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 Group I in the reply filed on June 19, 2026 is acknowledged.
Claims 13-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 19, 2026.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on applications filed in Singapore on October 21, 2021 and May 18, 2022. It is noted, however, that applicant has not filed a certified copy of the 10202111690U and 1020220515V application as required by 37 CFR 1.55.
Information Disclosure Statement
The IDS received on May 2, 2024 is proper and is being considered by the Examiner.
Drawings
The drawings received on April 22, 2024 are acceptable.
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 1-12, 23, and 24 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.
Claim 1 is indefinite for the following reasons.
Claim 1 is directed to a cartridge which is intended to improve contamination control by containment of the outside (contaminating) material from penetrating the inner parts of the cartridge during sample processing therein.
Claim 1, however, employs an intended use language of parts which are necessary for achieving this purpose. For example, claim 1 recites that “at least one cover layer” is “attachable to at least one of the plurality of receptacle top openings (see element 23, cover layer; element 22, receptacle top openings). For the outside elements to be prevented (i.e., “prevents a contamination of the ambience”, or “blocks an aerosol exchange between the ambience and the plurality of receptacles”), the cover layer must at least be fixed on to the receptacle tops. The usage of the word, “attachable” does not result in the cartridge presently claimed and renders it optional, incapable of providing the intended function.
Claim 1 is also indefinite for missing a conjunction between the last two elements (i.e., between the phrase pertaining to the at least one cover layer preventing contamination of the ambience due to spillage and the phrase pertaining to the at least one cover layer being attachable t at least one of the plurality of receptacle top openings). For the purpose of prosecution, the conjunction, “and” is assumed.
Claim 3 is incomprehensible.
Claim 5 is indefinite because the claim recites a process of providing a cover liquid onto the cover layer. However, the claim is directed to a product and therefore, recitation of the usage renders the claim indefinite. for the purpose of prosecution, the claim has been construed to mean that the cartridge further comprises a syringe.
Claim 8 is also indefinite because the claim recites that the cartridge comprises a liquid sealant, but then recites that this sealant is “dispensed over or under the at least one cover layer”, reciting a method of use. Therefore, it is unclear whether the claim is claiming a process of providing the liquid sealant, or the cartridge comprising a liquid sealant. The latter interpretation is assumed.
Claim 11 recites the phrase, “the isolated receptacles.” There is an insufficient antecedent basis for this limitation. The claim is also indefinite because it is unclear whether the receptacles are “isolated” from the outside environment, or each receptacle is isolated from each other. Based on the disclosure, the isolation appears to be from outside elements of the cartridge. This interpretation is assumed.
Claim 24 is also indefinite for the reasons behind the phrase, “cover layer being attachable to” as discussed above for claim 1.
Claim 24 is also indefinite for reciting the phrase, “cover liquid … provided to be dispensed at one of being over or under or within the at least one cover layer” as the claim is directed to a product, not a method.
Claims 2-12 and 23 are indefinite based on their dependency on claim 1.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1-12, 23, and 24 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-12, 27, and 28 of copending Application No. 18/641,454 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
No claims are allowed.
The Office suggests redrafting the claims for clarity, as the claims appear to be drafted via the aid of artificial intelligence and/or machine translation, resulting in the description being verbose and non-native in style.
Claims are free of prior art.
A microfluidic device/cartridge/microtiter plates comprising a sealable layer on top for the purposes of controlling contamination have been well-known in the art. For example, Williams et al. (US 2013/0210015 A1, published August 15, 2013) teach a device comprising a structure reproduced below (from Fig. 5A):
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As seen, the device comprises a plurality of receptacles (see the wells formed (113)), at least one cover layer (116) to isolate the plurality of receptacles from an ambience outside the at least one cover layer (see the closure of the cover layer 115 results in the sealing of the receptacle wells 113, also “a slotted rubber membrane … configured to provide access through the puncturable foil seal 115 to the set of wells 112”, section [0039]).
Williams et al. expressly teach that the slotted rubber membrane 116 serves to “prevent or reduce splashing, evaporation, and/or aerosolization of contents of the set of well 112” (section [0039]).
The artisans also teach at least one hollow tube (i.e., syringe, see section [0088], “syringe”), which delivers the reagents to the wells through the rubber membrane.
However, the artisans nor the prior art teach that the cover layer comprises an aerosol exchange between the ambience (i.e., outside) and the receptacles, which is pierceable, wherein this cover layer is porous.
The rubber membrane provides a covering through which syringe can pierce through to deliver and/or retract reagents/contents to/from the wells. However, the membrane is not considered porous. And while there exist gas permeable membranes which are utilized, these membranes are not pierced.
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Similarly, Koskinen et al. (WO 2011/0148055 A1, published December 2011, IDS ref) teach a device comprising the below reproduced configuration (from Fig. 2): As seen, the device as disclosed comprises:
at least one hollow tube (i.e., a syringe, see “a piercing needle”, page 5, line 22);
a plurality of receptacles (see the wells, element 6); and
at least one cover layer (see elements 8, 10, and 12) to isolate the plurality of receptacles from ambience outside the at least one cover layer, wherein each of the plurality of receptacles allows the at least one hollow tube, when attached to a syringe or a pipette tip in use, to dispense and aspirate an in use reagent liquid or an in use biological sample to and from each of the plurality of receptacles through the at least one cover layer only from a plurality of receptacle top openings (see “allow accurate dispensing with a piercing needle …”, page 5, line 24);
the at least one cover layer substantially blocks an aerosol exchange between the ambience and the plurality of receptacles during the whole process of the biological analyses or nucleic acid analyses even after the at least one hollow tube pierces the at least one cover layer and retracts (“ensure reversibly closing of the needle track upon retraction … eliminate cross-contamination caused by occasional spillovers”, page 7, lines 23-24); “reversibly closing the pierced opening to avoid spilling and evaporation”, (page 5, line 24); and
the at least one cover layer also substantially prevents a contamination of the ambience due to a spillage of the in use reagent liquid or the in use biological sample from each of the plurality of receptacles or the cartridge module (see above).
However, Koskinen et al. do not teach that the layer is porous. In fact, the artisans employ “closed-cell neoprene foam” which is not considered to be porous. In addition, the cut outs formed in the foam layer is not disclosed as being capable of preventing aerosols from escaping the reaction wells which it seals.
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.
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/YOUNG J KIM/Primary Examiner
Art Unit 1637 September 14, 2026
/YJK/
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