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 .
Response to Arguments
Applicant's arguments filed 12MAR2026 have been fully considered but they are not persuasive.
Regarding the amendment of Claim 1, Applicant’s arguments are not persuasive. Applicant argues that Grant does not teach “a valve portion that is rotatably arrange on the base body in a step-wise fashion”, but this feature is not claimed. The claim as written is understood to require the valve portion to hold a valve with the valve arranged on the base body, wherein the valve is held in a plurality of discrete positions defined by the steps. While this could be interpreted to require a plurality of steps which place the valve in discrete positions, the claim is currently not written with such a requirement. Grant teaches the valve is rotatably arranged and held in position by the steps.
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: “mixing element” in claims 10-13.
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.
Claims 1, 2, 4-6, 8-16, and 19-24 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 recites the valve portion is “configured to hold a valve with the valve rotatably arranged on the base body into a plurality of discrete positions defined by steps” which is unclear, and therefore indefinite. This statement is interpreted to require the valve portion to hold the valve, the valve to be rotatably arranged on the base body, there to be a plurality of discrete positions (e.g., at least “open” and “closed”), the positions to be defined by “steps”. Additionally, if the steps are considered to be physical structures, “the steps” would lack antecedent basis. The prior art rejection in view of Lauer is maintained to teach “step-wise” movement, while the teachings of Grant are updated to reflect “steps” which retain the valve in place, as the Claim as intended interpretation of amended Claim 1 is not understood.
Claim 24 recites the limitation "the steps" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 2, 4-6, 8-16, and 19-24 are rejected based on their dependency.
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) 1, 2, 4-6, 8-16, 19-21, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190298231 A1 (Grant et al.) in view of US 20170080205 A1 (Lauer).
Regarding claims 1 and 2, Grant teaches a valve island (10) for a hydraulic assembly for an extracorporeal blood treatment machine [0005], with a base body (12) (Fig. 1A), in/on which at least one fluid flow passage comprising a tube (Grant Annotated Fig. 10) is formed/integrally arranged,
one or more first connecting portions (96) (Fig. 6) provided on the valve island and configured to engage one or more second connecting portions (261) (Fig. 26) provided on a carrier or mounting adapter (260) (Fig. 26), wherein the one or more first connecting portions and the one or more second connecting portions comprise male (96) and female (261) connectors that are engageable and disengageable without tools (Grant teaching common male/female connectors which are interpreted to not require tools);
wherein the base body is manufactured by additive manufacturing or injection molding [0099], and wherein a valve portion (at least 124) is arranged at least one axial end of the at least one fluid flow passage (Fig. 10);
wherein the valve portion is configured to hold a valve with the valve rotatably arranged on the base body in a step-wise fashion into a plurality of discrete positions defined by steps (steps (39) and (21), described in [0197, 0219] restricting the valve in place and defining the possible positions).
Grant fails to teach the valve portion is integrally formed with the base body or the valve portion is rotatably arranged on the base body in a step-wise fashion.
Lauer teaches a valve island (900) for a hydraulic assembly for an extracorporeal blood treatment machine [0006], with a base body (830), in/on which at least one fluid flow passage (831) comprising a tube is formed/integrally arranged (Fig. 1b), wherein the base body is manufactured by additive manufacturing or injection molding [0208], and wherein a valve portion (1) is arranged at at least one axial end of the at least one fluid flow passage (as seen in Fig. 1b). Lauer further teaches the at valve portion is integrally formed with the base body (portions 37-39 forming the body of the valve) [0192] and the valve portion is rotatably arranged on the base body in steps [0171, 0194].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve of Grant to incorporate the integrally formed valve of Lauer to simplify device assembly [Lauer 0171].
“[W]herein the base body is manufactured by additive manufacturing or injection molding” is considered product-by-process claim limitation. The cited prior art teaches all of the positively recited structure of the claimed apparatus or product. The determination of patentability is based upon the apparatus structure itself. The patentability of a product or apparatus does not depend on its method of production or formation. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP § 2113).
Regarding claims 4-6, Grant further teaches at least one coupling receptacle, is formed integrally with the base body (Grant Annotated Fig. 10, or as channel ports 96 and 98 on other drawings), via which a hydraulic component (manifold 260) is connectable fluidically and positively to the at least one fluid flow passage [0124]. Grant teaches at least one spout (coupling receptacle) is formed integrally with the base body (Fig. 10), via which a fluidic line can be fluidically connected to the at least one fluid flow passage (said connection occurring as 266 acts as an adapter to mate components [0125]), said coupling receptacle or spout being at least one fluidic and/or mechanical connecting portion which is formed integrally with the base body (Grant Annotated Fig. 10), via which a component is connectable fluidically and/or mechanically [0125].
Regarding claims 8 and 9, Grant further teaches the hydraulic component (260) is a second valve (at least 267) that is fluidically and positively connected to the at least one fluid flow passage via the coupling receptacle [0127], wherein the second valve comprises a coupling portion (such as adapters 266, 268, and 270) inserted into the coupling receptacle and secured therein via a mounting element (said components mounted together as shown in Fig. 46).
Regarding claims 10, 12, and 13, Grant further teaches the incorporation of internal or external mixing elements [0105], individual cassettes being capable of acting as mixing elements as well [0109], wherein incorporated mixing elements (such as 236 in Fig. 20 [0113]) are integrated into a respective flow passages connected to valve elements which is fluidically and positively connected to a fluid flow passage (and having a plurality of fluid passages as would be required for entrance and exit of fluids) or the at least one fluid flow passage via a coupling receptacle (said elements being connected to the cassettes [0113]), and being secured therein via a mounting element (the frame of 226), and is therefore considered to teach the requirements of claims 10, 12, and 13.
Regarding claim 11, Grant further teaches a mixing element is integrated in a respective valve seat as the valve seat as depicted in Figs. 3A-3B would not result in laminar flow, thereby resulting in a mixing effect.
Regarding claims 14-16, Grant further teaches a carrier (246) (Fig. 23) on which at least one valve island is arranged indirectly or directly, the carrier including a surface on which the at least one valve island is or are disposed (as shown in the mounted configuration of Fig. 46), said contact surfaces being considered a common side.
Regarding claim 19, Grant further teaches a dialysis machine comprising a hydraulic assembly according to claim14 (Fig. 23) [0041].
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Grant Annotated Fig. 10
Regarding claim 20, Grant in view of Lauer fails to teach the valve portion comprises an electric valve coil.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve of Grant in view of Lauer to comprise an electric valve coil as use of electronically actuated valves is known in the art and allows a greater level of control, as taught by Grant [0003].
Regarding claim 21, Grant further teaches the plurality of fluid passages are arranged in parallel as seen in Fig. 9 where all passages are parallel along an axis created by the connection ports (96).
Regarding claim 24, Grant further teaches the steps ((39) and (21)) are arranged at 45° or less about an axis of the valve portion, the valves being essentially parallel to an axis perpendicular to that denoted in Figs. 1a-1c.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Lauer and further in view of US 20180215016 A1 (Allen et al.).
Regarding claim 22, Grant in view of Lauer fails to teach each male connector comprises a respective pin and each female connector comprises a respective slot, wherein each respective pin is engageable with a respective slot by inserting the respective pin in a first direction into the respective slot, and sliding the respective pin in a second direction along the respective slot, the second direction being perpendicular to the first direction.
Allen teaches a connector wherein each male connector (150) comprises a respective pin (150a) and each female connector (160) comprises a respective slot (160a), wherein each respective pin is engageable with a respective elongated slot by inserting the respective pin in a first direction into the respective slot, and linearly sliding the entire respective pin in a second direction along the respective slot (rotating as seen in Fig. 2A), the second direction being perpendicular to the first direction, in order to achieve a leak-free connection (directions shown at 245 being perpendicular to directions 255 and 260 in Fig. 2A, Allen [0004]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connectors of Grant in view of Lauer with the connectors taught by Allen to achieve leak-free connection [Allen 0004].
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Lauer and further in view of US 20150314055 A1 (Hogard et al.).
Regarding claim 23, Grant in view of Lauer at least one coupling receptacle is formed integrally with the base body (the plurality of connections), but fails to teach a hydraulic component is connectable fluidically and positively to the at least one fluid flow passage, wherein the hydraulic component comprises a tubular body with a first internal passage portion, a second internal passage portion, and a mixing element located between the first internal passage portion and the second internal passage portion, the mixing element comprising a plurality of parallel fluid passages fluidly joining the first internal passage portion to the second internal passage portion.
Hogard teaches a dialysis system wherein a hydraulic component (Fig. 15) is connectable fluidically and positively to the at least one fluid flow passage (via 236a or 236b), wherein the hydraulic component comprises a tubular body (inlet portion 236a) with a first internal passage portion (interior lumen of 236a), a second internal passage portion (interior lumen of 236b), and a mixing element (224) located between the first internal passage portion and the second internal passage portion (Fig. 15), the mixing element comprising a plurality of parallel fluid passages (238) fluidly joining the first internal passage portion to the second internal passage portion, in order to smooth the introduction of fluids [0118].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Grant in view of Lauer to incorporate the mixing chamber of Hogard to smooth the introduction of fluids [Hogard 0118].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HANS KALIHER/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
16 May 2026
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