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 .
Election/Restrictions
In the response filed July 1, 2026, Applicant elected claims 1-13, with traverse. The traversal is on the grounds that the is no undue burden on the Examiner to consider all claims in the single application. This is not found persuasive because, as stated in the office action mailed May 19, 2026, the claims are directed to distinct inventions which would require different fields of search and are likely to raise different non-prior art issues under 35 U.S.C. 101 and 35 U.S.C. 112(a). The Applicant has not provided specific arguments which rebut these points. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-22 are pending.
Claims 14-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim.
Claims 1-13 are examined herein.
Priority
It is acknowledged that the instant application is a continuation of International Patent Application No. PCT/CN2021/142714, filed December 29, 2021, which was published as WO 2023/123134 A1 on 07/06/2023. It is noted, however, that the content of WO 2023/123134 A1 publication is in Chinese and only Title and Abstract are in English. Therefore, the effective filing date is determined to be March 27, 2024, the filing date of instant application.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Objections
The claims are objected to because of the following informalities:
“characterized in that comprising” (line 1, claim 1) should read “comprising”
“wherein that the” (claims 7, 9, 12, and 13) should read “wherein the”
“wherein portion of” (line 6, claim 10) should read “wherein another portion of”
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 1-13 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.
Claims 1-13 are rejected for the recitation of “within its interior” in line 3 of claim 1 as indefinite. The grammar of the sentence makes it unclear which elements are intended to be located within which other elements. For example, is the solid-phase carrier located within the interior of the nucleic acid amplification solution, or are the analyte(s)/nucleic acid amplification solution(s)/solid-phase carrier(s) all located within the interior of the reaction unit (as potentially reiterated on lines 4 and 5)? As a result, one of skilled artisans would not be able to determine the metes and bounds of the claimed subject matter. If what is meant is ‘providing a reaction unit which includes within its interior at least one analyte, at least one nucleic acid amplification solution, and at least one solid-phase carrier,’ the claim must be amended to reflect that meaning.
Claims 1-4 and 6-13 are rejected for the recitation of “wherein the reaction unit and the content within its interior, including the analyte, the nucleic acid amplification solution, and the solid-phase carrier, are maintained at a cooling temperature in a cooling environment” as indefinite. The method requires thermal cycling for nucleic acid amplification. It is unclear how the analyte, nucleic acid amplification solution, and solid-phase carrier are meant to be maintained at a cooling temperature but also be subject to nucleic acid amplification dependent on thermal cycling. Additionally, the claims allow for the reaction unit or nucleic acid amplification solution to be merely ‘pre-cooled’ (claim 6). Therefore, it is also unclear what is intended by the recitation of the term “maintained.” Is the method requiring a system in which cooling is an active, constant process (i.e. the relevant elements are held at a constant temperature), or is it merely requiring a system where an environment remains cool (i.e. the temperature of the relevant elements may fluctuate or increase, as long as it remains below a particular threshold)? As a result, one of skilled artisans would not be able to determine the metes and bounds of the claimed subject matter. For the purposes of compact prosecution, this limitation is interpreted to mean that the reaction mixture remains at a cooler temperature relative to the local microenvironment around a solid-phase carrier (where amplification takes place).
Claims 1-13 are rejected for the recitation of “cooling temperature” and “cooling environment” in claims 1 and 5, which are relative terms that render the claims indefinite. The specification provides examples of a cooling temperature (par. 34, 94) and examples of cooling environments (par. 131), but neither the claims nor the specification provide a limiting definition of the terms. As a result, one of skill in the art would not be able to determine the metes and bounds of the claimed subject matter.
Claims 1-13 are rejected for the recitation of “modulating the output and the timing sequence of on and off of an external energy in coordination with…” The phrase has no clear meaning. As a result, one of skilled artisans would not be able to determine the metes and bounds of the claimed subject matter. Clarification is requested. For the purposes of compact prosecution, the claim is interpreted to mean that an external energy source provides output which excites the solid-phase carriers and which is pulsed on and off.
Claims 1-13 are rejected because the phrase “the solid phase carriers” lacks antecedent basis. Claim 1 provides antecedent basis for ‘at least one solid-phase carrier’ in line 3 of claim 1, but a plurality of solid-phase carriers is recited in the following locations:
Lines 10, 12, and 13 of claim 1
Lines 2, 4, 5, 6, and 8 of claim 2
Claims 3, 4, 10, and 13
It is unclear if the plurality recited in these locations is the same as the ‘at least one solid-phase carrier’ of claim 1, line 3. Overall, it is unclear whether the claims are intended to require ‘at least one solid-phase carrier, or if they’re meant to recite a plurality of said elements. As a result, one of skilled artisans in the art would not be able to determine the metes and bounds of the claimed subject matter.
Claims 1-13 are rejected because it is unclear whether the claims are intended to require ‘one or more thermal cycles’ (lines 8-9 of claim 1), or if they’re meant to recite a plurality of cycles (as implied in claim 1: “repetitive formation and dissipation”). As a result, one of skill in the art would not be able to determine the metes and bounds of the claimed subject matter so as to avoid infringement.
Claims 1-13 are rejected for a large number of items which lack antecedent basis. For example, “the output” and “the timing sequence” are recited in lines 6 and 7 of claim 1. However, “an output” and “a timing sequence” are not previously established, and it is unclear what these elements are intended to refer to. Further instances include:
“the respective in situ environment” – claim 1, lines 10-11
“the nucleic acid amplification” – claim 1, lines 12-13
“the repetitive formation and dissipation of the in-situ environment” – claim 1, lines 14 and 15.
“each excitation period” – claim 2, line 1
“each non-excitation period” – claim 2, line 7
“the amplicons replicated on the amplification ligand” – claim 9
It is unclear what these elements are intended to refer to. As a result, one of skill in the art would not be able to determine the metes and bounds of the claimed subject matter so as to avoid infringement.
Claims 1-13 are rejected for the recitation of “the nucleic acid amplification on solid-phase carriers, the analyte, and the nucleic acid amplification solution to take place” in line 12-14 of claim 1, as indefinite. It is not clear what is required by the limitation. Does the claim require that nucleic acid amplification involve the recited elements, or is it requiring that nucleic acid amplification take place on the surface of (“on”) the solid-phase carrier, or is something else being required? Furthermore, the dependent claim 7 requires that the analyte be a cell, organelle, etc. It is not clear how a cell itself would be the subject of nucleic acid amplification (i.e. how nucleic acid amplification would take place on it). As a result, one of skilled artisans would not be able to determine the metes and bounds of the claimed subject matter.
Claim 2 is rejected for the recitation of “retained within each of the solid-phase carriers,” as indefinite. Claims 1 and 2 recite that nucleic acid amplification/amplicon generation may occur on the solid-phase carriers, and the drawings of the instant disclosure all indicate that amplification occurs on or near the surface of the solid-phase carriers. It is therefore not clear whether the claim is intended to require that the solid-phase carriers retain amplicons inside of themselves (“within”), or if the amplicons are meant to be retained with or on the solid-phase carriers and the use of the term “within” is erroneous. As a result, one of skill in the art would not be able to determine the metes and bounds of the claimed subject matter. For the purposes of compact prosecution, this limitation is interpreted to mean amplification occurs on or near the surface of the solid-phase carriers.
Claims 8-11 are rejected because it is unclear whether the claims are intended to require “at least one” enrichment ligand and “at least one” amplification ligand (lines 4 and 6 of claim 8; lines 4 and 8 of claim 10), or a plurality of each (e.g. “the enrichment ligands” – line 4, claim 8). As a result, one of skill in the art would not be able to determine the metes and bounds of the claimed subject matter.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 5-7, and 12 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Zeng et al. (published November 26, 2020; Patent Application Publication No. US 2020/0370083).
Regarding claim 1, Zeng recites a nucleic acid amplification method comprising providing a reaction unit (par. 43, Fig. 1A/B) including at least one analyte, at least one nucleic acid amplification solution, and at least one solid-phase carrier within its interior (par. 29-30). Zeng recites modulating the output of an external energy source, thereby generating one or more thermal cycles required for nucleic acid amplification (par. 35). Zeng recites that in each of the thermal cycles, upon being excited by an external energy source, all the solid-phase carriers simultaneously form a respective in-situ environment (par. 35-36). In this case, the in-situ environment is a locally heated microenvironment. Zeng recites that nucleic acid amplification occurs during the thermal cycles, generating amplicons (par. 30, 88).
Although Zeng does not explicitly recite that the in-situ environment dissipates during pauses in excitations, Zeng does explain that the solid-phase carriers (here, ‘photothermal nanoparticles’) absorb energy from light to convert to heat, including from pulsed light (par. 35). In the case that energy is provided in the form of pulsed light, during the pauses in excitation, local increases in temperature will dissipate and the local environment will begin to cool (a process which could be accelerated by features such as a fan – par. 47). Therefore, the limitation is considered to have been met.
Zeng does not explicitly recite that the reaction unit and its content are ‘maintained at a cooling temperature in a cooling environment.’ However, Zeng does recite that the solid-phase carriers function by local heating of the reaction mixture (par. 27, 30) which is sufficient to rapidly raise the temperature of a small amount of the mixture immediately surrounding solid-phase carriers from cooler to hotter temperatures (par. 35, 46). Zeng also recites pre-cooling the nucleic acid amplification solution (par. 87). These recitations are interpreted to mean that Zeng’s larger reaction environment is cooler than the volume immediately surrounding a heated solid-phase carrier. Therefore, Zeng implicitly meets the limitation that the reaction unit and its content are maintained at a cooling temperature in a cooling environment.
Regarding claim 5, Zeng does not explicitly recite that the cooling temperature of the cooling environment is between -10ºC to 50ºC. However, Zeng recites pre-cooling nucleic acid amplification solutions on ice (par. 87), and achieving reaction temperatures ranging between 45ºC – 55ºC (par. 35, 82) through means of assisted cooling (par. 22, 47). Additionally, Zeng recites irradiation capable of increasing temperature from a baseline of 45ºC to 95ºC (par. 35). Temperatures of between at least 45ºC – 55ºC (for annealing phases or from a baseline temperature) and solutions pre-cooled to 0ºC (on ice) overlap the claimed range with sufficient specificity that the limitation is considered to have been met.
Regarding claim 6, Zeng recites that the nucleic acid amplification solution is pre-cooled to the cooling temperature (par. 87).
Regarding claim 7, Zeng recites analytes which are cells, organelles, bacteria, viruses, a combination thereof (par. 76, 79). To clarify, Zeng teaches amplification reactions involving nucleic acids which are released from samples including tissue cell cultures and lysates. As the samples are allowed to be mixtures of appropriate analytes (cells, etc.) and nucleic acids for amplification, Zeng meets the limitations of the claims.
Regarding claim 12, Zeng recites analytes which are a free deoxyribonucleic acid or a free ribonucleic acid (par. 76). For example, ‘free deoxyribonucleic acid’ encompasses the use of nucleic acids in blood.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as unpatentable over Zeng et al. (published November 26, 2020; Patent Application Publication No. US 2020/0370083), as applied to claim 1 above, and further in view of Daßen et al. (published April 18, 2019; Patent Publication No. DE102017123919A1; translation provided).
Zeng teaches the limitations of claim 1, as discussed in the rejections under 35 U.S.C. 102(a)(1).
Regarding claim 3, Zeng teaches that the ratio of the solid-phase carriers to the volume of the nucleic acid amplification solution is a variable subject to optimization, such as for achieving various heating rates (par. 21, 82).
Regarding claim 4, Zeng teaches that the shape and size of the solid-phase carrier is subject to optimization, such as for achieving a particular heating rate or to have a particular maximum peak extinction wavelength (par. 16, 31-32, 46).
Regarding claim 3, Zeng does not explicitly recite that the ratio of the total volume of the solid-phase carriers to the volume of the nucleic acid amplification solution is from 1:200 to 1:1x10⁹.
Regarding claim 4, Zeng does not explicitly recite that the size of each of the solid-phase carriers is further within the range of 8 to 2,000,000 nm.
Daßen teaches that ratios of the partial volume of a reaction solution excited/affected by an external energy source to the total volume of nucleic acid amplification solution is from 1:10 to 1:1x10^10 (par 55, 60). Daßen teaches solid-phase carriers (i.e. nanoparticles) having a size within a range of 1 to 1,000 nm (par. 57).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to optimize the size of the solid-phase carriers and the total volume of solid-phase carriers relative to the total volume of solution. One would have been motivated to do so because Zeng and Daßen establish that solid phase carrier size and its volume ratio relative to the nucleic acid amplifications solution are results-effective variables (Zeng: see above; Daßen: par. 57). One would have had reasonable expectation of success because both Zeng and Daßen are concerned with nucleic acid amplification using solid-phase carriers excited by external energy sources (Daßen: par. 59).
Claims 2 and 13 are rejected under 35 U.S.C. 103 as unpatentable over Zeng et al. (published November 26, 2020; Patent Application Publication No. US 2020/0370083), as applied to claims 1 and 12 above, and further in view of Schmidbauer et al. (published July 30, 2020; Patent Publication No. DE 102019114011 B3; translation provided).
Zeng teaches the limitations of claim 1, as discussed in the rejections under 35 U.S.C. 102(a)(1).
Regarding claim 2 (and as addressed for claim 1), Zeng recites that in each of the thermal cycles, upon being excited by an external energy source, all the solid-phase carriers simultaneously form a respective in-situ environment (par. 35-36). Zeng recites that nucleic acid amplification occurs during the thermal cycles, generating amplicons (par. 30, 88). As discussed in the rejection of claim 1, Zeng’s teachings meet the limitation that during each non-excitation period of the thermal cycle, the excitation each of the solid-phase carriers is paused, and each of the in-situ environments dissipates through the cooling temperature of the cooling environment.
Regarding claim 2, Zeng does not explicitly teach generating the amplicons on the carriers, or that a portion of the amplicons is retained on each of the solid-phase carriers while another portion of the amplicons is released into the nucleic acid amplification solution.
Regarding claim 13, Zeng does not explicitly teach solid-phase carriers comprising: an amplification body, and at least one amplification ligand, wherein each of the amplification ligands is bound to the surface of the amplification body and is used for capturing the analyte.
Regarding claim 2, Schmidbauer teaches generating amplicons on the surface of solid-phase carriers (par. 126; Figure 1B) wherein a portion of the amplicons is retained on the surface of each of the solid-phase carriers, while another portion of the amplicons is released into the nucleic acid amplification solution (par. 47, 93, 96). To clarify, a target nucleic acid template may bind to a forward primer attached to a solid-phase carrier and be subjected to nucleic acid amplification. After elongation of the primer using the target nucleic acid as a template, the duplex is denatured, leading to the release of the template and retention of an amplicon on the solid-phase carrier. Upon subsequent cycles, nearby free reverse primers in the vicinity may bind to this amplicon and initiate another round of synthesis. That newly synthesized amplicon would be untethered to the solid-phase carrier, and upon denaturation would be released into the nucleic acid amplification solution.
Regarding claim 13, Schmidbauer teaches solid-phase carriers comprising: an amplification body; at least one amplification ligand, wherein each of the amplification ligands is bound to the surface of the amplification body and is used for capturing the analyte (par. 95).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to combine the teachings of Zeng and Schmidbauer. One would have been motivated to do so in order to retain target nucleic acids within a heating zone, improving efficiency (par. 14, 48, 90). One would have had reasonable expectation of success because Zeng and Schmidbauer are both directed to using external energy sources to heat solid-phase carriers for localized nucleic acid amplification, and because the principles of solid-phase synthesis are well-known.
Claim 8 is rejected under 35 U.S.C. 103 as unpatentable over Zeng et al. (published November 26, 2020; Patent Application Publication No. US 2020/0370083), as applied to claims 1 and 7 above, and further in view of Mena et al. (published April 16, 2020; Patent Application Publication No. US 2020/0116699).
Zeng recites the limitations of claims 1 and 7, as addressed in the rejections under 35 U.S.C. 102(a)(1).
Regarding claim 8, Zeng does not explicitly disclose that the solid-phase carrier comprises: a multifunctional body; at least one enrichment ligand, wherein the enrichment ligands are bound to the surface of the multifunctional body and are used for capturing the analyte; and at least one amplification ligand, wherein the amplification ligands are bound to the surface of the multifunctional body and are used for binding a biological substance.
Mena teaches solid-phase carriers comprising: a multifunctional body (e.g. a bead – par. 77); at least one enrichment ligand; and at least one attachment ligand (par. 13, 77). Mena teaches enrichment ligands which are bound to the surface of the multifunctional body and used for capturing the analyte (e.g. antigens or binding proteins which bind cells of interest – par. 13, 77). Mena teaches amplification ligands bound to the surface of the multifunctional body and used for binding a biological substance (e.g. primers – par. 13, 77, 143).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to combine the teachings of Zeng and Mena. One would have been motivated to do so in order to isolate/enrich targets of interest or identify binding pairs (par. 13, 80, 182). One would have had reasonable expectation of success because the strategies of Manas require only knowledge and equipment available to one of skill in the art (e.g. par. 166, 274) and because Manas and Zeng are both drawn to methods of amplifying nucleic acids using solid-phase carriers.
Claims 9-11 are rejected under 35 U.S.C. 103 as unpatentable over Zeng et al. (published November 26, 2020; Patent Application Publication No. US 2020/0370083), as applied to claims 1 and 7 above, in view of Mena et al. (published April 16, 2020; Patent Application Publication No. US 2020/0116699), as applied to claim 8 above, and further in view of Daßen et al. (published April 18, 2019; Patent Publication No. DE102017123919A1; translation provided).
Zeng recites the limitations of claims 1 and 7, as addressed in the rejections under 35 U.S.C. 102(a)(1). Mena teaches the limitations of claim 8, as discussed above.
Regarding claims 9-11, Zeng and Mena teach biological substances which are either deoxyribonucleic acid or ribonucleic acid (Zeng: par. 76; Mena: par. 188). Zeng teaches that these may be released from an analyte (Zeng: par. 76, 79).
Regarding claim 10, Mena teaches the co-incubation/co-isolation of solid-phase carriers having one portion comprising an enrichment body and at least one enrichment ligand and another portion comprising an amplification body and at least one amplification ligand (par. 255). In this embodiment, Mena teaches enrichment ligands which are bound to the surface of the enrichment body (used for capturing an analyte) and amplification ligands bound to the surface of the amplification body (used to bind nucleic acids associated with the analyte). For clarity, the enrichment body would be the antigen/barcode beads, the enrichment ligand would be the antigens, the amplification body would be the linkage beads, and the amplification ligand would be attached primers (used to bind nucleic acids and indirectly ‘capture’ the analyte). In this particular embodiment, Mena does not explicitly utilize a ligand which captures an analyte which is a cell, organelle, bacterium, virus, or combination thereof. However, Mena does state that solid-phase carriers may be employed for the isolation of specific target cells (par. 79), and describes embodiments wherein ligands are attached to solid-phase carriers for capture of specific cells (par. 71, 222). Furthermore, Mena allows that various combinations of the embodiments may be used (par. 274). Therefore, Mena is considered to have met the limitation that the enrichment body be used for capturing an analyte which is a cell, bacterium, or virus.
Regarding claims 9-11, Zeng and Mena do not explicitly teach that the biological substance captured/bound by the amplification ligand is released from the analyte.
However, Zeng teaches that biological substances may be released from analytes (par. 76, 79) and Mena teaches providing solid-phase carriers (beads and/or polymer scaffolds) having ligands for both the analyte and its released biological substance (mRNA released from cells – par. 71, 239).
It would be obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to use an amplification ligand for binding a biological substance released from an analyte. One would have been motivated to do so in order to, for example, simplify a method of lysing a microorganism and amplifying released nucleic acids by using the same external energy source for both (Daßen: par. 59). One would have had reasonable expectation of success because Mena teaches attachment a variety of appropriate ligands to solid-phase carriers (par. 77) and Daßen demonstrates efficient lysis based on heating of gold nanoparticles (par. 82-83; Fig. 4 – bar 118 vs bar 102).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine M Jones whose telephone number is (571)272-2585. The examiner can normally be reached Monday - Friday, 8AM - 4PM.
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/C.M.J./Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
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