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 .
Amendments to the claims (filed on 1/31/25) and the specification (filed on 7/2/24) are acknowledged.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claims 1-29 are considered as being directed to a series of steps carried out by a generic processor/computer device(s). The Court (Alice Corporation Vs CLS Bank) determined that an instruction to apply abstract idea using some unspecified generic computer/controller is not patent-eligible.
Claims 1-29 merely include a generic computer component (an instrument; a network; database; system; etc.). Such inclusion will not be considered significantly more.
Regarding claims 1-29, the claimed inventions are directed to purely about data gathering/generating; maintaining a database; storing data; and analyzing (what analysis is being performed?), without significantly more. The claims recite nothing but data gathering/generating; maintaining a database; storing data; and analyzing (what analysis is being performed?). The claims do not recite any manipulations of data; any specific analysis; and absolutely do not include any practical applications.
Making suggestion to change a procedure/protocol, per se, does not involve any practical applications. None of the claims recites any particular operation of cells. None of the claims recites any particular data analysis/manipulations.
Claims appear to be all directed towards applicant’s mere statement of purpose, i.e. mere data gathering/generating; merely maintaining a database; merely storing data; and mere statement of analyzing something (what analysis is being performed?).
Implication(s) is/are not a standard for what is covered by the scope of the claim.
None of the claims recites anything integrated into a practical application with significantly more. As currently presented claims are all about data gathering/generating; maintaining a database; storing data; and mere statement of analyzing, which is/are not integrated to any practical applications.
The examiner notes that such inventions were ineligible even before the Bilski/Alice decisions. See for instance: In re Grams, 888 F2d 835 (Fed Cir. 1989); In re Walter, 618 F2d 758 (Fed Cir. 1980); and In re Abele and Marshal, 684 F2d (Fed Cir. 1982).
The judicial exception is not integrated into a practical application because instant claims are about purely data gathering and determination without significantly more. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Processes are eligible for patent protection under 35 U.S.C. § 101 if they are not directed to an abstract idea. See Bilski v. Kappos, 95 USPQ2d 1001 (U.S. 2010) (clarifying the standards for subject matter eligibility). Based upon consideration of all the relevant factors with respect to the claim as a whole, they are deemed to claim an abstract idea and are rejected under § 101. Claimed invention does not include any process steps involving significant problem-solving elements.
Nominal recitations of structure in an otherwise ineligible method fail to make the method a statutory process. Gottschalk v. Benson 409 U.S. 63, 70-72 (1972). The claims also do not transform any article into a different form; rather, they are only about data gathering/generating; maintaining a database; storing data; and analyzing (what analysis is being performed?). Thus, there is no clear evidence from which to conclude that the claims are not principally drawn to an abstract idea. The examiner recommends amending the claim to require that the problem-solving aspects of the claim (i.e., significant data manipulations; rather than mere data inputting, receiving, transmitting, outputting, controlling an apparatus, etc.) are performed by a particular machine in order to overcome this rejection.
** Furthermore, in order for a method to be considered a "process" under §101, a claimed process must either: (1) be tied to another statutory class (such as a particular apparatus) or (2) transform underlying subject matter (such as an article or materials).
If neither of these requirements is met by the claim, the method is not a patent eligible process under §101 and is non-statutory subject matter. Note that the tie to another statutory class should be in the body of the claim, and substantive.
There are two corollaries to the machine-or-transformation test.
First, a mere field-of-use limitation is generally insufficient to render an otherwise ineligible method claim patentable. This means the machine or transformation must impose meaningful limits on the method claim’s scope to pass the test.
Second, insignificant extra-solution activity will not transform an unpatentable principle into a patentable process.
Thus, a specific machine or particular transformation of a specific article in an insignificant step, such as data gathering, outputting storing, is not sufficient to pass the test. If neither of these requirements is met by the claim, the method is not a patent eligible process under 35 USC 101 and is non-statutory subject matter.
Nominal recitations of structure in an otherwise ineligible method fail to make the method a statutory process. The use of a specific machine or transformation of an article must impose meaningful limits on the claim’s scope to impart patent-eligibility.
Furthermore, the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity. Incidental physical limitations, such as data gathering, field of use limitations and extra solution activity is not enough to convert an abstract idea into a statutory process (In re Bilski, 88 USPQ2d 1385, 1385 (Fed Cir. 2008)). Basically, nominal or token recitations of structure in a method claim do not convert an otherwise ineligible claim into an eligible one. It is further noted that the mere recitation of a machine in the preamble in a manner such that the machine fails to patentably limit the scope of the claim does not make the claim statutory under 35 USC101.
The claimed subject matter is not limited to a particular/specific process (application), apparatus or machine. To at least qualify as a statutory process, the claims should require use of a machine (providing a non-generic structure) within the steps of the claimed subject matter and/or require transformation of an article to a different state or thing. As currently presented, for instance, steps in claim 1 may be performed manually.
Insignificant extra-solution activity (all of the steps) in the claimed subject matter will not be considered sufficient to convert a process that otherwise recites only mental steps into statutory subject matter.
The examiner respectfully reasserts that the instant claims are drawn only to an abstract/conceptual process that only involves data gathering/generating; maintaining a database; storing data; and analyzing (what analysis is being performed?). Therefore, are not directed to statutory subject matter. There is nothing that can be considered “significantly more” recited in the claim.
Lastly, tying a claim to a specific machine or transformation must not be merely “insignificant extra-solution” activity. The Bilski Court (Oct 08) may not have elaborated on the definition of “insignificant extra-solution activity.” However, the Court stated that the examples include: adding a final step. In the instant case, mere intent to store data or analyzing out of thin air (no specific analysis).
As currently presented, none of the claims are about any specific operability control of any specific incubator in any specific environment.
**Note: 2106.05(b) Particular Machine [R-07.2022]
When determining whether a claim integrates a judicial exception, into a practical application in Step 2A Prong Two and whether a claim recites significantly more than a judicial exception in Step 2B, examiners should consider whether the judicial exception is applied with, or by use of, a particular machine. "The machine-or-transformation test is a useful and important clue, and investigative tool” for determining whether a claim is patent eligible under § 101. Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010).
It is noted that while the application of a judicial exception by or with a particular machine is an important clue, it is not a stand-alone test for eligibility. Id.
All claims must be evaluated for eligibility using the two-part test from Alice/Mayo. If a claim passes the Alice/Mayo test (i.e., is not directed to an exception at Step 2A, or amounts to significantly more than any recited exception in Step 2B), then the claim is eligible even if it fails the machine-or-transformation test ("M-or-T test"). Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010) (explaining that a claim may be eligible even if it does not satisfy the M-or-T test); McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) (“[T]here is nothing that requires a method ‘be tied to a machine or transform an article’ to be patentable”). And if a claim fails the Alice/Mayo test (i.e., is directed to an exception at Step 2A and does not amount to significantly more than the exception in Step 2B), then the claim is ineligible even if it passes the M-or-T test. DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256, 113 USPQ2d 1097, 1104 (Fed. Cir. 2014) (“[I]n Mayo, the Supreme Court emphasized that satisfying the machine-or-transformation test, by itself, is not sufficient to render a claim patent-eligible, as not all transformations or machine implementations infuse an otherwise ineligible claim with an 'inventive concept.'”).
II. WHETHER THE MACHINE OR APPARATUS IMPLEMENTS THE STEPS OF THE METHOD
Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more. See CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) ("We are not persuaded by the appellant's argument that the claimed method is tied to a particular machine because it ‘would not be necessary or possible without the Internet.’ . . . Regardless of whether "the Internet" can be viewed as a machine, it is clear that the Internet cannot perform the fraud detection steps of the claimed method"). For example, as described in MPEP § 2106.05(f), additional elements that invoke computers or other machinery merely as a tool to perform an existing process will generally not amount to significantly more than a judicial exception. See, e.g., Versata Development Group v. SAP America, 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015) (explaining that in order for a machine to add significantly more, it must “play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly”).
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 1-29 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.
Regarding claim 1, line 7, the recitation “cell culturing protocols” renders the claim unclear, because it is not clear if it is referencing the cell culturing protocols recited in line 5; or applicant means some other cell culturing protocols. The examiner suggests applicant to use consistent terminologies throughout the claim(s).
Regarding claim 1, line 7, the recitation “results data” renders the claim unclear, because it is not clear if it is referencing the cell culturing result data recited in line 3; or applicant means some other results data. The examiner suggests applicant to use consistent terminologies throughout the claim(s).
The examiner omits raising the same/similar formality issues in claim 1 and in other claims.
Claim 1 recites the limitation "the protocols" in line 8. There is insufficient antecedent basis for this limitation in the claim. Is it referencing the cell culturing protocols or applicant means something else?
Claim 1 recites the limitation "the stored metadata and results data" in line 12. There is insufficient antecedent basis for this limitation in the claim. Is it referencing the cell culturing protocols or applicant means something else?
Claim 1 recites the limitation "the results" in line 14. There is insufficient antecedent basis for this limitation in the claim. What result is being referenced by the limitation?
Regarding claim 1, it is unclear what protocol is being referenced by “a cell culture protocol” in line 13. Does applicant mean one of the cell culturing protocols; or applicant means something else?
Regarding claim 14, line 6, the recitations “protocols” renders the claim unclear, because it is not clear if it is referencing the “protocols” recited in line 3; or applicant means some other “protocols”. The examiner suggests applicant to use consistent terminologies throughout the claim(s).
Regarding claim 14, line 6, the recitations “results data” and “metadata” render the claim unclear, because it is not clear if it is referencing the “results data” and “metadata” recited in line 4; or applicant means some other “results data” and “metadata”. The examiner suggests applicant to use consistent terminologies throughout the claim(s).
The examiner omits raising the same/similar formality issues in claim 1 and in other claims. The limitation: “operations on cells” line 8 should be recited as “the cell culturing operations on cells.”
Regarding claim 14, line 8, it is not even what is being referenced by the recitation: “instruments in the network in the database.” What does applicant mean by: “instruments in the network in the database?” The recitation does not make sense.
Claim 14 recites the limitation "the results" in line 12. There is insufficient antecedent basis for this limitation in the claim. What result is being referenced by the limitation?
Regarding claim 14, it is unclear what protocol is being referenced by “a cell culture protocol” in line 11. Does applicant mean one of the protocols, or applicant means something else?
Regarding claim 14, it is unclear what applicant means by: at least one processor configured to run protocols which control (controlling what?) the cell culturing operations on the cells and produce metadata and results data relating to the protocols.
Regarding claim 14, the "for" clauses in the claim are generally narrative and do not further structurally limit the claimed device/system. Claims 14-26 are replete with narrative intended use phrases that do not further structurally define the claimed device. The structure of a device is not further defined or structurally limited by applicant’s intended use/function of the device.
The examiner suggests applicant amend the claim and at least recite that the network of instruments; the database; the server, are “configured to” perform the recited functions.
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.
Claims 1-29 are rejected under 35 U.S.C. 103 as being unpatentable over Magnant (US 2014/0271571), in view of Kain (US 2015/0072871), in further view of McClain (US 6409654).
Regarding claims 1-29, Magnant discloses a system/device for performing a method for facilitating networked incubator operation including one or more processors to perform operations (an exemplary incubator 200 that monitors and processes cell cultures disposed in cassettes. The incubator 200 includes a programmable computing device 205 that controls the incubator’s operations. The computing device 205 executes instructions according to the parameters to control components of the incubator 200. The computing device 205 is configured to communicate over computer networks 305 with remote servers 310 ([0119]) comprising: receiving, from a first networked incubator system, data that comprises incubator operating parameters for operating a networked incubator system (a method of operating an incubator includes storing, by a computing device, parameters for a schedule of processes to apply to cell cultures in cassettes. The method also monitors data regarding environmental conditions within the cassettes. The method includes matching received data about the environment conditions with at least one parameter for a process on the schedule. The method includes applying the process to the cell culture within the cassettes ([0055]; [0119]; etc.);
storing the received parameter data in a database (the computing device is configured to store the received data on a remote server: [0051 ]-[0055]: the stored data would have be related to data for gathered from previous operations.);
receiving a protocol for incubator operating parameters from a second networked incubator system (operating an incubator includes storing, by a computing device, parameters for a schedule of processes to apply to cell cultures in cassettes. The method also monitors data regarding environmental conditions within the cassettes. The method includes matching received data about the environment conditions with at least one parameter for a process on the schedule. The method includes applying the process to the cell culture within the cassettes ([0055]-[0056]);
and transmitting, from the database in response to the received protocol from the second networked incubator system, parameter data that corresponds to the data received from the first networked incubator system and is arranged to control operation of the second networked incubator system (The incubator 200 includes a programmable computing device 205 that controls the incubator's operations. The computing device 205 executes instructions according to the parameters to control components of the incubator 200. The computing device 205 is configured to communicate over computer networks 305 with remote servers 310 ([0119]). The user can log into a remote computing device 205 that executes an application that instructs the sequence of events required to perform a particular experimental analysis. The application may include a similar user interface to the one depicted on the incubator. The user may create a schedule of actions for the incubator, as described herein. The computing device 205 executing the application transmits the user controls over a computer network 305 to the incubator, and the incubator’s computing device 205 stores the controls in its memory ([0133]-[0134]), but fails to specifically disclose receiving a protocol for incubator operating parameters from a second networked incubator system to control operation of the second networked incubator system (they are networked).
The incubator 200 includes a programmable computing device 205 that controls the incubator's operations. The computing device 205 executes instructions according to the parameters to control components of the incubator 200 L the computing device 205 is configured to communicate over computer networks 305 with remote servers 310L para [0119]).
Magnant does not explicitly tech that a cell culturing protocol is being changed in view of the stored data.
Kain in analogous art discloses receiving a protocol for incubator operating parameters from a second networked incubator system to control operation of the second networked incubator system ([0050]-[0051]: the base addition quality control routine will evaluate parameters of the sequencing system to determine whether changes should be made to the system operating settings or whether sequencing could or should continue under the same or different conditions . may be advantageous if the queries and steps involved in step 106 provide information that is useful in evaluating characteristics or qualities of samples and the system at step 104) and ([0071 ]-[0074]: as indicated at step 144, the system may query the fluid delivery and detection systems to determine whether operating parameters are within acceptable ranges. Alternatively, or in addition to this step, the base addition process may be repeated as indicated at step 146. In general, step 146, as with the re-imaging steps described above, may require that the sample be returned to a fluidics station for addition of the bases).
It would have been obvious to one of ordinary skill in the art to add Kain’s method of determining best operating parameters to Magnant's method as it is advantageous if the queries and steps involved in step 106 provide information that is useful in evaluating characteristics or qualities of samples and the system at step 104. Furthermore, as set forth in further detail below in regard to FIGS. 6-8, different queries and steps exemplified for the various QC steps of Fig. 5 can be carried out in different orders than specifically exemplified herein or even repeated more than once and in a variety of combinations to suit a particular synthetic technique or synthesis system ([0051]: Kain).
Modified Magnant also does not disclose that the changes to the protocols are analyzed and performed by artificial intelligence.
McClain discloses an incubator system with monitoring and communicating capabilities (title and abstract).
McClain teaches that (C5/L15-25): “The system will monitor itself for problems or malfunctions. Using artificial intelligence, the incubator 10 will offer suggestions to hospital or technical personnel in case of a failure. In such a case, the incubator will automatically generate a work order on the hard drive of the controller 33, with the option to automatically fax the work order to selected personnel. The incubator will also have the ability to automatically page such selected personnel in case of a major system failure via the central station server 62.”
Use of artificial intelligence for analysis was well known in the art. Skilled artisan would have been motivated to automate the changes to the protocols by using artificial intelligence for the purpose of reducing human intervention.
The claim would have been obvious because the technique for improving a particular class of devices was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations. The claim would have been obvious because a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art.
Response to Arguments
Applicant's arguments filed on 1/31/25 have been fully considered.
Amendments to the claims (filed on 1/31/25) and the specification (filed on 7/2/24) are acknowledged.
The objection to the specification from the previous action is withdrawn.
Applicant's arguments have been fully considered but are moot in view of the new ground(s) of rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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 SHOGO SASAKI whose telephone number is (571)270-7071. The examiner can normally be reached on Monday-Thursday 10:00-6:00.
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, Maris Kessel can be reached on 5712707698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SHOGO . SASAKI
Primary Examiner
Art Unit 1798
/SHOGO SASAKI/Primary Examiner, Art Unit 1758 5/1/2025
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