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`UNITEDSTATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/436,770
`
`09/07/2021
`
`Brian E. Brooks
`
`82436US007
`
`6852
`
`3M INNOVATIVE PROPERTIES COMPANY
`PO BOX 33427
`ST. PAUL, MN 55133-3427
`
`COLLINS, GARY
`
`2115
`
`01/05/2024
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`LegalUSDocketing@mmm.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-14 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`CL] Claim(s)__is/are allowed.
`Claim(s) 1-14 is/are rejected.
`(] Claim(s)__ is/are objectedto.
`C] Claim(s
`are subjectto restriction and/or election requirement
`)
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http://www.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) ) ) )
`
`Application Papers
`10)(C The specification is objected to by the Examiner.
`11){¥j The drawing(s)filed on 07 September 2021 is/are: a)(¥| accepted or b)L) objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)£) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`_—_c)L) None ofthe:
`b)L) Some**
`a)Q) All
`1.1) Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have been received in Application No. |
`3.2.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`*“ See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date
`12/21/22;3/1/22;9/6/23,
`U.S. Patent and Trademark Office
`
`3)
`
`4)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20231204
`
`Application No.
`Applicant(s)
`17/436,770
`Brooksetal.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`GARY COLLINS
`2115
`Yes
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1) Responsive to communication(s)filed on 07 September 2021.
`C) A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)() This action is FINAL. 2b)¥)This action is non-final.
`3) An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4)(2) Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`

`

`Application/Control Number: 17/436,770
`Art Unit: 2115
`
`Page 2
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`Notice ofPre-AIA or AIA Status
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`The presentapplication, filed on or after March 16, 2013, is being examined underthe
`
`first inventorto file provisions of the AIA.
`
`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 ofthis title.
`
`Claim 14 is rejected under 35 U.S.C. 101 because the claimed inventionis directed to
`
`non-statutory subject matter. The claim(s) does/do not fall within at least one of the four
`
`categories of patent eligible subject matter because “computer-readable storage media”
`
`encompassestransitory signals.
`
`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 underthis section madein this Office action:
`
`A personshall beentitled to a patent unless —
`
`(a)(1) the claimed invention waspatented, 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.
`
`Claims 1-3, 5-8, and 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
`
`Bourg, JR. et al. US 2011/0276164 Al.
`
`Bourg, JR. teaches:
`
`

`

`Application/Control Number: 17/436,770
`Art Unit: 2115
`
`1. (Original) A method comprising:
`
`Page 3
`
`e
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`repeatedly performing the following [para. 0073, “The process can be repeated as
`
`necessary. |]:
`
`o.
`
`selecting a configuration of input settings for manufacturing a batch ofa
`
`biologic pharmaceutical based on a causal model that measures current
`
`causalrelationships between input settings and a measure of a quality of
`
`batches of the biological pharmaceutical; [para. 0056, “The feedback updater
`
`and the modelwill then determine new optimal parameters which can be utilized
`
`by the advanced batch controller.”
`
`o determining a measure of the quality of a batch of the biological
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`pharmaceutical manufactured using the configuration of input settings;
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`[para. 0055, “Thus, information on the actual measured product quality or process
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`conditions reached in a batch are compared to the values of those predicted by the
`
`model. Corresponding feedback corrective action can then be applied to the model
`
`predictions for subsequent batches.”] and
`
`©
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`adjusting, based on the measureof the quality of the batch of the biological
`
`pharmaceutical, the causal model. [para. 0058, “In one embodiment the
`
`parameters of the modelitself are updated recursively with time in responseto the
`
`feedback described above. Thus, in one embodimentthe modelitself is made to
`
`track changes in the process, therefore maintaining accurate model predictions
`
`over time.”|
`
`Bourg, JR. teaches:
`
`

`

`Application/Control Number: 17/436,770
`Art Unit: 2115
`
`Page 4
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`2. (Original) The methodof claim 1, wherein: selecting the configuration of input settings
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`comprises selecting the configuration of input settings based on a set of internal control
`
`parameters, and the method further comprises adjusting the internal control parameters based on
`
`the measure of the quality of the batch.
`
`[para. 0027, “In one embodimentthe final or
`
`intermediate product properties are measured by on-line instruments located at the end of the
`
`batch. In other embodimentsthe final or intermediate product properties are measured off-line,
`
`for examplein a quality control laboratory.”]
`
`Bourg, JR. teaches:
`
`3. (Currently Amended) The method of claim 1,
`
`wherein the measure of the quality of the batch comprises one or moreof the following:
`
`a yield of the batch;
`
`a measure of an activity of the batch;
`
`a measure of an efficacy of the batch;
`
`a measure of impurities in the batch; a measureof a viability of transfected cells;
`
`a measure of transfection efficiency;
`
`a measure of a purity of the biologic pharmaceutical; [para. 0027, “Thefinal or
`
`intermediate product properties can include, but are not limited to moisture content, salt content,
`
`oil content, percent solids, color, texture, level of a compositional compoundincluding but not
`
`limited to Acrylamide, percentpurity or impurity, conversion, temperature, density, viscosity,
`
`molecular weight, concentration, coating thickness, etc.” (Emphasis added.)]
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`a measure of monodispersion; or
`
`a measure of cell density.
`
`

`

`Application/Control Number: 17/436,770
`Art Unit: 2115
`
`Page 5
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`Bourg, JR. teaches:
`
`5. (Currently Amended) The method of claim 1, wherein the input settings comprise one or more
`
`of the following:
`
`one or moresettings related to processing steps; [para. 0101, “At each decision point the model
`
`defined the settings for variables used to control the batch process via a PLC server.” ]
`
`one or moresettings related to a chemical composition of a substance;
`
`one or moresettings related to physical control during manufacturing; or
`
`one or moresettings related to purifying the batch of the biologic pharmaceutical.
`
`Bourg, JR. teaches:
`
`6. (Original) The methodof claim 5, wherein the settings related to processing steps comprise
`
`one or more of the following:
`
`an ordering of the processing steps;
`
`a time spent in each processing step; [para. 0103, “Further, the time betweenan initial (GO) and a
`
`high gas flow rate (G1) was also controlled by the advanced batch controller. ”]
`
`a time spent in each subprocess of a given processing step; or
`
`a choice of parameters for each processingstep.
`
`Bourg, JR. teaches:
`
`7. (Currently Amended) The method of claim 5, wherein the settings related to a chemical
`
`composition comprise a selection of one or moreof:
`
`

`

`Application/Control Number: 17/436,770
`Art Unit: 2115
`
`Page 6
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`a nutrient media; [para. 0115, “In bioreactors control is applied at various decision points
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`to manipulate the feed rate of nutrients, adjust the temperature pH or dissolved oxygen
`
`level in the medium in orderto achieve high yields of final product and constrain the
`
`concentrations of various byproductsin the final productto fall within acceptable
`
`limits.”|
`
`an ion exchangeresin;
`
`an affinity chromatography matrix;
`
`a polymer;
`
`a wash buffer; or
`
`an elution buffer.
`
`Bourg, JR. teaches:
`
`8. (Currently Amended) The method of claim 5, wherein the settings related to physical control
`
`during manufacturing comprise one or moreof:
`
`a time of manufacturing; [para. 0103, “Further, the time between aninitial (GO) and a
`
`high gas flow rate (G1) was also controlled by the advanced batch controller. ”]
`
`atime of purification;
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`a temperature during manufacturing;
`
`a temperature during purification;
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`a humidity during manufacturing;
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`a humidity during purification;
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`a flow rate used during manufacturing;
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`a flow rate used during purification;
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`

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`Page 7
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`Application/Control Number: 17/436,770
`Art Unit: 2115
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`a g-force used during manufacturing;
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`a measure of magnetism used during manufacturing;
`
`a measureof electricity used during manufacturing; or
`
`a measure of agitation used during manufacturing.
`
`Bourg, JR. teaches:
`
`10. (Currently Amended) The method of claim 1, wherein:
`
`selecting the configuration comprises selecting the configuration based on the causal model and
`
`a predeterminedset of external variables; [para. 0083, “At the decision point the model can
`
`predict, for example, a final product quality.”] and
`
`the method further comprises adjusting control parameters that parameterize the impactof the
`
`predetermined set of external variables. [para. 0083, “The advanced batch controller then makes
`
`the necessary adjustments to system.” ]
`
`Bourg, JR. teaches:
`
`11. (Original) The methodof claim 10, wherein the predeterminedset of external variables
`
`comprises one or more external variables related to an environmental climate during
`
`manufacturing.
`
`[para. 0041, “The disturbance variables can also include process conditions that
`
`affect the batch but that cannot easily be controlled. For example, atmospheric pressure at a
`
`given altitude, ambient temperature and ambient humidity are disturbance variables that can be
`
`taken into accountbutoften are not easily compensated for.” |
`
`Bourg, JR. teaches:
`
`

`

`Application/Control Number: 17/436,770
`Art Unit: 2115
`
`Page 8
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`12. (Original) The methodof claim 11, wherein the external variables related to the
`
`environmental climate comprise one or more of the following:
`
`a humidity during manufacturing; [para. 0041, “The disturbance variables can also
`
`include process conditionsthat affect the batch but that cannot easily be controlled. For example,
`
`atmospheric pressure at a given altitude, ambient temperature and ambient humidity are
`
`disturbance variables that can be taken into account but often are not easily compensated for.”]
`
`an external temperature during manufacturing; or
`
`a level of light during manufacturing.
`
`Regarding apparatus claim 13, this apparatus claim recites the execution on a computer of
`
`the method steps recited above andis rejected on the same grounds and rationale as
`
`corresponding method claims above.
`
`Regarding CRM 14, this claim recites the storage of instructions that when executed by
`
`computers perform the method steps recited above andis accordingly rejected on the same
`
`grounds andrationale as methodsteps above.
`
`Claim Rejections - 35 USC § 103
`
`The followingis a quotation of 35 U.S.C. 103 which formsthe basis for all obviousness
`
`rejections set forth in this Office action:
`
`A patent fora 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 obviousbefore 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.
`
`

`

`Application/Control Number: 17/436,770
`Art Unit: 2115
`
`Page 9
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`Claim(s) 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bourg, JR.
`
`et al. US 2011/0276164 Al in view of McCready US 2014/0136146 Al.
`
`Bourg, JR does not teach the following limitation, however, McCready teaches:
`
`4, (Original) The method of claim 3, wherein the purity of the biologic pharmaceutical
`
`comprises one or moreof the following:
`
`a measure of host cell protein impurity;
`
`a measure of DNA impurity;
`
`a measure of RNA impurity; or
`
`a measure of host cell metabolite impurity .[para. 0016, “The biological parameters can
`
`includeat least one of viable cell concentration, intra-cellular measurements or extra-cellular
`
`measurements. The one or more quality profiles can comprise a carbon dioxide profile, impurity
`
`profile, osmolality profile, viable cell concentration profile, and pH profile.”
`
`It would have been obvious to a person having ordinary skill in the art before the time of
`
`filing to combinethe teachings of McCready with those of Bourg, JR. A person having ordinary
`
`skill in the art would have been motivated to combine the teachings because McCready teaches
`
`that impurity profile of biological parameters of a cell can be used to achieve higher quality
`
`yields in a batch manufacturing process. (See backgroundsection).
`
`McCready further teaches:
`
`9. (Currently Amended) The methodof claim 5, wherein the settings related to purifying the
`
`batch of the biologic pharmaceutical comprise purifying the batch using one or more of
`
`

`

`Application/Control Number: 17/436,770
`Art Unit: 2115
`
`Page 10
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`electrostatic interactions;
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`hydrophobic interactions;
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`hydrophilic interactions;
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`affinity chromatography; or
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`size exclusion chromatography. [para.0047, “Examples of dependentvariables include
`
`chambertemperature, gas pressure, temperature or pressure gradients, impurity levels, spectral
`
`and/or chromatographic profiles, and others for a semiconductor manufacturing process.”]
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to GARY COLLINS whosetelephone numberis (571)270-0473.
`
`The examiner can normally be reached Monday- Friday 1-930PM EST.
`
`Examinerinterviews are available via telephone, in-person, and video conferencing using
`
`a USPTO supplied web-based collaboration tool. To schedule an interview, applicantis
`
`encouragedto use the USPTO Automated Interview Request (AIR)at
`
`http://www.uspto.gov/interviewpractice.
`
`If attempts to reach the examinerby telephone are unsuccessful, the examiner’s
`
`supervisor, Thomas Lee can be reached on (57 1) 272-3667. The fax phone numberfor the
`
`organization where this application or proceedingis assignedis 571-273-8300.
`
`Information regarding the status of published or unpublished applications may be
`
`obtained from Patent Center. Unpublished application information in Patent Centeris available
`
`

`

`Application/Control Number: 17/436,770
`Art Unit: 2115
`
`Page 11
`
`to registered users. To file and manage patent submissionsin Patent Center,visit:
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`
`/GARY COLLINS/
`Examiner, Art Unit 2115
`
`