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
As directed by the amendment filed on 20 November 2023: claim(s) 1-7 have been cancelled, claim(s) 8-14 have been added.
Specification
The disclosure is objected to because of the following informalities:
It is unclear what ACLP, VCLP, and PCLP stands for.
The structural limits of the “flow channel switch unit” is undefined.
Appropriate correction is required.
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8 contains redundant/confusing conditional logic statements such as “… wherein the control unit further executes a determination process in which the control unit generates a difference in pressure between the blood removal side circuit and the blood return side circuit by rotating the blood pump with the flow channel switch unit switched to the closed state, and then determines whether the blood circuit is the closed circuit by switching the flow channel switch unit to the open state and monitoring the difference in pressure based on a result of detection by the pressure detection unit, and in a case where it is determined in the determination process that the blood circuit is the closed circuit, the control unit executes the drainage process after the determination.” Furthermore, the “closed circuit” represents a connection state or configuration and not a static physical structure.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “flow channel switch unit” in claims 8-9, 12, and 14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 “flow channel switch 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. The disclosure is devoid of any structure that performs the function in the claim. 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 8 is 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 8 calls for “… a blood circuit having a blood removal side circuit into which blood removed from a patient flows and a blood return side circuit from which blood is returned to the patient and being able to form a closed circuit by having a first end portion of the blood removal side circuit and a first end portion of the blood return side circuit connected to each other via a blood purifier and by having a second end portion of the blood removal side circuit and a second end portion of the blood return side circuit connected to each other directly or indirectly; a blood pump provided at the blood circuit; a flow channel switch unit capable of switching between an open state in which fluid is able to flow through the first end portions of the blood removal side circuit and the blood return side circuit and a closed state in which the fluid is unable to flow through the first end portions of the blood removal side circuit and the blood return side circuit …”
The drawings show that a blood purifier 19 connects the A and V lines (Fig. 1). Therefore, the first end portions correspond to the lines above A chamber 14, and V chamber 20.
This makes claim 8 ambiguous since the first end portions can always communicate through blood purifier 19 regardless of whether patient connection portions 11 and 12 is being joined in AV coupled state 13.
Allowable Subject Matter
Claims 8-14 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance:
Regarding Claims 8 & 14, closest relevant art Oppegard et al. (US 20180093027 A1) discloses
A blood purification apparatus ("dialyzer or hemofilter for cleansing blood" [0018]; FIG. 1) comprising:
a blood circuit ("medical fluid delivery system 10" [0081]; FIG. 1) having a blood removal side circuit into which blood removed from a patient flows ("arterial line 14" [0082]) and a blood return side circuit from which blood is returned to the patient ("Venous line 16" [0082]) and being able to form a closed circuit by having a first end portion of the blood removal side circuit and a first end portion of the blood return side circuit connected to each other via a blood purifier ("blood filter 40" [0085]; FIG. 1) and by having a second end portion of the blood removal side circuit and a second end portion of the blood return side circuit connected to each other directly or indirectly (indirectly connected to each other via the patient);
a blood pump provided at the blood circuit ("blood pump 30" [0084]);
a flow channel switch unit ("line clamps 18a and 18v" [0084]) capable of switching between an open state in which fluid is able to flow through the first end portions of the blood removal side circuit and the blood return side circuit and a closed state in which the fluid is unable to flow through the first end portions of the blood removal side circuit and the blood return side circuit ([0083]);
a pressure detection unit that detects pressure inside the blood circuit ("pressure sensors" [0086]); and
a control unit ("control unit 50" [0086]) that executes a drainage process of draining liquid remaining in the blood circuit to a predetermined drainage destination with the blood circuit forming the closed circuit ([0089-0093]).
Oppegard fails to specify the control unit further executes a determination process in which the control unit generates a difference in pressure between the blood removal side circuit and the blood return side circuit by rotating the blood pump with the flow channel switch unit switched to the closed state, and then determines whether the blood circuit is the closed circuit by switching the flow channel switch unit to the open state and monitoring the difference in pressure based on a result of detection by the pressure detection unit, and in a case where it is determined in the determination process that the blood circuit is the closed circuit, the control unit executes the drainage process after the determination.
Vartia et al. (US 20230040372 A1) teaches a system and method for producing fluid for peritoneal dialysis (Abstract) wherein the control unit further executes a determination process in which the control unit generates a difference in pressure between the blood removal side circuit and the blood return side circuit (“a significant transmembrane pressure may build if the sides stay stiffly separated” [0079]) by rotating the blood pump (“first pump 41 provides a flow of PD-fluid from the container 9 to the outlet connector 5a, and the pressure is sensed with the second pressure sensor 55” [0081]) with the flow channel switch unit switched to the closed state (“valves 31, 32, 33 35, 37 and 38 are closed” [0079]) but fails to teach or suggest the control unit determines whether the blood circuit is the closed circuit by switching the flow channel switch unit to the open state and monitoring the difference in pressure based on a result of detection by the pressure detection unit, and in a case where it is determined in the determination process that the blood circuit is the closed circuit, the control unit executes the drainage process after the determination.
Thiebaud et al. (US 20190209766 A1) teaches a method for detecting a failure in a system adapted to provide a medical treatment to a patient ([0023]) comprising “a test generating a pressure by a pump” ([0112]) wherein “the pump generates a pressure preferentially in a temporarily closed pathway” and monitors the sensors wherein “if the system concludes to a failure or a success, the system passes to another test (for example so as to confirm the result or to check others elements) and/or records the data in a memory of the system and/or performs the treatment” ([0113]). While Thiebaud’s test process utilizes the pump and circuit pressure to conduct determination of failure or success ([0112-0133]), Thiebaud’s test process fails to specify determining whether the blood circuit is the closed circuit by switching the flow channel switch unit to the open state and monitoring the difference in pressure based on a result of detection by the pressure detection unit, and in a case where it is determined in the determination process that the blood circuit is the closed circuit, the control unit executes the drainage process after the determination.
No relevant references was found to ameliorate the deficiency. The remaining claim(s) is/are allowable due to dependency upon an allowable claim.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781