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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/19/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 02/19/2026 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Allowable Subject Matter
The indicated allowability of claim 53 is withdrawn in view of the newly discovered reference(s) to Harshman (US 2017/0238977 A1). Rejections based on the newly cited reference(s) follow.
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) 32, 34 – 40, 42, 44 - 48, 50, 51 and 55 - 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moore (US 2012/0065638 A1) in view of Harshman et al. (US 2017/0238977 A1).
Regarding claim 32, Moore discloses a method (Abstract), comprising:
forming a curved pathway in an intermedullary space of a humerus bone (Fig. 71), the curved pathway having a proximal insertion hole (ref. 46) configured to receive a bone-fracture fixation device (Fig. 76, ref. 62, paragraph [0178], please note that the figures showing the method of inserting the device into the humerus bone are also applicable to the device 62 as indicated in paragraph [0178]);
inserting, into the curved pathway, the bone-fracture fixation device in a flexible configuration (Fig. 76), the bone-fracture fixation device having a proximal end portion (located closest to the operator and insertion tool ref. 104, Fig. 77) and a distal end portion (opposite end as seen in Fig. 77);
securing the distal end portion of the bone-fracture fixation device within the intermedullary space (the distal section is secured via bone screws ref. 113, Fig. 78);
securing the proximal end portion of the bone-fracture fixation device at the proximal insertion hole (the proximal portion is secured via bone screws ref. 112, Fig. 78); and
transitioning the bone-fracture fixation device from the flexible configuration to a rigid configuration while the bone-fracture device has a curved shape (paragraphs [0004, 178] which disclose adding bone cement to keep the device in its desired configuration and thus transitioning to a rigid configuration),
wherein a length of the bone-fracture fixation device is the same in the flexible and rigid configurations (due to the hinged nature of the embodiment, the length will remain the same since one side of the device is continuous),
but is silent regarding the step of manipulating the proximal end portion of the bone-fracture fixation device to transition from the flexible to rigid configuration.
Harshman teaches a bone-fracture fixation device (Abstract) configured to transition from a flexible configuration to a rigid configuration and back, if desired (paragraph [0041]). The device is transitioned into the rigid configuration via a locking interface (paragraph [0047], ref. 120) at a proximal end portion (paragraph [0048], Fig. 1). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Moore to substitute the device of Moore with the device of Harshman such that the method comprises the step of manipulating the proximal end portion of the bone-fracture fixation device to transition from the flexible to rigid configuration, as taught by Harshman, for the purpose of reverting back to the flexible state for device removal if warranted (paragraph [0041]).
Regarding claim 34, Moore in view of Harshman discloses the method of claim 32, wherein forming the curved pathway comprises: inserting a guidewire through the proximal insertion hole (Moore, paragraph [0164]); and reaming the curved pathway by moving a reamer over the guidewire (Moore, paragraphs [0259, 271, 272]).
Regarding claim 35, Moore in view of Harshman discloses the method of claim 32, wherein inserting the bone-fracture fixation device comprises:
inserting a guidewire into the curved pathway; and inserting the bone-fracture fixation device over the guidewire (Moore, paragraph [0164] and Harshman, paragraph [0063]).
Regarding claim 36, Moore in view of Harshman discloses the method of claim 32, wherein the proximal end portion of the bone- fracture fixation device is angled (because the entire device may be curved the proximal end portion may also be angled or curved).
Regarding claim 37, Moore in view of Harshman discloses the method of claim 32, wherein the bone-fracture fixation device spans a fracture of the humerus (Moore, Fig. 78).
Regarding claim 38, Moore in view of Harshman discloses the method of claim 32, wherein the distal end portion of the bone-fracture fixation device is secured at or near the ball of the humerus (Moore, Fig. 78).
Regarding claim 39, Moore in view of Harshman discloses the method of claim 32, wherein the distal end portion of the bone-fracture fixation device is secured at or near a midsection of the humerus (Moore, Fig. 78, wherein the distal end portion is secure “near” a midsection).
Regarding claim 40, Moore in view of Harshman discloses the method of claim 32, wherein the proximal insertion hole is located at or near an elbow (Moore, Fig. 78).
Regarding claim 42, Moore discloses a method (Abstract), comprising:
forming a curved pathway in an intermedullary space of a radius and/or ulna bone (Fig. 14 shows the step of forming a curved pathway and paragraph [0179] discloses that the method may be used on the radius or the ulna), the curved pathway having a proximal insertion hole configured to receive a bone- fracture fixation device (at the top or the insertion hole as shown in Fig. 14 and the specific embodiment of the device is shown in Fig. 13, ref. 62);
inserting, into the curved pathway, the bone-fracture fixation device in a flexible configuration (Fig. 18), the bone-fracture fixation device having a proximal end portion and a distal end portion (the proximal portion being closest to the surgeon or operator and the distal portion opposite);
securing the distal end portion of the bone-fracture fixation device within the intermedullary space (Fig. 19, ref. 54);
securing the proximal end portion of the bone-fracture fixation device at the proximal insertion hole (Fig. 22, ref. 60); and
transitioning the bone-fracture fixation device from the flexible configuration to a rigid configuration while the bone-fracture device has a curved shape (paragraphs [0004, 178] which disclose adding bone cement to keep the device in its desired configuration and thus transitioning to a rigid configuration),
wherein a length of the bone-fracture fixation device is the same in the flexible and rigid configurations (due to the hinged nature of the embodiment, the length will remain the same since one side of the device is continuous),
but is silent regarding the step of transitioning the bone-fracture fixation device from the rigid configuration to the flexible configured and removing the bone-fracture fixation device from the intramedullary space after the bone has healed.
Harshman teaches a bone-fracture fixation device (Abstract) configured to transition from a flexible configuration to a rigid configuration and back, if desired (paragraph [0041]). The device is transitioned into the rigid configuration via a locking interface (paragraph [0047], ref. 120) at a proximal end portion (paragraph [0048], Fig. 1) and removed after the bone has healed (paragraph [0041]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Moore to substitute the device of Moore with the device of Harshman such that the method comprises the step of manipulating the proximal end portion of the bone-fracture fixation device to transition from the flexible to rigid configuration and removing the device from the intramedullary space after the bone has healed, as taught by Harshman, for the purpose of reverting back to the flexible state for device removal if warranted (paragraph [0041]).
Regarding claim 44, Moore in view of Harshman discloses the method of claim 42, wherein forming the curved pathway comprises: inserting a guidewire through the proximal insertion hole (Moore, paragraph [0164]); and reaming the curved pathway by moving a reamer over the guidewire (Moore, paragraph [0271]).
Regarding claim 45, Moore in view of Harshman discloses the method of claim 42, wherein inserting the bone-fracture fixation device comprises: inserting a guidewire into the curved pathway; and inserting the bone-fracture fixation device over the guidewire (Moore, paragraph [0164]).
Regarding claim 46, Moore in view of Harshman discloses the method of claim 42, wherein the proximal end portion of the bone- fracture fixation device is angled (because the entire device may be curved the proximal end portion may also be angled or curved).
Regarding claim 47, Moore in view of Harshman discloses the method of claim 42, wherein the bone-fracture fixation device spans a fracture of the radius and/or ulna (Moore, Fig. 22).
Regarding claim 48, Moore in view of Harshman discloses the method of claim 42, wherein the distal end portion of the bone-fracture fixation device is secured at or near an end of the radius and/or ulna (Moore, Fig. 22).
Regarding claim 50, Moore in view of Harshman discloses the method of claim 42, wherein the proximal insertion hole is located at or near an elbow (Moore, Fig. 22, given that the bone is a radius or ulna).
Regarding claim 51, Moore in view of Harshman discloses the method of claim 42, wherein the proximal insertion hole is located at or near a wrist (Moore, Fig. 22, given that the bone is a radius or ulna).
Regarding claim 55, Moore in view of Harshman discloses the method of claim 42, further comprising adding a compressive force across a fracture during implantation of the bone-fracture fixation device (Moore, Abstract).
Regarding claim 56, Moore discloses a method (Abstract), comprising:
forming a curved pathway in an intermedullary space of a humerus bone (Fig. 71), the curved pathway having an angled proximal insertion hole configured to receive a bone- fracture fixation device (Fig. 13, ref. 62);
inserting, into the curved pathway, the bone-fracture fixation device in a flexible configuration (Fig. 76);
securing the bone-fracture fixation device at the proximal insertion hole such that the bone-fracture fixation device does not protrude from the bone (Fig. 78); and
transitioning the bone-fracture fixation device from the flexible configuration to a rigid configuration while the bone-fracture device has a curved shape (paragraphs [0004, 178] which disclose adding bone cement to keep the device in its desired configuration and thus transitioning to a rigid configuration),
wherein a length of the bone-fracture fixation device is the same in the flexible and rigid configurations (due to the hinged nature of the embodiment, the length will remain the same since one side of the device is continuous),
but is silent regarding the step of transitioning the bone-fracture fixation device from the rigid configuration to the flexible configuration and removing the bone-fracture fixation device from the intramedullary space after the bone has healed.
Harshman teaches a bone-fracture fixation device (Abstract) configured to transition from a flexible configuration to a rigid configuration and back, if desired (paragraph [0041]). The device is transitioned into the rigid configuration via a locking interface (paragraph [0047], ref. 120) at a proximal end portion (paragraph [0048], Fig. 1) and removed after the bone has healed (paragraph [0041]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Moore to substitute the device of Moore with the device of Harshman such that the method comprises the step of manipulating the proximal end portion of the bone-fracture fixation device to transition from the flexible to rigid configuration and removing the device from the intramedullary space after the bone has healed, as taught by Harshman, for the purpose of reverting back to the flexible state for device removal if warranted (paragraph [0041]).
Regarding claim 57, Moore discloses a method (Abstract), comprising:
forming a curved pathway in an intermedullary space of a humerus bone (Fig. 71), the curved pathway having a proximal insertion hole configured to receive a bone-fracture fixation device (Fig. 13, ref. 62);
inserting, into the curved pathway, the bone-fracture fixation device in a flexible configuration (Fig. 76), the bone-fracture fixation device having a proximal end portion (located closest to the operator and insertion tool ref. 104, Fig. 77) and a distal end portion (opposite the end portion as seen in Fig. 77); and
transitioning the bone-fracture fixation device from the flexible configuration to a rigid configuration while the bone-fracture device has a curved shape (paragraph [0004]), wherein, after implantation, the bone-fracture fixation device is fully contained within the humerus (Fig. 78),
wherein a length of the bone-fracture fixation device is the same in the flexible and rigid configurations (due to the hinged nature of the embodiment, the length will remain the same since one side of the device is continuous),
but is silent regarding the step of manipulating the proximal end portion of the bone-fracture fixation device to transition from the flexible to rigid configuration.
Harshman teaches a bone-fracture fixation device (Abstract) configured to transition from a flexible configuration to a rigid configuration and back, if desired (paragraph [0041]). The device is transitioned into the rigid configuration via a locking interface (paragraph [0047], ref. 120) at a proximal end portion (paragraph [0048], Fig. 1). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Moore to substitute the device of Moore with the device of Harshman such that the method comprises the step of manipulating the proximal end portion of the bone-fracture fixation device to transition from the flexible to rigid configuration, as taught by Harshman, for the purpose of reverting back to the flexible state for device removal if warranted (paragraph [0041]).
Claim(s) 33 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moore (US 2012/0065638 A1) in view of Harshman et al. (US 2017/0238977 A1) and in view of Thakkar (US 2007/0173834 A1).
Regarding claim 33, Moore in view of Harshman discloses the method of claim 32, except further comprising: forming a second curved pathway in the intermedullary space of the humerus bone; and inserting a second bone-fracture fixation device into the second curved pathway.
Regarding claim 43, Moore in view of Harshamn discloses the method of claim 42, except further comprising: forming a second curved pathway in the intermedullary space of the radius and/or ulna bone; and inserting a second bone-fracture fixation device into the second curved pathway.
Thakkar teaches an analogous method (Abstract) comprising forming a second curved pathway for a second bone-fracture fixation device (Figs. 7A and 7B). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Moore in view of Harshman to include forming a second curved pathway in the intermedullary space of the humerus or radius or ulna bone; and inserting a second bone-fracture fixation device into the second curved pathway, as taught by Thakkar, for the purpose of forming multiple points of contact within the medullary canal to increase securing power (paragraph [0060]).
Claim(s) 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harshman et al. (US 2015/0257800 A1) in view of Harshman et al. (US 2017/0238977 A1) and in view of Zirkle, Jr. et al. (US 8,157,803 B1).
Regarding claim 54, Moore in view of Harshman discloses the method of claim 42, except wherein the proximal end portion of the bone- fracture fixation device further comprises an interface with a side plate configured to add a compressive force across a fracture.
Zirkle teaches an analogous method (Abstract) comprising an intramedullary nail (Fig. 1, ref. 76) and a side plate (Fig. 1, ref. 64). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Moore in view of Harshman to include a side plate that interfaces with a proximal end portion of the device, as taught by Zirkle, for the purpose added fixation and stability. Note that the plate and associated fasteners are fully capable of adding a compressive force across the fracture once the fasteners are fully screwed or tightened in.
Allowable Subject Matter
Claims 41, 49 and 52 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 PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TESSA M MATTHEWS/ Examiner, Art Unit 3773