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 .
Response to Arguments
Applicant’s arguments, filed 21 November 2025, with respect to the rejections of the claims, as amended over Das have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Das.
Applicant argues that the Examiner did not provide sufficient reasoning for asserting “routine optimization.” Das discloses that the 1µm-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 ¶0028. 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.
Claim 12 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2021/0339003 to Das et al.
With regard to claim 12, 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 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, ¶0008, 0014, 0049).
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 1-9,11, 36-39, 42-44 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0339003 to Das et al.
With regard to claims 1, 2, 4-6, 36, 37, 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 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, ¶0008, 0014, 0049).
With regard to Applicant’s recitation of first radial gap size, Das discloses that the first radial gap 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. Applicant claims a first radial gap in the range of 4µm-9µm, and further discloses alternate first radial gap ranges for different pumps. Applicant discloses in the instant Specification that other pumps would utilize alternate first radial gap sizes (see Specification ¶0056). Accordingly, Das teaches and Applicant discloses that the first radial gap size is a result-effective variable, in which the type and size of pump affect the resulting desired gap size.
With regard to claims 3 and 38, 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 7-9 and 42-44, Applicant is setting forth the intended use of the claimed apparatus. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. See MPEP § 2114. In the instant case, the concentration of bicarbonate in the fluid and filling of the gap are the results of operating the pump in a proscribed manner, and does not limit the structural limitations of the claimed medical device.
With regard to claims 11 and 46, 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 5 December 2025