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 the apparatus claims 1-11 in the reply filed on 8/26/2025 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claims 1-11, the claims set-forth a valve which is around the outside of a vein in a patient. The valve is controlled using a controller that takes sensed backflow from sensors to close the valve. However, its does not appear that this is enabled on how the valve could be placed next to the vein and controlled via the controller. Going through the wands factors shows that one of skill in the art would not be able to make or use the invention based on the present disclosure.
The following are the wands factors considered:
(A) The breadth of the claims: the claims broadly mention the control structure of the valves and broadly state what are the elements of the apparatus are broadly (for example, sensor, valve, spring, controller and how they interact with one another).
(B) The nature of the invention: the invention is a complicated device that has to be surgically inserted around a vein of a patient and then have a specific sensor to sense backflow within the vein and operate with a controller to close the valve. This would also require specific control structure and signal processing as well as signal transfer to accomplish back and forth between controller and device without specific electronics being shown. This is a complicated and is broadly described with broad terminology within the specification.
(C) The state of the prior art: there was no prior art found even similar to the present application. The prior art have blood pressure cuffs for detecting blood pressure and occluding any vasculature under it, or internal artificial valves within vasculature, or inserting occlusions into veins with reflux without using sensors and control structures. The attached PTO 892 illustrates the “closest” which is used loosely prior art that has no control structure based on sensing backflow/reflux through a vein to control a valve or even an external to a vein valve.
(D) The level of one of ordinary skill: the level of ordinary skill is relatively high being that of a doctor or PhD; however, similarly in the prior art search there are no scholarly papers in the realm of the invention.
(E) The level of predictability in the art: the predictability in the art is high as this appears to be a new field. Without more specific direction this would almost be impossible to recreate.
(F) The amount of direction provided by the inventor: the inventor mentions that this would be an invasive surgery and the components of the device and control structure very broadly within the specification. For example, there is no mention of what sensors are being used, just “sensors” that can sense backflow. This could be any known sensor. There is also a power and electromagnets with a spring and a controller that can control but broadly that it just receives information and then can control the electromagnets. There is no mention of the specifics of the electronics or the software/signal processing being done.
PNG
media_image1.png
342
842
media_image1.png
Greyscale
(G) The existence of working examples: there appear to be no working examples.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure: the amount of experimentation needed would be high based on what is present in the disclosure and the state of the field meaning types of valves, sensors, controllers and how to connect them would have to be experimented on.
Therefore, the claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention and the claims stand rejected.
It is suggested that applicant can present evidence for this invention either via response in the arguments or in an affidavit.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOANNE M RODDEN whose telephone number is (303)297-4276. The examiner can normally be reached Monday - Friday 9:00 AM-5:00 PM MST.
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, Jonathan Moffat can be reached at 571-272-4390. 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.
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794