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 .
DETAILED ACTION
Priority
The present application is a continuation of U.S. Application Number 17/293,431 filed May 12, 2021, which is the National Stage of International Application Number PCT/IB2019/001230 filed November 13, 2019, which claims the benefit of U.S. Provisional Application Number 62/760,439, filed on November 13, 2018, that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 05/15/2025 is acknowledged. Claims 16-41 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/15/2025 and 05/20/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) are being considered by the Examiner.
Claim Objections
Claims 31 and 33 are objected to for the following informalities:
Claims 31 and 33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 Langi, 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
on line using web-screens. An eTerminal Disclaimer that meets all requirements is autoprocessed
and approved immediately upon submission. For more information about eTerminal
Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16-30, 32 and 34-41 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12128100. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another.
The patented claims are directed to:
Claim 1. An immunogenic composition comprising: (a) an HBsAg antigen comprising S protein, Pre-S1 protein and Pre-S2 protein; and (b) an aluminum phosphate adjuvant, wherein the composition comprises at least 20 μg/ml of HBsAg antigen and the amount of non-adsorbed antigen is at least 30%; Claim 2. The immunogenic composition of claim 1 wherein the aluminum is present in a concentration of 500 μg/ml; Claim 3. The immunogenic composition of claim 1 wherein the HBsAg antigen is present in a concentration of 20 μg/ml; Claim 4. The immunogenic composition of claim 1 wherein the HBsAg antigen is present in a concentration of 40 μg/ml; Claim 5. The immunogenic composition of claim 1 wherein the HBsAg antigen is present in a concentration of 60 μg/ml;
The patented claim lists an aluminum phosphate adjuvant but does not disclose antigen/adjuvant ratios from about 40:62.5 to about 20:500, 40:500 and 60:500.
However, it is not inventive and considered routine and obvious to one of ordinary skill in the art to determine antigen/adjuvant ratios through routine experimentation. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. According to section 2144.05 of the M.P.E.P., "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). It would have been obvious for one of ordinary skill to determine the appropriate percentage/parts by weight of the components by routine experimentation procedures known in the art. Given the wide range of antigen-to-adjuvant ratio and absent unexpected results, one of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to achieve the maximum (production or activity or therapeutic) response from the composition (instant claims 16-23, 30, 32 and 34-36).
6. The immunogenic composition of claim 1 for use inducing a Th1 cell response in a mammal (instant claim 25).
7. Use of the immunogenic composition of claim 1 for manufacture of a drug for inducing a Th1 cell response in a subject (instant claim 25).
8. The use of claim 7 wherein the subject has been infected with Hepatitis B (instant claim 26).
9. A pharmaceutical composition comprising the immunogenic composition of claim 1 and a pharmaceutically acceptable excipient (instant claim 24).
10. The pharmaceutical composition of claim 9 for use in treating a subject suffering from Hepatitis B (instant claim 27).
11. A method of inducing a Th1 cell response in a mammal, said method comprising administering the immunogenic composition of claim 1 (instant claims 25 and 37).
12. A method of treating Hepatitis B in a subject, said method comprising administering a therapeutically effective amount of the immunogenic composition of claim 1 to the subject (instant claims 27 and 38).
13. The method of claim 12 wherein an additional Hepatitis B treatment is administered to the subject prior to, concurrently with, or after administration of the immunogenic composition to the subject (instant claims 27 and 39).
14. The method of claim 13 wherein the additional Hepatitis B treatment is a nucleoside inhibitor or a pegylated interferon alpha (instant claims 28 and 40).
15. The method of claim 13 wherein the additional Hepatitis B treatment is a polymerase inhibitor, an RNase H inhibitor, a TLR agonist, an N-glycosylation inhibitor, an antisense oligonucleotide, an anti-hepatitis B antibody, a capsid inhibitor, a core protein inhibitor, a core assembly modulator, an S-antigen reducer or sequesterer, a nucleic acid polymers, a ccc DNA inhibitor, an interferon, an immune modulator or an siRNA (instant claims 29 and 41).
There is no patentable difference between the claimed composition and methods of the present invention and the patented composition and methods in that the U.S. Patent No. 12128100 (‘100) discloses an immunogenic composition comprising:(a) an HBsAg antigen comprising S protein, Pre-S1 protein and Pre-S2 protein; and (b) an aluminum phosphate adjuvant, wherein the composition comprises at least 20 µg/ml of HBsAg antigen. The composition and the methods with the claimed HBsAg antigen and adjuvant would be prima facia obvious given that it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. According to section 2144.05 of the M.P.E.P., "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). It would have been obvious for one of ordinary skill to determine the appropriate percentage/parts by weight of the components by routine experimentation procedures known in the art. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to achieve the maximum (production or activity or therapeutic) response from the composition. Moreover, The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
Prosecution Insights