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 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 1-21 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 is unclear reciting “a liquid handling device of a sample preparation unit of the molecular diagnostic system; wherein the molecular diagnostic system comprises a sample preparation unit [...]” because it is unclear whether the sample preparation unit in L4 is the same as the sample preparation unit in L5.
Claims 1, 3 & 4 are unclear reciting ‘gate-type opening’, ‘non-gate-type opening’ because it is unclear whether the applicant is claiming structures or method steps. Claims 2, 5-7, 15-18, 20, 21 are unclear because the claims do not set forth any steps involved in the method. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
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.
Claim limitation ‘configured to’ has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “means” or generic placeholder is modified by a word, which is ambiguous regarding whether it conveys structure or function; and/or the claim limitation uses the word “means” or a generic placeholder coupled with functional language, but it is modified by some structure or material that is ambiguous regarding whether that structure or material is sufficient for performing the claimed function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanamaru (Kanamaru et al. WO 2020/090159 A1; see US equivalent US 2022/0074960 A1) in view of Wilson (Wilson et al. US 2015/0337400 A1).
Regarding claim 1, Kanamaru teaches:
Claim 1. A method for processing and analyzing a sample in a molecular diagnostic system comprising:
(a) preparing an analysis sample in a reaction vessel using a liquid handling device of a sample preparation unit of the molecular diagnostic system; wherein the molecular diagnostic system comprises a sample preparation unit (e.g., sample pretreatment device), a sample analysis unit (e.g., analysis device), and a transport device (e.g., sample conveyance unit); wherein the sample preparation unit, the sample analysis unit, and the transport device are enclosed (e.g., housing); wherein the sample preparation unit and the sample analysis unit are aligned such that the reaction vessel is transportable from the sample preparation unit to the sample analysis unit by the transport device; (b) transporting the reaction vessel from the sample preparation unit to the sample analysis unit by the transport device through a passage formed by a first local opening of the sample analysis unit and a second local opening of the sample preparation unit; and (c) analyzing the analysis sample accommodated in the reaction vessel in the sample analysis unit; wherein the second local opening of the sample preparation unit is located at a lower surface or a side surface of the sample preparation unit; wherein the first local opening of the sample analysis unit is located at an upper surface or a side surface of the sample analysis unit (see ¶ 0010-0013, 0052-0061, 0074, 0094-0096, claim 10, and Figs. 1 and 5);
wherein the first local opening of the sample analysis unit is capable of being opened during the transporting step, and closed during the sample preparation and sample analysis of steps (see ¶ 0019-0022, 0052-0061).
However, Kanamaru does not explicitly teach: amplifying the analysis sample accommodated in the reaction vessel in the sample analysis unit.
Wilson teaches controlled amplification of specific nucleic acid sequences and detection of the amplification products (¶ 0171+) using a PCR system comprising: a sample preparation unit; a sample analysis unit; and an XYZ transfer means for transferring a reaction container between the sample preparation unit and the sample analysis unit, wherein: the sample preparation unit and the sample analysis unit are separated by a physical barrier such as a partition in order to reduce contaminants; the used reaction container moves from the sample preparation unit to a waste storage area by the XYZ transfer means (Abstract, ¶ 0180-0185+).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kanamaru with the amplification and analysis specific nucleic acids, as taught by Wilson, since amplification improves analytical sensitivity by generating sufficient copies of nucleic acids found in the sample; and may also improve analytical specificity by selectively generating only those nucleic acids of clinical interest (Wilson ¶ 0003+).
With regard to limitations in claims 2, 5-7, 15-21 (e.g., [...] to perform UV irradiation while the molecular diagnostic system is maintained in a non-operational state and/or while performing step (c); [...] to form an air-out flow; [...] capable of [...], etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). It has been held that to be entitled to weight in method claims, the recited structure limitations therein must affect the method in a manipulative sense, and not to amount to the mere claiming of a use of a particular structure. Further, reciting “configured to” without identifying any structural differences between the structure in the claims and the structure disclosed by the prior art does not further limit the claims.
Regarding claims 3, 4, 8-11, 14, 15, 19, modified Kanamaru teaches:
Claim 3. The method of claim 1, wherein the second local opening of the sample preparation unit is an opening (see ¶ 0108 for example).
Claim 4. The method of claim 3, wherein the second local opening of the sample preparation unit is located at a lower surface of the sample preparation unit (a lower surface is sufficiently broad to have read on the opening 111 in ¶ 0094 and Fig. 5).
Claim 8. The method of claim 1, wherein the system further comprises a sealer in the sample preparation unit or the sample analysis unit (see ¶ 0076, and Figs. 3 and 4).
Claim 9. The method of claim 8, wherein the transporting of the reaction vessel comprises transporting the reaction vessel containing the analysis sample to the sealer in the sample preparation unit through the liquid handling device, and transporting the sealed reaction vessel to the sample analysis unit by the transport device (see ¶ 0086, 0102-0103 for example).
Claim 10. The method according to claim 8, wherein the transporting of the reaction vessel comprises transporting the reaction vessel containing the analysis sample to the sample analysis unit by a lift module of the transport device, transporting the reaction vessel to a sealer of the sample analysis unit by a crane module of the transport device, and transporting the reaction vessel sealed in the sealer to a sample analysis device of the sample analysis unit by the crane module of the transport device (see ¶ 0077, 0086, 0102-0103 for example).
Claim 11. The method of claim 1, wherein the sample preparation unit comprises a liquid handling device and a deck in which the reaction vessel, a reagent container, and a sample container are located (this limitation is sufficiently broad to have read on the housing, see Abstract and Figs. 1, 3 and 4 for example).
Claim 14. The method of claim 1, further comprising, after the step (c) is performed, discarding the reaction vessel by a crane module of the transport device (see ¶ 0083, and Figs. 3 and 4).
Claim 15. The method of claim 1, wherein the step (b) comprises: (b1) when preparing the analysis sample of the step (a) is completed, placing the transport device at a position capable of accommodating the reaction vessel; (b2) mounting the reaction vessel on the transport device by the liquid handling device; and (b3) transporting the mounted reaction vessel to the sample analysis unit by the transport device through a passage formed by the first local opening of the sample analysis unit and the second local opening of the sample preparation unit (see ¶ 0057-0060, 0094, 0102-0103, and Fig. 5).
Claim 19. The method according to claim 1, wherein the sample analysis unit comprises a sample analysis device, and the transporting step of the step (b) comprises: (b4) transporting the reaction vessel from the sample preparation unit to the sample analysis unit by a transport device through the passage formed by the first local opening of the sample analysis unit and the second local opening of the sample preparation unit; (b5) preparing the reaction vessel to be accommodated by the sample analysis device when the transport device is located at a position where the reaction vessel can be transported to the sample analysis device; and (b6) mounting the reaction vessel to the sample analysis device by the transport device (see ¶ 0057-0060, 0094, 0102-0103, and Fig. 5).
Regarding claim 2, Kanamaru does not explicitly teach: Claim 2. The method of claim 1, wherein the sample preparation unit is configured to perform UV irradiation while the molecular diagnostic system is maintained in a non-operational state and/or while performing step (c).
Wilson teaches: a sample preparation unit is configured to perform UV irradiation while the molecular diagnostic system is maintained in a non-operational state and/or while performing step (c) (see ¶ 0196, 0199, 0588). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kanamaru with the UV irradiation, as taught by Wilson, to reduce the probability of or minimize the impact of inadvertent release of contaminants (Wilson ¶ 0196, 0199, 0588).
Regarding claims 5-7, Kanamaru teaches: the shutter for opening and closing the sample transfer opening of the sample preprocessing device is closed even when the sample accommodation opening of the sample analysis device is open, and thus blocks the flow of air between the sample preprocessing device and the sample analysis device, thereby stabilizing the internal temperature of the sample preprocessing device and the sample analysis device (see ¶ 0023). However, Kanamaru does not explicitly teach: Claim 5. The method of claim 1, wherein the sample analysis unit comprises a ventilation apparatus configured to form an air-out flow. Claim 6. The method of claim 5, wherein the ventilation apparatus is operated while said step (c) is performed. Claim 7. The method of claim 5, wherein the ventilation apparatus is not operated during the transporting of said step (b) and/or the sample preparing of said step (a).
Wilson teaches: a sample analysis unit has a fan for air flow; and the fan is linked with a temperature adjustment device in order to remove heat more efficiently, and is controlled by a controller that utilizes data provided by a sensor for adjusting the speed of the fan (see ¶ 0189, 0417, 0426 and 0688). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kanamaru with the fan, as taught by Wilson, to remove heat more efficiently (Wilson ¶ 0189, 0417+).
Regarding claim 12, Kanamaru does not explicitly teach: Claim 12. The method of claim 1, wherein said step (a) of preparing an analysis sample comprises: extracting, by the liquid handling device, a nucleic acid sample from a specimen; and preparing an analysis sample comprising the extracted nucleic acid and a reaction reagent.
Wilson teaches: preparing an analysis sample comprises: extracting, by the liquid handling device, a nucleic acid sample from a specimen; and preparing an analysis sample comprising the extracted nucleic acid and a reaction reagent (see ¶ 0192, 0193, 0196 and 0475). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kanamaru with extracting a nucleic acid sample from a specimen with an additional reagent necessary to perform PCR processing (Wilson Abstract, ¶ 0192, 0193, 0196 and 0475).
Regarding claim 13, Kanamaru does not explicitly teach: Claim 13. The method of claim 11, wherein the reagent container comprises a positive control vessel having a pierceable cap attached thereto, and wherein said step (a) of preparing the analysis sample comprises, preparing a positive control reaction mixture in the reaction vessel by the liquid handling device piercing the pierceable cap of the positive control vessel.
Wilson teaches: the reagent container comprises a pierceable cap (see ¶ 0250 and 0266). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kanamaru with a pierceable cap to protect sample tube contents (Wilson ¶ 0250). In addition, utilizing a positive control would have been obvious to ensure that the experimental setup is capable of producing the expected outcome, and confirming that the conditions are suitable for detecting the effect being tested.
Regarding claims 16-18 and 20-21, Kanamaru teaches: after the preprocessing of the liquid sample is completed, the microplate having the preprocessed liquid sample is accommodated by a grip device of the transfer unit; and the grip device downwardly moves to a determined position of the sample analysis device, and releases a grip so as to arrange the microplate at the determined position of the sample analysis device (see ¶ 102-103 and Fig. 5). However, Kanamaru does not explicitly teach: Claim 16. The method according to claim 15, wherein the step (b1) comprises: (b10) sensing, by the transport device, a preparation complete signal. Claim 17. The method according to claim 15, wherein the step (b2) comprises: (b20) mounting, the reaction vessel on the transport device by the liquid handling device detecting a transport ready signal. Claim 18. The method of claim 17, wherein the transport device comprises a position sensor, and the step (b2) comprises detecting, by the position sensor, that the transport device is positioned. Claim 20. The method according to claim 19, wherein the step (b5) comprises: (b50) detecting, by the sample analysis device, a transport ready signal. Claim 21. The method of claim 19, wherein the step (b6) comprises (b60) detecting, by the transport device, an accommodation ready signal.
Wilson teaches: wherein a rail is provided in the sample preparation unit for transferring an assay cartridge including a reaction container, and a sensor detects the presence of the assay cartridge in a pusher; a sensor for detecting the position of the analysis device is attached to the XYZ transfer means moving between the sample preparation unit and the sample analysis unit; and the PCR system comprises a sensor system including a sensing circuit for providing feedback (see ¶ 0205, 0244, 0396, 0544, 0614 and 0617 for example). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kanamaru with the teachings of Wilson for the purpose of monitoring the sample motion path and transfer means (Wilson ¶ 0244+).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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