DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the set of claims received on 14 September 2023. Claims 1-31 are currently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Drawings
The drawings received on 14 September 2023 are accepted by the examiner.
Claim Objections
Claim 7 is objected to because of the following informality:
In line 4, it appears that the phrase “a bottom surface” should read “the bottom surface” (see line 5 of claim 1 for antecedent basis).
Claim 30 is objected to because of the following informality:
In lines 4-5, it appears that the phrase “the first bone and/or the second bone” should read “the first bone and the second bone” (see line 2 of claim 30 for antecedent basis).
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.
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Claims 1-8, 10-12 and 15 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/467,693 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely broader than the copending application claims. The only notable difference between the claims is that claim 1 of the current application states “a method of fixating bones” and claim 1 of the copending application states “a method of fixating spinal bones.”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheney et al. (U.S. Patent Application Publication 2022/0015812).
Cheney et al. disclose (as to claim 1) a method of fixating bones for fusion (see paragraph 0170), the method comprising positioning a first leg (393) of a staple (375) connected to an inserter (5) in a first implant hole (790) of a first bone (780) and a second leg (394) of the staple connected to the inserter in a second implant hole (791) of a second bone (781) (see paragraph 0207), wherein the first leg of the staple is connected to the second leg of the staple by a bridge (378), wherein the staple is positioned such that a bottom surface (380) of the staple faces the first bone (see Figure 44) and the second bone and a top surface (379) of the staple faces away from the first bone and the second bone (see Figure 44), wherein the inserter is connected to the staple through the top surface of the staple (i.e. via 387 and 389) without extending under the bottom surface of the staple (see paragraph 0174); and detaching the inserter from the staple (see paragraph 0208), wherein (as to claim 2) the method further comprises prior to positioning the first leg of the staple at the first implant hole and the second leg of the staple at the second implant hole, (i) connecting the inserter to a first side (i.e. side defining 387 and 393) of the staple having the first leg through the top surface of the first side of the staple without extending under the bottom surface of the first side of the staple (see paragraph 0207) and (ii) connecting the inserter to a second side (i.e. side defining 389 and 394) of the staple having the second leg through the top surface of the second side of the staple without extending under the bottom surface of the second side of the staple (see paragraph 0207), wherein (as to claim 3) the inserter is connected to the first side of the staple through the top surface of the first side of the staple without extending under the bottom surface of the first side of the staple and without contacting an outer perimeter (i.e. perimeter defined by outer periphery of 378) of the first side of the staple (i.e. due to connection between 29 and 387), and wherein the inserter is connected to the second side of the staple through the top surface of the second side of the staple without extending under the bottom surface of the second side of the staple and without contacting an outer perimeter (i.e. perimeter defined by outer periphery of 378) of the second side of the staple (i.e. due to connection between 45 and 389), wherein (as to claim 4) the method further comprises applying a load force (i.e. via 9) at the staple using the inserter (see paragraph 0207 referring to 5 being used to constrain 375 in an insertion shape), wherein, as the load force is applied at the staple using the inserter, the first leg and the second leg are caused to move apart from one another (i.e. to transition 375 from 376 to 377), wherein (as to claim 5) the method further comprises removing the load force from the staple (i.e. via transitioning 9 from the position seen in Figure 18C to the position seen in Figure 17C) (i) after positioning the first leg in the first implant hole and the second leg in the second implant hole and (ii) prior to detaching the inserter from the staple (see paragraph 0208), wherein (as to claim 6) removing the load force from the staple causes the first leg and the second leg to move toward one another (i.e. to transition 375 from 377 to 376) to apply a compression force (i.e. provided by stored energy) at the first bone and the second bone (see paragraph 0208), wherein (as to claim 7) the inserter comprises a first coupling shaft (15) connected through the top surface of the staple (i.e. via the connection between 29 and 387) without extending under the bottom surface of the staple (see paragraph 0174) and a second coupling shaft (16) connected through the top surface of the staple (i.e. via the connection between 45 and 389) without extending under the bottom surface of the staple (see paragraph 0174), and wherein applying the load force comprises biasing the first coupling shaft and the second coupling shaft toward each other (i.e. to the position seen in Figure 18C), wherein (as to claim 8) detaching the inserter from the staple comprises detaching, from the top surface, the first coupling shaft and the second coupling shaft from the staple (see paragraph 0208), wherein (as to claim 9) detaching the first coupling shaft and the second coupling shaft from the staple causes the first coupling shaft to move away from the second coupling shaft (i.e. as 375 transitions from 377 to 376 with the removal of 9), thereby removing the load force and causing the first leg of the staple in the first implant hole and the second leg of the staple in the second implant hole to apply the compression force in a direction toward one other (i.e. due to the release of stored energy resulting in the transition to 376), wherein (as to claim 10) the first coupling shaft is connected through the top surface of the staple over the first leg of the staple (where 15 is located over 387 and 393, see Figure 17C) and the second coupling shaft is connected through the top surface of the staple over the second leg of the staple (where 16 is located over 389 and 394, see Figure 17C), wherein (as to claim 11) a connector (9) joins the first coupling shaft and the second coupling shaft to bias the first coupling shaft and the second coupling shaft toward each other and maintain the load force at the staple while the connector joins the first coupling shaft and the second coupling shaft (see paragraph 0174), wherein (as to claim 12) the method further comprises removing the connector from the first coupling shaft and the second coupling shaft to cause the first coupling shaft to move away from the second coupling shaft (i.e. to transition 375 from 377 to 376, see paragraph 0208), wherein (as to claim 13) removing the connecting causes the load force at the staple to be removed (i.e. to transition 375 from 377 to 376, see paragraph 0208), and wherein (as to claim 14), when the connector joins the first coupling shaft and the second coupling shaft, the first leg of the staple is oriented generally parallel to the second leg of the staple (see Figure 16D, and paragraphs 0170 and 173), and wherein, when the connector is removed, the first leg of the staple and the second leg of the staple are oriented toward one another (see Figure 16C, and paragraphs 0170 and 0173) (see Figures 16A-18C and 43-46, and paragraphs 0170-0175 and 0207-0209).
Claims 17-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palmer et al. (U.S. Patent 11,426,158).
Palmer et al. disclose (as to claim 17) a method of fixating bones for fusion (see column 7, lines 59-64), the method comprising positioning a first leg (i.e. one instance of 15) of a staple (10) connected to an inserter (30) in a first implant hole (95) of a first bone (80) and a second leg (i.e. the other instance of 15) of the staple connected to the inserter in a second implant hole (95) of a second bone (85), wherein the first leg of the staple is connected to the second leg of the staple by a bridge (10), and the inserter comprises a first coupling shaft (i.e. one instance of 35) connected to the first leg of the staple (connection as best seen in Figure 7), a second coupling shaft (i.e. the other instance of 35) connected to the second leg of the staple (connection as best seen in Figure 7), and a connector (55), with the first coupling shaft and the second coupling shaft being biased toward each other (bias as best seen in Figure 7) to apply a load force to the staple and the connector joining the first coupling shaft and the second coupling shaft to maintain the load force applied to the staple while the connector joins the first coupling shaft and the second coupling shaft (see column 8, lines 51-58); and removing the connector from the inserter, thereby removing the load force and causing the first coupling shaft and the second coupling shaft to move apart from one another (see column 10, lines 27-51), wherein (as to claim 18), when the connector joins the first coupling shaft and the second coupling shaft, the first leg of the staple is oriented generally parallel to the second leg of the staple (see Figure 7 and column 9, lines 29-34), wherein (as to claim 19), when the connector is removed, the first leg of the staple and the second leg of the staple are configured to apply a compression force in a direction toward one another (see column 10, lines 27-51), wherein (as to claim 20), as the connector is being removed, the first leg of the staple and the second leg of the staple move toward one another (see column 10, lines 27-51), wherein (as to claim 21) the connector is removed after the first leg of the staple is positioned in the first implant hole of the first bone and after the second leg of the staple is positioned in the second implant hole of the second bone (see column 10, lines 27-51), and wherein (as to claim 22) the connector is removed after a bottom surface (i.e. any bottom surface defined by 15 and in contact with 80 and 85) of the staple is positioned in contact with the first bone and the second bone (see Figure 8) (see Figures 1-19, and column 7, line 59 – column 14, line 4).
Allowable Subject Matter
Claims 16 and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claim 16, in combination with the limitations required by claims 1, 4-7 and 11-12, no prior art reference could be found disclosing or making obvious wherein the method further comprises prior to removing the connector from the first coupling shaft and the second coupling shaft, moving the first coupling shaft toward the second coupling shaft to disengage the first retention feature from the first receptacle and moving the second coupling shaft toward the first coupling shaft to disengage the second retention feature from the second receptacle.
Regarding claim 23, in combination with the limitations required by claims 17 and 20-22, no prior art reference could be found disclosing or making obvious wherein the first coupling shaft is connected to the first leg of the staple at a location between the bottom surface of the staple and a top surface of the staple and the second coupling shaft is connected to the second leg of the staple at a location between the bottom surface of the staple and the top surface of the staple, and wherein the first coupling shaft and the second coupling shaft are removed from the staple after the connector is removed from the inserter.
Claims 24-31 are allowed.
Claims 24-31 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, a method of fixating bones for fusion, the method comprising: inserting a first wire into a first bone and a second wire into a second bone, the first bone being separated from the second bone by a space; aligning an inserter operatively connected to an implant with the first wire and the second wire by at least positioning the first wire in a first wire receiving opening of the inserter and the second wire in a second wire receiving opening of the inserter; and advancing the inserter along the first wire and the second wire to position the implant in contact with the first bone and the second bone with the implant bridging between the first bone and the second bone.
Note: Ginn et al. (U.S. Patent 12,496,193) disclose an invention closely resembling that of the current application; however, fail to explicitly disclose the invention as claimed in claims 24-31.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Venturini et al. (U.S. Patent Application Publication 2021/0015482) disclose a method of fixating bones for fusion comprising positioning a staple having first and second legs using coupling shafts.
Peterson et al. (U.S. Patent Application Publication 2002/0111641) disclose a method of fixating bones for fusion comprising positioning a staple having first and second legs using coupling shafts.
Michelson (U.S. Patent 6,120,503) discloses a method of fixating bones for fusion comprising positioning a staple having first and second legs using an inserter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775