UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
`
`15/322,585
`
`12/28/2016
`
`Krista Toler
`
`5394.A88US1
`
`8947
`
`Schwegman Lundberg & Woessner / Zlmmer
`P 0 BOX 2938
`
`Minneapolis, MN 55402
`
`DEJONG, ERIC S
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`PAPER NUMBER
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`ART UNIT
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`1631
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`NOTIFICATION DATE
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`DELIVERY MODE
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`10/03/2019
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
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`following e—mail address(es):
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`SLW@b1aekhillsip.eom
`USPTO @ s1wip.eom
`
`PTOL-90A (Rev. 04/07)
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`

`

`0,7709 A0170” Summary
`
`Application No.
`15/322,585
`Examiner
`ERIC 8 DEJONG
`
`Applicant(s)
`Toler et al.
`Art Unit
`1631
`
`AIA (FITF) Status
`Yes
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed after SIX (6) MONTHS from the mailing
`date of this communication.
`|f NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from 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, even if timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
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`Status
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`1). Responsive to communication(s) filed on 0614/2019.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a). This action is FINAL.
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`2b) C] This action is non-final.
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`3)[:] An election was made by the applicant in response to a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
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`4)[:] 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 Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
`5)
`Claim(s)
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`1—3,6—9,1 1—12,14,17 and 48—56 is/are pending in the application.
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`5a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`E] Claim(s)
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`is/are allowed.
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`Claim(s) 1—3,6—9,1 1—12,14,17 and 48—56 is/are rejected.
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`[:1 Claim(s) _
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`is/are objected to.
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`) ) ) )
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`
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`are subject to restriction and/or election requirement
`[j Claim(s)
`* If any claims have been determined aflowabie, you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`http://www.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPeredback@uspto.gov.
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`Application Papers
`10)[:] The specification is objected to by the Examiner.
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`11)[:] The drawing(s) filed on
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`is/are: a)D accepted or b)l:] objected to by the Examiner.
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`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:
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`a)D All
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`b)I:I Some**
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`c)C] None of the:
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`1.[:] Certified copies of the priority documents have been received.
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`2.[:] Certified copies of the priority documents have been received in Application No.
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`3.[:] Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
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`** See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1) C] Notice of References Cited (PTO-892)
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`2) E] Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date_
`U.S. Patent and Trademark Office
`
`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20190928
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`

`

`Application/Control Number: 15/322,585
`Art Unit: 1631
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`Page 2
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`DETAILED OFFICE ACTION
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`Applicant response filed 06/14/2019 is acknowledged.
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`Election/Restrictions
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`Applicant's election with traverse of Group I (claims 1-3, 6-9, 11, 12, 14, and 17)
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`in the reply filed on 03/04/2019 is acknowledged.
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`Claims 22, and 41-43, and 45-47 (now cancelled) were withdrawn from further
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`consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group of
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`invention, there being no allowable generic or linking claim
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`Claims 4, 5, 10, 13, 15, 16, 18-47 have been cancelled by applicant.
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`Claims 48-56 are newly presented.
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`Claims 1-3, 6-9, 11, 12, 14, 17 and 48-56 are currently under examination.
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`

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`Application/Control Number: 15/322,585
`Art Unit: 1631
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`Page 3
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`Claim Rejections - 35 USC § 101
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`35 U.S.C. 101 reads as follows:
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`Whoever invents or discovers anynew and useful process, machine, manufacture, or
`composition of matter, or any new and useful improvementthereof, mayobtain a patent
`therefor, subject to the conditions and requirements ofthis title.
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`Claims 1-3, 6-9, 11, 12, 14, 17 and 48-56 are rejected under 35 U.S.C. 101
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`because the claimed invention is directed to a judicial exception (Le, a law of nature, a
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`natural phenomenon, or an abstract idea) without including additional elements that are
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`sufficient to amount to significantly more than the judicial exception itself. This rejection
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`is further necessitated by applicant amendment to the instant claims.
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`The instant claims are directed to a method and related device for determining an
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`efficacy ratio associated with an input and output ratio of an anti-inflammatory cytokine.
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`The recited process carried out by the claimed invention comprises obtaining
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`concentrations of inflammatory cytokines and anti-inflammatory cytokines by processing
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`a donor sample, and calculating a first efficacy ratio.
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`The courts have clearly established that a method directed essentially to a series
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`of algorithmic/mathematical procedures is not a statutory process:
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`limitations, a process that employs mathematical algorithms to
`“Without additional
`manipulate existing information to generate additional
`information is not patent eligible.
`“if a claim is directed essentially to a method of calculating, using a mathematical
`formula, even if the solution is for a specific purpose, the claimed method is
`nonstatutory.” Parker v. Flook, 437 US. 584, 595 (1978) (internal quotations omitted).”
`(Precedential CAFC decision: Digitech Image Technologies, LLC. v. Electronics for
`Imaging,
`Inc., decided July 11, 2014).
`
`“A claim that directly reads on matter in the three identified categories is outside section
`101. Mayo, 132 S. Ct. at 1293. But the provision also excludes the subject matter of
`certain claims that by their terms read on a human-made physical thing (“machine,
`manufacture, or composition of matter”) or a hum an-controlled series of physical acts
`(“process”) rather than laws of nature, natural phenomena, and abstract ideas. Such a
`claim falls outside section 101 if (a) it is “directed to” matter in one of the three excluded
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`

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`Application/Control Number: 15/322,585
`Art Unit: 1631
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`Page 4
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`categories and (b) “the additional elements” do not supply an “inventive concept” in the
`physical realm of things and acts—a “new and useful application” of the ineligible matter
`in the physical realm—that ensures that the patent is on something “significantly more
`than” the ineligible matter itself. Alice, 134 S. Ct. at 2355, 2357 (internal quotation marks
`omitted); see Mayo, 132 S. Ct. at 1294, 1299, 1300. This two-stage inquiry requires
`examination of claim elements “both individually and ‘as an ordered com bination.”’
`Alice, 134 S. Ct. at 2355.” (Precedential CAFC decision: Buysafe Inc. v. Google lnc.,
`decided September 3, 2014).
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`The instant claims do recite additional elements beyond the judicial exception set
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`forth above. The claims recite the generic steps of processing a donor sample in order
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`to obtain the necessary input data in order to perform the calculations set forth in the
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`claims. The claims, however, do not recite anything special regarding the manner in
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`which data is collected such that the scope of said claims would exclude routine and
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`conventional biological experiments known to produce data required by the instant
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`analysis. As such, this element of the claims only adds a conventional data collection
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`methods as the source of the data to be analyzed. As such, this cannot amount to
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`something beyond the recitation of routine and conventional data gathering activities.
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`Independent claim 1 has been amended to recite reprocessing an anti-
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`inflammatory composition or repeating steps (a) to (e) if the calculated efficacy ratio is
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`greater than one. The amendment amounts to nothing more than insignificant post
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`solution activity involving additional analysis. Such additional analysis following the
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`determination of a first efficacy ration fails to provide for a practical application of the
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`judicial exception embraced by the instant claims.
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`Newly presented claims 48-56 introduce an additional final limitation of
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`administering the anti-inflammatory composition to a subject or storing said composition
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`IF the efficacy ration is greater or equal to one or IF the reprocessing of the anti-
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`inflammatory composition if the efficacy ratio is less than one. Again, the newly
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`

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`Application/Control Number: 15/322,585
`Art Unit: 1631
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`Page 5
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`introduced limitation provides for insignificant post solution activity following the
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`computational determination of a first efficacy ratio. The claims merely require a
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`practitioner to apply use a composition based on the computational determination of the
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`ratio. Further, the claims alternatively require a practioner to merely store a composition
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`under investigation is at the very height well understood, widely practiced, routine and
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`conventional
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`laboratory practices.
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`For these reasons, the instant claims encompass non-statutory subject matter.
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`Response to Arguments
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`Applicant's arguments filed 06/14/2019 have been fully considered but they are
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`not persuasive.
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`With regard to the rejection of claims under 35 USC 101, applicant argues that
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`the claims recite a practical application of the judicial exception by determining if a
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`threshold level is or in sot achieved for an anti-inflammatory composition.
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`This is not persuasive. The instant claims are directed to an abstract analysis of
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`data obtained using well understood, well-practiced, routine and convention procedures
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`to analyse anti-inflammatory compositions. The determination of whether or not a
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`threshold level is met is entirely accomplished by mathematical and algorithmic analysis
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`of data. This fails to provide a practical application of the judicial exception. Rather,
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`applicant merely argues the utility and usefulness of the analysis set forth by the claims.
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`It is emphasized that the claims are not rejected for lack of utility under 35 USC 101,
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`rather the claims are rejected under 35 USC 101 as being directed to non-statutory
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`subject matter.
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`

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`Application/Control Number: 15/322,585
`Art Unit: 1631
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`Page 6
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`Applicant further argues that the newly presented claims provide for a practical
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`application in treating a patient with an anti-inflammatory composition.
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`This is not persuasive because applicant merely identifies a general property (the
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`threshold level indication of anti-inflammatory properties) and instructs a practitioner to
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`generically treat a patient. This fails to do anything more than to merely “apply” the
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`composition without any more instruction than the general category of treatment. Unlike
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`the claims set forth in Vanda with provide a new and novel treatment of a known
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`schizophrenic drug, the instant claims merely identify a possible anti-inflammatory
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`product and provide generic instructions to “apply’ it.
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`For these reasons, the examiner has maintained the rejection of record under 35
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`USC 101.
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`Conclusion
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`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action.
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`In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action.
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`In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the mailing date of this final action.
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`

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`Application/Control Number: 15/322,585
`Art Unit: 1631
`
`Page 7
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to ERIC S DEJONG whose telephone number is (571)272-
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`6099. The examiner can normally be reached on 8:30-5:00.
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`Examiner interviews are available via telephone, in-person, and video
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`conferencing using a USPTO supplied web-based collaboration tool. To schedule an
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`interview, applicant is encouraged to use the USPTO Automated Interview Request
`
`(AIR) at http://www.uspto.gov/interviewpractice.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Marjorie Moran can be reached on (571) 272-0720. The fax phone number
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`for the organization where this application or proceeding is assigned is 571 -273-8300.
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`
`/ERIC S DEJONG/
`
`Primary Examiner, Art Unit 1631
`
`