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 Embodiment B, Claims 1-2 and 5-19, in the reply filed on October 27, 2025 is acknowledged.
Claims 3-4 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 27, 2025.
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 1-2 and 5-19 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 contains the limitation “…a proximal stem, and a distal stem, wherein the flexible membrane sac is attached with the proximal stem and the distal stem as a stress-relief suspension mechanism…” However, it is unclear how the proximal and distal stem function as a stress-relief suspension and the instant specification fails to detail how these function in order create a stress-relief suspension. The instant specification details in [0114] that the flexible sac membrane is suspended by stress-relief stems (e.g. proximal stem and distal stem) and [0178] details that the proximal stem and the distal stem as a stress-relief suspension mechanism. There fails to be adequate description to how the proximal and distal stem operate and function to create a stress-relief suspension mechanism. “An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). See MPEP 2163.03.
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.
Claims 1-2 and 5-19 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 1 contains the limitation “…a proximal stem, and a distal stem, wherein the flexible membrane sac is attached with the proximal stem and the distal stem as a stress-relief suspension mechanism…” However, it is unclear if the proximal and distal “stem” is a particular structure to create the “stress-relief suspension” or if merely a proximal and distal portion to “hold” the flexible membrane sac will inherently create this stress-relief suspension.
Claim 20 recites the limitation "the trench" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the same “superficial trench” in claim 19 or a different trench.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lu (US 2008/0300447 A1) discloses a dual pulsation bi-ventricular assist device wherein the blood pump (e.g. Fig 6) has an elastic membrane 205 that separates the blood into one sac/compartment 201 and the second compartment 202 holding a working fluid, but fails to have the stress-relief suspension mechanism, or a pressure sensing system.
Steingraber (US 2022/01111962 A1) teaches a blood pump with a blood pressure sensor for measuring a present pressure in the diaphragm blood pump (e.g. [0052]) with a working chamber of the piston pump to utilize a pressure line and air chamber (e.g. [0054]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jessandra Hough March 12, 2026
/J.F.H./Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
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