www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 2231371450
`
`14/764,601
`
`07/30/2015
`
`ANJA VAN DE STOLPE
`
`2012P01650WOUS
`
`7225
`
`11/09/2018
`759°
`24737
`PHILIPS INTELLECTUAL PROPERTY & STANDARDS
`
`465 Columbus Avenue
`Suite 340
`Valhalla NY 10595
`
`CROW” ROBERT THOMAS
`
`1634
`
`PAPERNUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`11/09/2018
`
`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):
`
`katelyn.mu]roy @ philips .Com
`marianne. fox @ philips . com
`patti. demichele @ Philips . com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Off/09 A0170” Summary
`
`Application No.
`14/764,601
`Examiner
`Robert T Crow
`
`Applicant(s)
`VAN DE STOLPE etal.
`Art Unit
`AIA Status
`1634
`No
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
`
`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).
`
`Status
`
`1). Responsive to communication(s) filed on 6 August 2018.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2a). This action is FINAL.
`
`2b) C] This action is non-final.
`
`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.
`
`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 Expa/te Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)
`Claim(s)
`
`1—5,8—9 and 11—17 is/are pending in the application.
`
`5a) Of the above claim(s) 2 and 15 is/are withdrawn from consideration.
`
`E] Claim(s) _ is/are allowed.
`
`Claim(s) 1,3—5,8—9,1 1—14 and 16—17 is/are rejected.
`
`Claim(s) 5 is/are objected to.
`
`) ) ) )
`
`6 7
`
`8
`
`
`
`are subject to restriction and/or election requirement
`E] Claim(s)
`9
`* If any claims have been determined aflowable. 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
`
`httpfiwww.usptogovlpatentslinit_events[pph[index.'§p or send an inquiry to PPeredback@usptg.ggv.
`
`Application Papers
`
`10)D The specification is objected to by the Examiner.
`
`is/are: a)C] accepted or b)l:] objected to by the Examiner.
`11):] The drawing(s) filed on
`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:
`
`a)D All
`
`1C]
`
`21:]
`
`b)U Some**
`
`c)U None of the:
`
`Certified copies of the priority documents have been received.
`
`Certified copies of the priority documents have been received in Application No.
`
`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)).
`
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) C] Notice of References Cited (PTO-892)
`
`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-
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20181106
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 2
`
`FINAL ACTION
`
`Notice of Pre-AIA or AIA Status
`
`1.
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`Status of the Claims
`
`2.
`
`This action is in response to papers filed 6 August 2018 in which claim 5 was
`
`amended, no claims were canceled, and new claims 16-17 were added. All of the
`
`amendments have been thoroughly reviewed and entered.
`
`The previous objections to the claims not reiterated below are withdrawn in view
`
`of the amendments.
`
`The previous rejections under 35 U.S.C. 112, (a)/pre-A|A first paragraph, and 35
`
`U.S.C. 103(a) are maintained and are reiterated below.
`
`Applicant’s arguments have been thoroughly reviewed and are addressed
`
`following the rejections necessitated by the amendments.
`
`Claims 1, 3-5, 8-9, 11-14, and 16-17 are under prosecution.
`
`3.
`
`This Office Action includes new objections and rejections necessitated by the
`
`amendments.
`
`Claim Objections
`
`4.
`
`Claim 5 is objected to because of the following informalities: claim 5 contains the
`
`recitation “oligonucleotides solution,” which appears to be a typographical error.
`
`Appropriate correction is required.
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 3
`
`Claim Rejections - 35 USC § 1 12
`
`The following is a quotation of the first paragraph of 35 U.S.C. 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 orjoint inventor of carrying out the invention.
`
`The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
`
`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 of carrying out his invention.
`
`6.
`
`Claims 1, 3-5, 8-9, 11-14, and 16-17 are rejected under 35 U.S.C. 112(a) or
`
`35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description
`
`requirement. The claim(s) contains subject matter which was not described in the
`
`specification in such a way as to reasonably convey to one skilled in the relevant art that
`
`the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application
`
`was filed, had possession of the claimed invention.
`
`This is a written description rejection maintained from the previous Office Action
`
`and applied to new claims 16-17.
`
`Claim 1 (upon which claims 3-5, 8-9, 11-14, and 16-17 depend) requires a
`
`processing circuit that is “configured and arranged for selective application..., and
`
`selectively increasing attractive electric potential...to further bind and flatted the
`
`attached nanoball...
`
`Claim 8 requires the processing circuit to be “configured to address
`
`electrodes...to specifically attract a plurality of nanoballs...
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 4
`
`Claim 11 requires the circuit to be “configured for measuring the capacitance of
`
`each electrode.”
`
`The methodology for determining adequacy of Written Description to convey that
`
`applicant was in possession of the claimed invention includes determining whether the
`
`application describes an actual reduction to practice, determining whether the invention
`
`is complete as evidenced by drawings or determining whether the invention has been
`
`set forth in terms of distinguishing identifying characteristics as evidenced by other
`
`descriptions of the invention that are sufficiently detailed to show that applicant was in
`
`possession of the claimed invention (Guidelines for Examination of Patent Applications
`
`under 35 U.S.C. § 112, p 1 “Written Description”Requirement; Federal Register/ Vol 66.
`
`No. 4, Friday, January 5, 2001; ll Methodology for Determining Adequacy of Written
`
`Description (3.)). The factors to be considered include disclosure of complete or partial
`
`structure, physical and/or chemical properties, functional characteristics,
`
`structure/function correlation, methods of making the claimed product, or any
`
`combination thereof.
`
`Limitations Present In the Claim
`
`In the instant case, the only factor present in the claim is a recitation of function;
`
`there is no identification of any structure, let alone any particular portion of the structure,
`
`that must be conserved or required to result in the claimed configurations. Accordingly,
`
`in the absence of sufficient recitation of the distinguishing identifying characteristics, the
`
`specification does not provide adequate written description of the claimed genus.
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Reduction to Practice
`
`Page 5
`
`The specification does not describe an actual reduction to practice of the claimed
`
`invention. A review of the specification provides no examples of any configurations that
`
`result in either reaction mixtures or probes having the claimed functions.
`
`Completion by Drawings
`
`The specification does not teach that the invention is complete as evidenced by
`
`drawings. A review of the Figures does not provide any structural characteristics that
`
`would indicate how any of the claimed limitations are “configured to” perform their
`
`claimed functions.
`
`Description of Identifying Characteristics
`
`The specification has not been set forth in terms of distinguishing identifying
`
`characteristics as evidenced by other descriptions of the invention. As noted above, a
`
`review of the specification does not provide any structural characteristics that would
`
`indicate how any of the claimed limitations are “configured to” perform their claimed
`
`functions.
`
`Conclusion
`
`Vas-Cath Inc. v. Mahurkar, 19USPQD2d 1111, clearly states that “applicant must
`
`convey with reasonable clarity to the skilled in the art that, as of the filing date sought,
`
`he or she was in possession of the invention. The invention is, for purposes of the
`
`'written description' inquiry, whatever is now claimed." (See page 1117). The
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 6
`
`specification does not "clearly allow persons of ordinary skill in the art to recognize that
`
`[he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed
`
`above, the skilled artisan cannot envision the detailed chemical structure of the
`
`encompassed genus of miRNA, and therefore conception is not achieved until the
`
`reduction to practice has occurred, regardless of the complexity or simplicity of the
`
`method of isolation. Adequate written description requires more than a mere statement
`
`that it is part of the invention and reference to a potential method of isolating it. The
`
`compound itself is required. See Fiers v. Revel, 25 USPQZd 1601 at 1606 (CAFC
`
`1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQZd 1016.
`
`One cannot describe what one has not conceived. See Fiddes v. Baird, 30
`
`USPQZd 1481 at 1483.
`
`In Fiddes, claims directed to mammalian FGFs were found to
`
`be unpatentable due to lack of written description for that broad class. The specification
`
`provided only the bovine sequence.
`
`Therefore, the full breadth of the claims does not meet the written description
`
`provision of 35 U.S.C. 112, first paragraph. Applicant is reminded that Vas-Cath makes
`
`clear that the written description provision of 35 U.S.C. 112 is severable from its
`
`enablement provision (see page 1115).
`
`7.
`
`The following is a quotation of 35 U.S.C. 112(b):
`
`(b) CONCLUSION—The specification shall conclude with one or more claims particularly
`pointing out and distinctly claiming the subject matter which the inventor or a joint inventor
`regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph:
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 7
`
`8.
`
`Claims 16-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA),
`
`second paragraph, as being indefinite for failing to particularly point out and distinctly
`
`claim the subject matter which the inventor or a joint inventor, or for pre-AIA the
`
`applicant regards as the invention.
`
`A.
`
`Claim 16 is indefinite in the recitation “each nanoball,” which lacks
`
`antecedent basis because claim 1 only recites “a” nanoball.
`
`B.
`
`Claim 17 is indefinite in the recitation “the nanoballs,” which lacks
`
`antecedent basis because claim 1 only recites “a” nanoball.
`
`Claim Rejections - 35 USC § 103
`
`9.
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
`
`for all obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described
`as set forth in section 102, if the differences between the subject matter sought to be patented
`and the prior art are such that the subject matter as a whole would have been obvious at the
`time the invention was made to a person having ordinary skill in the art to which said subject
`matter pertains. Patentability shall not be negatived by the manner in which the invention was
`made.
`
`10.
`
`This application currently names joint inventors. In considering patentability of the
`
`claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter
`
`of the various claims was commonly owned at the time any inventions covered therein
`
`were made absent any evidence to the contrary. Applicant is advised of the obligation
`
`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
`
`not commonly owned at the time a later invention was made in order for the examiner to
`
`consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C.
`
`102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 8
`
`11.
`
`Claims 1, 3, 8-9, 11-13, and 16-17 are rejected under pre-AlA 35 U.S.C. 103(a)
`
`as obvious over Schoeniger et al (U.S. Patent Application Publication No. US
`
`2003/0211637 A1, published 13 November 2003) and Sosnowski et al (U.S. Patent
`
`Application Publication No. US 2003/0190632 A1, published 9 October 2003),
`
`alternatively further in view of Voldman et al (U.S. Patent Application Publication No. US
`
`2011/0045994 A1, published 24 February 2011).
`
`Regarding claim 1, Schoeniger et al teach an array apparatus (i.e., device;
`
`Abstract) comprising an electrode in an array (paragraph 0008), an electrode having a
`
`single nanoball, in the form of a particle immobilized thereon via affinity binding ligands
`
`(paragraph 0061 and Figure 1). Schoeniger et al also teach the particle has a
`
`secondary ligand bound thereto (paragraph 0062), and that ligands are nucleic acids
`
`(i.e., oligonucleotides; paragraph 0061). Schoeniger et al further teach the array is
`
`connected to a capacitance circuit for selectively applying electric potential to the array
`
`(paragraph 0053), wherein the electrodes in the array are individually addressable
`
`(paragraph 0035). Schoeniger et al further teach the apparatus has the added
`
`advantage of allowing single particle detection sensitivity (Abstract). Thus, Schoeniger
`
`et al teach the techniques discussed above.
`
`Schoeniger et al do not teach repeated DNA sequences.
`
`However, Sosnowski et al teach an apparatus comprising an array of electrodes
`
`(i.e., microlocations; Abstract and paragraph 0043) which utilized nanoballs (i.e.,
`
`nanoparticles; paragraph 0210). Sosnowski et al further teach the use of single
`
`stranded DNA fragments (paragraph 0086) as well as tandem repeats (paragraph
`
`0088). The apparatus further comprises microlocation (i.e., electrodes) wherein
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 9
`
`selective application of electrical potentials is used to attract individual species to one
`
`microlocation and repel the species from other locations (e.g., paragraph 0054 and
`
`Figures 8a-d). Sosnowski et al teach also teach a processing circuit (i.e., circuitry) that
`
`allows for addressing each electrode (i.e., microlocation; paragraph 0166) and that the
`
`apparatus has a computer control/data collection system (paragraphs 0458-0463), as
`
`well as attracting species to the electrodes, wherein the species comprise different
`
`sequences (e.g., Figures 8a-d). Thus, the claimed processing circuit is interpreted as
`
`being the combined circuitry and computer control/data collection system of Sosnowski
`
`et al. Sosnowski et al further teach the apparatus has the added advantage of allowing
`
`control of multistep and multiplex reactions (Abstract) as well as allowing rapid
`
`discrimination of the short tandem repeats (paragraphs 0088 and 0202). Thus,
`
`Sosnowski et al teach the known techniques discussed above.
`
`It would therefore have been obvious to a person of ordinary skill in the art to
`
`have combined the teachings of Schoeniger et al and Sosnowski et al to arrive at the
`
`instantly claimed apparatus with a reasonable expectation of success. The ordinary
`
`artisan would have been motivated to make the modification because said modification
`
`would have resulted in an apparatus having the added advantage of allowing single
`
`particle detection sensitivity as explicitly taught by Schoeniger et al (Abstract) as well as
`
`the added advantage of allowing control of multistep and multiplex reactions and rapid
`
`discrimination of the short tandem repeats as explicitly taught by Sosnowski et al
`
`(Abstract and paragraphs 0088 and 0202).
`
`In addition, it would have been obvious to
`
`the ordinary artisan that the known techniques of Schoeniger et al and Sosnowski et al
`
`could have been combined with predictable results because the known techniques of
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 10
`
`Schoeniger et al and Sosnowski et al predictably result in reliable structures for
`
`transporting and assaying entities at electrodes in an array.
`
`It is noted that the courts have held that “while features of an apparatus may be
`
`recited either structurally or functionally, claims directed to an apparatus must be
`
`distinguished from the prior art in terms of structure rather than function.”
`
`In re
`
`Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997).
`
`In
`
`addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-
`
`Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528
`
`(Fed. Cir. 1990) (emphasis in original). Therefore, the various w recited in the claim
`
`(e.g., attracting or repelling nanoballs, and selectively increasing attractive potential to
`
`flatted an attached nanoball) fail to define additional structural elements of the claimed
`
`device. Because the prior art teaches the structural elements of the claim, the claim is
`
`obvious. See MPEP § 2114.
`
`Alternatively, with respect to the flattening of nanoballs, Voldman et al teach the
`
`use of electrical current to deform microparticles. Thus, Voldman et al teach the known
`
`technique of deforming (i.e., flattening) microparticles.
`
`It would therefore have been obvious to a person of ordinary skill in the art to
`
`have combined the teachings of Schoeniger et al and Sosnowski et al with the
`
`teachings of Voldman et al to arrive at the instantly claimed apparatus with a reasonable
`
`expectation of success.
`
`It would have been obvious to the ordinary artisan that the
`
`known techniques of Schoeniger et al and Sosnowski et al could have been combined
`
`with predictable results because the known techniques of Schoeniger et al and
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 11
`
`Sosnowski et al predictably result in reliable particles for capture on an array (Title and
`
`Abstract).
`
`Regarding claim 3, the sensor of claim 1
`
`is discussed above.
`
`It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594)
`
`discuss the support of rejections wherein the prior art discloses subject matter which
`
`there is reason to believe includes functions that are newly cited or is identical to a
`
`product instantly claimed.
`
`In such a situation the burden is shifted to the applicants to
`
`“prove that subject matter shown to be in the prior art does not possess the
`
`characteristic relied on” (205 USPQ 594, second column, first full paragraph).
`
`In the instant case, Schoeniger et al teach the diameter of the element (i.e.,
`
`electrode) matches the nanoball diameter (paragraph 0046 and Figure 2), and that the
`
`electrodes are nanoscale (paragraph 0032). Thus, Schoeniger et al are believed to
`
`meet the claimed limitations.
`
`Alternatively, the courts have found that “where the general conditions of a claim
`
`are disclosed in the prior art, it is not inventive to discover the optimum or workable
`
`ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235
`
`(CCPA 1955). See MPEP 2144.05 II.
`
`The courts have also stated where the claimed ranges “overlap or lie inside the
`
`ranges disclosed by the prior art” and even when the claimed ranges and prior art
`
`ranges do not overlap but are close enough that one skilled in the art would have
`
`expected them to have similar properties, a prima facie case of obviousness exists (see
`
`In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 12
`
`1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner,
`
`778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
`
`Therefore, the claimed ranges of the diameters merely represent routine
`
`optimization and/or an obvious variant of the dimension of the prior art.
`
`Applicant is advised that MPEP 716.01 (0) makes clear that “[t]he arguments of
`
`counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600,
`
`602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon
`
`counsel’s arguments instead of evidence in the record.
`
`It is noted that the Response above should not be construed as an invitation to
`
`file an after final declaration. See MPEP 715.09 [R-3].
`
`Regarding claim 8, the apparatus of claim 1
`
`is discussed above.
`
`In an alternative
`
`embodiment to that described in claim 1, Sosnowski et al teach the processing circuit
`
`(i.e., the circuitry) allows for addressing each electrode (i.e., microlocation; paragraph
`
`0166) and that the apparatus has a computer control/data collection system
`
`(paragraphs 0458-0463), as well as attracting species to the electrodes, wherein the
`
`species comprise different sequences (e.g., Figures 8a-d). Thus, the claimed
`
`processing circuit is interpreted as being the combined circuitry and computer
`
`control/data collection system of Sosnowski et al.
`
`It is also reiterated that the courts have held that apparatus claims cover what a
`
`device is, not what a device does. Therefore, the various & recited in the claim (e.g.,
`
`attracting different nanoballs to different locations using a supernatant solution) fail to
`
`define additional structural elements of the claimed apparatus because the different
`
`nanoballs and the supernatant are not actually part of the claimed device. Because the
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 13
`
`prior art teaches the structural elements of the claim, the claim is obvious over the cited
`
`prior art.
`
`Applicant is again cautioned to avoid merely relying upon counsel’s arguments in
`
`place of evidence in the record, and that the Response above should not be construed
`
`as an invitation to file an after final declaration.
`
`Regarding claim 9, the apparatus of claim 1
`
`is discussed above.
`
`With respect to the rolling circle amplification, the courts have stated:
`
`“even though product-by-process claims are limited by and defined by the process, determination
`of patentability is based on the product itself. The patentability of a product does not depend on
`its method of production. If the product in the product-by-process claim is the same as or obvious
`from a product of the prior art, the claim is unpatentable even though the prior product was made
`by a different process.”
`In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
`See MPEP§ 2113.
`
`While the cited art does not specifically teach rolling circle, these limitations are
`
`part of the process of Mg the DNA rather than structural limitations of the DNA.
`
`Because the prior art teaches the structural elements of the claim, the claim is obvious.
`
`Applicant is again cautioned to avoid merely relying upon counsel’s arguments in
`
`place of evidence in the record, and that the Response above should not be construed
`
`as an invitation to file an after final declaration.
`
`Regarding claim 11, the apparatus of claim 1
`
`is discussed above. Schoeniger et
`
`al further teach the processing (i.e., readout circuit) measures the capacitance of each
`
`electrode (paragraph 0035).
`
`Regarding claims 12-13, the apparatus of claim 1
`
`is discussed above.
`
`It is reiterated that the courts have held that apparatus claims cover what a
`
`device is, not what a device does. Therefore, the various & recited in the claim (e.g.,
`
`detection of binding and additions of oligonucleotides) fail to define additional structural
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 14
`
`elements of the claimed apparatus. Because the prior art teaches the structural
`
`elements of the claim is obvious in view of the cited prior art.
`
`Applicant is again cautioned to avoid merely relying upon counsel’s arguments in
`
`place of evidence in the record, and that the Response above should not be construed
`
`as an invitation to file an after final declaration.
`
`Regarding claim 16, the apparatus of claim 1
`
`is discussed above. Schoeniger et
`
`al teach each electrode in the array has surface attached affinity components which
`
`selectively capture particles (paragraph 0002), wherein each electrode location has
`
`different affinity ligands (paragraph 0034).
`
`In addition, Sosnowski et al teach each microlocation on an array has different
`
`molecules at each location (paragraph 0040).
`
`Thus, it would be obvious the have each electrode have a different nanoball.
`
`Regarding claim 17, the apparatus of claim 1
`
`is discussed above. Schoeniger et
`
`al teach each electrode in the array has surface attached affinity components which
`
`selectively capture particles (paragraph 0002), wherein each electrode location has
`
`different affinity ligands (paragraph 0034).
`
`In addition, Sosnowski et al teach each microlocation on an array has different
`
`nucleic acid sequences at each location (paragraph 0040).
`
`Thus, it would be obvious the have each electrode have a different nanoball with
`
`a different sequence thereon.
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 15
`
`12.
`
`Claims 4-5 and 14 are rejected under pre-AlA 35 U.S.C. 103(a) as obvious over
`
`Schoeniger et al (U.S. Patent Application Publication No. US 2003/0211637 A1,
`
`published 13 November 2003) and Sosnowski et al (U.S. Patent Application Publication
`
`No. US 2003/0190632 A1, published 9 October 2003), alternatively further in view of
`
`Voldman et al (U.S. Patent Application Publication No. US 2011/0045994 A1, published
`
`24 February 2011) as applied to claim 1 above, and further in view of Davey et al (U.S.
`
`Patent Application Publication No. US 2012/0109598 A1, published 3 May 2012).
`
`Regarding claims 4-5 and 14, the apparatus of claim 1
`
`is discussed above in
`
`Section 11.
`
`While Sosnowski et al teach the array (i.e., APEX chip) is in a device having an
`
`inlet (in the form of a port; Figure 18), neither Schoeniger et al, Voldman et al, nor
`
`Sosnowski et al explicitly teach the array is in a container.
`
`However, Davey et al teach apparatus comprising a chamber having an array of
`
`therein, which further comprises an inlet which is connected to at least four different
`
`reservoirs (i.e., claim 4) and further comprise means for sequentially exposing the array
`
`to different solutions, in the form of a valve block (i.e., claims 14; Figure 7). Davey et al
`
`also teach the sequential flow of each mononucleotide T, A, G, and C (Le, the dATP
`
`dCTP, dGTP, and dTTP of claims 5 and 14; paragraph 0080); thus because each
`
`reservoir contains a different nucleotide reagents (paragraph 0021 ), it would have been
`
`obvious that each mononucleotide is in a different reservoir. Davey et al also teach the
`
`apparatus has the added advantage of allowing accurate sequencing by synthesis
`
`(Abstract). Thus, Davey et al teach the known techniques discussed above.
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 16
`
`It is also reiterated that the courts have held that apparatus claims cover what a
`
`device is, not what a device does. Therefore, the various & recited in the claim (e.g.,
`
`an inlet to which reservoirs can be coupled, or the different solutions of claim 14, which
`
`are not actually required by the apparatus) fail to define additional structural elements of
`
`the claimed apparatus. Because the prior art teaches the structural elements of the
`
`claim, the claim is obvious over the cited prior art.
`
`It would therefore have been obvious to a person of ordinary skill in the art to
`
`have modified the apparatus taught by Schoeniger et al and Sosnowski et al
`
`alternatively in view of Voldman et al with the teachings of Davey et al to arrive at the
`
`instantly claimed apparatus with a reasonable expectation of success. The ordinary
`
`artisan would have been motivated to make the modification because said modification
`
`would have resulted in an apparatus having the added advantage of allowing accurate
`
`sequencing by synthesis as explicitly taught by Davey et al (Abstract).
`
`In addition, it
`
`would have been obvious to the ordinary artisan that the known techniques of Davey et
`
`al could have been applied to the apparatus of Schoeniger et al and Sosnowski et al
`
`alternatively in view of Voldman et al with predictable results because the known
`
`techniques of Davey et al predictably result in a reliable setup for passing fluids over the
`
`electrode array.
`
`

`

`Application/Control Number: 14/764,601
`Art Unit: 1634
`
`Page 17
`
`13.
`
`Claim 9 is rejected under pre-AlA 35 U.S.C. 103(a) as obvious over Schoeniger
`
`et al (U.S. Patent Application Publication No. US 2003/0211637 A1, published 13
`
`November 2003) and Sosnowski et al (U.S. Patent Application Publication No. US
`
`2003/0190632 A1, published 9 October 2003), alternatively further in view of Voldman
`
`et al (U.S. Patent Application Publication No. US 2011/0045994 A1, published 24
`
`February 2011) as applied to claim 1 above, and further in view of Nelson et al (U.S.
`
`Patent Application Publication No. US 2010/0055744 A1, published 4 March 2010).
`
`It is noted that while claim 9 has been rejected as described above, the claim is
`
`also obvious using the interpretation outlined below.
`
`Regarding claim 9, the apparatus of claim 1
`
`is discussed above in Section 11.
`
`Neither Schoeniger et al, Voldman et al nor Sosnowski et al explicitly teach
`
`tandem repeats are created using rolling circle amplification.
`
`However, Nelson et al teach the synthesis of tandem repeats using rolling circle
`
`amplification, which has the added advantage of providing high quality nucleic acids
`
`with less effort and expense (paragraph 0004). Thus, Nelson et al teach the known
`
`techniques discussed above.
`
`It would therefore have been obvious to a person of ordinary skill in the art to
`
`have modified the teachings of Schoeniger et al and Sosnowski et al alternatively in
`
`view of Voldman et al so that the tandem repeats are produces by rolling circle
`
`amplification as taught by Nelson et al to arrive at the instan