DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 21-27) in the reply filed on 7/28/26 is acknowledged.
Claims 28-30 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/28/26.
Newly submitted claims 31-35 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
the claim 35 is withdrawn for being drawn to a method claim when the claims originally selected by applicant in the response to election dated 7/28/26 were to apparatus claims.
Claims 31-34 are to a kit and methods of utilizing those kits. The claims 31 and 34 are to a combination while the original claim 21 is drawn to a subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the kit does not recite wherein the guide tool has an arcuate arm or wherein the forward drill guide is a set of guides that are selectively fixable relative to the arcuate segment of the arm in one of a plurality of preset positions. The subcombination has separate utility such as the tool could be used to drill into other substances other than bone such are plastic, concrete or metal. Therefore, the claims 31-34 are withdrawn.
Claim 32 is a method of utilizing a kit. This claim is withdrawn for being drawn to a method claim when the claims originally selected by applicant in the response to election dated 7/28/26 were to apparatus claims.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 31-35 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Therefore, the total withdrawn claims are claims 28-35.
Claim Objections
Claim 21 is objected to because of the following informalities: the claim recites “guide tool for use in drilling holes in bones for insertion of a legs of a first surgical staple” in line 1-2 is believed should recite “guide tool for use in drilling holes in bones for insertion of legs of a first surgical staple” (emphasis added). Appropriate correction is required.
Claim 26 is objected to because of the following informalities: the claim recites “the arcuate segment of the adjustable arm” in line 1-2 is believed should recite “the arcuate segment of the arm” (emphasis added). Appropriate correction is required since no adjustable arm has been introduced.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 21-22 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In regards to claim 21 the limitation recites “guide tool for use in drilling holes in bones” in line 1.
In regards to claims 22 the claims limitation recites “a drill bit can be inserted for drilling a hole in an adjacent bone” in lines 3-4.
This limitation cannot be satisfied without the inclusion of the human organism, or the bones or bone pieces, therefore, applicant is claiming the bones as part of the invention. Instead, applicant should use “adapted to” or “configured to” language to overcome the 101 rejections.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 21-27 is/are rejected under 35 U.S.C. 103 as being obvious over Campbell et al (US Patent Pub. 20210298748A1) in view of Chervitz et al (US Patent 5688284A).
Campbell discloses a guide tool for capable of use in drilling holes in bones for insertion of legs of a first surgical staple and legs of a second surgical staple. Specifically in regards to claim 21 and 25-27, Campbell discloses the guide tool (1100) comprising a handle (1106); a rearward set of drill guides (1131) fixed relative to the handle (1106); and an arm (1136) having an arcuate segment (portion with 1133), a forward set of drill guides (1133) with a plurality of preset positions (Fig. 11a-11c; and Para. [0169]-[0170]). However, the reference is silent as to the drill guides being selectively fixable on the arm.
Chervitz discloses a guide tool for capable of use in drilling holes in bones for insertion of legs of a first surgical staple and legs of a second surgical staple. Specifically in regards to claim 21, Chervitz recites a guide tool (10) having a handle (26) and an arm (30/35) having an arcuate segment (35), and a forward drill guide (60 on 46) selectively fixable relative to the arcuate segment of the arm (35) in one of a plurality preset positions (noted as 37 in Fig. 1) (Fig. 1; and Col. 5 line 52 to Col. 7 line 8). In regards to claims 25-27, Chervitz recites wherein the forward drill guide (60 on 46) are carried by a bracket (40) that is slidable along the arcuate segment (35) of the arm (30/35); comprising means (55) for selectively fixing the bracket (46) relative to the arcuate segment (35) of the arm in one of the plurality of preset positions (37); and wherein each of the drill guide (60 on 46) includes a sleeve (60) with a through-bore (62) for receiving, in use, a drill bit, the sleeves (60) of the drill guides being axially and rotationally fixed relative to the handle/ bracket (The sleeve 60 is fixed relative to the slide by means of the arm 70.) (Fig. 1-3; and Col. 6 line 3 to Col. 7 line 8). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the guides (1133) of Campbell to include sleeves on a track moving along arcuate arm as taught in Chervitz in order to select the angle at which to dispose the sleeve in the handle.
In regards to claim 22, Campbell recites wherein: each of the forward set of drill guides (1133) has a longitudinally extending opening with a central axis (axis through 1133), through which, in use, a drill bit (820, Fig. 11B) can be inserted for drilling a hole in an adjacent bone (10B); and each of the rearward set of drill guides (1131) has a longitudinally extending opening with a central axis (Axis through 1131), through which, in use, a drill bit (820, Fig. 11B) can be inserted for drilling a hole in an adjacent bone (10A) (Fig. 11B).
In regards to claim 23-24, Campbell recites wherein the forward set (1133) of drill guides includes two drill guides, and the arm is configured such that the central axes of the drill guides of the forward set (1133) of drill guides project between a projection of the central axes of the drill guides of the rearward set (1131) of drill guides (Fig. 11a-11b). However, the reference is silent as to the rearward set of drill guides having four drill guides. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the two rearward guides (1131) of Campbell to be four guides, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art.
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 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent 12220123B2, referred herein as Pat. 123. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of Pat. 123. Pat. 123 recites guide tool for use in drilling holes in bone pieces or bones for insertion of a legs of a first surgical staple and legs of a second surgical staple [claim 1 col. 7 lines 54-55], the tool comprising: a handle [claim 1 col. 7 lines 56-57]; a rearward set of drill guides fixed relative to the handle [claim 1 col. 7 lines 58]; an arm having an arcuate segment [claim 1 col. 7 lines 59-61]; and a forward set of drill guides selectively fixable relative to the arcuate segment of the arm in one of a plurality of preset positions [claim 1 col. 7 lines 62-64].
Claims 22-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-7 of U.S. Patent 12220123 B2 for reciting substantially similar limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775
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