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 .
Election/Restrictions
Applicant's election with apparent, although not explicit, traverse of Group 1, drawn to the blood collection system, in the reply filed on 3/19/26 is acknowledged.
The traversal is on the ground(s) that the 2/22/24 preliminary amendment was not considered and that the action did not consider the control unit as claimed when establishing special technical feature.
This is not found persuasive because:
as an initial matter, Examiner appreciates Applicant bringing to the Examiner’s attention a typographical error in the Election/Restriction requirement mailed 1/23/26, wherein the Requirement for unity of Invention incorrectly identified the claims of Groups 3 and 4. Group 3 should have read as claims 11-17 (instead of 11-16) and Group 4 should have read as claims 18-20 (instead of 17-20). The Examiner respectfully apologizes for any confusion and appreciates Applicant’s clarification.
Regarding Applicant’s concern of the control unit, the Examiner respectfully notes Feijen was relied upon for demonstrating that the shared technical feature of the control unit is not a corresponding special technical feature, particularly as broadly as claimed, such that unity of invention is lacking.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/19/26.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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:
“a flow component” in claim 1;
“a blood metering device” in claim 1;
“a control unit” in claim 1;
“an electronic module” in claim 1; and
“components” in claim 4;
“a user input control” in claim 4.
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 4 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 4 positively recites “for controlling components in the blood metering device”. Although it may be assumed that broadly the “component” in the blood metering device refer and/or include the claim elements comprising the blood metering device of claim 1, from which 4 depends, this assumption is not necessarily required by the claim language and the “components” could or may include any number of additional unrecited elements. The scope of the claim is indeterminate with respect to what “components” in the blood metering device are being controlled by the printed circuit board. One of ordinary skill in light of the instant Specification would not be apprised by the metes and bounds of the scope of the claimed invention because it is unclear what is explicitly, implicitly, inherently, and/or inferentially required and/or necessarily excluded by the recitation of “for controlling components in the blood metering device”.
Claim Rejections - 35 USC § 102
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(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feijen et al. (2/22/24 IDS Foreign Doc Cite No 1 WO 2021/023773 A1, hereinafter Feijen).
For claim 1, Feijen discloses a blood collection system (Fig 1) (abstract) ([0045-0049]), comprising inter alia:
a flow component (120) comprising a flow channel (lumen of 120) extending between a first end and a second end of the flow component (Fig 1) ([0045-0049]);
a butterfly needle (110) connected to the first end of the flow component (Fig 1) ([0045-0049]); and
a blood metering device (130) connected to the second end of the flow component (Fig 1) ([0045-0049]), the blood metering device comprising;
a control unit (140), the control unit including a housing (180) defining a blood flow conduit (162) (Figs 1-3A) ([0045-0054]) for blood from a patient to flow therethrough (Figs 1-3A) ([0045-0054]), a valve (189) disposed within the blood flow conduit (Figs 1-3A) ([0045-0049]), the valve adapted to allow the blood from the patient to flow through the blood flow conduit when the valve is in an open position (via valve actuator 188) (Fig 1 and 2A) ([0045-0049]) and to stop the blood from the patient from flowing through the blood flow conduit when the valve is in a closed position (via valve actuator 188) (Fig 1 and 2A) ([0045-0049]), and an electronic module (182) disposed within an electronic compartment (portion of 180 for 182) of the housing (Fig 1) ([0045-0049]);
a barrel (152) configured to align with a neck (163) of a collection vessel (160) for receiving the neck therewithin (Figs 1-3A) ([0045-0054]); and
an adapter (150) including a luer connector (connecting attachment spring-loaded biasing force of [0054] is the structural equivalent of the disclosed luer alternatives as conventional coupling means, see instant Specification [0034]) at a first end portion thereof for coupling with the control unit and a second end portion thereof for coupling with the barrel (Figs 1-3A) ([0045-0054]).
For claim 2, Feijen discloses the blood collection system of claim 1, wherein a connection cavity (cavity interfacing between 140 and 150) (Figs 1-3A) ([0045-0054]) is defined within the housing of the control unit for engaging and coupling with the adapter.
For claim 3, Feijen discloses the blood collection system of claim 1, wherein the blood flow conduit (162) defines a passageway therewithin for the blood from the patient to travel therethrough and to the collection vessel (Figs 1-3A) ([0045-0054]).
For claim 4, Feijen discloses the blood collection system of claim 1, wherein the electronic module includes a printed circuit board (182) for controlling components in the blood metering device (Figs 1-3A) ([0045-0054]), a pressure sensor (blood flow sensor electronics on PCB 182) ([0057-0058]) connected to the printed circuit board, and a user input control (colored light indicator [0046] and/or 190).
For claim 5, Feijen discloses the blood collection system of claim 1, wherein a channel (169) is defined in the housing of the control unit and connects the blood flow conduit and a pressure sensor disposed within the electronic compartment of the housing (Figs 1-3A) ([0045-0054]).
For claim 6, Feijen discloses the blood collection system of claim 5, wherein the channel allows the pressure sensor to measure a gas pressure in the collection vessel when the valve is closed, which stops the blood from flowing through the blood metering device and to the collection vessel ([0045-0054]).
For claim 7, Feijen discloses the blood collection system of claim 1, wherein the control unit, barrel, and adapter are all connected and in fluid communication with each other such that blood from the patient flows to the collection vessel (Fig 1 and abstract).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for blood collection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
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