Prosecution Insights
Last updated: April 19, 2026
Application No. 16/637,880

METHOD FOR INCREASING ACCURACY OF ANALYSIS BY REMOVING PRIMER SEQUENCE IN AMPLICON-BASED NEXT-GENERATION SEQUENCING

Final Rejection §101§112
Filed
Feb 10, 2020
Examiner
BAILEY, STEVEN WILLIAM
Art Unit
1687
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Ngenebio
OA Round
8 (Final)
35%
Grant Probability
At Risk
9-10
OA Rounds
4y 4m
To Grant
56%
With Interview

Examiner Intelligence

Grants only 35% of cases
35%
Career Allow Rate
23 granted / 66 resolved
-25.2% vs TC avg
Strong +21% interview lift
Without
With
+20.8%
Interview Lift
resolved cases with interview
Typical timeline
4y 4m
Avg Prosecution
53 currently pending
Career history
119
Total Applications
across all art units

Statute-Specific Performance

§101
36.7%
-3.3% vs TC avg
§103
22.5%
-17.5% vs TC avg
§102
5.6%
-34.4% vs TC avg
§112
26.1%
-13.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 66 resolved cases

Office Action

§101 §112
DETAILED ACTION The Applicant’s response, received 03 September 2025 has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. 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 . Status of the Claims Claims 1, 10, and 11 are pending. Claims 1, 10, and 11 are rejected. Claim 1 is objected to. Priority This application is a 371 of PCT/KR18/09088, 09 August 2018. Claims 1, 10, and 11 are given the benefit for priority to Foreign Application 10-2017-0101540, filed 10 August 2017. Therefore, the effective filing date of the claimed invention is 10 August 2017. Claim Interpretation Claim 1 recites “generating a fastq file.” This limitation is interpreted to mean creating a text-based file in a format for storing both biological sequence data and its corresponding quality scores, and outputting the data. Claim 1 recites “saving read information and primer information.” The term ‘saving’ is interpreted to mean outputting data to a storage device. Claim 10 recites the limitation “data abnormalities.” The term “abnormalities” is interpreted to mean genomic variations. Claim Objections The amendment received 03 September 2025 has been fully considered, however after further consideration, the objection to claim 1 in the Office action mailed 03 June 2025 is maintained in view of the amendment. Claim 1 is objected to because of the following informalities: The word “comprising” in line five should be followed by a colon, since sub-steps are listed afterwards. Appropriate correction is required. Claim Rejections - 35 USC § 112 The amendment received 03 September 2025 has been fully considered, however after further consideration, the following rejections in the Office action mailed 03 June 2025 are maintained in view of the amendment and arguments/remarks, and/or newly raised in view of the amendment, as noted below. 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, 10, and 11 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. The following rejections in the Office action mailed 03 June 2025 are maintained in view of the amendment and remarks/arguments received 03 September 2025. Claim 1 is indefinite for reciting at step (a-1) the limitation “producing a plurality of read sequences by carrying out primer amplification of the nucleic acid of the cell or tissue sample from the subject” because it is not clear as to whether the amplification process is producing sequences of DNA or producing sequences of data. Claim 1 is further indefinite for reciting at step (a-ii) the limitation “detecting at least 30,000 read sequences by an NGS system from the plurality of read sequences” because it is not clear as to whether the NGS system is detecting read sequences (i.e., data) or detecting DNA sequences. Claims 10 and 11 are indefinite for depending from independent claim 1 and for failing to remedy the indefiniteness of claim 1. The following rejection(s) are newly raised in view of the amendment received 03 September 2025. Claim 1 is indefinite for reciting “based on the result of sequencing of pair 1 and pair 2 of the read sequences,” because it is not clear as to which read sequences are regarded as pair 1 and pair 2, and further indefinite because although the claim recites “paired-end” sequencing at step (a), the claim does not further recite sequencing a pair 1 and pair 2 of the read sequences, and therefore it is further not clear how there can be a “result” of sequencing of pair 1 and pair 2. Claims 10 and 11 are indefinite for depending from independent claim 1 and for failing to remedy the indefiniteness of claim 1. Response to Arguments The Applicant's arguments/remarks received 03 September 2025 have been fully considered, but they are not persuasive. The Applicant states on page 7 of the Remarks in response to the rejection of steps (a-i) and (a-ii) of claim 1 in the Office action mailed 03 June 2025, that one of ordinary skill in the art operating or utilizing NGS systems knows and understands that such systems produce read sequence data from sample DNA sequences, and that primer amplification of the nucleic acid of a cell or tissue sample generates numerous copies of target sequences of DNA; and further states that the primer amplification in step (a-i) therefore produces a plurality of DNA sequences and such DNA sequences constitute the plurality of read sequences for the NGS system from which at least 30,000 read sequences are detected by the NGS system in step (a-ii). These arguments are not persuasive, for the reasons provided in the rejection above, and further because steps (a-i) and (a-ii) in claim 1 recite limitations that do not clearly limit the steps in the same manner that is provided in the foregoing remark provided by the Applicant. The Applicant provides an explanation of paired-end sequencing on page 8 of the Remarks, and states that the first and second reads formerly recited in claim 1 have been amended to pair 1 and pair 2, and that the read sequences correspondingly comprise pair 1 and pair 2. These arguments and explanations are not persuasive, for the reasons provided in the rejection above, and because it is not clear how amending the terms “first and second reads” to recite “pair 1 and pair 2” provide clarification to method of claim 1. 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. Claims 1, 10, and 11 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. Specifically, claim 1 has been amended appears to provide limitations which are not supported by the specification as provided in the final two wherein clause. In review of the specification, literal support for the range and embodiment of ‘95% of the number of read sequences’ does not appear consistent with the analysis steps that precede it and given the guidance of the specification appears to be relative to the data and does not flow from the analysis steps themselves. The limitation of ‘in a time of from 50 to 98 seconds’ appears to be a new range and does not appear to be consistent with the analysis method and also appears relative to what data is processed and not from the analysis method itself. Dependent claims are included because they fail to address the issue and require the practice of the independent claim. More clearly setting forth support for the limitations or providing amendments consistent with the result of practicing the analysis would address the basis of the rejection. Claim Rejections - 35 USC § 101 The Applicant’s amendment received 03 September 2025 has been fully considered, however after further consideration the rejection of claims 1, 10, and 11 under 35 U.S.C. 101 in the Office action mailed 03 June 2025 is maintained with modification in view of the amendment. 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1, 10, and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite: (a) mental processes, i.e., concepts performed in the human mind (e.g., observation, evaluation, judgement, opinion); and (b) mathematical concepts (e.g., mathematical relationships, formulas or equations, mathematical calculations). Subject matter eligibility evaluation in accordance with MPEP 2106. Eligibility Step 1: Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Claims 1, 10, and 11 are directed to a method (process) for increasing efficiency of read data analysis. Therefore, these claims are encompassed by the categories of statutory subject matter, and thus, satisfy the subject matter eligibility requirements under step 1. [Step 1: YES] Eligibility Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in Prong Two whether the recited judicial exception is integrated into a practical application of that exception. Eligibility Step 2A Prong One: In determining whether a claim is directed to a judicial exception, examination is performed that analyzes whether the claim recites a judicial exception, i.e., whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. Independent claim 1 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas: step (b) processing the read sequences from the outputting by the NGS system for determining the primer sequence in the read sequences (i.e., mental processes); step (c) removing the primer sequence from the read sequences (i.e., mental processes), and step (d) generating a fastq file indicative of presence or absence of the gene variation from the read sequences from which the primer sequence has been removed (i.e., mental processes), wherein the step (b) comprises: step (i) extracting at least 30,000 read sequences completely matching a primer sequence from each one of the at least 30,000 read sequences outputted from step (a) (i.e., mental processes); step (ii) extracting read sequences matching the primer sequence at a reference error value from the read sequences not extracted in the step (i) (i.e., mental processes); and step (iii) determining primer sequence information of a read not extracted in the step (ii) based on primer sequence information inside the read and the primer sequence (i.e., mental processes), and wherein the primer sequence information inside the read in the step (iii) is information corresponding to the primer sequence of another read present inside the read sequence (i.e., mental processes), wherein the read sequences of step (i) are characterized in that a 5' portion is removed in an amount of 5bp (i.e., mental processes), wherein the sequence comparison in step (i) is characterized by comparing the primer sequence with 50 bp of the 5' portion of the read sequence (i.e., mental processes), and wherein the determining the primer sequence in step (b) comprises determining and saving read information and primer information when the primers of the read sequences are forward (5') and reverse (3') primers, respectively, and match to each other, based on the result of sequencing of pair 1 and pair 2 of the read sequences (i.e., mental processes); and wherein the number of read sequences from which the primer sequence has been removed in step (c) is at least 95% of the number of read sequences outputted by the NGS system in step (b) (i.e., mental processes and mathematical concepts). Dependent claims 10 and 11 further recite the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas, as noted below. Dependent claim 10 further recites: reporting the presence or absence of data abnormalities through an amplicon production result (i.e., mental processes). Dependent claim 11 further recites: the amplicon production result is obtained by comparing the amplicon production result predicted based on a primer matching result of an experimental sample with the amplicon production result of the experimental sample compared to an actual control sample (i.e., mental processes). The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification. As noted in the foregoing section, the claims are determined to contain limitations that can practically be performed in the human mind with the aid of a pen and paper (e.g., searching for, finding, and deleting particular substrings of data, i.e., cleaning the data), and therefore recite judicial exceptions from the mental process grouping of abstract ideas. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas (e.g., determining a percentage of reads) are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind. Therefore, claims 1, 10, and 11 recite an abstract idea. [Step 2A Prong One: YES] Eligibility Step 2A Prong Two: In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d)(I); MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP 2106.04(d)(III)). The judicial exceptions identified in Eligibility Step 2A Prong One are not integrated into a practical application because of the reasons noted below. Dependent claims 10 and 11 do not recite any elements in addition to the judicial exception, and thus are part of the judicial exception. The additional elements in independent claim 1 include: step (a) conducting amplicon-based paired-end next-generation sequencing of nucleic acid of a cell or tissue sample from a subject; step (a-i) producing a plurality of read sequences by carrying out primer amplification of the nucleic acid of the cell or tissue sample from the subject; step (a-ii) detecting at least 30,000 read sequences by an NGS system from the plurality of read sequences; step (a-iii) outputting the read sequences thereof by the NGS system; a computer; and wherein in the computer-implemented processing operations (b)-(d), subsequent to completion of steps (b) and (c), the generating in step (d) of the fastq file indicative of presence or absence of the gene variation from the read sequences from which the primer sequence has been removed is completed in a time of from 50 to 98 seconds. The additional elements of conducting amplicon-based paired-end next-generation sequencing of nucleic acid of a cell or tissue sample from a subject (step (a)); producing a plurality of read sequences by carrying out primer amplification of the nucleic acid of the cell or tissue sample from the subject (step (a-i)); detecting at least 30,000 read sequences by an NGS system from the plurality of read sequences (step (a-ii)); and outputting the read sequences thereof by the NGS system (step (a-iii)); are insignificant extra-solution activities that are part of the data gathering process used in the recited judicial exceptions (see MPEP 2106.05(g)). The additional element of a computer (steps (b), (c), and (d)) is used as a tool to perform the abstract ideas, such that it amounts to no more than mere instructions to apply the exceptions using a generic computer (MPEP 2106.05(f)), and therefore is not an improvement to computer functionality itself, or an improvement to any other technology or technical field (MPEP 2106.04(d)(1)). The additional element in step (d) of the generating of the fastq file indicative of presence or absence of the gene variation from the read sequences from which the primer sequence has been removed is completed in a time of from 50 to 98 seconds does not amount to more than mere instructions to implement an abstract idea on a computer (MPEP 2106.05(f) (2) iii. (increased speed in the process comes solely from the capabilities of the general-purpose computer)). Thus, the additionally recited elements merely invoke a computer and/or computer related components as tools; and/or amount to insignificant extra-solution activity; and/or amount to no more than mere instructions to implement an abstract idea on a computer; and as such, when all limitations in claims 1, 10, and 11 have been considered as a whole, the claims are deemed to not recite any additional elements that would integrate a judicial exception into a practical application, and therefore claims 1, 10, and 11 are directed to an abstract idea (MPEP 2106.04(d)). [Step 2A Prong Two: NO] Eligibility Step 2B: Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are probed for a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they amount to significantly more than the judicial exception (MPEP 2106.05A i-vi). The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception(s) because of the reasons noted below. Dependent claims 10 and 11 do not recite any elements in addition to the judicial exception(s). The additional elements recited in independent claim 1 are identified above, and carried over from Step 2A: Prong Two along with their conclusions for analysis at Step 2B. Any additional element or combination of elements that was considered to be insignificant extra-solution activity at Step 2A: Prong Two was re-evaluated at Step 2B, because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and all additional elements and combination of elements were evaluated to determine whether any additional elements or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP 2106.05(d). The additional element of a computer is conventional (see MPEP at 2106.05(b) and 2106.05(d)(II) regarding conventionality of computer components and computer processes). The additional element of generating the fastq file indicative of presence or absence of the gene variation from the read sequences from which the primer sequence has been removed is completed in a time of from 50 to 98 seconds does not amount to more than mere instructions to implement an abstract idea on a computer (MPEP 2106.05(f)), and therefore does not amount to significantly more than the judicial exceptions. The additional elements of conducting amplicon-based paired-end next-generation sequencing of nucleic acid of a cell or tissue sample from a subject; producing a plurality of read sequences by carrying out primer amplification of the nucleic acid of the cell or tissue sample from the subject; detecting at least 30,000 read sequences by an NGS system from the plurality of read sequences; and outputting the read sequences thereof by the NGS system; are conventional. Evidence for the conventionality is shown by Chaitankar et al. (Progress in Retinal and Eye Research, 2016, Vol. 55, pp. 1-31, as cited in the Office action mailed 27 September 2023). Chaitankar et al. reviews next-generation sequencing technology and genome-wide data analysis with a focus on retinal tissue, but as stated are applicable to other tissues/cell types (Abstract). Chaitankar et al. further reviews technical specifications of major sequencing platforms and shows that the Illumina MiSeq is designed for amplicon sequencing and can produce total reads of 50 million (page 7, Table 1). Chaitankar et al. further shows PCR amplification with index primers (Figure 6B), single-end (SE) or paired-end (PE) sequencing (page 7, col. 2, para. 1); and outputting and storing data in FASTQ text file format (page 6, Box 2). Therefore, when taken alone, all additional elements in claims 1, 10, and 11 do not amount to significantly more than the above-identified judicial exception(s). Even when evaluated as a combination, the additional elements fail to transform the exception(s) into a patent-eligible application of that exception. Thus, claims 1, 10, and 11 are deemed to not contribute an inventive concept, i.e., amount to significantly more than the judicial exception(s) (MPEP 2106.05(II)). [Step 2B: NO] Response to Arguments The Applicant's arguments received 03 September 2025 have been fully considered, but they are not persuasive. The Applicant states on page 11 (para. 3) of the Remarks that the rejection of claim 1 ascribes mental steps character to various steps of the claimed method that cannot practically be performed in the human mind, do not constitute insignificant extra-solution activity, and are effective to integrate the judicial exception aspects of the claim into a practical application of rapid precision removal of primer sequences from next-generation sequencing reads to enhance detection of gene variation, such that the claim reflects an improvement to technology for gene variation detection in the field of next-generation sequencing. These arguments are not persuasive, because first, the recited steps of analyzing sequence read data are steps that can practically be performed in the human mind with the aid of a pen and paper, as discussed in the above rejection; second, steps of gathering data for use in the claimed process are insignificant extra-solution activities for the reasons provided in the above rejection; and third, the claims do not recite any additional elements that apply, rely on, or use the judicial exceptions in a manner that imposes a meaningful limit on the judicial exception, and therefore claim 1 does not integrate the judicial exceptions into a practical application, and thus, claim 1 does not reflect an improvement to technology for gene variation detection in the field of next-generation sequencing. The Applicant states on page 11 (middle) of the Remarks that the problem faced and overcome by the claimed invention is discussed in paragraphs [5] – [7] of the present application, and also in the Abstract of the present application. The Applicant further states on page 12 (bottom) that the improvement of speed, accuracy, and efficiency of the method of the claimed invention is demonstrated by the examples at pages 21-29 of the present application, in which the computer-implemented processing operations of the claimed method are described, and comparison is made to an industry-standard software for primer removal from next generation sequencing reads (Remarks, page 12, bottom; and page 13, top), and thus, the claimed method achieves superior speed, accuracy, and efficiency in performing primer removal from next generation sequencing reads and generating a fastq file indicative of gene variation. These arguments are not persuasive, because first, and as noted in the foregoing responses to arguments, the claims do not recite any additional elements that apply, rely on, or use the judicial exceptions in a manner that imposes a meaningful limit on the judicial exception, and therefore claim 1 does not integrate the judicial exceptions into a practical application, and thus, claim 1 does not reflect an improvement to technology for gene variation detection in the field of next-generation sequencing. Second, the instant claimed advantage of superior speed, accuracy, and efficiency in performing primer removal from next generation sequencing reads and generating a fastq file indicative of gene variation is a purported improvement to the abstract idea (data analysis), and not an improvement to computer functionality itself (e.g., the computer architecture itself), or an improvement to another technology or technical field. The Applicant states on page 13 (bottom) of the Remarks that steps (b) (i, ii, and iii) of claim 1 in the context of 30,000 read sequences applicable to such steps cannot practically be performed in the human mind, and therefore are not judicial exceptions, and constitute significant solution operations that are not cognizable as insignificant extra-solution activity, and hence are effective as additional elements to integrate judicial exception aspects of the claim into a practical application of rapid precision removal of primer sequences from next-generation sequencing reads to enhance detection of gene variation, such that the claim reflects an improvement to technology for gene variation detection in the field of next-generation sequencing. These arguments are not persuasive, because the amount of data and/or the amount of time to perform the process steps, in and of themselves is not a limitation which takes a process out of the realm of the human mind. It is the process performed on that data which is the mental step, and manipulating sequence data in the form of sequence reads is a data analysis process that can be practically performed by the human mind with the aid of pen and paper, as discussed in the above rejection. Thus, although the amount of data may be considered to be significantly large and take considerable time and effort to process manually, the use of a computer to perform the claimed method at a rate and accuracy that can far outstrip the mental performance of a skilled artisan does not change the nature of the activity being performed (i.e., an abstract idea), and therefore does not materially alter the patent eligibility of the claimed subject matter. The Applicant states on page 14 of the Remarks that in the context of 30,000 read sequences applicable to the claimed method step of generating a fastq file indicative of presence or absence of the gene variation from the read sequences from which the primer sequence has been removed, and the recited limitation in lines 36-39 of claim 1 that “in the computer-implemented processing operations (b)-(d), subsequent to completion of steps (b) and (c), the generating in step (d) of the fastq file indicative of presence or absence of the gene variation from the read sequences from which the primer sequence has been removed is completed in a time of from 50 to 98 seconds,” it is apparent that such claimed method step constitutes a significant solution operation that is not recognizable as insignificant extra-solution activity, and hence is effective as an additional element to integrate judicial exception aspects of claim 1 into a practical application of rapid precision removal of primer sequences from next-generation sequencing reads to enhance detection of gene variation, such that the claim reflects an improvement to technology for gene variation detection in the field of next-generation sequencing. These arguments are not persuasive, because first, and as noted in the foregoing response to Applicant’s arguments, the amount of data and/or the amount of time to perform the process steps, in and of themselves is not a limitation which takes a process out of the realm of the human mind. It is the process performed on that data which is the mental step, and manipulating sequence data in the form of sequence reads is a data analysis process that can be practically performed by the human mind with the aid of pen and paper, as discussed in the above rejection. Thus, although the amount of data may be considered to be significantly large and take considerable time and effort to process manually, the use of a computer to perform the claimed method at a rate and accuracy that can far outstrip the mental performance of a skilled artisan does not change the nature of the activity being performed (i.e., an abstract idea), and therefore does not materially alter the patent eligibility of the claimed subject matter. Second, the step of generating the fastq file indicative of presence or absence of the gene variation from the read sequences from which the primer sequence has been removed is completed in a time of from 50 to 98 seconds, does not amount to more than mere instructions to implement an abstract idea on a computer (MPEP 2106.05(f) (2) iii. (increased speed in the process comes solely from the capabilities of the general-purpose computer)), and therefore does not integrate the judicial exceptions into a practical application or provide significantly more. Conclusion No claims are allowed. 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. Inquiries Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN W. BAILEY whose telephone number is (571)272-8170. The examiner can normally be reached Mon - Fri. 1000 - 1800. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KARLHEINZ SKOWRONEK can be reached on (571) 272-9047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /S.W.B./Examiner, Art Unit 1687 /Joseph Woitach/Primary Examiner, Art Unit 1687
Read full office action

Prosecution Timeline

Feb 10, 2020
Application Filed
Feb 10, 2020
Response after Non-Final Action
Jan 12, 2023
Non-Final Rejection — §101, §112
Apr 18, 2023
Response Filed
Jun 29, 2023
Final Rejection — §101, §112
Sep 06, 2023
Request for Continued Examination
Sep 07, 2023
Response after Non-Final Action
Sep 21, 2023
Non-Final Rejection — §101, §112
Dec 27, 2023
Response Filed
Jan 23, 2024
Final Rejection — §101, §112
Apr 02, 2024
Interview Requested
Apr 04, 2024
Examiner Interview Summary
Apr 30, 2024
Response after Non-Final Action
May 30, 2024
Request for Continued Examination
Jun 03, 2024
Response after Non-Final Action
Jun 28, 2024
Non-Final Rejection — §101, §112
Oct 03, 2024
Response Filed
Dec 09, 2024
Final Rejection — §101, §112
Feb 05, 2025
Interview Requested
Feb 11, 2025
Examiner Interview Summary
Feb 18, 2025
Request for Continued Examination
Feb 21, 2025
Response after Non-Final Action
May 29, 2025
Non-Final Rejection — §101, §112
Sep 03, 2025
Response Filed
Dec 05, 2025
Final Rejection — §101, §112 (current)

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Prosecution Projections

9-10
Expected OA Rounds
35%
Grant Probability
56%
With Interview (+20.8%)
4y 4m
Median Time to Grant
High
PTA Risk
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