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 .
Applicant’s reply to the September 04, 2025 Office Action, filed December 04, 2025, is acknowledged. Claims 1-29 are currently pending and under examination.
Any objection or rejection of record in the previous Office Action which is not addressed
in this action has been withdrawn in light of Applicant’s amendments and/or arguments. This
action is FINAL.
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 3 and 4 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. This rejection is maintained in part and modified as necessitated by amendments.
A broad range or limitation together with a narrow range or limitation that falls within the
broad range or limitation (in the same claim) may be considered indefinite if the resulting claim
does not clearly set forth the metes and bounds of the patent protection desired. See MPEP §
2173.05(c). In the present instance claim 3, recites the broad recitation “at least one first primer a poly(dT) primer”, and the claim also recites “preferably including a 5'-extension of 2 to 50 nucleotides as anchor sequence”, which is a narrower statement of the range/limitation. Additionally, claim 4, recites the broad recitation “3'-alkyne- or 3'- azide-modified ddGTP or 3'-alkyne- or 3'-azide-modified ddCTP”, and the claim also recites “preferably 3'-azide- modified ddGTP”, as well as “most preferably 3'-azido-2',3'-dideoxy GTP (AzddGTP)”, which is the narrower statement of the range/limitation.
These claims are considered indefinite because there is a question or doubt as to
whether the feature introduced by such narrower language is (a) merely exemplary of the
remainder of the claim, and therefore not required, or (b) a required feature of the claims.
For purposes of examination, claim 3 is interpreted as including a 5'-extension of 2 to 50 nucleotides as anchor sequence, claims 4 are interpreted as the 3'-azido- or 3’-alkyne-modified ddGTP is used as the dideoxy nucleotide.
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.
Claims 1-2 and 4-29 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (WIPO International Application Publication WO 2015/026853 A2, published February 26, 2015), cited on the IDS filed March 02, 2022, in view of Teo et al. (WIPO International Application Publication WO 2018/075785 A1, published April 26, 2018), cited on the IDS filed March 02, 2022. This rejection is maintained and modified as necessitated by amendments.
Regarding claim 1, Kim teaches a method for amplifying and/or sequencing at least one RNA, contained in a sample (Abstract, Page 1, Lines 7-11, Page 5, Lines 17-21, Page 11, Lines 20-22, Page 19, Lines 1-2, Page 35, Lines 22-34, Page 36, Lines 21-32, Page 41, Lines 22-31 and Page 59, Lines 16-24). Kim teaches providing at least one first primer, which first primer includes a sequence which is complementary to a sequence which is located at or near the 3'-end of the at least one RNA to be amplified (Page 12, Lines 10-11 and Lines 24-28 and Fig. 7). Kim teaches adding said at least one first primer to the sample under conditions which allow for hybridization of at least one first primer to at least one RNA (Page 18, Lines 22-25 and Page 35, Lines 22-34). Kim teaches reverse transcribing the at least one RNA under conditions including addition of a reverse transcriptase and nucleotides to the sample to provide full length cDNA(s) of the at least one RNA (Page 35, Lines 22-34 and Page 41, Lines 25-30). Kim teaches purifying the sample at least from excess nucleotides (Page 82, lines 11-23). Kim teaches adding a dideoxy nucleotide, which dideoxy nucleotide is modified at the 3'- position to include a first partner of a pair of azide and alkyne molecules (Page 27, Lines 30-35). Kim teaches a template-independent polymerase to attach a single 3' -azide- or 3' -alkyne modified dideoxy nucleotide at the 3'-end of the cDNA(s) (Page 54, Lines 2-12). Kim teaches purifying the sample at least from excess modified dideoxy nucleotide (Page 82, lines 11-23). Kim teaches adding an adapter molecule, the adapter molecule comprising a polynucleotide sequence (Page 56, Line 12). Kim teaches attached to its 5' end, a second partner of said pair of azide and alkyne molecules, under conditions to perform a click reaction and to ligate the adapter molecule to the 3'-modified cDNA(s), under formation of a triazole linkage (Page 14, Lines 17-32, Page 19, Lines 1-35, page 22, 23-35 and Page 52, Line 21—53, Line 14). Kim teaches adding a second primer (Page 8, Line 8). Kim teaches the second primer is complementary to the adaptor sequences (Page 84, Lines 14-15). Kim teaches effecting hybridization and binding of the second primer to the ligated adapter/cDNA molecule at a position overlapping the triazole linkage (Page 82, Lines 25-34). Kim teaches adding a DNA polymerase to achieve chain extension of the second primer to produce second strand DNA(s) including sequences complementary to the whole cDNA(s) (Page 35, Lines 22-34, Page 39, Lines 4-15 and Page 9, Lines 7-9). Kim teaches adding a DNA polymerase to achieve chain extension of the second primer and simultaneously determining the sequence of the second strand DNA(s) and the whole cDNA(s) (Page 22, Lines 23-35, Page 39, Lines 4-15, Page 35, Lines 22-34, Page 59, Lines 16-24, Example 15 and Figure 11).
Regarding claim 2, Kim teaches a method for amplifying and or and/or sequencing at least one mRNA contained in a sample (Abstract, Page 1, Lines 7-11, Page 5, Lines 17-21, Page 11, Lines 20-22, Page 19, Lines 1-2, Page 35, Lines 22-34, Page 36, Lines 21-32, Page 41, Lines 22-31 and Page 59, Lines 16-24). Kim teaches providing at least one first primer, which first primer includes a sequence which is complementary to a sequence which is located at or near the 3'-end of the at least one mRNA to be amplified (Page 12, Lines 10-11 and Lines 24-28 and Fig. 7). Kim teaches the primer contains a modification by a first partner of a pair of azide and alkyne molecules at its 5' end (Page 14, Lines 26-32). Kim teaches adding said at least one first primer to the sample under conditions which allow for hybridization of at least one first primer to at least one mRNA (Page 18, Lines 22-25 and Page 35, Lines 22-34). Kim teaches reverse transcribing the at least one mRNA under conditions including addition of a reverse transcriptase and nucleotides to the sample to provide full length cDNA(s) of the at least one mRNA (Page 35, Lines 25-34 and Page 41, Lines 25-30). Kim teaches purifying the sample at least from excess nucleotides (Page 82, lines 11-23). Kim teaches adding a dideoxy nucleotide, which dideoxy nucleotide is modified at the 3'- position to include a second partner of a pair of azide and alkyne molecules (Page 27, Lines 30-35). Kim teaches a template-independent polymerase to attach a single 3' -azide- or 3' -alkyne modified dideoxy nucleotide at the 3'-end of the cDNA(s) (Page 54, Lines 2-12). Kim teaches purifying the sample at least from excess modified dideoxy nucleotide added (Page 82, Lines 11-23). Kim teaches performing a click ligation reaction to generate circular single stranded cDNA(s) under formation of a triazole linkage (Page 19, Lines 1-35). Kim teaches adding a second primer (Page 8, Line 8). Kim teaches the second primer is complementary to the adaptor sequences (Page 84, Lines 14-15). Kim teaches effecting hybridization and binding of the second primer to the ligated adapter/cDNA molecule at a position overlapping the triazole linkage (Page 82, Lines 25-34). Kim teaches adding a DNA polymerase to achieve chain extension of the second primer and subsequently amplify the full length cDNA(s) (Page 39, Lines 4-15, Page 35, Lines 22-34, Page 8, Lines 4-15 and Page 9, Lines 7-9). Kim teaches adding a DNA polymerase to achieve chain extension of the second primer and simultaneously determining the sequence of the circular single stranded DNA(s) including the whole cDNA(s) (Page 39, Lines 4-15, Page 35, Lines 22-34, Page 59, Lines 16-24, Example 15 and Figure 11).
Regarding claim 4, Kim teaches 3'-alkyne- or 3'- azide-modified ddGTP or 3'-alkyne- or 3'-azide-modified ddCTP, preferably 3'-azide- modified ddGTP is used as the dideoxy nucleotide (Page 20, Lines 19-30, Page 27, Line 32 and Page 30, Lines 8-12).
Regarding claim 5, Kim teaches a second primer is added which at the 3'-end contains dC or dG. (Page 83, Line 1).
Regarding claim 6, Kim teaches a second primer is added which at the second position on the 3'-end contains dC or dG. (Page 83, Lines 1).
Regarding claim 7, Kim teaches the template-independent polymerase (Page 54, Lines 2-3).
Regarding claim 8, Kim teaches an alkyne is preferably attached to the 5'-end of the adapter molecule (Page 48, Lines 6-10).
Regarding claim 9, Kim teaches the click reaction comprises a copper catalyzed azide-alkyne cycloaddition (CuAAC) (Page 14, Lines 21-32 and Example 7).
Regarding claim 10, Kim teaches preparing a full length mRNA library from a sample containing a plurality of mRNA molecules (Page 9, Lines 3-9, Page 36, Lines 28-32 and Page 41, Lines 23-30).
Regarding claim 11, Kim teaches the sample containing a plurality of mRNA molecules comprises the total mRNA of one or more types of cells or the whole exome of an organism (Page 58, Lines 15-24, Page 36, Lines 28-32, Page 16, Lines 8-11 and Page 35, Lines 29-34).
Regarding claim 12, Kim teaches a method for sequencing a plurality of mRNAs contained in a sample (Page 36, Lines 28-32, Page 41, Lines 22-31 and Page 45, Lines 26-27). Kim teaches the total mRNA of one or more types of cells or the whole exome of an individual (Page 58, Lines 20-24, Page 16, Lines 9-12 and 35, Lines 29-34). Kim teaches a sample containing such plurality of mRNAs, such total cell mRNA or exome of an individual (Page 36, Lines 28-32, Page 41, Lines 22-31 and Page 45, Lines 26-27). Kim teaches preparing a library of full-length mRNA and determining the sequence of the amplified mRNA or obtained mRNA library (Page 9, Lines 7-9, Page 15, Line 1, Page 36, Lines 28-32, Page 41, Lines 22-31, Page 58, Lines 20-22, and Page 45, Lines 26-27).
Regarding claim 13, Kim teaches long-read sequencing technology is applied (Page 18, Lines 20-23 and Page 60, Lines 28-30).
Regarding claim 14, Kim teaches variant mapping in complex disorders and investigation of genetic aberrations (Page 4, Lines 22-30, Page 9, Lines 6-12, Page 17, Lines 8-18, Page 18, Lines 14-19 and Page 72, Lines 27-35).
Regarding claim 15, Kim teaches a kit for amplifying RNA contained in a sample (Page 1, Lines 8-11, Page 14, Lines 17-19, Page 58, Lines 33-35, Page 36, Lines 28-32, Page 41, Lines 25-26 and Page 45, Lines 26-27). Kim teaches a first primer which primer includes a sequence which is complementary to a sequence which is located at or near the 3'-end of the at least one mRNA to be amplified (Page 12, Lines 10-11 and Lines 24-28 and Fig. 7). Kim teaches a reverse transcriptase (Page 35, Line 28). Kim teaches a dideoxy nucleotide which is modified at the 3' position to include a first partner of a pair of azide and alkyne molecules (Page 11, Lines 30-33, Page 27, Lines 30-35, Page 30, Line 9 and Page 14, Lines 26-32). Kim teaches a template-independent polymerase (Page 54, Lines 2-4). Kim teaches an adapter molecule comprising a polynucleotide sequence and attached to its 5'- end a second partner of said pair of azide and alkyne molecules (Page 11, Lines 30-33, Page 14, Lines 17-32, Page 19, Lines 1-35, page 22, 23-35 and Page 52, Line 21—53, Line 14). Kim teaches the second primer is complementary to the adaptor sequences (Page 84, Lines 14-15). Kim teaches a third primer which is identical to at least a part of the first primer (SEQ ID NO: 4 and SEQ ID NO: 6, Page 88, Lines 21-22 and Page 82, Line 35).
Regarding claim 16, Kim teaches a kit for amplifying RNA contained in a sample (Page 1, Lines 8-11, Page 14, Lines 17-19, Page 58, Lines 33-35, Page 36, Lines 28-32, Page 41, Lines 25-26 and Page 45, Lines 26-27). Kim teaches a first primer which primer includes a sequence which is complementary to a sequence which is located at or near the 3'-end of the at least one mRNA to be amplified (Page 12, Lines 10-11 and Lines 24-28 and Fig. 7). Kim teaches the primer contains a modification by a first partner of a pair of azide and alkyne molecules at its 5' end (Page 11, Lines 30-33, Page 14, Lines 17-32, Page 19, Lines 1-35, page 22, 23-35 and Page 52, Line 21—53, Line 14). Kim teaches a reverse transcriptase (Page 35, Line 28). Kim teaches a dideoxy nucleotide which is modified at the 3' position to include a second partner of a pair of azide and alkyne molecules (Page 11, Lines 30-33, Page 27, Lines 30-35, Page 30, Line 9 and Page 14, Lines 26-32). Kim teaches a template-independent polymerase (Page 54, Lines 2-4). Kim teaches the second primer is complementary to the adaptor sequences (Page 84, Lines 14-15).
Regarding claim 17, Kim teaches a kit with at least one of, all four kinds of naturally occurring nucleotides, reagents for performing a click reaction, buffers and solvents, reagents for performing cDNA amplification and reagents for purification (Page 20, Lines 28-29, Page 21, Lines 33-34, Page 26, Lines 30—Page 27, Line 20, Page 35, Lines 22-28, Page 38, Lines 1-9, Page 14, Lines 17-32, Page 19, Lines 12-14, Page 89, Lines 7-31 and Example 7).
Regarding claim 18, Kim teaches 3'-alkyne- or 3'- azide-modified ddGTP or 3'-alkyne- or 3'-azide-modified ddCTP (Page 20, Lines 19-30, Page 27, Line 32 and Page 30, Lines 8-12).
Regarding claim 19, Kim teaches a second primer is added which at the 3'-end contains dC or dG, preferably dC (Page 83, Line 1).
Regarding claim 20, Kim teaches a second primer is added which at the second position on the 3'-end contains dC or dG. (Page 83, Lines 1).
Regarding claim 21, Kim teaches the template-independent polymerase (Page 54, Lines 2-3).
Regarding claim 22, Kim teaches an alkyne is preferably attached to the 5'-end of the adapter molecule (Page 48, Lines 6-10).
Regarding claim 23, Kim teaches the click reaction comprises a copper catalyzed azide-alkyne cycloaddition (CuAAC) (Page 14, Lines 21-32 and Example 7).
Regarding claim 24, Kim teaches preparing a full length mRNA library from a sample containing a plurality of mRNA molecules (Page 9, Lines 3-9, Page 36, Lines 28-32 and Page 41, Lines 23-30).
Regarding claim 25, Kim teaches wherein the sample containing a plurality of mRNA molecules comprises the total mRNA of one or more types of cells or the whole exome of an organism (Page 58, Lines 15-24, Page 36, Lines 28-32, Page 16, Lines 8-11 and Page 35, Lines 29-34).
Regarding claims 26-28, Kim teaches a method for sequencing a plurality of mRNAs contained in a sample (Page 36, Lines 28-32, Page 41, Lines 22-31 and Page 45, Lines 26-27). Kim teaches the total mRNA of one or more types of cells or the whole exome of an individual (Page 58, Lines 20-24, Page 16, Lines 9-12 and 35, Lines 29-34). Kim teaches a sample containing such plurality of mRNAs, such total cell mRNA or exome of an individual (Page 36, Lines 28-32, Page 41, Lines 22-31 and Page 45, Lines 26-27). Kim teaches preparing a library of full-length mRNA and determining the sequence of the amplified mRNA or obtained mRNA library (Page 9, Lines 7-9, Page 15, Line 1, Page 36, Lines 28-32, Page 41, Lines 22-31, Page 58, Lines 20-22, and Page 45, Lines 26-27). Kim and Teo disclose the method of claims 1, 2
Regarding claim 29, Kim teaches a kit with at least one of, all four kinds of naturally occurring nucleotides, reagents for performing a click reaction, buffers and solvents, reagents for performing cDNA amplification and reagents for purification (Page 20, Lines 28-29, Page 21, Lines 33-34, Page 26, Lines 30—Page 27, Line 20, Page 35, Lines 22-28, Page 38, Lines 1-9, Page 14, Lines 17-32, Page 19, Lines 12-14, Page 89, Lines 7-31 and Example 7).
Kim does not teach or suggest the second primer comprising a nucleotide sequence which is complementary to at least 6 of the nucleotides at the 5'-end of the adapter molecule and contains at its 3'-end a nucleotide which is complementary to the dideoxy nucleotide at the 3'-end of the cDNA(s). Kim does not teach or suggest the second primer at the second position on the 3'-end of the nucleotide sequence contains dC or dG. Kim does not teach or suggest terminal deoxynucleotidyl transferase (TdT) is used as the template-independent polymerase.
Teo teaches preparing nucleic acid (cDNA or mRNA) libraries using click chemistry (Abstract and Page 11, [0048]-[0049]). Teo teaches using click chemistry with a 3’-azide and 5’-alkyne modified ddNTPs and a template independent polymerase that is specifically terminal deoxynucleotidyl transferase (TdT) (Pages 2-3, [0009], Page 20, [0084], Page 22, [0093] and Figs. 1-2). Teo teaches the click reaction comprises CuAAC or SPAAC (Page 23, [0096] and Page 24, [0098]). Teo teaches at least 3 primers (Page 27, [00110]]. Teo teaches the second primer is complimentary to the adaptor nucleic acids (Pages 4-5, [0014] and Page 27, [00110]). Teo teaches the second primer contains at its 3'-end a nucleotide which is complementary to the dideoxy nucleotide at the modified 3'-end (Page 10, [0045]). Teo teaches the second primer at the second position on the 3'-end of the nucleotide sequence contains dC or dG (Page 41, [00166]). Teo teaches using these methods can improve efficiency in preparing a nucleic acid library from a given sample (Page 2, [0007]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kim with the teachings of Teo, to use a second primer comprising a nucleotide sequence which is complementary to at least 6 of the nucleotides at the 5'-end of the adapter molecule and contains at its 3'-end a nucleotide which is complementary to the dideoxy nucleotide at the 3'-end and the second primer at the second position on the 3'-end of the nucleotide sequence contains dC or dGs well as a terminal deoxynucleotidyl transferase (TdT) being used as the template-independent polymerase. Using these methods allows for improved efficiency in preparing a nucleic acid library from a given sample, as taught by Teo (Page 2, [0007]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (WIPO International Application Publication WO 2015/026853 A2, published February 26, 2015), cited on the IDS filed March 02, 2022, and Teo et al. (WIPO International Application Publication WO 2018/075785 A1, published April 26, 2018), cited on the IDS filed March 02, 2022, as applied to claims 1-2 and 4-29 above, in view of Schaal et al. (U.S. Application Publication US 2019/0112648 A1, published April 18, 2019), previously cited in the September 04, 2025 Office Action. This rejection is maintained.
Regarding claim 3, Kim teaches a first primer as discussed above. Kim teaches a primer as an anchor sequence (Page 62, Lines 11-24). Kim teaches a primer extension product (Page 39, Lines 4-15).
Kim and Teo do not teach or suggest the at least one first primer a poly(dT) primer, including a 5'-extension of 2 to 50 nucleotides as anchor sequence, and added to the sample under conditions which allow for hybridization to the poly(A) tail(s) of the at least one RNA present in the sample.
Schaal teaches library preparation of nucleic acids, including cDNA and mRNA (Page 6, [0048], Page 7, [0052], Pages 7-8, [0059], Page 8, [0062], Page 14, [0114]-[0116] and Page 15, [0122]). Schaal teaches using click chemistry, including a modified azido and alkynyl group (Page 5, [0039]). Schaal teaches using at least 4 primers (Page 2, [0013]). Schaal teaches using reverse transcriptase to provide cDNA (Page 8, [0068] and Page 9, [0071]). Schaal teaches a first primer is a poly(dt) primer (Page 10, [0082]). Schaal teaches a 5'-extension of 2 to 50 nucleotides as anchor sequence (Page 24, [0182]). Schaal teaches the primer is added to the sample under conditions which allow for hybridization to the poly(A) tail(s) of the at least one mRNA present in the sample (Pages 9-8, [0076]-[0078]). Schaal teaches these methods allow for quantification of mRNA transcripts in single cells and allows users to count the absolute number of transcript molecules/cells to remove any variables from normalization (Page 25, [0190]).
As a common field of endeavor, Kim, Teo and Schaal, all disclose methods for preparing nucleic acid libraries using click chemistry.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Kim and Teo with the teachings of Schaal, to use a first poly(dT) primer, including a 5'-extension of 2 to 50 nucleotides as anchor sequence, and added to the sample under conditions which allow for hybridization to the poly(A) tail(s) of the at least one mRNA present in the sample. This allows for quantification of mRNA transcripts in single cells and allows users to count the absolute number of transcript molecules/cells to remove any variables from normalization as taught by Schaal (Page 25, [0190]).
Response to Arguments
Applicant’s arguments and amendments filed December 04, 2025, with respect to the rejections under 35 U.S.C. § 112 (b) have been fully considered and are persuasive in part. Therefore the 112 (b) rejections of claims 1-2, 5-29 have been withdrawn. Claims 3 and 4 remain rejected under 35 U.S.C. § 112 (b) as maintained above and discussed below.
Applicant asserts that claims 1-6, 15, 16 and 18-20 have been amended to address the 112 (b) issues. However, the amended section of claim 3 does not address the broad recitation “at least one first primer a poly(dT) primer”, and the claim also recites “preferably including a 5'-extension of 2 to 50 nucleotides as anchor sequence”, which is a narrower statement of the range/limitation. Additionally, while the status identifier of claim 4 has been changed to “currently amended”, claim 4 appears to be unamended and still includes the broad recitation “3'-alkyne- or 3'- azide-modified ddGTP or 3'-alkyne- or 3'-azide-modified ddCTP”, and the claim also recites “preferably 3'-azide- modified ddGTP”, as well as “most preferably 3'-azido-2',3'-dideoxy GTP (AzddGTP)”, which is the narrower statement of the range/limitation. Therefore these rejections are maintained as set forth above.
Applicant’s arguments and amendments filed December 04, 2025, with respect to the rejections under 35 U.S.C. § 103 have been fully considered and are not deemed to be persuasive.
Applicant asserts “Kim does not propose the targeted conversion of RNA into cDNA as a part of the method…Instead, only one section, which defines nucleic acids in general mentions that nucleic acids can also be cDNA obtained by reverse transcription from an RNA template. This simply means that cDNA can be subjected to the sequencing described by Kim et al. However, this does not guide the skilled person to first convert an mRNA template into cDNA and use this cDNA in a sequencing method to obtain information on the sequence of the RNA. Furthermore, the section cited by the patent office that mentions reverse transcription does not specifically disclose the reverse transcription of mRNA”.
As discussed above, Kim discloses that the invention provided is technology used for sequencing, identifying and amplifying one or more target nucleic acids (Abstract, Page 1, Lines 7-11, Page 5, Lines 17-21, Page 11, Lines 20-22 and Page 19, Lines 1-2). Kim, Page 35, Lines 22-34, describes how the term “nucleic acid” is to be interpreted and used throughout the invention, not just a general definition. Kim states the term “nucleic acid … also encompasses cDNA… produced from an RNA template…by the action of a reverse transcriptase” (Page 35, Lines 22-34). In an additional section, Kim further discloses “In some embodiments… the target nucleic acid may be DNA or RNA…e.g. mRNA… In some embodiments an RNA is first reverse transcribed to produce DNA” (Page 41, Lines 22-30). Moreover, Kim additionally discloses “mRNA expressed from a region of interest is analyzed” (Page 36, 28-32). Therefore Kim does in fact discloses targeted conversion of RNA specifically mRNA, into cDNA as a part of the method.
Applicant additionally asserts “Claim 13 is rejected under 35 U.S.C. 103 as allegedly being obvious over Kim et al. in view of Teo et al. and in further view of Schaal et al. (US Patent Application Publication No. US 2019/0112648. Applicants respectfully traverse this rejection… the patent office must rely on the further combination of Kim et al., Teo et al. and Schaal et al. to account for the deficiencies of Kim et al.” (It is noted that “Claim 13” is a typographical error and should read “Claim 3”).
As discussed above, Kim does in fact discloses targeted conversion of RNA specifically mRNA, into cDNA as a part of the method and therefore, no deficiencies remain.
Therefore, for these reasons and those listed above, Kim and Teo as well as Kim and Teo in view of Schaal, are deemed to render the instant invention obvious.
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 JESSICA DANIELLE PARISI whose telephone number is (571)272-8025. The examiner can normally be reached Mon - Friday 7:30-5:00 Eastern with alternate Fridays off.
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/JESSICA D PARISI/Examiner, Art Unit 1684
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684