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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 8, 2025 has been entered.
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.
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: “throughflow unit” in claims 15, 29, and 30 (referred to, but not a positively claimed element in each of these claim sets) and claim 25.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 25 – 27 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, but fails to recite a combination of elements as required by that statutory provision and thus cannot rely on the specification to provide the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim. In particular, the “throughflow unit” is the only claimed element of the system.
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 15 – 18, 20 – 27, 29, and 30 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. With regard to claim 15, the claim is directed to a “handheld blood testing device” wherein the only positively claimed element is a “housing”. While one could understand and assess whether a housing includes the claimed dimensions and weights, one of ordinary skill in the art would not recognize the property of “operated without cables” as being generally associated with a housing. As such, it is unclear how the limitation is intended to limit the positively claimed structure. In addition, the preamble of the claim refers to certain intended uses of the device (“direct connection to”, “recording of blood parameters”) but there do not appear to be claimed elements associated with these details. Claims 29 and 30 include parallel limitations to those of claim 15 and are rejected accordingly. With regard to claim 17, the claim refers to properties that are not readily associated with the positively claimed housing element of the claimed invention. Further, it is unclear how an autonomous measuring/processing element (if positively claimed) could operate without connection to a power supply, as the language appears to require. With regard to claims 20 - 22, it appears that the claims are directed to elements associated with the “throughflow unit”; however, claim 15, as currently set forth does not positively claim such an element, and therefore the claims do not appear to relate to any positively claimed element of the “blood testing device” itself. With regard to claim 24, the claim refers to properties that are not readily associated with the positively claimed housing element of the claimed invention (the only claimed structure). As such, the metes and bound of the claim limitation cannot be readily resolved. With regard to claim 25, the claim sets forth a system comprising a “throughflow unit” and indicates it is designed to be coupled to a blood testing device and also “the throughflow unit having a blood testing device according to claim 15”; however, the structure of claim 15 is claimed to be distinct from, but connectable to such a unit, consistent with the first aspect set forth in claim 25. It is unclear how the structure of claim 15, in context of claim 25, can satisfy both the requirements set forth therein and the details of claim 25 which are contrary thereto.
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.
Claim(s) 15 – 24, 29, and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Isaacson et al. (USPN 5,490,523). Isaacson et al. teach a clip sensor (Figures 5 – 7, 14) having a housing with dimensions (column 3, lines 41 – 45) consistent with the claim requirements. The clip includes emitter, detector, and processing elements, as well as indicator LEDs (column 5, lines 16 – 30) to display information to a user and batteries for supplying power. A communication interface permits connection to remote devices. Consistent with the details of the rejection set forth under 35 USC 112(b) above, one of ordinary skill in the art would recognize Isaacson et al. as meeting all positively claimed elements.
Claim(s) 25 - 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steuer et al. (USPN 5,351,686). Steuer et al. teach a disposable cuvette/throughflow unit (Figures 2, 4, 6, 8 and the descriptions thereof) for connection to tubing of a dialyzer system as well as connection with a detection apparatus that can perform optical detection of blood flowing through the cuvette element. Steuer et al. teach that the cuvette/conduit incorporates a transducer means, responsive to pressure pulsations to dampen movements/pressure transducer. The optical attachment position is axially displaced from the movable membrane (Fig 8 – 10 and the descriptions thereof), providing space for membrane movement.
Response to Arguments
Applicant’s arguments with respect to claim(s) 15 – 18, 20 – 27, 29, and 30 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Karkar et al. (USPN 4,745,279) teach an additional extracorporeal attachable blood sensing arrangement.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC FRANK WINAKUR whose telephone number is (571)272-4736. The examiner can normally be reached Mon-Fri 9 am - 6 pm.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
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