PlainSite. Legal Document. United States Patent and Trademark Office Case No Ostertagia Vaccine. Document. View Document.

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1 PlainSite Legal Document United States Patent and Trademark Office Case No Ostertagia Vaccine Document View Document View Docket A joint project of Think Computer Corporation and Think Computer Foundation. Cover art 2015 Think Computer Corporation. All rights reserved. Learn more at

2 United States Patent and Tradema APPLICATION NO. FILING 03/11/ /527, DATE 7590 FIRST NAME Edwin C 03/27/2006 intervet inc. PATENT DEPARTMENT PO BOX 318 MILLSBORO, DE Please find below and/or attached an Office communicat

3 4 App 10 Office Action Summdrv Exa Bri - The MAILING DATE of th communication appears Period for Reply A SHORTENED STATUTORY PERIOD FOR REPLY IS WHICHEVER IS LONGER, FROM THE MAILING DATE Extensions of time - after SIX (6) may be available under the provions of CFR 1.136(a). MONTHS from the mailing NO period for reply date of th communication. specified above, the maximum statutory period - If - Failure to reply within the set or Any 37 reply received by the Office extended period later for reply will, by will statute, app caus than three months after the mailing date earned patent term adjustment. See 37 CFR 1.704(b). Status 1 )K 2a)D 3) D Responsive Th action Since to communication(s) filed on 30 Januar 2b)K FINAL. th application in condition for closed in Th acti allowance e accordance with the practice under Ex pa Dposition of Claims 4) E3 Claim(s) /are pending in the application. 4a) Of the above claim(s) 30-33,37-39,41-43 and 45 5) D 6) IEI 7) Q Claim(s) /are allowed. Claim(s) 34-36,40 and 44 /are rejected. Claim(s) /are objected to. Claim(s) are subject to restriction and/or ele

4 Continuation Sheet (PTOL-326) IDS filing dates 3/11/2005, 1/30/2006, and 2/10/2006.

5 Application/Control Number: 1 0/527,77 1 DETAILED Election/Re Applicant's election with traverse of Grou acknowledged. The traversal 1. on the following Claims 30-40, 43 and 44 possess unity (SEQ ID NO: 10) of Group H encoded by the n that because the protein novel, the claims posse that the subject matter akin to example 39 of th examination guidelines and that according to the 2. Applicant argues that claims 41 and and 44 because they are dependent upon claim 3. Applicant argues that claims pos because they are dependent upon claims A drawn to a process of using the products of claims

6 Claims are pending. Claims 30-33, consideration as being drawn to non-elected inven under examination. Specifi The dclosure objected to because form of browser-executable code. Applicant other form of browser-executable code. See it co re MPE only exemplary and applicant should review the s embedded hyperlink and/or other form of browser The use of the trademark Triton X-100 capitalized wherever it appears and be accompani Although the use of trademarks perms

7 The specification shall contain a wtitten descriptio making and using it in such full clear, conce, an which it pertains, or with which it most nearly c the best mode contemplated by Applicant the 35 U.S.C. 112, No. 4, the inventor of car directed to the Guidelines for first paragraph "Written Descri pages , Friday January 5, Claims 34-36, 40, and 44 are rejected unde subject matter which was not described convey to one skilled in the relevant art that the in in the spec had possession of the claimed invention. The specification dcloses ostertagi protein and said 30 kd SEQ ID NO: SEQ ID NO: 9 that correspo Ostertagia ostertagi protein. provion of 35 USC , first paragraph. SEQ ID Howeve

8 1601, 1606 (CAFC In Fiddes 1993) and Baird, 30 v. Amgen USPQ2d Chu Inc. V. 1481, 1483, found unpatentable due to lack of written descript provided only the bovine sequence. Finally, University of California Lil v. Eli that:...to fulfill the written description requirement, a and does so in sufficient detail that invented the claimed invention." 41 USPQ2d 1961, 1966 (1997); one skilled in Lockwood v. In re Gosteli, A 8 must clearly inventor] invented what clai (Fed. Cir. 1989) (" [T]he description recognize that [the written description requirement "by describing th that which makes it diagrams, formulas, obvious," and by using "such etc., that set forth the claimed USPQ2datl966. An adequate written description of a DNA,

9 The specification shall contain a written descriptio making and using it in such full, clear, conce, an which it pertains, or with which it most nearly c the best mode contemplated by the inventor of car Claims 34-36, 40, and 44 are rejected unde specification, while being enabling for an olated protein having the sequence set forth in encoded by the nucleic acid sequence SEQ ED N set forth in enablement for the myriads of other polypeptides only for claims limited to proteins represented by the nucleic acid sequence represented by SEQ ID reasonably provide enablement for polypeptide va to SEQ ID NO: least 85% 10 (and fragments thereof) or to p sequence homology to SEQ ID NO:. 9 not enable any person skilled in the art to which ( i

10 such amino acid substitutions can be made with a are limited. Certain positions in the sequence are structure/function relationship no substitutions (column amino acid who in a 2, and these regions c page 1306). The sensi sequence are exemplified by Burg teach that replacement of a single lysine resi factor by glutamic acid led to the substantial loss biological activity of the protein and 8: ) who teach by Lazar that in transforming et gro position 47 with alanine or asparagine did not aff serine or glutamic acid sharply reduced the biolog demonstrate that even a single amino acid substit biological activity and charactertics to the polypeptides of SEQ ID NO: of a protein. 10 (or up to 1

11 Application/Control Number: 10/ although the current methods seem to capture imp of those features are msing or predicted wrongly the results further (p. 400, paragraph bridging col teachings of Bowie et al., Lazar et al. and Burgess using computational sequence analys and the translational modification and cellular context on proteins could not be predicted based on sequence identity with the encoding nucleic acid possesses art all un (SEQ ID N the structural limitations of the clai of record teaches what that polypeptide specific dease or establh, wha any involvement of t dease or teach which fragments might be active in a pharmaceutical composition. Clearly, variant, that it coul encodes a protein that shares only par

12 specification devoid dease. The of any teaching rejected claims are proteins against " drawn to prophyl Ostertagia osteriagi infection" ostertagi proteins or fragments with ID NO: 10 or Ostertagia homology that said pr 90% homolo ostertagi proteins encod to the nucleic acid sequence recited in composition, the composition must elicit protecti challenge experiments in a reasonable model syst the critical deficiency of th specification with re demonstration of protective immunity upon admin proteins described in the specification. capable of generating an active immune response animal against any type of dease. based on specific antigens, it Therefore Although ma well understood t

13 The specification shall conclude with one or the subject matter more which the applicant regards as h Claims 36, 40 and 44 are rejected under 3 indefinite for failing to particularly point out and applicant regards as the invention. Claim 36 rendered vague and indefinite Ostertagia ostertagi infection." To combat an inf however, a vaccine, by definition, prevents infect infection cannot Claim 36 be a vaccine. rendered vague and indefinite one Ostertagia ostertagi protein or an immunogen 34." The claim can be interpreted in two ways. F compring an immunogenic fragment of an Oster or as a vaccine compring an Ostertagia ostertag

14 A person shall be entitled to a patent unles (a) the invention was known or used by others in th co or a foreign country, before the invention thereof by the (b) the invention use or on sale in was patented or described in a pr th country, more than one year p States. Claims 36 and 40 are rejected under 35 U. et al. (Novel Approaches Meeting The instant claims are protein or an III, Moredun R drawn to a vaccine immunogenic fragment of said prote has a sequence homology of at least 90% to the a and a pharmaceutical carrier (claim 36); and to sa (claim 40). The claim interpreted as a vaccine protein. Claerebout et al. dclose a vaccine compri

15 Claim 44 rejected under 35 U.S.C. 102( Patent 6,232,086, May, 2001). The protein or instant claim drawn to a diagnostic immunogenic fragment wherein the im homology of at least 90% to the amino acid seque interpreted as a diagnostic kit compring a suitab Pastan et al dclose a diagnostic column 22, kit that lines 58-66). Claims 34-36, and 40 are rejected under 3 (US Patent 6,017,757, 1/25/2000). The instant claims are protein or an drawn to an olate immunogenic fragment of said prote fragment thereof has a sequence homology of at l

16 therefore the claims are drawn to a composition c Ostertagia ostertagi protein or an immunogenic f immunogenic fragment thereof has a sequence ho sequence as depicted in SEQ ID NO: 10; an Oster fragment of said protein, wherein said protein or i acid sequence that encodes an immunogenic frag or said part thereof having at least 85% homology Ostertagia ostertagi protein gene as depicted in S Office does not have the facilities for examining a the -compositions of the prior art reference, the bu between the material, structural composition of the prior art. and functional cha See In re Best, 562 F Conclu

17 The assigned fax Brian Gangle AU 1645 phone number for the organizatio