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 .
Response to Amendment
The amendment filed 5/20/26 has been entered and fully considered.
Claims 1-20, 22-30 remain pending, of which claims 28-30 were previously withdrawn.
The previous 35 USC 112 rejections have been withdrawn due to the amendments.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/1/26 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: distribution unit, activation unit, fluorescence generation unit, fluorescence detection unit and identification unit in claim 1, image acquisition unit in claim 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
Claim(s) 1-20, 22-23, 26-27 is/are rejected under 35 U.S.C. 102a1 as being anticipated by CHIU (US 2020/0208202).
Regarding claim 1, 22, 23, The following claim terms were interpreted under 35 USC 112f as stated above to be the following structures as per the specification:
Distribution unit- emulsification membrane, microchannels or injection portion i.e. nozzle [0110] and functional equivalents thereof.
Activation unit- environment adjuster i.e. incubator [0114] and functional equivalents thereof.
Fluorescence generation unit – environment adjuster i.e. incubator [0115] and functional equivalents thereof.
Fluorescence detection unit- any device that can detect fluorescence in individual compartments, i.e. plate reader or fluorescence microscope [0117, 0123-124] and functional equivalents thereof.
Identification unit- information processing system i.e. computer [0128] and functional equivalents thereof.
With respect to claim 1, CHIU discloses a system for performing assays using droplets which can be used for detection of nucleic acids (Abs) comprising:
a droplet system 1055 (distribution unit), that can be a multi-channel pipette (microchannels, injection portion/nozzle) (Fig 2a, 4) configured to distribute a sample and detectable agent to a well or chamber in a microfluidic chip or a droplet on a chip (0127-128, 0140);
a means for maintaining temperature (incubate at predetermined temperature) such as an incubator or other heat sources (activation unit, fluorescence generation unit are single incubator) that enable chemical processes to occur (configured to activate protein and modify molecule, and incubate the wells/chambers) (0137-0140, Fig 4);
an imaging source 1040 (fluorescence detection unit) such as a fluorescence microscope configured to detect fluorescence (0289, 0329, Fig. 2a, 4);
and a detection system 1000 with a computing device 1001 (identification unit) for analyzing the images (0291) to determine the fluorescence intensity in a droplet (fluorescence intensity of each individual independent separated compartment), and to identify droplets (compartments) having a fluorescence intensity exceeding a threshold pixel intensity valve (predetermined threshold value) (0150, 0200, 0236-0241).
It is noted the limitation directed to the contents of the sample and detection reagent are not positively recited limitations of the claim but are merely contents of the apparatus and therefore have been given appropriate weight. These limitations do not afford patentability to the apparatus or system because they are not defining any structural features of said apparatus but merely defining the contents used in the claimed apparatus during its use. It has been well established that it is fundamental that an apparatus claim defines the structure of the invention and not how the structure is used in a process, or what materials the structure houses in carrying out the process. Further, it has been held that "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." It is further noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. See MPEP 2114 and 2115. The above apparatus of CHIU is considered capable of use with any desired samples & reagents, including those specifically claimed, as the structure of the disclosed detection apparatus meets all the claimed structural limitations.
Regarding claim 2, The following claim terms were interpreted under 35 USC 112f as stated above to be the following structures as per the specification:
Image acquisition unit – fluorescence microscope [0124] and functional equivalents thereof.
With respect to claim 2, CHIU discloses the imaging source 1040 (fluorescence detection unit) can be a fluorescence microscope configured to detect fluorescence in the separate wells (configured to acquire an image containing the individual compartments) (0289, 0329, Fig. 2a, 4).
Regarding claim 3, CHIU discloses the detection system (identification unit) is configured to identify each droplet or well (compartments) having a fluorescence intensity exceeding a threshold pixel intensity value by processing the image (0150, 0200, 0236-0241, Fig 2C-2E).
Regarding claims 4-20, CHIU discloses the apparatus for use with a sample containing a nucleotide (target nucleic acid) and the detectable agent can be a variety of reagents, including proteins, RNA, probes or dyes (reporter molecules) (0128, 0149-150, 0168-171, 0311, 0423). It is noted the limitation directed to the contents of the detection reagent merely contents of the apparatus and therefore have been given appropriate weight. These limitations do not afford patentability to the apparatus or system because they are not defining any structural features of said apparatus but merely defining the contents used in the claimed apparatus during its use. It has been well established that it is fundamental that an apparatus claim defines the structure of the invention and not how the structure is used in a process, or what materials the structure houses in carrying out the process. Further, it has been held that "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." It is further noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. See MPEP 2114 and 2115. The above apparatus of CHIU is considered capable of use with any desired reagents, including those specifically claimed, as the structure of the disclosed detection apparatus meets all the claimed structural limitations.
Regarding claim 26, CHIU discloses the detection system (identification unit) is configured to identify each droplet or well (compartments) having a fluorescence intensity exceeding a threshold pixel intensity value based on a ratio between a fluorescence intensity of a reference and the droplet, well or chamber (0150, 0200, 0219, 0236-0241, 0278, Fig 2C-2E).
Regarding claim 27, CHIU discloses using a reference fluorescence (0219). It is noted this claim only recites functional limitations. It is well established that a recitation with respect to the manner in which an apparatus is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claims. Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such art reference, regardless of whether the prior art reference explicitly discloses such capacity for performing the recited function. In addition, where there is reason to believe that such functional limitation may be inherent characteristic of the prior art reference, applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon. MPEP 2114-2115.
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 (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 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(s) 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over CHIU (US 2020/0208202).
Regarding claim 24-25, CHIU discloses the droplets have a range of volumes, including from 100nL-1fL, from 10nL-10fL, from 1nL to 100fL (0072, 0096) but does not explicitly disclose the range of volumes claimed from 0.1fL-1000fL and 0.5fL-400fL. However, as the claimed range overlaps the range disclosed by CHIU, this is evidence of prima facie obviousness of the claimed range. See MPEP 2144.05.
Response to Arguments
Applicant's arguments filed 5/20/26 have been fully considered but they are not persuasive.
In response to applicant's argument that the claimed apparatus and prior art reference CHIU are used for different purposes, with different reagents and that a different process occurs in the claimed and reference incubators, it is noted a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As stated in the rejection CHIU discloses a device with means for maintaining or cycling temperature and further states the device can include without limitation, warm-water baths, incubators and other heat sources (0137). The examiner maintains that this disclosure meets the structure of the claimed limitation of an incubator and as it is disclosed as maintaining a temperature, it is considered capable of being used for the activation and fluorescence generation functions claimed. It is noted applicant has not presented any clear arguments as to how the claimed incubator and the disclosed incubator of CHIU structurally differ.
In response to applicant’s argument that the claimed volumes of the compartments in dependent claims 24-25 are separately patentable, the examiner respectfully disagrees. As CHIU discloses using volumes containing agents such as a well or chamber in a microfluid chip (0127, 0140) and that the device can include a plurality of chambers configured to form the plurality of droplets (0145) and that the droplets have a range of volumes, including from 100nL-1fL, from 10nL-10fL, from 1nL to 100fL (0072, 0096) which range overlaps the claimed range, the examiner maintains the disclosure of CHIU renders the claimed range of compartment volumes is prima facie obvious.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
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, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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