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 .
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12127775b2, referred herein as Pat. ‘775. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of Pat. ‘775. Pat. ‘775 recites a medical instrument component. Specifically in regards to claim 1 and 7, Pat. ‘775 recites a first shaft comprising a first portion and a second portion, a second shaft comprising a channel configured to receive the first portion of the first shaft [claim 1 lines 17-22]; and a sleeve configured to be positioned at least some of the time around the first portion of the first shaft [claim 1 line 23-24], wherein the first portion of the first shaft is configured to have a lower torsional strength than the second portion of the first shaft and the second shaft such that the first portion experiences torsional failure at a lower torque force than the second portion of the first shaft and the second shaft [claim 1 line 25-30], and wherein a positioning of the sleeve is adjustable along the first portion of the first shaft such that a torsional strength of the medical instrument component is adjustable based on the positioning of the sleeve; wherein a positioning of the sleeve is fixed relative to the second shaft [claim 1 line 31-36].
Claims 2-6 and 8-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-12 of Pat. ‘775 for reciting substantially similar subject matter.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 of Pat. ‘775. Pat. ‘775 recites a medical device comprising: a first shaft comprising a first portion and a second portion, a second shaft comprising a channel configured to receive the first portion of the first shaft [claim 14 line 17-21]; and a sleeve configured to be positioned around the first portion of the first shaft [claim 14 line 22-23], wherein the first portion of the first shaft is configured to have a lower torsional strength than the second portion of the first shaft and the second shaft such that the first portion experiences torsional failure at a lower torque force than the second portion of the first shaft and the second shaft [claim 14 line 24-29], and wherein a positioning of the sleeve is movable along the first portion of the first shaft such that a torsional strength of the medical instrument component is adjustable based on the positioning of the sleeve [claim 14 line 30-35].
Claims 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-19 of Pat. ‘775 for reciting substantially similar subject matter.
Claim Rejections - 35 USC § 102
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 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) 1-2, 7-8, 10-14, 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Daly et al (US Patent Pub. 20180153599A1).
Daly discloses a medical instrument. Specifically in regards to claim 1 and 14, Daly discloses a first shaft (2, Fig. 1) comprising a first portion (10) and a second portion (12/25), a second shaft (104) comprising a channel (180) configured to receive the first portion (10) of the first shaft (2); and a sleeve (106) configured to be positioned at least some of the time around the first portion (10) of the first shaft (2), wherein the first portion (10) of the first shaft (2) is configured to have a lower torsional strength (separates at 23) than the second portion (12/25) of the first shaft (2) and the second shaft (104) such that the first portion (10) experiences torsional failure at a lower torque force than the second portion (12/25) of the first shaft (2) and the second shaft (104), and wherein a positioning of the sleeve (106) is adjustable/movable along the first portion (10) of the first shaft (2) such that a torsional strength of the medical instrument component is adjustable based on the positioning of the sleeve (106) (Fig. 1-2 and 7-12; and Para. [0028]-[0032],[0042],[0056]-[0058]).
In regards to claim 2, Daly discloses wherein a cross sectional area of the first portion (10) of the first shaft (2) is non-circular (As can be seen in Fig. 1, member 10 has portions 22 that make the cross section non circular) (Fig. 1).
In regards to claim 7, Daly discloses wherein a positioning of the sleeve (106) is fixed relative to the second shaft (104) (Fig. 7-12; and Para. [0056]-[0058]).
In regards to claim 8, Daly discloses wherein at least a portion of the second portion (12/25) of the first shaft (2) comprises threads (Fi. 1).
In regards to claim 11, Daly discloses wherein the medical instrument component is a component of a reamer or a drill (Fig. 1).
In regards to claim 12, Daly discloses wherein the second shaft (104) is configured to removably couple with a driver (Fig. 6; and Para. [0056]).
In regards to claim 13 and 20, Daly discloses wherein an interior of the sleeve (106) comprises at least one flexible concave shaped portion (200) configured to apply an inward force towards the first shaft (2), wherein the positioning of the sleeve (106) is adjustable via the at least one flexible concave shaped portion (Fig. 16; and Para. [0071],[0077],[0079]).
Claim(s) 1, 8-10, 14, 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rinehart et al (US Patent Pub. 20130184759A1).
Rinehart discloses a medical instrument. Specifically in regards to claim 1 and 14, Rinehart discloses a first shaft (10/92) comprising a first portion (10) and a second portion (92), a second shaft (50/60) comprising a channel configured to receive the first portion (10) of the first shaft (10/92); and a sleeve (91) configured to be positioned at least some of the time around the first portion (10) of the first shaft (10/92), wherein the first portion (10) of the first shaft (10/92) is configured to have a lower torsional strength (separates at 20, Fig. 1b) than the second portion (92) of the first shaft (10/92) and the second shaft (50/60) such that the first portion (10) experiences torsional failure at a lower torque force than the second portion (92) of the first shaft (10/92) and the second shaft (50/60), and wherein a positioning of the sleeve (91) is adjustable/movable along the first portion (10) of the first shaft (10/92) such that a torsional strength of the medical instrument component is adjustable based on the positioning of the sleeve (91) (Fig. 1a-2a; and Para. [0029]-[0034],[0036]).
In regards to claim 8-9 and 18, Rinehart discloses wherein at least a portion of the second portion (92) of the first shaft (10/92) comprises threads (Fig. 1a-1d); and wherein the sleeve (91) is configured to be in threaded engagement with the threads of the second portion (92) of the first shaft (10/92), wherein the positioning of the sleeve (91) is adjustable via the threaded engagement of the sleeve with the threads of the second portion of the first shaft (10/92) (Fig.1b).
In regards to claim 10 and 19, Rinehart discloses wherein a proportion of the first portion (10) of the first shaft (10/92) positioned within the second shaft (50/60) determines the torsional strength of the medical instrument component (Fig. 1a-1d; and Para. [0028]-[0034]).
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) 3-6 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daly in view of Combrowski (US Patent Pub. 20120150237A1).
Daly discloses an instrument comprising a first and second shaft and a sleeve, wherein the first shaft has a first portion with lower torsional strength than the second shaft and a second portion of the first shaft. However, the reference is silent as to the first portion having an elongated opening. Combrowski discloses an instrument. Specifically in regards to claim 3 and 15, Combrowski discloses a first shaft (1) having first and second portions (2/3), wherein the first portion (2) of the first shaft (1) includes at least one elongated opening (10) (Fig. 1-3; and Para. [0049]-[0051]). In regards to claim 4 and 16, Combrowski discloses wherein each of the at least one elongated opening (10) comprises a first end portion and a second end portion (end at 29) opposite the first end portion, wherein the elongated opening (10) is elongated from the first end portion to the second end portion, wherein a size of the elongated opening at the first end portion is greater than a size of the elongated opening at the second end portion (29) (As can be seen in Fig. 2, the bore 10 narrows as it connects to shaft 3.) (Fig. 2). In regards to claim 5 and 17, Combrowski discloses wherein the second end (29) portion of the at least one elongated opening (10) is closer to the second portion (3) of the first shaft (1) than the first end portion of the at least one elongated opening (Fig. 2). In regards to claim 6, Combrowski discloses wherein the at least one elongated opening ( 10) comprises one or more symmetric openings (Fig. 2).
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