Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Application
The preliminary amendment filed on 12/01/23 is acknowledged.
Claims 1-36 were cancelled.
New claims 37-52 were added and are included in the prosecution.
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 37-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-50 of U.S. Patent No. 10,561,720 B2 (“the ‘720 Patent”).
Please note that the instant application is a continuation (CON) of Application No. 157/890,747, now abandoned, and is ultimately a CON of application No. 13/531,433, , now Pat. No. 10,561,720 B2.
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Application No. 13/531,433 was restricted on 03/13/13 into two groups (Group I – composition and Group II method of modulating an immune response). Applicant elected Group I without traverse on 04/12/13.
Based on MPEP 804.01, the prohibition against non-statutory double patenting (NSDP) is not in effect. 35 U.S.C. 121’s prohibition on double patenting only applies when a divisional application is filed as a result of a restriction requirement.
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of modulating an immune response in a mammalian subject comprising administering to the subject a composition consisting essentially of an emulsion, wherein the emulsion consists essentially of components (i); (ii); and (iii), and therefore, encompass overlapping or coextensive subject matter.
The difference is that instant claim 1 is drawn to a method of modulating an immune response in a mammalian subject comprising administering to the subject a composition consisting essentially of an emulsion, wherein the emulsion consists essentially of components (i); (ii); and (iii), whereas claim 1 of the ‘720 Patent is drawn to a composition consisting essentially of components (i); (ii); and (iii).
However, claims 23, 31, 39, and 44 recite that the composition consisting essentially of the same components (i); (ii); and (iii) modulates an immune response in a subject when administered to the subject, thereby rendering the instant method obvious.
Therefore, instant claims are obvious over claims of the ‘720 Patent and they are not patentably distinct over each other.
Pertinent Art
The closest prior art references are made of record but not relied upon for the reasons below.
Jenning (DE 199 35 763 A1 – English Espacenet machine translation – pp. 1-15 and original German document – pp. 16-25 of the attached PDF) is cited as art of interest for teaching a retinoid-containing oil-in-water emulsion comprising polyphenol(s) of catechol structure, retinol, retinol ester and/or retinaldehyde, an emulsion vehicle comprising a continuous water phase, an oil phase and physical stabilizers (Abstract, [0021], [0030], Example 1, and claims 1-14). Example 1 is an oil-in-water emulsion which contains 3.0% squalene, 1.0% tocopherol acetate, 0.1% retinol, and 0.2% of the flavonoid rutin ([0021] and [0030] in the English machine translation and the table on Page 5 of the original German document). However, Jenning does not teach or suggest a method of modulating an immune response comprising administering an emulsion consisting essentially of components (i), (ii), and (iii), particularly, grape seed oil or squalene oil, at least one flavonoid in an amount of about 0.1 to about 2000 mg as recited in instant claims 37, squalene oil or flavonoid as recited in claim 42, or aluminum hydroxide and an antigen as recited in instant claim 50.
Ishida et al. (US 2006/0088485 A1) disclose an emulsion comprising 0.05% by mass of tocopherol acetate, 2.0% by mass of squalene, and 1.0% by mass of the flavonoid arbutin (Abstract, [0063], and Example 7 – [0137]). However, Ishida et al. do not teach or suggest a method of modulating an immune response comprising administering an emulsion consisting essentially of components (i), (ii), and (iii), as recited in the instant claims.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615