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 Objections
Claims 1, 7, 11 and 17 are objected to because of the following informalities:
Claims 1, 7, 11 and 17 recite “digital holography images or videos,” but this should be digital holography images or digital holography videos to be more precise.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 (all claims) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of each of U.S. Application Nos. 18/542,154, 18/542,078, and 18/950,342 in view of the prior art as applied below.
This is a provisional nonstatutory double patenting rejection.
Both the pending claims and the conflicting applications are all directed to digital holography for microfluidics to determine how blood cells flow. Further, any differences between the present claims and the claims in any of the conflicting applications are obvious in view of the prior art as applied below. It would have been obvious to one of ordinary skill in the art, before the effective filing date, to combine the below prior art with any of the conflicting applications for implementation details (especially as the patent claims lack implementation details). Based on the findings herein, this is an example of “(A) Combining prior art elements according to known methods to yield predictable results.” MPEP 2143.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 (all claims) are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 11 recite quantifying and/or characterizing occlusion from “one or more digital holography images.” However, the specification only discloses determining occlusion by watching the flow (e.g., perfusion). Specification, [0039]. This requires more than just two images. One way to overcome this rejection is to limit the claim to video.
Claims 1 and 11 recite quantifying and/or characterizing occlusions but this is unlimited functional claiming because it is reciting a result rather than the steps/structure that accomplish this result. MPEP 2173.05(g).
Further, the specification relies on an unspecified “AI/ML model” to generate the occlusion status (while “Artificial Intelligence/Machine Learning” is explicitly recited in claims 7 and 17, this rejection applies to the independent claims as well). However, the specification does not demonstrate possession of the AI/ML model because, rather than providing sufficient details, there is no structure. Instead, the specification makes statements such as “The AI/ML module 114 may implement AI/ML algorithms to quantify occlusion formed within the one or more microfluidic channels 104.” Specification, [0065].
This is insufficient detail to demonstrate possession because it lacks details about the machine learning architecture (i.e., the computer vision technique), how the architecture was trained, and how the architecture performs.
In other words, the specification needs to provide enough detail to prove that the inventors either actually or constructively reduced this invention to practice – as opposed to simply having a desire for this to work. MPEP 2163(I) states “To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.”
Which architecture to use, how it was trained, and how it performs is so useful that it is traditionally provided in literature in this field.
Compare with the below articles that detail each of the training, architecture and performance (both are attached):
Kim J, Kim Y, Lee HS, Seo E, Lee SJ. Single-shot reconstruction of three-dimensional morphology of biological cells in digital holographic microscopy using a physics-driven neural network. Nature Communications. 2025 May 24;16(1):4840.
Mallery K, Bristow NR, Heller N, Travadi Y, Arafa A, Kamalanathan K, Galeano-Garces C, Ahmadi M, Schaap G, Hesch A, Hedeen O. Circulating tumor cell detection in cancer patients using in-flow deep learning holography. npj Biosensing. 2026 Apr 14;3(1):23.
Additionally, in order for claims 7 and 17 to narrow their parent claims, implicitly, the parent claims read on performing the claimed detecting occlusion without an Artificial Intelligence/Machine Learning module, but the specification does not disclose how this would occur.
Thus, the claims are rejected for lack of written description.
Dependent claims are likewise rejected.
Claims 1-20 (all claims) are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being arguably enabling for trivial implementations, does not reasonably provide enablement for more advanced techniques, such as three dimensional modeling or high levels of accuracy. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
MPEP 2164.06(a)(I) provides examples of enablement issues due to missing information for electrical and mechanical devices or processes. Here, the claimed inference is less predictable than other computer technologies, and thus the guidance from MPEP 2164.06(a)(I) applies here.
1) The claims are not limited to the level of performance that has been actually achieved. In other words, all future advances in inference are covered by this claim because the claim is written to encompass all models and all levels of performance. See the first paragraph of MPEP 2164.06(a)(I) discussing MagSil Corp. v. Hitachi Global Storage Technologies, Inc., 687 F.3d 1377, 103 USPQ2d 1769 (Fed. Cir. 2012) and Auto. Techs. Int'l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1283, 84 USPQ2d 1108, 1115 (Fed. Cir. 2007). Auto Techs. applies to the wide variety of models that could be used (e.g., if one were to use a vision transformer model instead of a convolutional neural network).
2) Neural networks are more complicated than electrical circuits, and thus if the disclosure for the neural networks in this application do not meet the requirements for electrical circuits, then they also fail to enable neural networks (i.e., the claimed inference). For example, the second and third paragraphs of MPEP 2164.06(a)(I) provide examples of applications (and patents) that were not enabling because they didn’t provide enough detail about how circuitry worked. Here, the same need applies for the neural network.
3) The last paragraph of MPEP 2164.06(a)(I) underscores the importance of adequate disclosure for “how complex components are constructed.” There is insufficient guidance on how the wide variety of neural networks architectures would be adapted to the claimed solution.
Summarizing the above in terms of the Wands factors:
(A) The breadth of the claims; – the claims cover all methods of inference, which is very broad
(B) The nature of the invention; – not a significant factor
(C) The state of the prior art; – not a significant factor
(D) The level of one of ordinary skill; – not a significant factor
(E) The level of predictability in the art; – neural networks are less predictable than traditional software. For example, one needs to build and train a neural network to determine how well it will perform.
(F) The amount of direction provided by the inventor; – there is scant direction provided
(G) The existence of working examples; and – there are no working examples
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. – There is not enough guidance to determine how much experimentation is needed for a given model at a non-trivial level of performance. This lack of guidance is compounded because the claim extends to a wide range of different models, and increasing performance requires increasing experimentation for each type of model.
Taking all of the factors together, an unreasonable amount of experimentation is required to reduce to practice a representative number of species for each of the types of models, particularly for top scoring performance.
Dependent claims are likewise rejected.
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 1-20 (all claims) 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 1 recites “an occlusion device comprising one or more microfluidic channels,” however, occlusion devices are not understood to have microfluidic channels. “Occlusion device” is not defined by the specification. Fig. 4A is described as showing an occlusion device, but the examiner (who is specialized in image analysis, not medical devices) does not recognize it. https://evtoday.com/device-guide/us/occlusion-devices (attached) provides a list of occlusion devices, but these appear to be devices for surgical insertion into the body (where digital holography is blocked by the body). Is the intent that the microfluidic channel itself is the occlusion device because it slows the passage of blood or other fluid?
Claim 10 recites “at least one user device,” but it is unclear if the user device is part of the claimed system or not.
Claim 11 recites “allowing,” but this lacks a precise meaning. For example, if a supervisor does not prohibit use of microfluidics in a lab, is that allowing the sample to flow? Additionally, the claim implies that “allowing” means that the blood actually flows (e.g., “blood cells transiting”), but allowing the cells to flow does not require any affirmative action.
Dependent claims are likewise rejected.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4 and 14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 4 and 14 fail to further limit because a microfluidic channel necessarily has an inlet and an outlet (i.e., a “channel”).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-20 (all claims) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grigorev GV, Lebedev AV, Wang X, Qian X, Maksimov GV, Lin L. Advances in microfluidics for single red blood cell analysis. Biosensors. 2023 Jan 9;13(1):117. (“Grigorev”)
1. A system comprising:
an occlusion device comprising one or more microfluidic channels with a predefined cross-sectional area, wherein the one or more microfluidic channels are configured to allow flow of plurality of blood cells of a blood sample within an interior surface of the one or more microfluidic channels; (Grigorev, title, “Advances in Microfluidics for Single Red Blood Cell Analysis”)
at least one imager configured to generate one or more digital holography images or videos of the plurality of blood cells transiting the one or more microfluidic channels; and (Grigorev, Fig. 3, “RBC tomographic flow cytometry by the digital holography.”)
at least one processor operationally coupled to the at least one imager and configured to:
receive the one or more digital holography images or videos; and (Grigorev, Fig. 3, “RBC tomographic flow cytometry by the digital holography.”)
analyze the generated one or more digital holography images or videos to quantify or characterize occlusions formed within the one or more microfluidic channels. (Grigorev, Fig. 2 and caption “(C) Hydrodynamic RBC deformation by quantitative phase microscopy and Zernike polynomials: the principle, experimental results and simulation photos of RBC stretching under the fluidic flow and without the fluidic flow [29]. (D) Schematic diagram of the quantitative phase microscopy of RBCs during planar trapping and propulsion [30].” Section 2.1 teaches that the quantitative phase imaging is done with holography.)
2. The system of claim 1, wherein the predefined cross-sectional area of the one or more microfluidic channels corresponds to cross-sectional area of small blood vessels. (Grigorev, Fig. 2 captioned “(A) Microvasculature on a chip: the study of RBCs, microfluidic network, and confocal images of RBCs in a channel”)
3. The system of claim 1, wherein the interior surface of the one or more microfluidic channels is coated with a plurality of endothelial cells. (Grigorev, Fig. 13, caption “Figure 13. (A) Endothelium-on-a-chip for probing the RBC adhesion to heme-activated endothelial cells to reflect clinical phenotype in sickle cell disease”)
4. The system of claim 1, wherein the one or more microfluidic channels comprises at least one inlet and an outlet. (Grigorev, Fig. 5)
5. The system of claim 4, wherein the at least one inlet receives the blood sample and the outlet allows to discharge the plurality of blood cells through the one or more microfluidic channels. (Grigorev, Fig. 5)
6. The system of claim 1, wherein a lensless in-line digital holography configuration is used for imaging. (Grigorev, Fig. 3, “RBC tomographic flow cytometry by the digital holography.” Grigorev’s digital holography teaches the claimed lensless in-line because lensless in-line digital holography is the default type of digital holography. MPEP 2131.02(III).)
7. The system of claim 1, wherein the at least one processor is configured to analyze the generated one or more digital holography images or videos using Artificial Intelligence/Machine Learning module to detect presence of occluded channels within the one or more microfluidic channels. (Grigorev, section 2.1, “Artificial intelligence algorithms and machine learning approaches impact the system architecture improving measurement accuracy becoming the focus in 3D QPI systems” Note that the mapping of claim 1 refers to this same QPI for the occlusion analysis.)
8. The system of claim 7, wherein to quantify or characterize occlusions of the occluded channels within the one or more microfluidic channels includes generating a score or relative indicator of a health status or indicating an efficacy of a medical treatment of a user based on a severity of a hematologic disease in the plurality of blood cells. (Grigorev, abstract, “microfluidic platforms for microscopic/tomographic/spectroscopic single RBC analyses, trapping arrays (including bifurcating channels), dielectrophoretic and agglutination/aggregation studies, as well as clinical implications covering cancer, sepsis, prenatal, and Sickle Cell diseases.”)
9. The system of claim 1, wherein the plurality of blood cells are unstained and untagged. (Grigorev, section 4, “fresh RBC units.” Grigorev’s fresh red blood cells teach the claimed unstained and untagged because staining and tagging happen in a lab as opposed to blood that is fresh from a person.)
10. The system of claim 8, wherein at least one user device is configured to receive a report related to the health status. (Grigorev, section 2.3 title, “2.3. Smartphone-Based Analysis of Single RBCs”)
Claims 11-20 are rejected as per their counterpart claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID ORANGE whose telephone number is (571)270-1799. The examiner can normally be reached Mon-Fri, 9-5.
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/DAVID ORANGE/Primary Examiner, Art Unit 2663
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