DETAILED 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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-9 in the reply filed on 01/17/2026 is acknowledged. Claims 10-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected election, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/17/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/27/2023, 04/10/2023, 08/06/2024, 11/07/2024, 08/22/2025 and 09/05/2025 and 02/20/2026 are being considered by the examiner.
Claim Rejections - 35 USC § 102
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 1-4 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holm et al. (“Simplifying microfluidic separation devices towards field-detection of blood parasites.” Anal. Methods, 2016, 8, 3291)(provided in the Applicant’s IDS of 08/22/2025).
Regarding claim 1, Holm teaches a diagnostic chip, comprising:
one or more inputs (inlet)(Fig. 3B), wherein a sample containing differently sized particles is introduced into at least one of said one or more inputs (interpreted as an intended use. the sample is not positively recited. The input meets the structural limitation of the intended use. Furthermore, for the purpose of compact prosecution, Fig. 3, the sample has leukocytes, erythrocytes and T. cyclops); and
a plurality of separation regions (sections 1, 2, 3 in Fig. 3B), wherein said sample is pressurized as it passes through said plurality of separation regions (p. 3292, “Device design”, flow is driven by a syringe), wherein each of said plurality of separation regions comprises a deterministic lateral displacement array (p. 3292, “Device design”, 3 DLD arrays in series), wherein said deterministic lateral displacement array in two or more of said plurality of separation regions has a different etch depth profile (Fig. 3 and p. 3292, “Device design”, three DLD arrays in series, each with its own depth. “etch” is interpreted as an intended use. The array meet the structural limitation the intended use. Moreover, the pillar array fabrication involves a step of etching that gives the depth as describes in p. 3292, “Device design”).
Regarding claim 2, Holm teaches all of the elements of the current invention as stated above with respect to claim 1. Holm further teaches wherein pillars in said deterministic lateral displacement array (pillars are being interpreted as an inherent characteristic of DLD) are fabricated using metal assisted chemical etching (Applicant is advised that this is a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. MPEP § 2113. The Examiner interprets “fabricated using metal assisted chemical etching” is any step in the process of fabricating the pillars. Since the end result of the pillars of the claimed invention does not appear to be different from the product of Holm, which uses of photo etching (p. 3292, “Device design”) instead of metal assisted chemical etching in creating the silicon master for fabricating the pillars, do not appear to have an effect on the final product and so this part of the claim is interpreted as a product-by-process limitation. The Applicant is advised that the limitation “fabricated using metal assisted chemical etching” is a product-by-process limitation. There is no apparent difference between the apparatus as claimed and the prior art as taught by Holm).
Regarding claim 3, Holm teaches all of the elements of the current invention as stated above with respect to claim 1. Holm further teaches wherein pillars in said deterministic lateral displacement array are fabricated using nanoimprint lithography (Applicant is advised that this is a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. MPEP § 2113. The Examiner interprets “nanoimprint lithography” is any step in the in process of fabricating the pillars. Since the end result of the pillars of the claimed invention does not appear to be different from the product of Holm, which uses of UV-lithography (p. 3292, “Device design”) instead of nanoimprint lithography in creating the silicon master for fabricating the pillars, do not appear to have an effect on the final product and so this part of the claim is interpreted as a product-by-process limitation. The Applicant is advised that the limitation “fabricated using nanoimprint lithography” is a product-by-process limitation. There is no apparent difference between the apparatus as claimed and the prior art as taught by Holm).
Regarding claim 4, Holm teaches all of the elements of the current invention as stated above with respect to claim 1. Holm further teaches wherein said deterministic lateral displacement array is used for particle separation (interpreted as an intended use. The deterministic lateral displacement array meets the structural limitation of the intended use. Moreover, Holm’s DLD arrays are used for separation blood cells and parasites in blood, Fig. 3).
Regarding claim 6, Holm teaches all of the elements of the current invention as stated above with respect to claim 1. Holm further teaches wherein pillars in said deterministic lateral displacement array are created using metal assisted chemical etching and silicon oxidation (Applicant is advised that this is a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. MPEP § 2113. The Examiner interprets “fabricated using metal assisted chemical etching” is any step in the in process of fabricating the pillars. Since the end result of the pillars of the claimed invention does not appear to be different from the product of Holm, which uses of photo etching (p. 3292, “Device design”) instead of metal assisted chemical etching and silicon oxidation in creating the silicon master for fabricating the pillars, do not appear to have an effect on the final product and so this part of the claim is interpreted as a product-by-process limitation. The Applicant is advised that the limitation “fabricated using metal assisted chemical etching and silicon oxidation” is a product-by-process limitation. There is no apparent difference between the apparatus as claimed and the prior art as taught by Holm).
Regarding claim 7, Holm teaches all of the elements of the current invention as stated above with respect to claim 1. Holm further teaches wherein the pillars in said deterministic lateral displacement (DLD) array have a diameter-to-pitch ratio of greater than 0.8 (the examiner interprets the ratio of “0.8” in the limitation encompasses 0.79; and p. 3239, top left para. and Fig. 5D teaches the pillars in Section 3 has a diameter-to-pitch ratio of 0.8, and thus meets this limitation.)(Calculation note: p. 3239, posts with a diameter of 8 mm and a 2 mm gap, and thus the ratio of the diameter of a pillar 8 mm and the pitch the center-to-center distance between two adjacent pillars 8 mm + 2 mm = 10 mm is 0.8), and wherein said pillars are designed to prevent clogging of particles in said sample (interpreted as an intended use. The pillars meets the diameter-to-pitch ratio meet the structural limitation of this claim).
Regarding claim 8, Holm teaches all of the elements of the current invention as stated above with respect to claim 1. Holm further teaches the chip further comprises: a side-barrier array (the row of pillars in section 1 most adjacent to section 2, see Fig. 5E) (“side-barrier” is interpreted as intended use, the row of pillars meets the structural limitation of the intended use) within said deterministic lateral displacement array for particle separation (p. 3292, “Device design” pillars in section 1 are for particle separation).
Regarding claim 9, Holm teaches all of the elements of the current invention as stated above with respect to claim 1. With respect to the limitation, “wherein said sample comprises one of the following: blood, serum, saliva and urine,” the sample is not positively recited. Since the limitation is directed to the sample, the limitation does not further limit the structure of the invention. However, for purpose of compact prosecution, the device of Holm includes samples comprising blood (abstract).
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Holm et al. (“Simplifying microfluidic separation devices towards field-detection of blood parasites.” Anal. Methods, 2016, 8, 3291)(provided in the Applicant’s IDS of 08/22/2025).
Regarding claim 7, if it is determined that the limitation is not anticipated by Holm above, then the following obviousness rejection is put forth.
Holm teaches “diameter-to-pitch ratio” is a result-effective variable. Specifically, Holm teaches a critical size is a result-effective variable because the particle sizes that get sorted/filtered in a DLD array is determined by the critical size. Holm further teaches the critical size is dependent on gap distance between two adjunction pillars (p. 3292, under “Deterministic lateral displacement”), the sum of the gap distance and the diameter of the pillar is the pitch. Since the critical size is dependent on the pitch, the “diameter-to-pitch ratio” is also a result-effective variable. Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modified the diameter-to-pitch ratio to greater than 0.8 in order to adjust the critical size of the DLD to filter particles of other sizes because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Holm et al. (“Simplifying microfluidic separation devices towards field-detection of blood parasites.” Anal. Methods, 2016, 8, 3291)(provided in the Applicant’s IDS of 08/22/2025) in view of Lane (US 20120037544 A1)(provided in the Applicant’s IDS of 09/05/2025).
Regarding claim 5, Holm teaches all of the elements of the current invention as stated above with respect to claim 1. Holm further teaches
Holm teaches a device comprising lateral displacement arrays for separation of particles of different sizes in sample such as blood.
Holm does not teach wherein pillars in said deterministic lateral displacement array are tapered.
However, Lane teaches a lateral displacement array for separation of particles of different sizes in a sample such as a blood sample (para. 0060, abstract). Lane teaches wherein pillars in the lateral displacement array are tapered (Fig. 4 and abstract). Lane further teaches the use of an array including vertically asymmetrical posts (e.g. tapered) that an overall benefit of facilitates low-cost manufacturing and operation because non-vertical posts are easier to manufacture. (paras. 0044 and 0045).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pillar in the deterministic lateral displacement array taught by Holm with pillars are tapered taught by Lane in order to have pillars that are easier to manufacture and thus facilitates lower production cost with a reasonable expectation of success (Lane, para. 0045) (MPEP 2143)(I)(G).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY CHIU whose telephone number is (571)272-1054. The examiner can normally be reached 9 am - 5 pm.
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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758