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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/847,613, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed application fails to provide support for the first and second outwardly projecting tabs facing away from each other (claim 24).
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: the first and second outwardly projecting tabs facing away from each other (claim 24).
Drawings
The drawings were received on August 3, 2026. These drawings have not been entered as they have not been submitted as a separate document but instead have been submitted as an appendix interspersed with annotated drawings.
The drawings are objected to because the figures appear to be distorted (drawings filed on September 23, 2024) compared to the figures provided in the parent. 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.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first and second outwardly projecting tabs facing away from each other (claim 24) 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 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: “securing element” in claims 21-24 and 26-38; and “stop” in claims 36 and 37. The securing element is described as a wire/pin (see “50” in Figs. 2 and 8). The stop is described as a surface that abuts the securing element (see “46” and “48” in Figs. 6 and 8).
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.
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 § 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.
Claim 24 is 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. It is unclear how the first and second outwardly projecting tabs face each other as the figures appear to show the first and second outwardly projecting tabs (tabs 34 and 36 in Figs. 2-4; tabs 134 and 136 in Figs. 15-17) facing away from each other. Furthermore, because the outwardly projecting tabs project outward from a post (end 64 in Figs. 2-4; end 164 in Figs. 15-17), it is unclear how they would be capable of facing each other. Because the figures show the outwardly projecting tabs facing away from each other, the Examiner has interpreted claim 24 as reciting such.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21-40 are rejected under 35 U.S.C. 103 as being unpatentable over Rawlins et al. (US 2006/0247628 A1) in view of Dickinson et al. (US 2013/0211456 A1).
Claim 21. Rawlins discloses a spinal implant system comprising:
bone screws (screw 22 and connector 34 is one bone screw; screw 24 and connector 36 is a second bone screw);
a spinal rod (rod 18) disposed with the bone screws;
an additional screw (screw 26); and
a spinal implant (connector 38) comprising a post (plate member 46) and a connector (housing member 50), an end (end portion 46b) of the post being attached with the additional screw, the post comprising a receiver (end portion 46a) that is attached with the connector, the receiver including an inner tab (countersunk portion 46f, which projects inwardly toward the center of countersunk bore 46e as shown in Fig. 4 and thus is a tab), the connector including an outwardly projecting tab (increased-size distal end portion 50h, which projects outwardly from arm 50f as shown in Fig. 4 and thus is a tab) that is configured for engagement with the inner tab, the connector defining a passageway (space between arms 50f and 50g that receives clip member 52) and an implant cavity (through-opening 50b), the spinal rod being disposed in the implant cavity, the spinal implant comprising a securing element (legs 52b and 52c of clip member 52) disposable in the passageway and engageable with the inner tab (see para. 0027, which states that legs 52b and 52c engage surface 46l) (Figs. 1-4).
Claim 22. Rawlins discloses a setscrew (set screw 54) that is threaded with threads (threads of bore 50c) of the connector to fix the spinal rod with the connector (Figs. 1-4).
Claim 24. Rawlins discloses wherein the outwardly projecting tab includes a first outwardly projecting tab (increased-size distal end portion 50h) and a second outwardly projecting tab (increased-size distal end portion 50i) that faces away from the first outwardly projecting tab (Figs. 1-4).
Claim 25. Rawlins discloses wherein the securing element is a wire (legs 52b and 52c) (Figs. 1-4).
Claim 26. Rawlins discloses wherein the passageway extends transverse to a longitudinal axis (unlabeled axis extending through housing member 50 as shown in Fig. 2) defined by the connector (note that the passageway extends both parallel and transverse to the longitudinal axis) (Figs. 1-4).
Claim 27. Rawlins discloses wherein the passageway extends from a distal facing opening (at the bottom of arms 50f and 50g as shown in Fig. 4) to a lateral facing opening (at the side of arms 50f and 50g as shown in Figs. 2 and 4) (Figs. 1-4).
Claim 29. Rawlins discloses wherein the outwardly projecting tab is movable relative to the receiver between a removable orientation (prior to clip member 52 being inserted into the space between arms 50f and 50g) and an attached orientation (after clip member 52 is inserted into the space between arms 50f and 50g) with the inner tab (Figs. 1-4).
Claim 32. Rawlins discloses wherein an end of the securing element is configured to engage with a sidewall of the inner tab to join the connector with the receiver (see para. 0027) (Figs. 1-4).
Claim 33. Rawlins discloses wherein the connector is rotatable relative to the receiver to a selected angular orientation to receive the spinal rod (see para. 0029) (Figs. 1-4).
Claim 34. Rawlins discloses wherein the connector is a closed spinal rod receiver (rod 18 cannot be top-loaded into through0opening 50b and thus housing member 50 is closed) (Figs. 1-4).
Claim 36. Rawlins discloses wherein the inner tab defines a stop (surface 46l) (Figs. 1-4).
Claim 37. Rawlins discloses wherein a first sidewall (surface 46l, which is a bottom sidewall as shown in Fig. 4) of the inner tab defines a first stop (surface 46l) and a second sidewall (inwardly-facing surface, which is an inner sidewall as shown in Fig. 4) of the inner tab defines a second stop (inwardly-facing surface) (Figs. 1-4).
Claim 38. Rawlins discloses wherein the passageway is spaced apart from the implant cavity (see Fig. 4, which shows that the space between arms 50f and 50g that receives clip member 52 is spaced apart, or separate, from through-opening 50b; note that “spaced apart” does not necessarily mean that the passageway and implant cavity are completely isolated from each other such that they are not in communication with each other) (Figs. 1-4).
Claim 39. Rawlins discloses a spinal implant system comprising:
bone screws (screw 22 and connector 34 is one bone screw; screw 24 and connector 36 is a second bone screw);
a spinal rod (rod 18) disposed with the bone screws;
an additional screw (screw 26);
a spinal implant (connector 38) comprising a post (plate member 46) and a connector (housing member 50), an end (end portion 46b) of the post being attached with the additional screw, the post comprising a receiver (end portion 46a) that is attached with the connector, the receiver including an inner tab (countersunk portion 46f, which projects inwardly toward the center of countersunk bore 46e as shown in Fig. 4 and thus is a tab), the connector including an outwardly projecting tab (increased-size distal end portion 50h, which projects outwardly from arm 50f as shown in Fig. 4 and thus is a tab) that is configured for engagement with the inner tab, the connector defining a passageway (space between arms 50f and 50g that receives clip member 52) and an implant cavity (through-opening 50b), the passageway extending transverse to a longitudinal axis (unlabeled axis extending through housing member 50 as shown in Fig. 2) defined by the connector (note that the passageway extends both parallel and transverse to the longitudinal axis), the spinal rod being disposed in the implant cavity, the spinal implant comprising a wire (legs 52b and 52c of clip member 52) disposable in the passageway and engageable with the inner tab (see para. 0027, which states that legs 52b and 52c engage surface 46l); and
a setscrew (set screw 54) that is threaded with threads (threads of bore 50c) of the connector to fix the spinal rod with the connector (Figs. 1-4).
Claim 40. Rawlins discloses a spinal implant system comprising:
bone screws (screw 22 and connector 34 is one bone screw; screw 24 and connector 36 is a second bone screw);
a spinal rod (rod 18) disposed with the bone screws;
an additional screw (screw 26); and
a spinal implant (connector 38) comprising a post (plate member 46) and a connector (housing member 50), an end (end portion 46b) of the post being attached with the additional screw, the post comprising a receiver (end portion 46a) that is attached with the connector, the receiver including an inner tab (countersunk portion 46f, which projects inwardly toward the center of countersunk bore 46e as shown in Fig. 4 and thus is a tab), the connector including an outwardly projecting tab (increased-size distal end portion 50h, which projects outwardly from arm 50f as shown in Fig. 4 and thus is a tab) that is configured for engagement with the inner tab, the connector defining a passageway (space between arms 50f and 50g that receives clip member 52) and an implant cavity (through-opening 50b), the passageway extending transverse to a longitudinal axis (unlabeled axis extending through housing member 50 as shown in Fig. 2) defined by the connector (note that the passageway extends both parallel and transverse to the longitudinal axis), the spinal rod being disposed in the implant cavity, the spinal implant comprising a wire (legs 52b and 52c of clip member 52) disposable in the passageway and engageable with the inner tab (see para. 0027, which states that legs 52b and 52c engage surface 46l) (Figs. 1-4).
Rawlins fails to disclose wherein the additional screw is an iliac screw (claims 21, 39, and 40), wherein the inner tab includes a first inner tab and a second inner tab that faces the first inner tab (claim 23), wherein the outwardly projecting tab is rotatable relative to the inner tab for alignment in an interference orientation (claim 28), wherein the removable orientation includes the outwardly projecting tab being disposed out of alignment with the inner tab and the attached orientation includes the outwardly projecting tab being aligned with the inner tab (claim 30), wherein the inner tab includes a first tab and a second tab defining at least one opening therebetween such that the removable orientation includes the outwardly projecting tab being aligned with the at least one opening and the attached orientation includes the inner tab being aligned with the outwardly projecting tab and disposed in an interference orientation (claim 31), and wherein the connector is an open spinal rod receiver (claim 35).
Dickinson teaches a spinal implant system comprising: bone screws (screws 20 attached to right rod 108 as shown in Fig. 3; see also para. 0050); a spinal rod (right rod 108 as shown in Fig. 3) disposed with the bone screws; an additional screw (screw 20 attached to ilium I2 as shown in Fig. 3) in the form of an iliac screw; and a spinal implant (see Figs. 8 and 9) comprising (a) a post (connector 322) including a receiver (first end 332) having a first inner tab (one of the inward projections defined by spaced apart arcuate keyways 337) spaced apart from a second inner tab (the other of the inward projections defined by spaced apart arcuate keyways 337) and (b) a connector (receiver 324) defining an open implant cavity (implant cavity 356) such that the connector is an open spinal rod receiver, wherein the connector includes a first outwardly projecting tab (one of keys 357) and a second outwardly projecting tab (the other of keys 357), wherein the outwardly projecting tabs are rotatable relative to the inner tabs for alignment in an interference orientation (see para. 0077), wherein the configuration of the spinal rod and ilium screw allow the system to be used to treat a spinal disorder affecting the spine and ilium (see para. 0048) (Figs. 3 and 8-9). The outwardly projecting tabs are movable relative to the receiver between a removable orientation (orientation when keys 357 are aligned with keyways 337) and an attached orientation (orientation when keys 357 are located in second passageway 339 and rotated away from keyways 337), wherein the removable orientation includes the outwardly projecting tabs being disposed out of alignment with the inner tabs and the attached orientation includes the outwardly projecting tabs being aligned with the inner tabs, wherein the removable orientation includes the outwardly projecting tabs being aligned with the spaces between the inner tabs and the attached orientation includes the inner tabs being aligned with the outwardly projecting tabs and disposed in an interference orientation (see para. 0077) (Figs. 3 and 8-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the additional screw such that it is an iliac screw (claims 21, 39, and 40) and the spinal rod such that the configuration of the spinal rod allows for connection with the ilium screw via the spinal implant, as suggested by Dickinson, in order to allow the system to be used to treat a spinal disorder affecting the spine and ilium. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner tab of Rawlins such that it includes a first inner tab and a second inner tab such that the outwardly projecting tabs of Rawlins can be inserted through the spaces between the inner tabs and the connector rotated relative to the receiver, as suggested by Dickinson, as such a means of connection between the receiver and the connector would require less force to initiate the connection. In view of such a modification, the inner tab would include a first inner tab and a second inner tab that faces the first inner tab (claim 23), the outwardly projecting tab would be rotatable relative to the inner tab for alignment in an interference orientation (claim 28), the removable orientation would include the outwardly projecting tab being disposed out of alignment with the inner tab and the attached orientation would include the outwardly projecting tab being aligned with the inner tab (claim 30), and wherein the inner tab would include a first tab and a second tab defining at least one opening therebetween such that the removable orientation includes the outwardly projecting tab being aligned with the at least one opening and the attached orientation includes the inner tab being aligned with the outwardly projecting tab and disposed in an interference orientation (claim 31). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector of Rawlins such that the implant cavity is an open implant cavity, as suggested by Dickinson, as doing so would allow for top-loading of the spinal rod in addition to side-loading. In view of such a modification, the connector would be an open spinal rod receiver (claim 35).
Response to Arguments
Applicant’s arguments filed August 3, 2026 with respect to the rejections of claims 1-20 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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