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 .
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 § 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.
Claims 1-10 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a proportional valve assembly positioned within a simulated torso of the human body, does not reasonably provide enablement for the proportional valve assembly to be positioned within any other simulated portion of the human. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. This is evidenced in at least Fig. 1 and the associated description in the specification which illustrates that the only meaningful embodiment is wherein the proportional valve assembly is positioned within the simulated torso. Para. 39, 40, 42, and 43 summarily recite that the proportional valve assembly may be contained in the simulated head, simulated right arm, simulated left arm, simulated right leg, and/or simulated left leg. One of ordinary skill in the art would recognize that the simulated torso is the only simulated portion of the human body with enough space for the proportional valve assembly to be positioned within. However, the disclosure is silent regarding how the other simulated portions accommodate the proportional valve assembly in such limited internal volume. Dependent claims 2-10 inherit the deficiencies of their respective parent claims, and are thus rejected under the same rationale.
Claim Rejections - 35 USC § 102
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.
(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.
Claims 11, 12, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vozenilek et al. (US 2014/0272872, hereinafter referred to as Vozenilek).
Regarding claim 11, Vozenilek teaches a proportional valve assembly (Vozenilek, para. 37, “A shaft passes through the solenoid coil of the solenoid valves. When the solenoid coil is energized, it extends the shaft head and forces the tubing at the end of the shaft against a stationary mass, thus occluding the tubing.” It is noted that in at least para. 42, the solenoid valves are pinch valves and proportional valves. It is further noted that while the claim recites “proportional valve”, a pinch valve is illustrated in the instant drawings with pinch valve functionality described in the instant specification. Thus, prior art teaching pinch valve functionality as claimed teaches the claimed proportional valve assembly.), comprising:
a resiliently deformable valve comprising an inlet and an outlet (Vozenilek, para. 37, “A shaft passes through the solenoid coil of the solenoid valves. When the solenoid coil is energized, it extends the shaft head and forces the tubing at the end of the shaft against a stationary mass, thus occluding the tubing.” The tubing entering and exiting the valve is the resiliently deformable valve comprising an inlet and an outlet.); and
a displacement assembly, wherein the displacement assembly is configured to selectively compress the resiliently deformable valve between the inlet and the outlet to control a flow of fluid and/or gas through the resiliently deformable valve (Vozenilek, para. 37, “A shaft passes through the solenoid coil of the solenoid valves. When the solenoid coil is energized, it extends the shaft head and forces the tubing at the end of the shaft against a stationary mass, thus occluding the tubing.” It is noted that in at least para. 42, the solenoid valves are pinch valves and proportional valves.).
Regarding claim 12, Vozenilek teaches the proportional valve assembly of claim 11, wherein the resiliently deformable valve is configured to provide a linear response in terms of the flow of the fluid and/or the gas to an amount of compression of the resiliently deformable valve (Vozenilek, para. 37, “By varying the linear distance in which the shaft of the valve can extend (the stroke length), it is possible to vary the degree of occlusion from a single valve. The solenoid valves on both lines (see elements 13 and 14) serve to develop dynamic pressure and resistance in a controlled manner for the purpose of altering the flow profile ejected from the pump 2 through the main line (see element 13).”).
Regarding claim 19, Vozenilek teaches the proportional valve assembly of claim 11, wherein the resiliently deformable valve is formed of a rubber (Vozenilek, para. 36, “flexible rubber… tubing”).
Regarding claim 20, Vozenilek teaches the proportional valve assembly of claim 11, wherein the resiliently deformable valve is formed of a silicone (Vozenilek, para. 36, “flexible… silicone tubing”).
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.
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 1, 2, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Vozenilek et al. (US 2014/0272872, hereinafter referred to as Vozenilek).
Regarding claim 1, Vozenilek teaches a patient simulator (Vozenilek, Abstract, “A device for simulating blood flow including an anatomical unit and a waveform generator for generating waveforms.” para. 31, “a training device that includes an anatomical unit, where the anatomical unit seeks to replicate exterior similarity to one or more sections of the human body.” Para. 62 and 63, “simulated patient”), comprising:
a simulated portion of a human body (Vozenilek, para. 31, “An embodiment of the present invention preferably includes a training device that includes an anatomical unit, where the anatomical unit seeks to replicate exterior similarity to one or more sections of the human body.”); and
the proportional valve assembly including a resiliently deformable valve and a displacement assembly, wherein the displacement assembly is configured to selectively compress the resiliently deformable valve to control a flow of fluid and/or gas through the resiliently deformable valve (Vozenilek, para. 37, “A shaft passes through the solenoid coil of the solenoid valves. When the solenoid coil is energized, it extends the shaft head and forces the tubing at the end of the shaft against a stationary mass, thus occluding the tubing.”).
Vozenilek does not teach that the proportional valve assembly is positioned within the simulated portion of the human body.
However these differences are only found in the nonfunctional descriptive material and are not functionally involved in the steps recited. The patient simulator would function the same regardless of whether the proportional valve assembly is positioned within the simulated portion of the human body or not. Thus, this descriptive material will not distinguish the claimed invention from the prior art in terms of patentability, see In re Gulack, 703 F.2d 1381, 1385, 217 USPQ 401, 404 (Fed. Cir. 1983); In re Lowry, 32 F.3d 1579, 32 USPQ2d 1031 (Fed. Cir. 1994).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention for the proportional valve assembly in Vozenilek to be positioned within the simulated portion of the human body because whether it is positioned within or not is merely a design choice that does not functionally relate to the simulator claimed and has not been disclosed to solve any stated problem or is for any particular purpose which does not patentably distinguish the claimed invention.
Regarding claim 2, Vozenilek teaches the patient simulator of claim 1, wherein the resiliently deformable valve is configured to provide a linear response in terms of the flow of the fluid and/or the gas to an amount of compression of the resiliently deformable valve (Vozenilek, para. 37, “By varying the linear distance in which the shaft of the valve can extend (the stroke length), it is possible to vary the degree of occlusion from a single valve. The solenoid valves on both lines (see elements 13 and 14) serve to develop dynamic pressure and resistance in a controlled manner for the purpose of altering the flow profile ejected from the pump 2 through the main line (see element 13).”).
Regarding claim 9, Vozenilek teaches the patient simulator of claim 1, wherein the resiliently deformable valve is formed of a rubber (Vozenilek, para. 36, “flexible rubber… tubing”).
Regarding claim 10, Vozenilek teaches the patient simulator of claim 1, wherein the resiliently deformable valve is formed of a silicone (Vozenilek, para. 36, “flexible… silicone tubing”).
Claims 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Vozenilek et al. (US 2014/0272872, hereinafter referred to as Vozenilek) as applied to claims 1 and 11, in view of Monsen1.
Regarding claims 3 and 13, Vozenilek teaches the patient simulator of claim 1 and the proportional valve assembly of claim 11.
Vozenilek does not explicitly teach the resiliently deformable valve includes a plurality of openings extending along a length of the resiliently deformable valve.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention for the resiliently deformable valve in Vozenilek to include a plurality of openings extending along a length of the resiliently deformable valve because it is a known method of source control of aerodynamic noise called “flow division” wherein “[e]very time you double the number of openings, you reduce the noise by 3 dBA”. The reduced noise is caused by the smaller openings shifting the noise to a higher frequency which is attenuated more as the sound passes through the pipe wall than lower frequencies as well as by the human ear. Thus, measured and perceived noise is decreased. See Monsen at pg. 1-2. Therefore, it is merely the use of a known technique to improve similar devices in the same way.
Regarding claims 4 and 14, Vozenilek in view of Monsen teaches the patient simulator of claim 3 and the proportional valve assembly of claim 13, wherein the displacement assembly is further configured to selectively compress the plurality of openings when compressing the resiliently deformable valve (Vozenilek, para. 37, “A shaft passes through the solenoid coil of the solenoid valves. When the solenoid coil is energized, it extends the shaft head and forces the tubing at the end of the shaft against a stationary mass, thus occluding the tubing. By varying the linear distance in which the shaft of the valve can extend (the stroke length), it is possible to vary the degree of occlusion from a single valve.”).
Regarding claims 5 and 15, Vozenilek in view of Monsen teaches the patient simulator of claim 4 and the proportional valve assembly of claim 14, wherein the displacement assembly comprises a linear actuator and an engagement structure, the linear actuator configured to control displacement of the engagement structure to selectively compress the plurality of openings through contact of the engagement structure with the resiliently deformable valve (Vozenilek, para. 37, “A shaft passes through the solenoid coil of the solenoid valves. When the solenoid coil is energized, it extends the shaft head and forces the tubing at the end of the shaft against a stationary mass, thus occluding the tubing. By varying the linear distance in which the shaft of the valve can extend (the stroke length), it is possible to vary the degree of occlusion from a single valve.”).
Regarding claims 6 and 16, Vozenilek in view of Monsen teaches the patient simulator of claim 5 and the proportional valve assembly of claim 15, further comprising:
a control unit in communication with the displacement assembly, wherein the linear actuator is controlled at least in part based on a communication from the control unit (Vozenilek, para. 40, “The circuit board 24 is used to control the mechanical elements 2, 3, 5 and regulate the power supplied to each device 2, 3, 5 individually based on user programmed settings.” Reference character “5” refers to the valves.).
Regarding claims 7 and 17, Vozenilek in view of Monsen teaches the patient simulator of claim 5 and the proportional valve assembly of claim 15, further comprising:
a mounting structure to which the resiliently deformable valve and the displacement assembly are coupled (Examiner notes that this is inherent in the pinch valve because it is an integral element of the valve assembly at least as illustrated in Fig. 2. Vozenilek further implies this structure in at least para. 37 when describing the actuation of the pinch valve as a solenoid valve – “A shaft passes through the solenoid coil of the solenoid valves. When the solenoid coil is energized, it extends the shaft head and forces the tubing at the end of the shaft against a stationary mass, thus occluding the tubing.” While not explicitly mentioned, the mounting structure is necessarily included so that the shaft can pass through the solenoid coil and press the tubing against a stationary mass as all of these elements are part of the coupled to the mounting structure. In an alternative embodiment, the stationary mass is part of the mounting structure.).
Regarding claims 8 and 18, Vozenilek in view of Monsen teaches the patient simulator of claim 7 and the proportional valve assembly of claim 17, wherein the mounting structure includes an additional engagement structure configured to compress the plurality of openings through contact of the additional engagement structure with the resiliently deformable valve opposite the engagement structure of the displacement assembly (Vozenilek, para. 37, “When the solenoid coil is energized, it extends the shaft head and forces the tubing at the end of the shaft against a stationary mass, thus occluding the tubing.” The stationary mass is the additional engagement structure.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Smith (US 3,717,176) illustrates the resiliently deformable valve includes a plurality of openings extending along a length of the resiliently deformable valve as being old.
Bardsley et al. (US 2008/0227073) discloses an autonomous casualty simulator including pinch valves.
Boutchko et al. (US 8,535,061 B2) a simulated torso for imaging of the heart with realistic modes of cardiac and respiratory motion using valves.
Vozenilek et al. (US 8,926,333 B2) is the patent associated with the primary reference.
Carvajal et al. (US 2016/0133161) discloses combat medical simulators using pump and valve systems in embodiments within and outside of simulated portions of the human body.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LANE whose telephone number is (303)297-4311. The examiner can normally be reached Monday - Friday 8:00 - 4:30 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai can be reached at (571) 272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL LANE/Examiner, Art Unit 3715
1 Monsen, J. (2011). Valve Aerodynamic Noise Reduction Strategies. Valin. https://www.valin.com/resources/whitepapers/valve-aerodynamic-noise-reduction-strategies
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