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 .
Status of the Claims
The Amendment filed March 24, 2026 has been entered. Claims 1, 4, and 6 have been amended; claim 23 is new; and claims 9-22 have been withdrawn. Claims 1-8 and 23 are currently examined herein.
Status of the Rejection
Applicant’s amendments to the Claims have overcome each objection previously set forth in the Non-Final Office Action mailed December 30, 2025.
All claim interpretations under 35 U.S.C. § 112(f) from the previous office action are maintained.
All 35 U.S.C. § 102 and 103 rejections from the previous office action are withdrawn in view of the Applicant’s amendment.
New grounds of rejection under 35 U.S.C. § 103 are necessitated by the amendments as outlined below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/24/2026 has been considered by the examiner.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 7-8 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Mor et al. (WO2020077244A1), and in view of Vasylyev et al. (US20050255446A1).
Regarding claim 1, Mor teaches a detection apparatus (an apparatus comprising a bore pipette as shown in Fig.1 [Ln 7-24 on page 13]) for testing biological cells (the large bore pipettes for measuring cell resistance, real-time measurement of membrane resistance and/or capacitance [Ln 11-12, 23-24 on page 13]; thus the disclosed apparatus is configured to perform the intended use of testing biological cells), the apparatus comprising:
a measuring means (an electrical resistance meter connected to the injection pipette tip [claim 1]; Fig.1 shows an electrophysiological amplifier 6 connected to the electrode wire of the injection micropipette 2 [Ln 30-34 on page 16]; measurement device comprising the electrical resistance meter and the electrophysiological amplifier 6 that is connected to the electrode wire of the pipette is deemed as the measuring means) for measuring an electrical property of a single biological cell present in a solution (for measuring membrane resistance [Ln 11-12, 23-24 on page 13] of a single biological cell 1 present in a petri dish with extracellular solution 7 as shown in Fig.1);
a sampling means (a pipette tip as shown in Fig.1; an injection pipette having a tip [claims 1 and 3]; a commercial egg/cell glass injection pipette with a tip curved at 30 degrees was attached to the right manipulator [Ln 27-28 on page 16]; the pipette tip is deemed as the sampling means) for sampling a membrane of the single biological cell (the tip is configured to penetrate a membrane of the cell, and wherein the electrical resistance meter is connected directly or indirectly to the injection pipette tip [claim 1]; Fig.1 shows the pipette tip for sampling a membrane of the single biological cell 1 for measuring membrane resistance and/or capacitance [Ln 18-24 on page 13; Ln 3-6 on page 12]), and
an adaptor (Figs.15A-15B show an adaptor for holding a pipette having a wire connected to the electrode wire on one end and connected to an alligator clip of a cable that can connect to one or more measuring devices [Ln 25-28 on page 6]) distinct from and located between said sampling means (pipette tip) and said measuring means (measurement device such as electrical resistance meter and/or amplifier disposed outside of the pipette) surrounding an electrically conductive material (the pipette having an electrical wire in the pipette lumen [Ln 18-22 on page 13]; electrolyte in the pipette [Ln 17 on page 12]; both the electrical wire and the electrolyte in the pipette are deemed as the electrically conductive material).
Mor is silent to wherein the adaptor is an electrically insulating component having resistance to an alkaline solution of pH of 8 to 11 containing chlorine ions.
Vasylyev teaches a perfusion system and apparatus for high throughput patch clamp measurements. Each patch clamp configuration comprises a cell sealed to a pipette (title and abstract). Fig.4C shows the single pipette 40 is held in place by a polyurethane (or other polymer or similar material) tube 54 [para. 0079], and the polyurethane tube 54 surrounds an electrically conductive material (electrode 4 and solution inside the pipette 40). Thus, Vasylyev teaches an adaptor (polyurethane tube 54 in Fig.4C) for holding a pipette 40. The adaptor made of polyurethane is deemed as the electrically insulating component having resistance to an alkaline solution of pH 8 to 11 containing chlorine solutions. Note that the disclosed polyurethane material of the electrically insulating component is the same as that used in the instant application, as evidenced by the last column in Table 3 of the instant specification.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adaptor in Mor to an adaptor made of polyurethane, which is distinct from and located between the sampling means and the measuring means surrounding the electrically conductive material, as taught by combined Mor and Vasylyev, since Vasylyev teaches the adaptor made of polyurethane would be suitable for holding the pipette in place for measuring electrical properties of the cell sealed to the pipette [para. 0079 and abstract in Vasylyev]. Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art [MPEP § 2144.07].
Since the disclosed electrically insulating component is made of polyurethane, which is the same as the material of the electrically insulating component used in this instant application (see the last column in Table 3 in instant specification), it is contended that the electrically insulating component of the prior art also has resistance to an alkaline solution of pH 8 to 11 containing chlorine ions. Accordingly, products of identical chemical composition cannot have mutually exclusive properties, and thus, the claimed property (i.e. the electrically insulating component has resistance to an alkaline solution of pH 8 to 11 containing chlorine ions), is necessarily present in the prior art material. The courts have held that “[p]roducts of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01 (II).
Regarding claim 2, modified Mor teaches the detection apparatus of claim 1, and Mor teaches wherein said electrical property is selected from the group consisting of membrane resistance (membrane resistance [Ln 5 on page 10; Ln 23-24 on page 13]), wherein said measuring means comprises an electrical resistance meter (an electrical resistance meter is connected directly or indirectly to the injection pipette tip [claim 1; Ln 12-14 on page 26]).
Regarding claim 3, modified Mor teaches the detection apparatus of claim 1, and Mor teaches wherein the electrically conductive material comprises a metal (electrical wire [Ln 20-22 on page 13]; electrical conductors include metal [e.g., copper, gold, silver] [Ln 23-26 on page 8]; metal wire selected from a silver wire and a copper wire [claim 9]) and/or a conductive fluid (electrical conductors include fluid [e.g., a liquid or a gel] containing charged particles [e.g., electrolytes] [Ln 25-27 on page 8]; the electrical conductor is an electrolyte solution [claim 10]).
Regarding claim 7, modified Mor teaches the detection apparatus of claim 1, and Mor teaches wherein the sampling means comprises a micropipette tip (These pipettes can have bore diameters that are about 4 micrometers to about 10 micrometers, or about 4 micrometers to about 7 micrometers, or about 4 micrometers to about 6 micrometers, or about 4 micrometers, or about 5 micrometers, or about 6 micrometers [Ln 14-17 on page 13]; an injection pipette having a tip [claim 1]; glass injection pipette with a tip curved at 30 degrees was attached to the right micromanipulator [Ln 28-29 on page 16]).
Regarding claim 8, modified Mor teaches the detection apparatus of claim 1, and Mor teaches which is a cell injection system (Intracytoplasmic sperm injection [ICSI] system as shown in Fig.1 [Ln 27 on page 13]; Two robotic micromanipulators were used. A commercial egg/cell glass injection pipette with a tip curved at 30 degrees was attached to the right manipulator [Ln 25-29 on page 16]).
Regarding claim 23, modified Mor teaches the detection apparatus of claim 1, and the limitations “wherein said resistance to said alkaline solution comprises at least one property selected from the group consisting of resistance to formation of microcracks for at least 1 minute upon exposure to said alkaline solution; resistance to electrical insulation failure for at least 12 minutes upon exposure to said alkaline solution; and resistance to visible structural integrity failure for at least 20 minutes upon exposure to said alkaline solution” are inherent characteristic of the adaptor made of polyurethane. Since the disclosed electrically insulating component is made of polyurethane, which is the same as the material of the electrically insulating component used in this instant application (see the last column in Table 3 in instant specification), it is contended that the electrically insulating component of the prior art also has the same resistance as that in the instant application. Accordingly, products of identical chemical composition cannot have mutually exclusive properties, and thus, the claimed property (i.e. said resistance to said alkaline solution comprises at least one property selected from the group consisting of resistance to formation of microcracks for at least 1 minute upon exposure to said alkaline solution; resistance to electrical insulation failure for at least 12 minutes upon exposure to said alkaline solution; and resistance to visible structural integrity failure for at least 20 minutes upon exposure to said alkaline solution), is necessarily present in the prior art material. The courts have held that “[p]roducts of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01 (II).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mor and Vasylyev, as applied to claim 3 above, and in view of Cliffel et al. (US20050014129A1).
Regarding claim 4, modified Mor teaches the detection apparatus of claim 3, and Mor further teaches wherein the electrically conductive material comprises silver (a silver wire [claim 9]).
Mor is silent to wherein the silver wire is coated with chloride.
Cliffel teaches an apparatus for detecting at least one analyte of interest either produced or consumed by a plurality of cell (abstract) and further teaches wherein the electrode is coated with silver chloride (A 2 mm wide pad 3101 of platinum on the glass substrate is coupled to interdigitated microstrip electrodes 3102 and 3103 that are five microns wide and separated by five microns and thus forming a plurality of fingers. Each of the individual fingers can be coated with silver/silver chloride [para. 0251]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the silver wire in modified Mor to silver wire coated with chloride, as taught by Cliffel, since Cliffel teaches silver coated with chloride as a suitable alternative electrode material for testing biological cells [para. 0251 and abstract]. Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art [MPEP § 2144.07].
Allowable Subject Matter
Claims 5-6 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.
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claim 5, modified Mor teaches the detection apparatus of claim 3, and further teaches a droplet of commercial MII medium was placed on a petri dish. Mineral oil was added until it fully covered the droplet to prevent droplet evaporation. A commercial egg/cell glass holding pipette with a tip curved at 30 degrees was attached to the left micromanipulator. A commercial egg/cell glass injection pipette with a tip curved at 30 degrees was attached to the right manipulator. Of note, the injection pipette was prefilled with MII medium and was attached to an electrophysiological headstage (available, e.g., from Axon instruments). A silver wire originating from the headstage was in contact with the MII medium in the injection pipette [Ln 22-32 on page 16]. Thus, the injection pipette was prefilled with MII medium, and the mineral oil covers the MII medium of the petri dish. Mor and other prior art of the record does not teach and/or suggest the injection pipette is filled with a mixture of electrolyte and mineral oil. Thus, claim 5 is allowable. Claim 6 is allowable because claim 6 depends from claim 5.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Response to Arguments
Applicant's arguments, see Remarks Pgs. 6-7, filed 3/24/2026, with respect to the 35 U.S.C. § 102(a)(1) and 35 U.S.C. § 103 rejections have been fully considered and all prior art rejections from the previous office action have been withdrawn.
Applicant’s Argument #1:
Applicant argues at pages 6-7 that Claim 1 as currently amended recites an apparatus in which the component having resistance to an alkaline solution comprising chloride ions is a component located between the sampling means and the measuring means i.e. not the pipette, but rather a component which connects that pipette to a measuring means. Mor does not teach or suggest a distinct component between the
sampling means and the measuring means, which is resistant to alkaline solution containing chloride ions, as defined in claim 1 as currently amended. Claims 2-4 and 7-8 depend from claim 1 and are allowable for the same reason as claim 1 above.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection for the amended claim 1 above.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V Van can be reached on 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIZHI QIAN/Examiner, Art Unit 1795