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
Applicant’s election without traverse of Species B (Figs. 4 – 4E) in the reply filed on 04/27/2026 is acknowledged.
Claim 8 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/27/2026.
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: “biasing members” in claims 1 and 17.
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 biasing members, paragraph [0100] discloses a pin spring ref. 204. Therefore, for purposes of examination, the structure determined sufficient to perform the function of biasing the piston towards the ring and into the head cavity is a pin and spring system 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 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) 1 – 2, 4 – 7, 11 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doubler (US 2019/0175224 A1).
Regarding claim 1, Doubler discloses a modular screw for a vertebral fixation system (Abstract), comprising:
a housing assembly, comprising:
a housing (ref. 28, paragraph [0088]) including a base (bottom portion and ref. 30) and at least one arm (refs. 31, 33), wherein the base and the at least one arm define a head cavity (Fig. 26 shows a head cavity in a distal portion), a piston cavity (Fig. 26 shows a piston cavity to hold piston/insert), and a channel able to receive a stabilization member (Fig. 26);
a piston (ref. 82) installed within the piston cavity and at least partially extending into the head cavity (Figs. 10 – 11);
a ring installed within the head cavity (either of refs. 34, 40a, 40b may be considered a ring); and
one or more biasing members that bias the piston toward the ring and into the head cavity (Fig. 19, ref. 100, paragraph [0100]); and
a fastener (ref. 18, Fig. 19) comprising a shank (Fig. 21, ref. 12) and a head (ref. 17), wherein the head is insertable into the head cavity via a bottom-loading of the head into the head cavity through a head aperture at a distal end of the housing (Abstract).
Regarding claim 2, Doubler discloses the modular screw of claim 1, wherein the one or more biasing members causes the piston to be biased toward the distal end of the housing absent an application of force to the piston by the head of the fastener (paragraph [0100]), wherein the ring is held in a first position by the piston prior to an application of force by the head on the piston (any of the disclosed rings may be held in a friction fit of the components), wherein the ring is released by the piston following an application of force by the head on the piston and engages the head, and wherein the ring engaging the head prevents removal of the head from the distal end of the housing (when the head is moved upwards, the rings are able to move into different positions in their respective channels, and when all components are working together the head is not able to be removed without an outside force).
Regarding claim 4, Doubler discloses the modular screw of claim 1, wherein the one or more biasing members comprises a spring inserted within the housing (Fig. 21) and engages the piston, wherein the spring is inserted at an oblique angle relative to a longitudinal axis through the housing (Fig. 21).
Regarding claim 5, Doubler discloses the modular screw of claim 1, wherein the piston comprises:
a first portion to engage with the one or more biasing members (Fig. 21, top portion); and
a second portion to engage with at least one of the ring and the head (Fig. 21, bottom portion).
Regarding claim 6, Doubler discloses the modular screw of claim 1, wherein the ring is a c-ring (Fig. 5 shows a c-ring).
Regarding claim 7, Doubler discloses the modular screw of claim 1, wherein the modular screw is configured for polyaxial movement of the housing relative to the head of the fastener (Title).
Regarding claim 11, Doubler discloses the modular screw of claim 1, being usable as a component of the vertebral fixation system with at least one of a set screw and a stabilization member that are each insertable into the housing (the modular screw is fully capable of being used in system as described due to the receiver channel).
Regarding claim 16, Doubler discloses a method, comprising:
providing a housing assembly (receiver and related components, ref. 28, paragraph [0090]) and a fastener of a modular screw (Fig. 19, ref. 18), the housing assembly comprising a piston (ref. 82) within a housing (Fig. 23) including a base (bottom portion to receive the head of the fastener) and at least one arm that define a head cavity (Fig. 21), a piston cavity (Fig. 21), and a channel able to receive a stabilization member (Fig. 26 shows the channel receiving a stabilization member ref. 70), the fastener comprising a shank (ref. 14) and a head (at ref. 17, Fig. 23); and
inserting at least a portion of the head of the fastener into the head cavity of the housing via bottom-loading into a head aperture at a distal end of the housing (Title, Fig. 21),
wherein engagement of interlocking features within the head cavity of the housing post- insertion of the at least a portion of the head of the fastener into the head cavity of the housing prevents removal of the head from the distal end of the housing (lower rings, refs. 40, 40’ would prevent removal).
Allowable Subject Matter
Claims 3, 10 and 17 - 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 12 - 15 allowed.
The following is a statement of reasons for the indication of allowable subject matter: Claims 12 - 15 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found to disclose, or suggest a modular screw comprising: the limitations of claim 23 and most notably a ring positioned within the head cavity and a least one biasing member configured to bias the piston toward the head cavity and a locking assembly comprising a least one member within a respective member channel in the housing assembly and at least one pin corresponding to a respective member of the at least one member.
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.
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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/TESSA M MATTHEWS/Examiner, Art Unit 3773
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