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 .
Receipt is acknowledged of Applicant’s IDS filed on 01/09/2025.
Claims 1-20 are pending in the instant application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 10,471,012 in view of SARALIDZE et al (Polymeric Microspheres for Medical Applications. Materials 2010, 3, 3537-3564).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent recites a polymer microsphere consisting essentially of poly-lactide-co-glycolide 50:50 (PLGA) and paclitaxel (Ptx), both being distributed throughout the microsphere, and configured to release Ptx in vitro in an initial burst lasting no more than approximately two days, followed by a steady-state release lasting approximately 15-20 days, wherein the PLGA consists essentially of PLGA having an average molecular weight of about 5,600 Daltons and PLGA having an average an average molecular weight of about 16,000 Daltons (see claim 1), wherein the polymer microsphere contains 5-10 wt paclitaxel (see claim 2). The patent does not recite placing the composition within a body lumen of a patient; however, the patent discloses that the composition is used for treating tumor (see title) by placing it into a body lumen of a patient (see Background) for embolizing blood vessels (see abstract). Thus, it would have been obvious to place the composition into a blood vessel of a patient for embolizing.
SARALIDZE teaches the prior art had known of using microspheres (see title; pg. 3550), such as PLGA (see pg. 3551) for embolization (see pg. 3538 and 3550-351), wherein anti-cancer drugs can be added for “double” treatment (see pg. 3550).
Thus, it would have been obvious to place the composition into a blood vessel of a patient for embolizing.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12,144,891.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent recites a method of treating a patient, the method comprising: placing, within a blood vessel of a tumor of the patient, polymer microspheres consisting essentially of poly-lactide-co-glycolide 50:50 and 5-10 wt % therapeutic agent such that the blood vessel is embolized (see claim 1), wherein the body lumen is a blood vessel which provides blood to a hepatocellular carcinoma (see claim 2), wherein the step of placing the polymer microspheres within the body lumen includes flowing a fluid suspension including the polymer microspheres through a catheter and into the blood vessel (see claim 3).
The difference between instant application and the patented claims is that the patent claims include narrower limitations, such as 5-10% versus 5-40%. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAKE M VU/Primary Examiner, Art Unit 1618
Prosecution Insights