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 .
Claims 1-20 are pending and are under examination.
Claim Objections Withdrawn
The objection to claim 16 is withdrawn in view of the amendment to the claim.
The rejection of claim(s) 17-18 and 20 under 35 U.S.C. 102(a)(1) as being anticipated by Helou et al. PLOS Neglected Tropical Diseases https://doi.org/10.1371/journal.pntd.0009627 August 17, 2021 (19 pages) is withdrawn. Applicant’s argument has been found persuasive regarding claims 17-18 and 20.
The rejection of Claim(s) 17-18 and 20 under 35 U.S.C. 102(a)(2) as being anticipated by Betbeder et al. US 2023/0338497 10/26/2023 with priority to PCT/FR2021/051270 filed 7/8/2021 is withdrawn. Applicant’s argument has been found persuasive regarding claims 17-18 and 20.
The rejection of claim(s) 1-2, 5-10, 12-18 and 20 under 35 U.S.C. 102(a)(2) as being anticipated by Betbeder et al. US 2023/0338497 10/26/2023 with priority to FR2007338 January, 10, 2020 (machine attached) as being a duplicate of the rejection of claims 1-2, 5-10, 12-18 and 20 under 35 U.S.C. 102(a)(2) as being anticipated by Betbeder et al. US 2023/0338497 10/26/2023 with priority to PCT/FR2021/051270 filed 7/8/2021.
The rejection of claim(s) 19 under 35 U.S.C. 103 as being unpatentable over Helou et al. PLOS Neglected Tropical Diseases | https://doi.org/10.1371/journal.pntd.0009627 August 17, 2021 (19 pages) in view of Doroud et al. Expert Rev. Vaccines 11(1), 69-86 (2012) is withdrawn. Applicant’s argument has been found persuasive regarding claim 19.
The rejection of claim(s) 1, 3, 11 and 19 under 35 U.S.C. 103 as being unpatentable over Betbeder et al. US 2023/0338497 10/26/2023 with priority to PCT/FR2021/051270 filed 7/8/2021
The rejection of claim(s) 1, 3, 11 and 19 under 35 U.S.C. 103 as being unpatentable over Betbeder et al. US 2023/0338497 10/26/2023 with priority to FR2007338 7/10/2020 (machine translation attached) is withdrawn.
The rejection of claims 17-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/004980 (‘980) as applied to claims 1-2, 5-10, 12-18 and 20 above, further in view of Doroud et al. Expert Rev. Vaccines 11(1), 69-86 (2012) is withdrawn. Applicants’ argument with regards to Doroud is found persuasive.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-10, 12-18 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Betbeder et al. US 9,731,005 8/15/17 cited in IDS.
Claim 1: Betbeder et al disclose a therapeutic vaccine for treating an individual carrying a disease or an intracellular pathogen that does not affect the central nervous system, comprising at least one cationic nanoparticle including a cationic polysaccharide core and a specific antigen, wherein the antigen is specific to the intracellular pathogen or disease. See column 3 lines 17-25 and claim 1.
Claim 2: Betbeder et al disclose the specific antigen is from a pathogen responsible for leishmaniasis. See column 3 lines 17-25 and claim 1.
Claim 5: Betbeder disclose that the cationic polysaccharide core is crosslinked. See column 3 lines 30-37.
Claim 6: Betbeder disclose that the cationic polysaccharide core is loaded with an anionic phospholipid. See abstract, column 2 lines 9-18, column 3 lines 38-42.
Claim 7: Betbeder disclose that the anionic phospholipid is selected from diacyl phosphatidylglycerol, diacyl phosphatidylserine or diacyl phosphatidylinositol. See column 3 lines 38-42.
Claim 8: Betbeder disclose that the anionic phospholipid is dipalmitoylphosphatidylglycerol (DG). column 3 lines 38-42.
Claim 9: Betbeder disclose a vaccine composition comprising a cationic nanoparticle consisting of a cationic polysaccharide core and a pathogen-specific antigen that cannot pass the a hematoencephalic barrier or a peripheral disease, for use in the treatment of diseases stemming from the pathogen. See column 2 lines 9-24, column 3 lines 60-67, column 4 line 24, column 6 lines 15-18, claim 1, claim 5 and claim 18.
Claim 10: Betbeder disclose the antigen is from the species Leishmania. See claim 1, claim 5 and claim 18.
Claim 12: Betbeder disclose the antigen is from a parasite. See column 3 lines 60-67, claim 1, claim 4, claim and claim 5.
Claim 13: Betbeder disclose the antigen is from a virus. See column 3 lines 60-67, claim 1, claim 4, claim and claim 5.
Claim 14: Betbeder disclose the antigen is from a bacterium. See column 3 lines 60-67, claim 1, claim 4, claim and claim 5.
Claim 15: Betbeder disclose the antigen is from a fungus. See column 3 lines 60-67, claim 1, claim 4, claim and claim 5.
Claim 16: Betbeder disclose the vaccine composition is in a form suitable for mucosal or injectable administration e.g. such as in liquid form. See column 5 lines 38-39.
Claim 17: Betbeder et al disclose a method of treating a patient an intracellular pathogen that does not affect the central nervous system, comprising administering to the patient a therapeutically effective amount of a substance comprising at least one cationic nanoparticle including a cationic polysaccharide core and a specific antigen, wherein the antigen is specific to the pathogen thereby treating the disease or pathogen in the patient. See claims 1-20 especially claims 10-14 and column 2 lines 11-56.
Claim 18: Betbeder et al disclose the antigen is from the species Leishmania. See claim 1, claim 5 and claim 18.
Claim 20: Betbeder et al disclose the cationic polysaccharide core is crosslinked See column 3 lines 30-37.
Response to Applicants’ Argument
Applicant argues that Betbeder discloses a prophylactic composition for use against intracellular pathogens, with the aim of preventing or delaying symptom onset and that the composition of Betbeder comprises cationic polysaccharide-based nanoparticles loaded with an anionic phospholipid and an antigen, designed for mucosal or parenteral administration and that nowhere in Betbeder is there any indication or suggestion of administering the composition therapeutically, i.e., after the onset of disease, nor of using the vaccine in patients already infected.
Applicants argue that In contrast, claim 1 is explicitly directed to a therapeutic vaccine for treating an individual carrying a disease or an intracellular pathogen that does not affect the central nervous system and that this distinction is critical, as therapeutic vaccines are fundamentally intended to modulate the immune system in already-infected patients, to control, reduce, or eliminate the pathogen, rather than to prevent infection.
Applicants argument has been considered but is not found persuasive. Applicants argument are drawn to the intended use of the therapeutic vaccine of claim 1 and dependent claims and claim 9 and dependent claims.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, Betbeder et al discloses the components of the therapeutic vaccine of claim 1 and claim 9 as claimed. Therefore, the compositions of claim 1 and claim 9 are capable of performing the intended use recited and thus claim 1, 9 and their dependent claims are anticipated.
Regarding claim 17 and dependent claims drawn to a method of treating a patient infection with a disease or an intracellular pathogen, Betbeder et al does disclose the method step of administering to a patient infected with an intracellular pathogen such as Leishmania which does not affect the central nervous system (see paragraph 24 and Betbeder et al claim 10 “an intracellular pathogen in a patient”) said method comprising to said patient a “therapeutic amount of the composition of claim 1”. Betbeder et al defines the term “treating” and “therapeutic”: the term “treating” includes the administration of the composition of the invention to prevent or delay, to alleviate, or to arrest or inhibit development of the symptoms or conditions associated with a disease, condition or disorder as described herein. The term “therapeutic” refers at least to the partial reduction, elimination, or prevention of the disease, symptoms of the disease, or side effects of the disease in the subject. See paragraph 12. Betbeder et al disclose in paragraph 39 “the present invention also relates to a method for eliciting an immune response against an intracellular pathogen in a patient, said method comprising administrating to a patient a therapeutic amount of a composition of the invention or a vaccine of the invention”.
Thus, Betbeder et al discloses administering therapeutic amount of a substance comprising at least one cationic nanoparticle including a cationic polysaccharide core and a specific antigen of an intracellular pathogen that does not affect the CNS wherein the pathogen is leishmania.
For this reason, Applicants arguments that there is no indication or suggestion of administering the composition therapeutically is not found persuasive.
For these reasons and for those set forth in the prior Office Action, the rejection is maintained.
Claim(s) 1, 4-6, 16, 17 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipate by Farokhzad et al. WO 2020/123661 6/18/2020.
Claims 1, 4: Farokhzad et al disclose a therapeutic vaccine for treating an individual carrying a disease that does not affect the central nervous system, comprising at least one cationic nanoparticle including a cationic polysaccharide core such as dextran, starch, chitosan, allyl sucrose crosslinked and a specific antigen (mRNA encoding tumor suppressor p53), wherein the antigen is specific to the disease. See abstract, p. 2 lines 15-17, p. 24 lines 27-33, p. 28, p. 29 lines 29-33, p. 30 line 8,
Claim 5: Farokhzad et al disclose that the cationic polysaccharide core is crosslinked e.g. allyl sucrose crosslinked. See p. 30 line 21.
Claim 6: Farokhzad disclose that the cationic polysaccharide core is loaded with an anionic phospholipid. See p. 46 starting from line 14 disclosing the core of the particle comprises a complexing agent and p. 49 lines 23-23 disclose the anionic phospholipid is 1,2-di-O-tetradecyl- sn-glycero-3 -phospho-( 1 '-rac- glycerol),1 ,2-dihexadecanoyl-sn-glycero-3 -phospho-( 1 '-sn- glycerol)).
Claim 16: Farokhzad et al disclose a vaccine composition comprising the cationic nanoparticle in a form suitable for mucosal e.g. nasal or injectable administration. See p. 55 lines 21-30 and p. 56 lines 16-20
Claim 17: Farokhzad et al disclose a method of treating a patient an intracellular pathogen that does not affect the central nervous system, comprising administering to the patient a therapeutically effective amount of a substance comprising at least one cationic nanoparticle including a cationic polysaccharide core and a specific antigen, wherein the antigen is specific to the disease (cancer). See p. 22 under methods of treating to page 24.
Claim 20: Farokhzad et al disclose that the cationic polysaccharide core is crosslinked e.g. allyl sucrose crosslinked. See p. 30 line 21.
Response to Applicant’s Argument:
Applicant argues that Farokhzad relies on mRNA vaccine technology in which antigen is encoded by a nucleic acid sequence encapsulated with within a lipid or polymer-based nanoparticle, and is translated in vivo by host cells and that in contrast, the present patent application claims a vaccine composition in which the antigen is already formed specifically, a purified protein or peptide derived from the pathogen, physically loaded into a solid nanoparticle and that this delivery approach involves direct antigen presentation via the MHC class II pathway, as opposed to endogenous translation and presentation via MHC class I and these two vaccine systems are fundamentally different in design, immunological function, and intended immune response.
Applicants’ argument has been carefully considered but is not found persuasive because the definition of antigen provided in the instant specification is much broader than protein alone.
The specification at paragraph 52 defines antigen to mean an antigenic protein, a mixture of antigen proteins or a partial or total extract of pathogen. For this rejection, the mRNA is considered a partial extract of a pathogen. Since Applicant intends for antigen to be limited to protein as evidenced by the desire for direct antigen presentation via MHC claims II pathway, the claims can be amended to recited protein antigen.
Applicant states that Farokhzad does not disclose a porous, solid cationic polysaccharide core-such as cross-linked chitosan or dextran-loaded with both an anionic phospholipid and a purified antigens as claimed in the present application.
Applicants’ argument has been carefully considered but is not found persuasive. This is because the dependent claims do not recite a porous, solid cationic polysaccharide core-such as cross-linked chitosan or dextran-loaded with both an anionic phospholipid and a purified antigens.
Moreover, as set forth in the rejection above Farokhzad et al disclose a therapeutic vaccine comprising at least one cationic nanoparticle including a cationic polysaccharide core such as dextran, starch, chitosan, allyl sucrose crosslinked and a specific antigen (mRNA encoding tumor suppressor p53), wherein the antigen is specific to the disease. See abstract, p. 2 lines 15-17, p. 24 lines 27-33, p. 28, p. 29 lines 29-33, p. 30 line 8,
Farokhzad et al disclose that the cationic polysaccharide core is crosslinked e.g. allyl sucrose crosslinked. See p. 30 line 21.
Farokhzad disclose that the cationic polysaccharide core is loaded with an anionic phospholipid. See p. 46 starting from line 14 disclosing the core of the particle comprises a complexing agent and p. 49 lines 23-23 disclose the anionic phospholipid is 1,2-di-O-tetradecyl- sn-glycero-3 -phospho-( 1 '-rac- glycerol),1 ,2-dihexadecanoyl-sn-glycero-3 -phospho-( 1 '-sn- glycerol)).
For these reasons and for those set forth in the prior Office Action, the rejection is maintained.
Claim(s) 1-2, 5-10, 12 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Helou et al. PLOS Neglected Tropical Diseases https://doi.org/10.1371/journal.pntd.0009627 August 17, 2021 (19 pages).
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Helou et al disclose a therapeutic vaccine comprising at least one cationic nanoparticle including a cationic polysaccharide core (maltodextrin) loaded with anionic phospholipid (1,2-dipalmitoyl-sn-glycero-3-phosphatidylglycerol) and Leishmania donovani antigen. Helou et al disclose that disclose the cationic polysaccharide is crosslinked (reticulation) and loaded with anionic phospholipid such as diacyl phosphatidyl glycerol, diacyl phosphatidyl serine, diacyl phosphatidyl inositol, dipalmitoylphospharidyl glycerol. Helo et al disclose the composition is in a form suitable for mucosal (intranasal) or injectable administration. See p. 3-4 under LdAg preparation and vaccination, p. 5 under NP preparation. Helou et al disclose a method of treating a patient infected with an Leishmania donovani, comprising administering the cationic particle in effective amounts to the patient. See p. 3-4 under LdAg preparation and vaccination and entirety of the reference.
Response to Applicants’ Argument.
Applicants argue that Helou describes strict prophylactic vaccination approach using L. donovani antigens and they are delivered prior to infection and that Helou does not suggest administration after infection has occurred.
Helou et al disclose the same composition as set forth in the rejection above regardless of whether the composition is administered before or after infection.
Regarding claim 1, 9 and their respective dependent claims, in response to applicant's argument, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Helou et al disclose the same composition as set forth in the rejection above regardless of whether the composition is administered before or after infection. Thus, claim 1, 9 and their respective dependent claims are anticipated.
Claim(s) 1-2, 5-10 and 12-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Betbeder et al. US 2023/0338497 10/26/2023 with priority to PCT/FR2021/051270 filed 7/8/2021.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Betbeder et al disclose a therapeutic vaccine comprising at least one cationic nanoparticle including a cationic polysaccharide core and an antigen wherein, the antigen can be from parasite, virus, bacterium or fungus or Leishmania spp. or intracellular parasites. Betbeder et al disclose the cationic polysaccharide is crosslinked and loaded with anionic phospholipid such as diacyl phosphatidyl glycerol, diacyl phosphatidyl serine, diacyl phosphatidyl inositol, dipalmitoylphospharidyl glycerol. Betbeder et al disclose the composition is an aqueous solution which is a form suitable for mucosal or injectable administration. See p. 1 to page 9, claims 1-14 and the list of pathogens at p. 3-4.
Response to Applicants’ Argument
Applicant argues that Betbeder discloses a vaccine strategy that is strictly prophylactic while claim 1 is directed to a therapeutic use and nowhere does Betbeder suggest administration to an already-infected individual, nor any curative or post-infection use.
Applicants argument has been considered but is not found persuasive. Applicants argument are drawn to the intended use of the therapeutic vaccine of claim 1 and dependent claims and claim 9 and dependent claims.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, Betbeder et al discloses the components of the therapeutic vaccine of claim 1 and claim 9 as claimed. Therefore, the compositions of claim 1 and claim 9 are capable of performing the intended use recited and thus claim 1, 9 and their dependent claims are anticipated. Furthermore, the claims are drawn to a composition and is not drawn to a method of administering the therapeutic vaccine to a subject who is already infected.
With respect to claim 1, 9 and their dependent claims, Betbeder et al disclose a therapeutic vaccine comprising at least one cationic nanoparticle including a cationic polysaccharide core and an antigen wherein, the antigen can be from intracellular pathogens such as parasite, virus, bacterium or fungus or Leishmania spp. or intracellular parasites that do not affect the central nervous system. See list of all the pathogens p. 3-4. Betbeder et al disclose the cationic polysaccharide is crosslinked and loaded with anionic phospholipid such as diacyl phosphatidyl glycerol, diacyl phosphatidyl serine, diacyl phosphatidyl inositol, dipalmitoylphospharidyl glycerol. Betbeder et al disclose the composition is an aqueous solution which is a form suitable for mucosal or injectable administration. See p. 1 to page 9, claims 1-14.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The rejection of claim(s) 1-3 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helou et al. PLOS Neglected Tropical Diseases | https://doi.org/10.1371/journal.pntd.0009627 August 17, 2021 (19 pages) in view of Doroud et al. Expert Rev. Vaccines 11(1), 69-86 (2012).
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Helou et al disclose a therapeutic vaccine comprising at least one cationic nanoparticle including a cationic polysaccharide core (maltodextrin) loaded with anionic phospholipid (1,2-dipalmitoyl-sn-glycero-3-phosphatidylglycerol) and Leishmania donovani antigen. Helou et al disclose that disclose the cationic polysaccharide is crosslinked (reticulation) and loaded with anionic phospholipid such as diacyl phosphatidyl glycerol, diacyl phosphatidyl serine, diacyl phosphatidyl inositol, dipalmitoylphospharidyl glycerol. Helou et al disclose the composition is in a form suitable for mucosal (intranasal) or injectable administration. See p. 3-4 under LdAg preparation and vaccination, p. 5 under NP preparation. Helou et al disclose a method of treating a patient infected with an Leishmania donovani, comprising administering the cationic particle in effective amounts to the patient. See p. 3-4 under LdAg preparation and vaccination and entirety of the reference.
Helou et al does not disclose the antigen is specific to Leishmania infantum.
Doroud et al disclose that nanoparticulate delivery systems can be used to induce an appropriate immune responses against leishmaniasis. See abstract. Doroud et al disclose the inadequate immunogenicity of Leishmania subcellular antigens might be improved through apply delivery systems in the form of nanocarrier which could protect antigenic proteins or DNA from rapid degradation. See p. 81 under key issues.
Doroud et al disclose that Leishmania infantum causes leishmaniasis particularly visceral leishmaniasis and can also induce cutaneous lesions. See under “what is Leishmania and leishmaniasis” from page 69-70, particular p. 70 column 2 paragraph 4 and entirety of Doroud et al.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date to have used the nanoparticle delivery system of Helou et al to deliver antigen from other medically important Leishmania species that cause visceral leishmaniasis such as from Leishmania infantum, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Helou et al disclose that a Leishmania antigen can be delivered with a cationic nanoparticle and Doroud et al disclose that nanoparticulate delivery systems can be used to induce an appropriate immune responses against leishmaniasis caused by Leishmania infantum, and therefore delivering Leishmania infantum antigens using the nanoparticle of Helou et al would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date. Moreover, Helou et al disclose that their study provides a simple and cost effective vaccine strategy against visceral leishmaniasis based on LdAg administration via intranasal route, which could be applicable to other parasitic diseases. See Helou et al at abstract.
Response to Applicants Argument
Applicants argue that Helou does not teach or suggest a therapeutic vaccine for treating an individual carrying a disease or an intracellular pathogen that does not affect the CNS, comprising at least one cationic nanoparticle including a cationic polysaccharide core and a specific antigen that is specific to the pathogen or disease as recited in claim 1.
Claim 1 and 9 and dependent claims are composition claims.
Applicants argue that Helou describes strict prophylactic vaccination approach using L. donovani antigens and they are delivered prior to infection and that Helou does not suggest administration after infection has occurred.
Helou et al disclose the same composition as set forth in the rejection above regardless of whether the composition is administered before or after infection.
Regarding claim 1, 9 and their respective dependent claims, in response to applicant's argument, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Helou et al disclose the same composition as set forth in the rejection above regardless of whether the composition is administered before or after infection. Thus, claim 1, 9 and their respective dependent claims are anticipated.
Applicants argue that Doroud et al is a literature review summarizing various nanoparticle based vaccine studies against leishmania in a prophylactic framework and that Doroud et al does not provide suggestion or motivation to apply the reviewed technologies for the treatment of already established infection.
Applicants argument are not found persuasive because Applicants argument is drawn to the intended use of the instant composition. The rejected claims are not drawn to a administering the composition to a subject infected with intracellular pathogen.
Claim(s) 1-3, 9-11 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Betbeder et al. US 9,731,005 8/15/17 cited in IDS in view of Doroud et al. Expert Rev. Vaccines 11(1), 69-86 (2012).
Betbeder et al disclose a therapeutic vaccine for treating an individual carrying a disease or an intracellular pathogen that does not affect the central nervous system, comprising at least one cationic nanoparticle including a cationic polysaccharide core and a specific antigen, wherein the antigen is specific to the intracellular pathogen or disease. See column 3 lines 17-25 and claim 1.
Betbeder et al disclose the specific antigen is from a pathogen responsible for leishmaniasis. See column 3 lines 17-25 and claim 1.
Betbeder et al does not disclose the antigen is specific to Leishmania infantum.
Doroud et al disclose that nanoparticulate delivery systems can be used to induce an appropriate immune responses against leishmaniasis. See abstract. Doroud et al disclose the inadequate immunogenicity of Leishmania subcellular antigens might be improved through apply delivery systems in the form of nanocarrier which could protect antigenic proteins or DNA from rapid degradation. See p. 81 under key issues.
Doroud et al disclose that Leishmania infantum causes leishmaniasis particularly visceral leishmaniasis and can also induce cutaneous lesions. See under “what is Leishmania and leishmaniasis” from page 69-70, particular p. 70 column 2 paragraph 4 and entirety of Doroud et al.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date to have used the nanoparticle delivery system of Betbeder et al to deliver an antigen (as the specific antigen) from Leishmania infantum, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Betbeder et al disclose the antigen in the cationic nanoparticle is from Leishmania and Doroud et al disclose that nanoparticulate delivery systems can be used to induce an appropriate immune responses against leishmaniasis caused by Leishmania infantum, and therefore delivering Leishmania infantum antigens using the nanoparticle of Betbeder et al would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date. Moreover, Doroud et al disclose that the immunogenicity of Leishmania subcellular antigens might be improved by delivery via a nanocarrier which could also protect antigenic proteins from rapid degradation. Furthermore, Betbeder et al states that the therapeutic vaccine is a Leishmania antigen and thus using a Leishmania infantum pathogen as one of ordinary skill in the art would have been motivated to treat a L. infantum infection as Doroud et al disclose that L. infantum causes visceral leishmaniasis and they can also induce cutaneous lesions in infected patients.
Response to Applicants’ Argument
Applicant argues that Betbeder there is no disclosure of a therapeutic treatment in already infected individuals and Doroud is a literature review that complies various prophylactic nanovaccine strategies and there is no mention in Betbeder about a therapeutic treatment.
Applicants argument has been considered but is not found persuasive. Applicants argument are drawn to the intended use of the therapeutic vaccine compositions.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, Betbeder et al discloses the components of the therapeutic vaccine or vaccine composition as claimed and are capable of performing the intended use recited.
Regarding the method claim Betbeder et al does disclose the method step of administering to a patient infected with an intracellular pathogen such as Leishmania which does not affect the central nervous system (see paragraph 24 and Betbeder et al claim 10 “an intracellular pathogen in a patient”) said method comprising to said patient a “therapeutic amount of the composition of claim 1”. Betbeder et al defines the term “treating” and “therapeutic”: the term “treating” includes the administration of the composition of the invention to prevent or delay, to alleviate, or to arrest or inhibit development of the symptoms or conditions associated with a disease, condition or disorder as described herein. The term “therapeutic” refers at least to the partial reduction, elimination, or prevention of the disease, symptoms of the disease, or side effects of the disease in the subject. See paragraph 12. Betbeder et al disclose in paragraph 39 “the present invention also relates to a method for eliciting an immune response against an intracellular pathogen in a patient, said method comprising administrating to a patient a therapeutic amount of a composition of the invention or a vaccine of the invention”.
Thus, Betbeder et al discloses administering therapeutic amount of a substance comprising at least one cationic nanoparticle including a cationic polysaccharide core and a specific antigen of an intracellular pathogen that does not affect the CNS wherein the pathogen is leishmania. Furthermore, Betbeder et al states that the therapeutic vaccine is a Leishmania antigen and thus using a Leishmania infantum pathogen as one of ordinary skill in the art would have been motivated to treat a L. infantum infection as Doroud et al disclose that L. infantum causes visceral leishmaniasis and they can also induce cutaneous lesions in infected patients.
For this reason, Applicants arguments that there is no indication or suggestion of administering the composition therapeutically is not found persuasive.
For these reasons and for those set forth in the prior Office Action, the rejection is maintained.
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.
Claim 1-2, 5-10 and 12-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/004980 (‘980). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘980 claims disclose a therapeutic vaccine comprising at least one cationic nanoparticle including a cationic polysaccharide core and an antigen wherein, the antigen can be from parasite, virus, bacterium or fungus or Leishmania spp. The ‘980 claims disclose the cationic polysaccharide is crosslinked and loaded with anionic phospholipid such as diacyl phosphatidyl glycerol, diacyl phosphatidyl serine, diacyl phosphatidyl inositol, dipalmitoylphospharidyl glycerol. The ’980 claims disclose the composition is an aqueous solution which is a form suitable for mucosal or injectable administration.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 3 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/004980 (‘980) as applied to claims 1-2, 5-10 and 12-16 above, further in view of Doroud et al. Expert Rev. Vaccines 11(1), 69-86 (2012).
The ‘980 claims are set forth above but does not disclose the Leishmania antigen is Leishmania infantum antigen and does not disclose a method of treating a patient infected with the intracellular parasite Leishmania.
Doroud et al disclose that Leishmania infantum causes leishmaniasis particularly visceral leishmaniasis and can also induce cutaneous lesions. See under “what is Leishmania and leishmaniasis” from page 69-70, particular p. 70 column 2 paragraph 4 and entirety of Doroud et al.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date to have used the nanoparticle delivery system of the ‘980 claims to deliver an antigen from Leishmania infantum, and administering therapeutically effective amounts of the resulting cationic nanoparticle to a subject infected with Leishmania infantum, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that the ‘980 claims disclose that the nanoparticle can be used to deliver Leishmania antigen and Doroud et al disclose that nanoparticulate delivery systems can be used to induce an appropriate immune responses against leishmaniasis caused by Leishmania infantum, and therefore delivering Leishmania infantum antigens using the nanoparticle of ‘the 980 claims would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date. Moreover, Doroud et al disclose that the immunogenicity of Leishmania subcellular antigens might be improved by delivery via a nanocarrier which could also protect antigenic proteins from rapid degradation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 4 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/004980 (‘980) as applied to claims 1-2, 5-10 and 12-16 above, further in view of Farokhzad et al. WO 2020/123661 6/18/2020.
The ‘980 claims are set forth above but does not disclose the antigen is a tumor antigen.
Farokhzad et al disclose a therapeutic vaccine for treating an individual carrying a disease that does not affect the central nervous system, comprising at least one cationic nanoparticle including a cationic polysaccharide core such as dextran, starch, chitosan, allyl sucrose crosslinked and a specific antigen (mRNA encoding tumor suppressor p53), wherein the antigen is specific to the disease. See abstract, p. 2 lines 15-17, p. 24 lines 27-33, p. 28, p. 29 lines 29-33, p. 30 line 8.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date to have used the nanoparticle delivery system of the ‘980 claims to deliver an tumor antigen, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that the ‘980 claims disclose that the nanoparticle can be used to deliver an antigen and Farokhzad et al disclose that a cationic nanoparticle including a cationic polysaccharide core such as dextran, starch, chitosan, allyl sucrose crosslinked can be used to deliver tumor specific antigen such as mRNA encoding tumor suppressor p53).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Double Patenting Rejections
Applicants arguments are essentially for the same reasons in that the ‘980 claims does not describe or suggest administration to an already infected individual nor any curative or post-infection use and in contrast they claims are drawn to a therapeutic vaccine for treating an individual carrying a disease or an intracellular pathogen.
Applicants argument has been considered but is not found persuasive. “Therapeutic vaccine” or “for use in the treatment of diseases stemming from the pathogen or the disease” is an intended use of the composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case the composition of the ‘980 claims does not recite in a structural difference from the claimed invention, thus the ‘980 claims are not distinguishable from the instant claims despite the recitation of intended uses. For this reason the rejection is maintained.
Status of Claims
Claims 1-20 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645