DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The IDS received on November 13, 2024, January 30, 2025, and May 22, 2025 are proper and are being considered by the Examiner.
Drawings
The drawings received on September 23, 2024 are acceptable.
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 16 and 17 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. This is a New Matter Rejection.
Claims 16 and 17 were filed subsequent to the filing date of the application. Claim 16 recites that the length of the first reaction chamber is at least six times greater than the width of along the axis and claim 17 recites a specific volume of fluid to be contained by a rection chamber, that is, at least 6 microliters.
These limitations are not supported by application as originally filed and therefore constitute new matter.
Applicants are requested to point to line and page number of the specification where such support could be found.
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 5, 7, and 19-21 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 5 and 7 are indefinite because the claims define a same resulting structure and metes and bounds between the established microfluidic cartridge is indistinguishable. The application contains a singular depiction of a microfluidic cartridge of the configuration that is established by claims 5 and 7, where the first and second banks of sample lanes are arranged in the required 5th transverse axis as represented by Fig. 32B. Applicants are invited to provide what the purported difference between the microfluidic cartridge having the configuration of claims 5 and 7 are which are supported by the application as filed.
Claims 19-21 are indefinite for reciting the phrase, “microfluidic cartridge … comprising a label”, or “barcode” because it is unclear whether the label and barcode is referencing to an assay reagent of molecular label/barcode, or a physical label/barcode that are placed as product identifier (e.g., machine readable SKU).
For the purpose of prosecution, the phrase has been construed to be referring to machine readable SKI and not the molecular identifiers.
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 2-8, 10, and 14 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Bedingham et al. (US 2002/0001848 A1, published June 3, 2023).
As pointed out in In re Mott, 190 U.S.P.Q. 536 (CCPA 1975), "Claims must be given broadest reasonable construction their language will permit in ex parte prosecution, and applicant who uses broad language runs the risk that others may be able to support the same claim with a different disclosure."
With regard to claim 2, Bedingham et al. teach a below microfluidic cartridge reproduced below (Figure 1, see below):
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As seen, Bedingham et al. teach a) a plurality of sample lanes comprising a first set and a second set of sample lanes, wherein the each of the plurality of sample lanes comprises a chamber (see 40, for example), a first valve and a second valve that flank the chamber (see 50 and 70 of Fig. 2, also “additional optional components such as valve 50 … and valve 70”, section [0052]),
wherein the plurality of sample lanes comprises a first bank of sample lanes comprising reaction chambers along a first axis (see the representative set going in a vertically down direction, left side),
wherein the plurality of sample lanes comprises a second bank of sample lanes comprising reaction chambers along a second axis (see the representative set going in a vertically down direction, right side),
wherein the reaction chambers of the first bank are a different distance from their respective first valves than the reaction chambers of the second bank are from their respective first valves (the valves for the first and the second bank of samples are different in distance as the second bank (or set) of sample chambers are further away from inlet).
With regard to claims 3 and 4, a third line1 intersects the first valve and the second valve present on the lanes.
With regard to claims 5 and 7, the first and second bank of sample lanes are aligned along the same axis (see above).
With regard to claims 6, 8, 10, and 14, the cartridge is long along its third line (or the third axis, see above), and short along the opposing axis (i.e., it is rectangular).
Therefore, the invention as claimed is deemed anticipated by Bedingham et al.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 9, 11-13, 15-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bedingham et al. (US 2002/0001848 A1, published, June 3, 2002; IDS ref) in view of Gallagher et al. (WO 99/34205, published July 1999).
The teachings of Bedingham et al. have been discussed above.
While the Bedingham et al. teach an example of the device comprising a first bank and a second bank of sample lanes, each bank comprising 8 lanes, do not explicitly teach 12 lanes each (claims 9 and 18).
Bedingham et al. do not teach that their device comprises a notch or registration member that allows a corrected orientation of fitting (claim 11), or ledges that space the cartridges when stacked (claim 12), having a height greater than an “inlet” (claim 13).
Bedingham et al. do not explicitly teach that the second reaction chamber comprises a length along the transverse axis greater than the width along the second axis (claim 15), where the length is 6x that of the width (claim 16), or that the first sample lane is configured to receive up to 6 ml of fluid (claim 17), said cartridge comprising a laminate, a substrate, and a label, said label being a barcode (claims 18-21).
Gallagher et al. teach a well-known concept of using a registration member such as notch to allow cartridges to fit in a single, predictable orientation (“microfluidic device is configured to that it can only be placed in the correct orientation (e.g., by a notch in one corner of the device”, page 18, lines 5-7).
It would have been prima facie obvious to one of ordinary skill in the art the time the invention was made to combine the teachings of Bedingham et al. with the teachings of Gallagher et al. and conventionally well-known elements of the prior art, thereby arriving at the invention as claimed.
As discussed above, Bedingham et al. already teach a microfluidic device comprising a plurality of lanes each comprising a sample processing chamber. While the artisans did not explicitly teach that the number of first and second banks of sample lanes should each be 12, given that Bedingham et al. teach a total of 16 lanes (8 per bank of sample lanes), one of ordinary skill in the art would have had a reasonable expectation of success at adding additional lanes for the widely known desire to increase the throughput of the assay.
As well, one of ordinary skill in the art would have had a reasonable expectation of success at utilizing any micro-volume of reaction in the reaction chambers of Bedingham et al. as the device taught by Bedingham et al. was a device which performed assays in a small volume (see section [0124]).
With regard to the employment of ledges that space the cartridges for stacking, as well as the laminate and labeling with barcodes, these are conventional knowledge in the art widely applicable products for storing and quick identification of products, yielding no more than a predictable outcome.
With regard to the shape of the sample chamber, while Bedingham et al. do not explicitly recite that the shape should have a longer length than width, such configuration would have been an obvious based on the general guidance given by Bedingham et al. who teach that while the chamber is substantially rectangular in shape (see section [0045]), and being that a rectangle has a shape having a longer side that the width, any such variations would have been well-within the purview contemplated by Bedingham.
Therefore, the invention as claimed is deemed prima facie obvious over the cited references.
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 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,128,402 (herein, “the ‘402 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
In addition, claims 2-21 are rejected on the same basis and rationale over: A) claims 1-18 of U.S. Patent 11,266,987; B) claims 1-10 of the U.S. Patent No. 10,065,185; and C) claims 1-20 of the U.S. Patent No. 9,238,223.
Claims of the of ‘402 patent also claims a microfluidic cartridge comprising a plurality of sample lanes, each of the sample lanes comprising a reaction chamber (see claim 1, “a plurality of sample lens, each of the sample lanes comprising a reaction chamber”), wherein
the first plurality of sample lanes comprise a first bank of sample lanes, wherein a first axis intersects the reaction chambers of the first bank, wherein the plurality of sample lanes comprise a second bank of sample lanes, wherein a second axis intersects the reaction chambers of the second bank, wherein
ii) the reaction chambers of the first bank are on a different distance from their respective first valves than the reaction chambers of the second bank are from their respective first valves (see claim 1, “the plurality of sample lanes comprise a first bank of sample lanes, wherein the reaction of chambers of the first bank are linearly arranged”2; “the plurality of sample lanes comprise a second bank of sample lanes, wherein the reaction chambers of the second bank are linearly arranged (see footnote), also “axis intersecting a reaction chamber of the first bank of sample lanes and a reaction chamber of the second bank of sample lanes is traverse to a reaction chamber axis along which the reaction chambers of the first bank of sample lanes are arranged”, claim 1; also claim 2, “inlets of the plurality of sample lanes are linearly arranged”).
The claims of the ‘402 patent do not explicitly claim an upstream and downstream valve located above and below (respectively) each sample lane.
However, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to arrive at the presently claimed configuration because the application of the ‘402 patent does not reasonably disclose any other configuration of a microfluidic device where the valves of the first bank and second banks are located on a different horizontal axis (see partial view of the below reproduced Figure 32B):
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As seen, the first bank and the second bank of sample lanes are arranged across their respective horizontal axes, with the first bank and a second bank of sample lanes being located vertically aligned (or transverse axis, fifth axis as claimed in claim 5).
Because the claims of the ‘042 patent contains an inlet through which a sample is delivered to its sample chamber, one of ordinary skill in the art would have recognized the need for a valve that provides a closed configuration in which the sample chamber can operate. Due to the only configuration shown by the instant application, the placement of such valves for the second chambers therefore, would required to be placed at a “lower” distance from those of the first chambers. As well, claim 12 of the ‘402 patent already allude that the inlet channels of the first and the second plurality of banks of sample lanes are “different”.
The fact that the claims have been drafted to omit such implicit requirements of a singularly disclosed configuration does not amount to a patentable difference and are well-within the understanding of the ordinarily skilled artisan.
With regard to instant claims 3-21, the claims are obvious over claims of the 402 patent, as the number of such chambers being 12 x 12 (first and second) are claimed in claim 1 (“first bank of sample lanes comprises 12 sample lanes and the second bank of sample lanes comprises 12 sample lanes”),
With regard to the presence of a microfluidic cartridge comprising a longer edge and short edge (i.e., rectangular shape), with ledges and notches, for stacking with spacing purpose, and for insert registration purposes, such are deemed practical well-known solution that have been incorporated into an otherwise obvious microfluidic cartridge, as notches which are cut to allow singular orientation of fit into a housing, as well as ledges that serve a spacers that allow easier access to stacked elements have been known in the material art regardless of the field.
The claims are obvious over the claims of the patents of record therefore.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782.
Papers related to this application may be submitted to Art Unit 1681 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YOUNG J KIM/Primary Examiner
Art Unit 1637 September 18, 2026
/YJK/
1 Multiple third lines can exist as multiple axis along that direction and intersect multiple first and second valves.
2 By “linear”, they are formed along a first axis.
Prosecution Insights