Detailed Action
This office action is for US application number 18/601,319 evaluates the claims 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 22, 2026 has been entered.
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 Garcia, Detweiler, and Whitaker 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 support for middle, indented, and gap features of the caddy are limited to plate 700 and caddy 500 as shown in Figs. 43-47, 54-56, 74, and 75 but the Office action overlooks Fig. 42 and caddy 500 (Remarks p. 13), Examiner agrees that Fig. 42 also shows caddy 500 having the claimed features and apologies for the typographical error.
With regards to Applicant’s argument that Figs. 48-53 show caddy 600 and paragraph 104 expressly states that this is similar to caddy 500 except that there is only a single fastener on each side (Remarks p. 13), Examiner agrees and notes that such provides the original disclosure for new claim 39.
With regards to Applicant’s argument that paragraph 103 expressly discloses that caddy 500 and its attachment features couple in the same manner as caddy 4 couples to plate 40 and consequently such are relevant to how caddy 500 engages the plate (Remarks p. 13), Examiner agrees and notes that it has not been asserted otherwise.
With regards to Applicant’s argument that the Office action overlooks other bone plate disclosures in paragraphs 107 and Figs. 66-68, paragraph 108 and Figs. 63-65, paragraphs109 and 110 for Figs. 66-68 and 69-71, paragraph 115 explains that caddies couple to plates 40, 700, etc., and many features like caddy 4 couple to plates in various ways (Remarks p. 13-14), Examiner notes that the relevance of this discussion is unclear and notes that it has not been asserted otherwise.
With regards to Applicant’s argument that paragraph 103 supports that when the caddy is attached to a bone plate, the caddy can be rocked (Remarks p. 14), Examiner notes that paragraph 103 discloses that “In the illustrated embodiments of FIGS. 42-47, no insertion tool is necessary to remove the fastener caddy 500 from the bone plate 700. Rather, 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. The flexibility is due to the materials used in the fastener caddy 500, the gap 551, and the openings 524, 525 in the central portion 522 of fastener caddy 500.” That is, rocking the caddy makes use of the flexibility of the caddy to remove the caddy from the plate. What was previously claimed was “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”. A disclosure of rocking the caddy makes use of the flexibility of the caddy to remove the caddy from the plate does not equate to support for having clip portions that allow the caddy to be rocked when attached to the plate as argued.
With regards to Applicant’s indication that the figure on Remarks p. 17 comprises red dashed lines, Examiners notes that documents are received as greyscale, which is discernable as dashed lines.
With regards to Applicant’s argument that Applicant’s caddy is attached at the connection portion across the width of the same connection portion which differentiates from Garcia as the Office action fails to establish how the tabs 1056 are configured to connect to the same connection portion as recited in the instant independent claims as Figs. 41 shows the 1056 on completely different connection portions (Remarks p. 16-22), Examiner notes that Applicant has made no comments or reference to the relied upon support for this feature, i.e. the disclosure of Garcia paragraph 334. Examiner agrees that the figures of Garcia do not to a great job of showing this feature, which is why paragraph 334 has been cited below as it was in prior office actions. Paragraph 334 discloses that “A pair of mounting tabs 1056 may extend downward from corresponding pairs of fastener guides 1050 so that the bracket 1016 may be received therebetween to restrict or prevent the base 1044 from sliding relative to the bracket 1016. In some embodiments, the tabs 1056 may clip the base 1044 to the bracket 1016.” That is, 2 tabs/clips extend downward from 2 caddy bodies as disclosed by Garcia paragraph 334 and therefore 4 tabs/clips extend downward from 4 caddy bodies instead of the 2 tabs/clips extending downward from 4 caddy bodies as illustrated in Applicant’s remarks. Examiner has provided illustrations of Garcia Figs. 41 and 43 in the below rejection in an attempt to render this more clear.
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. 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 “a gap is formed between the first and second bodies above the central portion” in claim 21 lines 27-28, claim 30 lines 21-22, claim 34 lines 19-20, and claim 36 lines 19-20.
Claim Objections
Claim(s) 21, 34, and 39 is/are objected to because of the following informalities:
Claim 21 lines 10-11 should read “a width extending across the connection portion in a direction from [[from ]]the first peripheral edge portion to the second peripheral edge portion;”.
Claim 34 lines 25-26 should read “wherein
Claim 39 lines 1-2 should read “wherein [[the]]each of the first body and the second body of the caddy comprises”.
Appropriate correction is required.
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 21, 22, 43, 38, 23-25, 28, 29, 30, 32, 33, and 36 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 21, 1, 3, 8, 9, 12, 12, 15-17, and 22 of U.S. Patent No. 11,957,394, respectively, i.e. as detailed in the table below. 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.
Instant claims
Claims U.S. Patent No. 11,957,394
21 and 22
1 and 2
43
21
44
2
38
1
23
3
24 and 25
8 and 9
28 and 29
12
30, 32, and 33
15-17
36
22
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) 41 and 42 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) 41 and 42 are unclear with regards to the claimed caddy further comprising the first/second fastener in line 1 of each of claims 41 and 42. That is, it is unclear how to reasonably construe a caddy to include fasteners. Examiner is interpreting this as referring to a system or kit that includes a caddy and fasteners, and suggests amending to clarify.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 23 and 24 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to reference to a claim previously set forth. That is, as written, claims 23 and 24 depend from claim 38. See MPEP 608.01(n) subsection III. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 22, 44, 26, 28, 29, 38, 23-35, 30, 32-34, 39, 40, 32, 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 a top surface (upper surface as shown in Figs. 40 and 43, Figs. 40 and 43), a bottom surface (lower surface as shown in Fig. 41, Fig. 41), a connection portion (see illustration of Fig. 41, Fig. 41), a first bone plate fastener aperture (1019, see illustration of Fig. 41, Fig. 41), and a second bone plate fastener aperture (1019, see illustration of Fig. 41, Fig. 41), wherein the connection portion of the bone plate extends between the first bone plate fastener aperture and the second bone plate fastener aperture (as defined, Fig. 41), the connection portion having a first peripheral edge portion (portion shown abutting the “First clip portion” as labeled on the illustration of Fig. 41, Fig. 41), a second peripheral edge portion (portion shown abutting the “Second clip portion” as labeled on the illustration of Fig. 41, Fig. 41) opposite the first peripheral edge portion (as defined, Fig. 41), and a width (Fig. 41) extending across the connection portion in a direction from the first peripheral edge portion to the second peripheral edge portion (as defined, Fig. 41); b) a caddy (left 1050, center 1050, and left pair of 1056s as shown in Fig. 43, Figs. 40-43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) capable of removingly connecting to the connection portion of the bone plate (Figs. 40 and 41, ¶334), wherein the caddy comprises: i) a first body (left 1050 as shown in Fig. 43, Figs. 40-43) comprising a first caddy fastener aperture (left 1058 as shown in Fig. 43, Fig. 43) formed in the first body (Fig. 43), wherein the first caddy fastener aperture extends from a top opening (upper portion of left 1058 as shown in Figs. 40 and 43, Figs. 40 and 43) to a bottom opening (lower portion of left 1058 as shown in Figs. 40 and 43, Fig. 41) and is capable of removingly holding a first fastener (left 1021 as shown in Fig. 43, Fig. 43), and wherein, while the caddy is removably connected to the connection portion, the first caddy fastener aperture is capable of being aligned with the first bone plate fastener aperture (Figs. 40-43); ii) a second body (front-center 1050 as shown in Fig. 43, Figs. 40-43) comprising a second caddy fastener aperture (front-center 1058 as shown in Fig. 43, Fig. 43) formed in the second body (Fig. 43), wherein the second caddy fastener aperture extends from a top opening (upper portion of front-center 1058 as shown in Figs. 40 and 43, Figs. 40 and 43) to a bottom opening (lower portion of front-center 1058 as shown in Figs. 40 and 43, Fig. 41) and is capable of removingly holding a second fastener (front-center 1021 as shown in Fig. 43, Fig. 43), and wherein, while the caddy is removably connected to the connection portion, the second caddy fastener aperture is capable of being aligned with the second bone plate fastener aperture (Figs. 40-43); iii) a central portion (see illustration of Fig. 43, Fig. 43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) located between the first and second bodies (as defined, Fig. 43) such that a gap (space between the first and second body and above the central portion as shown in Fig. 43, Fig. 43) is formed between the first and second bodies above the central portion (as defined, Fig. 43), wherein the central portion comprises a first connector (left 1056 as shown in Fig. 41, i.e. “First clip portion” as labeled on the illustration of Fig. 41, Fig. 41, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) and a second connector (“Second clip portion” as labeled on the illustration of Fig. 41, Fig. 41, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) each extending downwardly (Figs. 40, 41, and 43), wherein the first and second connectors are capable of engaging the connection portion of the bone plate across the width of the connection portion (in as much as Applicant’s, Figs. 40, 41, and 43, ¶334).
PNG
media_image1.png
784
1105
media_image1.png
Greyscale
PNG
media_image2.png
859
1058
media_image2.png
Greyscale
As to claim 22, Garcia discloses that the first and second connectors comprise first and second clip portions (see illustration of Fig. 41, Fig. 41) that are capable of providing respective first and second connections of the central portion of the caddy to the connection portion of the bone plate (Figs. 40, 41, and 43).
As to claim 44, Garcia discloses that both of the first and second clip portions deflect (Figs. 40, 41, and 43, ¶334 discloses pairs of 1056s that clip to the plate; where Fig. 43 shows that 1056 extends slightly under the plate and therefore must flex/deflect to achieve such positioning) to remove the caddy from the bone plate (Figs. 40, 41, 43, and 45, ¶334 discloses pairs of 1056s that clip to the plate; where Fig. 43 shows that 1056 extends slightly under the plate and therefore must flex/deflect to achieve such positioning).
As to claim 26, Garcia discloses that the central portion includes an aperture (defined by the central portion portions as labelled on the illustration of Fig. 43, Fig. 43).
As to claim 28, Garcia discloses an additional, separate caddy (right 1050, rear-center 1050, and right pair of 1056s as shown in Fig. 43, Figs. 40-43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) capable of removingly connecting to an additional, different connecting portion of the bone plate (see illustration of Fig. 41, Figs. 40 and 41, ¶334), wherein the additional, different connecting portion extends between additional bone plate fastener apertures in the bone plate (right 1019 and upper-center 1019 as shown in Fig. 41, Fig. 41) that are adjacent to the additional, different connecting portion (as defined, Fig. 41), wherein the additional caddy is capable of removingly holding at least one additional fastener (1021 as shown in Figs. 40-43, Figs. 40-43) capable of being advanced into a corresponding at least one of the additional bone plate fastener apertures of the bone plate (Figs. 40, 41, and 43).
As to claim 29, Garcia discloses that the additional caddy comprises: i) a first body (rear 1050 unshown in Fig. 43, Figs. 40-43) comprising a first caddy fastener aperture (rear 1058 unshown in Fig. 43, Fig. 43) capable of removingly holding a third fastener (1021), wherein the third fastener is capable of being advanced through the first caddy fastener aperture of the additional caddy and into an associated additional bone plate fastener aperture of the bone plate (Figs. 40-43); ii) a second body (right 1050 as shown in Fig. 43, Figs. 40-43) comprising a second caddy fastener aperture (right 1058 as shown in Fig. 43, Fig. 43) capable of removingly holding a fourth fastener (right 1021 as shown in Fig. 43, Fig. 43), wherein the fourth fastener is capable of being advanced through the second caddy fastener aperture of the additional caddy and into an associated additional bone plate fastener aperture of the bone plate (Figs. 40-43); iii) a central portion (defined by 1056s in the rear in the view of Fig. 43 and on the right in Fig. 41, Fig. 43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) located between the first and second bodies of the additional caddy (as defined, Fig. 43), wherein the central portion of the additional caddy is capable of removingly connecting to the additional connection portion of the bone plate (via clips 1056s, Figs. 40, 41, and 43, ¶334).
As to claim 38, Garcia discloses further comprising the first fastener and the second fastener (1021s, Figs. 40-43).
As to claim 23, Garcia discloses that each fastener of the first and second fasteners includes a head (see Fig. A, Fig. 43), and wherein each of said first and second caddy fastener apertures includes a rim (see Fig. A, Fig. 43), wherein the rim of the first caddy fastener aperture engages the head of the first fastener (see Fig. A, Fig. 43) and wherein the rim of the second caddy fastener aperture engages the head of the second fastener (see Fig. A, Fig. 43).
As to claim 24, Garcia discloses that each of the first and second fasteners comprises a threaded shank (see Fig. A, Fig. 43) and a threaded head (see Fig. A, Fig. 43).
As to claim 25, Garcia discloses that the threaded head of each of the fasteners is tapered (see Fig. A, Fig. 43).
PNG
media_image3.png
487
808
media_image3.png
Greyscale
Fig. A: Enlarged and annotated portion of Fig. 43.
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: a) providing the bone plate (1016), said bone plate comprising a top surface (upper surface as shown in Figs. 40 and 43, Figs. 40 and 43), a bottom surface (lower surface as shown in Fig. 41, Fig. 41), a connection portion (see illustration of Fig. 41, Fig. 41), a first bone plate fastener aperture (1019, see illustration of Fig. 41, Fig. 41), and a second bone plate fastener aperture (1019, see illustration of Fig. 41, Fig. 41), wherein the connection portion extends between the first bone plate fastener aperture and the second bone plate fastener aperture (as defined, Fig. 41), the connection portion having a first peripheral edge portion (portion shown abutting the “First clip portion” as labeled on the illustration of Fig. 41, Fig. 41), a second peripheral edge portion (portion shown abutting the “Second clip portion” as labeled on the illustration of Fig. 41, Fig. 41) opposite the first peripheral edge portion (as defined, Fig. 41), and a width (Fig. 41) extending across the connection portion in a direction from the first peripheral edge portion to the second peripheral edge portion (as defined, Fig. 41); b) providing a caddy (left 1050, center 1050, and left pair of 1056s as shown in Fig. 43, Figs. 40-43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050), said caddy comprising: i) a first body comprising a first caddy fastener aperture (left 1058 as shown in Fig. 43, Fig. 43) formed in the first body (Fig. 43), wherein the first caddy fastener aperture extends from a top opening (upper portion of left 1058 as shown in Figs. 40 and 43, Figs. 40 and 43) to a bottom opening (lower portion of left 1058 as shown in Figs. 40 and 43, Fig. 41); ii) a second (front-center 1050 as shown in Fig. 43, Figs. 40-43) comprising a second caddy fastener aperture (front-center 1058 as shown in Fig. 43, Fig. 43) formed in the second body (Fig. 43), wherein the second caddy fastener aperture extends from a top opening (upper portion of front-center 1058 as shown in Figs. 40 and 43, Figs. 40 and 43) to a bottom opening (lower portion of front-center 1058 as shown in Figs. 40 and 43, Fig. 41); iii) a central portion (see illustration of Fig. 43, Fig. 43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) located between the first and second bodies (as defined, Fig. 43) such that a gap (space between the first and second body and above the central portion as shown in Fig. 43, Fig. 43) is formed between the first and second bodies above the central portion (as defined, Fig. 43); iv) a first fastener (left 1021 as shown in Fig. 43, Fig. 43) removably held in the first caddy fastener aperture (Fig. 43); and v) a second fastener (front-center 1021 as shown in Fig. 43, Fig. 43) removably held in the second caddy fastener aperture (Fig. 43); c) connecting the central portion of the caddy to the connection portion of the bone plate (Figs. 40-43, ¶334) such that the first caddy fastener aperture is aligned with the first bone plate fastener aperture of the bone plate and the second caddy fastener aperture is aligned with the second bone fastener plate aperture of the bone plate (Figs. 40-43) and such that the central portion removably connects the caddy to the connection portion of the bone plate across the width of the connection portion (Figs. 40-43); d) while the central portion of the caddy connects the caddy to the connection portion of the bone plate, advancing each of the first and second fasteners through bottom openings of the first and second bone plate fastener apertures, respectively, to secure the bone plate to a bone (Figs. 40-43, ¶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 shows 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, 43, and 45, ¶334 discloses pairs of 1056s that clip to the plate; where Fig. 43 shows that 1056 extends slightly under the plate and therefore must flex/deflect to achieve such positioning).
As to claim 33, Garcia discloses a) providing an additional, separate caddy (right 1050, rear-center 1050, and right pair of 1056s as shown in Fig. 43, Figs. 40-43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050), wherein a third fastener (1021) and a fourth fastener (right 1021 as shown in Fig. 43, Fig. 43) are removably held in the additional, separate caddy (Fig. 43); b) connecting the additional, separate caddy to an additional connection portion of the bone plate (see illustration of Fig. 41, Figs. 40 and 41, ¶334) that extends between third and fourth bone plate fastener apertures of the bone plate (right 1019 and upper-center 1019 as shown in Fig. 41, Fig. 41) such that a first caddy fastener aperture of the additional caddy (rear 1050 unshown in Fig. 43, Figs. 40-43) holding the third fastener is aligned with the third bone plate fastener aperture of the bone plate (Figs. 40, 41, and 43) and a second caddy fastener aperture of the additional caddy (right 1050 as shown in Fig. 43, Figs. 40-43) holding the fourth fastener is aligned with the fourth bone fastener plate aperture of the bone plate (Figs. 40, 41, and 43); c) while the additional caddy connects the additional caddy to the additional connection portion of the bone plate, advancing each of the third and fourth fasteners through the third and fourth bone plate fastener apertures of the bone plate, respectively, to secure the bone plate to a bone (Figs. 40-43, ¶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 (left 1050, center 1050, and left pair of 1056s as shown in Fig. 43, Figs. 40-43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) that is capable of being removably connected to a bone plate (1016) comprising a first bone plate fastener aperture (1019, see illustration of Fig. 41, Fig. 41), a second bone plate fastener aperture (1019, see illustration of Fig. 41, Fig. 41), and a connection portion (see illustration of Fig. 41, Fig. 41) extending between the first bone plate fastener aperture and the second bone plate fastener aperture (as defined, Fig. 41), the connection portion having a first peripheral edge portion (portion shown abutting the “First clip portion” as labeled on the illustration of Fig. 41, Fig. 41) and a second peripheral edge portion opposite the first peripheral edge portion (portion shown abutting the “Second clip portion” as labeled on the illustration of Fig. 41, Fig. 41) and having a width (Fig. 41) extending across the connection portion in a direction from the first peripheral edge portion to the second peripheral edge portion (as defined, Fig. 41), said caddy comprising: i) a first body (left 1050 as shown in Fig. 43, Figs. 40-43) comprising a first caddy fastener aperture (left 1058 as shown in Fig. 43, Fig. 43) formed in the first body (Fig. 43), wherein the first caddy fastener aperture extends from a top opening (upper portion of left 1058 as shown in Figs. 40 and 43, Figs. 40 and 43) to a bottom opening (lower portion of left 1058 as shown in Figs. 40 and 43, Fig. 41) and is capable of removingly holding a first fastener (left 1021 as shown in Fig. 43, Fig. 43), 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 connection portion of the bone plate (Figs. 40-43); b) a second body (front-center 1050 as shown in Fig. 43, Figs. 40-43) comprising a second caddy fastener aperture (front-center 1058 as shown in Fig. 43, Fig. 43) formed in the second body (Fig. 43), wherein the second caddy fastener aperture extends from a top opening (upper portion of front-center 1058 as shown in Figs. 40 and 43, Figs. 40 and 43) to a bottom opening (lower portion of front-center 1058 as shown in Figs. 40 and 43, Fig. 41) and is capable of removingly holding a second fastener (front-center 1021 as shown in Fig. 43, Fig. 43), and wherein the second caddy fastener aperture is aligned with the second bone plate aperture when the fastener caddy guide is connected to the connection portion of the bone plate (Figs. 40-43); c) a central portion (see illustration of Fig. 43, Fig. 43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) located between the first and second bodies (as defined, Fig. 43) such that a gap (space between the first and second body and above the central portion as shown in Fig. 43, Fig. 43) is formed between the first and second bodies above the central portion (as defined, Fig. 43), wherein the central portion includes a first downwardly-extending clip portion (left 1056 as shown in Fig. 41, i.e. “First clip portion” as labeled on the illustration of Fig. 41, Figs. 40, 41, and 43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) between the first and second bodies (as defined, Figs. 40, 41, and 43) and a second downwardly-extending clip portion (“Second clip portion” as labeled on the illustration of Fig. 41, Figs. 40, 41, and 43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) opposite the first clip portion and between the first and second bodies (as defined, Figs. 40, 41, and 43), wherein the first and second downwardly-extending clip portions are capable of connecting to the connection portion of the bone plate across the width of the connection portion (in as much as Applicant’s, Figs. 40, 41, and 43, ¶334).
As to claim 39, Garcia discloses that each of the first body and the second body of the caddy comprises only a single caddy fastener aperture (as defined, Figs. 40, 41, and 43).
As to claim 41, Garcia discloses that further comprising the first fastener (left 1021 as shown in Fig. 43, Fig. 43), wherein the first fastener is removably held in the first caddy fastener aperture (Figs. 40, 41, and 43).
As to claim 42, Garcia discloses further comprising the second fastener (front-center 1021 as shown in Fig. 43, Fig. 43), wherein the second fastener is removably held in the second caddy fastener aperture (Figs. 40, 41, and 43).
As to claim 36, Garcia discloses a method (Figs. 40-45, ¶334) of assembling a surgical bone plate (1016) and fastener caddy (left 1050, center 1050, and left pair of 1056s as shown in Fig. 43, Figs. 40-43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050), the method comprising: a) providing the bone plate (1016), said bone plate comprising a top surface (upper surface as shown in Figs. 40 and 43, Figs. 40 and 43), a bottom surface (lower surface as shown in Fig. 41, Fig. 41), a connection portion (see illustration of Fig. 41, Fig. 41), a first bone plate fastener aperture (1019, see illustration of Fig. 41, Fig. 41), and a second bone plate fastener aperture (1019, see illustration of Fig. 41, Fig. 41), wherein the connection portion extends between the first bone plate fastener aperture and the second bone plate fastener aperture (as defined, Fig. 41), the connection portion having a first peripheral edge portion (portion shown abutting the “First clip portion” as labeled on the illustration of Fig. 41, Fig. 41), a second peripheral edge portion (portion shown abutting the “Second clip portion” as labeled on the illustration of Fig. 41, Fig. 41) opposite the first peripheral edge portion (as defined, Fig. 41), and a width (Fig. 41) extending across the connection portion in a direction from the first peripheral edge portion to the second peripheral edge portion (as defined, Fig. 41); b) providing the fastener caddy (left 1050, center 1050, and left pair of 1056s as shown in Fig. 43, Figs. 40-43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050), said caddy comprising: i) a first body comprising a first caddy fastener aperture formed in the first body (left 1050 as shown in Fig. 43, Figs. 40-43), wherein the first caddy fastener aperture extends from a top opening to a bottom opening (upper portion of left 1058 as shown in Figs. 40 and 43, Figs. 40 and 43) to a bottom opening (lower portion of left 1058 as shown in Figs. 40 and 43, Fig. 41); ii) a second (front-center 1050 as shown in Fig. 43, Figs. 40-43) comprising a second caddy fastener aperture (front-center 1058 as shown in Fig. 43, Fig. 43) formed in the second body (Fig. 43), wherein the second caddy fastener aperture extends from a top opening (upper portion of front-center 1058 as shown in Figs. 40 and 43, Figs. 40 and 43) to a bottom opening (lower portion of front-center 1058 as shown in Figs. 40 and 43, Fig. 41); and iii) a central portion (see illustration of Fig. 43, Fig. 43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) located between the first and second bodies (as defined, Fig. 43) such that a gap (space between the first and second body and above the central portion as shown in Fig. 43, Fig. 43) is formed between the first and second bodies above the central portion (as defined, Fig. 43); and c) connecting the central portion of the caddy to the connection portion of the bone plate (Figs. 40-43, ¶334) such that the first caddy fastener aperture is aligned with the first bone plate fastener aperture and the second caddy fastener aperture is aligned with the second bone fastener plate aperture (Figs. 40-43) and such that the central portion removably connects the caddy to the connection portion across the width of the connection portion (Figs. 40-43).
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) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garcia in view of Detweiler et al. (US 2019/0090925, hereinafter “Detweiler”).
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 43, Garcia discloses the invention of claim 21.
Garcia is silent to the connection portion comprises an indented section on the bottom surface of the bone plate extending between the first peripheral edge portion and the second peripheral edge portion.
Detweiler teaches a similar surgical bone plate and caddy assembly (400, 300, Figs. 10-19) comprising: a) a bone plate (400) comprising a top surface (Figs. 14 and 16), a bottom surface (Figs. 15 and 17), a connection portion (peripheral portions of 400, Figs. 14-16), a first bone plate fastener aperture (402), and a second bone plate fastener aperture (402), the connection portion having a first peripheral edge portion (outer peripheral portions of 400, Figs. 14-16), a second peripheral edge portion (inner peripheral portions of 400, Figs. 14-16) opposite the first peripheral edge portion (as defined, Figs. 14-16), and a width (Figs. 14-16) extending across the connection portion in a direction from the first peripheral edge portion to the second peripheral edge portion (as defined, Figs. 14-16); b) a caddy (300) capable of removingly connecting to the connection portion of the bone plate (Figs. 14-18), wherein the caddy comprises: i) a first body (302, Figs. 10-18) comprising a first caddy fastener aperture (centrally located, generally circular opening as shown in Fig. 13, Figs. 12-14) formed in the first body (Figs. 12-14), wherein the first caddy fastener aperture extends from a top opening (upper portion of the aperture as shown in Fig. 14) to a bottom opening (lower portion of the aperture as shown in Fig. 14) and is capable of removingly holding a first fastener (“fastener” of ¶59, ¶59), and wherein, while the caddy is removably connected to the connection portion, the first caddy fastener aperture is capable of being aligned with the first bone plate fastener aperture (Fig. 15); ii) a second body (314, Figs. 17-19) comprising a second caddy fastener aperture (centrally located, generally circular opening as shown in Fig. 19, Figs. 18 and 19) formed in the second body (Figs. 18 and 19), wherein the second caddy fastener aperture extends from a top opening (upper portion of the aperture as shown in Fig. 19)to a bottom opening (lower portion of the aperture as shown in Fig. 19) and is capable of removingly holding a second fastener (Fig. 19, ¶s 65-67), and wherein, while the caddy is removably connected to the connection portion, the second caddy fastener aperture is capable of being aligned with the second bone plate fastener aperture (Fig. 18); iii) a central portion (between the upper portion and the lower portion as shown in Fig. 13, Fig. 13), wherein the central portion comprises a first connector (left 308 as shown in Fig. 13, Fig. 13) and a second connector (right 308 as shown in Fig. 13, Fig. 13) each extending downwardly (Figs. 10-12, 14, 16, and 18), wherein the first and second connectors are capable of engaging the connection portion of the bone plate across the width of the connection portion (as defined, Figs. 14-18); wherein the connection portion comprises an indented section (404) on the bottom surface of the bone plate (Figs. 15 and 17) extending between the first peripheral edge portion and the second peripheral edge portion (as defined, Figs. 15 and 17); wherein the first and second connectors fit within the indented section of the connection portion (Figs. 15 and 17, ¶61).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the connection portion and the first and second connectors as disclosed by Garcia by adding an indented section to the connection portion and modifying the first and second connectors to fit therein as taught by Detweiler in order to removably couple the caddy to the plate (Detweiler ¶61; Garcia ¶334) by the first and second connectors moving/flexing away from one another and then snapping towards one another into the indented section (Detweiler ¶62).
Claim(s) 34 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Whitaker et al. (US 2018/0177510, hereinafter “Whitaker”) in view of Garcia.
As to claims 34 and 40, Whitaker discloses a surgical fastener caddy (1016, Figs. 12-25) that is capable of being removably connected to a bone plate (1012, Figs. 13 and 14) comprising a first bone plate fastener aperture (left-most 1028 as shown in Fig. 12, Fig. 12), a second bone plate fastener aperture (right-most 1028 as shown in Fig. 12, Fig. 12), and a connection portion (portion between the left-central 1028 and the right-central 1028 as shown in Figs. 12-14, Figs. 12-14) extending between the first bone plate fastener aperture and the second bone plate fastener aperture (as defined, Figs. 12-14), the connection portion having a first peripheral edge portion (front edge portion as shown in Figs. 12-14, Figs. 12-14) and a second peripheral edge portion (rear edge portion as shown in Fig. 14, Figs. 12-14) opposite the first peripheral edge portion (as defined, Figs. 12-14) and having a width (Figs. 12-14) extending across the connection portion in a direction from the first peripheral edge portion to the second peripheral edge portion (as defined, Figs. 12-14), said caddy comprising: a) a first body (left two 1078s as shown in Figs. 12-20, Figs. 12-20) comprising a first caddy fastener aperture (1088) formed in the first body (as defined, Figs. 12-20), wherein the first caddy fastener aperture extends from a top opening (upper portion of the aperture as shown in Fig. 20, Fig. 20) to a bottom opening (lower portion of the aperture as shown in Fig. 20, Fig. 20) and is capable of removingly holding a first fastener (1014, Fig. 22), 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 connection portion of the bone plate (Figs. 13, 14, and 21-25); b) a second body (right two 1078s as shown in Figs. 12-20, Figs. 12-20) comprising a second caddy fastener aperture (1088) formed in the second body (as defined, Figs. 12-20), wherein the second caddy fastener aperture extends from a top opening (upper portion of the aperture as shown in Fig. 20, Fig. 20) to a bottom opening (lower portion of the aperture as shown in Fig. 20, Fig. 20) and is capable of removingly holding a second fastener (1014, Fig. 22, ¶88), and wherein the second caddy fastener aperture is aligned with the second bone plate aperture when the fastener caddy guide is connected to the connection portion of the bone plate (Figs. 13, 14, and 21-25); c) a central portion (1066, Figs. 16-19) located between the first and second bodies (Figs. 16-19) such that a gap (space between the first and second body and above the central portion as shown in Fig. 17, Figs. 12-17) is formed between the first and second bodies above the central portion (as defined, Figs. 12-17), wherein the caddy includes a downwardly-extending plate alignment portion (1062, ¶95) capable of engaging the plate so that relative movement between the plate and the caddy is minimized or prevented in an attached configuration in which a portion of the caddy abuts a portion of the plate (¶95) and is capable of being removed from the plate after the fastener is secured to the plate (¶95). As to claim 40, Whitaker discloses that each of the first body and the second body of the caddy comprises an additional caddy fastener aperture (1088, Figs. 12-20) formed in the respective body (as defined, Figs. 12-20).
Whitaker is silent to wherein the central portion includes a first downwardly-extending clip portion between the first and second bodies and a second downwardly-extending clip portion opposite the first clip portion and between the first and second bodies, wherein the first and second downwardly-extending clip portions are configured to connect to the connection portion of the bone plate across the width of the connection portion.
Garcia teaches a similar surgical fastener caddy (left 1050, center 1050, and left pair of 1056s as shown in Fig. 43, Figs. 40-43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) that is capable of being removably connected to a bone plate (1016) comprising a first bone plate fastener aperture (1019, see illustration of Fig. 41, Fig. 41), a second bone plate fastener aperture (1019, see illustration of Fig. 41, Fig. 41), and a connection portion (see illustration of Fig. 41, Fig. 41) extending between the first bone plate fastener aperture and the second bone plate fastener aperture (as defined, Fig. 41), the connection portion having a first peripheral edge portion (portion shown abutting the “First clip portion” as labeled on the illustration of Fig. 41, Fig. 41) and a second peripheral edge portion opposite the first peripheral edge portion (portion shown abutting the “Second clip portion” as labeled on the illustration of Fig. 41, Fig. 41) and having a width (Fig. 41) extending across the connection portion in a direction from the first peripheral edge portion to the second peripheral edge portion (as defined, Fig. 41), said caddy comprising: i) a first body (left 1050 as shown in Fig. 43, Figs. 40-43) comprising a first caddy fastener aperture (left 1058 as shown in Fig. 43, Fig. 43) formed in the first body (Fig. 43), wherein the first caddy fastener aperture extends from a top opening (upper portion of left 1058 as shown in Figs. 40 and 43, Figs. 40 and 43) to a bottom opening (lower portion of left 1058 as shown in Figs. 40 and 43, Fig. 41) and is capable of removingly holding a first fastener (left 1021 as shown in Fig. 43, Fig. 43), 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 connection portion of the bone plate (Figs. 40-43); b) a second body (front-center 1050 as shown in Fig. 43, Figs. 40-43) comprising a second caddy fastener aperture (front-center 1058 as shown in Fig. 43, Fig. 43) formed in the second body (Fig. 43), wherein the second caddy fastener aperture extends from a top opening (upper portion of front-center 1058 as shown in Figs. 40 and 43, Figs. 40 and 43) to a bottom opening (lower portion of front-center 1058 as shown in Figs. 40 and 43, Fig. 41) and is capable of removingly holding a second fastener (front-center 1021 as shown in Fig. 43, Fig. 43), and wherein the second caddy fastener aperture is aligned with the second bone plate aperture when the fastener caddy guide is connected to the connection portion of the bone plate (Figs. 40-43); c) a central portion (see illustration of Fig. 43, Fig. 43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) located between the first and second bodies (as defined, Fig. 43) such that a gap (space between the first and second body and above the central portion as shown in Fig. 43, Fig. 43) is formed between the first and second bodies above the central portion (as defined, Fig. 43), wherein the central portion includes a first downwardly-extending clip portion (left 1056 as shown in Fig. 41, i.e. “First clip portion” as labeled on the illustration of Fig. 41, Figs. 40, 41, and 43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) between the first and second bodies (as defined, Figs. 40, 41, and 43) and a second downwardly-extending clip portion (“Second clip portion” as labeled on the illustration of Fig. 41, Figs. 40, 41, and 43, ¶334; where ¶334 discloses a pair of tabs 1056 extend downward from a pair of guides 1050) opposite the first clip portion and between the first and second bodies (as defined, Figs. 40, 41, and 43), wherein the first and second downwardly-extending clip portions are capable of connecting to the connection portion of the bone plate across the width of the connection portion (in as much as Applicant’s, Figs. 40, 41, and 43, ¶334).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the central portion as disclosed by Whitaker by adding a first downwardly-extending clip portion between the first and second bodies and a second downwardly-extending clip portion opposite the first clip portion and between the first and second bodies as taught by Garcia in order to clip the plate to the caddy to restrict or prevent the plate from sliding relative to the caddy (Garcia ¶334).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice or telephone the Examiner.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMY R SIPP/Primary Examiner, Art Unit 3775
Prosecution Insights