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 .
Response to Amendment
The amendment filed May 11th, 2026 is acknowledged. Regarding the Office Action mailed February 10th, 2026:
Maintained, modified, or new rejections are set forth below, as necessitated by the amendments. Responses to arguments, if necessary, follow their respective rejection sections.
Claim Summary
Claim 6 has been amended. Claims 1-5 and 8-12 have been canceled. Claims 6-7 and 13-15 are pending. Claims 6-7 and 13-15 are under examination and discussed in this Office action.
Claim Rejections - 35 USC § 112(b) – Modified – Necessitated by Amendment
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-7 and 13-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation “[a] method for synchronously sequencing a sense strand and an antisense strand of an insert DNA, comprising: performing a first round of rolling circle amplification using a circular DNA molecule of the insert DNA to be sequenced as an amplification template, to generate a first partial template strand; hybridizing the first partial template strand with blocked amplification primers, and performing a second round of rolling circle amplification using the circular DNA molecule as an amplification template to generate a second partial template strand; selecting the second partial template strand as a read1 strand sequencing template, and generating a read2 strand sequencing template by performing multiple displacement amplification using the first partial template strand as an amplification template; and hybridizing the read1 strand sequencing template with read1 strand sequencing primers, hybridizing the read2 strand sequencing template with read2 strand sequencing primers, and simultaneously performing read1 strand sequencing and read2 strand sequencing to obtain sequences of the sense strand and the antisense strand of the insert DNA, wherein a copy number of the read1 strand sequencing template and a copy number of the read2 strand sequencing template are controlled by controlling time of the rolling circle amplification and time of the multiple displacement amplification; wherein the copy number of the read1 strand sequencing template and the copy number of the read2 strand sequencing template have a difference in folds, and source of strands of the sequencing bases are positioned by using a signal difference caused by the difference in folds during the sequencing; wherein the blocked amplification primers are 3'-end reversibly modified read1 strand sequencing primers; and wherein the 3'-end reversibly modified read1 strand sequencing primers are subjected to modification removal subsequent to the second round of rolling circle amplification.” There are many issues of clarity identified for this claim, as follows:
It is unclear from this recitation how RCA is being carried out in two different rounds, wherein one round is paused to allow hybridization of primers before apparently restarting for another round of amplification. This could mean that there’s an undescribed heat-inactivation step, an undescribed separation of amplification products, or some other undescribed step. Furthermore, it is unclear how the recited amplification primers would not bind to the template created by the second round of RCA without an intermediate step to remove the primers, like a wash step, between rounds of amplification. Finally, it is unclear how MDA can be carried out without also activating RCA when, as the claim appears to indicate, both forms of amplification are occurring simultaneously in the same reaction mixture. RCA and MDA generally use the same polymerase for amplification. As taught by Nunez (Application of Circular Ligase to Provide Template for Rolling Circle Amplification of Low Amounts of Fragmented DNA, Promega, 2008, 1-7; previously cited), RCA and MDA both use phi29 polymerase (Page 1, paragraph 4). As evidenced by ThermoFisher (phi29 DNA Polymerase [online]. ThermoFisher, [2024] [retrieved on February 5th, 2026]. Retrieved from: https://documents.thermofisher.com/TFS-Assets/LSG/manuals/MAN0030290-phi29-DNA-pol-UG.pdf; previously cited), reaction conditions for RCA and MDA using phi29 polymerase are essentially the same, aside from the template being linear or circular (Pages 4 and 5). Assuming the Applicant is using standard protocols such as those cited for RCA and MDA, it isn’t clear how to carry out MDA without further producing more template by RCA when the components of both forms of amplification are in the same reaction mixture.
It is unclear from this recitation if the read1 strand sequencing primers recited in line 12 of the claim are the same as the read1 sequencing primers recited in line 23 of the claim. Given the recitations of these primers, it could be interpreted that they are two different read1 primers, especially considering that the read1 primers introduced in line 23 are a further limitation of the blocked primers, while the read1 primers introduced in line 12 of the claim are not further connected to any earlier described primers.
It is unclear from this recitation how the times of these amplification methods can be controlled when, as it appears to be claimed, RCA and MDA are occurring simultaneously in the same reaction mixture. RCA and MDA generally use the same polymerase for amplification. As taught by Nunez (Application of Circular Ligase to Provide Template for Rolling Circle Amplification of Low Amounts of Fragmented DNA, Promega, 2008, 1-7), RCA and MDA both use phi29 polymerase (Page 1, paragraph 4). As evidenced by ThermoFisher (phi29 DNA Polymerase [online]. ThermoFisher, [2024] [retrieved on February 5th, 2026]. Retrieved from: https://documents.thermofisher.com/TFS-Assets/LSG/manuals/MAN0030290-phi29-DNA-pol-UG.pdf), reaction conditions for RCA and MDA using phi29 polymerase are essentially the same, aside from the template being linear or circular (Pages 4 and 5). Assuming the Applicant is using standard protocols such as those cited for RCA and MDA, it is unclear how any sort of independent control of time could be enacted for each amplification method when both forms of amplification take place in the same reaction mixture. Furthermore, given the lack of clarity regarding control of time of RCA and MDA, it is unclear how the copy numbers of the read templates can be controlled through timing of RCA and MDA.
It is unclear from this recitation how it is possible to use a “signal difference” produced from a difference in folds of copy numbers of templates to position sequencing bases. Looking to the specification, the only defined signals are those that are read from recognizing bases in the sequence (Page 5, paragraph [0016]). This does not immediately relate to a signal difference caused by a difference in folds of copy numbers. Furthermore, it is unclear what is meant by “a difference in folds”. This could mean the more generally used “fold difference”, which is related to the change between an original measurement and a subsequent measurement, or it could mean something else that has not been adequately defined. Without knowing the meaning behind “a difference in folds”, it is unclear how this can be applied as a means for positioning sequencing bases. In addition, it is unclear how a “source of strands of the sequencing bases” are positioned. Based on the recited claim language, sequencing is occurring on amplified products produced from a template, wherein the template would generally be the “source of strands of the sequencing bases”. It is unclear why the template would need to be positioned, and what positioning the template using a signal difference would entail given the lack of clarity regarding why it would need to be positioned.
Finally, claim 6 recites the limitation "strands of the sequencing bases". There is insufficient antecedent basis for this limitation in the claim. The recitation of “the sequencing bases” lacks antecedent basis because the phrase was not earlier introduced in the claim. Therefore, the presence of strands of the sequencing bases is unclear.
Given the above noted issues, claim 6 is rejected under 35 U.S.C. 112(b) for lack of clarity. Claims 7 and 13-15 suffer from the same lack of clarity as claim 6 since they claim the same general method without further clarifying the issues presented here.
Response to Arguments
Applicant's arguments filed May 11th, 2026 have been fully considered but they are not persuasive.
The Applicant first provides the support and language related to the new amendment regarding the block amplification primers (Page 4 of the Remarks filed May 11th, 2026). The Applicant states that given these blocked primers, the template strand hybridized thereon dissociates from the circular template and no longer participates in the second round of rolling circle amplification (Page 4 of the Remarks filed May 11th, 2026). The Applicant also provides the support and language related to the new amendment regarding unblocking of the blocked primers (Page 4 of the Remarks filed May 11th, 2026). The Applicant states that this amendment clarifies that the primer is initially blocked and later unblocked to participate in subsequent extension reaction (Page 4 of the Remarks filed May 11th, 2026). The Applicant argues that given these amended limitations, a person of ordinary skill in the art would understand how amended claim 6 is carried out, and follows with a reproduction of Figure 1 (Page 5 of the Remarks filed May 11th, 2026).
In response to these arguments, it is noted that aspects of the argument upon which the Applicant relies are not recited in the rejected claims, or even in the instant disclosure at all. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). While it is now clear how the blocked primers are unblocked, there is no description in the disclosure as filed that a result of hybridization with blocked amplification primers is disassociation from the circular template and no further participation in the second round of rolling circle amplification. In addition, if this is indeed the intended function of the blocked primers, it is unclear how a second round of amplification can be carried out as claimed if blocked primers cause the template strand to dissociate from the circular RCA template. The Applicant is further advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel's arguments in place of evidence in the record. It is noted that the Response above should not be construed as an invitation to file an after final declaration. See MPEP 715.09.
The Applicant then provides what appears to be a hypothetical example of how the method works (Pages 5-7 of the Remarks filed May 11th, 2026). Pertinent statements and arguments are summarized as follows:
The Applicant states that a first round of RCA is performed to generate 100 copies that are hybridized with blocked amplification primers (Page of the Remarks filed May 11th, 2026). The Applicant states the second round of RCA is performed in the same system and therefore it is unnecessary to inactivate an enzyme as the first round of RCA is paused due to the hybridization of the blocked primers (Pages 5-6 of the Remarks filed May 11th, 2026). The Applicant states MDA is performed after blocked primers are unblocked (Page 6 of the Remarks filed May 11th, 2026). The Applicant argues that by controlling the reaction time of MDA, it is possible to limit each primer to a single extension event, which can be altered to achieve other copy numbers (Page 6 of the Remarks filed May 11th, 2026). The Applicant states that first partial templates are amplified by MDA, while the RCA reaction continues simultaneously given the compatible reaction conditions (Page 6 of the Remarks filed May 11th, 2026). The Applicant states that read1 and read2 sequencing primers are hybridized and sequencing is performed simultaneously, with copy number of the sequencing templates controlled by controlling the time of RCA and MDA (Page 6 of the Remarks filed May 11t5h, 2026). The Applicant argues that target copy numbers can be set in advance and required reaction times determined accordingly, which a person of ordinary skill in the art could do by adjusting reaction temperature as known in the art (Pages 6-7 of the Remarks filed May 11th, 2026). The Applicant further states that the required amount of blocked primers can be calculated in advance based on the desired final copy number (Page 7 of the Remarks filed May 11th, 2026). The Applicant then summarizes these aspects (Pages 7-8 of the Remarks filed May 11th, 2026).
In response to these arguments, it is noted that features upon which the Applicant relies are not recited in the rejected claims, or even in the instant disclosure at all. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, any explanation provided by the Applicant that does not have support in the instant disclosure, either in the claims or specification, cannot be considered a sufficient argument. There is no described number of amplification products numbering 100 copies, nor any further number of copies as argued. Any argument related to these copy numbers cannot be considered sufficient given the lack of description in either the claims or specification. This includes the arguments related to what is produced by each round of RCA and copies produced by MDA by limiting primers to single extension events. There are also no claims or description directed towards determining copy numbers in advance of the reaction, any specific way to control reaction time, any way to calculate the number of blocked primers needed, using an amount of primers to control the time of the reaction, or that the RCA and MDA reactions are intended to continue simultaneously with control exacted using the afore mentioned target copy number, number of blocked primers, or inactivation of enzymes.
With regards to the argument stating it is unnecessary to inactivate the enzyme for amplification, it is noted that the first round of RCA cannot be paused by the hybridization of blocked primers because the blocked primers are hybridizing to the amplification product produced by the first round of RCA. To block RCA, these primers would need to bind to the template used for RCA, not the product produced by RCA. Instead, these primers would block the MDA reaction.
Given the lack of claims or description related to the arguments presented by the Applicant, Applicant is again advised that “[t]he arguments of counsel cannot take the place of evidence in the record”. Thus, Applicant should not merely rely upon counsel's arguments in place of evidence in the record. It is noted that the Response above should not be construed as an invitation to file an after final declaration.
The Applicant further presents arguments related to the positioning and signal difference produced from the copy number difference. The Applicant first cites description from the specification relevant to positioning and signal difference (Page 8 of the Remarks filed May 11th, 2026). The Applicant argues that based on this disclosure, a person of ordinary skill in the art would understand that the read1 strand sequencing template and the read2 strand sequencing template can be distinguished based on base signals generation by the difference in copy number between the templates (Page 8 of the Remarks filed May 11th, 2026). The Applicant argues that because the copy numbers are different, the resulting signal difference can be used to determine whether a sequencing base originates from the sense strand or the antisense strand, and therefore the source strand of the sequencing case is determined (Page 8 of the Remarks filed May 11th, 2026). The Applicant argues that the term “positioned” as used in the specification refers to determining whether the sequencing base corresponds to the sense strand or the antisense strand (Page 8 of the Remarks filed May 11th, 2026).
In response to this arguments, it is noted that the amended claim language currently refers to “source of strands of sequencing bases” as what is being positioned, and not any of the produced sequencing products. As addressed above, it is unclear how and why a “source of strands of the sequencing bases” are positioned given that the source is being used as a template to produce amplified products, and the amplified products are further sequenced. However, even if the claim had not been amended to refer to “source of strands of sequencing bases”, it is noted that the cited description from the specification is still vague as to how positioning works. The argument provided by the Applicant is one interpretation of this passage, but without the Applicant’s further argument for context, the cited description does not describe the positioning as determining which strand the sequencing read comes from. It states “sequencing bases can be positioned”, which could be assigning them to a particular strand, or the more routine option of positioning within a sequencing read unrelated to assignment to either the sense or antisense strand. Ultimately, these arguments amount to arguments of counsel, and Applicant is again advised that “[t]he arguments of counsel cannot take the place of evidence in the record”. Thus, Applicant should not merely rely upon counsel's arguments in place of evidence in the record.
Overall, the presented arguments are not found persuasive.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description - Modified - Necessitated by Amendment
Claims 6-7 and 13-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to the issues related to possession of the claimed invention under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant is claiming and what Applicant has possession of. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). See MPEP § 2163.
Claim 6 recites the limitation “[a] method for synchronously sequencing a sense strand and an antisense strand of an insert DNA, comprising: performing a first round of rolling circle amplification using a circular DNA molecule of the insert DNA to be sequenced as an amplification template, to generate a first partial template strand; hybridizing the first partial template strand with blocked amplification primers, and performing a second round of rolling circle amplification using the circular DNA molecule as an amplification template to generate a second partial template strand; selecting the second partial template strand as a read1 strand sequencing template, and generating a read2 strand sequencing template by performing multiple displacement amplification using the first partial template strand as an amplification template; and hybridizing the read1 strand sequencing template with read1 strand sequencing primers, hybridizing the read2 strand sequencing template with read2 strand sequencing primers, and simultaneously performing read1 strand sequencing and read2 strand sequencing to obtain sequences of the sense strand and the antisense strand of the insert DNA, wherein a copy number of the read1 strand sequencing template and a copy number of the read2 strand sequencing template are controlled by controlling time of the rolling circle amplification and time of the multiple displacement amplification; wherein the copy number of the read1 strand sequencing template and the copy number of the read2 strand sequencing template have a difference in folds, and source of strands of the sequencing bases are positioned by using a signal difference caused by the difference in folds during the sequencing; wherein the blocked amplification primers are 3'-end reversibly modified read1 strand sequencing primers; and wherein the 3'-end reversibly modified read1 strand sequencing primers are subjected to modification removal subsequent to the second round of rolling circle amplification.” The claim as written embraces a method wherein RCA and MDA are used simultaneously to produce nucleic acid strands for sequencing, followed by synchronously sequencing the produced strands, wherein the copy numbers of the reads are controlled by controlling time of the RCA and MDA and the copy numbers have a difference in folds that can be used as a signal difference to position the sequencing bases. However, there are many gaps in the claimed method that indicate the Applicant does not have full possession of the claimed method. Turning to the specification, there is no description of the following noted aspects of the method:
There is no description in the specification of how to perform a first and second round of RCA. Generally, this would require a step to stop the RCA reaction, like heat inactivation of the polymerase enzyme being used to amplify the sequences of interest. The provided drawings seem to indicate that RCA arbitrarily stops after amplifying the circle template once, and similarly after amplifying the circle template a second time (Figures 1-3). Without further description of steps to stop and start RCA, it cannot be said that the Applicants possessed the method as claimed.
There is no description of a step wherein the amplification primers are removed from the reaction, which would mean that these primers are available to hybridize with any target sequence further produced by subsequent rounds of RCA. This would make the partial template intended for read1 unavailable to sequencing primers. Without further description of steps to control the hybridization of the blocked or unblocked amplification primers, it cannot be said that the Applicants possessed the method as claimed.
There is no description of how MDA can be carried out without also activating RCA. As indicated in the specification, Phi29 polymerase appears to be used for both amplification methods (Page 8, paragraph [0028] for RCA and Page 11, paragraph [0036] for MDA). As evidenced by ThermoFisher (phi29 DNA Polymerase [online]. ThermoFisher, [2024] [retrieved on February 5th, 2026]. Retrieved from: https://documents.thermofisher.com/TFS-Assets/LSG/manuals/MAN0030290-phi29-DNA-pol-UG.pdf; previously cited), reaction conditions for RCA and MDA using phi29 polymerase are essentially the same, aside from the template being linear or circular (Pages 4 and 5). If this polymerase is contained in a reaction where RCA and MDA can happen simultaneously, as the claimed method appears to be indicating, then there would need to be some description of how to carry out MDA without further producing more template by RCA. The only apparent description of this part of the methods is in the provided drawings, which do not describe how MDA can be carried out without also activating RCA (Figures 1-3). Without further description of steps to control RCA and MDA, it cannot be said that the Applicant possessed the method as claimed.
When turning to the specification regarding copy number control via controlling the time of RCA and MDA, the specification does not provide any method by which the time of RCA and MDA are controlled, whether simultaneously or sequentially. There are several mentions of the same idea as claimed, “a copy number of the read1 strand sequencing template and a copy number of the read2 strand sequencing template are controlled by controlling time of the rolling circle amplification and time of the multiple displacement amplification.” (Page 5, paragraph [0013]; Page 7, paragraph [0026]; Page 8, paragraph [0028], among others), but there is no further description or working examples directed towards actually enacting control over the timing of RCA and MDA, which would subsequently control the copy number of the read1 strand and the read2 strand. This does not supply adequate description as to actually possessing the ability to control timing of the amplification reactions and control the copy number of the reads. Based on the specification, the Applicant does not have possession of the method as claimed.
When turning to the specification regarding the read copy numbers having a difference in folds and positioning based on a signal difference caused by the difference in folds, the specification does not provide any description of how to relate these differences to positioning of bases. There is a mention of the same idea as claimed, “the copy number of the read1 strand sequencing template and the copy number of the read2 strand sequencing template have a difference in folds, and sequencing bases are positioned by using a signal difference caused by the difference in folds during the sequencing” (Page 5, paragraph [0014]), but there is no further description or working examples directed towards actually determining position based on a signal difference coming from a difference in folds of read copy numbers. This does not supply adequate description as to actually possessing the ability to determine position based on a signal difference coming from a difference in folds of read copy numbers. Based on the specification, the Applicant does not have possession of the method as claimed.
Claims 7 and 13-15 do not further present possession of the method as claimed in claim 6 and are also rejected here. Therefore, claims 6-7 and 13-15 are rejected for lacking written description.
Response to Arguments
Applicant's arguments filed May 11th, 2026 have been fully considered but they are not persuasive.
The Applicant first cites aspects of the MPEP related to written description requirements (Page 9 of the Remarks filed May 11th, 2026). The Applicant argues bases on these aspects that a person of ordinary skill in the art would understand the claimed method based on the present disclosure and that the disclosure is sufficient to demonstrate possession of the claimed method (Page 9 of the Remarks filed May 11th, 2026). The Applicant argues that feasibility of the claimed methods is verified in Example 1 of the specification with results shown in Figures 4-6 (Page 9 of the Remarks filed May 11th, 2026). The Applicant argues that the results demonstrate all 3 schemes are feasible (Page 9 of the Remarks filed May 11th, 2026). The Applicant further argues that based on the specification in combination with the common general knowledge in the art, one of ordinary skill would understand the Applicant has possession of the claimed method (Page 10 of the Remarks filed May 11th, 2026).
In response to these arguments, Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). The Applicant is essentially arguing that the provided disclosure is sufficient to show possession without further addressing the noted issues above. While the Applicant may state that verified Example 1 and the results in Figures 4-6 are sufficient to show possession, considering that the written description requirement does not require every implementation detail, it is still noted that there are missing aspects of the method such that one of ordinary skill in the art would not understand the claimed method. For instance, as also addressed earlier, the claimed blocked primers do not serve to pause the RCA reaction because they do not bind to the RCA template. They only serve to pause the MDA reaction, and there is no description in the instant disclosure showing possession of this separation of rounds of RCA. Thus, Applicant should not merely rely upon counsel's arguments in place of evidence in the record.
It is noted that the Response above should not be construed as an invitation to file an after final declaration. See MPEP 715.09.
New Matter - New - Necessitated by Amendment
Claims 6-7 and 13-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection necessitated by the amendments.
Claim 6 recites the limitation “source of strands of the sequencing bases are positioned by using a signal difference caused by the difference in folds during the sequencing.” As written, this limitation encompasses an interpretation wherein the source of strands of sequencing bases, or in other words the template used to produce amplified sequencing products, is positioned by using a signal difference caused by the difference in fold during the sequence. This limitation is not described in the specification such that the Applicant has possession of the claimed invention. Turning to the specification, positioning sequencing bases is described as “[t]he sequencing bases can be positioned for the read1 strand and the read2 strand simply by a signal difference brought by the copy number of the read2 strand and the copy number of the read1 strand, for example, the signal of the read2 being 2 times or other times the signal of the read1” (see paragraph [0036] of the clean copy of specification filed August 27th, 2025). This does not reference a source of strands being positioned, and there is no further description of the initial template strand used to produce the sequencing products being positioned in the instant disclosure. Therefore, the currently claimed “source of strands of the sequencing bases are positioned by using a signal difference caused by the difference in folds during the sequencing” is considered new matter that is not adequately described in the instant disclosure. Claims 7 and 13-15 are also rejected here for their dependence on claim 6, and therefore also encompassing the identified new matter.
Conclusion
All claims stand rejected.
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.
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/ALLISON E SCHLOOP/Examiner, Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
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