Detailed Action
This is the final office action for US application number 19/040,753. Claims are evaluated as filed on May 22, 2026.
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 Arguments
Applicant's arguments filed May 22, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Zwirkoski, Bryan, and Gramnas teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that they are being deprived of the opportunity to elect to use means-plus-function language because there is no “means for” in the specification and there is no such requirement in MPEP 2163.02 and 2163.02 (Remarks p. 8), Examiner notes that MPEP 2163 provides guidelines under 35 USC 112a, i.e. the written description requirement. Review of the non-final office action dated May 5, 2026 shows that no rejections were issued under 35 USC 112a; that is, it has NOT been asserted that the original claims dated April 7, 2026 comprised new matter. Nonetheless Examiner notes that MPEP 2163.02 provides that “An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.”…. Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, inventor was in possession of the invention as now claimed….. An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention….. The subject matter of the claim need not be described literally (i.e., using the same terms or in haec verba) in order for the disclosure to satisfy the description requirement. If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application.” That is, Examiner acted in compliance with MPEP 2163.02 in concluding that subject matter not clearly described in the application was not in compliance in providing clear support for limitations that were not described in reference to any described structure and appropriately provided rejections under 35 USC 112b as detailed on pages 14-23 of the non-final office action dated May 5, 2026.
Further, MPEP 2181(II) addresses the description necessary to support 35 USC 112f claim limitations wherein “35 U.S.C. 112(f) states that a claim limitation expressed in means- (or step-) plus-function language "shall be construed to cover the corresponding structure…described in the specification and equivalents thereof." "If one employs means plus function language in a claim, one must set forth in the specification an adequate disclosure showing what is meant by that language. If an applicant fails to set forth an adequate disclosure, the applicant has in effect failed to particularly point out and distinctly claim the invention as required by the 35 U.S.C. 112(b)”. MPEP 2181(II)(A) provides that “The proper test for meeting the definiteness requirement is that the corresponding structure (or material or acts) of a means- (or step-) plus-function limitation must be disclosed in the specification itself in a way that one skilled in the art will understand what structure (or material or acts) will perform the recited function. … ”. Thus, as Examiner was unable to identify such a description, the lack of clarity was appropriately detailed in the rejections under 35 USC 112b as provided on pages 14-23 of the non-final office action dated May 5, 2026. Examiner notes that Applicant has chosen not to identify any supporting descriptions that might identify the scope or intended structures of the originally filed means-plus-function language and has instead amended the claims to use language appropriately interpreted under a broadest reasonable interpretation. That is, Applicant has not been denied any opportunity to use means-plus-function language as argued but has instead made the choice to not identify the intended scope of the originally filed claims and provide new claims.
With regards to Applicant’s argument that the instant amendments are broadening in that “strings” of section 112 limit the scope to structure disclosed in the specification and equivalents thereto are no longer attached to the claims (Remarks p. 8), Examiner notes that the tremendous lack of clarity of the previous claims renders a direct comparison of the breadth of the scope impossible. Further, this argument is unclear as the what applicant is referring to as “strings” or to what section of 35 USC 112 this is intended to refer.
With regards to Applicant’s argument that Bryan can’t work if its telescoping structure is removed from the proximal location as it must be able to see the indicia on a distal location occupied by device 432 being advanced over the wire for the cap covering the distal end of the housing (Remarks p. 8), Examiner notes that it has not been proposed to remove any feature from Bryan or to modify the device of Bryan; thus, this argument is moot. Further, the embodiment of Bryan that include an element 432 have not been relied upon; thus, this argument is moot.
Claim Objections
Claim(s) 1-7 and 15-22 is/are objected to because of the following informalities:
Claim 1 line 1 should read “An apparatus[[,]] comprising:
Claim 1 lines 7-10 should read “the plate being biased to a first orientation[[,]] in which the surgical guide wire can move proximally through the opening and is prevented from being moved distally though the opening, the plate being capable of moving to a second configuration[[,]] in which the surgical guidewire can move both proximally and distally through the opening; and”.
Claims 2-7 and 22 should read “The apparatus of [[C]]claim”.
Claim 15 line 1 should read “A medical device[[,]] comprising:
Claim 15 lines 5-7 should read “the plate being biased to a first orientation[[,]] in which the guide wire can move axially through the opening in only one direction, the plate being movable to a second configuration[[,]] in which the guidewire can move axially through the opening in two directions;”.
Claims 16 and 20 should read “The medical device of [[C]]claim 15[[,]] comprising:”.
Claims 17-19 and 21 should read “The medical device of [[C]]claim”.
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: “a manually manipulable release element” in claims 6 and 20 and “an extending element” of claims 15 and 22.
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-3 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,226,135, i.e. application 18/440,809. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a genus of the claims of U.S. Patent No. 12,226,135.
Claim 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 12,226,135, i.e. application 18/440,809. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a genus of the claims of U.S. Patent No. 12,226,135.
Claim 6 is are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 12,226,135, i.e. application 18/440,809. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a genus of the claims of U.S. Patent No. 12,226,135.
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) 6 and 15-22 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) 6 and 20 are unclear with regards to “a manually manipulable release element” in line 1 as there appears to be no such disclosed structure or definition thereof originally disclosed to enable one to ascertain the intended scope and equivalents thereof. Examiner is interpreting this as referring to the portion of the plate that is shown in Figs. 9H and 9I extending outside of the housing and suggests amending to clarify.
Claim(s) 15 and 22 are unclear with regards to “an extending element” in line 1 as there appears to be no such disclosed structure or definition thereof originally disclosed to enable one to ascertain the intended scope and equivalents thereof. Examiner is interpreting this as referring to the post 235 as labeled on Fig. 2 and suggests amending to clarify.
Claim(s) 16-19 and 21 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) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zwirkoski et al. (US 2013/0079776, hereinafter "Zwirkoski") in view of Bryan et al. (US 2012/0203237, hereinafter "Bryan").
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, Zwirkoski discloses an apparatus (Figs. 21a-23) comprising: a device (2101, 2103, Figs. 21a-23) capable of advancement along a surgical guide wire (2205, Figs. 22a-23), wherein the device comprises: a housing (2101) through which the surgical guide wire can extend from a proximal aperture of the housing to a distal aperture of the housing (Figs. 22a and 22b); a plate (portion of 2103 positioned within 2101 in Fig. 22b, Fig. 22b) within the housing (in as much as Applicants’, Figs. 22a and 22b) between the proximal and distal apertures (Figs. 22a and 22b) and formed with an opening through which the surgical guide wire can extend (Figs. 22a and 22b), the plate being biased to a first orientation (Figs. 22a and 22b, ¶125 discloses being spring loaded) in which the surgical guide wire can move proximally through the opening and is prevented from being moved distally though the opening (Figs. 22a and 22b, ¶125), the plate being capable of moving to a second configuration (when 2101 is reversed on the wire towards a perpendicular orientation as described in ¶125, ¶125) in which the surgical guidewire can move both proximally and distally through the opening (¶125). As to claim 2, Zwirkoski discloses that the first orientation is an oblique orientation relative to an axis defined between the apertures (Fig. 22b). As to claim 3, Zwirkoski discloses that the plate is biased to the first orientation by a spring (¶125). As to claim 5, Zwirkoski discloses that the spring is a first spring (as defined, ¶125). As to claim 6, Zwirkoski discloses a manually manipulable release element (portion of 2103 positioned outside of 2101 in Fig. 22b, Fig. 22b) capable of moving the plate toward the second orientation (Fig. 22b, ¶125). As to claim 7, Zwirkoski discloses plate engagement with the surgical guidewire (Fig. 22b).
Zwirkoski is silent to a cap covering the distal aperture of the housing and formed with a hole through which the surgical guidewire can extend, the cap being axially movable relative to the housing and being biased distally relative to the housing. As to claim 4, Zwirkoski is silent to the cap is biased distally by a spring disposed between the cap and a distal portion of the housing. As to claim 5, Zwirkoski is silent to the cap is biased distally by a second spring disposed between the cap and a distal portion of the housing. As to claim 7, Zwirkoski is silent to movement of the cap relative to the housing absorbs backlash in plate engagement with the surgical guidewire.
Bryan teaches a similar apparatus (100, Figs. 3 and 5, ¶s 23 and 29; where ¶23 discloses that 110 includes an unshown clip selectively opening and closing by a user to grip and release the guide wire and 129 discloses that the indicator scale can be on one of 112 and 102) comprising: a device (100) capable of advancement along a surgical guide wire (Fig. 3, ¶23), wherein the device comprises: a housing (102) through which the surgical guide wire can extend from a proximal aperture of the housing to a distal aperture of the housing (Fig. 3); a guidewire connector (110, ¶24); and a cap (112) covering the distal aperture of the housing (Fig. 3) and formed with a hole (Fig. 3) through which the surgical guidewire can extend (Fig. 3), the cap being axially capable of moving relative to the housing (Fig. 3) and being biased distally relative to the housing (Fig. 3) by a second spring (220, Fig. 3, ¶21). As to claim 4, Bryan teaches that to the cap is biased distally by a spring (220, Fig. 3, ¶21) disposed between the cap and a distal portion of the housing (Fig. 3). As to claim 5, Bryan teaches that the cap is biased distally by a second spring (220, Fig. 3, ¶21) disposed between the cap and a distal portion of the housing (Fig. 3). As to claim 7, Bryan teaches that movement of the cap relative to the housing absorbs backlash (Fig. 3).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify device as disclosed by Zwirkoski by adding the cap and second spring as taught by Bryan in order to provide a quantitative indication of the longitudinal distance traveled by the cap with respect to the housing during movement (Bryan ¶29) to measure the compression involved in achieving the desired compression location (Zwirkoski ¶s 8 and 125) to aid in selection of an appropriately sized permanent fixation member for maintaining the desired compression.
As a result, as to claim 7, the combination of Zwirkoski and Bryan discloses movement of the cap relative to the housing absorbs backlash in plate engagement with the surgical guidewire (Bryan Fig. 3; Zwirkoski Fig. 22b).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zwirkoski and Bryan in view of Gramnas (US 6,235,062).
As to claim 22, the combination of Zwirkoski and Bryan discloses the invention of claim 1.
The combination of Zwirkoski and Bryan is silent to a fulcrum on the housing to limit movement of the plate in a first direction; and an extending element on the housing opposite the fulcrum with respect to the plate to limit movement of the plate in a second direction.
Gramnas teaches a similar apparatus (Figs. 1-4) comprising: a device (1) capable of advancement along a surgical guide wire (similar to that shown with peg 2 in Fig. 3, Fig. 3), wherein the device comprises: a housing (4) through which the surgical guide wire can extend from a proximal aperture of the housing to a distal aperture of the housing (Fig. 3); a plate (5) within the housing between the proximal and distal apertures (Fig. 3) and formed with an opening (Figs. 1-3) through which the surgical guide wire can extend (Fig. 3), the plate being biased to a first orientation (Fig. 3) in which the surgical guide wire can move proximally through the opening and is prevented from being moved distally though the opening (Fig. 3, col. 2 lines 12-18), the plate being capable of moving to a second configuration (when 6 acts against the force of springs 7 and 8 as described in col. 2 lines 18-22, col. 2 lines 18-22) in which the surgical guidewire can move both proximally and distally through the opening (when 6 acts against the force of springs 7 and 8 as described in col. 2 lines 18-22, col. 2 lines 18-22); and a fulcrum (62, Figs. 3 and 4, col. 3 lines 14-16) on the housing to limit movement of the plate in a first direction (Figs. 3 and 4, col. 3 lines 14-16); and an extending element (9, Fig. 3, col. 2 lines 55-60) on the housing opposite the fulcrum with respect to the plate (in as much as Applicant’s, Fig. 3) capable of limiting movement of the plate in a second direction (Fig. 3).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the housing as disclosed by the combination of Zwirkoski and Bryan to specify that the connection between the housing and the plate comprises a fulcrum and add the extending element as taught by Gramnas in order to secure the locking action of the plate (Gramnas col. 2 lines 23-27 and 50-60).
Claim(s) 15, 17, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zwirkoski in view of Gramnas.
As to claims 15, 17, 18, and 20, Zwirkoski discloses a medical device (2101, 2103, Figs. 21a-23) comprising: a housing (2101) through which a guide wire (2205, Figs. 22a-23) can extend from a proximal aperture of the housing to a distal aperture of the housing (Figs. 22a and 22b); a plate (portion of 2103 positioned within 2101 in Fig. 22b, Fig. 22b) within the housing (in as much as Applicants’, Figs. 22a and 22b) between the proximal and distal apertures (Figs. 22a and 22b) and formed with an opening through which the guide wire can extend (Figs. 22a and 22b), the plate being biased to a first orientation (Figs. 22a and 22b, ¶125 discloses being spring loaded) in which the guide wire can move axially through the opening in only one direction (Figs. 22a and 22b, ¶125), the plate being capable of moving to a second configuration (when 2101 is reversed on the wire towards a perpendicular orientation as described in ¶125, ¶125) in which the guidewire can move axially through the opening in two directions (¶125). As to claim 17, Zwirkoski discloses that the first orientation is an oblique orientation relative to an axis defined between the apertures (Fig. 22b). As to claim 18, Zwirkoski discloses that the plate is biased to the first orientation by a spring (¶125). As to claim 20, Zwirkoski discloses a manually manipulable release element (portion of 2103 positioned outside of 2101 in Fig. 22b, Fig. 22b) capable of moving the plate toward the second orientation (Fig. 22b, ¶125).
Zwirkoski is silent to a fulcrum on the housing to limit movement of the plate in a first direction; and an extending element on the housing opposite the fulcrum with respect to the plate to limit movement of the plate in a second direction.
Gramnas teaches a similar medical device (1) comprising: a housing (4) through which a surgical guide wire (similar to that shown with peg 2 in Fig. 3, Fig. 3) can extend from a proximal aperture of the housing to a distal aperture of the housing (Fig. 3); a plate (5) within the housing between the proximal and distal apertures (Fig. 3) and formed with an opening (Figs. 1-3) through which the surgical guide wire can extend (Fig. 3), the plate being biased to a first orientation (Fig. 3) n which the guide wire can move axially through the opening in only one direction (Fig. 3, col. 2 lines 12-18), the plate being capable of moving to a second configuration (when 6 acts against the force of springs 7 and 8 as described in col. 2 lines 18-22, col. 2 lines 18-22) in which the guidewire can move axially through the opening in two directions (when 6 acts against the force of springs 7 and 8 as described in col. 2 lines 18-22, col. 2 lines 18-22); and a fulcrum (62, Figs. 3 and 4, col. 3 lines 14-16) on the housing to limit movement of the plate in a first direction (Figs. 3 and 4, col. 3 lines 14-16); and an extending element (9, Fig. 3, col. 2 lines 55-60) on the housing opposite the fulcrum with respect to the plate (in as much as Applicant’s, Fig. 3) capable of limiting movement of the plate in a second direction (Fig. 3).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the housing as disclosed by Zwirkoski to specify that the connection between the housing and the plate comprises a fulcrum and add the extending element as taught by Gramnas in order to secure the locking action of the plate (Gramnas col. 2 lines 23-27 and 50-60).
Claim(s) 16, 19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zwirkoski and Gramnas in view of Bryan.
As to claims 16, 19, and 21, the combination of Zwirkoski and Gramnas discloses the invention of claim 15. As to claim 21, the combination of Zwirkoski and Gramnas discloses plate engagement with the surgical guidewire (Fig. 22b).
The combination of Zwirkoski and Gramnas is silent to a cap covering the distal aperture of the housing and formed with a hole through which the surgical guidewire can extend, the cap being axially movable relative to the housing and being biased distally relative to the housing. As to claim 19, the combination of Zwirkoski and Gramnas is silent to the cap is biased distally by a spring disposed between the cap and a distal portion of the housing. As to claim 20, the combination of Zwirkoski and Gramnas is silent to movement of the cap relative to the housing absorbs backlash in plate engagement with the surgical guidewire.
Bryan teaches a similar medical device (100, Figs. 3 and 5, ¶s 23 and 29; where ¶23 discloses that 110 includes an unshown clip selectively opening and closing by a user to grip and release the guide wire and 129 discloses that the indicator scale can be on one of 112 and 102) comprising: a housing (102) through which a guide wire (Fig. 3, ¶23) can extend from a proximal aperture of the housing to a distal aperture of the housing (Fig. 3); a guidewire connector (110, ¶24); and a cap (112) covering the distal aperture of the housing (Fig. 3) and formed with a hole (Fig. 3) through which the surgical guidewire can extend (Fig. 3), the cap being axially capable of moving relative to the housing (Fig. 3) and being biased distally relative to the housing (Fig. 3) by a second spring (220, Fig. 3, ¶21). As to claim 19, Bryan teaches that to the cap is biased distally by a spring (220, Fig. 3, ¶21) disposed between the cap and a distal portion of the housing (Fig. 3). As to claim 20, Bryan teaches that movement of the cap relative to the housing absorbs backlash (Fig. 3).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify device as disclosed by the combination of Zwirkoski and Gramnas by adding the cap and second spring as taught by Bryan in order to provide a quantitative indication of the longitudinal distance traveled by the cap with respect to the housing during movement (Bryan ¶29) to measure the compression involved in achieving the desired compression location (Zwirkoski ¶s 8 and 125) to aid in selection of an appropriately sized permanent fixation member for maintaining the desired compression.
As a result, as to claim 20, the combination of Zwirkoski, Gramnas, and Bryan discloses movement of the cap relative to the housing absorbs backlash in plate engagement with the surgical guidewire (Bryan Fig. 3; Zwirkoski Fig. 22b).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Monday through Thursday, 6:30am-4pm EST.
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
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