DETAILED ACTION
This action is in response to Applicant’s amendment filed September 1, 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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 of U.S. Patent No. 12,251,102. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claim 21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 10 of U.S. Patent No. 12,685,529. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent 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.
Claim(s) 21-28, 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palmer (U.S. Publication No. 2015/0133940).
Regarding claim 21, Palmer discloses a surgical staple implantation system (Figure 20), comprising: a surgical staple (5) comprising a crown (10) and first and second legs (15), the surgical staple being movable between a relaxed configuration in which the first and second legs extend toward one another (Figure 1, Paragraph 45) and a distracted configuration in which the first and second legs are spaced apart for insertion into respective bone holes (Figure 2, Paragraph 46); and a staple inserter (180) comprising: a body (185); a proximal handle (Figure 21, attached to screw drive 195); and a distal force applicator comprising a first grip (190), a second grip (190), and a driver (200) disposed between the first grip and the second grip (Figure 21), wherein the first grip and the second grip are configured to engage the crown of the surgical staple (Figure 21), wherein the driver is movable relative to the body toward and away from the crown, wherein movement of the driver toward the crown applies a force to the crown while the first and second grips apply opposing forces to the crown, thereby moving the surgical staple from the relaxed configuration toward the distracted configuration (Paragraph 97), and wherein movement of the driver away from the crown permits the surgical staple to move toward the relaxed configuration (it can be construed from figure 21 that rotating the driver one directions applies a force, and when rotated in an opposite direction, will move the drive away from the crown removing the bending force).
Regarding claim 22, the surgical staple comprises a shape-memory or superelastic metal alloy (paragraph 61).
Regarding claim 23, wherein the surgical staple comprises a plurality of bone-engaging teeth (25) disposed on at least one exterior surface of the surgical staple (FIGure 1).
Regarding claim 24, the plurality of bone- engaging teeth are disposed along each of the first and second legs (Figure 1).
Regarding claim 25, the first grip and the second grip are positioned on a common side of the crown (Figured 21).
Regarding claim 26, the proximal handle is mechanically coupled to the driver by a shaft extending through the body (Figure 21).
Regarding claim 27, the shaft comprises a threaded portion (195) configured to engage corresponding threads of the body such that rotation of the proximal handle relative to the body produces longitudinal movement of the driver (paragraph 97, Figure 21).
Regarding claim 28, the driver and the shaft comprise separate components coupled to one another (it can be construed from figure 21 that the handle and shaft are separate pieces coupled together).
Regarding claim 30, the first grip and the second grip have a separation distance corresponding substantially to a length of the crown (Figure 21).
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, 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) 32-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knight et al. (U.S. Publication No. 2013/0213843).
Knight et al discloses a sterile surgical implant kit, comprising: an instrument tray (200); a staple inserter (210) supported by the instrument tray (Figure 1B); a surgical staple supported by the staple inserter (Figure 1B); a drill guide (230) supported by the instrument tray (Figure 1B); a bone drill (330) supported by a second instrument tray (300); a locator pin (320) supported by the instrument tray (300); and a tamp (340) supported by the instrument tray (300),wherein the instrument trays (200, 300) are configured to retain the staple inserter, the surgical staple, the drill guide, the bone drill, the locator pin, and the tamp in a sterile condition (paragraphs 37-40), wherein the surgical staple comprises a crown and first and second legs movable between a relaxed configuration and a distracted configuration, and wherein the staple inserter is configured to move the surgical staple from the relaxed configuration to the distracted configuration for implantation into a pair of bone holes (paragraph 38).
Knight et al fails to disclose that the entire kit is held within one instrument tray. It would have been obvious to one having ordinary skill in the art to combine all elements into a single instrument tray, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claim 33, the drill guide comprises a proximal handle and a pair of substantially parallel sleeves (figure 5A, 5B).
Regarding claim 34, the pair of parallel sleeves comprises an opening configured to receive the bone drill (Figure 8C, 8D).
Regarding claim 35, the pair of parallel sleeves comprise distal teeth configured to engage bone and inhibit movement of the drill guide relative to the bone (Figure 5A).
Regarding claim 36, the drill guide comprises a size indicator corresponding to a spacing between the pair of parallel sleeves (Figure 7 shows a stapler sizer with various numbers. The drill guide as seen in figure 5A, 5B can be seen to have numbers on it. Thus it can be construed that those are markings are a size indicator).
Regarding claim 37, the size indicator identifies a size of the surgical staple configured for implantation into bone holes formed using the pair of parallel sleeves (paragraph 43).
Regarding claim 38, the drill guide and the surgical staple have complementary sizes (paragraph 43).
Regarding claim 39, the locator pin comprises a shaft having a diameter configured to be received within either of the pair of parallel sleeves (Figure 8E).
Regarding claim 40, the locator pin is configured to remain positioned in a first sleeve and a first bone hole while the bone drill is received in a second sleeve to form a second bone hole (Figure 8D).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palmer et al. in view of Honeck (U.S. Patent No. 7512446).
Palmer et al. discloses the claimed invention except for the proximal handle comprises a directional indicator indicating a direction of rotation associated with movement of the surgical staple toward the distracted configuration. Honeck teaches a tools with a rotational indicator 28 that provides proper rotational direction for lead implantation. It would have been obvious to one skilled in the art to construct the device of Palmer et al. with a directional indicator indicating a direction of rotation associated with movement of the surgical staple toward the distracted configuration in view of Honeck since such provides a quick visual reference for a desired rotation direction.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palmer et al. in view of Wahl (U.S. Publication No. 2016/0235460).
The applied reference has a common Assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). Palmer et al. discloses the claimed invention except for the separation distance between the first grip and the second grip is adjustable. Wahl teaches a surgical bending instrument having first and second grips that are adjustable so as to accommodate different sized staples (paragraph 9). It would have been obvious to one skilled in the art to construct the device of Palmer et al. with adjustable grips in view of Wahl in order to accommodate different sized staples.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-40 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 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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/ANDREW YANG/Primary Examiner, Art Unit 3775
