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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9 April 2026 has been entered.
Response to Arguments
Applicant's arguments, filed 9 April 2026, with respect to the rejections of the claims, as amended over Das have been fully considered and are partially persuasive.
Applicant argues that Das does not disclose the concentration of a fluid in the first and second gap as at least 50% and no more than 40%, respectfully. However, the claims and Specification indicate that such a fluid concentration is a result of the action of a blood pump, which is a recitation of the intended use of the claimed apparatus. There is nothing in the record to show that Applicant intended to claim a pump with fluid therein (see rejections below). Accordingly, the limitations drawn to the concentration of fluid within the gap is treated as an intended use of the claimed pump, and does not patentably distinguish from the prior art of record.
Applicant argues that the Examiner did not provide sufficient reasoning for asserting "routine optimization." Das discloses that the 1 µm-2µm gap range cited by Applicant is an example, not a limit, and the dimensions will vary with the type of pump, specifically teaching that the gap size is variable (see Das ||0028). Applicant discloses in the instant Specification that gap size varies based on pump type (see Specification ||0056). Accordingly, Das teaches and Applicant discloses that the gap size is a result-effective variable, in which the type and size of pump affect the resulting desired gap size.
Applicant argues that the instantly claimed gap size of 4µm-9µm is not a minor adjustment of Das' disclosed range of 1µm-2µm. However, Das' disclosed range is not limited to 1µm-2µm, as set forth in Das 10028. Das' range is an example, and is not limited to 1µm-2µm.
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.
1, 2, 4-9, 11, 12, 47, 49-53, are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0339003 to Das et al.
In the specification and figures, Das discloses the apparatus as claimed by Applicant. With regard to claims 1, 2, 4-9, 12, 47, 49-51, Das discloses a blood pump 100 with a tubular body, with a lumen therethrough, an impeller 170 coupled to a flexible shaft 160, a bearing 172 within the lumen creating a radial bearing gap (not labeled) and a second gap 180 between the bearing and an impeller surface, wherein the pump or purge device may flow a fluid comprising a bicarbonate and an aqueous dextrose, wherein a purge bag is connected to the pump (see FIG 1 and accompanying text, 10008, 0014, 0049).
With regard to Applicant’s recitation of a concentration of fluid within the gap, a concentration is defined as the amount of a component in a given area or volume. As such, the Examiner is interpreting the limitation to mean that the amount of bicarbonate water in the first gap is 50% of the entirety of the bicarbonate fluid, and the amount of bicarbonate fluid in the second gap may be no more than 40% of the entirety of the bicarbonate fluid.
Nonetheless, the recitation of the amount of fluid in the gaps is not a structural limitation that defines the metes and bounds of the pump itself. In fact, the claims set forth that the blood pump flows fluid into the gaps (see claims 1, 12). Furthermore, the Specification at ¶0016 discloses that the “method may include controlling a flow rate such that a concentration of the fluid…is at least 50% of all the fluid in the first gap…” and “the method may include controlling a flow rate of the fluid such that a concentration of the fluid…is no more than 40% of all fluid in the second gap.” This disclosure indicates that the fluid in the gaps is not a part of the original structure of the pump as claimed, and is a statement of the intended use of the claimed apparatus.
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.
Claims 3, 48, 52 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0339003 to Das et al.
In the specification and figures, Das discloses the apparatus substantially as claimed by Applicant (see rejections above).
With regard to claims 3 and 48, Das discloses that the purge fluid may comprise 1.5 mEq/L to 50mEQ/L, within the range claimed by Applicant. It has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP § 2144.05(II)(A).
With regard to claims 42 and 53, Das discloses that the second bearing gap size is preferably between 1µm-2µm, and that the dimensions vary with the type of pump and represent an example of a gap size, not a limitation. Accordingly, Das teaches that the second bearing gap size is a result-effective variable, in which the type and size of pump affect the resulting desired gap size.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 19 May 2026
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