DETAILED ACTION
Applicant’s preliminary amendment filed on May 17, 2024 is acknowledged. Claims 1-22 are pending and under examination in this Office action.
Applicant’s preliminary amendment filed on May 17, 2024 is acknowledged. Claims 1-22 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 17, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception without significantly more.
Claims are drawn to a composition comprising a nucleic acid that encodes a RSV-F protein or fragment thereof. The nucleic acid encoding RSV-F protein is a product of nature. Wright et al. (The Journal of Infectious Diseases, 2000, p. 1331-1342 in IDS on 5/17/22) discloses RSV as a leading cause of the respiratory disease in infants and children.
The present claims fail to recite any component of the composition that distinguish the composition comprising the RSV over the RSV found in nature. Therefore, the claims are rejected as being directed to judicial exception.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 8, and 21-22 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Wertz et al. (US Patent 5,149,650).
Regarding present claims 1 and 8. Wertz discloses a method of inducing protective immunity in an infant comprising administering a DNA RSV vaccine in a pregnant female and subsequently administering a DNA RSV vaccine in a 2 to 3 months old infant and a boost vaccination for infants at 6 to 9 months of age (see Example 5, in column 20, lines 60-68 and claims 1-12).
Regarding present claims 21-22. Wertz discloses a recombinant expression vector DNA molecule comprising a DNA sequence encoding human respiratory syncytial virus structural proteins selected from the group consisting of: a) F protein; b) G protein; c) 22K protein; d) 9.5K protein; and e) major capsid protein N (see claims 1-12 and Examples 1-5). Wertz discloses RNA encoding RSV (see Example 1).
Regarding present claims 1 and 8. Wertz discloses administering the RSV vaccine to the pregnant woman and to the infant born to the mother (see “(column 20, lines 60-68 in Wertz, “The vaccine can be administered to pregnant women or to women of child-bearing age to stimulate material HRSV antibodies. The female can be revaccinated as needed. Infants can be vaccinated at 2 to 3 months of age and revaccinated as necessary, preferably at 6 to 9 months of age. Babies born to unvaccinated mothers can be vaccinated at 2 to 3 months of age).
Regarding present claims 1 and 8. Wertz discloses administering an RSV vaccine in a pregnant woman and in an infant born to the pregnant woman (see Example 5 in column 20, lines 60-68). The RSV vaccine in Werts is a recombinant DNA molecule comprising a DNA sequence encoding human respiratory syncytial virus structural proteins selected from the group consisting of: F protein; G protein; 22K protein; 9.5K protein; major capsid protein N (see claims 1-26). Wertz teaches vaccinating babies born to vaccinated mother at 2 to 3 months of age (see column 20, lines 60-68).
Thus, by this disclosure Wertz anticipates the present claims.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wertz et al. (US Patent 5,149,650) in view of Fleeton et al. (Journal of Infectious Diseases, 2001, Vol. 183, p. 1395-1398 in IDS on 5/17/2022).
Regarding claims 1-20. Wertz teaches administering an RSV vaccine in a pregnant woman and in an infant born to the pregnant woman (see Example 5 in column 20, lines 60-68). The RSV vaccine in Werts is a recombinant DNA molecule comprising a DNA sequence encoding human respiratory syncytial virus structural proteins selected from the group consisting of: F protein; G protein; 22K protein; 9.5K protein; major capsid protein N (see claims 1-26). Wertz teaches vaccinating babies born to vaccinated mother at 2 to 3 months of age (see column 20, lines 60-68).
“The vaccine can be administered to pregnant women or to women of child-bearing age to stimulate material HRSV antibodies. The female can be revaccinated as needed. Infants can be vaccinated at 2 to 3 months of age and revaccinated as necessary, preferably at 6 to 9 months of age. Babies born to unvaccinated mothers can be vaccinated at 2 to 3 months of age. “(column 20, lines 60-68 in Wertz).
Wertz does not teach administering the RSV vaccine during the second or third trimester of pregnancy or wherein the administering occurs one or more times immediately after birth, two, four or six weeks after birth. Wertz does not expressly teach self-replicating RNA.
Regarding claims 2-6 and 9-15. It would have been prima facie obvious to provide the method of Wertz and to administer the RSV vaccine during the second or third trimester of pregnancy because Wertz teaches administering the RSV vaccine to pregnant women.
Regarding present claims 6-7. Fleeton teaches self-replication RNA RSV vaccine comprising RSV-F envelope protein and methods of inducing protective immune reposes due to immunization with a pSFV plasmid encoding F envelope protein from RSV (see Materials and Methods and Results, Figure 1).
Regarding claims 1-20. It would have been prima facie obvious to provide the method of Wertz comprising administering Fleeton’s self-replicating RNA encoding RSV F polypeptide because Fleeton teaches that the replicase functions to propagate the antigen-encoding mRNA inside the transfected host cell. This replication process affects an immune response in several ways by higher antigen production in vivo, which allows for the induction of effective immune responses with lower input doses of RNA than those required for conventional mRNA vaccination. Second, the amplification process, which mimics viral infection, results in the synthesis of double-stranded RNA intermediates that may operate as a natural adjuvant to the immune system (see page 1397 (left column). Fleeton teaches that responses induced by administering self-replication RNA encoding RSV F protein were sufficient to induce protective immunity from peripheral challenge with RSV. Fleeton teaches that similar to vaccination with other alpha viral vaccine vectors, a predominantly Th1 type immune response was induced, as determined by levels of IgG2a and IgG1 antibody isotypes in serum samples. Fleeton teaches that his is particularly important for vaccination against RSV, in which a Th2 type immune response, such as that elicited after FI-RSV vaccination, is associated with immunopathology and more severe lung disease after infection (see page 1398, left column).
Thus, the present invention would have been prima facie obvious at the time the invention was made
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,813,323. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claim are drawn to A method for providing protective immunity against RSV in an infant, comprising (a) administering a first anti-RSV immune response inducing composition to a female during pregnancy, wherein the first anti-RSV immune response inducing composition comprises an RSV nucleic acid, a recombinant viral vector, or a viral replication particle; and (b) administering a second anti-RSV immune response inducing composition to the infant that is born from the pregnancy, wherein the second anti-RSV immune response inducing composition comprises an RSV nucleic acid, a recombinant viral vector, or a viral replication particle.
Claims 21-22 are drawn to An anti-RSV immune response inducing composition comprising an RSV nucleic acid, a recombinant viral vector, or a viral replication particle that provides protective immunity against RSV in an infant born from a female who was administered an anti-RSV immune response inducing composition comprising an RSV nucleic acid, a recombinant viral vector, or a viral replication particle during pregnancy with said infant.
The present claims are obvious over the claims of the U.S. Patent No. 11,813,323 because they are all drawn to the same methods and products of providing protective immunity against RSV in an infant, comprising (a) administering a first anti-RSV immune response inducing composition to a female during pregnancy.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,342,862. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claim are drawn to A method for providing protective immunity against RSV in an infant, comprising (a) administering a first anti-RSV immune response inducing composition to a female during pregnancy, wherein the first anti-RSV immune response inducing composition comprises an RSV nucleic acid, a recombinant viral vector, or a viral replication particle; and (b) administering a second anti-RSV immune response inducing composition to the infant that is born from the pregnancy, wherein the second anti-RSV immune response inducing composition comprises an RSV nucleic acid, a recombinant viral vector, or a viral replication particle.
Claims 21-22 are drawn to An anti-RSV immune response inducing composition comprising an RSV nucleic acid, a recombinant viral vector, or a viral replication particle that provides protective immunity against RSV in an infant born from a female who was administered an anti-RSV immune response inducing composition comprising an RSV nucleic acid, a recombinant viral vector, or a viral replication particle during pregnancy with said infant.
The claims of the US Patent 10,342,862 are drawn to A method for providing protective immunity against RSV in an infant, comprising (a) administering a first anti-RSV immune response inducing composition to a female during pregnancy, wherein the first anti-RSV immune response inducing composition comprises an RSV subunit composition; and (b) administering a second anti-RSV immune response inducing composition to the infant that is born from the pregnancy, wherein the second anti-RSV immune response inducing composition comprises an RSV nucleic acid, a recombinant viral vector, or a viral replication particle.
The present claims are obvious over the claims of the US Patent 10,342,862 because both the present claims and the claims of the US Patent 10,342,862 are drawn to a method of inducing an immune response against RSV in an infant by immunizing a pregnant woman a composition comprising RSV-F protein.
The present claims are obvious over the claims of the U.S. Patent No. 11,813,323 because they are all drawn to the same methods and products of providing protective immunity against RSV in an infant, comprising (a) administering a first anti-RSV immune response inducing composition to a female during pregnancy.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,452,773. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claim are drawn to A method for providing protective immunity against RSV in an infant, comprising (a) administering a first anti-RSV immune response inducing composition to a female during pregnancy, wherein the first anti-RSV immune response inducing composition comprises an RSV nucleic acid, a recombinant viral vector, or a viral replication particle; and (b) administering a second anti-RSV immune response inducing composition to the infant that is born from the pregnancy, wherein the second anti-RSV immune response inducing composition comprises an RSV nucleic acid, a recombinant viral vector, or a viral replication particle.
Claims 21-22 are drawn to An anti-RSV immune response inducing composition comprising an RSV nucleic acid, a recombinant viral vector, or a viral replication particle that provides protective immunity against RSV in an infant born from a female who was administered an anti-RSV immune response inducing composition comprising an RSV nucleic acid, a recombinant viral vector, or a viral replication particle during pregnancy with said infant.
The claims of the US Patent 11,452,773 are drawn to A method for providing protective immunity against RSV in an infant, comprising (a) administering a first anti-RSV immune response inducing composition to a female during pregnancy, wherein the first anti-RSV immune response inducing composition comprises an RSV nucleic acid that encodes a RSV-F protein or fragment thereof, a recombinant viral vector that encodes a RSV-F protein or fragment thereof, or a viral replication particle that encodes a RSV-F protein or fragment thereof; and (b) administering a second anti-RSV immune response inducing composition to the infant that is born from the pregnancy, wherein the second anti-RSV immune response inducing composition comprises an RSV nucleic acid that encodes a RSV-F protein or fragment thereof, a recombinant viral vector that encodes a RSV-F protein or fragment thereof, or a viral replication particle that encodes a RSV-F protein or fragment thereof; wherein the first anti-RSV immune response inducing composition comprises a ribonucleic acid (RNA) that encodes a RSV-F protein or fragment thereof, the second anti-RSV immune response inducing composition comprises an RNA that encodes a RSV-F protein or fragment thereof, or the first and second anti-RSV immune response inducing compositions each comprise an RNA that encodes a RSV-F protein or fragment thereof.
The present claims are obvious over the claims of the US Patent 11,452,773 because both the present claims and the claims of the US Patent 11,452,773 are drawn to a method of inducing an immune response against RSV in an infant by immunizing a pregnant woman a composition comprising RSV-F protein.
Contact Information
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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