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, claims 1-13 and 23-28 in the reply filed on 3/13/2026 is acknowledged.
Claim Objections
Claim 3 is objected to because of the following informalities: the term “cone” should read as “one” in the expression “the .
Appropriate correction is required.
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 1-13 and 23-28 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 recites “the reservoirs defining a volume” in line 6. There is lack of antecedent basis for this limitation in the claim since claim 1 previously recites “one or more reservoirs”. The limitation will be interpreted as “the one or more reservoirs defining a volume” for consistency and clarity.
Dependent claims 2-13 stand rejected as being dependent on claim 1.
Claim 23 recites “the reservoirs defining a volume” in line 6. There is lack of antecedent basis for this limitation in the claim since claim 1 previously recites “one or more reservoirs”. The limitation will be interpreted as “the one or more reservoirs defining a volume” for consistency and clarity.
Dependent claims 24-28 stand rejected as being dependent on claim 23.
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) 1-13 and 23-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Griffin (US 7473397).
Regarding claim 1, Griffin teaches a device for analysis of a sample comprising a cartridge assembly, wherein the cartridge assembly comprises a first surface having a first seal (12 and 43), a second surface having a second seal (13), and one or more reservoirs (22) positioned between the first surface and the second surface, the reservoirs defining a volume, and wherein at least one of the one or more reservoirs contains a wet reagent; and a chip assembly (11), wherein the chip assembly comprises a microfluidic channel (14), and one or more puncture elements (45) configured to pierce the second seal to provide the wet reagent to the chip assembly. (Refer to Figure 11)
Regarding claim 2, a non-reactive layer (12) enclosing the one or more reservoirs, and a flexible layer (43) in contact with the non-reactive layer.
Regarding claim 3, the second seal comprises an inert layer (13) enclosing the cone or more reservoirs (22), and a compressible layer in contact with the inert layer.
Regarding claim 4, the cartridge assembly and the chip assembly are oriented so that engaging the cartridge assembly and the chip assembly causes the one or more puncture elements to pierce the second seal and the compressible layer to contact the chip assembly to fluidically seal the microfluidic channel. (Refer to Figure 11)
Regarding claim 5, the chip assembly further comprises an optically transparent seal, and wherein the optically transparent seal forms a bottom to the microfluidic channel. (Refer to Col. 6, Lines 60-65)
Regarding claim 6, the cartridge assembly and the chip assembly are oriented so that engaging the cartridge assembly and the chip assembly causes the one or more puncture elements to pierce the second seal and the compressible layer to contact the chip assembly to fluidically seal a top of the microfluidic channel. (Refer to Figures 11-13)
Regarding claim 7, the cartridge assembly further comprises a mechanism (54) configured to prevent the cartridge assembly from engaging the chip assembly until the mechanism is activated. This limitation is considered a process and/or intended use limitation, which do not further delineate the structure of the claimed apparatus (i.e. from apparatus claim 1) from that of the prior art. Since claim 1, etc. are drawn to an apparatus statutory class of invention, it is the structural limitations of the apparatus, as recited in the claims, which are considered in determining the patentability of the apparatus itself. This recited process or intended use limitation is accorded no patentable weight to an apparatus. Process limitations are not germane to patentability to a structure, which is not distinguished from the prior art. 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.
Regarding claim 8, the cartridge assembly and/or the chip assembly further comprise a sample port (17) for providing a biological sample.
Regarding claim 9, the chip assembly further comprises a plurality of metal beads configured to interact with RNA present in the biological sample. (Refer to Col. 8, Lines 56-67)
Regarding claim 10, the cartridge assembly further comprises one or more one- way clips that are configured to irreversibly engage portions of the chip. (Refer to Col. 11, Lines 18-24)
Regarding claim 11, the one or more reservoirs comprise: a first reservoir containing a wash and a second reservoir containing a master mix, wherein the master mix comprises at least one polymerase. . (Refer to Col. 8, Lines 56-67)
Regarding claim 12, the assay comprises polymerase chain reaction (PCR). . (Refer to Col. 8, Lines 56-67)
Regarding claim 13, the volume is 5 µL to 30 µL. (Refer to Col. 1, Lines 25-30)
Regarding claim 23, a first surface having a first seal (12 and 43), a second surface having a second seal (13), and one or more reservoirs (22) positioned between the first surface and the second surface, the reservoirs defining a volume, and wherein at least one of the one or more reservoirs contains a polymerase. (Refer to claim 1 rejection above and Col. 1, Lines 25-35)
Regarding claim 24, the first seal (12 and 43) and the second seal (13), respectively provide a top and a bottom enclosing the volume defined by the reservoirs (22).
Regarding claim 25, the first seal comprises a non-reactive layer (12) facing the one or more reservoirs (22), and a compressible layer (43) adhered to the non-reactive layer. (Refer to Figure 11)
Regarding claim 26, the second seal (13) comprises an inert layer facing the one or more reservoirs (22), and a flexible layer in contact with the inert layer. (Refer to Figure 11)
Regarding claim 27, the inert layer, the non-reactive layer, or both comprise: a metal foil, a fluorinated polymer, or combinations thereof. (Refer to claim 9)
Regarding claim 28, the fluorinated polymer is polytetrafluorocthylene. (Refer to claims 8 and 9)
Conclusion
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/JYOTI Mutreja/Primary Examiner, Art Unit 1798
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