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
Applicants’ election of Species DG (Figs. 20A-20B) in the reply filed on 06/25/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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: “cord-securing members” in claims 21, 33 and 38.
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.
Regarding the cord-securing members, paragraph [0202] discloses a needle ref. 2016 and a pin ref. 2018. Therefore, for purposes of examination, the structure configured to secure a flexible cord to the cord coupler is a pin or needle or functional 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 Objections
Claim 40 is objected to because of the following informalities: Claim 40, “within a tulip head” should read “within the tulip head”. 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 21 – 35 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 limitation “the cord coupler configured to receive a first portion of a first flexible cord” and “configured to receive a first portion of a second flexible cord”. Due to the language “configured to receive” it is understood that the first and second cord are not positively recited and not meant to be part of the claimed invention. However, claim 21 also recites “wherein the first and second flexible cords are distinct from one another” which is positively reciting the flexible cords and giving further distinctness to them. Therefore, it is unclear if the flexible cords are meant to be part of the claimed limitation or not. For purposes of examination the flexible cords are assumed to NOT be part of the claimed invention.
Claim 29 is rejected for the same reason and the first and second flexible cords are assumed to NOT be part of the claimed invention.
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.
Claim(s) 21 and 25 - 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hestad et al. (US 2009/0030464 A1).
Regarding claim 21, Hestad discloses a spinal stabilization apparatus (Abstract) fully capable for coupling portions of a flexible cord in a spinal stabilization system, the apparatus comprising:
a pair of bone anchors (Fig. 10B, ref. 14), each bone anchor including a tulip head (Fig. 10B, ref. 26);
a cord coupler (Fig. 10A, ref. 12) configured to couple the pair of bone anchors together (Fig. 11);
a first portion (one of ref. 54) of the cord coupler configured to receive a first portion of a first flexible cord (the first portion is shown receiving a first portion of a cord ref. 38, where the cord is fully capable of being flexible);
a second portion (the other one of ref. 54) of the cord coupler configured to receive a first portion of a second flexible cord (the second portion is shown receiving a first portion of a cord ref. 38, where the cord is fully capable of being flexible and Fig. 4 shows where the two cords may be separate); and
a pair of cord-securing members, each cord-securing member configured to secure a respective one of the first portions of the first and second flexible cords to the cord coupler (Figs. 10A – 11, ref. 54);
wherein the first and second flexible cords are distinct from one another (Fig. 4).
Regarding claim 25, Hestad discloses the apparatus of claim 21, wherein the cord coupler is configured to couple the first and second flexible cords together (Fig. 11).
Regarding claim 26, Hestad discloses the apparatus of claim 21, wherein the cord coupler is configured to be received within the tulip head of each of the pair of bone anchors (Fig. 11).
Regarding claim 27, Hestad discloses the apparatus of claim 26, wherein the cord coupler includes one or more notches configured to align with at least one of the tulip heads (the change in diameter between ref. 52 and 42, best shown in Fig. 10A is considered to be a notch).
Regarding claim 28, Hestad discloses the apparatus of claim 26, further comprising a set screw associated with at least one of the pair of bone anchors, the set screw configured to secure the cord coupler within the tulip heads (Fig. 11, ref. 30).
Regarding claim 29, Hestad discloses a spinal stabilization apparatus (Abstract) comprising:
a first bone anchor (Fig. 10B, ref. 20) including a first tulip head (ref. 26);
a second bone anchor including a second tulip head (Fig. 10B); and
a cord coupler (ref. 12) configured to couple a first flexible cord to a second flexible cord (Fig. 4), wherein the cord coupler comprises:
a first portion (one of ref. 52) configured to be received within the first tulip head and to receive and secure a first portion of the first flexible cord above the first bone anchor (Figs. 10B, 11); and
a second portion (the other one of ref. 52) configured to be received within the second tulip head and to receive and secure a first portion of the second flexible cord above the second bone anchor (Figs. 10B – 11), wherein the first flexible cord and the second flexible cord are distinct from one another (Fig. 4).
Regarding claim 30, Hestad discloses the apparatus of claim 29, further comprising a first set screw configured to secure the first portion of the cord coupler within the first tulip head (Fig. 11, ref. 30).
Regarding claim 31, Hestad discloses the apparatus of claim 30, further comprising a second set screw configured to secure the second portion of the cord coupler within the second tulip head (Fig. 11).
Regarding claim 32, Hestad discloses the apparatus of claim 29, wherein the cord coupler is configured such that the first flexible cord is secured to the first and second bone anchors and the second flexible cord is secured to the first and second bone anchors (Fig. 4).
Regarding claim 33, Hestad discloses the apparatus of claim 29, wherein the cord coupler includes a pair of cord- securing members configured to secure respective ones of the first portions of the first and second flexible cords (ref. 54).
Claim(s) 21, 23, 24, 27, 29, 33, 35 and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Belliard et al. (US 2016/0354118 A1).
Regarding claim 21, Belliard discloses a spinal stabilization apparatus (Abstract) for coupling portions of a flexible cord in a spinal stabilization system, the apparatus comprising:
a pair of bone anchors (Fig. 18A, ref. 12), each bone anchor including a tulip head (Fig. 2, ref. 14);
a cord coupler (Fig. 17, refs. 332, 24) configured to couple the pair of bone anchors together (Fig. 18A);
a first portion (one of ref. 332) of the cord coupler configured to receive a first portion of a first flexible cord (Fig. 18A, ref. 30);
a second portion (the other one of ref. 332) of the cord coupler configured to receive a first portion of a second flexible cord (the second portion is shown receiving a first portion of a cord ref. 30, where the cord is fully capable of being separate); and
a pair of cord-securing members, each cord-securing member configured to secure a respective one of the first portions of the first and second flexible cords to the cord coupler (Fig. 17, ref. 350);
wherein the first and second flexible cords are distinct from one another (the stabilization apparatus is fully capable of receiving two distinct cords).
Regarding claim 23, Belliard discloses the apparatus of claim 21, wherein each of the pair of cord-securing members comprises a pin (ref. 350) configured to retain the respective first portion of the first and second flexible cords (Fig. 18A).
Regarding claim 24, Belliard discloses the apparatus of claim 23, wherein each pin is a blunt-tipped element (Fig. 18A).
Regarding claim 27, Belliard discloses the apparatus of claim 26, wherein the cord coupler includes one or more notches configured to align with at least one of the tulip heads (Fig. 17, the notch is considered to be the portion between ref. 334 and 336).
Regarding claim 29, Belliard discloses a spinal stabilization apparatus (Abstract) comprising:
a first bone anchor (Fig. 18A, ref. 12) including a first tulip head (ref. 14);
a second bone anchor including a second tulip head (Fig. 18A); and
a cord coupler (refs. 24, 332) configured to couple a first flexible cord to a second flexible cord (the cord couple is fully capable of coupling two flexible cords ref. 30 to one another), wherein the cord coupler comprises:
a first portion (one of ref. 332) configured to be received within the first tulip head and to receive and secure a first portion of the first flexible cord above the first bone anchor (Fig. 18A); and
a second portion (the other one of ref. 332) configured to be received within the second tulip head and to receive and secure a first portion of the second flexible cord above the second bone anchor (Fig. 18A), wherein the first flexible cord and the second flexible cord are distinct from one another (the cords are fully capable of being distinct or separate).
Regarding claim 33, Belliard discloses the apparatus of claim 29, wherein the cord coupler includes a pair of cord- securing members configured to secure respective ones of the first portions of the first and second flexible cords (ref. 350).
Regarding claim 35, Belliard discloses the apparatus of claim 33, wherein each of the pair of cord-securing members comprises a pin (ref. 350, paragraph [0109]).
Regarding claim 36, Belliard discloses the apparatus of claim 29, wherein the cord coupler is formed from a material selected from the group consisting of a metal, a metallic alloy, a polymer, and a rubber (paragraph [0073] discloses metal).
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) 22 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belliard et al. (US 2016/0354118 A1) in view of Rawlinson et al. (US 2020/0345397 A1).
Regarding claim 22, Belliard discloses the apparatus of claim 21, except wherein each of the pair of cord-securing members comprises a needle configured to engage the respective first portions of the first and second flexible cords.
Regarding claim 34, Belliard discloses the apparatus of claim 33, except wherein each of the pair of cord-securing members comprises a needle.
Rawlinson teaches a spinal implant system (Abstract) comprising a flexible cord (ref. 20) and a cord-securing member (Fig. 4, ref. 184) wherein the cord-securing member is a needle (Figs. 4 – 5). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cord-securing member of Belliard to be a needle, as taught by Rawlinson, for the purpose of partially penetrating the cord to better secure it (paragraph [0052]).
Claim(s) 37 - 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hestad et al. (US 2009/0030464 A1) in view of Belliard (US 2016/0354118 A1).
Regarding claim 37, Hestad discloses a method of coupling cords in a spinal stabilization procedure, comprising:
providing a cord coupler (Fig. 5, ref. 40);
positioning a first bone anchor (ref. 20) in a first vertebra and a second bone anchor in a second vertebra (Fig. 6 shows multiple bone anchors configured to be inserted into a vertebra), each bone anchor including a tulip head (ref. 26);
placing a first portion of a first cord into the cord coupler (Fig. 5);
placing a first portion of a second flexible cord into the cord coupler (Fig. 5);
securing the first portion of the first flexible cord and the first portion of the second flexible cord to the cord coupler (paragraph [0035]); and
wherein the first cord and the flexible cord are distinct from one another (Fig. 5).
Hestad is silent that the cord is a flexible cord and a first and second portion of the cord coupler and the step of securing the cord coupler within a tulip head of at least one of the bone anchors.
Hestad in a different embodiment discloses a first and second portion of a cord-coupler (Figs. 10A-11, ref. 52 or Fig. 12, ref. 42) configured to be received within tulip portions of the bone anchor. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hestad such that the cord coupler comprises a first and second portion which are secured within the tulip heads for the purpose of achieving a stable multi-level construct (paragraph [0039]).
Belliard teaches an analogous spinal stabilization apparatus (Abstract) comprising a flexible cord (ref. 30, paragraph [0072]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cord of Hestad to be a flexible cord, as taught by Belliard, for the purpose of reduced biomechanical stress on the spine due to flexible cord absorbing movement and distributing forces.
Regarding claim 38, Hestad in view of Belliard discloses the method of claim 37, wherein securing the first portion of the first flexible cord and the first portion of the second flexible cord to the cord coupler comprises securing the first portion of the first flexible cord and the first portion of the second flexible cord using a pair of cord-securing members (Hestad, Fig. 10B, ref. 54).
Regarding claim 39, Hestad in view of Belliard discloses the method of claim 38, wherein each of the pair of cord-securing members comprises a set screw (ref. 54), but is silent that the cord-securing members comprises one of a needle or pin.
Belliard teaches a pair of cord-securing members (ref. 350), wherein the cord-securing members are a pin (paragraph [0109]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the set screw of Hestad for the pin of Belliard to better penetrate the flexible cord.
Regarding claim 40, Hestad in view of Belliard discloses the method of claim 37, wherein securing the cord coupler within a tulip head of at least one of the bone anchors comprises securing the cord coupler using a set screw (Hestad, Fig. 10B, ref. 30).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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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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/TESSA M MATTHEWS/Examiner, Art Unit 3773
