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 February 16th, 2026 is acknowledged. Regarding the Office Action mailed November 17th, 2025:
The objections to the drawings are withdrawn in view of the amendments.
The rejections set forth under 35 U.S.C. 112(b) are withdrawn in view of the arguments and amendments.
The rejection set forth under 35 U.S.C. 112(a) is withdrawn in view of the arguments and amendments.
Maintained, modified, or new rejections are set forth below, as necessitated by the amendments and further considerations. Responses to arguments, if necessary, follow their respective rejection sections.
Claim Summary
Claims 1 and 8 have been amended. Claims 1-21 are pending. Claims 13-21 are withdrawn from consideration as being drawn to a non-elected invention/species. Claims 1-12 are under examination and discussed in this Office action.
Claim Rejections - 35 USC § 112(b) - New - Necessitated by Further Considerations
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 3-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3-6 are indefinite in the recitation “at least about” in each of the claims. The phrase “at least” typically indicates a minimum point; however, the phrase “at least” is controverted by the term “about,” which implies that values above and below the indicated amount are permitted. Therefore, the juxtaposition of these two terms makes it unclear what maximum dimensions are encompassed by the claim.
In Amgen, Inc. v. Chugai Pharmaceutical co., 927 F.2d 1200 (CAFC 1991), the CAFC stated, “[t]he district court held claims 4 and 6 of the patent invalid because their specific activity of “at least about 160,000” was indefinite.” After review, the CAFC states “[w]e therefore affirm the district court’s determination on this issue.” Thus, the CAFC found the phrase “at least about” indefinite where the metes and bounds of the term were not defined in the specification. See MPEP 2173.05(b) III. For the purpose of compact prosecution, the phrase “at least about” in claims 3-6 will be interpreted as “at least”.
Claim Rejections - 35 USC § 103 - Modified - Necessitated by Amendment and Further Considerations
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 1-8 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wahba (US 20170283866 A1; previously cited), as evidenced by Semat (Physics, Chapter 28: Electrical Conduction in Liquids and Solids, Robert Katz Publications, 1958, 524-538; available at: digitalcommons.unl.edu/physicskatz/154; previously cited).
Regarding instant claim 1, Wahba teaches a method for forming a membrane over a well of a sequencing chip, the method comprising: flowing a solution comprising a membrane forming material and an organic solvent through a flow channel over a well of a sequencing chip to displace a first aqueous solution from the flow channel while leaving an aqueous phase of the first aqueous solution in the well (Page 6, paragraph [0078]; Pages 6-7, paragraph [0083]-[0084]), the well comprising a working electrode in electrical communication with a counter electrode (Figure 5); applying a first voltage between the working electrode and the counter electrode during the step of flowing the solution comprising the membrane forming material (Page 7, paragraph [0086]); displacing the solution comprising the membrane forming material from the flow channel by flowing a second aqueous solution through the flow channel (Page 7, paragraph [0090]), thereby leaving a layer of membrane forming material covering the well and sealing the first aqueous solution in the well (Page 7, paragraph [0090]); and thinning the layer of membrane forming material into a membrane capable of receiving a nanopore for a sequencing application, wherein the trapped charge in the well creates a voltage differential across the membrane even when no voltage is being applied (Page 7, paragraph [0086]; Page 7, paragraph [0090]).
Wahba teaches that the step of flowing a second solution happens after applying a voltage for thinning the layer of membrane. However, with respect to the order of steps, it is noted that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930); Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959)). See MPEP §2144.04 IV C. Thus, the claimed order of steps is an obvious variant of the steps of the cited prior art.
Wahba does not directly teach that the applied voltage traps charge in the aqueous phase of the first aqueous solution in the well. However, Wahba does teach that the lipid membrane is ion-impermeable (Page 2, paragraph [0027]). Wahba also teaches that a voltage is applied for thinning of the lipid bilayer while the lipid solution is still flowing to establish the lipid bilayer (Page 7, paragraph [0086]). Wahba further teaches that the first aqueous solution contains salts (Page 6, paragraph [0082]). As evidenced by Semat, salts break down into their respective ionic components when dissolved in water (Page 525, last paragraph to Page 526, second paragraph; Figure 28-1). Furthermore, as evidenced by Semat, ions have a charge (Page 525, last paragraph to Page 526, second paragraph; Figure 28-1). Given that Wahba has a salt solution, it can reasonably be said that a charge will be present in the wells of Wahba. Once the lipid bilayer forms, which is ion-impermeable as cited earlier, the charge will be trapped in the well. Therefore, it would be obvious to one of ordinary skill in the art that Wahba inherently teaches trapping a charge in a well in their method.
With regard to the limitation “wherein the trapped charge in the well creates a voltage differential across the membrane even when no voltage is being applied”, it is noted that the subject matter of a properly construed claim is defined by the terms that limit its scope. It is this subject matter that must be examined. As a general matter, the grammar and intended meaning of terms used in a claim will dictate whether the language limits the claim scope. Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. “Wherein” clauses are examples of language that may raise a question as to the limiting effect of the language in a claim. See MPEP 2103 I.C. and MPEP § 2111.04. Because the above cited limitation does not recite an active method step, and instead an intended outcome of the method steps, it does not serve to further limit the scope of the claim. Therefore, the method steps taught also serve to teach the wherein clause.
Regarding instant claim 2, Wahba, as evidenced by Semat, teaches the method of claim 1. Wahba further teaches wherein the first voltage applied between the working electrode and the counter electrode has a magnitude between about 10 to 2000 mV (Page 7, paragraph [0086]).
Regarding instant claim 3, Wahba, as evidenced by Semat, teaches the method of claim 1. Wahba further teaches wherein the first voltage applied between the working electrode and the counter electrode has a magnitude between about 10 to 2000 mV (Page 7, paragraph [0086]). Wahba does not directly teach wherein the first voltage applied between the working electrode and the counter electrode has a magnitude at least about 10 mV. However, it is noted that the courts have found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. The general conditions of establishing a trapped charge, along with the other claimed method steps, are disclosed in Wahba, as analyzed above. From there, determining a suitable voltage would amount to routine optimization. Thus, the claimed voltage merely represents routine optimization of the values of the cited prior art.
Regarding instant claim 4, Wahba, as evidenced by Semat, teaches the method of claim 1. Wahba further teaches wherein the first voltage applied between the working electrode and the counter electrode has a magnitude between about 10 to 2000 mV (Page 7, paragraph [0086]). Wahba does not directly teach wherein the first voltage applied between the working electrode and the counter electrode has a magnitude at least about 100 mV. However, it is noted that the courts have found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. The general conditions of establishing a trapped charge, along with the other claimed method steps, are disclosed in Wahba, as analyzed above. From there, determining a suitable voltage would amount to routine optimization. Thus, the claimed voltage merely represents routine optimization of the values of the cited prior art.
Regarding instant claim 5, Wahba, as evidenced by Semat, teaches the method of claim 1. Wahba further teaches wherein the first voltage applied between the working electrode and the counter electrode has a magnitude between about 10 to 2000 mV (Page 7, paragraph [0086]). Wahba does not directly teach wherein the first voltage applied between the working electrode and the counter electrode has a magnitude at least about 200 mV. However, it is noted that the courts have found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. The general conditions of establishing a trapped charge, along with the other claimed method steps, are disclosed in Wahba, as analyzed above. From there, determining a suitable voltage would amount to routine optimization. Thus, the claimed voltage merely represents routine optimization of the values of the cited prior art.
Regarding instant claim 6, Wahba, as evidenced by Semat, teaches the method of claim 1. Wahba further teaches wherein the first voltage applied between the working electrode and the counter electrode has a magnitude at least about 500 mV (Page 7, paragraph [0086]).
Regarding instant claim 7, Wahba, as evidenced by Semat, teaches the method of claim 1. Wahba further teaches wherein the step of thinning the layer of membrane forming material comprises flowing a fluid over the layer of membrane forming material (Page 7, paragraph [0090]).
Regarding instant claim 8, Wahba, as evidenced by Semat, teaches the method of claim 1. Wahba further teaches the method further comprising: flowing a nanopore solution over the membrane; and inserting a nanopore into the membrane (Page 3, paragraph [0037]; Figure 5).
Regarding instant claim 11, Wahba, as evidenced by Semat, teaches the method of claim 1. Wahba further teaches wherein the sequencing chip comprises an array of wells (Pages 1-2, paragraph [0025]: array of cells; Pages 2-3, paragraph [0035]: cells contain wells).
Regarding instant claim 12, Wahba teaches the method of claim 1. Wahba does not directly teach that the first voltage is applied as a first waveform having a frequency of at least 10 to 1000 Hz. However, Wahba does teach that a voltage source, which is used to establish the voltage as cited in claim 1 (Page 4, paragraph [0046]: Voltage source Vliq…is a square wave with… a frequency between 25 and 100 Hz; Page 7, paragraph [0086]: the absolute magnitude Vliq for lipid thinning may be between 250 mV to 500 mV), can be a square wave with a frequency between 25 and 100 Hz. Therefore, it would be obvious that the voltage source as earlier cited could be applied as a first waveform having a frequency of at least 10 to 1000 Hz.
Response to Arguments
Applicant's arguments filed February 16th, 2026 have been fully considered but they are not persuasive.
The Applicant first provides a summary of the Examiner’s previous rejection (Page 11 of the Remarks filed February 16th, 2026). The Applicant then provides information regarding obviousness rejections from the MPEP (Pages 11-12 of the Remarks filed February 16th, 2026). The Applicant states that claim 1 recites a specific sequence of events, and further argues that this sequence is not taught by Wahba (Page 12 of the Remarks filed February 16th, 2026). The Applicant states the Wahba teaches on controlling stimulus to avoid short-circuit conditions before sealing and to avoid breakdown of formed bilayers (Page 12 of the Remarks filed February 16th, 2026). The Applicant cites various aspects of Wahba, arguing that based on these citations, Wahba teaches disabling the electrical stimulus before sealing (Page 13 of the Remarks filed February 16th, 2026). The Applicant argues this directly contradicts the claimed application of voltage during membrane-forming flow to trap charge (Page 13 of the Remarks filed February 16th, 2026). The Applicant argues that a skilled artisan reading Wahba would be directed away from applying voltage during the deposition/unsealed interval in the manner required by claim 1 (Page 13 of the Remarks filed February 16th, 2026). The Applicant argues there is no predictable basis to combine Wahba with any modification that applies voltage during that interval, nor is there a reasonable expectation of success that such a modification would achieve the Applicant’s claimed invention (Page 13 of the Remarks filed February 16th, 2026).
In response to these arguments, it is first noted that as presented in the above rejection, Wahba teaches aspects of the claimed invention that are required to be in a specific sequence (flowing solution, applying first voltage while flowing solution), while also teaching aspects that while out of order as presented in the claim, result in the same outcome (thinning the membrane before flowing the second solution). As indicated in the above rejection, the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results (see MPEP §2144.04 IV C). Therefore, Wahba sufficiently teaches the sequence of the method as claimed. It is next noted that while there several embodiments of Wahba directed to disabling the electrical stimulus before sealing, the embodiment cited in the above rejection indicates that “[a]pplying the electrical lipid-thinning stimulus to the cells that have not had lipid bilayers formed therein yet can improve the efficiency of liquid flow above the thick lipid membranes, thereby facilitating the removal of any excess lipid solvent such that the thick lipid membranes can be thinned out and transitioned into lipid bilayers more efficiently” (Page 7, paragraph [0086]). This citation indicates an embodiment of Wahba where voltage is applied while the membrane forming material is flowing, while also providing a motivation for doing so, therefore teaching this aspect of the invention as claimed.
The Applicant further argues that Wahba's stimulus teachings are directed to controlled bilayer monitoring/thinning and to avoiding bilayer breakdown, not to trapping charge to create a persistent no-drive transmembrane potential (Page 13 of the Remarks filed February 16th, 2026). The Applicant argues that Wahba frames electrical stimulus as something to be carefully gated and managed for measurement purposes, with emphasis on preventing destructive conditions and shorts, rather than as a voltage applied during membrane deposition to intentionally create and preserve a trapped-charge condition (Page 13 of the Remarks filed February 16th, 2026). The Applicant argues that Wahba does not teach or suggest Applicant's amended claim 1, and that Wahba’s disclosures about electrolyte solutions and stimulus waveforms do not supply the amended features, namely because the amended claim is not satisfied by the mere presence of ions in solution (Page 14 of the Remarks filed February 16th, 2026). The Applicant argues that the amended claim instead recites a specific operational step (voltage applied during membrane-forming flow to trap charge in the retained aqueous phase) and a specific functional outcome (a persistent voltage differential across the membrane even absent applied voltage) (Page 14 of the Remarks filed February 16th, 2026).
In response to these arguments, as has been noted above, Wahba teaches an embodiment where voltage is applied while the membrane forming material is flowing, while also providing a motivation for doing so. With regard to the ions in solution not being a satisfactory teaching, it is noted that there is no requirement within the current claim language for the charge to be an electrical charge. Forming a membrane over a well with ions serves to trap a type of charge, which is taught by Wahba as rejected above. With regard to the specific functional outcome of a persistent voltage differential across the membrane even absent applied voltage, as has been addressed in the above rejection, the wherein clause does not represent an active method step and therefore does not limit the scope of the claim.
The Applicant argues that the Examiner’s previous rejection regarding salt being a trapped charge asserts inherency that does not supply the subject matter of claim 1 because inherency requires the missing feature to necessarily be present, not merely possible or conceptual extrapolation (Page 14 of the Remarks filed February 16th, 2026). The Applicant argues that Wahba's teaching to keep the switch open before sealing to avoid shorts, and to close it only after sealing, further undermines any contention that Wahba necessarily performs Applicant's claimed step of applying voltage during the membrane-forming flow to trap charge in the retained aqueous phase (Page 14 of the Remarks filed February 16th, 2026). The Applicant concludes by summarizing the arguments as presented (Page 14 of the Remarks filed February 16th, 2026).
In response to these arguments, it is noted that salts do provide an ionic charge when dissolved, as evidenced above, and Wahba teaches on salt solutions. The feature that can produce a charge is present, not merely possible or conceptual extrapolation. Furthermore, as stated above, the current claim language does not indicate that the trapped charge must be an electrical charge. As has also been noted above, Wahba teaches an embodiment where voltage is applied while the membrane forming material is flowing, while also providing a motivation for doing so, and also trapping a solution that contains salts that can provide an ionic charge. This reasonably comprises a trapped charge.
Claim Objections
Claims 9 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. There is no prior art that teaches or suggests the aspects of claims 9 and 10 as claimed.
Conclusion
Claims 1-8 and 11-12 stand rejected. Claims 9 and 10 are objected to for depending from a rejected claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allison E Schloop whose telephone number is (703)756-4597. The examiner can normally be reached Monday-Friday 8:30-5 ET.
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, Anne Gussow can be reached at (571) 272-6047. 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.
/ALLISON E SCHLOOP/Examiner, Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
Prosecution Insights