DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1, 5, 8, 11, 12 and 14 are objected to because of the following informalities:
At claims 1 and 11, “PTPRS” (protein tyrosine phosphatase) should be spelled out, subsequent uses of the abbreviation in dependent claims are acceptable.
At claim 5, “TLR9” and “IFNa” should be spelled out in the first instance.
At claims 8 and 14, “Ig” (Ig-like domain) should be spelled out in the first instance.
At claim 12, line 2, “pDCs” should be spelled out as it is in claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 or joint 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.
Claims 1-3, 5, 11 and 12 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant claims a composition comprising a PTPRS activating agent, that inhibits the association of proteoglycans with PTPRS on pDCs, and a method of treating an autoimmune disease having an interferon signature in a subject by administering said composition.
Applicant describes inhibition of interferon alpha induction in mouse plasmacytoid dendritic cells using protein tyrosine phosphatase Ig-like extracellular domain polypeptides, specifically a fusion of Ig1&2 (page 8 of the Specification and Fig. 1).
Applicant does not describe the broad genus of PTPRS activating agents, nor does Applicant describe using a Ig3 polypeptide alone or in combination.
Hence, it is unclear that Applicant was in possession of the invention as broadly claimed. See University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424, 1433 (DC WNY 2003) which teaches knowing the "starting point" is not enough; that is little more than a research plan. The court held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5 and 7-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bottini et al (U.S. 2015/0175979 A1).
At claim 13, Bottini et al disclose a pharmaceutical composition comprising a soluble extracellular domain of PTPRS, including Ig1, Ig2 and Ig3, and thus anticipates instant claims 11-15. At claim 3, Bottini et al disclose that the recombinant protein can comprise both the Ig1 and Ig2 domains. The instant Specification defines the “peptide linker” at instant claim 16 as including at least 2 amino acids as long as the linker does not interfere with extracellular domain of PTPRS ligand binding on page 13. Bottini et al disclose that the PTPRS extracellular domains can be linked together on page 10, right column, 1st paragraph, and thus anticipate instant claim 16.
At claim 55, Bottini et al disclose that the pharmaceutical composition can be used in a method of treating the autoimmune disease lupus. Hence, Bottini et al anticipate the method of instant claims 1-3, 5 and 7-10.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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/David H Kruse/
Primary Examiner, Art Unit 1663