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 11 is objected to because of the following informalities: the word “and” should be inserted after the semicolon (line 3). Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 8 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. Claim 8 recites the limitation "the controller" in line 1. There is insufficient antecedent basis for this limitation in the claim because claim 1 does not include a controller. Because claim 7 introduces a controller, the Examiner is interpreting claim 8 as depending from claim 7.
Claims 11-20 are 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. Claim 11 recites the limitation "providing an adjustable implant including a driver within a bone" in line 2. Such a recitation is unclear because, due to a lack of punctuation, it is unclear whether the adjustable implant includes (a) a driver or (b) a driver within a bone. Because the disclosure provides support for the adjustable implant including a driver, and not a driver within a bone, the Examiner is interpreting claim 11 as reciting “providing an adjustable implant within a bone, wherein the adjustable implant includes a driver.” Claims 12-20 are rejected because they depend from claim 11.
Claim 16 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. Claim 16 recites the limitation "the transceiver" in line 1. There is insufficient antecedent basis for this limitation in the claim because claim 11 does not include a transceiver. Because claim 1 indicates that the transceiver is part of the control module, the Examiner is interpreting claim 16 as reciting “wherein the control module includes a transceiver, and wherein the transceiver includes…”
Claim 17 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. Claim 17 recites the limitation "the transceiver" in line 2. There is insufficient antecedent basis for this limitation in the claim because claim 11 does not include a transceiver. Because claim 1 indicates that the transceiver is part of the control module, the Examiner is interpreting claim 17 as reciting “wherein the control module includes a transceiver, and further comprising…”
Claim 18 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. Claim 18 recites the limitation "the controller" in line 1. There is insufficient antecedent basis for this limitation in the claim because claim 11 does not include a controller. Because claim 17 introduces a controller, the Examiner is interpreting claim 18 as depending from claim 17.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19 is not further limiting because claim 11 recites “securing a control module to the bone” and thus the control module is placed subcutaneously. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 20 is not further limiting because claim 11 recites “securing a control module to the bone” and thus the control module is secured to the bone. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-5, 7-15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roschak et al. (US 2017/0333080 A1).
Claim 1. Roschak discloses a system for treatment of a deformity in a patient, comprising:
a control module (module 1004 in Fig. 1 of bone reshaping implant 1000 in Fig. 1 and corresponding to implant body 50 and attached components in Fig. 4) having a transceiver (transceiver 1007 in Fig. 1; transceiver 51 in Fig. 4); and
an adjustable implant (bone reshaping implant 1000 in Fig. 1 and corresponding to implant body 40 and attached components in Fig. 4) including a driver (actuator 1006 in Fig. 1), the adjustable implant configured to be implanted separately from the control module (see Fig. 4, which shows that implant body 40 and implant body 50 are separately attached to bone 10 via different bone screws),
wherein the control module adjusts the adjustable implant via a magnetic field generated between the control module and the adjustable implant (see para. 0034, which refers to a driven magnet system) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 2. Roschak discloses wherein the driver includes a first magnetic element (see para. 0034, which refers to a driven magnet system) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 3. Roschak discloses wherein the driver includes an actuator (actuator 1006 in Fig. 1) configured to rotate the first magnetic element (see para. 0043, which indicates that the driven magnets rotate) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 4. Roschak discloses wherein the first magnetic element includes a rotatable permanent magnet (see para. 0043, which indicates that the driven magnets rotate) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 5. Roschak discloses wherein the actuator includes an electric motor (see para. 0034, which refers to an electrical motor) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 7. Roschak discloses a controller (processor/control 1001 in Fig. 1) operably connected to one or more of the transceiver and the driver (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 8. Roschak discloses wherein the controller includes a microcontroller (see para. 0085, which states that the controller can be a microcontroller) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 9. Roschak discloses wherein the control module is configured for subcutaneous placement within a body of a patient (see Fig. 4) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 10. Roschak discloses wherein the control module is configured to be secured to a bone (bone 10 in Fig. 4) of a patient (see Fig. 4) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 11. Roschak discloses method for treatment of a deformity in a patient (see para. 0031, which refers to a variety of bone deformities), comprising the steps of:
providing an adjustable implant (bone reshaping implant 1000 in Fig. 1 and corresponding to implant body 40 and attached components in Fig. 4) within a bone (bone 10 in Fig. 4; note that the bone screws are “within” bone 10), wherein the adjustable implant includes a driver (actuator 1006 in Fig. 1);
securing a control module (module 1004 in Fig. 1 of bone reshaping implant 1000 in Fig. 1 and corresponding to implant body 50 and attached components in Fig. 4) to the bone separately from the adjustable implant (see Fig. 4, which shows that implant body 40 and implant body 50 are separately attached to bone 10 via different bone screws); and
adjusting the adjustable implant (see para. 0028, which refers to adjusting bone reshaping implants) via a magnetic field generated between the control module and the adjustable implant (see para. 0034, which refers to a driven magnet system) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 12. Roschak discloses wherein the driver includes a first magnetic element (see para. 0034, which refers to a driven magnet system) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 13. Roschak discloses wherein the driver includes an actuator (actuator 1006 in Fig. 1) configured to rotate the first magnetic element (see para. 0043, which indicates that the driven magnets rotate) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 14. Roschak discloses wherein the first magnetic element includes a rotatable permanent magnet (see para. 0043, which indicates that the driven magnets rotate) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 15. Roschak discloses wherein the actuator includes an electric motor (see para. 0034, which refers to an electrical motor) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 17. Roschak discloses wherein the control module includes a transceiver (transceiver 1007 in Fig. 1; transceiver 51 in Fig. 4), and further comprising a controller (processor/control 1001 in Fig. 1) operably connected to one or more of the transceiver and the driver (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 18. Roschak discloses wherein the controller includes a microcontroller (see para. 0085, which states that the controller can be a microcontroller) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 19. Roschak discloses wherein the control module is configured for subcutaneous placement within a body of a patient (see Fig. 4) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Claim 20. Roschak discloses wherein the control module is configured to be secured to a bone (bone 10 in Fig. 4) of a patient (see Fig. 4) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Roschak et al. (US 2017/0333080 A1) in view of Schwardt et al. (US 2019/0015138 A1).
Claim 16. Roschak discloses wherein the control module includes a transceiver (transceiver 1007 in Fig. 1; transceiver 51 in Fig. 4) (Figs. 1 and 4; paras. 0032-0040 and 0069-0070).
Roschak fails to disclose wherein the transceiver includes an ultrasonic transducer configured to send and receive ultrasound signals (claims 6 and 16).
Schwardt teaches that an ultrasonic transducer can be used to generate ultrasound signals in order to operate an ultrasonic motor in the implant (see para. 0045).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control module of Roschak such that the transceiver includes an ultrasonic transducer configured to send and receive ultrasound signals (claims 6 and 16), as suggested by Schwardt, as such can be used to operate an ultrasonic motor in the implant (note that Roschak contemplates the use of ultrasound signals in para. 0034).
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 1-10 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 18, respectively, of U.S. Patent No. 12,213,708 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The differences between the claims of the patent and those of this application are that claims 1 and 18 of the patent include more limitations than claims 1 and 12 of this application (the function of the transceiver, the function of the driver, the first magnetic element, the second magnetic element, and the way in which the adjustable implant is adjusted in claim 1 of the patent; the adjustable implant placed within an intramedullary cavity, the second magnetic element, the communicating step, and the way in which the adjustable implant is adjusted in claim 18 of the patent) and are thus more specific. Thus, the inventions of claims 1-10 and 18 of the patent are in effect species of the generic inventions of claims 1-10 and 12 of this application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Because claims 1-10 and 12 of this application are anticipated by claims 1-10 and 18 of the patent, they are not patentably distinct from claims 1-10 and 18 of the patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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