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 .
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. A copy of Korean Application KR10-2022-0084850 has been filed with priority date of 11 July 2022.
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: “a temperature expressing member for expressing the internal temperature of the PCR chamber …” in claim 6. For the purposes of examination the temperature expressing member will be interpreted as micro-encapsulated temperature sensitive materials and an infrared plate (see [0026] of specification and claim 8). Therefore, the disclose provides sufficient structure for performing the function of expressing an internal temperature.
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 § 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.
Claim 11 is 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 11 recites the limitation "the laser heating device" in line 2. There is insufficient antecedent basis for this limitation in the claim as claim 11 depends from claim 1 and a laser heating device was not introduced in the claims until claim 5.
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Korean Publication KR1020190074733A to Yoo et al. (herein Yoo) as cited on the 12 July 2023 IDS (see machine translation provided) in view of “Non-contact Temperature Control System Applicable to Polymerase Chain Reaction on a Lab-on-a-Disc” to Ko et al. (herein Ko).
Regarding Claim 1, Yoo discloses a lab-on-a-disk device (i.e., PCR disc apparatus) comprising a lab-on-a-disk 100 for performing polymerase chain reaction DNA amplification (i.e., PCR disc) (see [0113]; [0172-0174]; Figs. 1-4 & 11) comprising: a cell destruction chamber 29a (i.e., sample chamber) ([0174]; Figs. 1-4); a DNA amplification chamber 29b (i.e., PCR chamber) (see [0174]; Figs. 1-4); and a valve 14 comprising a tunneling channel connecting the sample chamber 29a to the PCR chamber 29b ([0049]; [0208]; Figs. 1-3), wherein the tunneling channel is formed by perforated thermoplastic resin (see [0049]; [0211]) disposed on an inlet channel of the PCR chamber 29b in such a way as for the perforation to pass through the thermoplastic resin (see Figs. 1-3).
Yoo fails to disclose a tunneling channel “formed by a micro-needle built in a thermoplastic resin” as recited in the instant claims.
Note that the claim is directed toward a PCR disc apparatus itself and not the method of making said PCR disc apparatus. Therefore, forming the tunneling channel by using a micro-needle built into the thermoplastic resin is not limiting as the end result would be the same product. The patentability of a product does not depend on its method of production (see MPEP 2113 Product-by- Process). Furthermore, “Non-Contact Temperature Control System Applicable to Polymerase Chain Reaction on a Lab-on-a-Disc” to Ko discloses using a microneedle to create a tunneling channel in thermoplastic resin (see 3.1. Sealing of Reagents).
Yoo and Koo are analogous in the field of PCR amplification devices. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the tunneling channel of Yoo to be a micro-needle tunneling channel formed by a micro-needle built in a thermoplastic resin as recited in the instant claims for the benefit of creating a tunnel that reliably and tightly seals a chamber when melted (see 3.1. Sealing of Reagents).
Regarding Claim 2, the combination of references above render obvious the invention of claim 1 and for the micro-needle to create the perforation (i.e., tunnel) of the thermoplastic resin, there must be an outlet through which the micro-needle is removed. Yoo discloses the PCR disc 100 is subjected to centrifugal force to control movement within the PCR disc 100 (see [0245]; [0284]). As Yoo in view of Ko renders obvious all the structural limitations of claim 2, the invention of claim 2 is therefore obvious. How the micro-needle is removed to form the PCR disc is not limiting when it comes the PCR disc apparatus itself (see MPEP 2113 Product-by- Process).
Regarding Claim 3, the combination of references above render obvious the invention of claim 1. Yoo fails to disclose all the limitations as recited, however, the instant invention is directed toward a PCR disc apparatus and not the method by which it was manufactured. The patentability of a product does not depend on its method of production (see MPEP 2113 Product-by- Process). Therefore, Yoo meets the limitations of claim 3.
Regarding Claim 4, the combination of references above render obvious the invention of claim 1 and Yoo discloses the thermoplastic resin is melted using laser heating to allow the tunneling channel to be melted so the inlet channel of the PCR chamber is closed (see [0049];[0211]).
Regarding Claim 5, the combination of references above render obvious the invention of claim 1 and Yoo discloses a driving control unit having a disk rotation motor 102 adapted to rotate the PCR disc 100 or stop the PCR disc 100 (see [0304-0313]; Fig. 11); a laser heating device 44 for heating the PCR chamber (see [0307]; Fig. 11); and a non-contact temperature sensor 46b for measuring an internal temperature of the PCR chamber (see [0237]; Fig. 3b).
Regarding Claim 6, the combination of references above render obvious the invention of claim 5 and Yoo discloses a heating film 30b that is stored inside the PCR chamber 29b to absorb heat generated from the laser heating device 44 or transfer the absorbed heat (see [0179]; Figs. 103); and a temperature display means (i.e., temperature expressing member) 24b/25b for expressing the internal temperature of the PCR chamber 29b through change in color or infrared light (see [0179]; Figs. 1 & 3).
Regarding Claim 7, the combination of references above render obvious the invention of claim 6 and Yoo discloses the heating film is a black film, a Vanta black sheet, or metal plate with a black coated surface (see [0096]).
Regarding Claim 8, the combination of references above render obvious the invention of claim 6 and Yoo discloses wherein the temperature expressing member is a combination of a micro-encapsulated temperature sensitive material 24b and an infrared radiator 25b comprising a metal plate (see [0065]; [0203-0207]; Figs. 1 & 3).
Regarding Claim 9, the combination of references above render obvious the invention of claim 8 and Yoo discloses wherein the non-contact temperature sensor is an image sensor for reading a change in color or transparency of the micro encapsulated temperature sensitive material or an infrared sensor for measuring the amount of infrared emitted from the infrared radiator ([0054]; [0065]).
Regarding Claim 10, the combination of references above render obvious the invention of claim 1 and Yoo discloses a sample inlet 28a for injecting a sample into the sample chamber 29a to temporarily store the sample (see [0026]; [0284]; Figs. 1-4 & 9); and an excess chamber 15 for storing excess of the sample exceeding the capacity (i.e., fixed amount) of the PCR chamber (see [0048]; [0208]; Figs. 1-3).
Regarding Claim 11, the combination of references above render obvious the invention of claim 1 and Yoo discloses the thermoplastic resin is melted using a laser heating device 44 to allow the tunneling channel to be melted so the inlet channel of the PCR chamber is closed (see [0049]; [0211]), wherein the laser heating device 44 is for heating the PCR chamber (see [0307]; Fig. 11) and a slider 211 movable in a radial direction of the PCR disc 100 (see [0290]; Fig. 10).
Regarding Claim 12, the combination of references above render obvious the invention of claim 1 and Yoo discloses peptide nucleic acid (PNA) probes disposed in the PCR chamber to bind PNA to DNA through hybridization, wherein PNA binds to normal DNA having a normal target sequence and does not bind to mutated target DNA and the normal DNA bound to the PNA is not amplified and the mutated DNA not bound to the PNA is amplified so the presence or absence of a disease or mutation is easily determined (see [0031-0032]).
Regarding Claim 13, the combination of references above render obvious the invention of claim 1 and Yoo discloses wherein the Thermoplastic resin is black thermoplastic resin (see [0001]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E LIMBAUGH whose telephone number is (571)272-0787. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797