UNITED STA (cid:9)I ES PA (cid:9)I ENT AND TRADEMARK OFFICE
`
`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
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`7590 (cid:9)
`
`126625 (cid:9)
`Dechert LLP
`P.O. Box 390460
`Mountain View, CA 94039-0460
`
`09/23/2014
`
`EXAMINER
`
`SKELDING, ZACHARY S
`
`ART UNIT
`
`PAPER NUMBER
`
`1644
`
`DATE MAILED: 09/23/2014
`
`APPLICATION NO. (cid:9)
`
`14/256,886 (cid:9)
`
`FILING DATE
`
`04/18/2014 (cid:9)
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO. (cid:9)
`
`CONFIRMATION NO.
`
`Steven A. FISCHKOFF
`
`381493-093C4 (130717)
`
`3521
`
`TITLE OF INVENTION: METHODS OF ADMINISTERING ANTI-TNFALPHA ANTIBODIES
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE (cid:9)
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`I PUBLICATION FEE DUE PREY. PAID ISSUE FEE TOTAL FEE(S) DUE
`$0 (cid:9)
`
`$0
`
`$960
`
`DATE DUE
`
`12/23/2014
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON THE MERITS IS CLOSED. THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`THIS APPLICATION IS SUBJECT TO WITHDRAWAL FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
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`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
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`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION. IF AN ISSUE FEE HAS
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`DUE.
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`HOW TO REPLY TO THIS NOTICE:
`
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`
`II. PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office
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`III. All communications regarding this application must give the application number. Please direct all communications prior to issuance to
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`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenance fees. It is patentee's responsibility to ensure timely payment of maintenance fees when due.
`
`PTOL-85 (Rev. 02/11)
`
`Page 1 of 3
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`Ex. 1010 - Page 1
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`

`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`or Fax (571)-273-2885
`
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1 through 5 should be completed where
`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`indicated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS" for
`maintenance fee notifications.
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change of address)
`
`7590
`
`126625 (cid:9)
`Dechert LLP
`P.O. Box 390460
`Mountain View, CA 94039-0460
`
`09/23/2014
`
`Note: A certificate of mailing can only be used for domestic mailings of the
`Fee(s) Transmittal. This certificate cannot be used for any other accompanying
`papers. Each additional paper, such as an assignment or formal drawing, must
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`
`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
`States Postal Service with sufficient postage for first class mail in an envelope
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (571) 273-2885, on the date indicated below.
`
`(Depositor's name)
`
`(Signature)
`
`(Date)
`
`APPLICATION NO. (cid:9)
`
`14/256,886 (cid:9)
`
`FILING DATE
`
`04/18/2014 (cid:9)
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO. (cid:9)
`
`CONFIRMATION NO.
`
`Steven A. FISCHKOFF
`
`381493-093C4 (130717)
`
`3521
`
`TITLE OF INVENTION: METHODS OF ADMINISTERING ANTI-TNFALPHA ANTIBODIES
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE (cid:9)
`
`I PUBLICATION FEE DUE PREY. PAID ISSUE FEE TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
`
`$0
`
`$960
`
`12/23/2014
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`SKELDING, ZACHARY S
`
`1644
`
`424-145100
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`q Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/122) attached.
`q "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Number is required.
`
`2. For printing on the patent front page, list
`(1) The names of up to 3 registered patent attorneys
`or agents OR, alternatively,
`(2) The name of a single firm (having as a member a
`registered attorney or agent) and the names of up to
`2 registered patent attorneys or agents. If no name is
`listed, no name will be printed.
`
`1 (cid:9)
`
`2 (cid:9)
`
`3 (cid:9)
`
`
`
`
`
`
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent. If an assignee is identified below, the document has been filed for
`recordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
`(A) NAME OF ASSIGNEE (cid:9)
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) :
`
`q Individual
`
`q Corporation or other private group entity
`
`q Government
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`4a. The following fee(s) are submitted:
`q Issue Fee
`q Publication Fee (No small entity discount permitted)
`q Advance Order - # of Copies (cid:9)
`
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`
`5. Change in Entity Status (from status indicated above)
`q Applicant certifying micro entity status. See 37 CFR 1.29
`
`q Applicant asserting small entity status. See 37 CFR 1.27
`
`q Applicant changing to regular undiscounted fee status.
`
`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`q A check is enclosed.
`q Payment by credit card. Form PTO-2038 is attached.
`q The Director is hereby authorized to charge the required fee(s), any deficiency, or credits any
`overpayment, to Deposit Account Number (cid:9)
`(enclose an extra copy of this form).
`
`NOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/15A and 15B), issue
`fee payment in the micro entity amount will not be accepted at the risk of application abandonment.
`NOTE: If the application was previously under micro entity status, checking this box will be taken
`to be a notification of loss of entitlement to micro entity status.
`NOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro
`entity status, as applicable.
`
`NOTE: This form must be signed in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 1.4 for signature requirements and certifications.
`
`Authorized Signature
`
`Typed or printed name
`
`Date (cid:9)
`
`Registration No. (cid:9)
`
`
`
`
`
`PTOL-85 Part B (10-13) Approved for use through 10/31/2013. (cid:9)
`
`OMB 0651-0033 (cid:9)
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`Page 2 of 3
`
`Ex. 1010 - Page 2
`
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`(cid:9)
`(cid:9)
`

`

`UNITED STA (cid:9)IES PA (cid:9)PENT AND TRADEMARK OFFICE
`
`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. (cid:9)
`
`14/256,886
`
`FILING DATE
`
`04/18/2014
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO. (cid:9)
`
`CONFIRMATION NO.
`
`Steven A. FISCHKOFF
`
`381493-093C4 (130717)
`
`3521
`
`7590
`
`126625 (cid:9)
`Dechert LLP
`P.O. Box 390460
`Mountain View, CA 94039-0460
`
`09/23/2014
`
`EXAMINER
`
`SKELDING, ZACHARY S
`
`ART UNIT
`
`PAPER NUMBER
`
`1644
`
`DATE MAILED: 09/23/2014
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(Applications filed on or after May 29, 2000)
`
`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
`
`Section 1(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i) to eliminate the
`requirement that the Office provide a patent term adjustment determination with the notice of allowance. See
`Revisions to Patent Term Adjustment, 78 Fed. Reg. 19416, 19417 (Apr. 1, 2013). Therefore, the Office is no longer
`providing an initial patent term adjustment determination with the notice of allowance. The Office will continue to
`provide a patent term adjustment determination with the Issue Notification Letter that is mailed to applicant
`approximately three weeks prior to the issue date of the patent, and will include the patent term adjustment on the
`patent. Any request for reconsideration of the patent term adjustment determination (or reinstatement of patent term
`adjustment) should follow the process outlined in 37 CFR 1.705.
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee payments should be
`directed to the Customer Service Center of the Office of Patent Publication at 1-(888)-786-0101 or (571)-272-4200.
`
`PTOL-85 (Rev. 02/11)
`
`Page 3 of 3
`
`Ex. 1010 - Page 3
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`

`

`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
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`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and
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`Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.0 552a). Records from this system of records
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`2. A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence
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`6. A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes
`of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C.
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`Services, or his/her designee, during an inspection of records conducted by GSA as part of that agency's
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`8. A record from this system of records may be disclosed, as a routine use, to the public after either publication
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`9. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`enforcement agency, if the USPTO becomes aware of a violation or potential violation of law or regulation.
`
`Ex. 1010 - Page 4
`
`

`

`Notice of Allowability
`
`Application No.
`14/256,886
`Examiner
`ZACHARY SKELDING
`
`Applicant(s)
`FISCHKOFF ET AL.
`Art Unit
`AIA (First Inventor to
`File) Status
`1644
`No
`
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application. If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and M PEP 1308.
`
`1. [E] This communication is responsive to 9-10-14.
`q A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on (cid:9)
`
`
`
`2. 0 An election was made by the applicant in response to a restriction requirement set forth during the interview on (cid:9)
`requirement and election have been incorporated into this action.
`
`• the restriction
`
`3. [E] The allowed claim(s) is/are 1-6. As a result of the allowed claim(s), 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
`hitp://www.uspto.gov/patentslinit events/mhlindex.jsp or send an inquiry to PPHfeedbackusotaaav
`
`4. 0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a) 0 All (cid:9)
`b) 0 Some *c) 0 None of the:
`1. 0 Certified copies of the priority documents have been received.
`
`2. 0 Certified copies of the priority documents have been received in Application No. (cid:9)
`3. 0 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)).
`* Certified copies not received: (cid:9)
`
`
`Applicant has THREE MONTHS FROM THE "MAILING DATE" of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5. 0 CORRECTED DRAWINGS ( as "replacement sheets") must be submitted.
`
`0 including changes required by the attached Examiner's Amendment / Comment or in the Office action of
`Paper No./Mail Date (cid:9)
`.
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the front (not the back) of
`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).
`
`6. 0 DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. [ZI Notice of References Cited (PTO-892)
`2. [ZI Information Disclosure Statements (PTO/SB/08), (cid:9)
`Paper No./Mail Date
`3. 0 Examiners Comment Regarding Requirement for Deposit (cid:9)
`of Biological Material
`4. 0 Interview Summary (PTO-413),
`Paper No./Mail Date (cid:9)
`.
`
`/ZACHARY SKELDING/
`Primary Examiner, Art Unit 1644
`
`5. [E] Examiner's Amendment/Comment
`6. E] Examiner's Statement of Reasons for Allowance
`
`7. 0 Other (cid:9)
`
`
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability (cid:9)
`
`Part of Paper No./Mail Date 20140919
`
`Ex. 1010 - Page 5
`
`(cid:9)
`

`

`Application/Control Number: 14/256,886 (cid:9)
`Art Unit: 1644
`
`Page 2
`
`The present application is being examined under the pre-AIA first to invent provisions.
`
`Examiner's Comment
`
`1. MPEP § 609.05(a) states that if an item of information in an IDS fails to comply with all the
`requirements of 37 CFR 1.97 and 37 CFR 1.98, that item of information in the IDS will not
`be considered and a line should be drawn through the citation to show that it has not been
`considered.
`
`In the instant case, a number of the non-patent documents cited in the IDS filed 4-18-14 do
`not indicate the relevant pages as required by 37 C.F.R. § 1.98(b) and therefore they have not
`been considered.
`
`This is of particular importance because when a large number of non-patent references
`submitted to the image file wrapper knowing the number of pages is essential because it is
`the only identifier that can begin the process of linking a citation to a given document in the
`IFW.
`
`Moreover, given that the claimed invention stands allowed should the printer require page
`numbers for these citations consistent with 37 CFR 1.98(b), each cited reference without
`page numbers will need to be tracked down in 10/163,657 and each non-compliant citation
`will need to be made compliant.
`
`REASONS FOR ALLOWANCE
`
`2. The following is an examiner's statement of reasons for allowance: the instant claims are
`drawn to methods of treating Crohn's disease in a human subject comprising subcutaneously
`administering a human anti-TNFa antibody having six sequence defined CDRs (3 Vh CDRs
`and 3 V1 CDRs) at a total body dose of 40 mg once every 13-15 days for a time period
`sufficient to treat Crohn's disease.
`
`The human anti-TNFa adalimumab was known in the prior art to be encompassed by the
`genus of anti-TNFa antibodies recited in the instant claims. While it would have been
`obvious to treat Crohn's disease by subcutaneously administering adalimumab based on the
`knowledge in the prior art (see, e.g., Salfeld et al., U.S. Patent No. 6,090,382, cited on an
`IDS; David Chantry, Current Opinion in Anti-Inflammatory and Immunomodulatory
`Investigational Drugs (2000), 2(1), 31-34, cited herewith; and the FDA product insert for
`Infliximab as well as the other Infliximab specific references referred to below), the question
`one must consider is: would it have been obvious to one of ordinary skill in the art to have
`treated Crohn's disease by subcutaneously administering adalimumab according to the
`claimed dosage regimen?
`
`In contemplating the specific dosage regimen that should be used to treat a patient having
`Crohn's disease with the claimed anti-TNFa antibody one of ordinary skill in the art would
`
`Ex. 1010 - Page 6
`
`

`

`Application/Control Number: 14/256,886 (cid:9)
`Art Unit: 1644
`
`Page 3
`
`have to consider a number of factors including the biophysical properties of the anti-TNFa
`antibody to be administered; the route of administration, e.g., intravenous vs. subcutaneous;
`the dosage form, e.g., dosing as a function of patient body weight vs. dosing with a
`predetermined quantity of active compound in the form of physically discrete units; and the
`frequency of dosage, e.g., weekly vs. biweekly.
`
`Moreover, one of ordinary skill in the art would have looked to experiences treating Crohn's
`disease with anti-TNFa antibodies in general. In this regard, prior to applicant's date of
`invention one of ordinary skill in the art would have known that the only other anti-TNFa
`antibody known to be effective for the treatment of human patients having Crohn's disease
`was the chimeric anti-TNFa antibody infliximab.
`
`The FDA approved dosage regimens for the treatment of Crohn's disease and rheumatoid
`arthritis with infliximab were 5 mg/kg at weeks 0, 2 and 6 or 3 mg/kg at weeks 0, 2 and 6 and
`every 8 weeks thereafter, respectively (see the Infliximab Product Label, ©Centocor, Inc.,
`December 1, 2000, pages 14-31, in particular page 29, 1st and 2nd paragraphs, cited on an
`IDS). Prior art publications describing the clinical use of infliximab in Crohn's disease
`patients pre-FDA approval support the notion that, while one of ordinary skill in the art may
`have suspected administering less infliximab than the FDA approved dose could be useful for
`the treatment of Crohn's disease (see, e.g., Targan et al., N Engl J Med. 1997 Oct
`9;337(15):1029-35, at page 1034, col. bridging paragraph; P.J. Rutgeerts, Aliment Pharmacol
`Ther 1999; 13 (Suppl 4), 9-15, at page 11, col bridging paragraph — page 13, 1st paragraph,
`both cited herewith), it would not have been clear to the ordinarily skilled artisan precisely
`how much less than the FDA approved dose of infliximab could be administered to
`effectively treat Crohn's disease.
`
`Thus, one of ordinary skill in the art at the time of applicant's invention would have thought
`that the treatment of Crohn's disease with adalimumab will likely require administering more
`adalimumab, and potentially as much as 66% more adalimumab, than one would administer
`to a rheumatoid arthritis patient.
`
`As described in Section 6 of the Office Action mailed April 21, 2014 in conjunction with
`parent application 10/163,657, it would have been obvious to one of ordinary skill in the art
`to treat rheumatoid arthritis in a human subject comprising subcutaneously administering
`adalimumab at a total body dose of around 62-88 mg on a biweekly basis for a time period
`sufficient to treat the rheumatoid arthritis.
`
`By contrast, it would not have been obvious to one of ordinary skill in the art to treat
`rheumatoid arthritis in a human subject comprising administering subcutaneously to a human
`subject having rheumatoid arthritis a total body dose of 40 mg of adalimumab once every 13
`- 15 days for a time period sufficient to treat the rheumatoid arthritis (see the Reasons for
`allowance mailed July 8, 2014 in conjunction with parent application 10/163,657).
`
`Ex. 1010 - Page 7
`
`

`

`Application/Control Number: 14/256,886 (cid:9)
`Art Unit: 1644
`
`Page 4
`
`When the above findings of fact are considered together, the claimed method of treatment
`would not have been obvious to one of ordinary skill in the art.
`
`Moreover, while the instant application does not provide a working example demonstrating
`the treatment of Crohn's disease in a human subject comprising subcutaneously
`administering a human anti-TNFa antibody having the CDRs of SEQ ID NOs: 3-8, such as
`the adalimumab antibody, at a total body dose of 40 mg once every 13-15 days for a time
`period sufficient to treat Crohn's disease, given the teachings of the specification and the
`knowledge in the prior art the skilled artisan could practice the claimed invention without
`having to resort to undue experimentation.
`
`As to applicant's designation of the instant application as a divisional of parent application
`10/163,657, MPEP 201.06 defines a divisional application as "[a] later application for a
`distinct or independent invention, carved out of a pending application and disclosing and
`claiming only subject matter disclosed in the earlier or parent application..." The instant
`application is a divisional application because the claimed invention is patentably distinct
`from the allowed claims set forth May 1, 2014 in application 10/163,657.
`
`Any comments considered necessary by applicant must be submitted no later than the
`payment of the issue fee and, to avoid processing delays, should preferably accompany the
`issue fee. Such submissions should be clearly labeled "Comments on Statement of Reasons
`for Allowance."
`
`3. Claims 1-6 are allowed.
`
`4. Any inquiry concerning this communication or earlier communications from the examiner
`should be directed to ZACHARY SKELDING whose telephone number is (571)272-9033.
`The examiner can normally be reached on Monday - Friday 8:00 a.m. - 5:00 p.m.
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor,
`Daniel E. Kolker can be reached on 571-272-3181. The fax phone number for the
`organization where this application or proceeding is assigned is 571-273-8300.
`Information regarding the status of an application may be obtained from the Patent
`Application Information Retrieval (PAIR) system. Status information for published
`applications may be 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.
`
`/ZACHARY SKELDING/
`Primary Examiner, Art Unit 1644
`
`Ex. 1010 - Page 8
`
`