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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-19 and 23-25) in the reply filed on May 29, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 20-22 are withdrawn from further consideration.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of the inclusion of legal phraseology such as “comprising”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-7, 10-11, 15-19 and 23-25 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.
On lines 1-2 of claim 4, the phrase “a number of cells” is indefinite and lacks antecedent basis since claims 1 and 3, from which claim 4 depends, do not positively recite the particles assessed with the system as being cells, and do not positively recite the presence of cells in the second structure. On line 4 of claim 4, the phrase “the processor” lacks antecedent basis since a processor is positively recited in claim 2, but claim 4 does not depend from claim 2.
On lines 1-2 of claim 5, the phrase “the processor” lacks antecedent basis since a processor is positively recited in claim 2, but claim 5 does not depend from claim 2. On line 3 of claim 5, the phrase “the number of particles that migrated” lacks antecedent basis and should be changed to –a number of particles--.
In claim 10, the phrase “the cells” lacks antecedent basis since claim 10 depends from claims 9 and 1, and claims 1 and 9 do not positively recite cells in the system.
On line 1 of claim 11, the phrase “the processor” lacks antecedent basis since a processor is positively recited in claim 2, but claim 11 does not depend from claim 2. Claim 11 depends from claim 5, which depends from claim 4, which depends from claim 3, which depends from claim 1.
On lines 9-10 of claim 15, the phrase “a second structure” should be changed to --the second structure—since the second structure is already positively recited on line 2 of claim 15.
On line 2 of claim 18, the phrase “a number of cells” is indefinite and lacks antecedent basis since claims 15 and 17, from which claim 18 depends, do not positively recite the particles assessed in the method as being cells, and do not positively recite the presence of cells in the second structure. On line 4 of claim 18, the phrase “the infectivity” lacks antecedent basis and is indefinite since the particles have not been positively recited as being a type of particle that causes an infectivity of a cell.
On line 1 of claim 23, the phrase “wherein the particles or viral particles that can bind to cell receptors” is indefinite since it does not make proper sense. This phrase should be changed to -- wherein the particles are viral particles that can bind to cell receptors-.
On lines 2-3 of claim 24, the phrase “a percentage of cells” is indefinite and lacks antecedent basis since claim 24 depends from claim 15, and claim 15 does not positively recite any cells in the method. On line 3 of claim 24, the phrase “or viral particle” is indefinite since claim 15, from which claim 24 depends, does not positively recite the particles as being viral particles. Clam 24 is also indefinite since it is not clear why single-molecule RNA fluorescence in situ hybridization is used in the method to determine a percentage of cells infected with the particles since independent claim 15 does not recite that the particles are labeled with any sort of fluorescent label or that the method involves any type of fluorescence.
On line 2 of claim 25, the phrase “the test sample” lacks antecedent basis since independent claim 15 does not positively recite any test sample in the method. In addition, the “fluorescent reporter” recited on line 2 of claim 25 lacks antecedent basis since independent claim 15 does not positively recite that a fluorescent reporter is delivered to any test sample.
Inventorship
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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 15-16 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hibbs et al (US 2009/0194429, submitted in the IDS filed on July 24, 2023).
With regards to claim 1, Hibbs et al teach of a system for assessing properties of particles (see Figure 3 in Hibbs et al) comprising a first structure 11 defined by wall 12 and barrier 14 defining an interior cavity 8 configured to contain an interior cavity fluid 10 (see Figure 3 and paragraph 0032 in Hibbs et al), and a barrier 14 separating the interior cavity 8 from an exterior cavity 4 configured to contain an exterior cavity fluid 6 (see Figure 3 and paragraph 0032 in Hibbs et al), the barrier 14 defining a nanopore 22 therethrough fluidically coupling the interior and exterior cavities 8 and 4 (see paragraph 0035 in Hibbs et al where it states “For the case of no membrane, the orifice diameter should be as small as possible, preferably less than 20 mm and more preferably less than 10 nm. This nanoscale-type orifice 22 can be constructed by the track etch method, by conventional silicon processing, or by the method of sealing a wire in glass and removing it”, thus a nanopore is disclosed by Hibbs et al). The first structure 11 further comprises at least one feature 16 configured to interface with at least one complementary feature 24 of a second structure that defines the exterior cavity 4 (see Figure 3, paragraph 0033 in Hibbs et al where it states “A mounting substrate 16 extends across the top of electrolyte bath 4 and sensing volume 8”, and paragraph 0037 in Hibbs et al where it states “Thick wall 12 and an outer wall 24 of electrolyte bath 4 are connected together by mounting substrate 16”, thus, the lid 16 supports the first structure 11 and closes and connects to the second structure 4 by connecting to the wall 24 of the second structure 4). The system further comprises electrodes 18, 19 configured to energize and apply a voltage gradient across the nanopore 22 between the interior cavity 8 and the exterior cavity 4 (see Figure 3 and paragraph 0037 in Hibbs et al), the voltage gradient of sufficient magnitude to induce particles to migrate via the nanopore 22 between the interior cavity 8 and the exterior cavity 4 and produce an electronic signature representative of at least one property of the particles (see Figure 3 and paragraph 0040 in Hibbs et al where it states “In use, a voltage source 17 is utilized to apply an electrical potential between electrodes 18 and 19 to drive an electrical current between them, and through nanometer-sized orifice 22… The fundamental parameter of interest is a time-varying ionic current Ic that passes through orifice 22 from bath 4 to sensing chamber 8, in response to a target analyte 29…”, wherein the measurement of the time varying ionic current constitutes an electronic signature representative of at least one property of the particles). Hibbs et al teach that the analyte particles analyzed in the system can comprise small particles such as viruses that can be counted in the system using the measurement of the electronic signature comprising changes in conductance or current as the virus particles pass through the orifice 22 (see paragraphs 0005, 0015 and 0018 in Hibbs et al).
With regards to claim 3, Hibbs et al teach that the second structure 4 in the system defines a wall 2 (the bottom wall of the second structure) that is separated from the barrier 14 with the exterior cavity fluid 6 therebetween while the at least one feature 16 of the first structure 11 is interfaced with the at least one complementary feature 24 of the second structure 4. See Figure 3 in Hibbs et al.
With regards to claim 15, Hibbs et al teach of a method for assessing properties of analyte particles comprising interfacing a first structure 12 to a second structure 4 by way of coupling at least one mechanical complementary feature 16 of the first structure 12 to at least one complementary feature 24 of the second structure 4, the first structure 12 defining an interior cavity 8, the first structure 12 further defining a barrier 14 separating the interior cavity 8 from an exterior cavity 4 configured to contain an exterior cavity fluid 6, the barrier 14 containing a channel structure defining a nanopore 22 therethrough fluidically coupling the interior and exterior cavities, and applying a voltage gradient across the nanopore 22 between the interior and exterior cavities by energizing electrodes 18 and 19, the voltage gradient being of sufficient magnitude to induce particles to migrate via the nanopore 22 between the interior cavity 8 and the exterior cavity 4 and to enable observing of an electronic signature representative of at least one property of the particles produced by passing through the nanopore 22. See Figure 3 and paragraphs 0005, 0015, 0020, 0032-0033, 0035, 0037 and 0039-0040 in Hibbs et al, especially paragraph 0035 in Hibbs et al where it states “For the case of no membrane, the orifice diameter should be as small as possible, preferably less than 20 mm and more preferably less than 10 nm. This nanoscale-type orifice 22 can be constructed by the track etch method, by conventional silicon processing, or by the method of sealing a wire in glass and removing it”, thus a nanopore is disclosed by Hibbs et al, paragraph 0033 in Hibbs et al where it states “A mounting substrate 16 extends across the top of electrolyte bath 4 and sensing volume 8”, and paragraph 0037 in Hibbs et al where it states “Thick wall 12 and an outer wall 24 of electrolyte bath 4 are connected together by mounting substrate 16”, thus, the lid 16 supports the first structure 11 and closes and connects to the second structure 4 by connecting to the wall 24 of the second structure 4, and paragraph 0040 in Hibbs et al where it states “In use, a voltage source 17 is utilized to apply an electrical potential between electrodes 18 and 19 to drive an electrical current between them, and through nanometer-sized orifice 22… The fundamental parameter of interest is a time-varying ionic current Ic that passes through orifice 22 from bath 4 to sensing chamber 8, in response to a target analyte 29…”, wherein the measurement of the time varying ionic current constitutes an electronic signature representative of at least one property of the particles).
With regards to claim 16, Hibbs et al teach of adding an interior cavity fluid 10 containing particles to the interior cavity 8. See paragraph 0032 in Hibbs et al.
With regards to claim 23, Hibbs et al teach that the analyte particles analyzed in the system and method can comprise small particles such as viruses that can be counted in the system using the measurement of the electronic signature comprising changes in conductance or current as the virus particles pass through the orifice 22 (see paragraphs 0005, 0015 and 0018 in Hibbs et al). It is generally known that virus particles bind to cell receptors.
Claim Rejections - 35 USC § 103
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.
Claim(s) 2, 8-10, 14, 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hibbs et al (US 2009/0194429, submitted in the IDS filed on July 24, 2023). For a teaching of Hibbs et al, see previous paragraphs in this Office action.
With regards to claims 2, 14 and 17, Hibbs et al fail to specifically teach that a detector in the system observes the electronic signature to produce an observed electronic signature, and that a processor determines a number of particles that migrated via the nanopore based on the observed electronic signature. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a detector and a processor in the system and method taught by Hibbs et al for determining a number of particles that migrated via the nanopore 22 based on the observed electronic signature because such a detector and processor would allow the method to be performed automatically and allow the results to be stored and analyzed for future use. It is noted that the court has held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art, see In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958).
With regards to claims 8-10 and 19, Hibbs et al fail to teach that the particles analyzed in the system and method can comprise microbes or vectors that provide nucleic acid to cells. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system and method taught by Hibbs et al for analyzing microbes or vectors that provide nucleic acid to cells because Hibbs et al disclose that the system and method can be used for analyzing small analyte particles of interest such as viruses (see paragraph 0005 in Hibbs et al), and both microbes and vectors are small analyte particles of interest to detect in a sample in order to determine possible infectious materials, ensure product safety, and to develop new gene therapies.
Allowable Subject Matter
Claims 4-7, 11, 18 and 24-25 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims since the closest prior art to Hibbs et al, described above, fails to teach or fairly suggest that the system and method further comprises an imager for determining a number of cells in the second structure 4 to which at least a subset of the particles associated themselves, wherein the particles are viral particles and an infectivity of the viral particles is determined based on a ratio of the number of viral particles that migrated via the nanopore 22 and the number of cells in the second structure 4 determined to have a least one viral particle associated therewith, and applying single-molecule RNA fluorescence in situ hybridization to determine a percentage of cells infected with the viral particles.
Claims 12-13 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 since the closest prior art to Hibbs et al, described above, fails to teach or fairly suggest that the second structure 4 in the system and method further comprises a microfluidic channel in fluidic communication with the nanopore 22, and that the second structure 4 comprises a cell culture chamber, wherein the system further comprises a cover configured to removably couple with the cell culture chamber by interfacing with the least one complementary feature 24 of the second structure 4, and the first structure 11 is a lid, substitutable for the cover.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Hibbs et al (US 2011/0162963) who teach of a system and a method for counting and discriminating molecules in a sample by passing the molecules through a nanopore using an electric field created by electrodes in an analyte chamber; Wang et al (US 2022/0090167) who teach of a system and a method for isolating viral particles comprising first and second chambers having a membrane located therebetween with nanopores in the membrane for allowing viral particles to pass through; and Holt (US 2013/0260472) who teaches of an apparatus and a method for molecular separation that causes an analyte molecule to move from a sampling chamber through an electroactive nanopore to a collection chamber.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 June 18, 2026
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