DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
none
Pending:
1-15
Withdrawn:
none
Examined:
1-15
Independent:
1 and 15
Allowable:
none
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
x
112/b "Means for"
BRI
Broadest Reasonable Interpretation
x
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
x
102, 103
JE
Judicial Exception
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
x
Double Patenting
XXDATE
date format
Priority
As detailed on the 9/27/2022 filing receipt, this application claims priority to no earlier than 12/3/2019. All claims have been interpreted as being accorded this priority date.
Claim objections
Claims 1-4, 7-9, 11 and 13-15 are objected to because of the following informalities. Appropriate correction is required. In each objection the claims are definite with respect to the issues cited here because interpretation would have been sufficiently clear to PHOSITA, but nonetheless the claims are objected to for consistency among the claims or as otherwise indicated. With regard to any suggested amendment below to overcome an objection, in the subsequent examination it is assumed that each amendment is made. However, equivalent amendments also would be acceptable. Any amendments in response to the following objections should be applied throughout the claims, as appropriate.
The following issues are objected to:
Claim
Recitation
Comment
1, 8-9 and 15
A... method...
production scale...
providing... production-scale
In claim 1, two instances of "production scale" should be recited consistently vs. "production-scale," probably "production-scale" with a hyphen. Also claim 8 (two instances) and claim 15 (one instance).
The same issue occurs with "process-control" vs. "process control" in claims 9 and 15.
1
when the first media is determined to be suitable
The indentation of this clause appears wrong and probably should be inline with the preceding steps, e.g. "determining..."
2, 4, 7, 11, 14
features of the powdered media including:...
In claim 2, each subsequent list element should begin a new line. Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. (MPEP 608.01(m)). The same issue causes claims 4, 7, 11 and 14 to be objected to similarly.
3
further comprising,
Possibly a colon, instead of a comma, should follow "comprising" before the subsequent list. This present recitation contrasts with other recited instances of "comprising" throughout the claims.
3, 8, 13-14
receiving...;
wherein...;
setting...
Possibly a comma, instead of a semi-colon, should separate the "wherein" clause from "receiving," the "receiving..." step including the "wherein" clause and the "receiving..." step being one of two steps in the recited list of steps. This also would be consistent with the "wherein" clause in the "setting..." step. Claims 8 and 13 are objected to similarly. In claim 14, generally the use of commas vs. semi-colons and the inclusion of new lines are inconsistent.
4
the portion micro- scale vessels
Missing "of" after "portion" and shouldn't be space after hyphen
13
...has n stages and the final stage... is
A comma should separate these two grammatically independent clauses.
13
controlling and monitoring is
Grammar, subject-verb agreement, probably should read "are"
Claim rejections - 112/b
The following is a quotation of 35 USC 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.
Claims 1-15 are rejected under 112/b, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However equivalent amendments also would be acceptable.
The following issues cause the respective claims to be rejected under 112/b as indefinite:
Claim
Recitation
Comment (suggestions in bold)
1
when...,
comparing...; and
controlling...,
based on the comparison.
In claim 1, it is unclear whether the recited "when..." clause is to be interpreted as merely timing of the "comparing..." step or as a conditional as to whether the "comparing..." and "controlling..." steps are to be performed. The lack of clarity results from the inconsistent indentation of the steps and from the recited "based on the comparison." The relationship is unclear between the "when..." clause and the "controlling..." step.
Claim 15 is rejected similarly, and, relatedly, in claim 15 the relationship is unclear between the final two steps "compare..." and "control...," for lack of a conjunction between these two steps versus the conjunction preceding the "when..." clause.
2-5, 7, 14
may be
Two instances. Unclear optionality or conditionality. MPEP 2111.04 and 2173.05(h).II pertain. Claims 3 (one instance), 4 (one instance: "may include"), 5 (one instance: "may reflect"), 7 (one instance: "may include") and 14 (two instances) are rejected similarly.
2
features of the powdered media including:...
The subsequent list lacks a conjunction between the final two list elements such that the relationship between the elements is unclear, e.g. as to "and" vs. "or."
2
wherein when...
...sampled media;
when...
The list of "when" clauses lacks a conjunction between the two list elements such that the relationship between the two is unclear, e.g. as to "and" vs. "or."
3, 5-6, 9-11, 14
receiving...;
...
setting...
In claim 3, the list of "receiving..." and "setting..." steps lacks a conjunction between the two listed steps such that the relationship between the two steps is unclear, e.g. as to "and" vs. "or." Similar issues cause claims 5-7, 9-11 and 14 to be rejected similarly.
11
scientific
Term of relative or vague degree or form of association, neither defined in the specification (p. 18, last para.; p. 28, 2nd and 3rd paras.; p. 33, 1st para.; p. 34, 5th para.) nor having a well-known and sufficiently particular definition in the art and in the instant context. (MPEP 2173.05(b) pertains.)
11
a molecule identification
instrument,
a metabolite measuring instrument,
a nutrient measuring instrument
Each recited "...instrument" renders the claim indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "instrument") and function and/or result (here "molecule identification," "metabolite measuring," "nutrient measuring") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. p. 18, last para.), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. While outputs are disclosed, e.g. "identification" and "measuring," there is not clear disclosure of the structure required to proceed from inputs to outputs. It also is not clear that any of the recitations must refer to a well-known instrument, e.g. a mass spectrometer. MPEP 2181 pertains, and MPEP 2187, FP 7.34.23 lists options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
15
the device comprising
In multiple instances, the antecedent of the recited "the device comprising..." is unclear, there being recited both "first" and "second" process control devices.
15
a controller operable to
This same element is instantiated twice such that the relationship between the two is unclear. Possibly the two instances should be recited as "first" and "second."
15
a controller operable to:
distribute...
Claim 15 is to a 101 machine or manufacture, i.e. a "system" in this instance, limited according to its claimed physical structure, but relating to the second recited "controller," it is not clear what is the structure associated with the recited "distribute...," ..., "control and monitor..." and similar steps. The recited "system" and "controller" are not interpreted as requiring structure clearly linking them to the recited steps in a structural sense appropriate to a claim to a machine or manufacture. Also, the "controller" is recited as "operable to...," reading on interpretations of intended use. This rejection might be overcome by, for example, reciting a data storage device, comprised by the "system" or "controller," and instructions stored therein and configured according to the recited elements and steps, as supported at, for example, p. 21, 3rd para. of the specification. The first recited "controller" and its associated "receive" step does not similarly cause the claim to be rejected because a "receive..." step is well-known. MPEP 2173.05(p).II pertains regarding a claim directed to both product and process.
Claim rejections - 112/a
The following is a quotation of 112/a:
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Regarding issues of written description support stemming even from the original claims and original disclosure, MPEP 2161.01.I (e.g. 6th para.), 2163.I and 2163.I.A pertain: "[O]riginal claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed" (MPEP 2161.01.I,6th para.).
Written description
Claim 11 is rejected under 112/a as failing to comply with the written description requirement. The claims read on subject matter which is not described in the specification in such a way as to reasonably convey to PHOSITA that the inventors, at the time the application was filed, had possession of the claimed invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted. With regard to any suggested amendment(s) below to overcome a rejection, equivalent amendments also would be acceptable.
Claim 11 recites "...a molecule identification instrument, a metabolite measuring instrument,
a nutrient measuring instrument..." The specification discloses these terms, but the specification does not detail any of molecule identification, metabolite measuring, or nutrient measuring, at least not as a definition to imported into the claim, for example (specification: p. 18, last para.). Corresponding to the earlier 112/f interpretation and 112/b rejection, these terms cause the claim to lack written description. Although claims are interpreted in light of the specification, examples from the specification are not imported into the claims as limitations absent a clearly limiting definition in the specification. (MPEP 2145.VI pertains.) MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
As appropriate, these rejections may be overcome, for example, (i) by narrowing to clearly supported embodiments and/or (ii) by clarifying on the record where support can be found and how that support relates to the recitations.
In general, it is requested that any claim amendment in this regard be accompanied by citations to support in the original disclosure.
MPEP 2163 generally pertains.
Claim interpretations
The following claim interpretations apply to all instances of the following terms throughout all claims:
Claim
Recitation
Comment
1, 9, 15
process-control device
Definite under 112/b after properly invoking 112/f. Recites means (or an equivalent, nonce term, here "device") and function and/or result (here "process control") without reciting steps or structure to prevent invoking. However, clearly linked portion of the specification do disclose sufficient structure, material, or acts and not just desired results, as exemplified at p. 7, 4th para.; p. 8, 4th para.; p. 19, 2nd para.; p. 21, last para.; p. 25, 4th para.; p. 26, 3rd para.; p. 32, 3rd para. through p. 34, last para.; and FIGs. 6-7 and associated specification text. MPEP 2181.III-IV pertain.
Claim rejections - 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 USC 102 and 103 is incorrect, any correction of the statutory basis 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 35 USC 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 of this title, 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.
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 USC 102(b)(2)(C) for any potential 35 USC 102(a)(2) prior art against the later invention.
Claims 1-5 and 12-15
Claims 1-5 and 12-15 are rejected under 35 USC 103 as unpatentable over De Kok (WO 2019/094787 as cited on the 6/1/2022 IDS) in view of Bruninghaus (US 2015/0353896 as cited on the 6/1/2022 IDS).
Regarding claim 1, the recited providing reads on "corpora of libraries including data such as... process condition data..." (De Kok: [59]; and entire document) and "strains for which actual plate and tank performance data are known" (De Kok: [110]; and entire document).
The recited receiving media reads on "media type/lot" (De Kok: [65, 93]; and entire document).
The recited sampling first and second media reads on "changes include, but are not limited to, media composition" (De Kok: [114]; and entire document).
De Kok does not teach a see train, but Bruninghaus does as "The term 'seed train process' is art-known..." (Bruninghaus: [21]; and entire document).
The recited micro-scale and production-scale vessels read on "a second scale larger than the first scale" (De Kok: Abstract; and entire document) and "development of a predictive model for an organism at a second scale based upon data observed at a first scale smaller" (De Kok: [23]; and entire document).
The recited process-control device reads on "other automated systems or devices... may be computer-implement" (De Kok: [283-4]; and entire document).
The recited controlling and monitoring in parallel read on "user control" (De Kok: [23]; and entire document); "test... and monitor... performance..." and "...tested in parallel..." (De Kok: [113]; and entire document) and "other automated systems or devices... may be computer-implement" (De Kok: [283-4]; and entire document).
The recited process trajectories, statistically representative trajectory, impact of media change read on "...combination of two or more measurements of organism performance..." (De Kok: [14]; and entire document); "...processes can... be combined..." (De Kok: [113]; also [79] and entire document); "prediction function may be represented as a weighted sum" (De Kok: [260]; and entire document); "...first scale statistical model represents organism features at the first scale" (De Kok: claim 3; and entire document) and "...changes may be made and evaluated to determine which physical plate model(s) yield the best transfer function. Examples of changes include... media composition..." (De Kok: [114]; and entire document).
De Kok teaches each of the limitations as described above, however De Kok does not teach the limitations in a single embodiment in the same, consecutive sequence as recited. It would have been prima facie obvious to try the recited sequence as an example of combining prior art elements taught within the same reference according to known methods to yield predictable results.
Regarding claim 2, the recited liquid media reads on "...media used for growing..." and "...fluid dynamics..." (De Kok: [93]; and entire document) and on "liquid culture medium" ([43]). In a BRI, the recited "powdered media" is optional.
Regarding claim 3, the recited parameters, settings and experimental differences in settings read on "adjust parameters" (De Kok: [21]; and entire document) and "adjustments" (De Kok: [114]; and entire document).
Regarding claim 4, the recited splitting into culture stations and set points read on "96-well plates" (De Kok: [67]; and entire document) and "...conditions under which that experiment was conducted, and include the optimizations listed above (e.g., location on the plate, plate characteristics, process characteristics, sample characteristics)" (De Kok: [74]; and entire document), in which the recited "culture station" reads on a plate, and, for example, the recited "about one third" results when there are three plates.
Regarding claim 5, the recited acceptance ranges and upper and lower limits of the reference multivariate process chart read on "...error (or P value) is reduced by a satisfactory amount..." (De Kok: [110], p. 21, step 6.b-7; and entire document).
Regarding claim 12, the recited defined media reads on "defined... medium" (Bruninghaus: [26]; and entire document).
Regarding claim 13, the recited staged seed train reads on "...seed train processes described herein... stages..." and "...seed train processes described herein can achieve an N-1 cell culture..." (Bruninghaus: [69]; and entire document).
Regarding claim 14, the recited volumes are obvious over the examples taught by Bruninghaus (Bruninghaus: [72]; and entire document), which reference also teaches starting with a "cryopreserved" sample (Bruninghaus: [4]; and entire document).
The art is applied to claim 15 as described for claim 1.
Combining De Kok and Bruninghaus
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the cell culture teaching of De Kok using the related teaching of Bruninghaus. As motivation to combine, an advantage taught by Bruninghaus of modifying methods such as those of De Kok would have been the teaching of Bruninghaus that "The present invention is based, at least in part, on the development of a seed train processes that result in several advantages..." (Bruninghaus: [5]). Thus, PHOSITA would have been motivated to modify De Kok using the above techniques of Bruninghaus in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because De Kok and Bruninghaus are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Bruninghaus to the related teaching of De Kok.
101 -- no rejections
35 USC 101 reads:
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.
Patent eligibility
Referring to 101 JE analysis as organized in MPEP 2106, no 101 rejection applies to claims 1-15, at least by analogy to analysis Step 2A, 2nd prong, 4th consideration relating to a transformation integrating possible judicial exceptions into a practical application (MPEP 2106.04(d) and 2106.05(c)), the transformation in this instance comprising at least the recited "controlling" (claim 1, two instances) and "control" (claim 15, two instances). The claims are interpreted as patent eligible.
Nonstatutory double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine to prevent the improper timewise extension of the "right to exclude" granted by a patent and to prevent multiple suits against an accused infringer by different assignees of the same invention (MPEP 804.II.B, 1st para.). A nonstatutory double patenting rejection is appropriate where the conflicting claims (instant v. reference) are not identical, but an examined-application claim (instant claim) is not patentably distinct from a reference claim because the instant claim is either anticipated by, or would have been obvious over, the reference claim (MPEP 804.II.B, 2nd para.).
In cases of double patenting rejections versus reference claims of pending applications, as opposed to claims of an issued patent, the rejections are provisional because the reference claims have not been patented. Presently, no rejections are provisional.
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 application or patent of the reference claim either is shown to be commonly owned with the instant application or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must comply fully with 37 CFR 3.73(b).
Applicant may wish to consider electronically filing a terminal disclaimer (MPEP 1490.V pertains, along with https://www.uspto.gov/patents-application-process/applying-online/eterminal-disclaimer). Electronic filing may lead to faster approval of the disclaimer. Also, if filing electronically, Applicant is encouraged to notify the examiner by telephone so that examination may resume more quickly.
Double patenting rejections of instant claims 1-15
Instant claims 1-15 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference patents 12,372,928 (from application 17/433,147) and 12,422,803 (from application 17/433,586) and one or more claims in reference applications 16/329,183 and 19/244,615 in view of De Kok (WO 2019/094787 as cited on the 6/1/2022 IDS) and Bruninghaus (US 2015/0353896 as cited on the 6/1/2022 IDS).
Although the reference claims are not identical to the instant claims, in a BRI they also are not patentably distinct from the instant claims: either (i) because the instant claims recite obviously equivalent or broader limitations in comparison to the reference claims or (ii) because the instant claims recite limitations which are obvious over the cited art. It is not clear that the instant claims recite limitations which are narrower than limitations in the reference claims.
It would have been obvious in view of the cited art to modify reference claims to arrive at the rejected instant claims. Either the instant limitations are interpreted as reading on a reference limitation, or the instant limitations would have been obvious in view of the cited art. That is, to the extent that any instant claims are narrower than reference claims, then any such narrowing would have been obvious over the cited art.
Citations to art
In the above citations to documents in the art, rejections refer to the portions of each document cited as example portions as well as to the entirety of each document, unless otherwise noted in the situation of lengthy, multi-subject documents. Other passages not specifically cited within a document may apply as well.
Conclusion
No claim is allowed.
A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication.
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The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686