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 .
Claim Objections
Claims 1-3, 6 and 8 are objected to because of the following informalities: In claims 1-3, 6 and 8, “the reaction well” should read – the at least one reaction well – for consistency. Appropriate correction is required.
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 blocking member” in claim 1; “a blocking member-receiving portion” in claim 2; “a storage portion” 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 § 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 1-14 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 limitation "the reaction wells" in line 7. There is insufficient antecedent basis for this limitation in the claim. Claims 2-8 are included in this rejection by virtue of their dependency upon a rejected base claim.
The term “narrow” in claim 3 is a relative term which renders the claim indefinite. The term “narrow” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 6 recites the limitation "a blocking member-receiving portion concavely formed on the body frame, disposed corresponding to each reaction well" in line 5. There is insufficient antecedent basis for this limitation in the claim. Claims 1 and 6 require only one reaction well, and it is unclear which reaction wells are being referred to by “each reaction well.” Moreover, it is unclear if claim 6 requires a single blocking member as previously recited in independent claim 1 or multiple blocking members.
Claim 9 recites the limitation "the receptacle" in line 5. It is unclear whether said limitation is referring to one of the plurality of receptacles or the reaction receptacle recited earlier in the claim. Claims 10-11 are included in this rejection by virtue of their dependency upon a rejected base claim.
Claim 12 recites the limitation "the receptacle" in line 9. It is unclear if said limitation is referring to one of the plurality of receptacles or the reaction receptacle recited earlier in the claim. Claims 13-14 are included in this rejection by virtue of their dependency upon a rejected base claim.
Appropriate correction is required.
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 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (already or record, US 2021/0053059; hereinafter “Park”).
Regarding claim 1, Park discloses a PCR plate comprising: a body having at least one reaction well (FGIS. 1-4: plate (200) reaction well (W); [0060]); an insertion portion extending from the body to be inserted into a nucleic acid extraction cartridge and having an injection port, into which a nucleic acid solution is injected (FIG. 3: portion (CC) of the PCR plate having an injection hole (h1); [0067]); a flow channel, along which the nucleic acid solution flows from the injection port to the reaction wells (FIGS. 3-4: flow channel unit (J); [0066]); and a blocking member mounted on the body and blocking a reverse flow of the nucleic acid solution from the at least one reaction well towards the flow channel (e.g., see FIGS. 2-3: valve (V); [0072]).
Regarding claim 5, Park further discloses wherein the blocking member comprises an elastic material ([0094]).
Therefore, Park meets and anticipates the limitations set forth in claims 1 and 5.
Claim 9 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (already or record, US 2022/0176373; hereinafter “’373”).
Regarding claim 9, ‘373 discloses a nucleic acid extraction cartridge comprising: a cartridge cover formed with a plurality of receptacles each receiving a solution for DNA extraction and having a partition structure (FIGS. 13-15: cover (R1) having partitioned receptacles (22-26); [0134]); and a cartridge body coupled to the cartridge cover through an insertion structure and formed with a reaction receptacle in which the solution supplied from the receptacles reacts with a specimen or is purified (FIGS. 13-15: cartridge body portion (R2) coupled to the cartridge cover portion (R1) in an insertion manner and includes a reaction accommodating portion (11); [0134]).
Therefore, ’373 meets and anticipates the limitations set forth in claim 9.
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.
Claim(s) 1-3, 6-8 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘373 (already or record, US 2022/0176373) in view of Baltekin et al. (US 2021/0008554; hereinafter “Baltekin”).
Regarding claim 1, ‘373 discloses a PCR plate comprising: a body having at least one reaction well (FIG. 8: PCR plate (200) including reaction wells (W); [0095]-[0097]); an insertion portion extending from the body to be inserted into a nucleic acid extraction cartridge and having an injection port, into which a nucleic acid solution is injected (FIG. 8: portion (220) having injection portion (h1); [0096]); and a flow channel, along which the nucleic acid solution flows from the injection port to the reaction wells (FIG. 8: channel 231; [0096], [0101]). ‘373 does not explicitly disclose a blocking member mounted on the body and blocking a reverse flow of the nucleic acid solution from the at least one reaction well towards the flow channel. Baltekin discloses a microfluidic device comprising a plate (substrate (110); FIG. 1; [0042])), a flow output channel (140; FIG. 1; [0042]), a plurality of flow channels (FIG. 1: channel 120) connected to the flow output channel ([0042]). The plurality of flow channels include blocking member (obstructions 125) designed to prevent flow of materials from the plurality of flow channels to the flow output channel ([0042]). In view of Baltekin, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the blocking member of Baltekin adjacent to the entrance of the at least one reaction well of the plate of ‘373 to arrive at the claimed invention. One of ordinary skill in the art would have made said modification in order to regulate fluid flow between components of a plate as suggested by Baltekin.
Regarding claim 2, modified ‘373 discloses wherein the body comprises: a body frame having the at least one reaction well (FIG. 8: PCR plate (200) including reaction wells (W); [0095]-[0097]); a connecting channel connecting (see FIG. 8 of ‘373, annotated and reproduced below); a storage portion concavely formed on the body to communicate with the flow channel and receiving the nucleic acid solution supplied thereto (see FIG. 8 of ‘373, annotated and reproduced below); and a channel guide communicating with the storage portion (see FIG. 8 of ‘373, annotated and reproduced below).
PNG
media_image1.png
803
580
media_image1.png
Greyscale
Modified ‘373 does not explicitly disclose a blocking member-receiving portion concavely formed on the body frame and receiving the blocking member therein. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of the blocking member on the PCR plate such that the blocking member is received in a blocking member-receiving portion concavely formed on the body frame, because such modification would have been a matter of an engineering design choice which a person of ordinary skill in the art would have found obvious since the claimed blocking member would not perform differently than the prior art device of modified ‘373.
Regarding the limitations “a connecting channel connecting the blocking member-receiving portion to the at least one reaction well; a storage portion concavely formed on the body to communicate with the flow channel and receiving the nucleic acid solution supplied thereto; and a channel guide communicating with the storage portion and guiding the nucleic acid solution to flow toward the blocking member,” the blocking member of ‘373 is arranged adjacent the entrance of the at least one reaction well and PCR plate of modified ‘373 thus meets said limitations.
Regarding claim 3, modified ‘373 does not explicitly disclose wherein the connecting channel has a bottleneck formed from the blocking member towards the at least one reaction well and having a narrow width. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the connecting channel of modified ‘373 to comprised the claimed shape for the purpose of regulating and achieving desired fluid flow into the at least one reaction well.
Regarding claim 6, modified further discloses wherein the body comprises: a body frame having the at least one reaction well ((FIG. 8: PCR plate (200) including reaction wells (W); [0095]-[0097]); and a connecting channel connecting (see FIG. 8 of ‘373, annotated and reproduced above) the blocking member-receiving portion to the at least one reaction well (blocking member of modified ‘373 is in fluidic communication with the connecting channel. Modified ‘373 does not explicitly disclose a blocking member-receiving portion concavely formed on the body frame, disposed corresponding to each reaction well, and formed in a circular shape to receive the blocking member having a circular shape. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of the blocking member on the PCR plate such that the blocking member is received in blocking member-receiving portion concavely formed on the body frame, and formed in a circular shape to receive the blocking member having a circular shape, because such modification would have been a matter of an engineering design choice which a person of ordinary skill in the art would have found obvious since the claimed blocking member would not perform differently than the prior art device of modified ‘373.
Regarding claim 7, modified ‘373 does not explicitly disclose wherein the blocking member comprises an elastic material. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the blocking member of modified ‘373 with elastic material, because doing so would have been the simple substitution of one known material for another for the predictable result of forming a blocking member. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Regarding claim 8, modified ‘373 further discloses wherein a sheet member is joined to the at least one reaction well (transparent cover film; see ‘373 at [0099]). Furthermore, the limitation “by thermal fusion” does not add any additional structural limitation to the claimed sheet member.
Regarding claim 12, ‘373 discloses a nucleic acid extraction cartridge assembly comprising: a nucleic acid extraction cartridge (FIGS. 13-15); and a PCR plate receiving a nucleic acid solution supplied from the nucleic acid extraction cartridge in a reaction well receiving a dried PCR mixture (FIG. 8: PCR plate (200) including reaction wells (W); [0095]-[0097]), wherein the nucleic acid extraction cartridge comprises: a cartridge cover formed with a plurality of receptacles each receiving a solution for DNA extraction and having a partition structure (FIGS. 13-15: cover (R1) having partitioned receptacles (22-26); [0134]); and a cartridge body coupled to the cartridge cover through an insertion structure and formed with a reaction receptacle in which the solution supplied from the receptacle reacts with a specimen or is purified (FIGS. 13-15: cartridge body portion (R2) coupled to the cartridge cover portion (R1) in an insertion manner and includes a reaction accommodating portion (11); [0134]), and wherein the PCR plate comprises: a body having at least one reaction well (FIG. 8: PCR plate (200) including reaction wells (W); [0095]-[0097]); an insertion portion extending from the body to be inserted into the nucleic acid extraction cartridge and having an injection port, into which the nucleic acid solution is injected (FIG. 8: portion (220) having injection portion (h1); [0096]); and a flow channel, along which the nucleic acid solution flows from the injection port to the at least one reaction well (FIG. 8: channel 231; [0096], [0101]). ‘373 does not explicitly disclose a blocking member mounted on the body and blocking a reverse flow of the nucleic acid solution from the at least one reaction well towards the flow channel. Baltekin discloses a microfluidic device comprising a plate (substrate (110); FIG. 1; [0042])), a flow output channel (140; FIG. 1; [0042]), a plurality of flow channels (FIG. 1: channel 120) connected to the flow output channel ([0042]). The plurality of flow channels include blocking member (obstructions 125) designed to prevent flow of materials from the plurality of flow channels to the flow output channel ([0042]). In view of Baltekin, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the blocking member of Baltekin adjacent to the entrance of the at least one reaction well of the plate of ‘373 to arrive at the claimed invention. One of ordinary skill in the art would have made said modification in order to regulate fluid flow between components of a plate as suggested by Baltekin.
Regarding claim 13, modified ‘373 discloses wherein the cartridge cover comprises a sealing portion contacting one side surface of each of the receptacles of the cartridge body (receptacles are sealed with a film or the like; [0138]). ‘373 does not explicitly disclose wherein the sealing portion is rubber portion comprising an elastic material. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the sealing portion of modified ‘373 with rubber comprising an elastic material, because doing so would have been the simple substitution of one known material for another for the predictable result of forming a sealing portion sealing receptacles. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Regarding claim 14, modified ‘373 discloses wherein the nucleic acid extraction cartridge is provided with a sealing member and preventing leakage of the nucleic acid solution (nucleic acid extraction cartridge (R2) includes at least one seal; [0148]). ‘373 does not explicitly disclose wherein the sealing member is rubber member comprising an elastic material. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the sealing member of modified ‘373 with rubber comprising an elastic material, because doing so would have been the simple substitution of one known material for another for the predictable result of forming a sealing member sealing components. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘373 as applied to claim 9 above.
Regarding claim 10, ‘373 discloses the nucleic acid extraction cartridge according to claim 9 as set forth above. ‘373 discloses wherein the cartridge cover comprises a sealing portion contacting one side surface of each of the receptacles of the cartridge body (receptacles are sealed with a film or the like; [0138]). ‘373 does not explicitly disclose wherein the sealing portion is rubber portion comprising an elastic material. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the sealing portion of ‘373 with rubber comprising an elastic material, because doing so would have been the simple substitution of one known material for another for the predictable result of forming a sealing portion sealing receptacles. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Regarding claim 11, ‘373 discloses wherein the nucleic acid extraction cartridge is provided with a sealing member and preventing leakage of the nucleic acid solution (nucleic acid extraction cartridge (R2) includes at least one seal; [0148]). ‘373 does not explicitly disclose wherein the sealing member is rubber member comprising an elastic material. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the sealing member of ‘373 with rubber comprising an elastic material, because doing so would have been the simple substitution of one known material for another for the predictable result of forming a sealing member sealing components. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Allowable Subject Matter
Claim 4 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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 on 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LIBAN M HASSAN/Primary Examiner, Art Unit 1799