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 37-55 on 7/2/24 is acknowledged. Claims 1-36 was canceled. Claims 37-55 are pending and are under examination.
Information Disclosure Statement
No IDS was filed.
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.
Claims 37-46 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 37 is an abstract idea because it recites the step, “one or more reagents for carrying out a method for detection of one or more analytes.” This step is an abstract idea because it’s a mental process, a concept performed in the human mind by observation, evaluation, judgement, or opinion. This judicial exception is not integrated into a practical application because after the “method for detection” step, then no action is taken, and thus, there is no application, much less a particular practical application. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because claim 37 recites a microslit filter with the claimed openings and dimensions which is well-understood, routine, conventional activity (see prior art cited below). Thus, claim 37 does not recite significantly more than the abstract idea.
Dependent claims all further refine the method steps and were considered, however, the subject matter does not affect the result established above.
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 37-55 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.
Claims 37, 39, 43, 46, 47, 49 and 53 are rejected because each claim claims both an apparatus (e.g., kit) and at least one method step of using the kit. See MPEP 2173.05(p)(II).
Claims 38 and 48 are rejected because it claims a process, e.g., “use” in a kit claim, which is an apparatus-type of claim. It is unclear how the “use” step structurally further defines the claimed kit. For examination purposes, the claim language will be given the appropriate weight and interpreted as functional claim language.
Claim Rejections - 35 USC § 103
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 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 37-55 are rejected under 35 U.S.C. 103 as being unpatentable over Sajay et al. (“Sajay,” Microfluidic platform for negative enrichment of circulating tumor cells, 2014) in view of Striemer et al. (“Striemer,” US Pub. No. 2016/0199787) and Kadel et al. (“Kadel,” US 6977042).
As to claim 37, Sajay discloses a kit comprising one or more devices (e.g., microfluidic chip in fig. 3) comprising: a microslit filter defining a plurality of openings (e.g., micro slit membrane has precise slits; wherein the microslit filter has a thickness from 50 nm to 25 um (e.g., 10 um thick micro slit membrane in section 2.2); the openings have a width from 0.5 um to 15 um (5.5 um in section 2.2) and a length from 5 um to 100 um (40 um in section 2.2), and the openings have an aspect ratio (width:length) from 1:0.33 to 1:0.002 (because Sajay discloses the width and length within the claimed ranges, Sajay discloses the claimed aspect ratio). Sajay also discloses one or more reagents for carrying out a method for detection of one or more analytes in section 2.3 et seq. because Sajay discloses a 4ml sample assay, which incorporates one or more reagents.
Regarding claim 37, Sajay does not specifically disclose a porosity from 1% to 75%. Striemer discloses a SiN membrane can have a range of pore sizes and porosity. For example, the pores can be from 10 nm to 100 nm, including all values to the nm and ranges therebetween. The pores also can be 10 nm or less or even 1 nm or less. For example, the porosity can be from <1% to 40%, including all integer % values and ranges therebetween. In a particular embodiment, the SiN pore sizes range from approximately 5 nm to 80 nm and the SiN porosity ranges from 1% to 40%. Of course, other pore size and porosity values are possible and these are merely listed as examples (e.g., [0025] 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 have the claimed porosity because it would be beneficial to manufacture membranes with a porosity that is compatible with a broad range of solutions ([0023] of Striemer).
Regarding claim 37, Sajay does not specifically disclose openings the shape of the openings are cubic prisms or trapezoids. Kadel discloses trapezoidal passages in col. 3, line 61 et al. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have trapezoidal openings because it would be beneficial to manufacture membranes with a particular shape to achieve efficient fluid flow.
As to claims 38-39 and 48-49, because a device would usually contain some form of instructions on how to use the device, it would be obvious to include “instructions for use” with applicant’s device.
As to claims 40-42 and 50-52, see fig. 1 et seq. of Sajay, which discloses micro particle and other particles to that act as capture particles and affinity agents.
As to claims 43 and 53, see PBS in section 2.6 of Sajay.
As to claims 44-45 and 54-55, see automated hematology analyzer in section 2.1.
As to claims 46-47, Sajay discloses a kit comprising one or more devices and one or more reagents for carrying out a method comprising: binding a first ligand on an analyte in a biofluid using a first binding agent, thereby forming an analyte-first binding agent complex; adding capture particles to the biofluid wherein the first binding agent is bound by the capture particles, thereby forming an analyte-first binding agent-capture particle complex; filtering the biofluid having the analyte-first binding agent-capture particle complex; and, optionally, eluting or disassociating any of the analyte-first binding agent-capture particle complex that is retained by a microslit filter. See section 2.1 et seq. of Sajay.
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 37-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11931739. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims and the patented claims comprise substantially the same subject matter. For example, examined claim 37 and patented claims 1 and 8 comprise a device comprising: a microslit filter defining a plurality of openings; wherein the microslit filter has a thickness from 50 nm to 25 μm; a porosity from 1% to 75% and wherein the openings are cubic prisms or trapezoids; the openings have a width from 0.5 μm to 15 μm and a length from 5 μm to 100 μm; and the openings have an aspect ratio (width:length) from 1:0.33 to 1:200.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on 571-272-1254.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
12/13/2025
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