3 Myriad Case Facts: Held: Myriad Genetics located and developed a test for the BRCA1 & BRCA2 genetic mutations which substantially increase the risk of breast and ovarian cancerExample Composition ClaimsClaim 1 “[a]n isolated DNA coding for a BRCA1 polypeptide,” which has “the amino acid sequence set forth in SEQ ID NO:2.” = DNAClaim 2 “[t]he isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.” SEQ ID NO:1 = cDNAHeld:DNA, an even isolated form- not patent eligible under 35 U.S.C. 101cDNA (Complementary DNA), which includes the same protein-coding information found in the DNA but omits segments that don’t code for proteins- may be patent eligible because it is not naturally occurring.
4 Myriad CaseNotes:No method claims- innovative method of manipulating genes while searching for BRCA gene = patent eligibleClaims don’t involve new applications of knowledgeDid not consider patent eligibility of DNA in which the nucleotides are altered
5 Myriad CaseJUSTICE SCALIA, concurring in part and concurring in the judgment.I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature.
6 Power of AttorneyHaving Powers of Attorneys kicked back from the USPTO because the Applicant is not designated on the ADSSolution: file ADS naming the Applicant along with Power of Attorney documents
7 AIA Transition Applications ADS- AIA StatementSecretary’s instructed to NOT check this box, unless attorney specifically instructs otherwise.Attorney’s responsibility to decide.
8 AIA Transition Applications How to fix if you accidentally checked the AIA Statement box on the ADSSubmit a corrected ADS with the box unchecked.Cover letter explaining that checking the box was inadvertent.
9 Cooperative Patent Classification (CPC) Joint (Global) Classification System Based on the European Classification system (ECLA)More granular than the International Patent Classification (IPC) systemParticipantsEPOUSPTOKorean Patent Office (KIPO)China (SIPO)
10 Cooperative Patent Classification (CPC) Now Implemented in the USPTO (January 1, 2013)2 Year TransitionNewly filed US applications ("A" publications) will be classified in the USPC and the CPCUS patent grants ("B" publications) will be classified in either the USPC or the USPC and the CPCCPC symbols will be printed on the front page, next to the IPC and USPC symbols.By January 1, USPTO will exclusively classify CPC (but will keep IPC)
14 Cooperative Patent Classification (CPC) Working on implementing CPC for our subject matter conflictsConverting US classes to CPCSearchesNeed to start using CPC
15 After Final Consideration Program Pilot 2.0 Avoids the Expense of RCE’sTimingResponses to Final Office Actions Filed From May 19, 2013 to September 30, 2013Requirements (NO FEE)Request for Consideration Under Pilot (PTO/SB/434)Amendment to at least one independent claim that does not broaden itWilling to participate in an interview
17 After Final Consideration Program Pilot 2.0 What does the Examiner Get?Up to 3 Hours non-production time10 day adjustment of docket management clockOutcomeExaminer can deny request (file RCE)Allow the applicationRequest interviewNeed to conduct interview within 10 daysOtherwise back to filing RCE
18 After Final Consideration Program Pilot 2.0 Results- it worksFiled Request June 5, 2013Examiner called yesterday (June 12) requesting a few minor changes for Notice of AllowanceSaved client the expense and time of an RCE!