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 without traverse of Group II, claims 12-20; and Species E. 1, F. 1, and G. 3 in the reply filed on 02/12/2026 is acknowledged.
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: “configured to [...]” in claims 14, 18, 19, 20.
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 12-20 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.
Claims 12, 13, 15, 16, 18, 20 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired. Claim 12 is unclear reciting “wherein the removable reagent pack and the removable test card are connected through respective interfaces, and calibration, sample detection and emptying are completed by providing power for the removable reagent pack and controlling on-off of a pipeline of the removable test card through the blood gas analyzer host.” The “wherein” clause renders the claim indefinite because it is unclear whether the limitation(s) following the clause are part of the claimed invention, i.e., the respective interfaces, power for the removable reagent pack, a pipeline of the removable test card. See also “wherein a pipeline between [...]” in claim 15; “wherein the device controls [...] through a power system such that [...]” in claim 16; “wherein a valve is inside [...], and the valve is configured to [...]” in claim 18; and “wherein [...] a sample inlet [...] a liquid path [...]; and an electrical coupling connection [...] an electrochemical sensor” in claim 20. In claim 13, the phrase "hemoglobin and derivatives" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "derivatives"), thereby rendering the scope of the claim unascertainable.
Claim 15 recites the limitation "the blood gas detection region" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the device" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the waste liquid area" in L7. There is insufficient antecedent basis for this limitation in the claim.
Claim limitation “configured to” has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “means” or generic placeholder is modified by a word, which is ambiguous regarding whether it conveys structure or function; and/or the claim limitation uses the word “means” or a generic placeholder coupled with functional language, but it is modified by some structure or material that is ambiguous regarding whether that structure or material is sufficient for performing the claimed function. The boundaries of this claim limitation are ambiguous; 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.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
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.
(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) 12-20 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Lin et al. (US 2013/0140179 A1).
Regarding claim 12, Lin et al. teach:
12. A system, comprising:
an analyzer host (e.g., 10; ¶ 0002);
a removable test card (e.g., 20); and
a removable reagent pack (e.g., calibration cartridge 30),
wherein the removable reagent pack and the removable test card are connected through respective interfaces (see Figs. 10-11 for example).
With regard to limitations in claims 12-20 (e.g., blood gas analyzer [...], and calibration, sample detection and emptying are completed by providing power for the removable reagent pack and controlling on-off of a pipeline of the removable test card through the blood gas analyzer host; a blood gas detection [...] and a hemoglobin and derivatives detection [...]; and a detection [...] is implemented by colorimetric method, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 13-15, 17-20, Lin et al. teach:
13. The system as claimed in claim 12, wherein the removable test card comprises detection areas (see i.e., electrochemical sensors which can accurately detect certain biological analytes in blood ¶ 0002).
14. The system as claimed in claim 12, wherein the removable reagent pack comprises at least one liquid storage device (e.g., fluid pack 54) comprising an output pipeline (e.g., 52), at least one transport control device (e.g., 47, 48) capable of controlling at least a flow direction in a pipeline inside of the removable reagent pack (see ¶ 0094 for example), and at least one positioning mechanism capable of fixing the removable reagent pack on the analyzer host (see i.e., The calibration cartridge door 14 and the opening behind the door 14 are sized to receive a disposable calibration cartridge 30 [...] Behind the calibration cartridge door 14 is a calibration cartridge port configured to receive the calibration cartridge 30. ¶ 0081; see also ¶ 0093-0094, 0116, 0121 for example).
15. The system as claimed in claim 13, wherein a pipeline between the detection areas (see i.e., A pinch valve 46 may be used to open or close the fluid channel 32, allowing the fluid sample 39 to travel into the testing portion 42. ¶ 0098).
17. The system as claimed in claim 12, wherein the removable reagent pack at least comprises calibration liquid (see ¶ 0010 for example).
18. The system as claimed in claim 12, wherein a valve is inside of the removable test card, and the valve is capable of implementing an on-off connection of the pipeline at a corresponding position of the removable test card (see i.e., the pinch valves 46-48 may be integrated pinch valves, having a thin film that is elastically biased out and can be closed by applying pressure in toward the cartridge 20 or 30. In these embodiments, the pinch valves 46-48 include flexible film areas 76 (shown in FIG. 25). The pinch valves 46-48 may be constructed at least in part with polyethylene terephthalate. ¶ 0100).
19. The system as claimed in claim 12, wherein the removable test card comprises at least three external interfaces; and the at least three external interfaces comprise a first interface (i.e., at the T-connector 52 to the needle 56) configured to inject a calibration liquid (see Fig. 10C for example), a second interface (e.g., 38) configured to inject a sample (see Fig. 10A for example), and a third interface (i.e., at the vacuum pump 50 to the fluid channel 32) connected to a waste liquid area of the removable test card (see Fig. 11A for example).
20. The system as claimed in claim 12, wherein the removable test card comprises at least three pipeline control parts (e.g., pinch valve actuators 78 for the pinch valves 46-48, valve control mechanisms); the at least three pipeline control parts are respectively capable of controlling an on-off connection (see ¶ 0100 for example).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798