DETAILED ACTION
In application filed on 04/27/2023, Claims 1-19 are pending. The claim set submitted on 03/13/2026 is considered because this is the most recent claim set. Claims 11-19 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/22/2023 and 03/09/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election of Group II in the reply filed on 03/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim.
Group I, Claims 11-19 are considered on the merits below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. All claims are directed to statutory categories, i.e., a method (Claim 14) (Step 1: YES).
Analysis:
Claim 14: Ineligible.
Step 1:
The claim recites a series of steps or acts, including “comparing the platelet and fibrin deposition before adding the target drug with the measured platelet and fibrin deposition after adding the target drug”. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1: YES).
Step 2A, Prong 1:
Claim 14 recites “comparing the platelet and fibrin deposition before adding the target drug with the measured platelet and fibrin deposition after adding the target drug”. Therefore, the claim is directed towards an abstract idea, and more specifically to the abstract idea group of a math or mental process since claim 14 relates to using a math or mental process to “compare the platelet and fibrin deposition before adding the target drug with the measured platelet and fibrin deposition after adding the target drug”. (Step 2A, Prong 1: YES).
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claim recites ‘additional elements’ which are the steps performed before and after the recited abstract ideas. However, the steps before the abstract ideas are performed in order to gather data necessary to perform the determination step. Thus, these steps do not add a meaningful limitation since these steps are insignificant pre-solution activity.
In addition, it appears that the steps of “measuring platelet and fibrin deposition before adding the target drug” are recited at a high level of generality that they amount to mere data gathering (insignificant extra-solution activity). See MPEP 2106.05(g).
Further, all of the recited structures: “platelet”, “fibrin” and target drug” (Claim 13); and “an endothelial cell”, “hydrogel” and “a device comprising a plurality of channels comprising an intravascular channel, an extravascular channel, and a vessel wall channel” (Claim 11) appears not to be particular machines. See MPEP 2106.05(b). They are used to gather data that is ultimately used in the comparison.
Accordingly, these steps are ‘additional elements’ which do not integrate the abstract ideas into a practical application. Therefore these ‘additional elements’ of claims 11 and 13 do not integrate the abstract ideas (the determining step) into a practical application because they do not impose meaningful limits on practicing the abstract ideas (Step 2A, Prong Two: NO).
Step 2B:
Furthermore, the courts have found that limitations adding insignificant extrasolution activity to the judicial exception, such as mere data gathering in conjunction with a law of nature or abstract idea, are limitations found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception (see the 2014 Interim Guidance on Patent Subject Matter Eligibility of the Federal Register dated December 16, 2014; and MPEP 2106.05(I)(A)). Note that mere data gathering is not significantly more than the abstract idea. See MPEP 2106.05(g).
Here, there are no additional elements which are significantly more than the abstract idea.
The steps of “measuring platelet and fibrin deposition before adding the target drug” (Claim 13); “seeding an endothelial cell in a hydrogel using a device …”; “culturing the endothelial cell by adding culture medium…”; “forming an endothelial monolayer in the vessel wall channel”; and “adding a target drug into the culture medium” and “measuring platelet deposition” (Claim 11) appears to be well-understood, routine, and conventional (WURC) in the field of Organ-ON-A-CHIP models, then the claims do not amount to significantly more (Step 2B: NO).
Therefore, Claim 14 is ineligible.
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.
Claims 11-19 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Sakurai et al. ("A microengineered vascularized bleeding model that integrates the principal components of hemostasis." Nature communications 9.1 (2018): 509.).
Regarding 11, Sakurai teaches a method for drug screening, comprising:
seeding an endothelial cell (See Page 2, Results… seeded with human umbilical cord vein or aortic endothelial cells, thereby teaching “seeding an endothelial cell”) in a hydrogel (See page 2, Results…collagen type 1) using a device (referred to as the polydimethylsiloxane (PDMS)-based microfluidic bleeding time device [Page 2, Results, Fig. 1a]) comprising a plurality of channels (See Page 8…All the microchannels (vascular, outlet, and valve)) comprising an intravascular channel (See Page 4, 6…any one of the vascular microchannels; Under BRI, Examiner interprets the vascular microchannels as “at least 2 vascular microchannels”), an extravascular channel (See Page 4, 6…any one of the vascular microchannels; Under BRI, Examiner interprets the vascular microchannels as “at least 2 vascular microchannels”), and a vessel wall channel (referred to as endothelialized vascular channel [Results, Page 2]; Also (See Page 4, 6…any one of the vascular microchannels; Under BRI, Examiner interprets the vascular microchannels as “at least 2 vascular microchannels”), wherein the hydrogel (‘collagen’) is located (See Page 4…collagen-coated microchannels) in the vessel wall channel (referred to as endothelialized vascular channel [Results, Page 2]); See Page 8… All the microchannels (vascular,outlet, and valve) of pre-vacuumed devices were infused with collagen type 1 (BD,1mgml−1),) and comprises tissue factor (See Page 6…vascular microchannels were precoated with 1 nM of TF and collagen)
culturing the endothelial cell by adding culture medium (‘growth media/fresh media’) (See Page 8 for the steps of Endothelialization of the microfluidic device …using the growth media/fresh media for incubating the HUVECs or HAECs (Lonza)… cell growth media was connected and media was perfused into the vascular channel using a syringe pump (PhD Ultra, Harvard Apparatus) at shear rates of 500 or 2500 s−1 until cells grew to confluence.) to the intravascular channel and the extravascular channel (See Page 8, Endothelialization of the microfluidic device …only the vascular channel was infused with fibronectin (Sigma-Aldrich, 50 μgml−1) before HUVECs or HAECs (Lonza) were seeded at a concentration of 10 million cells ml−1 in 8% Dextran (Sigma-Aldrich) in their growth media (EGM-2, Lonza); (See Page 4, 6…any one of the vascular microchannels; Under BRI, Examiner interprets the vascular microchannels as “at least 2 vascular microchannels”))
forming an endothelial monolayer in the vessel wall channel (See Results, Page 2… as endothelialized vascular channel, thereby teaching “forming an endothelial monolayer in the vessel wall channel”);
adding a target drug (See Page 4… eptifibatide-treated blood samples (Fig. 2a).) into the culture medium (See Page 8, Mechanical induction of vascular injury and bleeding assay … Whole blood collected in sodium citrate buffer (BD) and treated with CTI (40 μgml−1, Haematologic Technologies) was conditioned and recalcified before the experiments and perfused into the channel using a syringe pump at shear rates of 500 or 2500 s−1; Examiner submits that the eptifibatide-treated blood samples is perfused in to channel which is already perfused with the cell growth media during the Endothelialization of the microfluidic device ); and
measuring platelet deposition (See Fig. 2a-c, Page 4, Visualizing hemostasis under altered microenvironments. … platelet aggregation and contraction of those aggregates, as shown via saturated platelet fluorescence; See Page 5, Fig. 2…measuring the areas of saturated intensity of fluorescently labeled platelets over time).
Regarding 12, Sakurai teaches measuring fibrin deposition (See Page 4; Fig. 1-2… fibrinogen/fibrin accumulation (fluorescent tagged fibrinogen, green); See Fig. 2g…plotted against the pixel intensity of the green channel (y axis), corresponding to fibrin(ogen), of each pixel in the respective image; See Fig. 5 for fibrinogen/fibrin accumulation).
Regarding 13, Sakurai teaches measuring platelet and fibrin deposition before adding the target drug (See Page 2; Fig. 2. Fig. 5… “control” conditions for measuring platelet and fibrin deposition; Also see Page 4… There was no significant difference in bleeding time between eptifibatide-treated and vehicle control blood samples (Fig. 2a)…. platelet aggregation and contraction of those aggregates, as shown via saturated platelet fluorescence, was more pronounced in control blood than in eptifibatide-treated blood; See Fig. 2, Page 4… Higher magnification visualization of the bleeding site revealed clear co-localization of fibrin(ogen) with platelets in control conditions but not in the eptifibatide-treated condition).
Regarding 14, Sakurai teaches comparing (See Fig. 2…comparing Pearson correlation coefficients between healthy control and eptifibatide-treated samples; See Page 4… Higher magnification visualization of the bleeding site revealed clear co-localization of fibrin(ogen) with platelets in control conditions but not in the eptifibatide-treated condition (Fig. 2e)… There was no significant difference in bleeding time between eptifibatidetreated and vehicle control blood samples) the platelet and fibrin deposition before adding the target drug (See Page 2… we first characterized various aspects of bleeding and hemostasis in our “control” conditions) with the measured platelet and fibrin deposition after adding the target drug (See Fig. 2; Page 4… platelet aggregation and contraction of those aggregates, as shown via saturated platelet fluorescence, was more pronounced in control blood than in eptifibatide-treated blood; See Fig. 2, Page 4… Higher magnification visualization of the bleeding site revealed clear co-localization of fibrin(ogen) with platelets in control conditions but not in the eptifibatide-treated condition).
Regarding 15, Sakurai teaches that the target drug is selected from the group consisting of an anticoagulant drug, an antiplatelet drug, and a combination thereof (See Page 2… the anti-platelet agent eptifibatide predominantly affects hemostatic plug formation via attenuation of platelet aggregate density and clot contraction).
Regarding 16, Sakurai teaches that the endothelial cell is HUVEC (See Page 2… confluent human umbilical vein endothelial cells (HUVECs)).
Regarding 17, Sakurai teaches that the target drug (See Page 4…using healthy human blood was treated with 10 μgml−1 eptifibatide) is added through an inlet port (See Page 8…inlet holes) of the device (See Page 8… Whole blood collected in sodium citrate buffer (BD) and treated with CTI (40 μgml−1, Haematologic Technologies) was conditioned and recalcified before the experiments and perfused into the channel using a syringe pump at shear rates of 500 or 2500 s−1).
Regarding 18, Sakurai teaches that the hydrogel (See page 2, Results…collagen type 1) is a collagen hydrogel (See page 2, Results…collagen type 1).
Regarding 19, Sakurai teaches generating puncture injury (See Page 2… vascular “injury” is introduced by providing positive fluidic pressure through and into the vascular channel and layer,) on the endothelial monolayer (See Page2… surface of endothelial cells at the site of vascular injury).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
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