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 .
Claim Status
Claims 1 are pending and being examined.
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. Claim 1 recites the limitations “means for dividing…” in lines 6-7; “means for optically detecting…” in line 8; and “means for automatically communicating…” in line 9.
Claim 1 recites the limitation “means for dividing the fluid sample into sub-samples and conveying a sub-sample to each of said test strips” lines 6-7. The limitation “means for dividing…” is discussed in the instant specification on paragraph [7, 24, 31] and Figure 3. The examiner notes the means for dividing and distributing the fluid subsamples comprises a sample pad 34 having a collar-shape or cylindrical-shape as best seen in FIG. 3. The examiner interprets the “means for dividing…” to be defined by the sample pad 34.
Claim 1 recites the limitation “means for optically detecting the results displayed on each test strip” in line 8. The limitation “means for optically detecting…” is discussed in the instant specification on paragraph [7, 24]. The specification states that the means for optically detecting the result on each test strip. However, no structural limitations are related to the means for optically detecting. The examiner interprets that any form of optical detection that can read the test strip would meet the limitation.
Claim 1 recites the limitation “means for automatically communicating those test results to an electronic data collection device” in line 9. The limitation “means for automatically communicating…” is discussed in the instant specification on paragraph [24]. The specification states that the communication means are located in a communications housing 28 at the distal end of the test housing 14. However, it is unclear what structures provide the function of “communicating”. The examiner interprets that any form of communicating/transferring data meets the claim limitation.
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 1 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 limitation “means for optically detecting the results displayed on each test strip” in line 8 and “means for automatically communicating those test results to an electronic data collection device” in line 9 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. 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 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 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.
Claim(s) 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramel et al (US 20050227370 A1; hereinafter “Ramel”).
A multi-test lateral flow assay device for performing multiple tests on a single fluid sample (Ramel; Abstract), comprising:
a. a test housing (Ramel; Fig. 1; para [108]; a housing 102);
b. a fluid-sample collection nosepiece connected in fluid communication with said test housing (Ramel; Fig. 1; para [108]; cover 104 having a receptor such as inlet port 106 that extends from the exterior surface 108 of the cover to the interior 110 of the housing for receiving a sample 112);
c. a plurality of isolated lateral flow assay test strips within said test housing (Ramel; Fig. 1; para [112]; one or more sampling areas 152 on a first 154 and second 156 assay strip);
d. means for dividing the fluid sample into sub-samples and conveying a sub-sample to each of said test strips (Ramel; para [113]; The assay strips 154 and 156 mount in strip carriers 158 and 160 respectively. The carriers 158, 160 mount to the top face 148 of the optics assembly to rigidly hold the assay strips 154 and 156 in position);
e. means for optically detecting the results displayed on each test strip (Ramel; para [112]; The top face 148 of the optics assembly is also configured to transmit the diffusely reflected optical radiation returning from the sampling areas 152 to one or more of the zone detectors 138, 140); and,
f. means for automatically communicating those test results to an electronic data collection device (Ramel; para [171, 172]; The second method utilized “reusable” units. In this method, HbA1c test strips were placed into units and clamped shut on the docking station as described above. Samples were applied to the units for evaluation, and the reflectance data automatically downloaded in a fashion similar to that for the method described above, except that it took place in “real” time).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.Q.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796