Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-9 are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Gossett, D.R. et al. “Deformabitly Cytometry: High-throughput, Continuous Measurement of Cell Mechanical Properties in Extension flow”, 14th International Conference on Miniaturized Systems for Chemistry and Life Science 3-7 October 2010, Groningen, The Netherlands, 1382-1384.
Regarding claim 1, Gossett discloses a system (Fig. 1a-1e) for deforming a plurality of particles carried in a sample volume, the system comprising:
a reusable substrate (see 1a, 1e. regarding the reusable limitation, this limitation does not further structurally limit the substrate because there is not structure that is related to being reusable. Reusable is drawn to a process/intended use and there is no structure that differentiates from the prior art with respect to being reusable) defining an inlet (fig. 1b, left side inlet or right side inlet), configured to receive the sample volume (this limitation does not further structurally limit the instant claims as the sample volume is not positively claimed and can be added to the inlet at a later time), and an outlet (fig. 1a 1b, top or bottom outlet from deformation and measurement region), wherein the inlet or outlet is configured to couple to a module to introduce or collect a washing or a flushing solution (this limitation does not further structurally limit the instant claim as there is not structure associated with the coupling of the substrate to a module. The outlet is capable of being connected to a collection device and the inlets are capable of being connected to a feeding conduit as shown in fig. 1a, 1e);
a fluidic pathway (any number of channels that are shown in fig. 1a-1e, that is capable of passing a fluid) disposed in the reusable substrate and fluidically coupled to the inlet and the outlet and comprising:
a delivery region (inertial focusers as seen in fig. 1a) fluidically coupled to the inlet and configured to focus the plurality of particles along at least one streamline (there is no structure related to what focus the plurality of particles. The broadest reasonable interpretation is a straight channel with a length. Fig. 1a shows a series of rising peaks within the delivery region); and
a deformation region (fig. 1b) located downstream with respect to the delivery region (inertial focusers) and formed by an intersection of the fluidic pathway and an opposing inlet channel (four channels converge, two inlets and two outlets), wherein flow of a fluid from the opposing inlet channel at the intersection mechanically deforms the plurality of particles passing through the deformation region (this limitation does not further structurally limit the instant claim as the flow of a fluid is not positively recited and application has not positively claimed for example a second inlet to the deformation that is opposite the first inlet).
Regarding claim 2, the system of claim 1, wherein the reusable substrate is configured for washing and reuse (this limitation does not further structurally limit the instant claims as it is directed to a process/intended use limitation).
Regarding claim 3, the system of claim 2, wherein the reusable substrate is self-washing (this limitation does not further structurally limit the instant claims as it is directed to a process/intended use limitation).
Regarding claim 4, the system of claim 1, wherein the reusable substrate is reusable for a plurality of uses and is configured to be replaceable (this limitation does not further structurally limit the instant claims as it is directed to a process/intended use limitation. Further there is no structure that differentiates from the prior art with respect to being reusable).
Regarding claim 5, the system of claim 4, wherein the reusable substrate comprises aligners (see fig. 1e which has corners that are broadly interpreted as aligners as it provides a reference to the detector for alignment purposes) that align the reusable substrate relative to a detection module configured to capture a morphology dataset comprising multiple positions and/or deformations of the plurality of particles upstream and downstream of the deformation region (A detection module is not positively recited in the instant claims as it can be connected to the substrate at a later time. Further the process/intended use limitation doe not further structurally limit the instant claims with respect to detecting particles as the detection module is not positively recited).
Regarding claim 6, the system of claim 4, wherein the system is configured to be reusable for a certain number of uses (this limitation does not further structurally limit the instant claims as it is directed to a process/intended use limitation. Further there is no structure that differentiates from the prior art with respect to being reusable).
Regarding claim 7, the system of claim 4, wherein the system is configured it be reusable until failure by clogging (this limitation does not further structurally limit the instant claims as it is directed to a process/intended use limitation. Further there is no structure that differentiates from the prior art with respect to being reusable until failure by clogging).
Regarding claim 8, Gossett discloses a method of using the system of claim 1, comprising:
introducing a first sample volume into the inlet and mechanically deforming the plurality of particles therein (a first sample is introduced into the device as shown in fig. 1a);
introducing the washing or the flushing solution into the inlet or outlet from the module (a module as recited in claim 1 is not positively recited as part of the system. The system as recited in claim 1 comprises a substrate and a fluidic pathway with a delivery region and a deformation region. The system of claim 1 only requires that the system be capable of connecting to a module. Gossett is provided with various inlets and outlets that are capable of connecting to modules for input or collecting various fluids from the system);
introducing one or more additional sample volumes into the inlet and mechanically deforming the plurality of particles therein (see fig. 1a-1e), wherein the washing or the flushing solution is introduced into the inlet or outlet from the module prior to the one or more additional sample volumes being introduced into the inlet (A first sample is inputted into the system and a detection of deformation is recorded. A second sample test introduced after the first sample is run broadly reads on this limitation as the washing or flushing solution is not defined as being different that a sample fluid).
Regarding claim 9, the method of claim 8 comprising replacing the reusable substrate with another reusable substrate and introducing another sample volume into the inlet and mechanically deforming the plurality of particles therein (A first sample is inputted into the system and a detection of deformation is recorded. A second sample test introduced after the first sample is run broadly reads on this limitation as the washing or flushing solution is not defined as being different that a sample fluid).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,969,327. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader than US 10,969,327 and therefore are fully encompassed by the claims.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,295,455. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader than US 10,295,455 and therefore are fully encompassed by the claims.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,107,735. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader than US 10,107,735 and therefore are fully encompassed by the claims.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,464,977. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader than US 9,464,977 and therefore are fully encompassed by the claims.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,151,705. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader than US 9,151,705 and therefore are fully encompassed by the claims.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,638,620. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader than US 9,638,620 and therefore are fully encompassed by the claims.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,007,321. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader than US 12,007,321 and therefore are fully encompassed by the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday-Friday 8-5.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758
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