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 .
Status of the Claims
This Office Action is responsive to the preliminary amendment filed November 18, 2024. As directed by the preliminary amendment: Claims 9 and 20 have been amended. Claims 6-8, 10, 17-19, and 21 have been cancelled. Claims 1-5, 9, 11-16, 20, and 22-27 are presently pending in this application.
Claim Objections
Claim 3 is objected to because of the following informalities: In ll. 4, the phrase “and.” should be re-written as --and,--. Appropriate correction is required.
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.
Claims 1-5, 9, 11-16, 20, and 22-27 are 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). Regarding claims 1, 12, and 23, Il. 3 and Il. 5, the phrases “a superior rod attachable to a superior portion of a bone via the bone anchors” and “an inferior rod attachable to an inferior portion of the bone via the bone anchors” are directed to or encompassing a human organism. Applicant is suggested to use the language such as “configured to” or “adapted to” in order to overcome this rejection.
Claims 2-5, 9, 11, 13-16, 20, 22, and 24-27 are rejected on being dependent to a rejected base claim.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 24 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 24, Il. 5, the phrase “an outlet check valve” is unclear whether applicant is introducing another outlet check valve or referring to the previously stated outlet check valve stated in claim 23. It appears applicant is referring to the previously stated outlet check valve. Amendment and clarification are required.
Examiner’s Note
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.
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) 1-5, 9, 11-16, 20, and 22-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullaney et al. (US 2021/0259748), herein referred to as Mullaney, and in view of Spievack (US 5,350,379).
Regarding claim 1, Mullaney discloses a bone implant system (210) (figure 11) comprising a superior rod (201), the superior rod (201) comprising a superior end (figure 11), an inferior rod (202), the inferior rod (202) comprising an inferior end (figure 11), wherein the inferior rod (202) is movably coupled (¶83-¶85) to the superior rod (201) such that a length of the combined superior and inferior rods (201, 202), measured between the superior end (figure 11) and the inferior end (figure 11), is adjustable (¶83-¶85), a chamber (figure 11), and a micropump (207) configured to (i.e. capable of) urge fluid to flow into the chamber to cause the length to increase (¶84 and figures 11 and 12).
Yet, Mullaney lacks a detailed description on a plurality of bone anchors, the superior rod attachable to a superior portion of a bone via the bone anchors, the inferior rod attachable to an inferior portion of the bone via the bone anchors.
However, Spievack teaches a plurality of bone anchors (34, 36), a superior rod (8) attachable to a superior portion of a bone (2) via the bone anchors (elements 34), an inferior rod (6) attachable to an inferior portion of the bone (2) via the bone anchors (elements 36) (figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Mullaney’s bone implant system with a plurality of bone anchors, the superior rod attachable to a superior portion of a bone via the bone anchors, the inferior rod attachable to an inferior portion of the bone via the bone anchors as taught by Spievack, since such a modification would secure the IM nail to the fractured bone.
Regarding claim 2, the modified Mullaney’s bone implant system has wherein the superior rod (201 of Mullaney) telescopically engages the inferior rod (202 of Mullaney) such that a cavity (figure 11 of Mullaney) is present within at least one of the superior rod (201 of Mullaney) and the inferior rod (202 of Mullaney), and the chamber is within the cavity (figure 11 of Mullaney).
Regarding claim 3, the modified Mullaney’s bone implant system has wherein the micropump (207 of Mullaney) is within the cavity (figures 11 and 12 of Mullaney), and the micropump (207 of Mullaney) comprises one of: a piezoelectric motor, and a thermal phase change pump (¶85 of Mullaney).
Regarding claim 4, the modified Mullaney’s bone implant system has further comprising an outlet check valve (CV of Mullaney) (¶87 of Mullaney) configured to (i.e. capable of) permit flow of the fluid from the micropump (207 of Mullaney) to the chamber (figure 1 of Mullaney), and restrict flow of the fluid from the chamber (figure 11 of Mullaney) to the micropump (207 of Mullaney).
Regarding claim 5, the modified Mullaney’s bone implant system has further comprising a reservoir (considered as where the volume is contained of Mullaney), and an inlet check valve (CV of Mullaney) (¶87 and figure 20 of Mullaney) configured to (i.e. capable of) permit flow of the fluid from the reservoir (considered as where the volume is contained of Mullaney) to the micropump (207 of Mullaney), and restrict flow of the fluid from the micropump (207 of Mullaney) to the reservoir (considered as where the volume is contained of Mullaney).
Regarding claim 9, the modified Mullaney’s bone implant system has further comprising a control system (221c, 1010 of Mullaney), operatively connected to the micropump (207 of Mullaney), that is configured to (i.e. capable of) control operation of the micropump (207 of Mullaney) (¶86 of Mullaney), and a sensor (¶86 of Mullaney) operatively connected to provide sensor data to the control system (221c, 1010 of Mullaney), wherein the control system (221c, 1010 of Mullaney) is configured to (i.e. capable of) control the micropump (207 of Mullaney) based on the sensor data, wherein the sensor data (¶86 of Mullaney) is indicative of: a pressure of the fluid (¶86 of Mullaney), and/or a displacement of the superior rod (201 of Mullaney) relative to the inferior rod (202 of Mullaney).
Regarding claim 11, the modified Mullaney’s bone implant system has wherein the inferior rod (202 of Mullaney) is movably coupled (¶83-¶85 of Mullaney) to the superior rod (201 of Mullaney) such that the superior rod (201 of Mullaney) moves along an arcuate pathway (figure 11 of Mullaney) relative to the inferior rod (202 of Mullaney).
Regarding claim 12, Mullaney discloses a bone implant system (210) (figure 11) comprising a superior rod (201), the superior rod (201) comprising a superior end (figure 11), an inferior rod (202), the inferior rod (202) comprising an inferior end (figure 11), wherein the inferior rod (202) is movably coupled (¶83-¶85) to the superior rod (201) such that a length of the combined superior and inferior rods (201, 202), measured between the superior end (figure 11) and the inferior end (figure 11), is adjustable (¶83-¶85) along an arcuate axis (figure 11), and a pump (207), positioned on the arcuate axis (figure 11) and configured to (i.e. capable of) pressurize a fluid to urge the length to increase (¶84 and figures 11 and 12).
Yet, Mullaney lacks a detailed description on a plurality of bone anchors, the superior rod attachable to a superior portion of a bone via the bone anchors, the inferior rod attachable to an inferior portion of the bone via the bone anchors.
However, Spievack teaches a plurality of bone anchors (34, 36), a superior rod (8) attachable to a superior portion of a bone (2) via the bone anchors (elements 34), an inferior rod (6) attachable to an inferior portion of the bone (2) via the bone anchors (elements 36) (figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Mullaney’s bone implant system with a plurality of bone anchors, the superior rod attachable to a superior portion of a bone via the bone anchors, the inferior rod attachable to an inferior portion of the bone via the bone anchors as taught by Spievack, since such a modification would secure the IM nail to the fractured bone.
Regarding claim 13, the modified Mullaney’s bone implant system has wherein the superior rod (201 of Mullaney) telescopically engages the inferior rod (202 of Mullaney) (¶83-¶85 of Mullaney) such that a cavity (figure 11 of Mullaney) is present within at least one of the superior rod (201 of Mullaney) and the inferior rod (202 of Mullaney), and the bone implant system further comprises a chamber (figure 11 of Mullaney), positioned within the cavity (figure 11 of Mullaney), into which the pump (207 of Mullaney) expels the fluid to urge the length to increase in response to pressurization of the fluid (figure 11 and 12 of Mullaney).
Regarding claim 14, the modified Mullaney’s bone implant system has wherein the pump (207 of Mullaney) is within the cavity (figures 11 and 12 of Mullaney), and the pump comprises a micropump (207 of Mullaney) that comprises one of: a piezoelectric motor, and a thermal phase change pump (¶85 of Mullaney).
Regarding claim 15, the modified Mullaney’s bone implant system has further comprising an outlet check valve (CV of Mullaney) (¶87 of Mullaney) configured to (i.e. capable of) permit flow of the fluid from the pump (207 of Mullaney) to the chamber (figure 11 of Mullaney), and restrict flow of the fluid from the chamber (figure 11 of Mullaney) to the pump (207 of Mullaney).
Regarding claim 16, the modified Mullaney’s bone implant system has further comprising a reservoir (considered as where the volume is contained of Mullaney), and an inlet check valve (CV of Mullaney) configured to (i.e. capable of) permit flow of the fluid from the reservoir (considered as where the volume is contained of Mullaney) to the pump (207 of Mullaney), and restrict flow of the fluid from the pump (207 of Mullaney) to the reservoir (considered as where the volume is contained of Mullaney).
Regarding claim 20, the modified Mullaney’s bone implant system has further comprising a control system (221c, 1010 of Mullaney), operatively connected to the pump (207 of Mullaney), that is configured to (i.e. capable of) control operation of the pump (207 of Mullaney) (¶86 of Mullaney), and a sensor (¶86 of Mullaney) operatively connected to provide sensor data to the control system (221c, 1010 of Mullaney), wherein the control system (221c, 1010 of Mullaney) is configured to (i.e. capable of) control the pump (207 of Mullaney) based on the sensor data, wherein the sensor data (¶86 of Mullaney) is indicative of: a pressure of the fluid (¶86 of Mullaney), and/or a displacement of the superior rod (201 of Mullaney) relative to the inferior rod (202 of Mullaney).
Regarding claim 22, the modified Mullaney’s bone implant system has wherein the inferior rod (202 of Mullaney) is movably coupled (¶83-¶85 of Mullaney) to the superior rod (201 of Mullaney) such that the superior rod (201 of Mullaney) moves along an arcuate pathway (figure 11 of Mullaney) relative to the inferior rod (202 of Mullaney).
Regarding claim 23, Mullaney discloses a bone implant system (210) (figure 11) comprising a superior rod (201), the superior rod (201) comprising a superior end (figure 11), an inferior rod (202), the inferior rod (202) comprising an inferior end (figure 11), wherein the inferior rod (202) is movably coupled (¶83-¶85) to the superior rod (201) such that a length of the combined superior and inferior rods (201, 202), measured between the superior end (figure 11) and the inferior end (figure 11), is adjustable (¶83-¶85), a chamber (figure 11), a pump (207) configured to (i.e. capable of) urge fluid to flow into the chamber to cause the length to increase (¶84 and figures 11 and 12), an outlet check valve (CV) (¶87 and figure 20) configured to (i.e. capable of) permit flow of the fluid from the pump (207) to the chamber (figure 11) to allow the length to increase (¶87, ¶89), and restrict flow of the fluid from the chamber to the pump (207) to restrict reduction in the length (¶87, ¶89).
Yet, Mullaney lacks a detailed description on a plurality of bone anchors, the superior rod attachable to a superior portion of a bone via the bone anchors, the inferior rod attachable to an inferior portion of the bone via the bone anchors.
However, Spievack teaches a plurality of bone anchors (34, 36), a superior rod (8) attachable to a superior portion of a bone (2) via the bone anchors (elements 34), an inferior rod (6) attachable to an inferior portion of the bone (2) via the bone anchors (elements 36) (figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Mullaney’s bone implant system with a plurality of bone anchors, the superior rod attachable to a superior portion of a bone via the bone anchors, the inferior rod attachable to an inferior portion of the bone via the bone anchors as taught by Spievack, since such a modification would secure the IM nail to the fractured bone.
Regarding claim 24, the modified Mullaney’s bone implant system has further comprising a reservoir (considered as where the volume is contained of Mullaney), an inlet check valve (CV of Mullaney) (¶87 and figure 20 of Mullaney) configured to (i.e. capable of) permit flow of the fluid from the reservoir (considered as where the volume is contained of Mullaney) to the pump (207 of Mullaney), and restrict flow of the fluid from the pump (207 of Mullaney) to the reservoir (considered as where the volume is contained of Mullaney), and an outlet check valve (CV of Mullaney) (¶87 of Mullaney) configured to (i.e. capable of) permit flow of the fluid from the pump (207 of Mullaney) to the chamber (figure 11 of Mullaney), and restrict flow of the fluid from the chamber (figure 11 of Mullaney) to the pump (207 of Mullaney).
Regarding claim 25, the modified Mullaney’s bone implant system has further comprising a control system (221c, 1010 of Mullaney), operatively connected to the pump (207 of Mullaney), that is configured to (i.e. capable of) control operation of the pump (207 of Mullaney), wherein the control system (221c, 1010 of Mullaney) comprises a wireless communication device (¶86 of Mullaney) configured to (i.e. capable of) transmit and/or receive wireless signals.
Regarding claim 26, the modified Mullaney’s bone implant system has wherein the superior rod (201 of Mullaney) telescopically engages the inferior rod (202 of Mullaney) (¶83-¶85 of Mullaney) such that a cavity (figure 11 of Mullaney) is present within at least one of the superior rod (201 of Mullaney) and the inferior rod (202 of Mullaney), the pump (207 of Mullaney) and the chamber are within the cavity (figure 11 of Mullaney), and the inferior rod (202 of Mullaney) is movably coupled (¶83-¶85 of Mullaney) to the superior rod (201 of Mullaney) such that the superior rod (201 of Mullaney) moves along an arcuate pathway (figure 11 of Mullaney) relative to the inferior rod (202 of Mullaney).
Regarding claim 27, the modified Mullaney’s bone implant system has wherein the pump comprises a micropump (207 of Mullaney) that comprises one of: a piezoelectric motor, and a thermal phase change pump (¶85 of Mullaney).
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 1-5, 9, 11-16, 20, and 22-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12,156,683. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the USP claims lies in the fact that the USP claims includes more elements and are thus, more specific. Thus, the USP is in effect a “species” of the “generic” invention of the instant application’s claims. It has been held that the generic invention is “anticipated” by the “species”.
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775