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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 1/16/26 is acknowledged.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by
20230134609 (CHONG et al) 4 May 2023.
Regarding claims 1-6, Chong teaches a nerve culture testing system which includes a neuronal cell culture wherein the neuronal cell culture is configured to function as a substrate in conjunction with an electronic computing device. The culture is previously trained to perform a goal-oriented task as Chong teaches that they train the neural culture to perform tasks [0071] [0080]. Chong teaches their device has sensors configured to detect spiking activity in the cells [0043-6] and the device has a stimulator configured to apply stimulation to the neuronal cell culture particularly in the form of an MEA [0034-44]. Chong’s nerve culture can be 2-D, 3-D or organoid [0035-36] [0023-4] and can be cells derived from hIPSCs [0037]. The Chong device has a chemical (drug) delivery mechanism to apply the chemicals to the culture [0042]. The Chong device has circuitry to communicate the MEA and sensors with a computing device. Chong teaches that their input device (106) and output device (106) are configured to communicate the sensors and MEA to the computer [0024]. Chong’s computer executes an interface with the MEA and sensors so that the neuronal cell culture is configured to function with the computer [0071]. The Chong server computing devices may include physical machines including rackmount servers and desktop computers [0033]. Chong’s computer is configured so that the electrodes on an MEA transduce the change in voltage from the environment carried by ions into currents carried by electrons (electronic currents) [0056].
Regarding claim 7, Chong teaches a variety of sizes of neuronal cell cultures and multitudes of MEAs and sensors such that it is conceivable that each section (or even individual neuron) could be considered its own culture and it’s corresponding MEA and sensor could then be considered a second sensor and stimulator as the claim does not require a certain sizing, spacing or separation. Interpreted as such, Chong’s system would anticipate claim 7 as well.
The reference anticipates the claim subject matter.
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.
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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Chong (above).
Chong teaches a nerve culture testing system which includes a neuronal cell culture wherein the neuronal cell culture is configured to function as a substrate in conjunction with an electronic computing device. The culture is previously trained to perform a goal-oriented task as Chong teaches that they train the neural culture to perform tasks [0071] [0080]. Chong teaches their device has sensors configured to detect spiking activity in the cells [0043-6] and the device has a stimulator configured to apply stimulation to the neuronal cell culture particularly in the form of an MEA [0034-44]. Chong’s nerve culture can be 2-D, 3-D or organoid [0035-36] [0023-4] and can be cells derived from hIPSCs [0037]. The Chong device has a chemical (drug) delivery mechanism to apply the chemicals to the culture [0042]. The Chong device has circuitry to communicate the MEA and sensors with a computing device. Chong teaches that their input device (106) and output device (106) are configured to communicate the sensors and MEA to the computer [0024]. Chong’s computer executes an interface with the MEA and sensors so that the neuronal cell culture is configured to function with the computer [0071]. The Chong server computing devices may include physical machines including rackmount servers and desktop computers [0033]. Chong’s computer is configured so that the electrodes on an MEA transduce the change in voltage from the environment carried by ions into currents carried by electrons (electronic currents) [0056].
Regarding claim 7, Chong teaches a variety of sizes of neuronal cell cultures and multitudes of MEAs and sensors such that it is conceivable that each section (or even individual neuron) could be considered its own culture and it’s corresponding MEA and sensor could then be considered a second sensor and stimulator as the claim does not require a certain sizing, spacing or separation. Even if not anticipatory, Chong is strongly suggestive of using multiple cultures, etc together as it does teach varying the culture size & shape and also the number type and quantity as well as types of sensors and simulators. Simply multiplying the device components would have been obvious to one of ordinary skill in the art at the time the invention was made as a matter of design choice and scale. "[W]here 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was filed especially in the absence of evidence
to the contrary.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Chong (above) and Staples et al 20190074092.
Chong teaches a nerve culture testing system which includes a neuronal cell culture wherein the neuronal cell culture is configured to function as a substrate in conjunction with an electronic computing device. The culture is previously trained to perform a goal-oriented task as Chong teaches that they train the neural culture to perform tasks [0071] [0080]. Chong teaches their device has sensors configured to detect spiking activity in the cells [0043-6] and the device has a stimulator configured to apply stimulation to the neuronal cell culture particularly in the form of an MEA [0034-44]. Chong’s nerve culture can be 2-D, 3-D or organoid [0035-36] [0023-4] and can be cells derived from hIPSCs [0037]. The Chong device has a chemical (drug) delivery mechanism to apply the chemicals to the culture [0042]. The Chong device has circuitry to communicate the MEA and sensors with a computing device. Chong teaches that their input device (106) and output device (106) are configured to communicate the sensors and MEA to the computer [0024]. Chong’s computer executes an interface with the MEA and sensors so that the neuronal cell culture is configured to function with the computer [0071]. The Chong server computing devices may include physical machines including rackmount servers and desktop computers [0033]. Chong’s computer is configured so that the electrodes on an MEA transduce the change in voltage from the environment carried by ions into currents carried by electrons(electronic currents) [0056].
Regarding claim 7, Chong teaches a variety of sizes of neuronal cell cultures and multitudes of MEAs and sensors such that it is conceivable that each section (or even individual neuron) could be considered its own culture and it’s corresponding MEA and sensor could then be considered a second sensor and stimulator as the claim does not require a certain sizing, spacing or separation. Even if not anticipatory, Chong is strongly suggestive of using multiple cultures, etc together as it does teach varying the culture size & shape and also the number type and quantity as well as types of sensors and simulators. Simply multiplying the device components would have been obvious to one of ordinary skill in the art at the time the invention was made as a matter of design choice and scale. "[W]here 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
As specifically in claim 8, Chong does not specifically disclose wherein the data is stored and computed in a cloud-based datastore however it would have been obvious at the time the invention was filed to include a cloud-based datastore in the device of Chong because clou-based datastores were old and well known in the art at the tine of filing and one of ordinary skill in the art would have known to use cloud-based storage as was taught, for example, by Staples [0058] as a storage device fir biological data, because of at least the cost and accessibility of the cloud-base datastore. Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one (emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was filed especially in the absence of evidence
to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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 reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18382010 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because though the instant claims are drafted as “a drug testing system comprising a neuronal cell culture, wherein the neuronal cell culture was previously trained to perform a goal-oriented behavioral task;
a sensor configured to detect spiking activity in the neuronal cell culture; a stimulator configured to apply stimulation to the neuronal cell culture; a drug delivery mechanism configured to apply a drug to the neuronal cell culture; and circuitry configured to communicatively connect the sensor and stimulator to a computing device,” the components of the “system” claimed in ‘010 also contain the elements of a neuronal cell culture and an interface and a computing device which while not appearing to be of eth same scope would render obvious the claimed invention. Dependent claims of the instant application correspond directly with the reference limiting the type of culture.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18367392 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because though the instant claims are drafted as “a drug testing system comprising a neuronal cell culture, wherein the neuronal cell culture was previously trained to perform a goal-oriented behavioral task;
a sensor configured to detect spiking activity in the neuronal cell culture; a stimulator configured to apply stimulation to the neuronal cell culture; a drug delivery mechanism configured to apply a drug to the neuronal cell culture; and circuitry configured to communicatively connect the sensor and stimulator to a computing device,” the components of the “computing system” claimed in ‘392 also contain the elements of a neuronal cell culture and an interface and a computing device which while not appearing to be of eth same scope would render obvious the claimed invention. Dependent claims of the instant application correspond directly with the reference limiting the type of culture.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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/BLAINE LANKFORD/Primary Examiner, Art Unit 1657