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 .
Status of Claims
Claims 1-13 are pending and currently under consideration for patentability.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/11/2024 and 08/21/2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
Claim limitation “a pressure measurement unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no significant structure associated with “a pressure measurement unit” Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 (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 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.
Claim(s) 14-15, 19-21, and 25-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hobro (US 20200338255 A1).
Regarding Claim 14, Hobro teaches a blood purification apparatus (130) that drains a residual liquid in a circuit, comprising:
a sealed blood circuit including a blood removal side circuit (artery side circuit, 101) and a blood return side circuit (vein line 102) connected to each other (figures 1-4 paragraphs [0055-0056]);
a drainage circuit (dialysate fluid circuit 194) that is connected to the blood circuit and drains a residual liquid in the blood circuit (paragraph [0071]);
an air introducer (air pump 121) that is connected to the blood circuit and introduces air into the blood circuit (paragraph [0073]); and
a liquid delivery pump (peristaltic blood pump 122) that is provided to at least one of the blood circuit and the drainage circuit and, by rotating, delivers the residual liquid to the drainage circuit from the blood circuit with the introduced air (the "gas, i.e., air" described in paragraph [0077]) as a medium for pushing out the residual liquid.
Regarding Claim 15, Hobro teaches the blood purification apparatus according to claim 14. Hobro further teaches wherein the liquid delivery pump is provided to the blood circuit, and draws in the residual liquid and pushes out the residual liquid to the drainage circuit (paragraph [0077])(figure 4).
Regarding Claim 19, Hobro teaches the blood purification apparatus according to claim 14. Hobro further comprising:
a pressure measurement unit that measures pressure of the air introduced into the blood circuit (paragraph [0400]); and
a controller that determines whether the pressure measured by the pressure measurement unit is above a preset threshold value and causes the air introducer to stop introducing air in a case of determining that the pressure is above the threshold value (paragraph [0072]).
Regarding Claim 20, Hobro teaches the blood purification apparatus according to claim 19. Hobro further teaches wherein the controller determines a plurality of times whether the pressure is above the threshold value, causes the air introducer to stop introducing the air in a case of determining in a first determination that the pressure is above the threshold value (paragraph [0071], a threshold is defined as a point in which an effect takes place: ie the pressure difference is not in the controlled range), and causes the air introducer to resume introducing the air in a case of determining in a second determination that the pressure is not above the threshold value (paragraph [0071] a threshold is defined as a point in which an effect takes place: ie the pressure difference is not in the controlled range) (paragraph [0389]).
Regarding Claim 21, Hobro teaches the blood purification apparatus according to claim 16. Hobro further teaches wherein: the air pump introduces the air into the blood circuit by a first rotation, and draws the air from the blood circuit by a second rotation (Paragraph [0389]), and the blood purification apparatus further comprises:
a pressure measurement unit that measures pressure of the air introduced into the blood circuit (paragraph [400]]).; and
a controller that determines whether the pressure measured by the pressure measurement unit is above a preset threshold value and causes the air introducer to draw the air from the blood circuit in a case of determining that the pressure is above the threshold value( Paragraph [0071] a threshold is defined as a point in which an effect takes place: ie the pressure difference is not in the controlled range)
Regarding Claim 25, Hobro teaches the blood purification apparatus according to claim 15. Hobro further teaches further comprising a controller that controls the blood purification apparatus so as to execute one of a first drainage process and a second drainage process and then execute the other of the first drainage process and the second drainage process (paragraph [0105]),, the first drainage process being a process in which the liquid delivery pump performs a first rotation to draw in and push out the residual liquid in a first direction (paragraph [0105]), and the second drainage process being a process in which the liquid delivery pump performs a second rotation to draw in and push out the residual liquid in a second direction opposite to the first direction paragraph [0105]).
Regarding Claim 26, Hobro teaches a method of draining a residual liquid in a circuit executed by a blood purification apparatus (130), the blood purification apparatus including:
a sealed blood circuit including a blood removal side circuit (artery side circuit, 101) and a blood return side circuit (vein line 102) connected to each other (figures 1-4 paragraphs [0055-0056]); and
a drainage circuit (dialysate fluid circuit 194) that is connected to the blood circuit and drains a residual liquid in the blood circuit (paragraph [0071]), the method comprising the steps of:
introducing air into the blood circuit (air pump 121); and
delivering the residual liquid to the drainage circuit from the blood circuit with the introduced air as a medium for pushing out the residual liquid (paragraph [0077])(figure 4).
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.
Claim(s) 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hobro (US 20200338255 A1).
Regarding Claim 16, Hobro teaches the blood purification apparatus according to claim 14. Hobro further teaches wherein the air introducer includes an air pump that introduces the air into the blood circuit (paragraph [0077]). Although Hobro does not describe that the air pump rotates when feeding the air, the form of a pump is merely a matter that can be selected, as appropriate, by a person skilled in the art. Thus, a person skilled in the art could easily conceive of configuring the invention as in claim 15 on the basis of the invention described in Hobro.
Regarding Claim 17, Hobro teaches the blood purification apparatus according to claim 16. Hobro further teaches wherein the air introducer is connected to the blood removal side circuit (102), and the air pump introduces the air in a same direction as a direction in which the liquid delivery pump delivers the residual liquid (figure 4)(paragraph [0077]) .
Regarding Claim 18, Hobro teaches the blood purification apparatus according to claim 16. Hobro further teaches wherein the air introducer is connected to the blood return side circuit (vein line, 102), and the air pump introduces the air in a same direction as a direction in which the liquid delivery pump delivers the residual liquid (figure 4).
Claim(s) 23 are rejected under 35 U.S.C. 103 as being unpatentable over Hobro (US 20200338255 A1) in view of Wallace (ES 2647349 T3).
Regarding Claim 23, Hobro teaches the blood purification apparatus according to claim 14. Hobro further teaches wherein the liquid delivery pump draws in the residual liquid in a first draw amount per unit time (Paragraph [0389]), and the blood purification apparatus further comprises:
a pressure measurement unit that measures pressure of the air introduced into the blood circuit (paragraph [0072]).; and
a controller that determines whether the pressure measured by the pressure measurement unit is above a preset threshold value and causes the air introducer to draw the air from the blood circuit in a case of determining that the pressure is above the threshold value(paragraph [0072]).
Hobro fails to teach wherein the second draw amount per unit time greater than the first draw amount. In the same field of endeavor, Wallace teaches a dialysis machine wherein the second draw amount per unit time greater than the first draw amount (Page 15, paragraph 1). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the liquid pumps wherein the second draw amount per unit time greater than the first draw amount ensuring accuracy in when the valve closes.
Claim(s) 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Hobro (US 20200338255 A1) in view of Kouda (US 8408040 B2).
Regarding Claim 22, Hobro teaches the blood purification apparatus according to claim 21. Hobro fails to explicitly teach wherein the controller determines a plurality of times whether the pressure is above the threshold value, causes the air introducer to draw the air from the blood circuit in a case of determining in a first determination that the pressure is above the threshold value, and in a case of determining in a second determination that the pressure is above the threshold value, causes the air introducer to draw the air from the blood circuit in a larger amount than in the first determination. In the same field of endeavor, Kouda teaches wherein the controller determines a plurality of times whether the pressure is above the threshold value (column 3, lines 42 – column 4). , causes the air introducer to draw the air from the blood circuit in a case of determining in a first determination that the pressure is above the threshold value, and in a case of determining in a second determination that the pressure is above the threshold value, causes the air introducer to draw the air from the blood circuit in a larger amount than in the first determination (column 3, lines 42 – column 4). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify apparatus of Hobro so the controller determines a plurality of times whether the pressure is above the threshold value, causes the air introducer to draw the air from the blood circuit in a case of determining in a first determination that the pressure is above the threshold value, and in a case of determining in a second determination that the pressure is above the threshold value, causes the air introducer to draw the air from the blood circuit in a larger amount than in the first determination, similar to Kouda so that the equilibrium pressure is maintained.
Regarding Claim 24, Hobro teaches the blood purification apparatus according to claim 23. Hobro fails to explicitly teach wherein the controller determines a plurality of times whether the pressure is above the threshold value, causes the air introducer to draw the air from the blood circuit in a case of determining in a first determination that the pressure is above the threshold value, and in a case of determining in a second determination that the pressure is above the threshold value, causes the air introducer to draw the air from the blood circuit in a larger amount than in the first determination. In the same field of endeavor, Kouda teaches wherein the controller determines a plurality of times whether the pressure is above the threshold value (column 3, lines 42 – column 4). , causes the air introducer to draw the air from the blood circuit in a case of determining in a first determination that the pressure is above the threshold value, and in a case of determining in a second determination that the pressure is above the threshold value, causes the air introducer to draw the air from the blood circuit in a larger amount than in the first determination (column 3, lines 42 – column 4). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify apparatus of Hobro so the controller determines a plurality of times whether the pressure is above the threshold value, causes the air introducer to draw the air from the blood circuit in a case of determining in a first determination that the pressure is above the threshold value, and in a case of determining in a second determination that the pressure is above the threshold value, causes the air introducer to draw the air from the blood circuit in a larger amount than in the first determination, similar to Kouda so that the equilibrium pressure is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781