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
Claims 10 and 14 are objected to because of the following informalities: Claim 10 is objected to because it inconsistently refers to the medical device body as “the device body” (line 1) and should recite “the medical device body” to be consistent with other claims. Claim 14 is objected to because acronyms (e.g. SCI) should be defined at their first occurrence. 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 8, 10-11 and 21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Publication No. 2022/0183844 to Clawson et al. “Clawson”.
As for Claims 1, 4 and 11, Clawson discloses an implantable medical device configured to receive ultrasound energy (Paragraph [0047]) comprising an implantable medical device body having an outer surface, inner surface, first side and second side (Figs. 1-2 and corresponding descriptions), a sonolucent window disposed in the device body and sized configured and fabricated from a sonolucent material to allow ultrasound energy to pass therethrough (Paragraphs [0045]-[0048]).
With respect to Claims, 2 and 10, Clawson explains the sonolucent material is suitable for ultrasound imaging and made out of similar material disclosed by Applicant (e.g. polymethyl methacrylate (PMMA); Paragraphs [0047]-[0048]). Examiner notes the sonolucent window described by Clawson would have a mass density and elastic modulus that corresponds to an intrinsic longitudinal sound speed value close to a nominal soft issue (1540 m/s) and an acoustic impedance value close to nominal soft tissue (1.5 MRayls) in its broadest reasonable interpretation.
Regarding Claim 3, Clawson’s window is homogenous and void free in its broadest reasonable interpretation.
As for Claim 8, Clawson’s medical device body is monolithic in its broadest reasonable interpretation.
Regarding Claim 21, Clawson discloses implanting the implant disclosed above and using the sonolucent window to provide visualization and treatment (Paragraphs [0048], [0055] and [0066]). In one embodiment, the ultrasound window can be used for focused ultrasound hyperthermia treatments of tumors (Paragraph [0048]).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clawson in view of U.S. 2018/0338835 to Gordon.
As for Claim 5, Clawson discloses an implant with a sonolucent window for imaging and treatment as described above. While Clawson provides wire channels for treatment (Paragraph [0055]), Clawson does not specifically disclose a port for a drug delivery needle as claimed.
Gordon teaches from within a similar field of endeavor with respect to implants with a conduit to accept treatment (Abstract) where the conduit may allow a syringe needle to penetrate and deliver medicine (Paragraphs [0057] and [0059]).
Accordingly, one skilled in the art would have been motivated to have modified the implant body described by Clawson to include syringe needle ports to deliver medicine to the patient as described by Gordon in order to enhance/improve the treatment. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clawson alone.
As for Claims 6-7, Clawson discloses an implant with a sonolucent window for imaging and treatment as described above. Examiner notes that while Clawson depicts one window, one skilled in the art would have been motivated to have modified the implant to include multiple windows arranged in any pattern (e.g. vertically adjacent) as such a modification merely involves a duplication of parts (MPEP 2144.04) to improve visualization at multiple areas of the implant.
Claim(s) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clawson in view of U.S. Publication No. 2011/0313323 to Henderson et al. “Henderson”.
As for Claim 9, Clawson discloses an implant with a sonolucent window for imaging and treatment as described above. However, Clawson does not disclose wherein the implant has a material to promote bone regeneration, growth of new vessels, tissue repair or combinations thereof.
Henderson teaches from within a similar field of endeavor with respect to therapeutic scaffolding implants (Paragraphs [0086]-[0093]) where the implant may include a porous member synthesized from any suitable biocompatible material coated with tissue growth proteins or morphogenic proteins (Paragraphs [0194], [0199] and [0233]).
Accordingly, one skilled in the art would have been motivated to have modified Clawson’s implant to include a therapeutic coating as described by Henderson in order to enhance the treatment of patient conditions. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
With respect to Claim 12, Henderson explains the coating may be applied to spinal scaffold implants (Paragraph [0085]) or cranial attachment systems (Paragraph [0085]-[0086]). Accordingly, one skilled in the art would have been motivated to have inserted Clawford’s acoustic window in other implant systems and methods (e.g. spinal scaffolds) in order to visualize treatment/healing progress. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 13 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clawson in view of U.S. Publication No. 2019/0350557 to Shi et al. “Shi”.
As for Claims 13 and 18, Clawson discloses an implant with a sonolucent window for imaging and treatment and a method of use as described above. However, Clawson does not disclose a step of measuring a physiological parameter, monitoring the medical condition or adjusting the treatment as claimed.
Shi teaches from within a similar field of endeavor with respect to therapeutic ultrasound systems and methods (Abstract) where a controller may adjust treatment parameters based on, at least in part, received ultrasound data (Abstract, Paragraphs [0005] and [0021]). Examiner notes the receive ultrasound data is used to monitor a physiological parameter in its broadest reasonable interpretation (Paragraphs [0002], [0024], [0026], [0034]).
Accordingly, one skilled in the art would have been motivated to have modified the treatment method described by Clawson to include a feedback step of adjusting parameters when necessary as described by Shi in order to improve treatment targeting.
As for Claim 19, Shi explains the treatment may include a chemical agent (Paragraphs [0002] and [0024]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clawson and Shi as applied to claim 13 above, and further in view of U.S. Publication No. 2014/0081659 to Nawana et al. “Nawana”.
As for Claim 15, Clawson and Shi discloses an implant with a sonolucent window for imaging and treatment and a method of use as described above. However, the art of record does not specify monitoring or treating myelopathy.
Nawana teaches from within a similar field of endeavor with respect to ultrasound systems and methods where ultrasound may be used to assess myelopathy (Paragraphs [0137] and [0240]).
Accordingly, one skilled in the art would have been motivated to have used Clawson’s implant window at other sites of the body in order to assess other types of conditions such as myelopathy as such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clawson and Shi as applied to claim 13 above, and further in view of U.S. Publication No. 2024/0366182 to Bonnefous et al. “Bonnefous”.
As for Claim 16, Clawson and Shi discloses an implant with a sonolucent window for imaging and treatment and a method of use as described above. However, the art of record does not specify monitoring blood flow values as claimed.
Bonnefous teaches from within a similar field of endeavor with respect to ultrasound systems and methods where ultrasound may be used to assess blood vessels, nerve fibers, spinal cord and tumors in any part of the body (Paragraph [0056]).
Accordingly, one skilled in the art would have been motivated to have used Clawson’s implant window at other sites of the body in order to assess other types of conditions such as spinal cord vessel health as such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
*Alternate Rejections
Claim(s) 1-4, 6, 8 and 10-12 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over 2021/0401586 to Zakelj in view of Clawson.
As for Claims 1, 4, 6 and 11-12, Zakelj discloses a spinal implant (Abstract, Paragraphs [0002]-[0003]) including an outer surface, inner surface, first side and second side and “windows” configured to allow for visualization of a graft area by aiming ultrasound through the wall (Paragraph [0034], Fig. 1 and corresponding descriptions).
However, Zakelj does not expressly disclose wherein the windows are sonolucent.
Clawson teaches from within a similar field of endeavor with respect to medical implants with windows (Abstract) where the window can be sonolucent in order to allow for visualization and treatment including for example ultrasound waves (Paragraphs [0044]-[0048] and [0055]).
Accordingly, one skilled in the art would have been motivated to have modified the spinal implant described by Zakelj, particularly the windows to be sonolucent windows described by Clawson in order to protect the treatment site while still allowing for visualization and treatment. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
With respect to Claims 2 and 10, Clawson explains the sonolucent material is suitable for ultrasound imaging and made out of similar material disclosed by Applicant (e.g. polymethyl methacrylate (PMMA); Paragraphs [0047]-[0048]). Examiner notes the sonolucent window described by Clawson would have a mass density and elastic modulus that corresponds to an intrinsic longitudinal sound speed value close to a nominal soft issue (1540 m/s) and an acoustic impedance value close to nominal soft tissue (1.5 MRayls) in its broadest reasonable interpretation.
Regarding Claim 3, Clawson’s window is homogenous and void free in its broadest reasonable interpretation.
As for Claim 8, Clawson’s medical device body is monolithic in its broadest reasonable interpretation.
Regarding Claim 21, Clawson discloses implanting the implant disclosed above and using the sonolucent window to provide visualization and treatment (Paragraphs [0048], [0055] and [0066]). In one embodiment, the ultrasound window can be used for focused ultrasound hyperthermia treatments of tumors (Paragraph [0048]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zakelj and Clawson as applied to claim 1 above, and further in view of Gordon.
As for Claim 5, Zakelj and Clawson discloses an implant with a sonolucent window for imaging and treatment as described above. While Clawson provides wire channels for treatment (Paragraph [0055]), Clawson does not specifically disclose a port for a drug delivery needle as claimed.
Gordon teaches from within a similar field of endeavor with respect to implants with a conduit to accept treatment (Abstract) where the conduit may allow a syringe needle to penetrate and deliver medicine (Paragraphs [0057] and [0059]).
Accordingly, one skilled in the art would have been motivated to have modified the implant body described by Zakelj and Clawson to include syringe needle ports to deliver medicine to the patient as described by Gordon in order to enhance/improve the treatment. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zakelj and Clawson as applied to claim 1 above, and further in view of U.S. Publication No. 2021/0137573 to Jackson III et al. “Jackson”.
As for Claims 7, Zakelj and Clawson discloses an implant with a sonolucent window for imaging and treatment as described above. However, the art of record does not provide a plurality of vertically adjacent windows.
Jackson teaches from within a similar field of endeavor with respect to spinal implants where the implantable plate can be part of a modular system for stabilizing vertebral bodies and forms a plurality of vertically adjacent “windows” (Figs. 20-22). Jackson explains the implant can be used to treat cervical myelopathy or as a bone graft which heals over time (Paragraphs [0005] and [0008]).
Accordingly, one skilled in the art would have been motivated to have used sonolucent windows for visualizing and treating areas in the body in other types of spinal implants as described by Jackson in order to treat other areas of the body as needed and to monitor the healing over time as such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zakelj and Clawson as applied to claim 1 above, and further in view of U.S. Publication No. 2011/0313323 to Henderson et al. “Henderson”.
As for Claim 9, Zakelj and Clawson discloses an implant with a sonolucent window for imaging and treatment as described above. However, Zakelj and Clawson does not disclose wherein the implant has a material to promote bone regeneration, growth of new vessels, tissue repair or combinations thereof.
Henderson teaches from within a similar field of endeavor with respect to therapeutic scaffolding implants (Paragraphs [0086]-[0093]) where the implant may include a porous member synthesized from any suitable biocompatible material coated with tissue growth proteins or morphogenic proteins (Paragraphs [0194], [0199] and [0233]).
Accordingly, one skilled in the art would have been motivated to have modified Clawson’s implant to include a therapeutic coating as described by Henderson in order to enhance the treatment of patient conditions. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 13, 15, 18 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zakelj, Clawson and Jackson.
As for Claims 13, 15, 18 and 21, Zakelj discloses a spinal implant and method of use (Abstract, Paragraphs [0002]-[0003]) including an outer surface, inner surface, first side and second side and “windows” configured to allow for visualization of a graft area by aiming ultrasound through the wall (Paragraph [0034], Fig. 1 and corresponding descriptions).
However, Zakelj does not expressly disclose wherein the windows are sonolucent.
Clawson teaches from within a similar field of endeavor with respect to medical implants with windows (Abstract) where the window can be sonolucent in order to allow for visualization and treatment including for example ultrasound waves (Paragraphs [0044]-[0048] and [0055]).
Accordingly, one skilled in the art would have been motivated to have modified the spinal implant described by Zakelj, particularly the windows to be sonolucent windows described by Clawson in order to protect the treatment site while still allowing for visualization and treatment. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Regarding the step of measuring a physiological parameter, Jackson teaches from within a similar field of endeavor with respect to spinal implants where the implantable plate can be part of a modular system for stabilizing vertebral bodies and forms a plurality of vertically adjacent “windows” (Figs. 20-22). Jackson explains the implant can be used to treat cervical myelopathy or as a bone graft which heals over time (Paragraphs [0005] and [0008]).
Accordingly, one skilled in the art would have been motivated to have used sonolucent windows for visualizing and treating areas in the body in other types of spinal implants as described by Jackson in order to treat other areas of the body as needed and to monitor the healing over time as such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 14, 17 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zakelj, Clawson and Jackson as applied to claims 13 and 18 above, and further in view of Henderson.
As for Claims 14, 17 and 19-20, Zakelj, Clawson and Jackson disclose a spinal implant with a sonolucent window as described above to facilitate treatment and diagnostic imaging of a healing process. However, the art of record does not expressly disclose treating all the claimed conditions.
Henderson teaches from within a similar field of endeavor with respect to therapeutic scaffolding implants (Paragraphs [0086]-[0093]) where the implant may include a porous member synthesized from any suitable biocompatible material coated with tissue growth proteins or morphogenic proteins (Paragraphs [0194], [0199] and [0233]). Henderson explains where the material may facilitate blood vessel formation (Paragraphs [0092], ) which would address the claimed conditions (ischemia, hypotension, etc.).
Accordingly, one skilled in the art would have been motivated to have modified the implant to include a therapeutic coating as described by Henderson in order to enhance the treatment of patient conditions and monitor the therapeutic effect of the treatment. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zakelj, Clawson and Jackson as applied to claim 13 above, and further in view of U.S. Publication No. 2024/0366182 to Bonnefous et al. “Bonnefous”.
As for Claim 16, Zakelj, Clawson and Jackson discloses an implant with a sonolucent window for imaging and treatment and a method of use as described above. However, the art of record does not specify monitoring blood flow values along the spinal cord.
Bonnefous teaches from within a similar field of endeavor with respect to ultrasound systems and methods where ultrasound may be used to assess blood vessels, nerve fibers, spinal cord and tumors in any part of the body (Paragraph [0056]).
Accordingly, one skilled in the art would have been motivated to have monitored other physiological conditions around the modified spinal implant as described by Bonnefous in order to provide a complete diagnosis of the patient. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Publication No. 2018/0000522 to Linares et al. which discloses a spinal scaffold assembly with one or more openings (Fig. 10 and corresponding descriptions).
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U.S. Publication No. 2020/00077974 to Avanaki et al. which discloses utilizing ultrasound imaging techniques to display one or more images of the brain or spinal cord through an acoustic window (Abstract).
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797
