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 .
Applicant’s filing of claims 1-20 on 12/15/23 is acknowledged. Claims 1-20 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/6/24 and 11/30/25 were acknowledged. Accordingly, the information disclosure statements are being considered by the examiner.
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 7-10, 16 and 17 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.
Claim 7 is rejected because it claims a process, e.g., “using” in a system claim, which is an apparatus-type of claim. Thus, it is unclear how the “using” step structurally further defines the claimed system. For examination purposes, the claim language will be given the appropriate weight and interpreted as functional claim language.
Claim 8 is rejected because it is unclear how the claim language, “a quantification of the plurality of RBCs adhered is configured to generate a score or relative indicator of a user's health status or indicate an efficacy of a medical treatment” structurally further defines the claimed invention. For examination purposes, the Office will interpret the claim language as intended use or functional claim language.
Claim 9 is rejected because it is unclear how the claim language, “the plurality of diseased RBCs are unstained, untagged and unmodified,” structurally further defines the claimed invention. For examination purposes, the Office will interpret the claim language as intended use or functional claim language.
Claim 10 is rejected because it is unclear how the claim language structurally further defines the claimed invention. For examination purposes, the Office will interpret the claim language as intended use or functional claim language.
Claims 16 and 17 are rejected for indefiniteness because each claim merely recites a use, e.g., “uses” or “using,” without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05(q).
Claim Interpretation
The Office asserts that terms and phrases like “configured to” and “wherein” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “configured to” language, the claim language that follows such recitations does not necessarily denote structure MPEP 2173.05(g). The functional limitation was evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. Similarly, a “wherein” clause may have a limiting effect on a claim if the language limits the claim to a particular structure. MPEP 2111.04. The determination of whether a “wherein” clause is a limitation in a claim depends on the specific facts of the case. While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
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.
Claims 1 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gusyatin (Us Pub. No. 2019/0011882).
As to claim 1, Gusyatin discloses a system comprising: a device comprising one or more microfluidic channels (e.g., [0056] et seq.) configured to adhere a plurality of diseased red blood cells (RBCs) of a blood sample on an interior surface of the one or more microfluidic channels (e.g., [0009] et seq.); at least one imager (e.g., optoelectronic sensor array in [0007] et seq.) configured to generate one or more digital holography images or videos of the plurality of diseased RBCs adhered to the interior surface of the one or more microfluidic channels; and at least one processor (controller 622 and/or one of the computing devices indicated in [0093] et seq.) operationally coupled to the at least one imager and configured to: receive the one or more digital holography images or videos; and analyze the generated one or more digital holography images or videos to quantify adhesion of the plurality of diseased RBCs to the interior surface of the one or more microfluidic channels. See e.g., [0012] et seq., and claim interpretation above.
As to claim 6, Gusyatin discloses the at least one imager uses a lensless in-line digital holography configuration to generate the one or more digital holography images or videos. See [0012] et seq.
As to claim 7, Gusyatin discloses the at least one processor is configured to analyze the generated one or more digital holography images or videos using an Artificial Intelligence/Machine Learning (AI/ML) module to determine a number of adhered RBCs of the plurality of diseased RBCs on the interior surface of the one or more microfluidic channels. See [0012] et seq. For the “configured to” claim language, see above.
As to claim 8, Gusyatin discloses a quantification of the plurality of RBCs adhered is configured to generate a score or relative indicator of a user's health status or indicate an efficacy of a medical treatment. See e.g., [0101] et seq. and claim interpretation above.
As to claim 9, Gusyatin discloses the plurality of diseased RBCs are unstained, untagged and unmodified. See e.g., [0009] et seq. See claim interpretation above.
As to claim 10, Gusyatin discloses at least one user device is configured to receive the quantified adhesion of the plurality of diseased RBCs to display a report related to the user's health status. See e.g., [0095] et seq. and claim interpretation above.
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.
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Gusyatin in view of Levner et al. (“Levner,” US Pub. No. 2018/0017586).
See Gusyatin above.
As to claims 2-3, Gusyatin does not specifically disclose the channels are coated with a coating such as laminin. Levner discloses in [0047], the microchannel (or portion thereof) or membrane can be coated with substances such as various cell adhesion promoting substances or ECM proteins, such as fibronectin, laminin or various collagen types or combinations thereof. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to coat the channels with laminin because it would be desirable to utilize a coating that promotes cell adhesion for particular substances ([0047] of Levner).
As to claims 4-5, Gusyatin does not specifically disclose two inlets and an outlet. Levner discloses in fig. 2, for example, multiple inlets (211, 219, 217) and multiple outlets (215, 221) in [0131] et seq. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include multiple inlets to allow different samples to be tested simultaneously, and to include an outlet to dispose of the samples after analysis. The purpose of the inlets and outlet are considered intended use, see claim interpretation above.
Claims 11 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gusyatin in view of Masaeli et al. (“Masaeli,” US Pub. No. 2020/0231927).
See Gusyatin above.
As to claim 11, Gusyatin teaches method comprising: adhering a plurality of blood samples on an interior surface of one or more microfluidic channels; generating, via at least one imager, one or more digital holography images or videos of the plurality of RBCs adhered to the interior surface of the one or more microfluidic channels; and analyzing, via at least one processor, the generated one or more digital holography images or videos to quantify adhesion of the plurality of RBCs to the interior surface of the one or more microfluidic channels. See e.g., [0007] et seq.
Regarding claim 11, Gusyatin does not specifically teach diseased RBCs. Masaeli teaches system and methods disclosed herein are used to measure the count of fetal nucleated red blood cells (RBCs), wherein an increase in fetal nucleated RBC count indicates the presence of fetal aneuploidy in [0171]. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to analyze diseased RBCs because it would help allow for early detection of a disease in a subject.
As to claim 16, the combination of Gusyatin and Masaeli teach the at least one imager uses a lensless in-line digital holography configuration to generate the one or more digital holography images or videos. See [0012] et seq. of Gusyatin.
As to claim 17, the combination of Gusyatin and Masaeli teach analyzing, via the at least one processor, the generated one or more digital holography images or videos using an Artificial Intelligence/Machine Learning (AI/ML) module to determine a number of adhered RBCs of the plurality of diseased RBCs on the interior surface of the one or more microfluidic channels. See e.g., [0012] et seq. of Gusyatin and [0132] of Masaeli. For the “configured to” claim language, see above. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include artificial intelligence because it would provide an enhanced analysis support for analyzing the blood samples.
As to claim 18, the combination of Gusyatin and Masaeli teach a quantification of the plurality of diseased RBCs adhered is configured to generate a score or relative indicator of a user's health status or indicate an efficacy of a medical treatment. See e.g., [0162] et seq. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to analyze quantify the diseased RBCs because it would help allow for early detection of a disease in a subject.
As to claim 19, the combination of Gusyatin and Masaeli teach the plurality of diseased RBCs are unstained, untagged, and unmodified. See e.g., [0171] et seq. of Masaeli. For motivation statement, see above.
As to claim 20, the combination of Gusyatin and Masaeli teach transmitting, to at least one user device, the quantified adhesion of the plurality of diseased RBCs to display a report related to the user's health status. See e.g., [0008] et seq. of Gusyatin and [0220] et seq. of Masaeli. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to transmit the data to the user because it would help allow for early detection of a disease in a subject.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gusyatin in view of Masaeli, as applied to claim 11 above, and further in view of Levner.
See Gusyatin, Masaeli and Levner above.
As to claims 12-13, the combination of Gusyatin, Masaeli and Levner teach the interior surface of the one or more microfluidic channels is coated with a coating such as laminin to cause the plurality of diseased RBCs to adhere to the interior surface of the one or more microfluidic channels. See [0171] of Masaeli and [0047] of Levner. For motivation statement, see above.
As to claims 14-15, the combination of Gusyatin, Masaeli and Levner teach the at least two inlets receives the blood sample and the outlet allows to discharge the plurality of diseased RBCs that are not adhered to the interior surface of the one or more microfluidic channels.. See [0171] of Masaeli and [0131] of Levner. For motivation statement, see above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
7/8/2026
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