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 Group I (claims 1-12, 16-18) in the reply filed on 5/22/2026 is acknowledged.
However, applicant failed to elect a species. Hence, the response to restriction requirement filed 5/22/2026 is non-responsive. In order to expedite the examination, Species 1 (claim 10) is tentatively examined and other species (claims 11-12, 17-18) are withdrawn.
Claims 11-15, 17-19 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/22/2026.
Claims 1-10 and 16 are examined in this office action.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. See references cited in Paragraph [00154] in the specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the control valve for metering a flow rate of the fluid to the process fluid must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 depends on claim 5 which claims the mineral; however, claim 6 claims the vitamin which is not mineral. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-2, 4, 7, 10 and 16 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US 2011/0142700 A1 (hereinafter “Gura”).
Regarding Claim 1, Gura discloses a portable and wearable renal therapy system (see Paragraphs [0002]-[0003]) comprising:
a dialyzer (730) or purification device configured to remove toxins from process fluid e.g., blood and deliver a blood thinner and/or anticoagulant or therapeutic substance to the process fluid (see Fig. 12, Paragraphs [0082]-[0083], [0098]);
a drug delivery device (734, 736) coupled to the purification device (730), the drug delivery device comprising: a reservoir (734) for a fluid comprising the blood thinner and/or anticoagulant or therapeutic substance (see Fig. 12, Paragraphs [0082]-[0083], [0098]); and
a fluid connection coupling the drug delivery device with the dialyzer or purification device, the fluid connection configured for fluidly communicating the reservoir with the process fluid (see Fig. 12, Paragraphs [0082]-[0083], [0098]).
Regarding Claim 2, Gura discloses the system of claim 1, comprising a pump (736) configured for moving the fluid to the process fluid (see Fig. 12, Paragraphs [0082]-[0083], [0098]).
Regarding Claim 4, Gura discloses the system of claim 1, comprising electrolytes, drugs, vitamins from reservoirs (784) (see Paragraph [0111], Fig. 12) and a buffer e.g. sodium bicarbonate (see Paragraphs [0046], [0130]).
Regarding Claim 7, Gura discloses the system of claim 1, wherein the renal therapy system comprises a power connection coupling the purification device with the drug delivery device in electrical communication to power the drug delivery device (see Fig. 12: microcontroller 714 controls drug delivery pump (734) and blood pump (724a) operated by battery (716)).
Regarding Claim 10, Gura discloses the system of claim 1, wherein the purification device is configured to release at least one of electrolytes and buffer solutions into the process fluid (see Fig. 12: dialyzer (730) implicitly release electrolytes and buffer solution via membrane diffusion process).
Regarding Claim 16, Gura discloses the system of claim 1, comprising a controller (714) configured to deliver at least one of electrolytes, drugs, vitamins from reservoirs (784) (see Paragraph [0111], Fig. 12) and a buffer e.g. sodium bicarbonate (see Paragraphs [0046], [0130]).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gura as applied to claim 1 above, and further in view of US Patent No. 8,834,400 B2 to Houwen et al. (hereinafter “Houwen”).
Regarding Claim 3, Gura discloses the system of claim 1.
Gura fails to explicitly disclose the system, comprising a control valve for metering a flow rate of the fluid to the process fluid. Houwen teaches that it is known in the art to utilize a control valve to generate a fluid flow of a EDTA component to a separator in a haemo-dialysis system (see Fig. 7; Col. 13, Lines. 52-65; Col. 14, Lines 20-45).
It would have been obvious to one of ordinary skill in the art to modify Gura with the teaching of Houwen, for the purpose of including the recited control valve in the system, and thereby controlling fluid flow of blood thinner and/or anticoagulant or drug from the drug delivery device as suggested by Houwen (see Fig. 7; Col. 13, Lines. 52-65; Col. 14, Lines 20-45).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Gura as applied to claim 4 above, and further in view of US 2010/0187476 A1 to Yugari et al. (hereinafter “Yugari”).
Regarding Claims 5-6, Gura discloses the system of claim 4.
Gura fails to explicitly disclose the system comprising the therapeutic substance comprising iron and vitamin B12 or folate.
Yugari teaches dialysate solution comprising minerals including ferric iron (see Paragraph [0024]) and vitamins including vitamin B12 or folic acid (see Paragraph [0025]).
It would have been obvious to one of ordinary skill in the art to modify Gura with the teaching of Yugari to provide iron and vitamin B12 as chemicals and additives in the system of Gura to freshen the dialysate and prolong its ability to act as a dialysate (see Gura: Paragraph [0107]).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gura.
Regarding Claims 8-9, Gura discloses the system of claim 1 or claim 7.
Gura fails to explicitly disclose the system comprising a releasable coupling for reversibly coupling the drug delivery device with the purification device.
A releasable coupling for reversibly coupling devices are well-known in the art for fluid connection.
It would have been obvious to one of ordinary skill in the art to modify Gura with well-known releasable coupling for reversibly coupling the drug delivery device with the purification device for simplifying the fluid connection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2004/0226874 A1 teaches device and system for body fluid purification system including a sorbent cartridge comprising hydrogel (see Fig. 1; Paragraphs [0149], [0153]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, INSUK BULLOCK can be reached on 571-272-5954. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/John Kim/Primary Examiner, Art Unit 1772
JK
8/19/26
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