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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/17/2026 has been entered.
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that “Cork et al. does not recognize or identify the problem of needing to gain much more widespread separation and collection of biomarkers during routine WB donations, uniquely achieved within a standardized whole blood donation collection kit, consistent with the present invention”, and that “Cork et al. does not contemplate or suggest a simple and cost efficient solution to achieve this advantageous result” (See in Remarks pg. 5), the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “screening for biomarkers with no additional pumping or processing hardware incorporated into the kit or hardware to manipulate the kit”) are not recited in the rejected claim(s) (See in Remarks pg. 3). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that “Cork et al. is not a standardized blood donation kit for use by the masses during regular WB donations, without pumping or additional processing”, and that “Cork et al. includes substantial hardware for processing blood or blood components, a cassette and numerous MEMS sensors, flow paths and containers for a multitude of additional purposes” (See in Remarks pg. 5), 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.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Claim Interpretation
One with ordinary skill in the arts would define a "LOC" as a specific type or application of a "MEMS device". MEMS can perform various complex functions (sensing, actuation, etc.), while LOCs are specifically designed to perform integrated laboratory processes, often involving fluid handling. A LOC is a device that integrates one or more laboratory functions onto a single, compact chip, often using microfluidics to manipulate tiny volumes of fluids. The goal of a LOC is to miniaturize and automate complex laboratory processes for tasks such as chemical analysis, point-of-care diagnostics, and biological research. MEMS is the overarching technology and fabrication methodology, while LOC is a specific application or device type built using MEMS technology. In summary, all LOCs are essentially MEMS devices, but not all MEMS devices are LOCs. As presented, the instant invention is interpreted as a LOC with the ability to sense or actuate the whole blood by biomarkers in order to collect or separate the blood by biomarkers (while actively connected to a blood source/kit/system).
The term(s) “LOC”, “flow path”, “system”, “kit”, “collection”, “separation”, and “connected” in claim 1 are relative terms which renders the claim indefinite and/or open to the broadest reasonable interpretation. The term(s) “LOC”, “flow path”, “system”, “collection”, “separation”, and “connected” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Explicitly defining/incorporating the size, orientation, or topographic characteristic of the claimed technical components in instant claim 1 may help to limit the scope of the claim set in comparison to the prior art.
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) 1-20 rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention. The instant invention is anticipated by Cork et al. (US20050269251A1).
Regarding Claim 1, Cork et al. teaches a standardized, pumpless blood pack donation kit configured for use in whole blood donation and simultaneous use with a lab-on-a-chip device (See the Abstract, Claim 1, and the disposable one-time-use processing assembly or fluid circuit 104, i.e. a blood pack donation kit, embodying the MEMS cassette/carrier 96, i.e. a lab-on-a-chip "LOC", in [0075]-[0085] in Fig. 5; Also, see the discussion of using capillary connectors in in [0096]) for separation and collection of biomarkers without further hardware for blood processing (See how the whole blood is donated or collected from the donor 54 into the combined fluid circuit 104 and the MEMS cassette 96, i.e. a blood pack donation kit, to simultaneously separate, sense, and collect biomarkers in [See in [0060], [0083], [0088] in Fig. 1, 5, and 7A-B), wherein the kit comprises:
a) a blood collection container having a volume and at least one opening (See the storage container 110c, i.e. a blood collection container, in [0076] in Fig. 5);
b) a biomarker collection container having a volume and at least one opening (See the storage container 110f, i.e. a biomarker collection container, in [0080] in Fig. 5);
c) a first flow path having a first end connected to the opening in the blood collection container and a second end configured to be connected to a first outlet opening of a lab-on-a-chip device (See how the fluid connection 126, i.e. a first flow path, is connected to the storage container 110c, i.e. a blood collection container, and the MEMS cassette 96, i.e. a LOC, in [0085] in Fig. 5);
d) a second flow path having a first end connected to the opening in the biomarker collection container and a second end configured to be connected to a second outlet opening of the lab-on-a-chip device (See how the fluid connection 128, i.e. a second flow path, is connected to the storage container 110f, i.e. a biomarker collection container, and the MEMS cassette 96, i.e. a LOC, in [0085] in Fig. 5); and
e) a third flow path having a first end connected to a needle and a second end configured to be connected to an inlet opening of the lab on-a-chip device (See how the fluid connection 122, i.e. a third fluid flow path, is connected to the needles 116-117 at a first end, and the MEMS cassette 96, i.e. a LOC, at a second end in [0083], [0080] in Fig. 5).
Note what is discussed in MPEP § 2114 I-II. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The instant application recites the limitation “A standardized, pumpless blood pack donation kit configured for whole blood donation and simultaneous use with a lab-on-a-chip device for separation and collection of biomarkers without further hardware for other blood processing”, but fails to cover the structural components that execute said “separation or collection of biomarkers” or define how that the other apparatus components functions "standardized", "pumpless", or "without further hardware". Thus, claim(s) 1-20 are anticipated in view of the prior art.
Regarding Claim(s) 2-20, see the Rejection(s) cited in the Final Office Action mailed on 11/26/2025. Thus, Cork et al. still reads on the amended independent claim 1, and the amended dependent claim(s) 2-20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following prior arts disclose similar blood separation and collection systems, devices, and methods: Sage Jr. et al. (US20050209518A1), Mathias et al. (US20050148993A1), Kunnecke (US20120071788A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITNEY N WASHINGTON whose telephone number is (703)756-5959. The examiner can normally be reached Monday-Friday 7:00am - 3:30pm CT.
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/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797