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 .
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 30-36, 40-41, 44, 47, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-14, 20-21, and 24 of U.S. Patent No. 12,097,170 in view of Rowe (“Dextrose”, Handbook of Pharmaceutical Excipients, 2009) and in further view of Devouassoux et al. (US 2014/0262883 A1).
Regarding independent application claims 30, 40, and 44, patent claims 1, 20, and 24 respectively disclose all of the elements of application claims 30, 40, and 44, but do not explicitly disclose that the formulation includes a tonicity agent or that the primary container is an intravenous (IV) bag as claimed. However, patent claims 1, 20, and 24 each recite that the formulation comprises dextrose, and Rowe teaches that dextrose is widely used in solutions to adjust tonicity (Rowe: Page 222, section 7). Devouassoux teaches a packaging system for storing an oxygen-sensitive drug (¶0003), such as norepinephrine (¶0008), comprising a primary container containing the drug formulation (¶0040-0046), a secondary container containing the primary container (¶0047-0054), and an oxygen absorber or scavenger inside the secondary container such that it is in fluid communication with the contents of the primary container (¶0054-0064), which is similar to the packaging system of patent claims 1, 20, and 24 and application claims 30, 40, and 44. Devouassoux further teaches that IV bags are suitable primary containers for oxygen sensitive drugs (¶0040). Because Rowe teaches that dextrose is a widely used tonicity adjusting agent and Devouassoux teaches that IV bags are suitable primary containers for oxygen sensitive drugs in a packaging system that is similar to that of patent claims 1, 20, and 24, one of ordinary skill in the art would conclude that the inventions of application claims 30, 40, and 44 are obvious variations of those of patent claims 1, 20, and 24.
Regarding application claims 31-36, patent claims 8-13, which are dependent on patent claim 1, respectively recite the subject matter of application claims 31-36, which are dependent on application claim 30. Therefore, because the invention of application claim 30 is an obvious variation of that of patent claim 1 in view of the teachings of Rowe and Devouassoux, the inventions of application claim 31-36 are obvious variations of those of patent claims 8-13, respectively, in view of the teachings of Rowe and Devouassoux.
Regarding application claim 41, patent claim 21, which is dependent on patent claim 20, recites the subject matter of application claim 41, which is dependent on application claim 40. Therefore, because the invention of application claim 40 is an obvious variation of that of patent claim 20 in view of the teachings of Rowe and Devouassoux, the invention of application claim 41 is an obvious variation of that of patent claim 21 in view of Rowe and Devouassoux.
Regarding application claim 47, patent claim 14, which is dependent on patent claim 1, discloses all of the elements of the method of application claim 47, but does not explicitly disclose that the formulation used in the method includes a tonicity agent or that the primary container of the packed, sealed container system used in the method is an intravenous (IV) bag. However, as discussed above, patent claim 1 recites that the formulation comprises dextrose, and Rowe teaches that dextrose is widely used in solutions to adjust tonicity (Rowe: Page 222, section 7). Devouassoux teaches a packaging system for storing an oxygen-sensitive drug (¶0003), such as norepinephrine (¶0008), comprising a primary container containing the drug formulation (¶0040-0046), a secondary container containing the primary container (¶0047-0054), and an oxygen absorber or scavenger inside the secondary container such that it is in fluid communication with the contents of the primary container (¶0054-0064), which is similar to the packaging system of patent claim 1 and used in the method of patent claim 14, and to the packaging system used in the method of application claim 47. Devouassoux further teaches that IV bags are suitable primary containers for oxygen sensitive drugs (¶0040). Because Rowe teaches that dextrose is a widely used tonicity adjusting agent and Devouassoux teaches that IV bags are suitable primary containers for oxygen sensitive drugs in a packaging system that is similar to that of patent claim 1, one of ordinary skill in the art would conclude that the invention of application claim 47 is an obvious variation of that of patent claim 14.
Regarding application claim 50, patent claim 1, which patent claim 14 is dependent on, discloses that the norepinephrine is present in the formulation at a concentration of 0.015 mg/ml to 0.035 mg/ml. This prior art range overlaps the ranges recited in application claim 50, and therefore render them obvious. Please see MPEP §2144.05(I). Therefore, because the invention of application claim 47 is an obvious variation of the invention of patent claim 14 in view of the teachings of Rowe and Devouassoux, the invention of application claim 50 is also an obvious variation of the invention of patent claim 14 in view of the teachings of Rowe and Devouassoux.
Claims 30-36, 40-41, 44, 47, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 11-12, and 15 of U.S. Patent No. 12,290,494 in view of Rowe (“Dextrose”, Handbook of Pharmaceutical Excipients, 2009).
Regarding independent application claims 30, 40, and 44, patent claims 1, 11, and 15 respectively disclose all of the elements of application claims 30, 40, and 44, but do not explicitly disclose that the formulation includes a tonicity agent. However, patent claims 1, 11, and 15 each recite that the formulation comprises dextrose, and Rowe teaches that dextrose is widely used in solutions to adjust tonicity (Rowe: Page 222, section 7). Therefore, in view of the teachings of Rowe, one of ordinary skill in the art would conclude that the inventions of claims 30, 40, and 44 are obvious variations of those of patent claims 1, 11, and 15, respectively. Furthermore, because patent claims 1, 11, and 15 disclose formulations including dextrose, which Rowe teaches is a widely used tonicity adjusting agent, one of ordinary skill in the art would conclude that the inventions of patent claims 1, 11, and 15 are also obvious variations of the inventions of application claims 30, 40, and 44.
Regarding application claims 31-36, patent claims 2-7, which are dependent on patent claim 1, respectively recite the subject matter of application claims 31-36, which are dependent on application claim 30. Therefore, because the invention of application claim 30 is an obvious variation of that of patent claim 1 in view of the teachings of Rowe, the inventions of application claim 31-36 are obvious variations of those of patent claims 2-7, respectively, in view of the teachings of Rowe. Likewise, because the invention of patent claim 1 is an obvious variation of the invention of application claim 30 in view of the teachings of Rowe, the inventions of patent claims 2-7 are also obvious variations of those of application claims 31-36, respectively, in view of the teachings of Rowe.
Regarding application claim 41, patent claim 12, which is dependent on patent claim 11, recites the subject matter of application claim 41, which is dependent on application claim 40. Therefore, because the invention of application claim 40 is an obvious variation of that of patent claim 11 in view of the teachings of Rowe, the invention of application claim 41 is an obvious variation of that of patent claim 12 in view of Rowe. Likewise, because the invention of patent claim 11 is an obvious variation of the invention of application claim 40 in view of the teachings of Rowe, the invention of patent claim 12 is also an obvious variation of that of application claim 41 in view of the teachings of Rowe.
Claims 30-36, 40-41, 44, 47, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10, and 14 of U.S. Patent No. 12,714,681 in view of Rowe (“Dextrose”, Handbook of Pharmaceutical Excipients, 2009).
Regarding independent application claims 30, 40, and 44, patent claims 1, 8, and 14 respectively disclose all of the elements of application claims 30, 40, and 44, but do not explicitly disclose that the formulation includes a tonicity agent. However, patent claims 1, 8, and 14 each recite that the formulation comprises dextrose, and Rowe teaches that dextrose is widely used in solutions to adjust tonicity (Rowe: Page 222, section 7). Therefore, in view of the teachings of Rowe, one of ordinary skill in the art would conclude that the inventions of claims 30, 40, and 44 are obvious variations of those of patent claims 1, 8, and 14, respectively. Furthermore, because patent claims 1, 8, and 14 disclose formulations including dextrose, which Rowe teaches is a widely used tonicity adjusting agent, one of ordinary skill in the art would conclude that the inventions of patent claims 1, 8, and 14 are also obvious variations of the inventions of application claims 30, 40, and 44.
Regarding application claims 31-36, patent claims 2-7, which are dependent on patent claim 1, respectively recite the subject matter of application claims 31-36, which are dependent on application claim 30. Therefore, because the invention of application claim 30 is an obvious variation of that of patent claim 1 in view of the teachings of Rowe, the inventions of application claim 31-36 are obvious variations of those of patent claims 2-7, respectively, in view of the teachings of Rowe. Likewise, because the invention of patent claim 1 is an obvious variation of the invention of application claim 30 in view of the teachings of Rowe, the inventions of patent claims 2-7 are also obvious variations of those of application claims 31-36, respectively, in view of the teachings of Rowe.
Regarding application claim 41, patent claim 10, which is dependent on patent claim 8, recites the subject matter of application claim 41, which is dependent on application claim 40. Therefore, because the invention of application claim 40 is an obvious variation of that of patent claim 8 in view of the teachings of Rowe, the invention of application claim 41 is an obvious variation of that of patent claim 10 in view of Rowe. Likewise, because the invention of patent claim 8 is an obvious variation of the invention of application claim 40 in view of the teachings of Rowe, the invention of patent claim 10 is also an obvious variation of that of application claim 41 in view of the teachings of Rowe.
Allowable Subject Matter
Independent claims 30, 40, 44, and 47 recite, among other things, a packaged, sealed container system for storage of an antioxidant free norepinephrine formulation with a norepinephrine concentration between 0.015 mg/ml to about 0.035 mg/ml and dextrose, or a method of treating hypotension with such a container system. As discussed in the Notice of Allowance dated 07/30/24 of family application no. 17/249,642, which issued as U.S. Patent No. 12,097,170, the combination of the claimed norepinephrine concentration range with the other components of the formulation are not disclosed or rendered obvious by the prior art. As discussed above, independent claims 30, 40, 44, and 47, and their respective claims are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 8-14, 20-21, and 24 of U.S. Patent No. 12,097,170 in view of Rowe and in further view of Devouassoux, over claims 1-7, 11-12, and 15 of U.S. Patent No. 12,290,494 in view of Rowe, and/or over claims 1-8, 10, and 14 of U.S. Patent No. 12,714,681 in view of Rowe.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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, Sarah Al-Hashimi can be reached at 5712727159. 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.
/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
Prosecution Insights