REQUEST
`
`C°NNNNE° EWN (RCE)
`TRANSM'TTAL
`
`Address to:
`
`Commissioner for Patents
`
`P-O- BOX 1450
`Alexandria, VA 22313-1450
`
`Attorney Docket Number
`
`200146.402013
`
`This is a Request for Continued Examination (RCE) under 37 CFR 1.114 of the above-identified application.
`Request for Continued Examination (RCE) practice under 37 CFR 1.114 does not apply to any utility or plant application filed prior to June 8, 1995,
`or to any design application. See instruction Sheet for RCEs (not to be submitted to the USPTO) on page 2.
`
`Submission required under 37 CFR 1.114 Note: If the RCE is proper, any previously filed unentered amendments and amendments
`enclosed with the RCE will be entered in the order in which they were filed unless applicant instructs otherwise.
`If applicant does not wish to
`have any previously filed unentered amendment(s) entered, applicant must request non-entry of such amendment(s).
`
`If a final Office action is outstanding, any amendments filed after the final Office action may be
`a. D Previously submitted.
`considered as a submission even if this box is not checked.
`
`i.
`ii.
`b. E
`i.
`ii
`
`
`
`:I Consider the arguments in the Appeal Brief or Reply Brief previously filed on
`:| Other _.
`Enclosed
`2] Amendment/Reply
`:I Affidavit(s)/Dec|aration(s)
`
`
`
`'
`
`.
`
`E Information Disclosure Statement (IDS)
`B] Other Petition for Removal from Issue' IDS
`Transmittal Cited References (8)' Fee Deficiency Authorization
`
`2. Miscellaneous
`
`
`
`
`
`
`8
`
`Suspension of action on the above-identified application is requested under 37 CFR 1.103(c) for
`a period of
`months. (Period of suspension shall not exceed 3 months; Fee under 37 CFR 1.17(i) required)
`Other
`
`The RCE fee under 37 CFR 1.17(e) is required by 37 CFR 1.114 when the RCE is filed.
`
`The Director is hereby authorized to charge the following fees, any underpayment of fees, or credit any
`overpayments, to Deposit Account No. 19-1090.
`
`
`
`2] RCE fee required under 37 CFR 1.17(e)
`1 Extension of time fee (37 CFR 1.136 and 1.17)
`2] Other Petition fee
`Check in the amount of $
`
`enclosed
`
`Payment by credit card (Form PTO-2038 enclosed)
`WARNING:
`Information on this form may become public. Credit card information should not be included on this form.
`Provide credit card information and authorization on PTO-2038.
`
`SIGNATURE OF APPLICANT, ATTORNEY, 0R AGENT REQUIRED
`
`Signature
`
`IKarI R. Hermanns/
`
`Name (Print /Type)
`
`Karl R. Hermanns
`
`April 25, 2012
`
`Registration No.
`
`33,507
`
`CERTIFICATE OF MAILING OR TRANSMISSION
`
`I hereby certify that this correspondence is being deposited with the United States Postal Service with sufficient postage as first class mail in an envelope
`addressed to: Mail Stop RCE, Commissioner for Patents, PO. Box 1450, Alexandria, VA 22313-1450, orfacsimile transmitted to the US. Patent and Trademark
`Office on the date shown below.
`
`SEND TO: Mail Stop RCE, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`2161244_1.DOC
`
`

`

`SPECIAL PROCEDURES SUBMISSION
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicants
`
`Application No.
`
`Filed
`
`For
`
`:
`
`:
`
`:
`
`Sung Hwan Moon et al.
`
`13/194,428
`
`July 29, 2011
`
`: REVERSE-TURN MIMETICS AND METHOD RELATING
`
`THERETO
`
`Date of Notice of Allowance
`
`: April 4, 2012
`
`Docket No.
`
`:
`
`200146.402C13
`
`Date
`
`: April 25, 2012
`
`Mail Stop 313(c)
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`PETITION FOR REMOVAL FROM ISSUE — ISSUE FEE PAID
`
`137 CFR1.3131cn
`
`Commissioner for Patents:
`
`Applicants hereby petition to withdraw the above-noted patent application from
`
`issuance. The issue fee for this application was paid on April 6, 2012.
`
`This withdrawal is voluntary in order to permit the Patent Office to consider an
`
`Information Disclosure Statement under 37 CFR 1.97 (see 37 CFR 1.313(c)(2)) and Request for
`
`Continued Examination filed herewith per Patent Office procedures.
`
`Applicants submit herewith a Request
`
`for Continued Examination (RCE),
`
`Submission/Remarks Accompanying RCE, Supplemental Information Disclosure Statement
`
`Transmittal, Supplemental Information Disclosure Statement, and copies of the cited references.
`
`

`

`The Director is authorized to charge any additional fees due by way of this
`
`Petition, or credit any overpayment, to our Deposit Account No. 19-1090.
`
`Should the Examiner have any additional questions, he is respectfully encouraged
`
`to contact the undersigned patent agent at (206) 622-4900.
`
`Respectfully submitted,
`
`SEED Intellectual Property Law Group PLLC
`
`/Karl R. Hermanns/
`
`Karl R. Hermanns
`
`Registration No. 33,507
`
`QXL :kw
`
`Enclosures:
`
`Request for Continued Examination
`Submission/Remarks Accompanying RCE
`Supplemental Information Disclosure Statement Transmittal
`Supplemental Information Disclosure Statement
`Cited References (8)
`
`701 Fifth Avenue, Suite 5400
`Seattle, Washington 98104-7092
`(206) 622-4900
`Fax: (206) 682-6031
`
`C:\NrP011bl\iManage\KARENWILL\2 16123 971.DOC
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`7PATENT
`
`Applicants
`
`Assignee
`
`Application No.
`
`Filed
`
`For
`
`:
`
`:
`
`:
`
`:
`
`:
`
`Sung Hwan Moon et al.
`
`Choongwae Pharma Corporation
`
`13/194,428
`
`July 29, 2011
`
`REVERSE-TURN MIMETICS AND METHOD RELATING
`
`THERETO
`
`Examiner
`
`Art Unit
`
`Docket No.
`
`Date
`
`:
`
`:
`
`:
`
`:
`
`Kahsay Habte
`
`1624
`
`200146.402C13
`
`April 25, 2012
`
`Mail Stop RCE
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 223 1 3- 1450
`
`SUBMISSION/REMARKS ACCOMPANYING RCE
`
`FILED PURSUANT TO 37 C.F.R. 1.114
`
`Commissioner for Patents:
`
`This Submission is being submitted simultaneously with a Request for Continued
`
`Examination (RCE) filed pursuant to 37 C.F.R. 1.114. Since the Issue Fee has already been
`
`paid, Applicants have also filed a Petition to Withdraw from Issue pursuant to 37 C.F.R.
`
`1 .3 13(c).
`
`A Listing of Claims begins on page 2 of this paper.
`
`Remarks begin on page 7 of this paper.
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`Amendments to the Claims:
`
`No claim amendments have been made pursuant
`
`to this submission.
`
`The
`
`following claims were previously passed to issuance.
`
`Listing of Claims:
`
`1-42.
`
`(Canceled)
`
`43.
`
`(Previously Presented)
`
`A compound having formula (VI)
`
`Rb
`
`n
`
`\/
`R
`
`c\N/
`
`o C1_—,a|ky|
`Ra
`J
`o
`
`N
`
`0
`
`N
`NS(
`
`x1
`
`\
`| —X2
`//
`*3
`
`(VI)
`
`wherein,
`
`Ra is a phenyl group; a substituted phenyl group haVing one or more
`
`substituents wherein the one or more substituents are independently selected from one or more of
`
`amino, amidino, guanidino, hydrazino, amidazonyl, C1_4alkylamino, C1_4dialkylamino, halogen,
`
`perfluoro C1_4alkyl, C1_4alkyl, C1_3alkoxy, nitro, carboxy, cyano, sulfuryl, and hydroxyl groups;
`
`or a bicyclic aryl group haVing 8 to 11 ring members, which may have 1
`
`to 3 heteroatoms
`
`selected from nitrogen, oxygen and sulfur;
`
`Rb is a monocyclic aryl group haVing 5 to 7 ring members, which may
`
`have 1 to 2 heteroatoms selected from nitrogen, oxygen or sulfur, and aryl ring in the compound
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`may have one or more substituents selected from a group consisting of halogen, hydroxy, cyano,
`
`lower alkyl, and lower alkoxy groups;
`
`RC is a saturated or unsaturated C1_6alkyl, C1_6alkoxy, perfluoro C1_6alkyl
`
`group; and
`
`X1, X2, and X3 may be the same or different and independently selected
`
`from hydrogen, hydroxyl, and halide.
`
`44.
`
`(Previously Presented) The compound of claim 43, wherein Ra is an
`
`unsubstituted bicyclic aryl group.
`
`45.
`
`(Previously Presented) The compound of claim 43, wherein Ra is a
`
`substituted bicyclic aryl group.
`
`46.
`
`(Canceled)
`
`47.
`
`(Previously Presented) The compound of claim 43, wherein the C1_7alkyl
`
`is methyl.
`
`48.
`
`(Previously Presented) The
`
`compound of claim 47, wherein the
`
`compound is selected from the group consisting of:
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`, and
`
`49-53. (Canceled)
`
`54.
`
`(Previously Presented) A pharmaceutical composition comprising a
`
`compound according to claim 43 and a pharmaceutically acceptable carrier.
`
`55.
`
`(Previously Presented) The pharmaceutical composition of claim 54,
`
`wherein Ra is an unsubstituted bicyclic aryl group.
`
`56.
`
`(Previously Presented) The pharmaceutical composition of claim 54,
`
`wherein Ra is a substituted bicyclic aryl group.
`
`57.
`
`(Canceled)
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`58.
`
`(Previously Presented)
`
`The pharmaceutical composition of claim
`
`54, wherein the C1_7alkyl is methyl.
`
`59-61. (Canceled)
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`REMARKS
`
`Reconsideration of this application in view of the following remarks is
`
`respectfully requested.
`
`Claims 43-45, 47-48, 54-56 and 58 are currently pending. No
`
`amendments have been made by way of this submission.
`
`Status ofApplication
`
`The pending claims were previously allowed by Notice of Allowance mailed
`
`April 4, 2012, and the issue fee paid on April 6, 2012. For the reasons discussed below,
`
`Applicants file herewith a (1) Request for Continued Examination (RCE) pursuant to 37 C.F.R.
`
`1.114, and (2) a Petition for Withdrawal from Issue pursuant to 37 C.F.R. 1.313(c). This paper
`
`serves as the Submission accompanying the RCE.
`
`Purpose 0fRCE
`
`Assignee files the present RCE in order to make of record a further Declaration
`
`by Dr. Michael Kahn (“Kahn”) dated April 12, 2012 (“the more recent Kahn Declaration”), and
`
`to cross-cite various Office Actions issued in related applications. As the Examiner is aware,
`
`Assignee has already made of record the Declaration of Kahn dated May 12, 2010 (“the prior
`
`Kahn Declaration”). While Assignee is of the opinion that the more recent Kahn Declaration is
`
`duplicative and/or cumulative to the prior Kahn Declaration, Assignee wishes to cite the same in
`
`the interest of full disclosure and good faith in dealing with the US. Patent Office. To that end,
`
`the more recent Kahn Declaration, as well as various Office Actions issued in related
`
`applications, are set forth in the Supplemental IDS submitted herewith.
`
`The More Recent Kahn Declaration
`
`As with the prior Kahn Declaration, the more recent Kahn Declaration was not
`
`requested by Assignee, and represents yet a further attempt at preventing claims from issuing
`
`that would detrimentally impact Kahn in view of his relationship with a third-party company.
`
`Further, the more recent Kahn Declaration fails to mention a pending lawsuit involving the
`
`parties. Accordingly, before turning to the substance of the more recent Kahn Declaration,
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`Assignee will
`
`first
`
`summarize the relationship between Assignee (Choongwae Pharma
`
`Corporation or “CWP”) and Kahn. Next, Assignee will address the main contentions of the
`
`more recent Kahn Declaration; namely, the assertion that the pending claims fail to satisfy the
`
`first paragraph requirements of 35 U.S.C. §112.
`
`Relationship Between Assignee and Kahn
`
`Kahn is one of seven co-inventors of the pending application and was employed
`
`as a consultant for CWP from 1999 to 2005.
`
`In 2005, due to a dispute related to the research
`
`conducted by Kahn and The Institute of Chemical Genomics (“ICG”) founded by Kahn and
`
`others, CWP filed a lawsuit in the United States District Court Western District of Washington
`
`against Kahn (Case No. C06-0977). In 2007, Kahn, ICG and CWP resolved their dispute by way
`
`of a confidential Settlement Agreement, resulting in dismissal of the lawsuit.
`
`Since 2006, Kahn co-founded and has been an outside board member of Prism
`
`BioLabs Corporation (“Prism”). On February 6, 2012, a further lawsuit was filed by JW
`
`Pharmaceutical Corp. (JWP), the successor to CWP, in United States District Court for the
`
`Central District of California (Case No. CV12-1006) against Kahn and Prism (a copy of the
`
`Complaint is attached with the Supplemental IDS). This more recent lawsuit alleges breach of
`
`contract, fraud, breach of confidentiality and trade secret misappropriation on the part of Kahn.
`
`As alleged in the Complaint at page 14, Kahn secretly founded Prism to develop
`
`competing compounds.
`
`In 2008, Prism filed the US. provisional application that served as the
`
`priority document for WO 2009/ 148192 (hereinafter the “Prism PCT”). Assignee believes that
`
`Prism is actively taking steps to commercialize one or more compounds of the Prism PCT, which
`
`compounds are encompassed within the scope of the claims allowed in the pending application.
`
`Accordingly, in view of Kahn’s significant involvement in the founding and operations of Prism,
`
`he stands to gain financially by preventing claims from issuing from the pending application, and
`
`the veracity of his opinion on this matter should be viewed in light of his personal interest in the
`
`outcome.
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`Enablement of Pendin Claims
`
`Rb
`
`Pending claim 43 recites compounds having the following formula (VI):
`H
`N
`0
`V \l/
`R°\ /
`
`Cflalkyl
`
`Ra
`9 N)
`
`
`
`x:
`
`(VI)
`
`Compounds of Formula (VI) may be made, for example, by the synthetic route
`
`illustrated in Figure l (reproduced below).
`
`In general, compounds of Formula (VI) are made by
`
`coupling different individual component pieces in a series of amide bond formations, followed
`
`by a ring closure step. The resulting product is then converted to compounds of Formula (VI) by
`
`conventional techniques.
`
`0/
`
`B:
`
`on
`
`R;
`
`(a) Hyu/
`
`(3) DMSO
`{b} HATU t nizArNMP
`(c) DE‘iperidinEKDMF
`ii) HUET 1’ [MC {13th
`(d) HCOOH, mom temp.
`
`o/Pol
`
`OF:
`
`~'
`N/P‘
`H
`
`H
`
`OH
`
`+
`
`,/N
`
`quc
`
`“
`{b'
`O M
`
`0/?“
`
`H
`N
`
`on
`
`R
`N/ 2
`
`First Component Piece
`
`R4
`Second Cnmpanent Piece
`
`Frwc/
`
`Rd
`
`
`
`o
`
`n,
`
`limos
`
`/NH
`
`G
`
`t-
`
`O
`
`R‘
`
`0R1
`
`3) piperidiue/DMF YNH
`
`WM
`
`6/
`
`2;)
`
`(J
`
`0R.
`
`R6
`
`OH
`
`a
`
`H
`
`5
`
`OH
`
`5
`
`c:
`
`Third Component Plow
`
`meh Component HEW
`
`FIG. I
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`A significant assertion of the more recent Kahn Declaration is that the presence of
`
`a C1_7alkyl group at
`
`the 9-position of Formula (VI) somehow prevents the reaction from
`
`proceeding, particularly when R2 (which corresponds to the —CH2Ra group in the compounds of
`
`pending claims 43) is a large group such as a bicyclic moiety. The location of the C1_7alkyl
`
`group is shown below in reference to Figure l of the pending application.
`
`c.” 3‘: :1
`
`(K
`a:
`
`DR
`
`:
`
`(A)
`
`H?”
`
`R
`/ 9
`
`(a) DMSU
`Cb) HIXTU mum f NM?
`(6) ill’ipefidinel’DMF
`ii) HOST ! DB: : DMF
`(d) HCOOH, 11301111831111
`
`C1,}- alkyl
`
`O/le/
`N/ 2
`
`,
`
`52
`
`H
`
`OR
`
`H
`
`{N
`
`:quc
`
`+
`
`08
`
`bx
`' W
`0
`
`g
`
`'
`
`C1773]? ’l
`
`R
`
`QXM/ . ‘ g
`but]! 2
`
`H
`N
`
`on
`
`7,
`First Coxnpnnent Pier/c
`
`R4
`Second Csmponent Piece
`
`Fax-loaf
`
`0
`
`
`
`0
`
`0R1
`
`PM
`
`G
`
`/NH
`
`3) pipel‘idinei‘DMF
`NHW
`8",-
`
`
`
`2;.
`
`o
`
`(21R1
`
`0H Y R
`
`9
`
`Ci
`
`5
`
`DH
`
`0
`
`Rs
`
`R5
`
`Third Component Piece
`
`Fourth Component Piece
`
`This is an odd argument since Prism (the company that Kahn co-founded) utilizes
`
`this same general pathway to synthesize the compounds disclosed and claimed in the Prism PCT.
`
`10
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`This similarity can be seen by comparing the above synthetic route to the third reaction scheme
`
`(Step 3) shown in Figure l of the Prism PCT (depicted below):
`
`R910
`R2
`on92
`NH 1 I
`G
`HR \N R3
`Kn,N‘A’J\\O
`
`0
`
`Compound [1
`
`WSCIHOBUDMAP
`or
`
`HATU/DIEA
`Step3
`
`R3
`91
`_
`R OxrkN-R
`ORszH
`
`1
`
`+
`
`R?
`G_NH
`OH
`H
`(\n’N~A’go
`
`0
`
`Compound 1X
`
`Compound VH1
`
`Step 3 0fPrism PCT (Figure I)
`
`In the above reaction from the Prism PCT, R1 and R3 correspond to the —CH2Ra
`
`and C1_7alkyl groups, respectively, in the compounds of pending claim 43. To better appreciate
`
`compound similarity, one need only look at the first compound (Compound No. I-l) listed in the
`
`Prism PCT (page 179) and compare it to the compounds of the pending application, such as
`
`Compound No. 24 (page 304) of the pending application:
`
`
`
`Ex. No
`Structure
`
`1,;
`
`H
`
`I
`E,
`\«jvN\II/‘O :
`.
`N
`'
`
`
`
`
`‘
`.44413-‘drox)r‘immyl)7
`‘
`inhale u— 1 —x,- l iuethvl}
`Hrm-‘i‘agzmol‘l,l—
`
`
`{:fi E ,Zsi'iu‘mznn - 5 -L urhraxaniinle
`
`/’
`
`I
`
`
`
`
`
`
`24s:
`
`“Cxfiflfi.
`
`O
`
`N
`
`56373::
`
`5.0::
`
`
`
`From Pending Application (Page 3 04)
`
`ll
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`The only structural difference in the above compounds is that the Prism PCT is
`
`l-naphthyl (vs. 2-naphthyl) and has a methyl group at the 9-position (vs. hydrogen). Thus,
`
`Assignee considers it quite remarkable that the same reaction scheme that somehow lacks
`
`enablement in the pending application was sufficient in the Prism PCT to make compounds
`
`haVing methyl at the 9-postion in combination with a bicylic aryl at the Ra position.
`
`It should
`
`also be noted that the R1 group of the Prism PCT compounds (corresponding to the -CH2Ra
`
`group of pending claim 43) are all —CH2-bicyclic compounds (i.e., -CH2-naphthyl in the above
`
`example), which the recent Kahn Declaration asserts cannot be made by this technique due to
`
`their large size (which is clearly incorrect).
`
`The recent Kahn Declaration also asserts that one skilled in the art could not make
`
`the First Component Piece as noted in Figure l of the pending application when the 9-position is
`
`a moiety other than hydrogen. Again, this assertion is incorrect. The First Component Piece
`
`depicted in Figure l of the pending application (shown with a C1_7alkyl group) has the following
`
`general structure:
`
`First Component Piece
`
`Such compounds are readily prepared from amino acids, with C1_7alkyl
`
`representing the amino acid side chain moiety:
`
`e — ah
`
`{I .7 aka
`
`noN. «f’L‘w R3
`
`:’
`
`»H
`
`Q‘*%~»‘"“"‘L"\NH.
`
`3
`
`1. W4“
`
`*3“
`
`on
`
`Amino Acid
`
`First Component Piece
`
`For instance, the First Component Piece can readily be prepared from natural amino acids, such
`
`as those listed in Table l of the pending application, at page 19.
`
`In this regard, the amino acid
`
`side chain moiety includes lower chain alkyl groups: such as CH alkyls (see page 20, lines 19-
`
`Q). Thus, C1_7alkyl is methyl (C1) when the amino acid is alanine, isopropyl (C3) when the
`
`12
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`amino acid is valine, isobutyl (C4) when the amino acid is leucine, and sec-butyl (C4) when the
`
`amino acid is isoleucine.
`
`Protection at the C-terminal of the amino acid, and further modification at the
`
`N—terminal to introduce R2, are all within the knowledge of one skilled in the art. For instance,
`
`protection at the C-terminal can be carried out by standard procedures known in the art of
`
`peptide synthesis. The C-terminal protection may also include coupling to a solid support (e. g.,
`
`one R is a polymer resin) according to known methods in the art. Further, coupling of the amine
`
`terminal with an appropriate R2 precursor, such as an acid chloride (Rz-COCl), provides the R2
`
`group of the First Component Piece.
`
`Referring again to the Prism PCT, Compound IX of Step 3 (which corresponds to
`
`the First Component Piece of the pending application) is made by Steps 15 and 16 of Figure 3
`
`(depicted below):
`
`R910
`
`,
`
`.R1
`
`R3
`1/LG
`0R9
`Compound IX
`
`-
`
`.
`
`(A 0) BEN
`c
`a
`3
`
`Ste 15
`p
`
`1
`
`NH
`
`R3
`R9 OYL
`2
`ORQZ
`Compound XVIII
`
`+
`
`RILG
`
`Compound XX
`
`91
`
`R3
`R (kl/2%
`0R
`Compound XVIII
`
`l)MeNH(OMe), WSC, HOBt, Et3N
`2)LiAIH
`3)ROH, HCl
`4)PdC/Hz
`
`
`-
`
`Step16
`
`R3 O
`HofiNJLO
`/\©
`o
`H
`Compound m1
`
`Steps 15 and I6 0fPrism‘PCT (Figure 3)
`
`In discussing preparation of Compound XVIII in Step 16, the Prism PCT states
`
`
`
`that such compounds “are commerciall available from a variet of sources or can be re ared
`
`by methods well known in organic chemistgy” (see Prism PCT at page 41, lines 19-21). The
`
`Prism PCT continues by stating that “Compound IX may be readily synthesized by reductive
`
`animation
`
`or by a displacement reaction”, and that R91 and R92 are suitable protecting groups
`
`which may be joined to a solid support (see Prism PCT at page 40, lines 25-39).
`
`13
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`Again, what
`
`the recent Kahn Declaration asserts is lacking in the pending
`
`application is the very same synthetic procedure disclosed in the Prism PCT for making
`
`compounds which fall within the scope of pending claim 43.
`
`With regard to stereochemistry at the 9-position, Assignee again disagrees. As an
`
`initial matter, the compounds recited in claim 43 do not even recite specific stereochemistry at
`
`the 9-position. Further, any stereochemistry introduced in the synthesis of the First Component
`
`Piece is carried throughout the sequential coupling as shown in Figure l of the pending
`
`application. Thus, one skilled in this art can readily make the compounds of claim 43 with
`
`desired stereochemistry at the 9-position (which is a chiral carbon when 9-position substituent is
`
`other than hydrogen) by employing a First Component Piece having the desired stereochemistry.
`
`This is illustrated in the pending application by the compounds made and tested.
`
`In particular, the compounds listed in Table 4 of the pending application (see pages 300-337)
`
`were made according to the disclosed synthetic procedures, and IC50 values determined in the
`
`reporter gene assay as described in Example 6. Compounds of Table 4 having specific
`
`stereochemistry at the 9-position are shown below:
`
`
`Table 4
`
`IC50(uM) OF SELECTED LIBRARY COMPOUNDS
`
`
`
`l4
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`STRUCTURE
`
`
`
`
`
`
`
`
`
`15
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`STRUCTURE
`
`
`
`
`
`In summary, Assignee submits that the compounds of pending claim 43 can (and
`
`were) readily made by one skilled in the art (without undue experimentation) based on the
`
`disclosure of the specification as originally filed, and that the assertions made in the recent Kahn
`
`Declaration to the contrary are without merit for the reasons noted above.
`
`Written Description Support for Pending Claims
`
`In addition to enablement, the recent Kahn Declaration also questions whether the
`
`pending claims satisfy the written description requirement. As the Examiner is aware, the
`
`written description requirement ensures that the inventor had possession of the claimed subject
`
`matter as of the filing date of the application.
`
`It is not a requirement that a claim be described
`
`literally or in z'psz's verbis in order for the specification to satisfy the written description
`
`requirement. As long as the specification conveys clearly to those skilled in the art the
`
`information that is being claimed, this requirement is satisfied.
`
`Clearly, there is ample support for the 9-position being hydrogen. The pending
`
`application exemplifies over 3000 compounds, a significant portion of which are compounds of
`
`structure (VI) as recited in claim 43 wherein the 9-position moiety is hydrogen. Further, the
`
`16
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`specification provides numerous examples of Ra being naphthyl (a bicyclic moiety) when the 9-
`
`position is hydrogen (see, Compound No. 24 shown above).
`
`The application as originally filed also exemplifies a number of compounds
`
`wherein the 9-position is other than hydrogen — see Compound Nos. 69, 78, 80, 81, 82, 83, 84
`
`and 111 shown in Table 4 above fiom the pending application. Of these, Compound Nos. 69, 78,
`
`80, 83, 84 and 111 exemplify the embodiment wherein the 9-position is methyl. While the Ra
`
`group is a substituted phenyl
`
`in the exemplified compounds noted above, Assignee is not
`
`required to specifically exemplify every possible combination of R groups (e.g., Ra = bicyclic) in
`
`order to have possession of the claimed subject matter (especially when bicyclic moieties are
`
`exemplified by numerous compounds in which the 9-position is hydrogen).
`
`Lastly, the C1_7alkyl moiety at the 9-position is introduced to the compounds of
`
`claim 43 via the First Component Piece discussed above, and the 9-position substituent
`
`corresponds to the amino acid side chain moiety used to make the First Component Piece. Table
`1 of the s ecification at a e 19 lists the amino acid side chain moieties of naturall occurrin
`
`
`
`amino acids: including those with alkyl side chains. The specification continues on page 20 by
`
`disclosing that naturally occurring amino acids may be used, as well as derivatives thereof.
`
`In
`
`the case of alanine, valine, leucine and isoleucine, such side chains constitute lower chain alkyls
`
`(see specification at page 20, line 9-11). The specification defines lower chain alkyl derivatives
`
`as including Cflalkyl gsee specification at page 20, lines 18-19 1.
`
`Having specifically exemplified representative compounds of claim 43 wherein
`
`the 9-position is methyl (i.e., Compound Nos. 69, 78, 80, 83, 84 and 111 set forth above), and
`
`having disclosed naturally occurring amino acid side chain moieties and alkyl derivatives
`
`thereof, Assignee clearly had possession of lower chain alkyl groups (C1_7 alkyl) at this position
`
`as of the priority filing date. Accordingly, Assignee submits that the assertions made in the
`
`recent Kahn Declaration with regard to lack of written description support are without merit for
`
`the reasons noted above.
`
`Conclusion
`
`In view of the above amendments and remarks, allowance of claims 43-45, 47-48,
`
`54-56 and 58 is respectfully requested. A good faith effort has been made to place this
`
`17
`
`

`

`Application No. 13/194,428
`Submission/Remarks Accompanying RCE
`
`application in condition for allowance. However, should any further matter require attention, the
`
`Examiner is requested to contact the undersigned at (206) 622-4900 to resolve the same.
`
`The Director is authorized to charge any additional fees due by way of this
`
`Amendment, or credit any overpayment, to our Deposit Account No. 19-1090.
`
`Respectfully submitted,
`
`SEED Intellectual Property Law Group PLLC
`
`On Behalf of Choongwae Pharma Corporation
`
`/Karl R. Hermanns/
`
`Karl R. Hermanns
`
`Registration No. 33,507
`
`KRH:kw
`
`701 Fifth Avenue, Suite 5400
`
`Seattle, Washington 98104
`Phone: (206) 622-4900
`Fax: (206) 682-6031
`
`l7l6983_l.DOC
`
`18
`
`