Detailed Action
This is the final office action for US application number 18/601,319. Claims are evaluated as filed on January 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 January 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 Garcia teaches all the newly-amended limitations and is 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 Applicant respectfully traverses the obviousness-type double patenting rejection (Remarks p. 12), Examiner notes that no reasoning is provided. Thus, the double patenting rejection has been considered in light of the claim amendments filed January 22, 2026 and repeated where appropriate below.
With regards to Applicant’s clarifying remarks regarding the intended support for the claimed middle portion, indented portion, and “across the width” terminology (Remarks p. 12-15), Examiner thanks Applicant for the clarification and notes that it appears that the only embodiment that comprises all of such a middle portion, indented portion, and gap above the central portion of the caddy is that of plate 700 and caddy 500 as shown in Figs. 43-47, 54-56, 74, and 75.
With regards to Applicant’s argument that paragraph 103 discloses that the central connection strategy allows the caddy to be flexed or rocked side to side as a direct consequence of the geometry and placement of the connection and enables the caddy to remain properly registered with the plate apertures when the plate is flexed over a curved bone surface and by allowing controlled relative angular motion about a localized central region the caddy can accommodate angular mismatch at the fastener locations without loss of alignment (Remarks p. 15-17), Examiner notes that review of paragraph 103 shows that it is discloses that “once the fasteners 70 are advanced into the bone plate 700 and bone, the fastener caddy 500 can be pulled, rocked, and/or twisted off given the flexibility of the fastener caddy 500” (¶103). There appears to be no support in the specification for the asserted ability of the caddy to flex or rock side to side to maintain aperture alignment when the plate is flexed over a curved bone surface as appears to be argued.
With regards to Applicant’s argument that Garcia does not disclose a pivot-capable connection (Remarks p. 17), Examiner notes that as shown in Applicant’s Figs. 74 and 75, when the caddy is clipped to the bone plate the lower surfaces of the caddy rest upon the surfaces of the plate, similar to that of Garcia; where Garcia Figs. 40, 41, and 43 show similar clip-plate interactions with the lower surfaces of the caddy rest upon the surfaces of the plate as shown in Applicant’s Fig. 74 and similar clips across the indented portion as shown in Applicant’s Fig. 75. Thus, it is unclear how it can be reasonably asserted that the capability of similarly shown structures differs. Thus, it appears that Garcia discloses a pivot-capable connection in as much as Applicant’s connection is pivot-capable.
With regards to Applicant’s argument that Garcia discloses rigid, longitudinal structures that are rails or tabs 1056 that constrain relative motion between the fixture and the plate and enforce a fixed angular relationship between them which is mechanically incompatible with the rocking motion required by the present claims as Garcia’s rails span a substantial length of the plate and eliminate an localized pivot axis and prevent relative angular motion between the fixture and the plate where paragraph 293 reflects the underlying assumption that such remain aligned during use (Remarks p. 17-19), Examiner notes that the assertion that Garcia’s 1056 are rigid, longitudinal structures that are rails that constrain relative motion between the fixture and the plate and enforce a fixed angular relationship therebetween does not appear to be founded in the disclosure of Garcia. Instead, Garcia discloses that the tabs 1056s clip to the plate to prevent relative sliding (¶334) and Figs. 41 and 43 show that 1056 extends slightly under the plate. Therefore, the clips 1056s must be capable of flexing sufficiently to attach and detach from the plate in order for the shown positioning to be achieved and for the plate to remain attached to the bone following the procedure, i.e. cannot be fully rigid as appears to be argued. Garcia is silent as to the material used for the cited plate 1016, but does disclose such in regards to other embodiments, including that plate 16 and 3716 are metallic and/or polymeric materials that may be relatively flexible to enable the plate to conform to the contours of the bone when the plate is fastened thereto (¶s 288, 405, 497). Thus, it appears unreasonable to infer that the plate 1016 and caddy have a rigid angular relationship when such are disclosed to be connected via the clips 1056. Further, Examiner notes that there has been no claim limitation provided to require a capability of the caddy to rock relative to the plate or for the caddy to have relative angular motion between the fixture and the plate as appears to be argued. In regards to Garcia paragraph 293, such is a description of an uncited embodiment of Figs. 8 and 9, which is shown to be a very different structure from that cited in the rejection, i.e. Figs. 40-43. Further, paragraph 293 simply indicates that the apertures of the caddy align with the apertures of the plate. Thus, it is unclear what is intended by Applicant’s comments regarding the disclosure of remaining aligned during use as such is also the function provided by Applicant’s device.
With regards to Applicant’s argument that the present invention expressly recognizes that bone plates often flex when applied to curved bone surfaces and that a cady rigidly locked will not remain properly aligned which is a problem solved by the centralized, localized connection that allows the caddy to rock as needed while remaining referenced to the plate (Remarks p. 18), Examiner notes that no citation has been provided to indicate where such is expressly recognized for the present disclosure. Instead, review of the specification for ‘flex’ reveals only discussions regarding the caddy materials and review of paragraph 103 shows no mention of the caddy being able to rocking while remaining connected to the plate as appears to be asserted.
With regards to Applicant’s argument that Garcia’s figures illustrate fixtures that span large portions of the bone plate and include multiple fastener guides simultaneously engaging the bone plate which precludes rocking or pivoting about a central region (Remarks p. 18), Examiner notes that the presence of additional guide features in the manner shown in Figs. 40, 41, and 43 does not prevent rocking or pivoting as such are shown to merely rest on a surface of the plate. Further, a broad comparison of the space surrounding the clip in Applicant’s Fig. 75 shows that 519 appears to rest in a defined portion of the indent with no space on either side to permit the argued pivoting whereas Garcia Figs. 41 and 43 show that 1056 is not as long as the indent and thus has space around the clip that could permit pivoting. Thus, it is unclear how it can reasonably be asserted that Applicant’s caddy pivots relative to the plate and Garcia’s device cannot pivots relative to the plate as the structures of Garcia are shown to be similar and have space surrounding the clip that could permit the argued pivoting.
With regards to Applicant’s argument that the installation structures shown in Figs. 32, 34, and 35 cover substantially the entire plate and thus rule out the possibility of a central connection that permits side-to-side rocking as recited in the present claims (Remarks p. 18), Examiner notes as an initial matter, that such is not recited in claim 34. Further, Examiner notes that the embodiment of Figs. 32, 34, and 35 has not been relied upon nor does such show a caddy for guiding bone screws. Thus, this argument appears moot.
With regards to Applicant’s argument that, in conclusion, Garcia fails to disclose a caddy connected to the bone plate only at a central region, a connection across the width of the indented section using localized clip portions, or a structure that permits the caddy to rock relative to the bone plate to accommodate bone plate flexing (Remarks p. 18), Examiner notes that it has not been claimed that the caddy is connected to the bone plate only at a central region or that the caddy is permitted to rock relative to the bone plate to accommodate bone plate flexing nor does such appear to be supported by the original disclosure. As detailed below and in the non-final office action dated October 23, 2025, Garcia discloses clips 1056 that provide the argued connection across the width of the indented section using localized clip portions and are capable of permitting the caddy to rock relative to the bone plate to accommodate bone plate flexing due to the structure shown in Figs. 40, 41, and 43.
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 application, Application No. 17/114,566, fails 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. 17/114,566 fails to provide adequate support for “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” in claim 21 lines 28-30, claim 30 lines 32-34, and claim 36 lines 28-30.
The disclosure of the prior-filed application, Application No. 16/802,713, fails 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. 16/802,713 fails to provide adequate support for “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” in lines 28-30, claim 30 lines 32-34, and claim 36 lines 28-30.
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 21, the specification appears to lack proper antecedent basis for “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” in lines 28-30. That is, the specification appears to be silent to the caddy being able to be rocked when attached to the plate and instead discloses in paragraph 103 that the caddy can be rocked off given the flexibility of the caddy. Further, the only embodiment shown to comprise all of the claimed plate middle portion, plate indented section, and caddy gap appears to be that of Figs. 43-47, 54-56, 74, and 75 for plate 700 and caddy 500; however, Fig. 75 shows that tab 519 or clip 518 is confined without any space on either side that could potentially permit such rocking while the plate and caddy maintain connection. Finally, such was not originally claimed. Thus, the specification fails to provide proper antecedent basis for “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” in lines 28-30.
As to claim 30, the specification appears to lack proper antecedent basis for “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” in lines 32-34. That is, the specification appears to be silent to the caddy being able to be rocked when attached to the plate and instead discloses in paragraph 103 that the caddy can be rocked off given the flexibility of the caddy. Further, the only embodiment shown to comprise all of the claimed plate middle portion, plate indented section, and caddy gap appears to be that of Figs. 43-47, 54-56, 74, and 75 for plate 700 and caddy 500; however, Fig. 75 shows that tab 519 or clip 518 is confined without any space on either side that could potentially permit such rocking while the plate and caddy maintain connection. Finally, such was not originally claimed. Thus, the specification fails to provide proper antecedent basis for “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” in lines 32-34.
As to claim 36, the specification appears to lack proper antecedent basis for “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” in lines 28-30. That is, the specification appears to be silent to the caddy being able to be rocked when attached to the plate and instead discloses in paragraph 103 that the caddy can be rocked off given the flexibility of the caddy. Further, the only embodiment shown to comprise all of the claimed plate middle portion, plate indented section, and caddy gap appears to be that of Figs. 43-47, 54-56, 74, and 75 for plate 700 and caddy 500; however, Fig. 75 shows that tab 519 or clip 518 is confined without any space on either side that could potentially permit such rocking while the plate and caddy maintain connection. Finally, such was not originally claimed. Thus, the specification fails to provide proper antecedent basis for “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” in lines 28-30.
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 “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” of claim 21 lines 28-30, “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” of claim 30 lines 32-34, and “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” of claim 36 lines 28-30 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.
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.
Claims 34 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 11,957,394. 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 species of U.S. Patent No. 11,957,394.
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) 21-26, 28-30, 32, 33, and 36 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 21-26, 28, and 29, “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” in claim 21 lines 28-30 appears to be new matter. That is, the specification appears to be silent to the caddy being able to be rocked when attached to the plate and instead discloses in paragraph 103 that the caddy can be rocked off given the flexibility of the caddy. Further, the only embodiment shown to comprise all of the claimed plate middle portion, plate indented section, and caddy gap appears to be that of Figs. 43-47, 54-56, 74, and 75 for plate 700 and caddy 500; however, Fig. 75 shows that tab 519 or clip 518 is confined without any space on either side that could potentially permit such rocking while the plate and caddy maintain connection. Finally, such was not originally claimed. Thus, “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” in claim 21 lines 28-30 constitutes new matter.
As to claims 30, 32, and 33, “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” in claim 30 lines 32-34 appears to be new matter. That is, the specification appears to be silent to the caddy being able to be rocked when attached to the plate and instead discloses in paragraph 103 that the caddy can be rocked off given the flexibility of the caddy. Further, the only embodiment shown to comprise all of the claimed plate middle portion, plate indented section, and caddy gap appears to be that of Figs. 43-47, 54-56, 74, and 75 for plate 700 and caddy 500; however, Fig. 75 shows that tab 519 or clip 518 is confined without any space on either side that could potentially permit such rocking while the plate and caddy maintain connection. Finally, such was not originally claimed. Thus, “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” in claim 30 lines 32-34 constitutes new matter.
As to claim 36, “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” in lines 28-30 appears to be new matter. That is, the specification appears to be silent to the caddy being able to be rocked when attached to the plate and instead discloses in paragraph 103 that the caddy can be rocked off given the flexibility of the caddy. Further, the only embodiment shown to comprise all of the claimed plate middle portion, plate indented section, and caddy gap appears to be that of Figs. 43-47, 54-56, 74, and 75 for plate 700 and caddy 500; however, Fig. 75 shows that tab 519 or clip 518 is confined without any space on either side that could potentially permit such rocking while the plate and caddy maintain connection. Finally, such was not originally claimed. Thus, “first and second clip portions that provide a connection to the base plate in a manner to allow the caddy to be rocked when attached to the bone plate” in lines 28-30 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) 21-26, 28-30, 32, 33, and 36 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) 21 recites/recite the limitation "the base plate" in line 29. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, "the [[base]]bone plate".
Claim(s) 30 recites/recite the limitation "the base plate" in line 33. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, "the [[base]]bone plate".
Claim(s) 22-26, 28, 29, 32, 33, and 36 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) 21-26, 28-30, 32-34, and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garcia et al. (US 2015/0038969, hereinafter “Garcia”).
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 21, Garcia discloses a surgical bone plate and caddy assembly (1016, 1044, Figs. 40-43) comprising: a) a bone plate (1016) comprising first and second, spaced apart segments (segment shown comprising upper aperture 1019 as shown in Fig. 41, segment shown comprising right aperture 1019 as shown in Fig. 41, Fig. 41) connected by a middle portion (portion shown in Fig. 41 between first and second segments and between clips 1056, Fig. 41, ¶334), wherein each of the first and second segments comprises a top surface (Fig. 45), a bottom surface (Fig. 41), an indented section (adjacent middle portion in as much as Applicant’s, Figs. 41 and 45), and first and second bone plate fastener apertures (1019s), wherein in each of the first and second segments the indented section is between the first and second bone plate fastener apertures of said segment (as defined, Figs. 41 and 45) and has a first peripheral edge (outer edge, Figs. 41 and 45), a second peripheral edge (inner edge, Figs. 41 and 45), and a width (Figs. 41 and 45) extending across the indented section from the first peripheral edge to the second peripheral edge (Figs. 41 and 45); b) a caddy (upper 150, right 1050, right pair of 1056s as shown in Fig. 41, Figs. 40 and 41, ¶334) connected to the first and second peripheral edges of the indented section of the first segment of the bone plate (Figs. 40 and 41, ¶334), wherein the caddy comprises: i) a first body (upper 150 as shown in Fig. 41, Figs. 40 and 41) comprising a first caddy fastener aperture (upper 1058 as shown in Fig. 41, Figs. 40 and 41) formed in the first body (Fig. 41), wherein the first caddy fastener aperture extends from a top fastener opening (Figs. 40 and 41) to a bottom fastener opening (Figs. 40 and 41), and wherein the first caddy fastener aperture is aligned with the first bone plate fastener aperture of the first segment of the bone plate (Figs. 40 and 41, ¶334); ii) a second body (right 1058 as shown in Fig. 41, Figs. 40 and 41) comprising a second caddy fastener aperture (right 1058 as shown in Fig. 41, Figs. 40 and 41) formed in the second body (Fig. 41), wherein the second caddy fastener aperture extends from a top fastener opening (Figs. 40 and 41) to a bottom fastener opening (Figs. 40 and 41), and wherein the second caddy fastener aperture is aligned with the second bone plate fastener aperture of the first segment of the bone plate (Figs. 40 and 41, ¶334); iii) a central portion (1056s and portions connecting 1056s to 1050s, Figs. 40 and 41, ¶334) located between the first and second bodies such that a gap (Figs. 40 and 41) is formed between the first and second bodies above the central portion (Figs. 40 and 41), wherein the central portion is connected to the first and second peripheral edges of the indented section of the first segment of the bone plate (Figs. 40 and 41, ¶334) such that the central portion removably connects the caddy to the first segment at first and second connections (1056s, Figs. 40 and 41, ¶334) across the width of the indented section between the first and second bodies and between the first and second bone plate fastener apertures of the first segment (in as much as Applicant’s, Figs. 40 and 41), wherein the first and second connections comprise first and second clip portions (1056s, Figs. 40 and 41, ¶334) that provide a connection (1056s, Figs. 40 and 41, ¶334) to the bone plate in a manner capable of allowing the caddy to be rocked when attached to the bone plate (due to the structure shown in Figs. 40, 41, and 43, the caddy is capable of being rocked in order to detach from the plate as well as relative to the plate due to the free space shown alongside at least the outer 1056 before contacting the first/second aperture portion of the plate, Figs. 40, 41, and 43, ¶334 discloses 1056 clip 1044 to 1016; thus, such must be capable of flexing/deflecting to achieve the shown position and permit removal of the caddy when the plate remains attached to bone at the completion of surgery); c) a first fastener (upper 1021 as shown in Fig. 41, Figs. 40 and 41) inserted into and held in the first caddy fastener aperture of the first body (Figs. 40 and 41, ¶334) in a manner such that the first caddy fastener aperture holds the first fastener as the first fastener is advanced through the first caddy fastener aperture into the aligned first bone plate fastener aperture in a direction from the top fastener opening toward the bottom fastener opening of the first caddy fastener aperture (Figs. 40 and 41, ¶334); and d) a second fastener (right 1021 as shown in Fig. 41, Figs. 40 and 41) inserted into and held in the second caddy fastener aperture of the second body (Figs. 40 and 41, ¶334) in a manner such that the second caddy fastener aperture holds the second fastener as the second fastener is advanced through the second caddy fastener aperture into the aligned second bone plate fastener aperture in a direction from the top fastener opening toward the bottom fastener opening of the second caddy fastener aperture (Figs. 40 and 41, ¶334).
As to claim 22, Garcia discloses that both of said first and second clip portions deflect to remove the caddy from the bone plate (Figs. 40, 41, and 43, ¶334 discloses pairs of 1056s that clip to the plate; where Fig. 43 show that 1056 extends slightly under the plate and therefore must deflect to achieve such positioning).
As to claim 23, Garcia discloses that each fastener of the first and second fasteners includes a head (upper portion of 1021 as shown in Figs. 40, 41, and 43, i.e. see illustration of enlarged portion of Fig. 43, Figs. 40, 41, and 43), and wherein each of said first and second caddy fastener apertures includes a rim (see illustration of enlarged portion of Fig. 43, Fig. 43) , wherein the rim of the first caddy fastener aperture engages the head of the first fastener (Fig. 43) and wherein the rim of the second caddy fastener aperture engages the head of the second fastener (Fig. 43).
As to claim 24, Garcia discloses that each of the plurality of first and second fasteners comprises a threaded shank (see illustration of enlarged portion of Fig. 43, Fig. 43) and a threaded head (see illustration of enlarged portion of Fig. 43, Fig. 43).
As to claim 25, Garcia discloses that the threaded head of each of the fasteners is tapered (Fig. 43).
As to claim 26, Garcia discloses that the central portion includes an aperture (see illustration of enlarged portion of Fig. 43, Fig. 43).
As to claim 28, Garcia discloses comprising an additional caddy (lower 150, left 1050, left pair of 1056s as shown in Fig. 41, Figs. 40 and 41, ¶334) connected to the first and second peripheral edges of the indented section of the second segment of the bone plate (Figs. 40 and 41, ¶334), wherein the additional caddy comprises :i) a first body (lower 150 as shown in Fig. 41, Figs. 40 and 41) comprising a first caddy fastener aperture (lower 1058 as shown in Fig. 41, Figs. 40 and 41) formed in the first body of the additional caddy (Fig. 41), wherein the first caddy fastener aperture of the additional caddy extends from a top fastener opening (Figs. 40 and 41) to a bottom fastener opening (Figs. 40 and 41), and wherein the first caddy fastener aperture of the additional caddy is aligned with the first bone plate fastener aperture of the second bone plate segment (Figs. 40 and 41, ¶334); ii) a second body (left 150 as shown in Fig. 41, Figs. 40 and 41) comprising a second caddy fastener aperture (left 1058 as shown in Fig. 41, Figs. 40 and 41) formed in the second body of the additional caddy (Fig. 41), wherein the second caddy fastener aperture of the additional caddy extends from a top fastener opening (Figs. 40 and 41)to a bottom fastener opening (Figs. 40 and 41), and wherein the second caddy fastener aperture of the additional caddy is aligned with the second bone plate fastener aperture of the second bone plate segment (Figs. 40 and 41, ¶334); and iii) a central portion located (1056s and portions connecting 1056s to 1050s, Figs. 40 and 41, ¶334) between the first and second bodies of the additional caddy such that a gap (Figs. 40 and 41) is formed between the first and second bodies of the additional caddy above the central portion of the additional caddy (Figs. 40 and 41), wherein the central portion of the additional caddy is connected to the first and second peripheral edges of the indented section of the first bone plate segment (Figs. 40 and 41) such that the central portion of the additional caddy removably connects the additional caddy to the second bone plate segment at first and second connections (1056s, Figs. 40 and 41, ¶334) across the width of the indented section of the second bone plate segment between the first and second bodies of the additional caddy and between the first and second bone plate fastener apertures of the second bone plate segment (in as much as Applicant’s, Figs. 40 and 41).
As to claim 29, Garcia discloses comprising: a) a third fastener (lower 1021 as shown in Fig. 41, Figs. 40 and 41) inserted into and held in the first caddy fastener aperture of the first body of the additional caddy (Figs. 40 and 41, ¶334) in a manner such that the additional caddy holds the third fastener as the third fastener is advanced through the first caddy fastener aperture of the additional caddy into the aligned first bone plate fastener aperture of the second segment in a direction from the top fastener opening toward the bottom fastener opening of the first caddy fastener aperture of the additional caddy; (Figs. 40 and 41, ¶334) and b) a fourth fastener (left 1021 as shown in Fig. 41, Figs. 40 and 41) inserted into and held in the second caddy fastener aperture of the second body of the additional caddy (Figs. 40 and 41, ¶334) in a manner such that the additional caddy holds the fourth fastener as the fourth fastener is advanced through the second caddy fastener aperture of the additional caddy into the aligned second bone plate fastener aperture of the second segment in a direction from the top fastener opening toward the bottom fastener opening of the second caddy fastener aperture of the additional caddy (Figs. 40 and 41, ¶334).
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As to claim 30, Garcia discloses a method (Figs. 40-45, ¶334) of installing fasteners (1021s) into a bone plate (1016, Figs. 40-45, ¶334), the method comprising the steps of: a) providing the bone plate (Figs. 40-45), said bone plate comprising first and second, spaced apart segments (segment shown comprising upper aperture 1019 as shown in Fig. 41, segment shown comprising right aperture 1019 as shown in Fig. 41, Fig. 41) connected by a middle portion (portion shown in Fig. 41 between first and second segments and between clips 1056, Fig. 41, ¶334), wherein each of the first and second segments comprises a top surface (Fig. 45), a bottom surface (Fig. 41), an indented section (adjacent middle portion in as much as Applicant’s, Figs. 41 and 45), and first and second bone plate fastener apertures (1019s), wherein in each of the first and second segments the indented section is between the first and second bone plate fastener apertures of said segment (as defined, Figs. 41 and 45) and has a first peripheral edge (outer edge, Figs. 41 and 45), a second peripheral edge (inner edge, Figs. 41 and 45), and a width (Figs. 41 and 45) extending across the indented section from the first peripheral edge to the second peripheral edge (Figs. 41 and 45); b) providing a caddy (upper 150, right 1050, right pair of 1056s as shown in Fig. 41, Figs. 40 and 41, ¶334), said caddy comprising: i) a first body (upper 150 as shown in Fig. 41, Figs. 40 and 41) comprising a first caddy fastener aperture (upper 1058 as shown in Fig. 41, Figs. 40 and 41) formed in the first body (Fig. 41), wherein the first caddy fastener aperture extends from a top fastener opening (Figs. 40 and 41) to a bottom fastener opening (Figs. 40 and 41); ii) a second body (right 1058 as shown in Fig. 41, Figs. 40 and 41) comprising a second caddy fastener aperture (right 1058 as shown in Fig. 41, Figs. 40 and 41) formed in the second body (Fig. 41), wherein the second caddy fastener aperture extends from a top fastener opening (Figs. 40 and 41) to a bottom fastener opening (Figs. 40 and 41); iii) a central portion (1056s and portions connecting 1056s to 1050s, Figs. 40 and 41, ¶334) located between the first and second bodies such that a gap (Figs. 40 and 41) is formed between the first and second bodies above the central portion (Figs. 40 and 41); iv) a first fastener (upper 1021 as shown in Fig. 41, Figs. 40 and 41) held in the first caddy fastener aperture (Figs. 40 and 41, ¶334), wherein the first caddy fastener aperture holds the first fastener (Figs. 40 and 41, ¶334); and v) a second fastener (right 1021 as shown in Fig. 41, Figs. 40 and 41) held in the second caddy fastener aperture (Figs. 40 and 41, ¶334), wherein the second caddy fastener aperture holds the second fastener (Figs. 40 and 41, ¶334); c) connecting the central portion of the caddy to the first and second peripheral edges of the indented section of the first segment of the bone plate (Figs. 40 and 41, ¶334) such that the first caddy fastener aperture is aligned with the first bone plate fastener aperture of the first segment of the bone plate (Figs. 40 and 41, ¶334) and the second caddy fastener aperture is aligned with the second bone fastener plate aperture of the first segment of the bone plate (Figs. 40 and 41, ¶334) and such that the central portion removably connects the caddy to the first segment of the bone plate at first and second connections (1056s, Figs. 40 and 41, ¶334) across the width of the indented section of the first segment of the bone plate between the first and second bodies of the caddy and between the first and second bone plate fastener apertures of the first segment of the bone plate (in as much as Applicant’s, Figs. 40 and 41), wherein the first and second connections comprise first and second clip portions (1056s, Figs. 40 and 41, ¶334) that provide a connection (1056s, Figs. 40 and 41, ¶334) to the bone plate in a manner capable of allowing the caddy to be rocked when attached to the bone plate (due to the structure shown in Figs. 40, 41, and 43, the caddy is capable of being rocked in order to detach from the plate as well as relative to the plate due to the free space shown alongside at least the outer 1056 before contacting the first/second aperture portion of the plate, Figs. 40, 41, and 43, ¶334 discloses 1056 clip 1044 to 1016; thus, such must be capable of flexing/deflecting to achieve the shown position and permit removal of the caddy when the plate remains attached to bone at the completion of surgery); d) while the central portion of the caddy connects the caddy to the first segment of the bone plate, advancing each of the first and second fastener through bottom openings of the first and second bone plate fastener apertures, respectively, to secure the bone plate to a bone (Figs. 40, 41, 43, 44, and 45, ¶s 334 and 339); and e) removing the caddy from the bone plate (Fig. 45, ¶339).
As to claim 32, Garcia discloses that the caddy is flexible (Figs. 40, 41, and 43, ¶334 discloses pairs of 1056s that clip to the plate; where Fig. 43 show that 1056 extends slightly under the plate and therefore must flex/deflect to achieve such positioning), and wherein the removing step comprises flexing the flexible caddy (Figs. 40, 41, and 43, ¶334 discloses pairs of 1056s that clip to the plate; where Fig. 43 show that 1056 extends slightly under the plate and therefore must flex/deflect to achieve such positioning).
As to claim 33, Garcia discloses further comprising a) providing an additional caddy (lower 150, left 1050, left pair of 1056s as shown in Fig. 41, Figs. 40 and 41, ¶334) comprising :i) a first body (lower 150 as shown in Fig. 41, Figs. 40 and 41) comprising a first caddy fastener aperture (lower 1058 as shown in Fig. 41, Figs. 40 and 41) formed in the first body of the additional caddy (Fig. 41), wherein the first caddy fastener aperture of the additional caddy extends from a top fastener opening (Figs. 40 and 41) to a bottom fastener opening (Figs. 40 and 41); ii) a second body (left 150 as shown in Fig. 41, Figs. 40 and 41) comprising a second caddy fastener aperture (left 1058 as shown in Fig. 41, Figs. 40 and 41) formed in the second body of the additional caddy (Fig. 41), wherein the second caddy fastener aperture of the additional caddy extends from a top fastener opening (Figs. 40 and 41)to a bottom fastener opening (Figs. 40 and 41); iii) a central portion located (1056s and portions connecting 1056s to 1050s, Figs. 40 and 41, ¶334) between the first and second bodies of the additional caddy such that a gap (Figs. 40 and 41) is formed between the first and second bodies of the additional caddy above the central portion of the additional caddy (Figs. 40 and 41); iv) a third fastener (lower 1021 as shown in Fig. 41, Figs. 40 and 41) held in the first caddy fastener aperture of the additional caddy (Figs. 40 and 41, ¶334), wherein the first caddy fastener aperture of the additional caddy holds the third fastener (Figs. 40 and 41, ¶334); and b) a fourth fastener (left 1021 as shown in Fig. 41, Figs. 40 and 41) held in the second caddy fastener aperture of the additional caddy (Figs. 40 and 41, ¶334), wherein the second caddy fastener aperture of the additional caddy holds the fourth fastener (Figs. 40 and 41, ¶334); b) connecting the central portion of the additional caddy to the first and second peripheral edges of the indented section of the second segment of the bone plate (Figs. 40 and 41, ¶334) such that the first caddy fastener aperture of the additional caddy is aligned with the first bone plate fastener aperture of the second segment of the bone plate (Figs. 40 and 41, ¶334) and the second caddy fastener aperture of the additional caddy is aligned with the second bone fastener plate aperture of the second segment of the bone plate (Figs. 40 and 41, ¶334) and such that the central portion of the additional caddy removably connects the caddy to the second segment of the bone plate at first and second connections (1056s, Figs. 40 and 41, ¶334) across the width of the indented section of the second segment of the bone plate between the first and second bodies of the additional caddy and between the first and second bone plate fastener apertures of the second segment of the bone plate (in as much as Applicant’s, Figs. 40 and 41); c) while the central portion of the additional caddy connects the additional caddy to the second segment of the bone plate, advancing each of the third and fourth fastener through bottom openings of the first and second bone plate fastener apertures of the additional caddy, respectively, to secure the bone plate to a bone (Figs. 40, 41, 43, 44, and 45, ¶s 334 and 339); and d) removing the additional caddy from the bone plate (Fig. 45, ¶339).
As to claim 34, Garcia discloses a surgical fastener caddy guide (1044, Figs. 40-43) that is capable of being removably connected to a bone plate (1016) comprising first and second bone plate fastener apertures (1019s), said caddy comprising: a) a first body (upper 150 as shown in Fig. 41, Figs. 40 and 41) comprising a first caddy fastener aperture (upper 1058 as shown in Fig. 41, Figs. 40 and 41) formed in the first body (Fig. 41), wherein the first caddy fastener aperture extends from a top fastener opening (Figs. 40 and 41) to a bottom fastener opening (Figs. 40 and 41), and wherein the first caddy fastener aperture is aligned with the first bone plate fastener aperture when the fastener caddy guide is connected to the bone plate (Figs. 40 and 41, ¶334); ii) a second body (right 1058 as shown in Fig. 41, Figs. 40 and 41) comprising a second caddy fastener aperture (right 1058 as shown in Fig. 41, Figs. 40 and 41) formed in the second body (Fig. 41), wherein the second caddy fastener aperture extends from a top fastener opening (Figs. 40 and 41) to a bottom fastener opening (Figs. 40 and 41), and wherein the second caddy fastener aperture is aligned with the second bone plate fastener aperture when the fastener caddy guide is connected to the bone plate (Figs. 40 and 41, ¶334); iii) a central portion (1056s and portions connecting 1056s to 1050s, Figs. 40 and 41, ¶334) located between the first and second bodies such that a gap (Figs. 40 and 41) is formed between the first and second bodies above the central portion (Figs. 40 and 41), wherein the central portion includes a first clip portion (outer periphery 1056, Figs. 40 and 41, ¶334) that removably couples the caddy to a first peripheral edge of the bone plate at a first connection between the first and second bodies (Figs. 40 and 41, ¶334) and a second clip portion (outer periphery 1056, Figs. 40 and 41, ¶334) that removably couples the caddy to a second peripheral edge of the bone plate at a second connection between the first and second bodies (Figs. 40 and 41, ¶334).
As to claim 36, Garcia discloses a method (Figs. 40-45, ¶334) of assembling a surgical bone plate (1016) and fastener caddy (1044, Figs. 40-45, ¶334), the method comprising the steps of: a) providing the bone plate (Figs. 40-45), said bone plate comprising a first segment (segment shown comprising upper aperture 1019 as shown in Fig. 41), wherein the first segment comprises a top surface (Fig. 45), a bottom surface (Fig. 41), an indented section (adjacent middle portion in as much as Applicant’s, Figs. 41 and 45), and first and second bone plate fastener apertures (1019s), wherein the indented section is between the first and second bone plate fastener apertures of said first segment (as defined, Figs. 41 and 45) and has a first peripheral edge (outer edge, Figs. 41 and 45), a second peripheral edge (inner edge, Figs. 41 and 45), and a width (Figs. 41 and 45) extending across the indented section from the first peripheral edge to the second peripheral edge (Figs. 41 and 45); b) providing the fastener caddy, said caddy comprising: i) a first body (upper 150 as shown in Fig. 41, Figs. 40 and 41) comprising a first caddy fastener aperture (upper 1058 as shown in Fig. 41, Figs. 40 and 41) formed in the first body (Fig. 41), wherein the first caddy fastener aperture extends from a top fastener opening (Figs. 40 and 41) to a bottom fastener opening (Figs. 40 and 41); ii) a second body (right 1058 as shown in Fig. 41, Figs. 40 and 41) comprising a second caddy fastener aperture (right 1058 as shown in Fig. 41, Figs. 40 and 41) formed in the second body (Fig. 41), wherein the second caddy fastener aperture extends from a top fastener opening (Figs. 40 and 41) to a bottom fastener opening (Figs. 40 and 41); and iii) a central portion (1056s and portions connecting 1056s to 1050s, Figs. 40 and 41, ¶334) located between the first and second bodies such that a gap (Figs. 40 and 41) is formed between the first and second bodies above the central portion (Figs. 40 and 41); and c) connecting the central portion of the caddy to the first and second peripheral edges of the indented section of the first segment of the bone plate (Figs. 40 and 41, ¶334) such that the first caddy fastener aperture is aligned with the first bone plate fastener aperture of the first segment of the bone plate (Figs. 40 and 41, ¶334) and the second caddy fastener aperture is aligned with the second bone fastener plate aperture of the first segment of the bone plate (Figs. 40 and 41, ¶334) and such that the central portion removably connects the caddy to the first segment of the bone plate at first and second connections (1056s, Figs. 40 and 41, ¶334) across the width of the indented section of the bone plate segment between the first and second bodies of the caddy and between the first and second bone plate fastener apertures of the first bone plate segment (in as much as Applicant’s, Figs. 40 and 41), wherein the first and second connections comprise first and second clip portions (1056s, Figs. 40 and 41, ¶334) that provide a connection (1056s, Figs. 40 and 41, ¶334) to the bone plate in a manner capable of allowing the caddy to be rocked when attached to the bone plate (due to the structure shown in Figs. 40, 41, and 43, the caddy is capable of being rocked in order to detach from the plate as well as relative to the plate due to the free space shown alongside at least the outer 1056 before contacting the first/second aperture portion of the plate, Figs. 40, 41, and 43, ¶334 discloses 1056 clip 1044 to 1016; thus, such must be capable of flexing/deflecting to achieve the shown position and permit removal of the caddy when the plate remains attached to bone at the completion of surgery).
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