DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
none
Pending:
1-20
Withdrawn:
none
Examined:
1-20
Independent:
1 and 11
Allowable:
none
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
102, 103
JE
Judicial Exception
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
x
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 9/17/2021 filing receipt, this application claims priority to no earlier than 6/23/2016. All claims have been interpreted as being accorded this priority date.
Interpretation regarding non-substantive color
While the color green appears in various figures (e.g. Fig. 12A), the use of color does not appear to be substantively essential to the disclosure and does not appear to be referenced in the specification. Also, no petition for color drawings has been filed. Therefore, the drawings will not be reproduced or otherwise considered as color drawings, and no petition is required. See 37 CFR 1.84.
Objection to the specification: title
The title should be amended to more specifically reflect the claims, particularly the independent claims and referencing steps/elements: setting the context of the invention, particular to all claims, and distinguishing the instant application from any related applications. The title should be "descriptive" and "as... specific as possible" (MPEP 606, 1st para. and 37 CFR 1.72; also MPEP 606.01 pertains).
Claim rejections - 112/b
The following is a quotation of 35 USC 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.
Claims 1-20 are rejected under 112/b, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However equivalent amendments also would be acceptable.
The following issues cause the respective claims to be rejected under 112/b as indefinite:
Claim
Recitation
Comment
1-2
a measurement circuit that acquires
Regarding claim 1, a claim to a machine or manufacture, e.g. here a "system," cannot recite a process step such as "that acquires..." MPEP 2173.05(p).II pertains. This rejection may be overcome, for example, by amending to "configured to acquire..." (as in the preceding steps). Claim 2 is rejected similarly.
1, 5, 7-8 and 10
a processor configured to...
Claim 1 is to a 101 machine or manufacture, i.e. a "system" in this instance, interpreted by statute according to its claimed physical structure, but it is not clear what is the structure associated with the recited "processor configured to...," "determine...," and similar steps. Therefore, it is not clear whether the claim is limited according to these steps. MPEP 2106.03, 5th-6th paras. pertain. The recited "system" and "processor" are interpreted as not clearly requiring structure linking the "system" to the recited steps in a structural sense appropriate to a claim to a machine or manufacture. While the recited elements may comprise unrecited software storage in some embodiments, it is not clear that all embodiments of these elements must comprise software storage corresponding to the recited process steps. Structure should be recited specifically corresponding to stored software. The recited process steps are not properly claimed without corresponding structure. This rejection might be overcome by, for example, reciting a data storage device, comprised by the "system," and instructions stored therein and configured according to the recited elements and steps. MPEP 2173.05(p).II pertains regarding a claim directed to both product and process. Similar issues are repeated in claims 5, 7-8 and 10.
1 and 11
determine a shifted set of voltage data
In claim 1, it is unclear whether the recited "shifted" is limited to shifts in time or also reads on shifts in voltage. Both are disclosed, e.g. [93] regarding shifting in time and [36, 87. 107, 127] regarding shifting in voltage, however only one appears consistent with the subsequent recitations of "determine...," "compute..." and "identify..." It is assumed that shifting in time is intended, and this rejection could be overcome, for example, by amending claim 4 into claim 1. Claim 11 is rejected similarly.
Subject matter clear of the prior art
Claims 1-20 are clear of the prior art. Close art, for example Ju (US 2015-0119259), Fernandez (US 2017-0089858) and Wang (2015 NPL), each as cited on the 9/3/2021 IDS, as well as art found in the accompanying search histories, does not teach the instant combination of determining time-shifted voltage data and then difference data and finally determining a threading event based on data processed as recited.
Judicial exceptions (JE) to 101 patentability
Referring to 101 analysis as organized in MPEP 2106, no rejection applies to claims 1-20, at least by analogy to analysis step 2A, 2nd prong, 3rd consideration, relating to a particular machine integrating any possible judicial exceptions into a practical application, in that a particular machine in this instance comprises at least the recited nanopore along with the equipment inherent in the recited process steps.
Nonstatutory double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine to prevent the improper timewise extension of the "right to exclude" granted by a patent and to prevent multiple suits against an accused infringer by different assignees of the same invention (MPEP 804.II.B, 1st para.). A nonstatutory double patenting rejection is appropriate where the conflicting claims (instant v. reference) are not identical, but an examined-application claim (instant claim) is not patentably distinct from a reference claim because the instant claim is either anticipated by, or would have been obvious over, the reference claim (MPEP 804.II.B, 2nd para.).
In cases of double patenting rejections versus reference claims of pending applications, as opposed to claims of an issued patent, the rejections are provisional because the reference claims have not been patented. Presently, no rejections are provisional.
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the application or patent of the reference claim either is shown to be commonly owned with the instant application or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must comply fully with 37 CFR 3.73(b).
Applicant may wish to consider electronically filing a terminal disclaimer (MPEP 1490.V pertains, along with https://www.uspto.gov/patents-application-process/applying-online/eterminal-disclaimer). Electronic filing may lead to faster approval of the disclaimer. Also, if filing electronically, Applicant is encouraged to notify the examiner by telephone so that examination may resume more quickly.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used.
A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Double patenting rejections of instant claims 1-20
Instant claims 1-20 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference patents 11,124,827 (from application 15/628,353) and 11,531,021 (from application 16/946,534) and in reference application 18/069,117 (12/20/2022 claims) in view of Ju (US 2015-0119259), Fernandez (US 2017-0089858) and Wang (2015 NPL), each as cited on the 9/3/2021 IDS.
Each reference patent and application as well as the instant application recite claims which involve applying an alternating signal across a nanopore sequencing cell, molecule transit in a threading event, voltage data acquisition, computational signal analysis to determine a type of threading event, e.g. nucleotide base calling.
Although the reference claims are not identical to the instant claims, in a BRI they also are not patentably distinct from the instant claims: either (i) because the instant claims recite obviously equivalent or broader limitations in comparison to the reference claims or (ii) because the instant claims recite limitations which are obvious over the cited art. It is not clear that the instant claims recite limitations which are narrower than limitations in the reference claims.
It would have been obvious in view of the cited art to modify reference claims to arrive at the rejected instant claims. Either the instant limitations are interpreted as reading on a reference limitation, or the instant limitations would have been obvious in view of the cited art. That is, to the extent that any instant claims are narrower than reference claims, then any such narrowing would have been obvious over the cited art.
Conclusion
No claim is allowed.
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The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
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