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
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/13/2026.
Applicant's election with traverse of claims in the reply filed on 5/13/2026 is acknowledged. The traversal is on the ground(s) that the apparatus of Invention I is used in the method of Invention II. This is not found persuasive because restrictions among an apparatus and process of use only require one-way distinctness. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus can be used in a materially different process such as being inserted into walls for mounting or construction rather than into tissues. Further, the tension component of the process is not required to be flexible, as required in the apparatus, thus the process can be performed with a materially different apparatus. Thus, the claims in the instant invention satisfy both tests to determine whether the claimed inventions are distinct.
The requirement is still deemed proper and is therefore made FINAL.
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: “attachment component” in claim 1.
Claim 1 recites the limitation of a “attachment component”. The term “component” is used as a substitute for “means” and is modified by functional language “configured to couple the tension component with the first implant”. There is no corresponding structure in the claim, therefore invoking 112(f). Based on the specification, the corresponding structure for “attachment component” is “a u-shaped groove” (Paragraph 00188) or equivalents thereof.
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 6 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.
Claim 6 recites the limitation "the compressible locking component" in line 5. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be seen as “a compressible locking component”.
Claim Rejections - 35 USC § 102
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, 5, 8, 10-11, 14 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Torrie et al. (US 20050283192 A1).
Regarding claim 1, Torrie discloses a tissue or fracture fixation system, comprising:
a) a flexible tension component (10) (Figure 1; Paragraph 0101);
b) a first implant (16) comprising an attachment component (16a, 16b) configured to couple the tension component with the first implant (Figure 2; Paragraph 0104) (As indicated above, the limitation “attachment component” invokes 112(f). The corresponding structure in Torrie is through hole, which is equivalent to a u-shaped groove, as disclosed in the present disclosure.); and
c) a second implant (18) configured to engage the tension component to secure the first implant relative to the second implant (Figure 1; Paragraph 0101; 0105).
Regarding claim 5, Torrie further discloses wherein the tension component comprises a compressible locking component (28) configured to be disposed within the second implant, wherein the compressible locking component comprises a sliding knot bundle (Figure 14; Paragraph 0104).
Regarding claim 8, Torrie further discloses wherein the second implant has a tapering outer diameter such that the second implant has a reduction in size at its distal end (152) (Figure 4A; Paragraph 0107) (Paragraph 0107 states fixation members 16 and 18 have the same shape, thus components on 16 are considered equivalent to the corresponding elements on 18), wherein the second implant is configured to capture and drive a suture, into a hole, wherein the tapered distal end allows for easier insertion of said tissue, suture, or suture tape by into said hole (Paragraph 0107).
Regarding claim 10, Torrie further discloses wherein the second implant is T-shaped (1730) (Figure 28A-B; Paragraph 0013; 0175), wherein the second implant comprises T-arms (arms of 1730) disposed at its proximal end (1732), wherein the T-shaped arms are configured to anchor tissue (Figure 28A-B; Paragraph 0013; 0175).
Regarding claim 11, Torrie further discloses wherein the second implant is L-shaped (1014) (Figure 18A-B; Paragraph 0131; 0145), wherein the second implant has an arm (1036) disposed at its proximal end (1029b) for anchoring tissue (Paragraph 0130-131).
Regarding claim 14, Torrie further discloses a driver tool (99) for implanting the first implant and the second implant (Figure 3; Paragraph 0106), wherein the driver tool comprises a drive shaft (200) having a lumen (202) for receiving the tension component and a drive distal tip (distal tip of 200) (Figure 3; Paragraph 0106), wherein the driver tool comprises a handle (180) connected to the drive shaft (Figure 5; Paragraph 0109).
Regarding claim 17, Torrie further discloses wherein the driver tool comprises a ferrule (150) connected to the drive shaft (Figure 4; Paragraph 0107), wherein the ferrule is configured to retain the second implant prior to use (Paragraph 0107).
Claim(s) 1, 4, 6, 9, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McDevitt et al. (US 5935129 A).
Regarding claim 1, McDevitt discloses a tissue and fracture fixation system (5) (Figure 1A), comprising:
a) a flexible tension component (60) (Figure 3; Col 7, line 57-61);
b) a first implant (2) comprising an attachment component (1) configured to couple the tension component with the first implant (Figure 1A; Col 4, line 17-29) (As indicated above, the limitation “attachment component” invokes 112(f). The corresponding structure in McDevitt is essentially a u-shaped groove, which is equivalent to a u-shaped groove, as disclosed in the present disclosure.); and
c) a second implant (4) configured to engage the tension component to secure the first implant relative to the second implant (Figure 1A; Col 4, line 30-34).
Regarding claim 4, McDevitt further discloses wherein the attachment component is a U-shaped groove, wherein the attachment component acts as a pulley mechanism that engages the tension component (Figure 1A; Col 5, line 16-21).
Regarding claim 6, McDevitt further discloses wherein the second implant comprises a lumen (14) through which the tension component is disposed (Figure 2, 3B; Col 7 line 66-Col 8 line 8), wherein the second implant has an opening (distal opening into 14) coupled to the lumen (Figure 2; Col 7 line 66-Col 8 line 8), wherein the opening is a tapering wedge (labeled in Annotated Figure 1(a)) from the proximal end (considered to taper from proximal end of 7) into an interior of the lumen, wherein the opening of the second implant is sized to receive and capture a compressible locking component (the opening is sufficiently sized to be capable of receiving a knot, which is a compressible locking component according to the present disclosure) (Figure 1A-B; Col 7 line 66-Col 8 line 8).
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Regarding claim 9, McDevitt further discloses wherein the second implant has a threaded surface or barbs (53), disposed at its proximal end (Figure 2; Col 6, line 39-48).
Regarding claim 12, McDevitt further discloses further comprising at least one supporting implant (51) disposed between the first implant and the second implant (Figure 1B), wherein the tension component is disposed through a lumen (lumen of 51) of the supporting implant or adjacent to the supporting implant (Figure 1B).
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thornes (US 20070016208 A1).
Regarding claim 1. Thornes discloses a tissue and fracture fixation system (5), comprising:
a) a flexible tension component (70) (Figure 6; Paragraph 0049);
b) a first implant (60) comprising an attachment component (64a) configured to couple the tension component with the first implant (Figure 6; Paragraph 0046) (As indicated above, the limitation “attachment component” invokes 112(f). The corresponding structure in Thornes is a through hole, which is equivalent to a u-shaped groove, as disclosed in the present disclosure.); and
c) a second implant (50) configured to engage the tension component to secure the first implant relative to the second implant (Figure 6).
Regarding claim 2, Thornes further discloses wherein the first implant further comprises a lumen (62) which is fully capable of being configured for use with a guidewire (Figure 6; Paragraph 0047), wherein the attachment component is offset from a central axis of the lumen (Figure 6; Paragraph 0046), wherein the tension component is coupled and routed through the first implant such that the tension component does not interfere with the lumen when used with the guidewire (Figure 6) (the suture goes through the apertures 64a-d and does not enter aperture 62).
Regarding claim 3, Thornes further discloses wherein the first implant is radially symmetric (Figure 6).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt as applied to claim 1 above, in view of Lizardi (US 20050075668 A1).
Regarding claim 7, McDevitt discloses the system of claim 1, but fails to explicitly disclose wherein the second implant comprises a V-shaped notch disposed on its distal end, wherein the V-shaped notch is configured to capture a tissue, a suture, or suture tape.
However, Lizardi is directed to an anchor system and teaches wherein the implant (110) comprises a V-shaped notch (142) disposed on its distal end (116) (Figure 3; Paragraph 0053), wherein the V-shaped notch is configured to capture a suture (80) (Paragraph 0053).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify McDevitt such that wherein the second implant comprises a V-shaped notch disposed on its distal end, wherein the V-shaped notch is configured to capture a suture, as taught by Lizardi, as both references and the claimed invention are directed to anchor systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified McDevitt with the teachings of Lizardi by incorporating wherein the implant comprises a V-shaped notch disposed on its distal end, wherein the V-shaped notch is configured to capture a tissue, a suture, or suture tape in order to secure the suture to the implant (Lizardi Paragraph 0053).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt, as applied to claim 12 above, in view of Frazier et al. (US 20080208265 A1).
Regarding claim 13, McDevitt discloses the system of claim 12, but fails to explicitly disclose wherein the first implant (110), the second implant (130), at least one supporting implant (300), or a combination thereof is treated with one or more anti-clotting, antithrombogenic coatings surface treatments, or nanotechnology treatments to stimulate bone growth.
However, Frazier is directed to a fixation system and teaches all the components of the invention may contain antithrombogenic agents, bone growth accelerators or agents (Paragraph 0258).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify McDevitt such that the components include antithrombogenic agents, bone growth accelerators or agents, as taught by Frazier, as both references and the claimed invention are directed to fixation systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified McDevitt with the teachings of Frazier by incorporating antithrombogenic agents, bone growth accelerators or agents in order to accelerate healing of the injury or provide mechanical support (Frazier Paragraph 0258).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torrie as applied to claim 14 above in view of Martinek et al. (US 20050240199 A1).
Regarding claim 15, Torrie discloses the system (100) of claim 14, but fails to explicitly disclose wherein the handle comprises a receiving area disposed within the handle and intersects a pathway for the tension component; a storage compartment; and grooves that lead to said storage compartment; wherein the storage compartment is configured to retain at least the second implant prior to use, wherein the grooves are configured to retain at least portion of the tension component prior to use.
However, Martinek is directed to a suture anchor system and teaches wherein the handle (102) comprises a receiving area (inside of handle) disposed within the handle and intersects a pathway for the tension component (300) (Figure 4; Paragraph 0062); a storage compartment (170) (Figure 4; Paragraph 002); and grooves (174) that lead to said storage compartment (Paragraph 0062); wherein the storage compartment is configured to retain at least the second implant prior to use (Paragraph 0062), wherein the grooves are configured to retain at least portion of the tension component prior to use (Paragraph 0062).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Torrie such that wherein the handle comprises a receiving area disposed within the handle and intersects a pathway for the tension component; a storage compartment; and grooves that lead to said storage compartment; wherein the storage compartment is configured to retain at least the second implant prior to use, wherein the grooves are configured to retain at least portion of the tension component prior to use, as taught by Martinek, as both references and the claimed invention are directed to suture anchor systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Martinek by incorporating wherein the handle comprises a receiving area disposed within the handle and intersects a pathway for the tension component; a storage compartment; and grooves that lead to said storage compartment; wherein the storage compartment is configured to retain at least the second implant prior to use, wherein the grooves are configured to retain at least portion of the tension component prior to use in order to secure the anchor and suture to prevent unwanted movement in the device prior to deployment (Martinek Paragraph 0062).
Regarding claim 16, Torrie as modified by Martinek discloses the system of claim 15, but fails to further disclose a winder tool configured to be inserted into the receiving area of the handle, and capture and wind the tension component, wherein as the tension component is wound onto the winder tool, tension is applied to the tension component.
However, Martinek is directed to a suture anchor system and teaches a winder tool (112) configured to be inserted into the receiving area (110) of the handle (102), and capture and wind the tension component (300), wherein as the tension component is wound onto the winder tool, tension is applied to the tension component (Figure 4; Paragraph 0051).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Torrie to include a winder tool configured to be inserted into the receiving area of the handle, and capture and wind the tension component, wherein as the tension component is wound onto the winder tool, tension is applied to the tension component, as taught by Martinek, as both references and the claimed invention are directed to suture anchor systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Martinek by incorporating a winder tool configured to be inserted into the receiving area of the handle, and capture and wind the tension component, wherein as the tension component is wound onto the winder tool, tension is applied to the tension component in order to be able to control the length and tension of the suture as the anchors are deployed (Martinek Paragraph 0051).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DARWIN EREZO can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Z.J./Examiner, Art Unit 3771
/BRIGID K BYRD/Examiner, Art Unit 3771
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