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 .
This action is in response to the election/restriction response filed on 11/10/2025. Claims 1-26 are pending. Claims 1, 12, and 20 are independent. Claims 5, 6, 11, and 20-26 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Species B (Figures 3-6) in the reply filed on 11/10/2025 is acknowledged.
Claims 5, 6, 11, and 20-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 11/10/2025.
Withdrawn claims 5, 6, and 11 can be rejoined at the time of allowance if they require all the limitations of an allowable claim at the time of allowance. Applicant should be noted that claim 6 has the same 35 USC 112 issues similar to claim 7.
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: “locking element” in claim 12. Based on the disclosure, the locking element is an element (14, Figs. 3-6) that is configured to fit into and mate with the button for locking at least one tensionable fixation member.
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.
Claims 7-9 and 12-19 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 7 recites the limitation "the proximal direction" in lines 2-3 of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation is interpreted to be --a proximal direction--.
Claim 7 recites the limitation "the fixation angle" in lines 8-9 of the claim. Claim 1 recites “variable fixation angles” but does not provide the antecedent basis for any particular angle. There is insufficient antecedent basis for the limitation, “the fixation angle” in claim 7. For the purpose of examination, the limitation is interpreted to be --a fixation angle--.
Claim 8 recites the limitation "the proximal direction" in lines 2-3 of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation is interpreted to be --a proximal direction--.
Claim 8 recites the limitation "the fixation angle" in line 8 of the claim. Claim 1 recites “variable fixation angles” but does not provide the antecedent basis for any particular angle. There is insufficient antecedent basis for the limitation, “the fixation angle” in claim 8. For the purpose of examination, the limitation is interpreted to be --a fixation angle--.
Claim 9 is rejected because it depends on claim 8.
Claim 12 recites the limitation "the proximal direction" in line 26 of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation is interpreted to be --a proximal direction--.
Claim 12 recites the limitation "the fixation angle" in line 33 of the claim. Claim 1 recites “variable fixation angles” but does not provide the antecedent basis for any particular angle. There is insufficient antecedent basis for the limitation, “the fixation angle” in claim 12. For the purpose of examination, the limitation is interpreted to be --a fixation angle--.
Claims 13-19 are rejected because they depend on claim 12.
Allowable Subject Matter
Claims 1-4 and 10 are allowed.
Claims 7-9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 12-19 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Fritzinger et al. (US Pub. No. 2013/0172944) discloses a tensionable fixation assembly configured to fix tissue or bone to tissue, bone, or other member (a bone fixation assembly for providing variable tension; paragraph [0043]), comprising: a button (suture button 32; paragraph [0036]) comprising a proximal facing surface (as shown; figure 4), a distal facing surface (as shown; figure 3), a circumferential outer mating surface (as shown; figure 2), and at least one opening extending therethrough (as shown; figure 13), the button defining a first end of the tensionable fixation assembly (as shown; figure 3); a receiver (bone plate 30; figure 4; paragraph [0036]) having an opening extending therethrough (as shown; figures 2, 4); and at least one tensionable fixation member interacting with the button and receiver (suture 36 interacting with the button and plate; paragraph [0036]). However, Fritzinger does not disclose a receiver having an opening extending therethrough and an inner recess surrounding the opening, the inner recess defining a receiving surface configured to interface with the button such that the button is angularly moveable relative to the receiver and configured to be secured within the recess at variable fixation angles while maintaining contact between the outer mating surface and the receiving surface.
Lyon (US Pub. No. 2013/0123841) discloses a tensionable fixation assembly configured to fix tissue or bone to tissue, bone, or other member (suture button apparatus capable of fixing bone to tissue; paragraphs [0034], [0088]), comprising: a button (button 12; figure 1; paragraph [0034]) comprising a proximal facing surface (as shown; figure 1 ), a distal facing surface (as shown; figure 1 ), a circumferential outer mating surface (as shown; figure 1 ), the button defining a first end of the tensionable fixation assembly (as shown; figure 1 ); a receiver having an opening extending therethrough (plate 14 having an opening therethrough; figure 1; paragraph [0034]); and at least one tensionable fixation member interacting with the button and receiver (suture 18 interacting with the button and plate; figure 1; paragraph [0034]). However, Lyon does not disclose a receiver having an opening extending therethrough and an inner recess surrounding the opening, the inner recess defining a receiving surface configured to interface with the button such that the button is angularly moveable relative to the receiver and configured to be secured within the recess at variable fixation angles while maintaining contact between the outer mating surface and the receiving surface.
Chavan M.D. (US Pub. No.: 2020/0289109) discloses a tensionable fixation assembly configured to fix tissue or bone to tissue, bone, or other member (paragraph [0005]), comprising: a button (button 101; figure 4; paragraph [0056]) comprising a proximal facing surface (as shown; figures 1-6), a distal facing surface (as shown; figures 1-6), a circumferential outer mating surface (as shown; figures 1-6), and at least one opening extending therethrough (center opening 105; figure 6; paragraph [0056]), the button defining a first end of the tensionable fixation assembly (as shown; figure 1 ); and at least one tensionable fixation member interacting with the button (tensioning member 102; figure 1; paragraph [0055]). However, Chavan does not disclose a receiver having an opening extending therethrough and an inner recess surrounding the opening, the inner recess defining a receiving surface configured to interface with the button such that the button is angularly moveable relative to the receiver and configured to be secured within the recess at variable fixation angles while maintaining contact between the outer mating surface and the receiving surface.
Zeuner et al. (US Pub. No.: 2023/0095119) discloses angularly moveable relative to the receiver and configured to be secured within the recess at variable fixation angles (the screw holes are of variable angle design so that the screws can each be oriented in an angular range; paragraph [0110]).
However, it would not have been obvious to one of ordinary skill in the art at the time of the invention to have modified Fritzinger, Lyon, Chavan, and Zeuner, with a tensionable fixation assembly configured to fix tissue or bone to tissue, bone, or other member, comprising: a button comprising a proximal facing surface, a distal facing surface, a circumferential outer mating surface, and at least one opening extending therethrough, the button defining a first end of the tensionable fixation assembly; a receiver having an opening extending therethrough and an inner recess surrounding the opening, the inner recess defining a receiving surface configured to interface with the button such that the button is angularly moveable relative to the receiver and configured to be secured within the recess at variable fixation angles while maintaining contact between the outer mating surface and the receiving surface; and at least one tensionable fixation member interacting with the button and receiver, as described, because the references of record fail to disclose all of the elements of the inventive device.
Claims 5, 6, and 11 can be rejoined at the time of allowance if they still require all the limitations of an allowable claim at the time of allowance. Applicant should be noted that claim 6 has the same 35 USC 112 issues similar to claim 7.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hoover; Timothy R. et al. US 20160220347 A1 discloses a tensionable fixation assembly comprising a button, a receiver; and tensionable suture.
Chavan; Prithviraj et al. US 20180249998 A1 discloses a tensionable fixation assembly comprising a button, a receiver; and tensionable suture.
Martins; Harold M. et al. US 5306290 A discloses a tensionable fixation assembly comprising a first anchor and a second anchor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JING RUI OU/Primary Examiner, Art Unit 3771