Detailed Action
This is the first office action on the merits for US application number 18/125,626.
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 .
Claim Objections
Claim(s) 1, 8, and 15 are objected to because of the following informalities:
Claim 1 lines 14-15 should read “from a first proximal position closer to the body[[,]] to a second distal position further away from the body”.
Claim 1 lines 22-24 should read “from a third proximal position relative to the body[[,]] to a fourth distal position relative to the body;”.
Claim 1 lines 25-27 should read “a relative to the first marking on the body is indicative of an amount of tension force applied to the syndesmosis construct.”.
Claim 8 lines 13-15 should read “from a first proximal position closer to the body[[,]] to a second distal position further away from the body”.
Claim 8 lines 23-24 should read “the slide translates distally along the body from a third proximal position relative to the body[[,]] to a fourth distal position relative to the body.”.
Claim 15 lines 13-14 should read “from a first proximal position closer to the body[[,]] to a second distal position further away from the body”.
Claim 15 lines 25*26 should read “the slide translates distally along the body from a third proximal position relative to the body[[,]] to a fourth distal position relative to the body.”.
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.
Claim(s) 1-20 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 1 is/are unclear with regards to “when the syndesmosis construct is coupled to the slide, and the distal end of the shaft is moved from the first proximal position to the second distal position: the slide is configured to translate distally along the body from a third proximal position relative to the body, to a fourth distal position relative to the body;” in lines 20-21 and the recitation of a condition that requires a usage of structures (syndesmosis construct) that are not positively recited and how such can be achieved without being required of the claimed invention. Examiner is interpreting this as referring to, and suggests amending as, “whereinconfigured to be coupled to the slidewhile the distal end of the shaft is moved from the first proximal position to the second distal position: the slide is configured to translate distally along the body from a third proximal position relative to the body[[,]] to a fourth distal position relative to the body;”
Claim(s) 8 is/are unclear with regards to “when the engagement tip is engaged with the first portion of the syndesmosis construct, the second portion of the syndesmosis construct is coupled to the slide, and the engagement tip is moved from the first proximal position to the second distal position: a tension force is applied to the syndesmosis construct” in lines 19-22 and the recitation a method step within a product claim as well as usage of structures (syndesmosis construct and its ‘portions’) that are not positively recited and how such can be used without being required of the claimed invention. Examiner is interpreting this as referring to, and suggests amending as, “whereinconfigured to be engaged with the first portion of the syndesmosis construct[[,]] while the second portion of the syndesmosis construct is coupled to the slide[[,]] and the engagement tip is moved from the first proximal position to the second distal position[[:]] to cause a tension force to be [[is]] applied to the syndesmosis construct;”
Claim(s) 8 is/are unclear with regards to “the slide translates distally along the body from a third proximal position relative to the body, to a fourth distal position relative to the body, in relation an amount of tension force applied to the syndesmosis construct” in lines 23-25 and the intended scope of “in relation to” and force applied to a functionally recited structure. Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 11 is/are unclear with regards to “a second prong, opposite the first prong, shaped to be received within a second recess formed in the first portion of the syndesmosis construct, opposite the first recess.” in lines 4-5 and the unusual comma usage is unclear as the missing nouns prior to each recitation of “opposite” and prior to “shaped to”. Examiner is interpreting this as referring to, and suggests amending as, “a second prong[[,]] opposite the first prong, the second prong shaped to be received within a second recess formed in the first portion of the syndesmosis construct, the second recess opposite the first recess.”.
Claim(s) 15 is/are unclear with regards to “when the first and second flexible elements are coupled to the slide, and the distal end of the shaft is moved from the first proximal position to the second distal position: a first tension force is applied to the first flexible element; a second tension force is applied to the second flexible element” in lines 20-24 and the recitation a method step within a product claim as well as usage of structures (the first and second flexible elements) that are not positively recited and how such can be used without being required of the claimed invention. Examiner is interpreting this as referring to, and suggests amending as, “wherein configured to be coupled to the slidewhile the distal end of the shaft is moved from the first proximal position to the second distal position[[:]] to cause a first tension force to be [[is]] applied to the first flexible element[[;]] and a second tension force to be [[is]] applied to the second flexible element”.
Claim(s) 15 is/are unclear with regards to “the slide translates distally along the body from a third proximal position relative to the body, to a fourth distal position relative to the body, in relation to a combined magnitude of the first and second tension forces that are applied to the first and second flexible elements” in lines 25-28 and the intended scope of “in relation to” and force applied to a functionally recited structure. Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 2-7, 9-14, and 16-20 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, and 4-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gleason (US 2003/0083669).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claim 1, Gleason discloses a tensioner (10, Figs. 1-12, ¶23) capable of applying tension force to a syndesmosis construct implanted relative to a syndesmosis joint of a patient (Figs. 2-12, ¶25 discloses use with a loop system), the tensioner comprising: a body (12) comprising: a proximal end (right end as shown in Fig. 2); a distal end (left end as shown in Fig. 2); and an intermediate portion (central portion as shown in Fig. 2, Fig. 2) extending between the proximal and distal ends of the body (Fig. 2); and a first marking (see “First marking” on the illustration of enlarged portion of Fig. 1, Fig. 1, i.e. the markings viewable through window 70) disposed along the intermediate portion of the body (Figs. 1 and 2); a shaft (40) comprising: a proximal end (42); a distal end (left end as shown in Fig. 2, Fig. 2); and a longitudinal axis (along the longest dimension of 12, Figs. 1 and 2), wherein the distal end of the shaft is capable of translatingly moving relative to the body (Figs. 1 and 2, ¶24) from a first proximal position closer to the body (Fig. 1) to a second distal position further away from the body (¶s 24, 26, and 29); and a slide (14) comprising: a second marking (see “Second marking” on the illustration of enlarged portion of Fig. 1, Fig. 1, i.e. “scale marking on the sliding tie off” of ¶26, ¶26) disposed on the slide (Figs. 1 and 2); and a coupler (78, 80) capable of coupling at least a portion of the syndesmosis construct to the slide (¶28), wherein the syndesmosis construct is capable of being coupled to the slide while the distal end of the shaft is moved from the first proximal position to the second distal position (Figs. 1 and 2, ¶s 28 and 29): the slide is capable of translating distally along the body from a third proximal position relative to the body to a fourth distal position relative to the body (Figs. 1 and 2, ¶s 28 and 29); and a position of the second marking on the slide relative to the first marking on the body is indicative of an amount of tension force applied to the syndesmosis construct (Figs. 1 and 2, ¶26).
As to claim 2, Gleason discloses that the first marking is located on the intermediate portion of the body (Figs. 1 and 2).
As to claim 4, Gleason discloses that the first marking comprises a plurality of first markings (Fig. 1) disposed along the intermediate portion of the body (Figs. 1 and 2), wherein each of the plurality of first markings is capable of indicating a different amount of tension force applied to the syndesmosis construct (Fig. 1, ¶26).
As to claim 5, Gleason discloses that the second marking comprises a plurality of second markings (Figs. 1 and 2) disposed along the slide (Figs. 1 and 2), wherein each of the plurality of second markings is capable of indicating a different amount of tension force applied to the syndesmosis construct (Figs. 1 and 2, ¶26).
As to claim 6, Gleason discloses that the slide further comprises a window (70) formed therethrough (Figs. 1 and 2) and capable of displaying the first marking on the body in positional relationship to the second marking on the slide (Figs. 1 and 2, ¶26).
As to claim 7, Gleason discloses that the second marking disposed on the slide comprises at least one edge on the slide (Figs. 1 and 2).
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Claim(s) 8-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bernardoni et al. (US 2023/0218330, hereinafter “Bernardoni”).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claim 8, Bernardoni discloses a tensioner (1, Figs. 1-4, ¶58) capable of applying tension force to a syndesmosis construct implanted relative to a syndesmosis joint of a patient (¶58 discloses tensioning a surgical thread), the tensioner comprising: a body (16, 31) comprising: a proximal end (16a); a distal end (16b); and an intermediate portion (central portion as shown in Fig. 2, Fig. 2) extending between the proximal and distal ends of the body (Fig. 2); a shaft (15) comprising: a proximal end (15c); a distal end (left end of 15 as shown in Figs. 1-4, Figs. 1-4); and an engagement tip (11) located on the distal end of the shaft (Figs. 1-4) shaped to engage a first portion of the syndesmosis construct (Figs. 1-4), wherein the engagement tip is capable of translatingly moving relative to the body (Figs. 2-3, ¶81) from a first proximal position closer to the body (Fig. 3) to a second distal position further away from the body (Fig. 2); and a slide (20) capable of coupling with a second portion of the syndesmosis construct and translating distally along the body in response to tension applied to the second portion of the syndesmosis construct (Figs. 2 and 3, ¶s 62, 64, 71, and 81), wherein the engagement tip is capable of being engaged with the first portion of the syndesmosis construct while the second portion of the syndesmosis construct is coupled to the slide and the engagement tip is moved from the first proximal position to the second distal position capable of causing a tension force to be applied to the syndesmosis construct (Figs. 1-4, ¶s 62-68); the slide translates distally along the body (Figs. 2 and 3, ¶81) from a third proximal position relative to the body (Fig. 3) to a fourth distal position relative to the body (Fig. 2), in relation to an amount of tension force applied to the syndesmosis construct (Figs. 2 and 3, ¶s 81 and 87).
As to claim 9, Bernardoni discloses that the engagement tip located on the distal end of the shaft is shaped to engage a lateral button of the syndesmosis construct (Figs. 1-4 show the tip features shaped to be capable of achieving such a function, Figs. 1-4).
As to claim 10, Bernardoni discloses the engagement tip comprises at least one prong (14s, Figs. 1-4) shaped to be received within at least one recess formed in the first portion of the syndesmosis construct (Figs. 1-4 show the tip features shaped to be capable of achieving such a function, Figs. 1-4).
As to claim 11, Bernardoni discloses the engagement tip comprises: a first prong (upper-right 14 as shown in Fig. 1, Fig. 1) shaped to be received within a first recess formed in the first portion of the syndesmosis construct (Figs. 1-4 show the tip features shaped to be capable of achieving such a function, Figs. 1-4); and a second prong (lower-right 14 as shown in Fig. 1, Fig. 1) opposite the first prong (Fig. 1), the second prong shaped to be received within a second recess formed in the first portion of the syndesmosis construct (Figs. 1-4 show the tip features shaped to be capable of achieving such a function, Figs. 1-4), the second recess opposite the first recess (Figs. 1-4 show the tip features shaped to be capable of achieving such a function, Figs. 1-4).
As to claim 12, Bernardoni discloses that the engagement tip comprises an engagement tip slot (17) intermediate the first prong and the second prong (Fig. 1) capable of receiving a ridge of the first portion of the syndesmosis construct that is formed intermediate the first recess and the second recess (Figs. 1-4 show the tip features shaped to be capable of achieving such a function, Figs. 1-4).
As to claim 13, Bernardoni discloses that the engagement tip comprises at least one angled ramp (19s) shaped to guide the second portion of the syndesmosis construct during tension (Figs. 1-4 show the tip features shaped to be capable of achieving such a function, Figs. 1-4, ¶96).
As to claim 14, Bernardoni discloses that the engagement tip comprises: a first angled ramp (upper 19 as shown in Fig. 1, Fig. 1) shaped to guide a first flexible element of the syndesmosis construct during tension (Figs. 1-4 show the tip features shaped to be capable of achieving such a function, Figs. 1-4); and a second angled ramp (lower 19 as shown in Fig. 1, Fig. 1) shaped to guide a second flexible element of the syndesmosis construct during tension (Figs. 1-4 show the tip features shaped to be capable of achieving such a function, Figs. 1-4).
As to claim 15, Bernardoni discloses a tensioner (1, Figs. 1-4, ¶58) capable of applying tension force to a syndesmosis construct implanted relative to a syndesmosis joint of a patient (¶58 discloses tensioning a surgical thread), the tensioner comprising: a body (16, 31) comprising: a proximal end (16a); a distal end (16b); and an intermediate portion (central portion as shown in Fig. 2, Fig. 2) extending between the proximal and distal ends of the body (Fig. 2); a shaft (15) comprising: a proximal end (15c); a distal end (left end of 15 as shown in Figs. 1-4, Figs. 1-4); and a longitudinal axis (X,Y, Figs. 1, 3, and 4, i.e. horizontal as shown in Fig. 4), wherein the distal end of the shaft is capable of translatingly moving relative to the body (Figs. 2-3, ¶81) from a first proximal position closer to the body (Fig. 3) to a second distal position further away from the body (Fig. 2); and a slide (20) comprising: a first coupler (left 21 as shown in Fig. 1, Fig. 1) capable of coupling a first flexible element of the syndesmosis construct to the slide (¶62); and a second coupler (left 21 as shown in Fig. 1, Fig. 1) capable of coupling a second flexible element of the syndesmosis construct to the slide (¶62); wherein the first and second flexible elements are capable of being coupled to the slide (¶61) while the distal end of the shaft is moved from the first proximal position to the second distal position (Figs. 1-4, ¶s 62-68, 71, and 81) capable of causing a first tension force to be applied to the first flexible element (Figs. 1-4, ¶s 62-68) and a second tension force to be applied to the second flexible element (Figs. 1-4, ¶s 62-68);and the slide translates distally along the body (Figs. 2 and 3, ¶81) from a third proximal position relative to the body (Fig. 3) to a fourth distal position relative to the body (Fig. 2), in relation to a combined magnitude of the first and second tension forces that are applied to the first and second flexible elements (Figs. 2 and 3, ¶s 81 and 87).
As to claim 16, Bernardoni discloses that the slide comprises: a first wing (left segment including left 21 as shown in Fig. 1, Fig. 1) projecting away from the slide along a first direction (Fig. 1); and a second wing (right segment including right 21 as shown in Fig. 1, Fig. 1) projecting away from the slide along a second direction (Fig. 1).
As to claim 17, Bernardoni discloses that the first and second directions are opposite each other (as defined, Fig. 1).
As to claim 18, Bernardoni discloses that the first wing comprises a first shoulder (see left “Shoulder” on the illustration of enlarged portion of Fig. 1, Fig. 1) capable of receiving at least a portion of the first flexible element thereon (¶65); and the second wing comprises a second shoulder (see right “Shoulder” on the illustration of enlarged portion of Fig. 1, Fig. 1) capable of receiving at least a portion of the second flexible element thereon (¶65).
As to claim 19, Bernardoni discloses that the first coupler is formed on the first wing (as defined, Fig. 1); and the second coupler is formed on the second wing (as defined, Fig. 1).
As to claim 20, Bernardoni discloses that the first coupler comprises: a first proximal cleat (see upper left “Cleats” on the illustration of enlarged portion of Fig. 1, Fig. 1) capable of receiving at least a first portion of the first flexible element therein (¶65); and a first distal cleat (lower left “Cleats” behind the body on the illustration of enlarged portion of Fig. 1, Fig. 1) capable of receiving at least a second portion of the first flexible element therein (¶65); and the second coupler comprises: a second proximal cleat (see upper right “Cleats” on the illustration of enlarged portion of Fig. 1, Fig. 1) capable of receiving at least a first portion of the second flexible element therein (¶65); and a second distal cleat (lower right “Cleats” on the illustration of enlarged portion of Fig. 1, Fig. 1) capable of receiving at least a second portion of the second flexible element therein (¶65).
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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 of this title, 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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gleason in view of Carroll (US 1,393,009).
As to claim 3, Gleason discloses the invention of claim 1 as well as that the first marking is located on a scale coupled to the intermediate portion of the body (Figs. 1 and 2).
Gleason is silent to the scale being discrete from the body.
Carroll teaches a similar measuring device (Figs. 1-5, page 1 lines 60-80) comprising: a body (1) comprising: a proximal end (left end as shown in Figs. 1 and 3, Figs. 2 and 3); a distal end (right end as shown in Figs. 1 and 3, Figs. 2 and 3); an intermediate portion (central portion as shown in Figs. 1 and 3, Figs. 2 and 3) extending between the proximal and distal ends of the body (Fig. 1); and a first marking (shown in scale 13s in Fig. 1, Fig. 1) disposed along the intermediate portion of the body (as defined, Fig. 1); and a slide (7, 9) comprising: a second marking (22, page 2 lines 44-50) disposed on the slide (as defined, Fig. 1); and wherein when the distal end of the shaft is moved from the first proximal position to the second distal position: the slide is capable of translating distally along the body from a third proximal position relative to the body to a fourth distal position relative to the body (Fig. 1, page 2 lines 14-50); and a position of the second marking on the slide relative to the first marking on the body may be measured (page 2 lines 40-55); wherein the first marking is located on a discrete scale coupled to the intermediate portion of the body (Figs. 1 and 2, page 1 line 109 – page 2 line 5 and page 2 lines 50-62) and removably secured within a recess (12, Fig. 2).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the scale as disclosed by Gleason to be discrete and removably secured within a recess as taught by Carroll in order to enable a user to appropriately determine which scale to employ based on a particular application (Carroll page 2 lines 50-62), e.g. for a particular spring rate (Gleason ¶26).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775