving feature;
an external bore-engaging surface defining an external diameter of the head portion; and
a proximally oriented screw bore having a proximal portion defining an opening having a continuous perimeter with a first, narrower internal width and a medial portion with a second, broader internal width; and
a member adapted to extend between adjacent pedicle screws, the member comprising:
a female member comprising a receiving bore adapted to receive the head portion of the pedicle screw, the receiving bore having an inner diameter that is smaller than the external diameter of the head portion. It is noted that the relative diameters and language pertaining to deformation and a press-fit is considered to be satisfied by the receiving bore of the female member having an inner diameter that is smaller than a diameter of the head portion, resulting in the press-fit configuration.
Regarding application claim 6, issued patent claim 11 also discloses wherein the continuous perimeter of the opening is generally circular.
Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,514,616 in view of Hayes et al. (2008/0097441).
Regarding application independent claim 1, issued patent claim 1 discloses a coupling assembly comprising:
a first pedicle screw comprising:
a threaded shaft; and
a head portion comprising:
a driving feature; and
a proximally oriented bore; and
a member adapted to extend between the first pedicle screw and a second pedicle screw, the member comprising:
a (first) protrusion adapted for insertion into the bore of the first pedicle screw, the protrusion having a protrusion diameter that is larger than a portion of the proximally oriented bore.
Issued patent claim 1 does not recite a cannula extending through the first protrusion, the cannula being configured to receive a component for guiding insertion of the first protrusion into the bore of the first pedicle screw.
Hayes et al. disclose a coupling assembly (Fig. 13A) and teach a cannula 246 extending through desired portions of the device (e.g., 200, 238; para. 0092), including a first protrusion 245, for guiding insertion of the first protrusion into a bore (central opening of 226) of a pedicle screw 222, 226 along a guidewire and facilitating installation of the assembly (Fig. 13A; para. 0092).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the coupling assembly of issued patent claim 1 with a cannula extending through the first protrusion, the cannula being configured to receive a component, i.e., a guidewire, for guiding insertion of the first protrusion into the bore of the first pedicle screw, in view of Hayes et al., to facilitate installation of the assembly.
Regarding application claim 2, issued patent claim 1 as modified (supra) also discloses wherein a distal end portion of the first protrusion is configured to be received within a distal end portion of the proximally oriented bore comprises a contiguous surface.
Claims 3 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of the issued patent in view of Hayes et al. (supra), as applied above, further in view of Kim (CA-2650223-A1).
Regarding application claims 3 and 4, claim 1 of the issued patent as modified by Hayes et al. (supra) recites the claimed invention except for the first protrusion being integrally coupled to a first end portion of the member (claim 3), and except for a second protrusion integrally coupled to a second end portion of the member (claim 4).
Kim discloses a coupling assembly of a spinal stabilization device 920 (Fig. 35) wherein a member 946 comprises a first protrusion 942 integrally coupled to a first end portion of member 946 (claim 3), and a second protrusion 944 integrally coupled to a second end portion of the member 946 (claim 4). The integral coupling provides stable support for the protrusions and the member and does not require assembly thereof.
It would have been further obvious to a person having ordinary skill in the art to have integrally coupled the first and second protrusions to the first and second end portions, respectively, in view of Kim, to provide stable support for the protrusions and the member and to not require assembly thereof.
Response to Arguments
Applicant's arguments filed 03 August 2026 have been fully considered but they are not persuasive.
Regarding the replacement drawings filed 03 August 2026, it is noted that not all necessary corrections were made (see objection above).
The amended abstract is accepted.
Applicant's arguments regarding the rejections under 35 U.S.C. 102(a)(1) fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
The amended claims stand rejected as set forth above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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.
DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
Prosecution Insights