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 claims 1-3, 5, 7, 8, 15, 16, 19, 23, 24, 31, 38, 39, 46, 51-53, 60 and 62-66 in the reply filed on February 4, 2026 is acknowledged. Claims 73-75 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 18, 2023 is being considered by the examiner.
Claim Objections
Claims 2, 7, 24 and 62 are objected to because of the following informalities:
The last line of claims 2 and 62 appears to be grammatically incorrect.
The preamble of claim 7 is grammatically incorrect. In addition, nomenclature should be consistent throughout the claims to avoid potential indefiniteness. That said, the limitation “the controller” should be referred to as “the at least one controller”.
In claim 24, the limitation “compresses” is misspelled.
Applicant is advised that should claims 2 and 23 be found allowable, claims 62 and 65 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 62 and 65 are claims 2 and 23 rewritten as independent claims, respectively.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
In the event the determination of the status of the application as subject to AIA (or as subject to pre-AIA ) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the rationale supporting the rejection would be the same under either status.
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.
Claims 1-3, 5, 7, 8, 15, 16, 19, 23, 24, 31, 38, 39, 46, 51-53, 60 and 62-66 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 62 and 63 recite “the processed sample”. There is no antecedent basis for the limitation.
Claims 2, 62 and 63 recite “the device”. There is no antecedent basis for the limitation. It appears that the limitation should be “the body”.
In claim 16, there is no antecedent basis for “the further Peltier device”. It appears that it should be “the further Peltier assembly”.
Claims 16 and 24 recite “preferably…”. Such recitation renders the claims indefinite because it is unclear whether the recitation intends to further limit the claimed invention.
Likewise, claims 19, 51 and 66 are indefinite due to the recitations “could comprise”, “may be”, “for example” and “such as”, which are considered indefinite for the same reason as “preferably”.
In addition, claim 51 recites the trademark/trade name Bluetooth®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b). See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
The scope of claims 23 and 65 is rendered indefinite by the recitation that attributes the fluorophore emission to the optical system. According to claim 1 and earlier recitation in 65, fluorescence emission originates from the sample. It is unclear whether claims 23 and 65 intend the sample to be a part of the optical system.
Claim 46 is indefinite because it recites that the light source comprises photo-diodes, which detect light. It is unclear whether the claim intends to recite light-emitting diodes (LED).
Claim 60 is indefinite because it recites alternative embodiments, yet the second embodiment refers to a feature (sample well(s)) introduced in the recitation of the first embodiment. Consequently, it is unclear what features are considered alternatives (e.g. does the second embodiment also comprise an exposure window?).
In addition, it is unclear to which well the limitation “the…sample well” refers in the second alternative. The claim previously introduces “a plurality of sample wells”.
Claims not explicitly rejected are rejected due to dependency.
Any changes made to the claims to correct antecedent basis may require changes to other claims that were not rejected since the rejected claims provide antecedent basis.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 5, 7, 23, 51-53, 60 and 62-66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Egan et al. (“Egan”) (US 2014/0295441 A1).
With respect to claim 1, Egan discloses an apparatus for processing and analyzing a biological sample, the apparatus comprising (see Fig. 1):
a) an apparatus housing 100 (analyzer 100 must have a physical housing);
b) a sample extraction system 400 (see Fig. 4) configured to receive and hold the biological sample, and to provide an extract of the biological sample into a microfluidic chip 415 (see Fig. 4 and [0026] disclosing that extraction occurs within “sample acceptor”, which is element 400);
c) a thermal system 110/115 configured to control the temperature of the biological sample in the sample extraction system (module 110 controls temperature in the extraction system 400, see [0026]), and to independently control the temperature of the extracted biological sample in the microfluidic chip (module 115 controls temperature in the chip, see [0027]);
d) an optical system 130 comprising at least one light source configured to illuminate the sample in the chip and to generate fluorescence from the sample in the chip (see [0032]-[0033]), and an optical detector configured to detect the fluorescence and generate an output signal indicative of the fluorescence (see [0032]); and
e) at least one controller 140/145 configured to control the sample extraction system, the thermal system and the optical system (see arrows depicting communication in Fig. 1), the controller being configured to receive and process the output signal from the optical system to determine one or more properties of the sample (see [0033]).
With respect to claim 2, the sample extraction system 400 is configured to receive or hold a body at least partially formed of a heat-deformable material*.
*The recitation not explicitly addressed in the rejection is directed to an article worked upon. According to the claim language, the body is not a part of the claimed invention. It is merely an article intended to be received/held by the sample extraction system. Consequently, prior art need not teach the body to reject the claim. The claim is anticipated if the sample extraction system of the prior art is simply capable of holding a body having the claimed features. In this case, because the claim does not further limit the dimensions/size of the body, the sample extraction system is deemed to be capable of holding a body having the claimed features, provided such a body is provided to be held by the sample extraction system.
With respect to claim 3, the sample extraction system 400 comprises a sample holder 425 comprising at least one cavity in which a sample is held (see Fig. 4 and [0044] disclosing that element 425 is a barrel).
With respect to claim 5, the sample holder 425 comprises a sample holding block (portion of holder 425 in physical contact with thermal module 610, see Fig. 6), the sample holding block being a thermal block configured to be temperature-regulated by the thermal system (see [0048]-[0049] and Fig. 6).
With respect to claim 7, thermal system is controlled by the at least one controller according to:
a sample extraction algorithm in which the thermal system thermally regulates the sample in the sample extraction system (see [0048]); and subsequently according to:
a sample analysis algorithm in which the thermal system thermally regulates the sample during analysis (PCR) of the sample (see [0054]).
With respect to claim 23, the optical system is configured to generate spectrally discrete excitation and fluorophore emission wavelengths bands such that an optical signal received at the optical detector can be attributed to one excitation wavelength and matching target fluorophore pair (see [0060] disclosing that the optical system comprises a light source, e.g. laser, that excites fluorescent molecules).
With respect to claim 51, the apparatus comprises an electrical power source in the form of a battery (see [0029]).
With respect to claim 52, the apparatus further comprises the sample microfluidic chip (cartridge, see [0025]) configured to receive the extracted sample from the sample extraction system (see Fig. 4), and locate the extracted sample in a desired position (inside the chip) in the apparatus.
With respect to claim 53, the microfluidic chip 415 is substantially oblong (see Fig. 4), and it can be inserted into a chip slot 105 in the apparatus (see [0025]).
With respect to claim 60, Egan discloses that the chip comprises a sample well 730 in which amplification occurs, wherein the sample well 730 is in contact with the thermal system 740 that performs thermal cycling associated with amplification (see Fig. 7). Naturally, the sample well 730 comprises a thermal surface configured to be thermally regulated by the thermal system 740.
With respect to claim 62, it is claim 2 rewritten as an independent claim. Because claim 2 is rejected (see above), claim 62 is rejected.
With respect to claim 63, Egan discloses an apparatus comprising elements a) through e), as discussed above (see rejection of claim 1). Moreover, as discussed above (see rejection of claim 2), the limitations directed to the body merely further limit an intended use of the sample extraction system. The sample extraction system taught by Egan anticipates the intended use, as discussed above (see rejection of claim 2).
With respect to claim 64, Egan discloses an apparatus comprising elements a) through e), as discussed above (see rejection of claim 1). Moreover, the sample extraction system comprises a sample holder comprising a plurality of cavities 425 each configured to hold a respective biological sample (see Fig. 4). Naturally, the apparatus is configured to simultaneously hold and analyze a plurality of samples.
With respect to claim 65, it is claim 23 rewritten as an independent claim. Because claim 23 is rejected (see above), claim 65 is rejected.
With respect to claim 66, the apparatus is configured to analyze the sample in the microfluidic chip using PCR (see [0039]).
Claim Rejections - 35 USC § 103
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.
Claims 8, 15, 16, 19 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Egan in view of Goel (US 2016/0016171 A1).
With respect to claim 8, Egan discloses that the thermal system can perform contact heating using contact heating units (see [0026] and Fig. 6 illustrating elements 610), and it further comprises a cooling system to enable thermal cycling necessary for performing PCR (see [0054]), wherein the thermal system is controlled by a controller 145 (see Fig. 1).
However, Egan does not disclose the specifics of how contact heating is achieved. That said, 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 any conventional contact-based heating mechanism suitable for use within the apparatus taught by Egan, for example a Peltier assembly, as taught by Goel (see [0105] disclosing a microfluidic PCR chip that uses Peltier elements to heat the chip). Via use of current, Peltier elements can alter temperature quickly, which is ideal for PCR. If the modification is made, then the Peltier assembly of the modified Egan apparatus would be controlled by the thermal controller 145.
With respect to claim 15, given that the thermal system comprises separate modules 110 and 115 (one for extraction and one for amplification, see Fig. 1), the modified thermal system would naturally comprise multiple Peltier assemblies, specifically a first Peltier assembly 110 configured to thermally regulate the sample when the sample is in the sample extraction system, and a further Peltier assembly 115 configured to regulate the sample when the sample is being amplified in the microfluidic chip.
With respect to claim 16, given that Egan teaches contact heating, it is evident that the further Peltier assembly would comprise a Peltier device positioned adjacent the microfluidic chip (i.e. in contact with the chip).
With respect to claim 19, the subject matter of the claim is directed to an alternative embodiment not chosen to reject claim 16. Absent the claim first positively limiting the scope of claimed apparatus to the embodiment comprising a thermal plate, limitations directed to the thermal plate need not be addressed.
With respect to claim 39, other than schematic disclosure broadly disclosing that the optical system 960 is situated above the chip (see Fig. 9), Egan is silent regarding the manner in which the optical system directs and receives light from the sample. Consequently, Egan does not disclose an optical system comprising a dichroic filter positioned between the sample in the microfluidic chip and the optical detector. Nevertheless, based on the lack of specific details regarding the optical system, 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 apparatus with any conventional optical system that is consistent with the schematic disclosure provided by Egan. For example, Goel discloses a microfluidic chip-based PCR apparatus (see Fig. 1 and [0103]), wherein the apparatus uses an optical system comprising a dichroic filter to detect PCR products (see [0166] and Fig. 9B). Specifically, the filter is situated between the PCR products and a photodetector, and the filter blocks wavelengths corresponding to a light source used to excite the PCR products such that only fluorescence emitted by the PCR products reaches the photodetector (see [0166] and Fig. 9B). In light of the disclosure of Goel, 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 optical system taught by Egan with a dichroic filter situated between the sample and the optical detector. The modification would eliminate detection of excitation light, which could potentially interfere with detection of fluorescence emitted by the sample.
Claims 24, 38 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Egan in view of Hasson et al. (“Hasson”) (US 2008/0003588 A1).
With respect to claim 24, Egan discloses a light source in the form of a laser (see [0032]). Consequently, it does not disclose a plurality of light sources. However, 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 optical system with a plurality of light sources, for example an array of LEDs as taught by Hasson (see [0137] disclosing a microfluidic PCR chip that utilizes an array of LEDs as a source of excitation light). The modification would enable the optical system to produce a spectrum of wavelengths not possible with a single laser.
With respect to claim 38, the subject matter of the claim is directed to an intended use of claimed apparatus. Because the claimed invention is directed to an apparatus (as opposed to a method), the patentability of the claimed apparatus is based on the apparatus itself, not how it is used. Nevertheless, Egan discloses that the apparatus performs PCR (see abstract), which inherently involves subjecting a sample to multiple temperature cycles, and the sample is analyzed optically after amplification (see [0003]).
With respect to claim 46, as discussed above (see rejection of claim 24), the light source of the modified Egan apparatus would comprise an array of diodes.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Egan in view of Hasson as applied to claims 24, 38 and 46 above, and further in view of Goel.
With respect to claim 31, as discussed above (see rejection of claim 39), Egan is silent regarding the manner in which the optical system directs and receives light from the sample. While the schematic disclosure suggests that the optical detector is spaced vertically from the chip so as to define a straight, vertical fluorescence path between the chip and the optical detector (see Fig. 9), Egan does not explicitly disclose the subject matter of claim 31. Nevertheless, based on the lack of specific details regarding the optical system, 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 apparatus with any conventional optical system that is consistent with the schematic disclosure provided by Egan. For example, Goel discloses a microfluidic chip-based PCR apparatus (see Fig. 1 and [0103]), wherein the apparatus uses an optical system comprising a light source 1002 and an optical detector 1012 arranged on opposite sides of the chip (see Fig. 9B). Specifically, the optical detector 1012 is spaced vertically from the chip so as to define a straight, vertical fluorescence path between the chip and the optical detector, and light from the light source 1002 travels along a path 1004 that is perpendicular to the fluorescence path (see Fig. 9B). Since Egan is silent regarding the arrangement of the light source and optical detector, 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 the arrangement of light source and detector taught by Goel, which is considered conventional.
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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/PAUL S HYUN/Primary Examiner, Art Unit 1796