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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 16-19) in the reply filed on 1/21/2026 is acknowledged. All non-elected claims were cancelled by the Applicant.
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.
Claim(s) 16, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duerig et al. (US 20190276921 A1, hereafter “Duerig”) in view of Eigler et al. (US 20210338990 A1, hereafter Eigler), and in further view of Sanders et al. (US 20070173800 A1, hereafter “Sanders”).
Regarding claim 16, Duerig discloses a shape memory nitinol material for use in medical implants wherein the medical device has a martensite finish temperature (Mf) less than body temperature (“Mf [is] below a normal body temperature” para. [0009]),
a R-phase finish temperature (Rf) above body temperature (“R-phase has been stabilized and shifted to above body temperature,” para. [0065]), and
an austenite finish temperature (Af) above body temperature (“Af is above body temperature,” para. [0063]).
However, Duerig fails to disclose an implantable shape memory actuator for treating a human subject, wherein the implantable shape memory actuator is configured to adjust fluid flow through an adjustable shunting system.
Eigler teaches a similar device in the same field of endeavor—an implantable shape memory actuator (700) for treating a human subject (para. [0121]), wherein the implantable shape memory actuator is configured to adjust fluid flow through an adjustable shunting system (para. [0123, 0125]).
Duerig discloses a wide range of various medical implants that its shape memory material can be used for (see para. [0014]) and Eigler discloses the use of a nitinol material that also has the austenitic and martensitic phases (see para. [0087]); therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the material of Duerig for a shape memory actuator as taught by Eigler with predictable results namely, a temperature-sensitive shape memory material for medical implants.
However, Duerig is silent as to the exact degree amount the Mf is below body temperature.
Sanders teaches an implantable medical device formed of a shape memory material wherein the Mf is at least 10 0C less than body temperature (para. [0031] discloses Mf is 10-20 degrees C below the martensite start temperature of 10-15 degrees C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the non-specific Mf of Duerig to at least 10 degrees C below body temperature as taught by Sanders yielding predictable results namely, a shape memory material that can transition to a rigid austenitic state to a more flexible martensitic state based on the temperature and allowing sufficient time to manipulate the material as needed (para. [0006, 0031]).
Regarding claim 18, the combination of Duerig, Eigler, and Sanders discloses the actuator of claim 16. Duerig fails to disclose wherein the Mf is at or below 25°C.
Sanders teaches wherein the Mf is at or below 25°C (para. [0031] discloses Mf is 10-20 degrees C below the martensite start temperature of 10-15 degrees C—i.e., Mf can be 5 degrees C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the non-specific Mf of Duerig to at or below 25 degrees C as taught by Sanders yielding predictable results namely, a shape memory material that can transition to a rigid austenitic state to a more flexible martensitic state based on the temperature and allowing sufficient time to manipulate the material as needed (para. [0006, 0031]).
Regarding claim 19, the combination of Duerig, Eigler, and Sanders discloses the actuator of claim 16. Duerig fails to disclose wherein the Mf is above about 5°C.
Sanders teaches wherein the Mf is above about 5°C (para. [0031] discloses Mf is 10-20 degrees C below the martensite start temperature of 10-15 degrees C—i.e., Mf can be 5 degrees C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the non-specific Mf of Duerig to above about 5 degrees C as taught by Sanders yielding predictable results namely, a shape memory material that can transition to a rigid austenitic state to a more flexible martensitic state based on the temperature and allowing sufficient time to manipulate the material as needed (para. [0006, 0031]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duerig (US 20190276921 A1) in view of Eigler (US 20210338990 A1), Sanders (US 20070173800 A1), and in further view of Frantzen et al. (US 5776114 A, hereafter “Frantzen”).
Regarding claim 17, the combination of Duerig, Eigler, and Sanders discloses the actuator of claim 16. However, the combination fails to disclose wherein the Af is between about 45°C and about 65°C.
Frantzen teaches a nitinol material wherein the Af is between about 45°C and about 65°C (column 2 line 67 – column 3 line 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the non-specific Af of Duerig to between about 45°C and about 65°C as taught by Frantzen yielding predictable results namely, a shape memory material that transitions between austenite and martensite phases (column 2 line 67 – column 3 line 4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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, Rebecca Eisenberg can be reached at (571) 270-5879. 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.
/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 11 February 2026