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 .
Notes
All the objections and rejections in the previous Office Action not reiterated herein have been withdrawn.
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 6 and 8 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 6 recites the limitation "a blocking member-receiving portion concavely formed on the body frame, disposed corresponding to each of the plurality of reaction wells and formed in a circular shape to receive the blocking member having a circular shape" in lines 12-15. It is unclear whether a single blocking member is received into the blocking member-receiving portions of the plurality of reaction wells (as shown in FIG. 13), or each of blocking member-receiving portions of the wells receives an independent blocking member (FIG. 14).
Claim 8 is included in this rejection by virtue of their dependency upon a rejected base claim.
Appropriate correction is required.
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (already or record, US 2022/0176373; hereinafter “’373”) in view of Sweet et al. (US 2021/0163869; hereinafter “Sweet”) and Park et al (KR 20170024827-A; hereinafter “’827”).
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 one of the plurality of 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]), and wherein the cartridge cover is formed with a plurality of openings (FIG. 14: holes 21-1,21-2,27,28,29; [0138]). ‘373 does not explicitly disclose wherein the cartridge cover comprises a rubber portion contacting one side surface of each of the receptacles of the cartridge body and comprising an elastic material, wherein the rubber portion seals a space between the cartridge cover and the cartridge body during assembly of the cartridge cover and the cartridge body. Sweet discloses contacting a rubber portion with one side surface of receptacles of a body member (see FIG. 1: reservoir (102) having receptacles coupled to a gasket 116a; [0059]). The rubber portion seals a space between the cartridge cover and the cartridge body during assembly of the cartridge cover and the cartridge body (see FIG. 1). In view of Sweet, 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 coupled the gasket of Sweet to the receptacles of ‘373 in order to seal the receptacles from the external environment, as disclosed by Sweet ([0059]). One of ordinary skill in the art would have made said modification for the purpose of preventing contaminants from entering the interior of the nucleic acid extraction cartridge. Modified ‘373 does not explicitly disclose wherein each of the plurality of openings is provided with an anti-leakage rubber member for preventing leakage of a solution, and the anti-leakage rubber member comprises an elastic material. ‘827 discloses a stopper for sealing openings of a cartridge ([0122]). In view of ‘827, 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 stopper of ‘827 with the openings of the cartridge cover of ‘373 in order to seal the interior of the nucleic acid extraction cartridge from the external environment. One of ordinary skill in the art would have made said modification for the purpose of preventing contaminants from entering the interior of the nucleic acid extraction cartridge.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over ‘373 (already or record, US 2022/0176373) in view of Baltekin et al. (already of record; US 2021/0008554; hereinafter “Baltekin”), Sweet (US 2021/0163869) and ‘827 (KR 20170024827-A).
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 plurality of reaction wells 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 one of the plurality of 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 a plurality of reaction wells (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 plurality of reaction wells (FIG. 8: channel 231; [0096], [0101]), wherein the cartridge cover is formed with a plurality of openings (FIG. 14: holes 21-1,21-2,27,28,29; [0138]). ‘373 does not explicitly disclose a blocking member mounted on the body and blocking a reverse flow of the nucleic acid solution from the plurality of reaction wells 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. ‘373 does not explicitly disclose wherein the cartridge cover comprises a rubber portion contacting one side surface of each of the receptacles of the cartridge body and comprising an elastic material, wherein the rubber portion seals a space between the cartridge cover and the cartridge body during assembly of the cartridge cover and the cartridge body. Sweet discloses contacting a rubber portion with one side surface of receptacles of a body member (see FIG. 1: reservoir (102) having receptacles coupled to a gasket 116a; [0059]). The rubber portion seals a space between the cartridge cover and the cartridge body during assembly of the cartridge cover and the cartridge body (see FIG. 1). In view of Sweet, 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 coupled the gasket of Sweet to the receptacles of ‘373 in order to seal the receptacles from the external environment, as disclosed by Sweet ([0059]). One of ordinary skill in the art would have made said modification for the purpose of preventing contaminants from entering the interior of the nucleic acid extraction cartridge. Modified ‘373 does not explicitly disclose wherein each of the plurality of openings is provided with an anti-leakage rubber member for preventing leakage of a solution, and the anti-leakage rubber member comprises an elastic material. ‘827 discloses a stopper for sealing openings of a cartridge ([0122]). In view of ‘827, 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 stopper of ‘827 with the openings of the cartridge cover of ‘373 in order to seal the interior of the nucleic acid extraction cartridge from the external environment. One of ordinary skill in the art would have made said modification for the purpose of preventing contaminants from entering the interior of the nucleic acid extraction cartridge.
Allowable Subject Matter
Claims 1, 3 and 5 are allowed.
Claims 6 and 8 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.
Response to Arguments
Applicant’s arguments with respect to claims 9 and 12 have been considered but are moot in view of the new ground of rejection.
In response to the Applicant’s argument regarding the interpretation of claims limitation under 35 U.S.C. 112(f). 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. Claim limitation “a blocking member” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “member” coupled with functional language “blocking a reverse flow” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term "member" is not limited to a specific structure for performing the recited function(s). The term "member" is considered to be non-structure modifier that fails to recite sufficiently definite structure, material or acts to perform the claimed function. Claim limitation “a blocking member-receiving portion” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “portion” coupled with functional language “receiving the blocking member therein” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term "portion" is not limited to a specific structure for performing the recited function(s). The term "portion" is considered to be non-structure modifier that fails to recite sufficiently definite structure, material or acts to perform the claimed function. Claim limitation “a storage portion” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “portion” coupled with functional language “to communicate with the flow channel and receiving the nucleic acid solution supplied thereto” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term "portion" is not limited to a specific structure for performing the recited function(s). The term "portion" is considered to be non-structure modifier that fails to recite sufficiently definite structure, material or acts to perform the claimed function. 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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
Prosecution Insights