Detailed Action
This is the first office action on the merits for US application number 18/567,761.
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 .
Response to Amendment
Examiner notes that it appears Applicant has submitted the claim amendment with non-black font which causes legibility difficulties and Examiner to retype large portions text . Examiner has attempted to interpret the claim amendments appropriately but requests submission of amendments in black font and in compliance with 37 CFR 1.121(c). Examiner has provided two examples provided by office software here:
“1. (Currently Amended) A device for passing cerclage wire, the device comprising:
PNG
media_image1.png
9
71
media_image1.png
Greyscale
PNG
media_image2.png
12
191
media_image2.png
Greyscale
PNG
media_image3.png
9
87
media_image3.png
Greyscale
PNG
media_image4.png
12
299
media_image4.png
Greyscale
PNG
media_image5.png
12
461
media_image5.png
Greyscale
PNG
media_image6.png
12
483
media_image6.png
Greyscale
PNG
media_image7.png
12
510
media_image7.png
Greyscale
PNG
media_image8.png
12
473
media_image8.png
Greyscale
PNG
media_image9.png
12
526
media_image9.png
Greyscale
PNG
media_image10.png
12
454
media_image10.png
Greyscale
PNG
media_image11.png
12
154
media_image11.png
Greyscale
PNG
media_image12.png
9
66
media_image12.png
Greyscale
a first member having a first region and a second region, the first member having a cannula aXis formed therein, the first region being substantially linear in shape and the second region being hooked a second member having a third region and a fourth region, the second member having a second cannula w formed therein, the third region being substantially linear in shape and the fourth region being hooked wherein the first region includes at least one aperture that is fluidly connected to the cannula and configured to receive cerclage wire--the third region includes at least one aperture fluidly connected with the second cannula.”
“10. (Currently Amended) The device of claim 1 es-p-
PNG
media_image13.png
12
140
media_image13.png
Greyscale
PNG
media_image14.png
12
513
media_image14.png
Greyscale
PNG
media_image15.png
12
515
media_image15.png
Greyscale
PNG
media_image16.png
12
514
media_image16.png
Greyscale
PNG
media_image17.png
12
485
media_image17.png
Greyscale
PNG
media_image18.png
12
517
media_image18.png
Greyscale
PNG
media_image19.png
12
515
media_image19.png
Greyscale
configured to be
PNG
media_image20.png
12
213
media_image20.png
Greyscale
-
PNG
media_image21.png
12
87
media_image21.png
Greyscale
--.m-e
PNG
media_image22.png
9
31
media_image22.png
Greyscale
PNG
media_image23.png
12
517
media_image23.png
Greyscale
PNG
media_image24.png
12
246
media_image24.png
Greyscale
-'-
PNG
media_image25.png
12
179
media_image25.png
Greyscale
PNG
media_image26.png
12
520
media_image26.png
Greyscale
.":'.,
PNG
media_image27.png
11
49
media_image27.png
Greyscale
PNG
media_image28.png
9
54
media_image28.png
Greyscale
”.
Election/Restrictions
Applicant's election with traverse of Invention I, the device of claims 1-12, and species 1) of Figs. 1-3, in the reply filed on September 24, 2025 is acknowledged. The traversal is on the ground(s) that claim 1 has been amended to recite a “telescoping member”, all claims now depend from claim 1, Songer does not disclose the invention of claim 1, and therefore all of the claims now include a special technical feature. Examiner notes that this traversal is immaterial to the restriction requirement as such is based upon claims upon which were not subjected to the restriction requirement and appears to have no bearing on the disclosed species. Further, it has not been asserted that Songer reads on previous or current claim 1, thus, such an argument is moot.
Applicant has presented a traversal that telescoping member has a broader meaning than the “classical type of telescoping parts, i.e. concentric telescopic parts” that move relative to one another to shorted or lengthen a part, as paragraph 17 refers to a telescoping cannula in Fig. 4 which illustrates a non-concentric telescoping member in the form of parts arranged side by side, for example by a tongue and groove connection, and thus Figs. 4-7 should be included in the same species as Figs. 1-3 as such are directed to the same non-concentric telescoping member. Examiner notes that, while paragraph 17 does disclose that the device of Fig. 4 has a telescoping cannula, it has not been disclosed how such is telescoping. Further, Applicant’s argued interpretation of “telescoping member” is highly unusual, inconsistent with the ordinary meaning in the art, inconsistent with Applicant’s specification, was not defined in Applicant’s original disclosure, and appears to be irrelevant to the restriction requirement.
In regards to Applicant’s argued interpretation of “telescoping member”, Examiner notes that it does not appear that Applicant has chosen to act as their own lexicographer by providing a definition of the term. Ordinary meanings appear to define telescoping with “having parts that slide one inside another” or “to have one part slide into another part like the concentric tubes of a small, collapsible telescope” (https://www.collinsdictionary.com/dictionary/english/telescope). Applicant’s response dated September 24, 2025 appears to be interpreting “telescoping” in a manner that is inconsistent with the original disclosure filed December 6, 2023. The original disclosure includes a broadly mentioned a “telescoping member” in paragraph 7 that is not disclosed in reference to any of the specific embodiments shown but discloses that such is coaxially disposed in an overlapping arrangement with one of the second region or the fourth region and slidably displaceable. The original disclosure later discloses a “telescoping portion” 225 that is disclosed in at least paragraphs 39 and 40 in a similar manner to the “telescoping member” in paragraph 7. Thus, Examiner has interpreted the disclosed “telescoping portion” 225 as the “telescoping member” of claim 1. That said, Applicant’s arguments dated September 24, 2025 and at least claim 9 amendments appear to conflate “telescoping member” with the “slidable locking mechanism” 357 shown in Figs. 5-7 and disclosed in at least paragraph 47 to be a grooved member 360 with groove 365 that receives protruding member 370, i.e. a tongue-and-groove connection, that paragraph 47 discloses can include one or more “locking features”. Examiner notes that it would be unusual usage of the term “telescoping” to be associated with a tongue-and-groove connection, which, while broadly accurate, such usage is inconsistent with the usage of the term in Applicant’s original disclosure. Thus, when claims are considered in light of the specification, it would be improper to attribute the BRI of “telescoping member” as the disclosed tongue-and-groove connection of 357 per paragraph 47 and Figs. 5-7.
In regards to the related requirement, as detailed on page 5 of the restriction requirement dated June 24, 2025, the species 1)-6) lack unity of invention because their common technical features of two substantially linear regions, two hooked regions, and two cannula are disclosed by Songer. A comparison of species 1) of Figs. 1-3, species 2) of Fig. 4, and species 3) of Figs. 5-7 readily shows that species 1) of Figs. 1-3 uniquely comprises a telescoping portion 225 that slides along the hooked region of the second member (¶s39-45), species 2) of Fig. 4 uniquely comprises stationary solid-state components to circumnavigate cerclage wire through a surgical site (¶46) with a protruding member 370 that slides within groove 365 (¶47), and species 3) of Figs. 5-7 which uniquely comprises a generally rectilinear substantially linear region of the first member (Figs. 5-7) with a sliding lock mechanism 357 that can be coupled prior to insertion of the first member into the surgical site (¶49). Thus, the restriction requirement is proper.
The requirement is still deemed proper and is therefore made FINAL.
Applicant's election did not identify which claims are intended to read on the elected species 1) of Figs. 1-3.
As to claim 2, the limitation of the first terminal end of the second region is configured to be received within the second terminal end of the fourth region does not read on the elected species with telescoping portion 225 where “the end 240 of the telescoping portion 225 may be joined with the end 275 of the second member 255” (¶44). Further, the first terminal end of the second region is configured to be received within the second terminal end of the fourth region is disclosed in paragraph 58 in reference to device 500, i.e. non-elected species 5) and 6). Therefore, claim 2 does not read on the elected species.
As to claim 3, the limitation of the first terminal end of the second region is configured to receive the second terminal end of the fourth region does not read on the elected species with telescoping portion 225 where “the end 240 of the telescoping portion 225 may be joined with the end 275 of the second member 255” (¶44). Further, the first terminal end of the second region is configured to receive the second terminal end of the fourth region is disclosed in paragraph 58 in reference to device 500, i.e. non-elected species 5) and 6). Therefore, claim 3 does not read on the elected species.
Accordingly, claims 2 and 3 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.
Priority
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 applications, Application No. PCT/US2002/040090 and 63/231,981, fail 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. Application No. PCT/US2002/040090 and 63/231,981 fail to provide adequate support for the “telescoping member being slidably displaceable from the one of the second region or the fourth region to at least partially overlap with both of the second region and the fourth region in the closed configuration” of claim 4 lines 3-5, “the telescoping member is configured to slidably displace through approximately 90 to 270 degrees” of claim 5, “the telescoping member is configured to slidably displace through up to 360 degrees” of claim 6, “a linear actuator coupled to the telescoping member and being slidably disposed on one of the first region or the third region, wherein displacement of the linear actuator causes displacement of the telescoping member” of claim 7, “the linear actuator extends between the first region and the second region” of claim 8, “the telescoping member is arranged between the first and third regions and further comprising a first handle connected to the first member and a second handle connected to the second member, wherein user interaction with the first handle and the second handle linearly positions the first member and the second member relative to one another via the telescoping member for placing the device alternately in the open configuration and the closed configuration” of claim 9, “the telescoping member includes a first linear extending part attached to and extending parallel to one of the first and third linear regions”, “the telescoping member includes a second linear extending part attached to and extending parallel to the other of the first and third linear regions”, etc., i.e. the entirety of claim 10, “the second device is disposed within the third device” of claim 15, “passing a cerclage wire through the surgical site using the first device” of claim 16 line 10, “inserting the first member of the first device into the surgical site; circumnavigating the second region of the first member about an anatomical feature within the surgical site; inserting the cerclage wire through the at least one aperture within the first region of the elongated member of the first device; advancing the cerclage wire through the cannula of the first device; and removing the first device from the surgical site;” of claim 16 lines 12-18, “passing a terminal end of the cerclage wire into the locking mechanism of the second device; creating a tension within the cerclage wire by displacing the locking mechanism within the second device” of claim 16 lines 22-25, and “securing a first portion adjacent the terminal end of the cerclage wire using a third device; and cutting the terminal end of the cerclage wire using a fourth device” of claim 16 lines 27-29.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claim 5, the specification appears to lack proper antecedent basis for “the telescoping member is configured to slidably displace through approximately 90 to 270 degrees”. That is, such does not appear to be described in the specification, shown in the drawings, and was not originally claimed for the telescoping member that overlaps both of the second region and fourth regions. Instead, paragraph 39 discloses that “telescoping portion 225 is structured to extend by 90 degrees or more such that the device 200 may circumnavigate within the range of 180 to 270 degrees. In various embodiments, the telescoping portion 225 is configured to extend by less than 90 degrees. In yet other embodiments, the telescoping portion 225 is configured to circumnavigate up to approximately 360 degrees.” Further, for the structure shown in Fig. 3, it does not appear to be physically possible for the telescoping portion 225 to slide 90-270 degrees. Thus, the specification fails to provide proper antecedent basis for “the telescoping member is configured to slidably displace through approximately 90 to 270 degrees”.
As to claim 6, the specification appears to lack proper antecedent basis for “the telescoping member is configured to slidably displace through up to 360 degrees”. That is, such does not appear to be described in the specification, shown in the drawings, and was not originally claimed for the telescoping member that overlaps both of the second region and fourth regions. Instead, paragraph 39 discloses that “telescoping portion 225 is structured to extend by 90 degrees or more such that the device 200 may circumnavigate within the range of 180 to 270 degrees. In various embodiments, the telescoping portion 225 is configured to extend by less than 90 degrees. In yet other embodiments, the telescoping portion 225 is configured to circumnavigate up to approximately 360 degrees.” Further, for the structure shown in Fig. 3, it does not appear to be physically possible for the telescoping portion 225 to slide up to 360 degrees. Thus, the specification fails to provide proper antecedent basis for “the telescoping member is configured to slidably displace through up to 360 degrees”.
As to claims 7 and 8, the specification appears to lack proper antecedent basis for “linear actuator coupled to the telescoping member and being slidably disposed on one of the first region or the third region” of claim 7 and “the linear actuator extends between the first region and the second region” of claim 8. That is, such does not appear to be described in the specification, shown in the drawings, and was not originally claimed for the telescoping member that overlaps both of the second region and fourth regions. Instead, Fig. 3 indicates 235 along the second, hooked region of the first member and paragraph 40 discloses that 235 is an actuator. It does not appear that the arcuate motion indicated by 235 on second/hooked region 220 in Fig. 3 can be reasonably interpreted as linear or disposed on the first or third region. Thus, the specification fails to provide proper antecedent basis for “linear actuator coupled to the telescoping member and being slidably disposed on one of the first region or the third region” of claim 7 and “the linear actuator extends between the first region and the second region” of claim 8.
As to claim 9, the specification appears to lack proper antecedent basis for “the telescoping member is arranged between the first and third regions and further comprising a first handle connected to the first member and a second handle connected to the second member, wherein user interaction with the first handle and the second handle linearly positions the first member and the second member relative to one another via the telescoping member for placing the device alternately in the open configuration and the closed configuration”. That is, such does not appear to be described in the specification, shown in the drawings, and was not originally claimed. Instead, the telescoping member is disclosed to be “coaxially disposed in an overlapping arrangement with one of the second region or the fourth region” (¶7), handle grip 145 is disclosed for the first member and handle 150 is disclosed for the second member which provide a sliding mechanism for relative movement of the first and second members (¶36). Thus, the specification fails to provide proper antecedent basis for “the telescoping member is arranged between the first and third regions and further comprising a first handle connected to the first member and a second handle connected to the second member, wherein user interaction with the first handle and the second handle linearly positions the first member and the second member relative to one another via the telescoping member for placing the device alternately in the open configuration and the closed configuration”.
As to claim 10, the specification appears to lack proper antecedent basis for “the telescoping member includes a first linear extending part attached to and extending parallel to one of the first and third linear regions”, “the telescoping member includes a second linear extending part attached to and extending parallel to the other of the first and third linear regions”, etc., i.e. the entirety of claim 10. That is, such does not appear to be described in the specification, shown in the drawings, and was not originally claimed. Instead, the telescoping member is disclosed to be “coaxially disposed in an overlapping arrangement with one of the second region or the fourth region” (¶7) which claim 1 lines 4 and 7 define as being hooked. Thus, the specification fails to provide proper antecedent basis for “the telescoping member includes a first linear extending part attached to and extending parallel to one of the first and third linear regions”, “the telescoping member includes a second linear extending part attached to and extending parallel to the other of the first and third linear regions”, etc., i.e. the entirety of claim 10.
Drawings
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 “telescoping member being slidably displaceable from the one of the second region or the fourth region to at least partially overlap with both of the second region and the fourth region in the closed configuration” of claim 4 lines 3-5, “the telescoping member is configured to slidably displace through approximately 90 to 270 degrees” of claim 5, “the telescoping member is configured to slidably displace through up to 360 degrees” of claim 6, “a linear actuator coupled to the telescoping member and being slidably disposed on one of the first region or the third region, wherein displacement of the linear actuator causes displacement of the telescoping member” of claim 7, “the linear actuator extends between the first region and the second region” of claim 8, “the telescoping member is arranged between the first and third regions and further comprising a first handle connected to the first member and a second handle connected to the second member, wherein user interaction with the first handle and the second handle linearly positions the first member and the second member relative to one another via the telescoping member for placing the device alternately in the open configuration and the closed configuration” of claim 9, “the telescoping member includes a first linear extending part attached to and extending parallel to one of the first and third linear regions”, “the telescoping member includes a second linear extending part attached to and extending parallel to the other of the first and third linear regions”, etc., i.e. the entirety of claim 10, “the second device is disposed within the third device” of claim 15, “passing a cerclage wire through the surgical site using the first device” of claim 16 line 10, “inserting the first member of the first device into the surgical site; circumnavigating the second region of the first member about an anatomical feature within the surgical site; inserting the cerclage wire through the at least one aperture within the first region of the elongated member of the first device; advancing the cerclage wire through the cannula of the first device; and removing the first device from the surgical site;” of claim 16 lines 12-18, “passing a terminal end of the cerclage wire into the locking mechanism of the second device; creating a tension within the cerclage wire by displacing the locking mechanism within the second device” of claim 16 lines 22-25, and “securing a first portion adjacent the terminal end of the cerclage wire using a third device; and cutting the terminal end of the cerclage wire using a fourth device” of claim 16 lines 27-29 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 Objections
Claim(s) 13 is/are objected to because of the following informalities:
Claim 13 line 17 should read “a second[[s]] shaft coaxially disposed”.
Appropriate correction is required.
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: “telescoping member” in claim 1 line 11, “locking mechanism” of claim 13 line 11, "cutting interface" of claim 13 line 19, “locking mechanism” of claim 16 line 20, and "cutting interface" of claim 16 lines 31-32.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 5-10 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claim 5, “the telescoping member is configured to slidably displace through approximately 90 to 270 degrees” appears to be new matter. That is, such does not appear to be described in the specification, shown in the drawings, and was not originally claimed for the telescoping member that overlaps both of the second region and fourth regions. Instead, paragraph 39 discloses that “telescoping portion 225 is structured to extend by 90 degrees or more such that the device 200 may circumnavigate within the range of 180 to 270 degrees. In various embodiments, the telescoping portion 225 is configured to extend by less than 90 degrees. In yet other embodiments, the telescoping portion 225 is configured to circumnavigate up to approximately 360 degrees.” Further, for the structure shown in Fig. 3, it does not appear to be physically possible for the telescoping portion 225 to slide 90-270 degrees. Thus, “the telescoping member is configured to slidably displace through approximately 90 to 270 degrees” constitutes new matter.
As to claim 6, “the telescoping member is configured to slidably displace through up to 360 degrees” appears to be new matter. That is, such does not appear to be described in the specification, shown in the drawings, and was not originally claimed for the telescoping member that overlaps both of the second region and fourth regions. Instead, paragraph 39 discloses that “telescoping portion 225 is structured to extend by 90 degrees or more such that the device 200 may circumnavigate within the range of 180 to 270 degrees. In various embodiments, the telescoping portion 225 is configured to extend by less than 90 degrees. In yet other embodiments, the telescoping portion 225 is configured to circumnavigate up to approximately 360 degrees.” Further, for the structure shown in Fig. 3, it does not appear to be physically possible for the telescoping portion 225 to slide up to 360 degrees. Thus, “the telescoping member is configured to slidably displace through up to 360 degrees” constitutes new matter.
As to claims 7 and 8, “linear actuator coupled to the telescoping member and being slidably disposed on one of the first region or the third region” of claim 7 and “the linear actuator extends between the first region and the second region” of claim 8 appears to be new matter. That is, such does not appear to be described in the specification, shown in the drawings, and was not originally claimed for the telescoping member that overlaps both of the second region and fourth regions. Instead, Fig. 3 indicates 235 along the second, hooked region of the first member and paragraph 40 discloses that 235 is an actuator. It does not appear that the arcuate motion indicated by 235 on second/hooked region 220 in Fig. 3 can be reasonably interpreted as linear or disposed on the first or third region. Thus, “linear actuator coupled to the telescoping member and being slidably disposed on one of the first region or the third region” of claim 7 and “the linear actuator extends between the first region and the second region” of claim 8 constitutes new matter.
As to claim 9, “the telescoping member is arranged between the first and third regions and further comprising a first handle connected to the first member and a second handle connected to the second member, wherein user interaction with the first handle and the second handle linearly positions the first member and the second member relative to one another via the telescoping member for placing the device alternately in the open configuration and the closed configuration” appears to be new matter. That is, such does not appear to be described in the specification, shown in the drawings, and was not originally claimed. Instead, the telescoping member is disclosed to be “coaxially disposed in an overlapping arrangement with one of the second region or the fourth region” (¶7), handle grip 145 is disclosed for the first member and handle 150 is disclosed for the second member which provide a sliding mechanism for relative movement of the first and second members (¶36). Thus, “the telescoping member is arranged between the first and third regions and further comprising a first handle connected to the first member and a second handle connected to the second member, wherein user interaction with the first handle and the second handle linearly positions the first member and the second member relative to one another via the telescoping member for placing the device alternately in the open configuration and the closed configuration” constitutes new matter.
As to claim 10, “the telescoping member includes a first linear extending part attached to and extending parallel to one of the first and third linear regions”, “the telescoping member includes a second linear extending part attached to and extending parallel to the other of the first and third linear regions”, etc., i.e. the entirety of claim 10, appears to be new matter. That is, such does not appear to be described in the specification, shown in the drawings, and was not originally claimed. Instead, the telescoping member is disclosed to be “coaxially disposed in an overlapping arrangement with one of the second region or the fourth region” (¶7) which claim 1 lines 4 and 7 define as being hooked. Thus, “the telescoping member includes a first linear extending part attached to and extending parallel to one of the first and third linear regions”, “the telescoping member includes a second linear extending part attached to and extending parallel to the other of the first and third linear regions”, etc., i.e. the entirety of claim 10, constitutes new matter.
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 and 13-16 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 recites/recite the limitation "the ends of the first and second terminal ends" in line 10. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “a closed configuration when there is no gap between the
Claim(s) 1 is/are unclear with regards to “telescoping member” in claim 1 line 11 and the intended structure in a manner that enables one to discern the claimed structure and equivalents thereof. This is particularly unclear in light of Applicant’s remarks dated September 24, 2025 that appear to be interpreting “telescoping” in a manner that is inconsistent with the originally filed disclosure, e.g. as a tongue and groove structure shown in Figs. 4-7 (Remarks p. 11). The only mention of a “telescoping member” in the original disclosure is in paragraph 7, which is not disclosed in reference to any shown embodiment nor is a description of the structure provided. Instead, paragraph 7 merely provides that the “telescoping member” is coaxially disposed in an overlapping arrangement with the second region/the fourth region and is slidably displaceable from the second region/fourth region to at least partially overlap with the other when the device is in a closed configuration. This seems to be consistent with the disclosed “telescoping portion” 225 of at least paragraphs 39 and 40 that is shown in Fig. 3. However, the structural description appears to be limited to ‘an end’ which may be blunted, may include a cap, or may include multiple telescoping members (¶40) and an end may be joined with the end of the second member (¶44), where the only one of these that appears to be shown is that the end may be blunted. With regards to Applicant’s argued tongue and groove structure of non-elected Figs. 4-7 as the asserted “telescoping member”, Examiner notes that this appears to refer to what Applicant’s original disclosure provides is a “slidable locking mechanism” 357 shown in Figs. 5-7 and disclosed in at least paragraph 47 to be a grooved member 360 with groove 365 that receives protruding member 370, i.e. a tongue-and-groove connection, that paragraph 47 discloses can include one or more “locking features”. Examiner notes that it is an unusual assertion to interpret the term “telescoping” as a tongue-and-groove connection in the art, which, while broadly accurate, is inconsistent with the usage of the term in Applicant’s original disclosure. Thus, when claims are considered in light of the specification, it would be improper to attribute “telescoping member” as the disclosed tongue-and-groove connection of 357 per paragraph 47 and Figs. 5-7. Examiner is interpreting the claimed “telescoping member” as referring to the originally disclosed “telescoping member” of paragraph 7 and the “telescoping portion” 225 of at least paragraphs 39 and 40, and suggests amending to clarify by claiming sufficient structure to invoke a broadest reasonable interpretation of the intended structure instead of interpretation under 35 USC 112f, e.g. by broadly claiming the structure shown in Fig. 3.
Claim(s) 1 is/are unclear with regards to how it is physically possible to have both a closed configuration when there is no gap between the first and second terminal ends and a telescoping member attached to at least one of the first and second members for changing between the open and closed configurations of the device in lines 9-14 and where such is supported by the original disclosure. That is, it is unclear how the first and second terminal ends can have no gap between then and have the telescoping member for changing between the open and closed configurations as it appears that, if the terminal ends can achieve a configuration with no gap, then the telescoping member does not function in changing between the open and closed configurations of the device as claimed. Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 13 is/are unclear with regards to “a first device for passing cerclage wire constructed according to the device defined in claim 1,” in lines 3-4 and the cerclage wire claimed to be “constructed to the device defined in claim 1” as the device of claim 1 does not construct a cerclage wire. Examiner is interpreting this as referring to, and suggests amending as, “a first device for passing cerclage wire, the first device comprising of claim 1”.
Claim(s) 16 is/are unclear with regards to “providing a first device constructed according to the device defined in claim 1,” in lines 3-4 and the cerclage wire claimed to be “constructed to the device defined in claim 1” as the device of claim 1 does not construct a cerclage wire. Examiner is interpreting this as referring to, and suggests amending as, “providing a first device comprising of claim 1”.
Claim(s) 14 and 15 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 § 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) 1 and 4-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al. (US 2007/0088362, hereinafter “Bonutti”) in view of German (US 2022/0330996), further in view of Acker et al. (US 2004/0010264, hereinafter “Acker”).
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 claims 1 and 4-8, Bonutti discloses a device (20, Figs. 19 and 1-4) capable of passing cerclage wire (56, Figs. 19 and 1-4), the device comprising: a first member (24) having a first region (linear region of 24 as shown in Figs. 19 and 1-4, Figs. 19 and 1-4) and a second region (28, i.e. arcuate lower region of 24 as shown in Figs. 19 and 1-4, Figs. 19 and 1-4), the first member having a cannula (lumen of ¶49, ¶s 49 and 81, where ¶81 discloses pushrod 54 moving through the lumen of 24 to position fastener 52 with suture 56 as shown in Fig. 4) with a central axis formed therein (along the linear region, Figs. 19 and 1-4), the first region being substantially linear in shape (as defined, Figs. 19 and 1-4) and the second region being hooked (as defined, Figs. 19 and 1-4) and having a first terminal end (lower end as shown in Figs. 19 and 1-4, Figs. 19 and 1-4); a second member (32) having a third region (linear region of 84 as shown in Figs. 19 and 1-4, Figs. 19 and 1-4) and a fourth region (96), the second member having a second cannula (lumen of ¶108, Fig. 19, ¶s 98 and 108 disclose passage of the drill system, suture claw, and suture) with a central axis formed therein (along the linear region, Figs. 19 and 1-4), the third region being substantially linear in shape (as defined, Figs. 19 and 1-4) and the fourth region being hooked (as defined, Fig. 19) and having a second terminal end (lower end as shown in Fig. 19, Fig. 19), wherein the first and third linear regions extend generally parallel to one another (¶51) and wherein the device has an open configuration (Fig. 19) when there is a gap (Fig. 19) between the first and second terminal ends (Fig. 19); and wherein the first region includes at least one aperture (opening at upper end of 24 as shown receiving sutures 56 and pushrod 54 in Fig. 4, Fig. 4) that is fluidly connected to the cannula (in order to pass the sutures 56 and pushrod 54 to the position shown Fig. 4 as disclosed in ¶81, Fig. 4, ¶81) and capable of receiving cerclage wire (56) and the third region includes at least one aperture (opening at upper end of 84 as shown in Fig. 19, Fig. 19, ¶108) fluidly connected with the second cannula (Fig. 19, ¶108), wherein the fourth region comprises a deformable bone contacting surface (88, ¶101).
Bonutti is silent to the first and third linear regions extend parallel to one another, wherein the device has a closed configuration when there is no gap between the first and second terminal ends, and a telescoping member attached to at least one of the first and second members and being movable in one direction or the other of the central axis of a cannula portion in the first or second member adjacent the telescoping member for changing between the open and closed configurations of the device. As to claim 4, Bonutti is silent to the telescoping member is coaxially disposed in an overlapping arrangement with one of the second region or the fourth region in the open configuration, the telescoping member being slidably displaceable from the one of the second region or the fourth region to at least partially overlap with both of the second region and the fourth region in the closed configuration. As to claim 5, Bonutti is silent to the telescoping member is configured to slidably displace through approximately 90 to 270 degrees. As to claim 6, Bonutti is silent to the telescoping member is configured to slidably displace through up to 360 degrees. As to claim 7, Bonutti is silent to a linear actuator coupled to the telescoping member and being slidably disposed on one of the first region or the third region, wherein displacement of the linear actuator causes displacement of the telescoping member. As to claim 8, Bonutti is silent to the linear actuator extends between the first region and the second region.
German teaches a similar device (100, Figs. 1-17) capable of passing cerclage wire (400, Figs. 15-17), the device comprising: a first member (130, 140) having a first region (130) and a second region (140), the first member having a cannula (180, Figs. 11, 12, and 16) with a central axis formed therein (Figs. 11, 12, and 16), the first region being substantially linear in shape (Fig. 16) and the second region being hooked (Fig. 16, ¶31) and having a first terminal end (144, Fig. 10); a second member (230, 240) having a third region (230) and a fourth region (240), the second member having a second cannula (280, Figs. 12, 14, and 16) with a central axis formed therein (Figs. 12, 14, and 16), the third region being substantially linear in shape (Fig. 16) and the fourth region being hooked (Figs. 12, 14, and 16) and having a second terminal end (244, Figs. 12, 14, and 16), wherein the device has an open configuration (prior to insertion of 244 into 144, Fig. 2, ¶48) when there is a gap between the first and second terminal ends (prior to insertion of 244 into 144, Fig. 2, ¶48) and a closed configuration (Figs. 11, 12, and 16) when there is no gap between the first and second terminal ends (Figs. 11, 12, and 16, ¶47); and the second terminal end slides into the first terminal end (Figs. 11, 12, and 16, ¶48), wherein the first region includes at least one aperture (134) that is fluidly connected to the cannula (Fig. 16, ¶46) and capable of receiving cerclage wire (400, ¶46) and the third region includes at least one aperture (280) fluidly connected with the second cannula (Fig. 14, ¶47), wherein the fourth region comprises a portion of the cannula of the second member (Fig. 14) and an elongated portion (234) configured to contact a bone surface (Figs. 16 and 17) and provide clear passage for a cerclage wire into or from the first member (Figs. 16 and 17).
Acker teaches a similar device (Figs. 1-11) capable of passing cerclage wire (cable of ¶5, ¶5), the device comprising: a first member (220, 230) having a first reg