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 claims 1-13 in the reply filed on 8/28/2026 is acknowledged.
Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/28/2026.
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 5, 6, 12 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.
Regarding claim 5, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 6, it is unclear to the metes and bounds of the claim as the claim recites: "microfluidic test card further comprises or being connected to one or more of fluid outlets". It is not clear what the test card further comprises as it immediately is followed by the "or". For prosecution, the claim will be interpreted as being a typo with "or" not being part of the limitation.
Regarding claim 12, it is unclear to the metes and bounds of the claim as the claim recites: " system according to claim 1", but claim 1 is directed to "a microfluidic device". There is insufficient antecedent basis for this limitation in the claim. For prosecution, the claim will be interpreted as depending on claim 11, which is directed
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation "sensor unit", and the claim also recites "preferably the sensor unit is selected from an optical unit, a CMOS camera, and a colorometry detection unit" which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim limitation “storage/communication means” 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. The specification fails to disclose and corresponding structure, material, or acts for performing the entire claimed function or why there is no clear linkage between the structure, material, or acts and 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 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 12 recites, “storage/communication means” that meets the three prongs.
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.
Claim(s) 1-7, 9-13 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Higashino et al (US 20080112849).
Regarding claims 1 and 11, Higashino et al teach a microfluidic device (Abstract: micro total analysis chip) comprising
a disposable microfluidic test card for capillary driven liquid sample processing (Abstract, Para. 0024; Fig. 1,2: 100 micro flow chip), the disposable microfluidic test card comprising
a sample inlet arranged for receiving liquid sample at the microfluidic test card (Fig. 2: 301)
at least one test reagent reservoir arranged for holding of test reagent (Fig. 2: reagent A 303,reagent B 305),
an analysis zone for analysis of liquid sample components (Fig. 2: First detector 143, Second detector 163), and
a microfluidic sample processing zone (Fig. 2: 131 joining path and mixing path 141)) arranged in fluidic connection with the sample inlet and the at least one test reagent reservoir for receiving of liquid sample and test reagent, respectively, therefrom, the microfluidic sample processing zone being further arranged for
metering and providing a predetermined volume of liquid sample (Para. 0036: specimen 301 is fed at a flow ratio of 1:2 and L1 and L2 have defined length, width, and depths, thus have a predetermined volume of liquid sample),
mixing or contacting of the predetermined volume of liquid sample with test reagent (Fig. 2: mixing portion 141 and 161),
allowing processing of liquid sample mixed or contacted with test reagent (Fig. 2: mixing portion 141 and 161) , and
fluidic connection with the analysis zone for providing processed liquid sample to the analysis zone, ( (Fig. 2: mixing portion 141 and 161 fluidic connection to first detector 143 and second detector 163)
wherein the analysis zone is arranged for presenting processed liquid sample to a reader. (Fig. 1, Para. 0026: 253 light receiving element (PD) and LED 251 compose the detector 250)
Regarding claim 2, Higashino et al teach the disposable microfluidic test card further comprises a microfluidic chip comprising the microfluidic sample processing zone (Fig. 1: 100 testing chip).
Regarding claim 3, Higashino et al teach the disposable microfluidic test card further comprises
at least one pre-processing test reagent channel arranged for capillary drive of test reagent from the at least one test reagent reservoir to the microfluidic sample processing zone (Para. 0065: capillary force; Fig. 2; Para. 0033: flow path 113 and 115),
at least one pre-processing sample channel arranged for liquid communication with the sample inlet, and arranged for capillary drive of liquid sample to the microfluidic sample processing zone (Fig. 2: specimen main flow path 111),
at least one sample analysis channel for receiving processed liquid sample from the microfluidic sample processing zone and for analysis of the processed liquid sample (Para. 2: first mixing path 141 and second mixing path 161), and
wherein the microfluidic sample processing zone comprises
a processing channel system comprising at least one liquid sample entrance, arranged for receiving liquid sample from the at least one pre-processing sample channel (Fig. 2: sample entrance into joining portion 131 and 151 from 133 and 153)
at least one test reagent entrance arranged for receiving test reagent from the at least one pre-processing test reagent channel (Fig. 2: test reagent entrance into joining portion 131 and 151 from 135 and 155),
at least one sample metering capillary channel having a predetermined volume, and arranged for providing the predetermined volume of received liquid sample to at least one processing channel (Fig. 2: water repellent valves 133 and 135 with defined dimensions), and
the at least one processing channel, arranged for contacting, in the at least one processing channel, the test reagent and the predetermined volume of liquid sample, thereby allowing processing of liquid sample, and further arranged for capillary drive of processed liquid sample to the at least one sample analysis channel for analysis (Fig. 2: joining portions 131 and 151 to contact the sample and the test reagent and delivering to the first detector 143 and second detector 163).
Regarding claim 4, Higashino et al teach the disposable microfluidic test card is arranged for providing capillary driven flows of liquid through the channels of the disposable microfluidic test card. (Para. 0065: capillary force of the flow path)
Regarding claim 5, Higashino et al teach the mixing or contacting of the predetermined volume of liquid sample with test reagent, and the allowing processing of liquid sample mixed or contacted with test reagent is controlled in time, such as by use of capillary timing circuits and/or trigger valves. (Para. 0044: stop liquid for desired timing)
Regarding claim 6, Higashino et al teach the disposable microfluidic test card further comprises or being connected to one or more of fluid outlets, collecting or waste reservoirs, and capillary pumps for driving of capillary driven flows within or out of the disposable microfluidic test card, optionally, the disposable microfluidic test card further comprises or being connected to vents for venting of gaseous medium from one or more channels of the disposable microfluidic test card. (Para. 0065: capillary force of the flow path)
Regarding claim 7, Higashino et al teach the capillary pumps are selected from one or more of paper pump or elongated channel type of pumps. (Para. 0065: capillary force of the flow path, the flow path has elongated channels, Fig. 6: 123a)
Regarding claim 9, Higashino et al teach the disposable microfluidic test card is manufactured from or comprises material selected from the group consisting of polymer, silica and glass, and combinations thereof (Para. 0027: glass).
Regarding claim 10, Higashino et al teach the reservoirs for the liquid sample and the test reagents. The limitation, "the liquid sample is blood or liquid derived from or comprising blood" is considered a material worked upon by an apparatus and does not patentably define the claimed apparatus over the prior art (see MPEP 2115). The limitation of the "test reagent is lysing buffer comprising lysing reagent for lysing of red blood cells present within the microfluidic sample processing zone, or dilution buffer for diluting the predetermined volume of liquid sample" does not positively recite the test reagent because claim 1 recites "at least one test reagent reservoir arranged for holding of test reagent ", and thus they are not part of the invention. The limitation, "the at least one sample analysis channel is for analysis comprising determining a measure of leukocytes, and/or determining a measure of red blood cells" is considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. Since these claims are drawn to an apparatus statutory class of invention, it is the structural limitations of the apparatus, as recited in the claims, which are considered in determining the patentability of the apparatus itself. These recited process or intended use limitations are accorded no patentable weight to an apparatus. Process limitations do not add patentablility to a structure, which is not distinguished from the prior art. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that it is well settled that the recitation of a new intended use, for an old product, does not make a claim to that old product patentable. See In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997). 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) (see MPEP § 2114).
Regarding claim 12, Higashino et al teach a reader comprising a sensor unit arranged for receiving a signal for processing and transmitting a processed signal to a computer (Fig.1: detector 250 and drive controller 270). It is noted the limitation: "preferably the sensor unit is selected from an optical unit, a CMOS camera, and a colorometry detection unit," and, "optionally, a computer readable medium configured to display information from the processed signal, and a storage/communication means." are optional limitations.
Regarding claim 13, Higashino et al teach the sensor unit senses and receives the signal indicative of presence of processed liquid sample in the analysis zone. (Para. 0015,0017, 0025: detector 250 detects target material optically)
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Higashino et al (US 20080112849) in view of Spaid et al (US 2007/0154895).
Regarding claim 8, Higashino et al teach detectors 143 and 163, but is silent the analysis zone comprises a flow cell. Spaid et al teach a microfluidic device with reagents 100 and samples 104 delivered to a microfluidic device 103, the detection region is a flow cells detected by detector 109 (Para. 0034). It is desirable to provide the analysis zone with a flow cell to provide ongoing reactions in a flow to analyze more samples continuously. Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the detector of Higashino to provide the above advantage of providing ongoing reactions in a flow to analyze more samples continuously.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Dennis White/Primary Examiner, Art Unit 1758
