DETAILED CORRESPONDENCE
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
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 1-4 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. The claims are indefinite because of the following reasons:
In claim 1, the limitation of “the dialysate is prepared by mixing an A-drug solution and a B-drug solution introduced into the line section and diluting the A-drug solution and the B-drug solution to predetermined concentrations” is unclear since the recited function does not follow from the structure recited in the claim, so it is unclear whether the function requires some other structure or is simply a result of operating the blood purification apparatus in a certain manner. Thus, one of ordinary skill would not be able to draw a clear boundary between what is and is not covered by the claim. See MPEP 2173.05(g). As shown in figure 5 and described in the specification, aforementioned functions are provided by stirring chambers 9a, 9b, solution containers T1, T2 and pumps 8a, 8b.
In claim 1, the limitation of “the bicarbonate solution being obtained by heating the B-drug solution introduced into the line section”, is unclear since the recited function does not follow from the structure recited in the claim, so it is unclear whether the function requires some other structure or is simply a result of operating the blood purification apparatus in a certain manner in a certain manner. Thus, one of ordinary skill would not be able to draw a clear boundary between what is and is not covered by the claim. See MPEP 2173.05(g). Did Applicant intend to claim the HEX 3 and/or heating unit 4 shown in figure 5?
Claims 2-4 are also rejected since claims suffer the same defects as the claims from which they depend.
Claim Rejections - 35 USC § 102
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. 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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP 3,335,742 B1, hereinafter ‘742.
As for claim 1, ‘742 teaches a blood purification apparatus ("Dialysemaschine") configured to purify a patient's blood by causing the blood ("Blut") to extracorporeally circulate through a blood purifier and a blood circuit ("extrakorporalen Blutbehandlung", "Blutwäsche"), the blood purification apparatus comprising:
a line section ("Hydraulikkreislauf") including a dialysate introduction line through which dialysate is to be introduced into the blood purifier, and a drain-liquid discharge line through which drain liquid is to be discharged from the blood purifier (inherent and implicit feature of "Hydraulikkreislauf");
a delivery unit ("Pumpe") configured to deliver fluid in the line section (see e.g. paragraphs 47, 48);
a control unit ("Gerätesteuerung ") configured to execute a blood purification treatment process ("Blutbehandlung") and a defatting washing process ("Reinigung und Entfettung") by controlling the delivers unit (see e.g. paragraphs 47-49), the blood purification treatment process being executed when blood purification treatment is performed in which the dialysate is delivered to the blood purifier (via "Hydraulikkreislauf"), the dialysate being prepared by mixing an A-drug solution (see e.g. paragraph 39: "saure Konzentrat") and a B-drug solution (see e.g. paragraph 47: "Bicarbonat") introduced into the line section and diluting the A-drug solution and the B-drug solution (with "(RO)-Wasser") to predetermined concentrations (see e.g. paragraphs 39, 48), the defatting washing process being executed when defatting washing is performed in which oil and fat in the line section is removed (see e.g. paragraph 26) by causing a bicarbonate solution to flow through the line section (see e.g. paragraphs 48-49: "im Hydraulikkreislauf zirkuliert"); the bicarbonate solution being obtained by heating the B-drug solution introduced into the line section (see paragraph 49),
wherein the control unit causes carbon dioxide to be discharged to an outside of the line section during the defatting washing process, the carbon dioxide being generated when the bicarbonate solution is caused to flow.
“Subsequently, the fed bicarbonate is circulated in the hydraulic circuit and heated to 50 ° C, preferably 85 ° C and most preferably higher than 85 ° C to just below the boiling points of the bicarbonate solution. From 50 ° C the bicarbonate decomposes into water, carbon dioxide and soda. The costs incurred during the heating process Amount of carbon dioxide can be removed via a device for gas separation. It is advantageous to keep the bicarbonate solution in this temperature range for a certain duration before exceeding the temperature range at which the outgassing takes place in order to prevent a sudden rapid outgassing. This is in the Fig. 2 described in more detail. The formed soda is the washing substance, with which existing grease and dirt in the hydraulic system are solved.”
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.
The factual inquiries that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over ‘742 in view of Yardimci et al. (U.S. 7,871,462), hereinafter “Yardimci”.
‘742 doesn’t specify his gas separator to be a trap configured to capture bubbles in the dialysate while allowing dialysate to flow through the trap. But such is taught by Yardimci.
PNG
media_image1.png
543
531
media_image1.png
Greyscale
Yadimci teaches a trap (figure 3) configured to trap the bubbles while allowing dialysate to flow through the trap, wherein upon modification with ‘742 would perform the function capturing the carbon dioxide during the washing process [as in claim 2]. It is considered that it would have been obvious to one ordinarily skilled in the art before the effective filing date of the invention to have the trap of Yardimci in the invention of ‘742 since Yardimci teaches the benefit of provide improved air seapation chamber for the removal of air from the dialysis fluid or blood flowing through a disposable dialysis fluid apparatus (col. 5, lines 52-56)—further perfecting the invention of ‘472.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over ‘742 in view of Yardimci and in further view of Meyer et al. (U.S. 10,874,787 B2), hereinafter “Meyer”.
As for claim 3, the modified ‘742 also teaches a fluid-pressure a fluid-pressure detector configured to detect fluid pressure, wherein if a predetermined change in the fluid pressure is detected by the fluid-pressure detector in the defatting washing process, the control unit would cause the carbon dioxide captured by the trap to be discharged to the outside of the line section (via valves 26a,26b in response to a pressure sensor measuring pressure within the air separation chamber, see col. 7, lines 50-62 of Yardimci).
The modified ‘742 doesn’t specify that the pressure detector is provided at the dialysate introduction line on a downstream side or an upstream side relative to the trap, but such is taught by Meyer. Meyer also teaches a degassing system for dialysis that teaches a pressure sensor upstream from the fluid inlet to the gas separator including after resistor 13 and also downstream from the separator down to the pump 12 (see col. 2, lines 63-65; col. 8, lines 19-21) [as in claim 3]. It is considered that it would have been obvious to one ordinarily skilled in the art before the effective filing date of the invention to have the pressure sensor of the modified ‘742 positioned downstream or upstream of the gas separator, as in Meyer since Meyer teaches the benefit of control of a system for “improved removal or carbon dioxide” (col. 8, line 23) and removal of carbon dioxide with minimal foaming, col. 1, lines 22-23).
As for claim 4, the modified ‘742 (as shown in Yadimci expanded above) teaches a first upstream part 84 of the trap storing captured bubbles, a second downstream part 82 allowing dialysate received to flow through the second region, and a line section including a bypass line 70 through which the first region and the drain line are connected to communication with each other and including an on-off valve 26a or 26b controlled by pressure detected by a pressure detector to discharge gas therethrough to the drain.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/397,107 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the instant claim 1 is anticipated by those of the reference application, and because anticipation is the epitome of obviousness.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mr. TERRY K CECIL whose telephone number is (571)272-1138. The examiner can normally be reached Normally 7:30-4:00p M-F.
Examiner interviews are available via telephone, in-person, and 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) at http://www.uspto.gov/interviewpractice.
If repeated attempts to reach the examiner by telephone are unsuccessful (including leaving a voice message), the examiner’s supervisor, Bobby Ramdhanie can be reached on (571) 270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TERRY K CECIL/Primary Examiner, Art Unit 1779