February 22, 2023
CareDx is the exclusive licensee of U.S. Patents 8,703,652, 9,845,497, and 10,329,607 entitled “Non-Invasive Diagnosis of Graft Rejection in Organ Transplant Patients” owned by Stanford. The patents describe diagnosing or predicting organ transplant status by using methods to detect a donor’s cell-free DNA (“cfDNA”). When an organ transplant is rejected, the recipient’s body, through its natural immune response, destroys the donor cells, thus releasing cfDNA from the donated organ’s dying cells into the blood. The increased levels of donor cfDNA, which occur naturally as the organ’s condition deteriorates, can be detected and used to diagnose the likelihood of an organ transplant rejection. Claim 1 of the ’652 patent reads (simplified):<... Read more
February 7, 2023
In the matter of Ex parte Taleb, et al., the Patent Trial and Appeal Board (PTAB) determined on January 31, 2023, that an examiner (James Anderson, supported by Supervisory Patent Examiners, Jeffrey Lundgren and Kortney Klinkel) failed to establish the obviousness of claims by failing to establish a reasonable expectation of success in achieving a claimed result of a method claim. The claim in question recited<... Read more
January 23, 2023
Update by Kasumi Kanetaka & Grace Kim
Last month, the Federal Circuit issued a non-precedential decision affirming the PTAB’s holdings in two final written decisions. P Tech, LLC (herein “P Tech”) appealed the PTAB decisions holding that claims 1 and 4 of U.S. Patent 9,192,395 (herein “’395 patent”) and claims 1-20 of U.S. Patent 9,149,281 (herein “’281 patent”) are unpatentable because they would have been obvious over the cited prior art, U.S. Patent 6,331,181 (herein “Tierney”) in view of U.S. Patent 5,518,163 (herein “Hooven”).P Tech, LLC, v. Intuitive Surgical, Inc., No. 22-1102, No. 22-1115 (December 15, 2022)<... Read more
December 14, 2022
Update by Grace Kim
Colgate-Palmolive Co. appealed the Examiner’s rejection of U.S. Application No. 15/539,725 (filed June 26, 2017) as indefinite under 35 U.S.C. §112(b) and obvious under §103 in light of U.S. Application No. 2007/0025928 A1 (published February 1, 2007), “Glandorf.” The PTAB reversed the Examiner’s rejections under §112(b) and several of the Examiner’s rejections based on the Glandorf reference but affirmed an obviousness-type double patenting rejection over U.S. Patent No. 10,350,151 B2 (issued July 16, 2019) to Qiao in view of Glandorf. The Board quickly dispatched the Examiner’s indefiniteness rejection based on the claims’ express limitation that the complex must have a 20:1 phosphorous to zinc mole ratio before focusing on the obviousness rejections.<... Read more
December 13, 2022
Update by Grace Kim and Sara Pistilli, PharmD.
On December 6, 2022, the Patent Trial and Appeal Board (PTAB) overturned a rejection of a claim to a plant extract based on patent ineligible subject matter (Appeal 2022-001062). Claim 1 of the application US 15/521,212 (the 212 Application) is directed towards:<... Read more
December 9, 2022
The USPTO has published a Federal Register Notice announcing a new program: the Cancer Moonshot Expedited Examination Pilot Program. Beginning on February 1, 2023, the new program expedites examination for a broad scope of technologies to prevent cancer and cancer mortality. Patent applications pertaining to the qualifying technologies will be accorded special status and reviewed earlier. The program is scheduled to run until either January 31, 2025, or the date by which the USPTO accepts a total of 1,000 grantable petitions, whichever is earlier.... Read more
November 21, 2022
While an adequate written description is essential for patentability, 35 U.S.C. § 112(a), like everything else too much can have adverse consequences as uniQure biopharma recently learned in IPR2021-00926 (IPR) involving U.S.P. 9,982,248 (‘248).<... Read more
November 11, 2022
On October 19, 2022, the Patent Trial and Appeal Board (PTAB) overturned the obviousness rejection of a claim to an aqueous dispersion. Claim 1 of the application in question, USSN 16/083,182 (the 182 Application), recited<... Read more
October 26, 2022
Mylan Pharmaceuticals, Inc. (“Mylan”) appealed from the final written decision of the USPTO Patent Trial and Appeal Board (the “Board”) holding that Mylan failed to show that claims 1–4, 17, 19, and 21–23 of U.S. Patent 7,326,708 (the “’708 patent”) were anticipated or would have been obvious over the cited prior art.<... Read more
October 24, 2022
To accelerate innovation in the health and medical fields, the USPTO published a Federal Register Notice announcing a fifth extension of its Cancer Immunotherapy Pilot Program. Petitions requesting participation in the pilot program that are compliant with the program’s requirements and are filed on or before January 31, 2023, will be accepted. The extension will also allow the USPTO to continue the program while it evaluates potential expansion opportunities. The USPTO first implemented the Cancer Immunotherapy Pilot Program in June 2016, in support of the White House’s National Cancer Moonshot initiative, which sought to accelerate cancer research. It permits patent applications pertaining to cancer immunotherapy to be advanced out of turn for examination and reviewed earlier. The extension reflects the continued effectiveness of the pilot program. All parameters will remain the same as in the original pilot through the January 31, 2023, extension.<... Read more