DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The preliminary amendment filed on November 9, 2023 is acknowledged. The application will be examined accordingly.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on February 26, 2024 are being considered by the examiner.
Specification
The abstract of the disclosure is objected to because it does not properly reflect the nature of the claimed invention. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The specification is objected to because it does not contain cross-references to related applications. See 37 CFR 1.78 and MPEP § 211 et seq.
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 21, 22 and 30-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of US 10,357,772 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 11 of US 10,357,772 B2 anticipates the claims of the instant application.
While claim 11 of US 10,357,772 B2 does not explicitly recite a microchannel, the claim recites an inlet that is in fluid communication with a plurality of microwells. It is evident that the device recited in claim 11 of US 10,357,772 B2 comprises a microchannel that connects the inlet to each microwell.
Claims 21, 22 and 30-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of US 10,675,626 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 10 of US 10,675,626 B2 anticipates the claims of the instant application.
While claim 10 of US 10,675,626 B2 does not explicitly recite a microchannel, the claim recites an inlet that is in fluid communication with a plurality of microwells. It is evident that the device recited in claim 10 of US 10,675,626 B2 comprises a microchannel that connects the inlet to each microwell.
Claims 21, 22 and 30-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of US 10,960,397 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 9 of US 10,960,397 B2 anticipates the claims of the instant application.
While claim 9 of US 10,960,397 B2 does not explicitly recite a microchannel, the claim recites an inlet that is in fluid communication with a plurality of microwells. It is evident that the device recited in claim 9 of US 10,960,397 B2 comprises a microchannel that connects the inlet to each microwell.
Claims 21, 22 and 30-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of US 11,224,876 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 14 of US 11,224,876 B2 anticipates the claims of the instant application.
Claim Objections
Claims 25-27 are objected to because of the following informalities:
In claim 25, the limitation “microwell” should be changed to “microwells”.
In claim 26, the limitation “microfluidic channel having at least one dimension” should be changed to “microfluidic channel, the region having at least one dimension”.
In claim 27, the limitation “has” should be changed to “having”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
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.
Claim 23 is rejected under 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 23 recites that each microwell is formed as part of the microchannel. It is unclear what the claim is trying to convey. Claim 21 explicitly recites the microwells and the microchannel as separate elements that are coupled (i.e. they are physically separate/distinct), and even recites that the aqueous fluid flows from the channel to the microwells. That said, it is unclear how the microwells are part of the microchannel.
Claim Rejections - 35 USC § 112
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 31 is rejected under pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The subject matter of claim 31 is already explicitly recited in claim 21. Consequently, claim 31 does not further limit claim 21.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 21-26, 28-31 and 36 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Fraden et al. (“Fraden”) (US 2007/0052781 A1).
The applied reference has a common inventor and assignee with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor or joint inventors (i.e., the inventive entity) of this application and is thus not the invention “by another,” or if the same invention is not being claimed, by an appropriate showing under 37 CFR 1.131(a).
With respect to claim 21, Fraden discloses a method comprising:
providing a microfluidic device comprising a substrate comprising a microfluidic channel 56 operably coupled to a plurality of microwells 82/83 (see Fig. 4 and [0047]);
providing a solution of an aqueous fluid (see [0046]) containing at least one target molecule and one or more reagents for conducting a reaction with the at least one target molecule (see [0033]);
introducing the solution of aqueous fluid into the microfluidic channel and flowing the solution of aqueous fluid through the microfluidic channel to position portions of the aqueous fluid into the microwells (see [0044]);
maintaining separation among the portions from one another by the microwells (see [0044] and Fig. 4); and
conducting the reaction in one or more of the microwells (see [0032] and [0046] disclosing performance of a reaction inside the portions of the aqueous fluid).
With respect to claims 22 and 23, each microwell 82/83 is formed as part of the microfluidic channel 56 such that each microwell is fluidically coupled to the microchannel (see Fig. 4).
With respect to claim 24, the portions of the aqueous fluid form droplets in the microwells (see [0044]).
With respect to claim 25, each microwell has a larger cross-sectional dimension than the microfluidic channel (see [0047]).
With respect to claim 26, each microwell 82/83 defines a region that protrudes from a surface of the microfluidic channel, the region having at least one dimension that is larger than a dimension of the microfluidic channel (see [0047] and Fig. 4).
With respect to claims 28 and 29, the substrate is made from polydimethylsiloxane (PDMS) (see [0036]).
With respect to claim 30, it is evident that flowing the solution of aqueous fluid through the microchannel is in response to application of pressure upon the microfluidic device. Otherwise, fluid flow would not be possible.
With respect to claim 31, as discussed above (see rejection of claim 21), the aqueous solution comprises a target molecule.
With respect to claim 36, the reaction is a chemical reaction (see [0046] and [0108]).
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 negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 27 and 32-35 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Fraden.
The applied reference has a common inventor and assignee with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 103(a) might be overcome by: (1) a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor of this application and is thus not an invention “by another”; (2) a showing of a date of invention for the claimed subject matter of the application which corresponds to subject matter disclosed but not claimed in the reference, prior to the pre-AIA 35 U.S.C. 102(e) date of the reference under 37 CFR 1.131(a); or (3) an oath or declaration under 37 CFR 1.131(c) stating that the application and reference are currently owned by the same party and that the inventor or joint inventors (i.e., the inventive entity) named in the application is the prior inventor under pre-AIA 35 U.S.C. 104 as in effect on March 15, 2013, together with a terminal disclaimer in accordance with 37 CFR 1.321(c). This rejection might also be overcome by showing that the reference is disqualified under pre-AIA 35 U.S.C. 103(c) as prior art in a rejection under pre-AIA 35 U.S.C. 103(a). See MPEP §§ 2146 et seq.
With respect to claim 27, Fraden does not explicitly disclose that each microwell defines a region having a hydrophobic surface. However, Fraden discloses that a region in which a droplet is positioned (e.g. a microwell) may have a patterned surface (e.g. a hydrophobic patch) that favors the positioning and/or containing a droplet therein (see [0056]). In light of the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the microwell with a hydrophobic region.
With respect to claims 32-35, Fraden does not explicitly disclose a step of monitoring the reaction. However, Fraden discloses that crystallization (another type of process that can occur inside the microwells) inside the microwells can be optically analyzed using a detector for subsequent quantitative or kinetic analysis (see [0087]). Based on the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a detector to measure an optical property (e.g. fluorescence) associated with the reaction within each microwell for the purpose of assaying the at least one target molecule.
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 21-36 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Oldham et al. (“Oldham”) (US 2005/0226779 A1).
With respect to claim 21, Oldham discloses a method comprising:
providing a microfluidic device (microplate, see abstract) comprising a substrate 20/404/408 comprising a microfluidic channel 406 operably coupled to a plurality of microwells 410/26 (see Figs. 20-23b);
providing a solution of an aqueous fluid 1000 (see [0402]) containing at least one target molecule (molecule being assayed) and one or more reagents for conducting a reaction with the at least one target molecule (see [0403]);
introducing the solution of aqueous fluid into the microfluidic channel and flowing the solution of aqueous fluid through the microfluidic channel to position portions of the aqueous fluid into the microwells (see [0402]-[0403]);
maintaining separation among the portions from one another by the microwells (see [0403] and Fig. 22b); and
conducting the reaction in one or more of the microwells (see [0403]).
With respect to claims 22, 23 and 26, each microwell defines a region 414 that protrudes from a surface of the microfluidic channel 406, the region 414 having at least one dimension (height) that is larger than a dimension of the microfluidic channel 406 (see Fig. 22b). Naturally, each microwell is fluidically coupled to the microchannel 406 and each microwell is formed as part of the microchannel 406 (each microwell is contiguous with the microfluidic channel).
With respect to claim 24, the portions of the aqueous fluid form droplets in the microwells 26 (see Fig. 22b illustrating droplets dripping into microwell 26).
With respect to claim 25, each microwell has a larger cross-sectional dimension (height) than the microfluidic channel (see Fig. 22b).
With respect to claim 27, each microwell defines a region 450 having a hydrophobic surface (see [0409]).
With respect to claim 28, the substrate is made from a polymer (see [0261] and [0489]).
With respect to claim 29, the substrate comprises a PDMS layer 494 (see Fig. 108 and [0419]).
With respect to claim 30, it is evident that flowing the solution of aqueous fluid through the microchannel is in response to application of pressure upon the microfluidic device. Otherwise, fluid flow would not be possible.
With respect to claim 31, as discussed above (see rejection of claim 21), the aqueous solution comprises a target molecule.
With respect to claims 32-35, the method further comprises monitoring the reaction using a detector 10 (see [0403]), specifically a fluorescence detector (see [0391]). Naturally, the detector measures an optical property (fluorescence) of one or more microwells.
With respect to claim 36, the reaction is a chemical reaction (assay) (see [0403]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached at 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796
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