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 .
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10, line 1, “module” should be changed to “modules”.
Appropriate correction is required.
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.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Orthospin (WO 2022/024133 A1; cited by Applicant).
Regarding claim 1, Orthospin discloses a method of implementing a correction plan to correct a deformity in a bone of a patient using an external fixation system (see, e.g., Figs. 1, 3, 7F, 7G, 9A-9G, 10A-10D; page 5, line 14 - page 6, line 17; page 23, lines 21-29), the method comprising:
coupling a first fixation ring 1003 to a first portion of the bone of the patient;
coupling a second fixation ring 1005 to a second bone portion of the bone of the patient;
coupling the first fixation ring to the second fixation ring with a plurality of adjustable length struts 1006, each strut having a first joint proximate a first end of the strut (see Fig. 10A and 10B) and a second joint proximate a second end of the strut opposite the first end (id.), and an actuator 916 (Fig. 9C) configured to change an effective length of the strut;
providing a plurality of controller modules, e.g., 912 (Fig. 9D; i.e., the controller modules control rotation and actuation) each controller module configured to couple to a corresponding one of the plurality of struts 1006 (id.);
after coupling the first fixation ring 1003 to the second fixation ring 1005 and while the first joint of each of the plurality of struts is coupled to the first fixation ring 1003 and the second joint of each of the plurality of struts is coupled to the second fixation ring 1005, coupling the plurality of controller modules 912 to corresponding ones of the plurality of struts 1006 (page 14, lines 23-25); and
while the plurality of controller modules 912 are coupled to corresponding ones of the plurality of struts 1006, activating a first one of the controller modules to actuate the actuator of a first one of the plurality of struts 1006 to change the effective length of the first one of the plurality of struts 1006 (e.g., page 15, lines 24-25).
Regarding claim 2, the plurality of controller modules 912 are configured to be decoupled from the corresponding ones of the plurality of struts 1006 while the first joint of each of the plurality of struts 1006 remains coupled to the first fixation ring 1003 and the second joint of each of the plurality of struts remains coupled to the second fixation ring 1005 (e.g., page 12, lines 15-23).
Regarding claim 3, the method comprises decoupling the plurality of controller modules 912 from the corresponding ones of the plurality of struts 1006 while the first joint of each of the plurality of struts 1006 remains coupled to the first fixation ring 1003 and the second joint of each of the plurality of struts remains coupled to the second fixation ring 1005 to transition the external fixation system from an automated mode of operation to a manual mode of operation (id. and, e.g., page 11, lines 20-28).
Regarding claim 4, while the external fixation system is in the manual mode of operation, manually activating the actuator 916 of the first one of the plurality of struts 1006 to change the effective length of the first one of the plurality of struts 1006 (e.g., Fig. 10B; page 11, lines 20-28; page 12, lines 15-23; page 33, line 18 - page 34, line 12).
Regarding claim 5, activating the first one of the controller modules 912 is performed wirelessly via a mobile device (e.g., page 8 lines 3-5; page 35, lines 21-23).
Regarding claim 6, the actuator 916 is a gear (Fig. 9C; page 34, lines 3-4).
Regarding claim 7, coupling the plurality of controller modules 912 to corresponding ones of the plurality of struts 1006 includes engaging a gear (of each of the plurality of controller modules 912 with the gears (of the actuator 916) of the corresponding ones of the plurality of struts 1006 (Fig. 9D; page 34, lines 7-12).
Regarding claim 8, each of the plurality of struts 1006 includes a rod 914 (Fig. 9C) and a tube 904 (id.) that receives the rod 914 (id.).
Regarding claim 9, rotation of the actuator 916 causes rotation of the rod to drive the rod axially relative to the tube (e.g., page 5, line 14 - page 6, line 17; page 34, lines 3-12).
Regarding claim 10, each of the plurality of controller modules 912 includes an internal motor (e.g., Fig. 9D and page 34, lines 7-8).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Orthospin (WO 2022/024133 A1; cited by Applicant) in view of Singh (2016/0113681).
Regarding claim 11, Orthospin discloses the claimed invention except for explicitly reciting each of the plurality of controller modules 912 including an internal power source.
Singh also discloses a detachable controller module 300 for changing the length of a strut (e.g., Figs. 6A, 6B; para. 0012) teaches providing a controller module 300 alternatively including an internal power source 307 and corresponding components (Fig. 7B; para. 0063). Providing the power source within a single unit (i.e., the controller module 300) eliminates the need for external wires and facilitates a convenient procedure.
Thus, it would have been obvious to a person having ordinary skill in the art before the effective filing date to substitute an internal power source for the external power source of Orthospin, in view of Singh, to eliminate the need for external wires and to facilitate a convenient procedure.
Regarding claim 12, the internal power source of the combination (supra) is a battery 307 (Fig. 7B; para. 0063).
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 1-4, 19 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17 of U.S. Patent No. 11,896,267.
Although the claims at issue are not identical, they are not patentably distinct from each other because the differences amount to minor changes in the arrangement and phraseology of the claims. The claims of both the present application and the issued patent are directed to the substantially same invention of a metho of implementing a correction plan to correct a deformity in a bone of a patient using an external fixation system comprising coupling first and second rings to bone, coupling the rings with adjustable length struts including joints at each end and an actuator configured to change the length of the strut. Controller modules are coupled to the struts and activated to change the length of the struts. Where differences exist, the claims of the issued patent include more elements and are more specific (e.g., the strut including a rod and a tube, the actuator driving the rod axially relative to the tube, claiming manual vs. automated mode of operation, and claiming dynamization mode in the independent claim). Thus, the invention of the patent claims is 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.
Regarding independent application 1, patent claim 15 recites a method of implementing a correction plan to correct a deformity in a bone of a patient using an external fixation system, the method comprising:
coupling a first fixation ring to a first portion of the bone of the patient;
coupling a second fixation ring to a second bone portion of the bone of the patient;
coupling the first fixation ring to the second fixation ring with a plurality of adjustable length struts, each strut having a first joint proximate a first end of the strut and a second joint proximate a second end of the strut opposite the first end, and an actuator configured to change an effective length of the strut;
providing a plurality of controller modules, each controller module configured to couple to a corresponding one of the plurality of struts;
after coupling the first fixation ring to the second fixation ring and while the first joint of each of the plurality of struts is coupled to the first fixation ring and the second joint of each of the plurality of struts is coupled to the second fixation ring (included within the sequential order of claimed steps), coupling the plurality of controller modules to corresponding ones of the plurality of struts; and
while the plurality of controller modules are coupled to corresponding ones of the plurality of struts (included within the sequential order of claimed steps), activating (“operating”) a first one of the controller modules to actuate the actuator of a first one of the plurality of struts to change the effective length of the first one of the plurality of struts.
Regarding dependent claims 2 and 3, it is noted that decoupling is within the language “wherein the correction plan may be implemented using either (i) a manual mode of operation or (ii) an automated mode of operation” and “in the manual mode of operation, there is no coupling between any of the plurality of controller modules and any of the plurality of struts”. Further, regarding claim 3, “to transition the external fixation system from an automated mode of operation to a manual mode of operation” is likewise within the above language (id.).
Each of the claims of the present application and the claims of the issued patent are mapped as follows:
Appl. 19/332,682
Pat. 11,896,267
1
15
2
15
3
15
4
15
5
N/A
6
N/A
7
N/A
8
N/A
9
N/A
10
N/A
11
N/A
12
N/A
13
N/A
14
N/A
15
N/A
16
N/A
17
N/A
18
N/A
19
15
20
17/16/15
Allowable Subject Matter
Claims 13-18 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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