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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1
“the blood purification treatment process being executed when blood purification treatment is performed in which the dialysate is delivered to the blood purifier” is indefinite as it is unclear if this is limiting the control unit or if it is a process step claiming when the controller operates. The claim is to an apparatus and it is unclear what structure is required by this limitation.
It is unclear if the “the dialysate being prepared…” clause is limiting to the controller configuration or if it is simply a process step. It is unclear what structure is required. For prior art search and claim interpretation it is interpreted that this is a process step that is not limiting to the structure of the apparatus.
“the defatting washing process being executed when defatting washing is performed…” is indefinite as it is unclear if this is a process step or a structural limitation. It is unclear if the “configured to execute” is triggered when the “defatting washing” occurs or if the control unit is configured to carry out the defatting washing process itself. It is unclear what structure is required and what limitations are process limitations. The claim is to an apparatus. For the purpose of a prior art search, it is interpreted that the control unit is simply configured to carry out defatting washing process.
“generated by a predetermined amount” is indefinite as it is unclear what is the “predetermined amount” describing.
“when executing” is indefinite as it is unclear what this is referring to and what structure is required.
It is unclear what “is used” is referring to and what structure is required.
Claim 10
Claim 10 recites “an upstream side relative to the b-drug-solution introduction line…” however this is indefinite as it compares it to the “direction of delivery of the bicarbonate solution in the defatting washing process” wherein the “direction of delivery…” is not a structural limitation and, therefore, cannot be a point of reference from which an “upstream side” of the line can be claimed. The “defatting process” is not a structural limitation and it is unclear how this would define the “upstream” side.
“upstream side relative to the heating unit” is indefinite for the same reason.
“the direction of delivery” lacks antecedent basis in the claim.
“the direction of delivery” is also indefinite as it is unclear if or what structure this implies.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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 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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ritter (EP3335742B1, English translation in file) and further in view of Meyer et al. (US Pub. No. 2014/0217020).
Claim 1: Ritter teaches a blood purification apparatus comprising a blood purifier [0023, dialysis fluid filter; 0051 “device for extracorporeal blood treatment”], a line section [0018, “all hose and pipe connections which are used for the dialysis fluid circuit”], a drain-liquid discharge [0018, “outlet lines for dialysis fluid components”], a heating unit [0053], a deaerator [0053, “device for gas separation”], and a control unit configured to execute a blood purification treatment process [0058, “therapy sequence”] and a defatting washing process [0053-0055].
Ritter does not specifically teach a delivery unit (i.e. pump or series of pumps) configured to deliver a dialysate and a drain liquid. Ritter does not go into detail of the structure of the generic dialysis device that they apply their controlled process to.
However, Ritter makes reference to Meyer et al. Meyer et al. teach a generic type of extracorporeal blood treatment apparatus wherein they teach a control pump [0026-0027, 0176] that controls fluid flow in and out of the flow path. The control pump provides fluid access to both solution reservoirs (i.e. dialysate) and waste reservoir (i.e. drain) [0138].
One of ordinary skill in the art at the time of the invention would have found it obvious that Ritter’s description of a generic extracorporeal blood treatment apparatus included a delivery unit configured to deliver dialysate and drain liquid as Meyer et al. demonstrate that pumps are well-known for moving fluid around.
Claim 2: There is a circulatory flow route which the bicarbonate solution is introduced [0053-0055], the other limitations of the claim are process limitations and do not further limit the structure of the apparatus. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)).
“Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim.” Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, “[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” See 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)) (see MPEP § 2115).
Claim 3: there is no further limiting structure recited in Claim 3. Please see the case law and MPEP excerpts cited in the rejection of Claim 2.
Claims 4 and 5: Ritter teaches a “storing part” in their disclosure of the bicarbonate solution being “fed to the hydraulic system” [0031, 0034] which requires a pipe/line.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ritter (EP3335742B1, English translation in file) and Meyer et al. (US Pub. No. 2014/0217020) as applied to claim 1 above, and further in view of Lindsay et al. (USP 5244568).
Claim 6: The combination of Claim 1 does not teach the storing part (i.e. line) comprises a heat exchanger.
Lindsay et al. teach a heat exchanger that provides heat from waste fluid in a dialysis operation to preheat input water (col. 3, lines 16-20). It would have been obvious to include a heat exchanger between the input and waste line in order to capture heat from the waste fluid and recycle that heat to warm incoming fluid, therein reducing energy requirements.
The combination of claim 1 does not teach
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ritter (EP3335742B1, English translation in file) and Meyer et al. (US Pub. No. 2014/0217020) as applied to claim 1 above, and further in view of Shouldice (USP 4814073).
Claim 7: the combination of Claim 1 does not teach that the storing part is a container integrated with the heating unit and the deaerator.
Shouldice teaches a blood treatment apparatus comprising a combined heater and deaerator (col. 2, lines 16-26). This is a typical, well-known configuration.
Given that Ritter does not teach details of their overall treatment apparatus, one of ordinary skill in the art at the time of the invention would have looked to the prior art such as Shouldice to determine typical configuration which includes a combined heater and deaerator. In order to deaerate there must be a container portion to contain the fluid.
Claim 8: Ritter teaches that their process and apparatus is performed between therapy for blood treatment which includes heating the dialysate [0003]. Therefore, while not clearly defined, one of ordinary skill in the art at the time of the invention would have found it obvious to connect the heater to the dialysate introduction line for the benefit of heating the dialysate as needed.
Claim 9: there is an “a-drug-solution introduction line” [0043, the line that transports the acidic concentrate; 0058], and a “b-drug-solution introduction line” [0058, wherein the acidic concentrate and bicarbonate concentrate fed to the system which requires lines]. The container – now including the heater – is connected to the bicarbonate line as it is intended to heat the bicarbonate solution.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ritter (EP3335742B1, English translation in file) and Meyer et al. (US Pub. No. 2014/0217020) as applied to claim 1 above, and further in view of Olsson (US Pub. No. 2004/0020852).
Claim 10: The prior art of Claim 1 does not teach the heater and degasser upstream of the b-drug-solution introduction line.
Olsson teaches a heater [0030](Fig. 1, 2) and a deaerating device (Fig. 1, 6) upstream of the solutions being introduced into the lines (Fig. , 25 and 55). Providing the heater and degassing upstream allows for heating and deaerating of the water incoming as well.
One of ordinary skill in the art at the time of the invention would have found it obvious to provide the heater and deaerator upstream as is typical in the art for warming the incoming water and deaerating.
The rest of the limitations of claim 10 with respect to the controller are process limitations and are not further limiting to the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON FITZSIMMONS whose telephone number is (571)270-1767. The examiner can normally be reached M-F 9:30 am - 2:00 pm.
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ALLISON FITZSIMMONS
Primary Examiner
Art Unit 1773
/ALLISON G FITZSIMMONS/Primary Examiner, Art Unit 1773
Prosecution Insights