DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 66-68, 70, 74-77, 79, 80 and 84-91 are pending and under examination.
35 USC § 101 rejections maintained
The rejections of claims 86-91 as not being directed to patent eligible subject matter under 35 USC § 101 are maintained
Applicant state that as found in nature, the protein comprising SEQ ID NO: 1 (CLT Antigen 1) is found in cancer cells. In particular, the instant specification shows that peptides from CLT Antigen 1 are found in cutaneous melanoma cells. These peptides also do not correspond to any polypeptide sequence present within the entire
human proteome as recorded in the UniProt database. Applicant states that CLT Antigen 1 is specific to cancer cells.
Applicant states that the instant specification further shows that peptides from CLT Antigen 1 associated with the HLA Class I molecules are detected in samples derived from cutaneous melanoma cells. This demonstrates that CLT Antigen 1 is translated in melanoma tissues, proteolyzed within the melanoma cells and processed through the HLA Class I pathway and finally presented to the immune system in a complex with HLA Class I molecules. It appears that naturally occurring CLT Antigen 1, being highly enriched in cancer cells, is rapidly proteolyzed within said cancer cells and largely generates peptides presented using the HLA Class I pathway Class II pathway.
Applicant has amended claims 86 and 88 to clarify that the isolated peptide is
required to be capable of binding an MHC class II molecule. Applicant argues that the isolating of the polypeptide comprising the amino acid sequence of SEQ ID NO: 1 changes the function of the peptide. Applicant argues that the isolated peptide could be used to generate a more extensive HLA Class II based response than the peptide can in nature because of the high enrichment of the peptide in cancer cells in vivo. Applicant argues that the isolated polypeptide of claims 86-91 has a markedly different function than the peptide found in nature.
Applicant’s arguments have been considered but are not persuasive. The limitation “wherein the polypeptide is capable of binding a MHC class II molecule” does give the isolated polypeptide comprising the amino acid sequence of SEQ
ID NO: 1 any structural difference between the isolated polypeptide comprising the amino acid sequence of SEQ ID NO: 1, which has been understood as being a natural product. There are no structural differences between the isolated polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and the isolated polypeptide comprising the amino acid sequence of SEQ ID NO: 1 capable of binding a MHC class II molecule. The limitation “wherein the polypeptide is capable of binding a MHC class II molecule” has been interpreted as being a property of the isolated polypeptide.
MPEP 2112 states
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)
The ability of the polypeptide comprising the amino acid sequence of SEQ ID NO: 1 to be capable of binding an MHC class II molecule is an inherent property of that polypeptide. Products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus, an isolated polypeptide comprising the amino acid sequence of SEQ ID NO: 1, wherein the polypeptide is capable of binding an MHC class II molecule is determined to be a nature-based product and does not qualify as eligible subject matter.
Summary
Claims 86-91 stand rejected.
Claims 66-68, 70, 74-77, 79, 80, 84 and 85 are allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MARK HALVORSON/ Primary Examiner, Art Unit 1646
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