`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www .uspto.gov
`
`APPLICATION NO.
`
`
`
`
` FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATIONNO.
`
`15/010,436
`
`01/29/2016
`
`Joost Louwagie
`
`5545-00054
`
`1064
`
`AndrusIntellectual Property Law, LLP a|
`PANNE
`ww,LLP
`tual
`And
`100 EAST WISCONSIN AVENUE,SUITE 1100
`SISSON, BRADLEY L
`MILWAUKEE,WI 53202
`
`ART UNIT
`
`PAPER NUMBER
`
`1634
`
`MAIL DATE
`
`10/28/2016
`
`DELIVERY MODE
`
`PAPER
`
`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.
`
`PTOL-90A (Rev. 04/07)
`
`Geneoscopy Exhibit 1019, Page 1
`
`Geneoscopy Exhibit 1019, Page 1
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`

`

`
`Application No.
`Applicant(s)
`15/010,436
`LOUWAGIE, JOOST
`
`Examiner
`Art Unit
`AIA (First Inventor toFile)
`Bradley L. Sisson
`1634
`No
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address--
`Period for Reply
`
`Office Action Summary
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`after SIX (6) MONTHS from 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) 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, evenif timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, may a reply be timely filed
`
`-
`-
`
`Status
`1) Responsive to communication(s) filed on 07/25/2016.
`L] A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filedon___
`2a)X] This action is FINAL.
`2b)L] This action is non-final.
`3)L] An election was made bythe applicant in responseto a restriction requirementset forth during the interview on
`
`; the restriction requirement and election have been incorporated into this action.
`4)L] Sincethis application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordancewith the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
` Attachment(s)
`
`Disposition of Claims*
`
`5)K] Claim(s) 82,86,88,92 and 100-105 is/are pending in the application.
`
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6)L] Claim(s)___is/are allowed.
`
`7) Claim(s) 82,86,88,92 and 100-105is/are rejected.
`8)L] Claim(s)___ is/are objectedto.
`
`9)L] Claim(s)
`are subjectto restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`nito:/www. uspte.dovi
`
`atenis/init events/peh/index.jsp or send an inquiry to PPHfeedback@uspto.dov.
`
`
`
`
`
`
`Application Papers
`10) The specification is objected to by the Examiner.
`
`11) The drawing(s) filed on
`is/are: a)[_] accepted or b)[_] 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)L] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)LJ All
`b)[] Some** c)L] None ofthe:
`1.) Certified copies of the priority documents have been received.
`2.L] Certified copies of the priority documents have been received in Application No.
`3.L] 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.
`
`3) TC Interview Summary (PTO-413)
`1) X Notice of References Cited (PTO-892)
`Paper No(s)/Mail Date.
`;
`,
`O Oth
`2) X Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`
`Paper No(s)/Mail Date 07/25/2016. ther
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Geneos€apyt Extibite1@49pRage 21 027
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`Geneoscopy Exhibit 1019, Page 2
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`

`

`Application/Control Number: 15/010,436
`
`Art Unit: 1634
`
`Page 2
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`DETAILED ACTION
`
`Notice of Pre-AIA or AIA Status
`
`The present application is being examined underthe pre-AJAfirst to invent provisions.
`
`Claim Rejections - 35 USC § 112, Fourth Paragraph
`
`The following is a quotation of 35 U.S.C. 112(d):
`
`(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form
`shall contain a reference to a claim previously set forth and then specify a further limitation of the
`subject matter claimed. A claim in dependent form shall be construed to incorporate by referenceall the
`limitations of the claim to whichitrefers.
`
`The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
`
`Subject to the following paragraph[i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in
`dependent form shall contain a reference to a claim previously set forth and then specify a further
`limitation of the subject matter claimed. A claim in dependentform shall be construed to incorporate by
`referenceall the limitations of the claim to which itrefers.
`
`3.
`
`Claim 86 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph,as
`
`being of improper dependent form for failing to further limit the subject matter of the claim upon
`
`which it depends, or for failing to include all the limitations of the claim upon which it depends.
`
`Claim 86 depends from canceled claim 83. Applicant may cancel the claim(s), amend the
`
`claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent
`
`form, or present a sufficient showing that the dependent claim(s) complies with the statutory
`
`requirements.
`
`Claim Rejections - 35 USC § 101, Judicial Exception
`
`4,
`
`35 U.S.C. 101 reads as follows:
`
`Geneoscopy Exhibit 1019, Page 3
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`Geneoscopy Exhibit 1019, Page 3
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`

`

`Application/Control Number: 15/010,436
`
`Art Unit: 1634
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`Page 3
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`Whoeverinvents or discovers any new and useful process, machine, manufacture, or composition of
`matter, or any new and useful improvementthereof, may obtain a patent therefor, subject to the
`conditions and requirementsofthistitle.
`
`5.
`
`Effective December 16, 2014, subject matter eligibility determinations under 35 U.S.C. §
`
`101 follow the procedure explained in the Federal Register notice titled 2014 Interim Guidance
`
`on Patent Subject Matter Eligibility (79 FR 74618), which is foundat:
`
`o.
`ysipke/PR-2014-12-16/pdf/2014-20414 pdf. These guidelines were
`hitp://www.epo.gov/fds
`
`
`
`updated May 2, 2016, in the Federal Register notice titled May 2016 Subject Matter Eligibility
`
`Update, (81 FR 27381), which can be foundat: https:/Avww.gpo.gov/tdsys/pke/FR-20 16-05-
`
`
`
`
`O6/pdf/2016-10724 pdf.
`
`6.
`
`Additionally, attention is directed to Gottschalk, Comr. Pats. v. Benson, et al. (US, 1972)
`
`175 USPQ 673, 675:
`
`The Court stated in MacKayCo. v. Radio Corp., 306 U.S. 86, 94, 40 USPQ 199, 202,
`that “While a scientific truth, or the mathematical expression of it, is not a patentable
`invention, a novel and useful structure created with the aid of knowledge ofscientific
`truth may be.” That statement followed the long-standingrule that “An ideaofitself is
`not patentable.” Rubber-Tip Pencil Co. v. Howard, 20 Wall. 498, 507. “A principle, in
`the abstract, is a fundamental truth; an original cause; a motive; and these cannot be
`patented, as no one can claim in either of them an exclusive right.” LeRoy v. Tatham, 14
`How. 156, 175. Phenomena of nature, though just discovered, mental processes, abstract
`intellectual concepts are not patentable, as they are the basic tools of scientific and
`technological work, As westated in Funk Bros. Seed Co. v. Kalo Co., 333 U.S. 127, 130,
`76 USPQ 280, 281, “He who discovers a hitherto unknown phenomenonof nature has no
`claim to a monopoly of it which the law recognizes. If there is to be invention from such
`a discovery, it must come from the application of the law of nature to a new and useful
`end.”” We dealt there with a “product” claim, while the present case deals only with a
`“process” claim. But we think the same principle applies. (Emphasis added)
`
`Here the “process” claim is so abstract and sweeping as to cover both known and
`unknown usesof the BCD to pure-binary conversion. The end use may (1) vary from the
`operation ofa train to verification of drivers’ licenses to researching the law books for
`
`Geneoscopy Exhibit 1019, Page 4
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`Geneoscopy Exhibit 1019, Page 4
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`Application/Control Number: 15/010,436
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`Art Unit: 1634
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`Page 4
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`precedents and (2) be performed through any existing machinery or future-devised
`machinery or without any apparatus. (Emphasis added)
`
`7.
`
`Attention is also directed to the precedential decision in Ariosa Diagnostics, Inc., et al. v.
`
`Sequenom, Inc., et al. 115 USPQ2d 1152 (Fed. Cir. 2015):
`
`, 1328.
`In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S.
`Ct. 1289 (2012), the Supreme Court set forth a frameworkfor distinguishing patents that
`claim lawsof nature, natural phenomena,andabstract ideas from those that claim patent-
`eligible applications of those concepts. First, we determine whetherthe claimsat issue
`are directed to a patent-ineligible concept. /d. at 1297. If the answeris yes, then we next
`consider the elements of each claim both individually and “as an ordered combination” to
`determine whether additional elements “transform the nature of the claim” into a patent-
`eligible application. Jd. at 1298.
`
`
`
`oR
`
`Mayo madeclear that transformation into a patent-eligible application requires “more
`than simply stat[ing] the law of nature while adding the words ‘applyit.’” Jd. At 1294. A
`claim that recites an abstract idea, law of nature, or natural phenomenon must
`include “additional features” to ensure “that the [claim] is more than a drafting
`effort designed to monopolize the [abstract idea, law of nature, or natural
`phenomenon].” /d. at 1297. For process claims that encompass natural phenomenon,
`the process steps are the additional features that must be new anduseful. See Parker
`v. Flook, 437 U.S. 584, 591 (1978) (“The processitself, not merely the mathematical
`algorithm, must be new and useful.”’). (Emphasis added)
`
`oR
`
`Thus, in this case, appending routine, conventional steps to a natural phenomenon,
`specified at a high level of generality, is not enough to supply an inventive concept.
`
`oR
`
`Sequenom and amici encourageus to draw distinctions among natural phenomena based
`on whetheror not they will interfere significantly with innovation in other fields now or
`in the future. The Supreme Court cases, however, have not distinguished among different
`laws of nature or natural phenomenon according to whetheror not the principles they
`embodyare sufficiently narrow. See, e.g., Parker v. Flook, 437 U.S. 584 (1978) (holding
`narrow mathematical formula unpatentable). In Parker v. Flook, the Supreme Court
`stated the issue in the case as follows: “The question in this case is whether the
`
`Geneoscopy Exhibit 1019, Page 5
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`Geneoscopy Exhibit 1019, Page 5
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`Application/Control Number: 15/010,436
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`Art Unit: 1634
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`Page 5
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`identification of a limited category of useful, though conventional, post-solution
`applications of such a formula makes respondent’s methodeligible for patent protection.”
`Id. at 585. The answerto that question was “no” because granting exclusive rights to the
`mathematical formula would be exempting it from any future use.
`
`8.
`
`Claims 82, 88, 102 and 105 are rejected under 35 U.S.C. 101 because the claimed
`
`invention is directed to a judicial exception (1.e., a law of nature, a natural phenomenon,or an
`
`abstract idea) without significantly more.
`
`9.
`
`Asnoted in Seqguenom:
`
`First, we determine whether the claimsat issue are directed to a patent-ineligible concept.
`Id. at 1297.
`
`Asseen in the Interim Guidelines, one asks the question
`
`Is the claim to a process, machine, manufacture or composition of matter?
`
`In the present case, the claims are dawn to a composition of matter.
`
`10.
`
`Next, one applies the tests set forth in Mayo:
`
`Is the claim directed to a law of nature, a natural phenomenon,or an abstract idea?
`
`11.
`
`In the present case, the claim(s) is/are directed to a natural phenomenon. As can be seen
`
`in claims 102 and 105, the system (claim 102) and the kit (claim 105) are to include
`
`“components for performing a polymerase chain reaction.” Such an embodimenthas been
`
`construed as encompassing the presence of Tag polymerase, whichis recognized as being a
`
`product of nature (isolated from Thermus aquaticus). In support of this position, attention is
`
`directed to US 4,889,818 (Gelfand et al.). As stated in the abstract:
`
`Geneoscopy Exhibit 1019, Page 6
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`Geneoscopy Exhibit 1019, Page 6
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`Art Unit: 1634
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`Page 6
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`A purified thermostable enzymeis obtained that has unique characteristics. Preferably
`the enzymeis isolated from the Thermus aquaticus species and has a molecular weight
`of about 86,000-90,000 daltons.
`
`12.
`
`Having answeredthefirst test in Mayo, one turnsto the secondtest:
`
`Doesthe claim recite additional elements that amountto significantly more than the
`judicial exception?
`
`Aspresently worded, the “system” and “kit” do not require the reagent, e.g., polymerase, to be
`
`combined with any other componentthat does not occur with the polymerase, and whichalters
`
`the properties of same.
`
`13.
`
`It is noted that claim 102 dependsfrom claim 82, and that claim 105 depends from claim
`
`88. Accordingly, claims 82 ad 88 must encompass the embodiments of claims 102 and 105,
`
`respectively. Accordingly, and in the absence of convincing evidenceto the contrary, claims 82,
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`88, 102 and 105 are rejected under 35 U.S.C. 101 because the claimed inventionis directed to a
`
`judicial exception (i.e., a law of nature, a natural phenomenon,or an abstract idea) without
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`significantly more.
`
`Claim Rejections - 35 USC § 103
`
`14.
`
`In the event the determination of the status of the application as subject to AIA 35 U.S.C.
`
`102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the
`
`statutory basis for the rejection will not be considered a new groundofrejection if the prior art
`
`relied upon, and the rationale supporting the rejection, would be the same undereither status.
`
`Geneoscopy Exhibit 1019, Page 7
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`Geneoscopy Exhibit 1019, Page 7
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`Application/Control Number: 15/010,436
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`Art Unit: 1634
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`Page 7
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`15.
`
`Claims 82, 86, 88, 92, and 100-105 are is/are rejected under pre-AIA 35 U.S.C. 103(a) as
`
`being unpatentable over US 4,582,811 (Pucci et al.) in view of US 2004/0091881 Al (Olek et
`
`al.), US 7,371,527 B1 (Baylin et al.), US 2002/0187476 Al (Koroulis et al.).
`
`Standard for Obviousness.
`
`16.
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459
`
`(1966), that are applied for establishing a background for determining obviousness underpre-
`
`AIA 35 U.S.C. 103(a) are summarized as follows:
`
`1. Determining the scope and contents ofthe prior art.
`
`2. Ascertaining the differences between the prior art and the claimsat issue.
`
`3. Resolving the level of ordinary skill in the pertinent art.
`
`4. Considering objective evidence present in the application indicating obviousnessor
`
`nonobviousness.
`
`17.
`
`Attention is directed to In re Jung, 98 USPQ2d 1174, 1178 (Fed. Cir. 2011) wherein is
`
`stated:
`
`There has never been a requirement for an examiner to make an on-the-record claim
`construction of every term in every rejected claim and to explain every possible
`difference between the prior art and the claimed invention in order to make out a prima
`facie rejection. This court declines to create such a burdensomeand unnecessary
`requirement. “[Section 132] does not mandate that in order to establish prima facie
`anticipation, the PTO must explicitly preempt every possible responseto a section 102
`rejection. Section 132 merely ensures that an applicantat least be informedof the broad
`statutory basis for the rejection of his claims, so that he may determine what the issues
`are on which he can or should produce evidence.” Chester, 906 F.2d at 1578 (internal
`citation omitted). As discussed above,all that is required of the office to meet its prima
`facie burden of production is to set forth the statutory basis of the rejection and the
`reference or referencesrelied upon in a sufficiently articulate and informative manneras
`
`Geneoscopy Exhibit 1019, Page 8
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`Geneoscopy Exhibit 1019, Page 8
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`Application/Control Number: 15/010,436
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`Art Unit: 1634
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`Page 8
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`to meet the notice requirement of § 132. Asthe statute itself instructs, the examiner must
`99 66
`“notify the applicant,” “stating the reasons for such rejection,”
`“together with such
`information and references as may be useful in judging the propriety of continuing
`prosecution of his application.” 35 U.S.C. § 132.
`
`18.
`
`Attention is directed to the decision in KSR InternationalCo. v. Teleflex Inc., 82 USPQ2d
`
`1385 (U.S. 2007):
`
`Whenthere is a design need or market pressure to solve a problem andthere areafinite
`numberofidentified, predictable solutions, a person of ordinary skill in the art has good
`reason to pursue the knownoptions within his or her technical grasp. If this leads to the
`anticipated success,it is likely the product not of innovation but of ordinary skill and
`commonsense.
`
`19,
`
`It is further noted thatpriorart is not limited to the four corners of the documentary prior
`
`art being applied. Prior art includes both the specialized understanding of one of ordinary skill in
`
`the art, and the common understanding of the layman. It includes “background knowledge
`
`possessed by a person having ordinary skill in the art. .
`
`. [A] court can take accountof the
`
`inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at
`
`1396.
`
`20.
`
`Suggestion, teaching or motivation does not have to be explicit and “may be found in any
`
`numberof sources, including common knowledge, the prior art as a whole or the nature of the
`
`problem itself’” Pfizer, Inc. v. Apotex, Inc. 480 F.3d 1348, 82 USPQ2d 1321 (Fed. Cir. 2007)
`
`citing Dystar Textilfarben GMBH vy. C. H. Patrick Co., 464 F.3d 1356 (Fed. Cir. 2006).
`
`Rationale.
`
`21.
`
`Pucciet al., column 2, lines 24-28, teach the use of monoclonal antibody to bind human
`
`hemoglobin that is present in fecal samples. As stated therein:
`
`Geneoscopy Exhibit 1019, Page 9
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`Geneoscopy Exhibit 1019, Page 9
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`Application/Control Number: 15/010,436
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`Art Unit: 1634
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`Page 9
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`This invention provides a diagnostic aid for use in detecting occult faecal blood
`consisting of a carrier which bindsprotein, the surface of which carrier is at least partly
`coated with monoclonal antibody which is specific for human hemoglobin.
`(Emphasis added)
`
`22.
`
`Such a showing is deemed to meeta limitation of the two independent claims- claims 82
`
`and 88.
`
`23.
`
`Pucci etal., has not been found to teach using bisulfite reagents, “primers that hybridize
`
`to methylated NDRG4 DNAafter the methylated NDRG4 DNAhasbeentreated with a chemical
`
`reagent that selectively modifies non-methylated cytosine in CpG dinucleotide motifs and
`
`converts the non-methylated cytosine to uracil to produce modified NDRG4 DNA, wherein the
`
`primers maybe utilized to amplify the modified NDRG4 DNAto produce a detectable
`
`amplicon”, nor probes capable of binding to said resultant amplicons.
`
`24.
`
`Olek et al., paragraph [0085], teaches bisulfite treatment of DNA sequences and the
`
`subsequent amplification of same wherein non-methylated cytosine bases had been changed to
`
`uracil. As stated therein:
`
`[0085] In the first step, a genomic sequenceis treated using bisulfite (hydrogen sulfite,
`disulfite) in such a mannerthat all cytosines which are not methylated at the 5-position of
`the base are modified in such a mannerthat a different base is substituted with regard to
`the base pairing behaviour, while the cytosines methylated at the 5-position remain
`unchanged. If bisulfite solution in a concentration range between 0.1 and 6M is used for
`the reaction, then an addition takes place at the non-methylated cytosine bases.
`Moreover, a denaturating reagent or solvent as well as a radical interceptor is present. A
`subsequent alkaline hydrolysis then gives rise to the conversion of non-methylated
`cytosine nucleobasesto uracil. Chemically converted DNAis then used for the detection
`of methylated cytosines. In the second methodstep, the treated DNA sampleis diluted
`with water or an aqueoussolution. Preferably, the DNA is subsequently desulfonated
`(10-30 min, 90-100.degree. C.) at an alkaline pH value. In the third step of the method,
`the DNA sample is amplified in a polymerase chain reaction, preferably using a heat-
`resistant DNA polymerase. (Emphasis added)
`
`Geneoscopy Exhibit 1019, Page 10
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`Geneoscopy Exhibit 1019, Page 10
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`Application/Control Number: 15/010,436
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`Art Unit: 1634
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`Page 10
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`25.
`
`Baylin et al., claim a methodof detecting the amount of methylation in the promoter
`
`region of genes. As seen in claims 2 and 6:
`
`2. The method of claim 1, wherein the chemical reagent comprisesbisulfite ions,
`wherein unmethylated cytosine residues in the 5' promoter region of the nucleic acid are
`converted to bisulfite modified cytosine residues, said method further comprising
`exposing the bisulfite ion treated nucleic acid to alkaline conditions, whereby bisulfite
`modified cytosine residues are converted to uracil residues, and detecting an amount or
`distribution of uracil residues in the 5' promoter region ofthe bisulfite ion treated nucleic
`acid in the sample, wherein a decrease in the amountor distribution of uracil residues in
`the 5' promoter region of nucleic acid in the sample, as compared to the amount or
`distribution of uracil residues in a corresponding bisulfite ion treated unmethylated
`nucleic acid following exposureto alkaline conditions, is indicative of methylation of
`cytosine residues in CpG dinucleotides in the 5’ promoter region of the nucleic acid,
`thereby detecting methylation silencing of the nucleic acid in the sample.
`
`6. The method of claim 2, wherein detecting the amountordistribution of uracil residues
`comprises contacting the 5’ promoter region of the nucleic acid with an amplification
`primer pair comprising a forward primer and a reverse primer under conditions suitable
`for amplification, wherein at least one primer of the primer pair comprises an
`oligonucleotide that selectively hybridizes to a nucleotide sequence of the 5' promoter
`region containing uracil residues, wherein generation of an amplification productis
`indicative of methylation of cytosine residues in CpG dinucleotides in the 5' promoter
`region of the nucleic acid, thereby detecting methylation silencing of the nucleic acid in
`the sample.
`
`26.
`
`Asseen above, not only wasit well knownin the art to use bisulfite treatment so to
`
`convert unmethylated cytosines to uracil, but the prior art teaches specifically of having primers
`
`that are not only specific to the promoter region, but one used “‘at least one primer of the primer
`
`pair comprises an oligonucleotide that selectively hybridizes to a nucleotide sequence of the 5’
`
`promoter region containing uracil residues” as well as the polymerase that can enable one to
`
`perform an amplification reaction.
`
`27.
`
`Neither Pucciet al., Olek et al., nor Baylin et al., have been found to teach primersthat
`
`would anneal to the promoter of NDRG4,or to any resulting amplicon.
`
`Geneoscopy Exhibit 1019, Page 11
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`Geneoscopy Exhibit 1019, Page 11
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`Application/Control Number: 15/010,436
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`Art Unit: 1634
`
`Page 11
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`28.
`
`Koroulis et al., at paragraph [0006], teach of arrays of oligonucleotides that compriseall
`
`possible oligonucleotides of a given length n. As stated therein:
`
`[0006] An oligonucleotide array is comprised of a numberof individual oligonucleotide
`species tethered to the surface of a solid support in a regular pattern, each species in a
`different area, so that the location of each oligonucleotide is known. An array can
`contain a chosen collection of oligonucleotides, e.g., probes specific for all known
`clinically important pathogensor specific for all knownclinically important pathogens or
`specific for all known sequence markers of genetic diseases. Such an array cansatisfy
`the needs of a diagnostic laboratory. Alternatively, an array can contain all possible
`oligonucleotides of a given length n. Hybridization of a nucleic acid with such a
`comprehensive array results in a list of all its constituent n-mers, which can be used for
`unambiguous geneidentification (e.g., in forensic studies), for determination of unknown
`gene variants and mutations (including the sequencing of related genomes once the
`sequence of one of them is known), for overlapping clones, and for checking sequences
`determined by conventional methods. (Emphasis added)
`
`29.
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`It is noted that the oligonucleotides of the array can be used as primer and/or probe. Asa
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`result of all possible sequencesare present, the array must comprise those sequences“that
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`selectively hybridizes to a nucleotide sequence of the 5' promoter region containing uracil
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`residues.” It is further noted that the claimed system andkit do not limit the numberof primers
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`that can be present. Rather, applicant’s use of the term “comprising” in both of claims 82 and 88
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`fairly opens the claims to where they can comprise even significant amounts of unrecited
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`components.
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`30.
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`In view of the above showing, it would have been obviousto one of ordinary skill in the
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`art at the time offiling to have combined monoclonal antibodies specific for human hemoglobin
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`in fecal samples, but to also include those reagents that would enable oneto assess the
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`methylation of promoters of genesof interest (bisulfite), whereby said promoter sequences could
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`be subjected to selective amplification whereby oneuses primers "that selectively hybridizes to a
`
`ul
`i
`ul
`i
`ining
`nucleotide sequence of the 5' promoter region containing
`
`uraci
`idues.
`ve,
`uracil residues.’”’ As seen above,
`
`the
`
`Geneoscopy Exhibit 1019, Page 12
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`Geneoscopy Exhibit 1019, Page 12
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`

`

`Application/Control Number: 15/010,436
`
`Art Unit: 1634
`
`Page 12
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`reagents were well known and available. To include such a variety of reagents, be it in a
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`“system” or a “kit,” would have enabled the ordinary artisan to practice a wide variety of known
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`assays.
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`31.
`
`In view of the above showing and in the absence of convincing evidence to the contrary,
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`claims 82, 86, 88, 92, and 100-105 are is/are rejected under pre-AIA 35 U.S.C. 103(a) as being
`
`unpatentable over US 4,582,811 (Pucci et al.) in view of US 2004/0091881 Al (Olek et al.), US
`
`7,371,527 B1 (Baylin et al.), US 2002/0187476 A1 (Koroulis et al.) and applicant’s admissions.
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`Conclusion
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`32.
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`The prior art made of record and notrelied upon is considered pertinent to applicant's
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`disclosure.
`
`33.
`
`EP 0032782 A2 (Partanenet al.) at page 4, bridging to page 5, teaches the specific
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`binding of human hemoglobin in fecal samples by use of antibodies that bind specifically to
`
`same. As stated therein:
`
`The method in accordancewith the present invention is mainly characterized in that
`human hemoglobinis isolated from the sample by means of an immunologicalreaction,
`Le. a reaction between an antibody and an antigen, by using an antibody specific for
`human hemoglobin and attachedto the solid phase, and that the human hemoglobin
`boundto the antibody is established hereupon. This immunological method based on
`antigen detection is sufficiently sensitive to detect even verylittle quantities of
`hemoglobin or of its decomposition products.
`
`By meansof the method in accordance with the present invention, any blood occult in
`human feces is detected immunologically. The method is based on the use of a specific
`antibody. By its means, only hemoglobin derived from a humanis detected.
`
`34.
`
`Objections and/or rejections which appearedin the prior Office action and which have
`
`not been repeated hereinabove have been withdrawn.
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`Geneoscopy Exhibit 1019, Page 13
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`Geneoscopy Exhibit 1019, Page 13
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`

`

`Application/Control Number: 15/010,436
`
`Art Unit: 1634
`
`Page 13
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`35.
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`Applicant's amendmentnecessitated the new ground(s) of rejection presented in this
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`Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
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`Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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`36.
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`A shortenedstatutory period for reply to this final action is set to expire THREE
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`MONTHSfrom the mailing date of this action. In the eventafirst reply is filed within TWO
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`MONTHSof the mailing date of this final action and the advisory action is not mailed until after
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`the end of the THREE-MONTHshortened statutory period, then the shortened statutory period
`
`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
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`CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event,
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`however, will the statutory period for reply expire later than SIX MONTHSfrom the date of this
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`final action.
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`37.
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`Anyinquiry concerning this communication or earlier communications from the
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`examiner should be directed to Bradley L. Sisson whose telephone numberis (571)272-0751.
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`The examiner can normally be reached on 6:30 a.m. to 5 p.m., Monday through Thursday.
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`38.—If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Dave T. Nguyen can be reached on (571) 272-0731. The fax phone numberfor the
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`organization where this application or proceeding is assigned is 571-273-8300.
`
`Geneoscopy Exhibit 1019, Page 14
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`Geneoscopy Exhibit 1019, Page 14
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`

`

`Application/Control Number: 15/010,436
`
`Art Unit: 1634
`
`Page 14
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`39,
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`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`maybe obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`applications is available through Private PAIR only. For more information about the PAIR
`
`system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR
`
`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
`
`like assistance from a USPTO Customer Service Representative or access to the automated
`
`information system, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`Bradley L. Sisson
`Primary Examiner
`Art Unit 1634
`
`/Bradley L. Sisson/
`
`Primary Examiner, Art Unit 1634
`
`Geneoscopy Exhibit 1019, Page 15
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`Geneoscopy Exhibit 1019, Page 15
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`