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 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.
DETAILED NON-FINAL ACTION
This is the initial Office Action (OA), on the merits, based on the 18/565,987 application filed on November 30, 2023. Claims 1-12 are pending and have been fully considered. All claims are directed toward an apparatus.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The Examiner has considered the information disclosure statements (IDS) submitted on 11/30/2023, 04/08/2025 and 1/09/2026. Please refer to the signed copy of the PTO-1449 form attached herewith.
Specification
The title of the invention is quite broad and is therefore not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Interpretation
The examined claims are apparatus claims requiring only the positively recited structural components, although structured with physical features that can perform the stated functions or accomplish the intended uses. Functional limitations state either an intended use or operation, a manner of operating a device, apparatus or system, or what the apparatus/system does. Apparatus claims cover what a device is, not what a device does. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). Also, a claim containing 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” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Of course, in the patentability analysis of these apparatus claims, functional features are considered and Applicant can and should employ such language where appropriate and helpful. However, if a prior art structure is capable of performing the intended use, or if such apparatus can operate in the manner described, then it meets the claim limitation (MPEP §§ 2114, 2173.05(g)).
The recited blood, dialysate and water, for example, are considered materials potentially contained within, transient or passing through, generated or produced, or otherwise worked upon by the apparatus rather than structural components of the apparatus.
According to the MPEP §2115 [R-2], a material or article worked upon does not limit apparatus claims: Expressions relating an apparatus to contents thereof during an intended operation are of no significance in determining patentability of apparatus claims. Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, “inclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)).
In summary, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997).
In the patentability analysis, the Office applies the broadest reasonable interpretation (BRI) consistent with the specification. However, specific limitations from the specification are not read into the claims. See MPEP §§2111, 2173.01 I. Unless otherwise specified, any citation to Applicant’s specification will generally refer to the original and any substitute or amended specification rather than a published application.
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 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Utterberg (US5,895,571)(IDS of 1/09/2026).
Note that these are apparatus claims. In the patentability analysis below, the italicized portions represent functional aspects, whereas the bolded portions represent structure.
Regarding claims 1-7, Utterberg discloses a blood purification device to perform blood purification treatment through a blood purifier 18 (Abstract, Fig. 1-3), the blood purification device comprising:
a dialysate supply-and-discharge unit 10 that supplies a dialysate to the blood purifier (using tubing 16) and discharges a waste liquid from the blood purifier (using tubing 22);
an extracorporeal circulation unit 24 comprising an extracorporeal circulation part 30, 36, 37, 42, 44 to extracorporeally circulate blood of a patient through the blood purifier; and
a control unit 14 capable of controlling the dialysate supply-and-discharge unit and the extracorporeal circulation unit (col. 5, line 19-39),
wherein the dialysate supply-and-discharge unit comprises a water removal control part to control an amount of water removed from the blood (col. 4, ln. 30 - col. 5, ln. 3; col. 5, lines 47-54), and
wherein the extracorporeal circulation unit is configured as a separate component from the dialysate supply-and-discharge unit (col. 5, ln. 61-67, Fig. 1).
Additional Disclosures Included: Claim 2: The control unit is mounted on the extracorporeal circulation unit (co. 5, lines 31-39); Claim 3: The control unit comprises a dialysate supply-and-discharge unit specifying part to specify the dialysate supply-and-discharge unit used (col. 3, lines 36-46); Claim 4: The control unit is mounted on the dialysate supply-and-discharge unit (co. 5, lines 31-39); Claim 5: A tube to convey the dialysate and the waste liquid is configured to directly connect the dialysate supply-and-discharge unit to the blood purifier without interposition of the extracorporeal circulation unit. (Figs. 1 & 2); Claim 6: The extracorporeal circulation unit is configured to be detachable from the dialysate supply-and-discharge unit, and wherein a fixing mechanism is provided to fix the extracorporeal circulation unit and the dialysate supply-and-discharge unit to each other when the extracorporeal circulation unit is attached to the dialysate supply-and-discharge unit (Fig.. 3); and Claim 7: A blood tube to convey blood is detachably provided in the extracorporeal circulation unit (Fig. 2).
Claims 1-4 and 8-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Curtis et al. (US20110189048; Curtis)(IDS of 1/09/2026).
Regarding claims 1-4 and 8-12, Curtis discloses a blood purification device to perform blood purification treatment through a blood purifier (Abstract, Figs. 1-17), the blood purification device comprising:
a dialysate supply-and-discharge unit that supplies a dialysate to the blood purifier and discharges a waste liquid from the blood purifier ([0024]-[0033]);
an extracorporeal circulation unit comprising an extracorporeal circulation part to extracorporeally circulate blood of a patient through the blood purifier ([0024]-[0033]); and
a control unit capable of controlling the dialysate supply-and-discharge unit and the extracorporeal circulation unit ([0043], [0049]),
wherein the dialysate supply-and-discharge unit comprises a water removal control part to control an amount of water removed from the blood ([0030], [0031], [0053]), and
wherein the extracorporeal circulation unit is configured as a separate component from the dialysate supply-and-discharge unit.
Additional Disclosures Included: Claim 2: The control unit is mounted on the extracorporeal circulation unit ([0042]-[0045], Fig. 15); Claim 3: The control unit comprises a dialysate supply-and-discharge unit specifying part to specify the dialysate supply-and-discharge unit used ([0042]-[0045], Fig. 15); Claim 4: The control unit is mounted on the dialysate supply-and-discharge unit ([0042]-[0045], Fig. 15); Claim 8: The extracorporeal circulation unit comprises a monitor to display progress of dialysis and an operation part to perform an operation related to the blood purification treatment ([0042]-[0045], Fig. 7); Claim 9: At least one of a monitor to display progress of dialysis or an operation part to perform an operation related to the blood purification treatment is provided separately from the dialysate supply-and-discharge unit and the extracorporeal circulation unit and is configured to be able to wirelessly communicate with the dialysate supply-and-discharge unit or the extracorporeal circulation unit ([0042]-[0045], Fig. 7); Claim 10: The dialysate supply-and-discharge unit comprises a movement mechanism to move the dialysate supply-and-discharge unit on a floor ([0039], Fig. 6); Claim 11: The dialysate supply-and-discharge unit comprises a dialysate preparation part to prepare the dialysate from pure water supplied thereto and a dialysate concentrate ([0042]-[0045], Fig. 15); and Claim 12: The dialysate supply-and-discharge unit comprises a pure water production part to produce pure water from externally supplied tap water, and wherein the dialysate preparation part prepares the dialysate from pure water supplied from the pure water production part and a dialysate concentrate ([0029], [0047]).
Conclusion
Examiner recommends that Applicant carefully review each identified reference and all objections/rejections before responding to this office action to properly advance the case in light of the pertinent objections/rejections and the prior art. With respect to the patentability analysis, Examiner has attempted to claim map to one or more of the most suitable structures or portions of a reference. However, with respect to all OAs, Examiner notes that citations to specific pages, columns, paragraphs, lines, figures or reference numerals, in any prior art or evidentiary reference, and any interpretation of such references, should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably disclosed and/or suggested to one having ordinary skill in the art. The use of publications and patents as references is not limited to what one or more applicant/inventor/patentee describes as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. MPEP §2123.
Examiner further recommends that for any substantive claim amendments made in response to this Office Action, or to otherwise advance prosecution, or for any remarks concerning support for added subject matter or claim priority, that Applicant include either a pinpoint citation to the original Specification (i.e. page and/or paragraph and/or line number and/or figure number) to indicate where Applicant is drawing support for such amendment or remarks, or a clear explanation indicating why the particular limitation is implicit or inherent to the original disclosure.
Electronic Inquiries
Any inquiry concerning this communication or an earlier communications from the examiner should be directed to Hayden Brewster whose telephone number is (571) 270-1065. The examiner can normally be reached M-Th 9 AM - 4 PM.
Alternatively, to contact the examiner, Applicant may send a communication, via e-mail or fax. Examiner’s direct fax number is: (571) 270-2065. Examiner's official e-mail address is: "Hayden.Brewster@uspto.gov." However, since e-mail communication may not be secure, Examiner will not respond to a substantive e-mail unless Applicant’s communication is in accordance with the provisions of MPEP §502.03 & related sections that discuss the required Authorization for Internet Communication (AIC). Nonetheless, all substantive communications will be made of record in Applicant’s file.
To facilitate the Internet communication authorization process, Applicant may file an appropriate letter, or may complete the USPTO SB439 fillable form available at https://www.uspto.gov/sites/default/files/documents/sb0439.pdf, preferably in advance of any substantive e-mail communication. Since one may use an electronic signature with this particular form, Applicant is encouraged to file this form via the Office’s system for electronic filing of patent correspondence (i.e., the electronic filing system (Patent Center)). Otherwise, a handwritten signature is required. In addition to Patent Center, Applicant can submit their Internet authorization request via US Postal Service, USPTO Customer Service Window, or Central Fax. Examiner can also provide a one-time oral authorization, but this will only apply to video conferencing. It is improper to request Internet Authorization via e-mail.
Examiner interviews are available via telephone, in-person, and via video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) form available at http://www.uspto.gov/interviewpractice, or Applicant may call Examiner, if preferable. Applicant can access a general list of patent application forms at either https://www.uspto.gov/patent/forms/forms-patent-applications-filed-or-after-september-16-2012 (applications filed on or after September 16, 2012) or https://www.uspto.gov/patent/forms/forms (applications filed before September 16, 2012). Note that the language in an AIR form is not a substitute for the requirements of an AIC, where appropriate. The mere filing of an Applicant Initiated Interview Request Form (PTOL-413A) or a Letter Requesting Interview with Examiner, in EFS-Web, may not apprise Examiner of such a request in a timely manner.
If attempts to reach the Examiner are unsuccessful, Applicant may reach Examiner’s supervisor, Bobby Ramdhanie at 571-270-3240. The central fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAYDEN BREWSTER/Examiner, AU 1779