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 Group I, claims 1-3, 6, 9, 14-15, and 32-35 in the reply filed on 10/03/2025 is acknowledged.
Claims 19, 21-25, 28-29, and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/03/2025.
Drawings
The drawings are objected to because: In Fig. 10, the text and numbers are illegible due to the size. It is suggested to increase the text size within Fig. 10 to provide a more legible and clearer figure. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: In line 8, it is suggested to recite “reaction mix” as “the reaction mix” to improve antecedent basis to the previously established “reaction mix”. Appropriate correction is required.
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 32-34 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.
Regarding claim 32, claim 32 recites “it” in line 9. It is unclear which term is being referred to, i.e. is the “biological sample” or “the mixture” being referred to? For examination purposes, “it” is being interpreted as “the mixture”. It is suggested to recite “it” has “the mixture”. Claims 33-34 are rejected by virtue of their dependency on claim 32.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6, 9, 32, 34, and 35 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Tang et al. (US 20170173588 A1; cited in the IDS filed 02/14/2024).
Regarding claim 1, Tang teaches an apparatus (abstract) for nucleic acid amplification (abstract; paragraphs [0005],[0035]), the apparatus comprising:
a receptacle (Fig. 16 and paragraph [0131], receiving tube 163) configured to receive a sample (Fig. 16 and paragraph [0131]);
a heater (Fig. 16, paragraph [0130] teaches first and second chambers 104, 105 configured to hold a temperature; paragraphs [0107]-[0108] teaches the multichamber cartridges for thermocycling reactions uses a heater for control of temperature; Fig. 1 shows heaters 12, 13 below chambers 4, 5; therefore, chambers 104 and 105 of Fig. 16 are implied to comprise heaters);
an amplification chamber (Fig. 16, one of chambers 104 or 105); and
a reaction mix (Fig. 16 and paragraphs [0114],[0131]-[0132] teach buffer solutions; paragraph [0115] and [0121] teaches buffer solutions delivered to the chambers), wherein:
the apparatus is configured to heat the reaction mix to a temperature of at least about 60°C (interpreted as a functional limitation, see MPEP 2114; paragraphs [0045],[0054] teaches chambers can be heated by heater blocks; paragraph [0004] teaches maintaining temperatures between 55-65 ° C and 95 ° C; therefore, the reaction mix, i.e. buffer, in the system is capable of being heated to at least 60° C); and
the apparatus is configured to combine the sample with reaction mix after the reaction mix has been heated to the temperature of at least about 60°C (interpreted as a functional limitation, see MPEP 2114; paragraph [0045] teach the chambers can be heated and compressed to mix fluids or propel fluids from one chamber into another chamber; paragraph [0072] teaches lyophilized master mix reagents can be maintained at 65 ° C and then mixed with a sample fluid to be ready for thermocycling; paragraph [0148] teaches DNA and a master mix can be heated to at least 60 ° C and transferred between each chamber; therefore the apparatus is structurally capable of combining, e.g. transferring or mixing, a sample with buffers/reagents after the buffers/reagents are heated as claimed).
Note that the sample is not positively recited structurally and is interpreted as a functional limitation of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“sample”) worked upon by a structure (apparatus) being claimed does not impart patentability to the claims (see MPEP 2115).
Note that a functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitations, then it meets the claim. See MPEP 2114. The apparatus of Tang is identical to the presently claimed structure. Tang discloses the claimed receptacle, heater, amplification chamber, and reaction mix as claimed and therefore, would have the ability to perform the use recited in the claim. See MPEP 2112.01 (I). Moreover, the prior art of Tang teaches the temperatures of the chambers can be heated and maintained at temperatures such as 65 and 95 ° C (paragraphs [0004],[0071]-[0072]) and the chambers can be heated and compressed to mix fluids or propel fluids from one chamber into another chamber (paragraph [0045]). Thus, the apparatus of Tang is structurally capable of heating and combining a sample and reaction mix as claimed at a later time.
Regarding claim 2, Tang further teaches wherein the apparatus is configured to heat the reaction mix to a temperature of approximately 95°C (interpreted as a functional limitation, see MPEP 2114; paragraphs [0045],[0054] teaches chambers can be heated by heater blocks; paragraph [0004] teaches maintaining temperatures, such as at 95 ° C; therefore, the reaction mix, i.e. buffer, in the system is capable of being heated to approximately 95°C).
Regarding claim 3, Tang further teaches the apparatus of claim 1 further comprising a diluent (paragraph [0081] teaches a sample can include detergent, therefore the apparatus comprises a diluent; paragraph [0081] teaches the cartridge includes Tween-20, i.e. diluent).
Regarding claim 6, Tang further teaches the apparatus of claim 1 further comprising a prefilter (Fig. 16, filter membrane 166; paragraph [0065] teaches a sample is processed through a pre-filter), wherein the prefilter is configured to filter the sample after the sample is received in the receptacle and prior to the sample being introduced into the amplification chamber (interpreted as a functional limitation, see MPEP 2114; paragraph [0065] teaches a sample is processed through a pre-filter prior to purification; paragraph [0133] teaches the filter membrane 166 controls release of a sample to chamber 168, therefore is configured to filter the sample after being received in receiving tube 163 and prior to introduction into one of chambers 104 and 105).
Regarding claim 9, Tang further teaches wherein the reaction mix comprises a polymerase enzyme thermostable DNA polymerase with reverse transcriptase activity (paragraph [0002] teaches the thermocyclers are used to perform PCR; paragraph [0035] teaches selective and repeated amplification using DNA polymerase, such as Taq polymerase, which is a polymerase enzyme thermostable DNA polymerase capable of reverse transcriptase activity; paragraph [0139] teaches reactions include reverse transcription PCR; therefore, the system includes a reaction mix including a polymerase enzyme thermostable DNA polymerase with reverse transcriptase activity for proper reverse transcription PCR).
Regarding claim 35, Tang further teaches the apparatus of claim 3 wherein the diluent comprises a detergent (paragraph [0081] teaches a sample can include detergent, therefore the diluent comprises detergent; paragraph [0081] teaches the cartridge includes Tween-20, i.e. detergent).
Regarding claim 32, Tang teaches an apparatus (abstract) for nucleic acid amplification (abstract; paragraphs [0005],[0035]), the apparatus comprising:
a mechanical prefilter (Fig. 16, rotating filter membrane 166);
a diluent (paragraph [0081] teaches a sample can include detergent, therefore the apparatus comprises a diluent; paragraph [0081] teaches the cartridge includes Tween-20, i.e. diluent);
a reaction mix (Fig. 16 and paragraphs [0114],[0131]-[0132] teach buffer solutions; paragraph [0115] and [0121] teaches buffer solutions delivered to the chambers); and
an amplification chamber (Fig. 16, one of chambers 104 or 105), wherein:
the diluent and reaction mix are combined into a mixture and raised to a temperature of at least about 60°C (interpreted as an intended use of the apparatus, see MPEP 2114; paragraphs [0045],[0054] teaches chambers can be heated by heater blocks; paragraph [0045] teach the chambers can be heated and compressed to mix fluids or propel fluids from one chamber into another chamber; paragraph [0072] teaches lyophilized master mix reagents can be maintained at 65 ° C and then mixed with a sample fluid to be ready for thermocycling; paragraph [0148] teaches DNA and a master mix can be heated to at least 60 ° C and transferred between each chamber; therefore the apparatus is structurally capable of combining, e.g. transferring or mixing, the diluent and reaction mix and raised to the claimed temperature); and
a biological sample is combined with the mixture after it has reached at least about 60°C (interpreted as an intended use of the apparatus, see MPEP 2114; paragraph [0045] teach the chambers can be heated and compressed to mix fluids or propel fluids from one chamber into another chamber; paragraph [0072] teaches lyophilized master mix reagents can be maintained at 65 ° C and then mixed with a sample fluid to be ready for thermocycling; paragraph [0148] teaches DNA and a master mix can be heated to at least 60 ° C and transferred between each chamber; therefore the apparatus is structurally capable of combining, e.g. transferring or mixing, a biological sample with buffers/reagents after the buffers/reagents are heated as claimed).
Note that the biological sample is not positively recited structurally and is interpreted as a functional limitation of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“biological sample”) worked upon by a structure (apparatus) being claimed does not impart patentability to the claims (see MPEP 2115).
Note that a functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitations, then it meets the claim. See MPEP 2114. The apparatus of Tang is identical to the presently claimed structure. Tang discloses the claimed mechanical prefilter, diluent, reaction mix, and amplification chamber as claimed and therefore, would have the ability to perform the use recited in the claim. See MPEP 2112.01 (I). Moreover, the prior art of Tang teaches the temperatures of the chambers can be heated and maintained at temperatures such as 65 and 95 ° C (paragraphs [0004],[0071]-[0072]) and the chambers can be heated and compressed to mix fluids or propel fluids from one chamber into another chamber (paragraph [0045]). Thus, the apparatus of Tang is structurally capable of heating and combining a sample, diluent, and reaction mix as claimed at a later time.
Regarding claim 34, Tang further teaches where the reaction mix is lyophilized (paragraph [0072], “Lyophilized “Master Mix” reagents”; paragraph [0127]).
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.
In an alternative interpretation of claim 9, claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Tang as applied to claim 1 above.
Regarding claim 9, if it is determined that Tang fails to explicitly teach: wherein the reaction mix comprises a polymerase enzyme thermostable DNA polymerase with reverse transcriptase activity, Tang teaches: the thermocyclers are used to perform PCR (paragraph [0002]); selective and repeated amplification using DNA polymerase, such as Taq polymerase, which is a polymerase enzyme thermostable DNA polymerase capable of reverse transcriptase activity (paragraph [0035]); and performing reactions including reverse transcription PCR (paragraph [0139]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reaction mix of Tang to incorporate the teachings of performing PCR using thermostable DNA polymerase and performing reverse transcription PCR of Tang (paragraphs [0035],[0139]) to provide: wherein the reaction mix comprises a polymerase enzyme thermostable DNA polymerase with reverse transcriptase activity. Doing so would have a reasonable expectation of successfully allowing for performing reverse transcription PCR, therefore improving versatility of the apparatus.
Claims 14-15 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Tang as applied to claims 1 and 32 above, and further in view of Viljoen et al. (US 20100291536 A1; cited in the IDS filed 02/14/2024).
Regarding claim 14, while Tang teaches samples can include blood, urine, saliva, sweat, and mucous (paragraph [0122]), Tang fails to teach wherein the reaction mix contains a reducing agent.
Viljoen teaches a method and device for collecting, treating, and analyzing biological material (abstract). Viljoen teaches treatment includes chemical modification of the source material to promote flow and mixing, lysis of cells to release materials, and transfer to an amplification location (paragraph [0022]). Viljoen teaches a processing device including a well for DNA amplification (paragraph [0032]). Viljoen teaches a source material samples can have high viscosity and may require contacting with a chemical processing agent that will assist mixing to reduce viscosity, such as a reducing agent (paragraph [0035]), wherein the reducing agent can include DTT and TCEP (paragraph [0035]).Viljoen teaches the concentration of reducing agent may be low enough that effective PCR amplification and analysis will not be inhibited (paragraph [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reaction mix of Tang to incorporate the teachings of the use of reducing agents for PCR amplification of Viljoen (paragraphs [0035]-[0036]) to provide: wherein the reaction mix contains a reducing agent (e.g. DTT or TCEP). Doing so would have a reasonable expectation of successfully improving sample processing of samples that may have a high viscosity as taught by Viljoen (paragraphs [0035]-[0036]).
Regarding claim 15, modified Tang teaches wherein the reducing agent comprises dithiothreitol (DTT) or tris(2-carboxyethyl)phosphine) (TCEP) (see above claim 14; Viljoen in combination with Tang teaches a reducing agent such as DTT or TCEP; Viljoen, paragraph [0035], teaches DTT and TCEP).
Regarding claim 33, while Tang teaches samples can include blood, urine, saliva, sweat, and mucous (paragraph [0122]), Tang fails to teach where the reaction mix contains a reducing agent.
Viljoen teaches a method and device for collecting, treating, and analyzing biological material (abstract). Viljoen teaches treatment includes chemical modification of the source material to promote flow and mixing, lysis of cells to release materials, and transfer to an amplification location (paragraph [0022]). Viljoen teaches a processing device including a well for DNA amplification (paragraph [0032]). Viljoen teaches a source material samples can have high viscosity and may require contacting with a chemical processing agent that will assist mixing to reduce viscosity, such as a reducing agent (paragraph [0035]), wherein the reducing agent can include DTT and TCEP (paragraph [0035]).Viljoen teaches the concentration of reducing agent may be low enough that effective PCR amplification and analysis will not be inhibited (paragraph [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reaction mix of Tang to incorporate the teachings of the use of reducing agents for PCR amplification of Viljoen (paragraphs [0035]-[0036]) to provide: where the reaction mix contains a reducing agent (e.g. DTT or TCEP). Doing so would have a reasonable expectation of successfully improving sample processing of samples that may have a high viscosity as taught by Viljoen (paragraphs [0035]-[0036]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Myers et al. (US 20190094114 A1) teaches devices for preparing and delivering biological assay samples (abstract). Myers teaches a lysis solution is heated by a heat source, and methods include adding to contents of a sample receiving module one or more heating reagents which, when mixed, cause an exothermal reaction (paragraph [0144]).
Thatcher et al. (US 20170122851 A1) teaches devices for collecting and handling samples (abstract). Thatcher teaches a PCR master mix may be pre-heated in blister prior to movement to second-stage wells for second-stage amplification; such preheating may obviate the need for a hot-start component (antibody, chemical, or otherwise) in the second-stage PCR mixture (paragraph [0063]).
Latham et al. (US 20050208510 A1) teaches methods of separating polynucleotides (abstract). Latham teaches methods where DNA was eluted in EDTA that was pre-heated (paragraph [0112]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758