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 .
Status of the Claims
Currently, claims 38-39, 42-44, 46-47, 49-50, 53-55, 57-58, 60, 66-67, 70, 72, and 78 are pending in the instant application.
Priority
The instant application is a CON of application 16/914,100, filed on 06/26/2020, and claims priority to provisional application 62/868,615, filed on 06/28/2019. Parent application 16/914,100 has been issued as US Patent No. 11865177.
Election/Restrictions
Per the Restriction Requirement submitted on 11/28/2025, Applicant has elected the following invention to which the claims shall be restricted to:
II. Claims 46-47, 49-50, 53-55, 57-58, 60, 66-67, 70, 72, and 78 drawn to a method of making a liquid formulation comprising adding a polypeptide and a surfactant to an aqueous solution, classified in A61K 9/08.
Accordingly, claims 46-47, 49-50, 53-55, 57-58, 60, 66-67, 70, 72, and 78 are pending examination, while claims 38-39 and 42-44 are withdrawn as being directed to a non-elected invention.
In response to the species election, Applicant has chosen the following compound of Formula (I):
PNG
media_image1.png
297
624
media_image1.png
Greyscale
A method of preparing a composition comprising the elected compound appears to be essentially free of the art. Accordingly, the election requirement is hereby withdrawn. Claims 46-47, 49-50, 53-55, 57-58, 60, 66-67, 70, 72, and 78 are pending examination.
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 46-47, 49-50, 53-55, 57-58, 60, 66-67, 70, 72, and 78 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-35 of U.S. Patent No. 11865177 (herein the ‘177 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application and issued patent are significantly overlapping in scope.
Claim 1 of the instant application recites a method for making a liquid formulation comprising adding a polypeptide and a surfactant to an aqueous solution, wherein at least 70% wt of the surfactant are isosorbide POE fatty acid esters and POE fatty acid esters.
Claim 53 of the instant application recites the method of claim 1 wherein the isosorbide POE fatty acid ester is a compound of Formula (I):
PNG
media_image2.png
87
305
media_image2.png
Greyscale
Claim 1 of the ‘177 patent recites a liquid formulation comprising a polypeptide and a surfactant, wherein at least about 70% (wt %) of the surfactant are isosorbide polyoxyethylene (POE) fatty acid esters.
Claim 8 of the ‘177 patent recites the formulation of claim 1 wherein the isosorbide POE fatty acid ester is a compound of Formula (I):
PNG
media_image3.png
132
355
media_image3.png
Greyscale
Claim 18 of the ‘177 patent recites the formulation of claim 1 wherein the surfactant further comprises POE fatty acids.
Firstly, claim 46 of the instant application is drawn to a method of making a formulation, while claim 1 of the ‘177 patent is drawn to a formulation. While the claim of the instant application may not be explicitly drawn to composition of matter, it is drawn to the making of a composition of matter of overlapping scope to the composition of the ‘177 patent. The main difference in the composition being made in the instant application and the composition of the ‘177 patent is the inclusion of POE fatty acid esters. However, the inclusion of POE fatty acid esters is taught in claim 8 of the ‘177 patent. Furthermore the composition being made by the method of claim 46 of the instant application would fall squarely within the scope of the composition of the ‘177 patent, as claim 1 of the ‘177 patent is broader. With regards to the isosorbide POE fatty acid itself, both claim 53 of the instant application and claim 8 of the ‘177 patent recite identical isosorbide compounds. Given that the inventions of the instant application and the ’177 patent are drawn to such overlapping subject matter, they cannot be considered as patentably distinct inventions.
Conclusion
Claims 46-47, 49-50, 53-55, 57-58, 60, 66-67, 70, 72, and 78 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC TRAN whose telephone number is (571)272-7854. The examiner can normally be reached Mon-Fri 8:00-5:00.
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, Jeffrey S Lundgren can be reached at (571) 272-5541. 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.
/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
Prosecution Insights