Detailed Office Action
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
Acknowledgement is hereby made of receipt and entry of the communication filed 07 August, 2025. Claims 1, 2, 4-7, 10, 11, 16-26, and 29 are pending in the instant application. Applicant’s election without traverse of Group I (claims 1, 2, 4-7, 10, 11, and 16-18 is noted. Claims 19-26 and 29 have been withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.
37 C.F.R. § 1.98
The information disclosure statements filed 14 October, 2022 (2), have been placed in the application file and the information referred to therein has been considered. Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 C.F.R. § 1.98(b) requires a list of all patents, publications, applications, or other information submitted for consideration by the Office, and M.P.E.P. § 609.04(a), subsection I. states, “the list may not be incorporated into the specification but must be submitted in a separate paper.” Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
37 C.F.R. § 1.84
The drawing is objected to because it is illegible. Corrected drawing sheets in compliance with 37 C.F.R. § 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 C.F.R. § 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
35 U.S.C. § 112(b)
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 2, 4-7, 10, 11, and 16-18 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Two separate requirements are set forth under this statute: (1) the claims must set forth the subject matter that applicants regard as their invention; and (2) the claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant.
The claims are directed toward a method of treating an infectious disease in a subject comprising administering effector cells comprising two or more antibodies to a subject in an amount effective to treat an infectious disease. The reference to effector cells comprising an antibody is confusing. Effector cells can comprise, inter alia, natural killer (NK) cells, neutrophils, macrophages, T-cells, and B-cells. However, most of these cell types do not comprise antibodies. While B-cells (plasma cells) produce antibodies, the other cell types typically don’t comprise antibodies. Thus, the type of composition being administered to the patient is not readily manifest. Appropriate correction is required.
35 U.S.C. § 112(a)
The following is a quotation of 35 U.S.C. § 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Written Description
Claims 1, 2, 4-7, 10, 11, and 16-18 are rejected under 35 U.S.C. § 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. Amgen, Inc. v. Sanofi, 872 F.3d 1367, 124 U.S.P.Q.2d 1354 (Fed. Cir. 2017). AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 111 U.S.P.Q.2d 1780 (Fed. Cir. 2014). Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 920, 69 U.S.P.Q.2d 1886, (Fed. Cir. 2004). Enzo Biochem, Inc. v. Gen-Probe, Inc., 296 F.3d 1316, 63 U.S.P.Q.2d 1609, (Fed. Cir. 2002). Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 U.S.P.Q.2d 1398, (Fed. Cir. 1997). Fiers v. Revel Co., 984 F.2d 1164, 25 U.S.P.Q.2d 1601, (Fed. Cir. 1993). Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 U.S.P.Q.2d 1016, (Fed. Cir. 1991). In re Rasmussen, 650 F.2d 1212, 211 U.S.P.Q. 323 (C.C.P.A. 1981). In re Wertheim, 541 F.2d 257, 191 U.S.P.Q. 90 (C.C.P.A. 1976).
The crux of the statutory requirement governing written description is whether one skilled in the art, familiar with the practice of the art at the time of the filing date, could reasonably have found the later claimed invention in the specification as filed. In re Kaslow, 707 F.2d 1366, 1375, 217 U.S.P.Q. 1089, 1096 (Fed. Cir. 1983). In re Wilder, 736 F.2d 1516, 1520 222 U.S.P.Q. 349, 372 (Fed. Cir. 1984, cert. denied, 469 U.S. 1209 (1985). Texas Instruments, Inc. v. International Trade Comm’n, 871 F.2d 1054, 1063, 10 U.S.P.Q.2d 1257, 1263 (Fed. Cir. 1989). Moreover, the courts have stated that the evaluation of written description is highly fact-specific, and that broadly articulated rules are inappropriate. In re Wertheim, 541 F.2d 257, 263, 191 U.S.P.Q. 90, 97 (C.C.P.A. 1976). In re Driscoll, 562 F.2d 1245, 1250, 195 U.S.P.Q. 434, 438 (C.C.P.A. 1977). It is also important to remember that the true issue in question is not whether the specification enables one of ordinary skill in the art to make the later claimed invention, but whether or not the disclosure is sufficiently clear that those skilled in the art will conclude that the applicant made the invention having the specific claim limitations. Martin v. Mayer, 823 F2d 500, 505, 3 U.S.P.Q.2d 1333, 1337 (Fed. Cir. 1987).
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor has possession of the claimed invention. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 U.S.P.Q.2d 1961, 1966 (Fed. Cir. 1997). The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 U.S.P.Q.2d 1895, 1905 (Fed. Cir. 1996).
Determination of adequate written description requires the Examiner to read and analyze the specification for compliance with 35 U.S.C. § 112(a). In particular, each claim should be analyzed to determine its broadest reasonable interpretation consistent with written description. Each claim should be evaluated to determine if sufficient structures, acts, or functions are recited to make clear the scope and meaning of the claim, including the weight to be given the preamble. The entire application should be reviewed including the specific embodiments, figures, and sequence listings, to understand how applicant provides support for the various features of the claimed invention. The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated that the inventor was in possession of the claimed invention. Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. Finally, the Examiner should determine whether there is sufficient written description to inform a skilled artisan that the inventor was in possession of the claimed invention as a whole at the time of filing.
The claims are broadly directed toward a method of treating an infectious disease in a subject comprising administering effector cells comprising two or more antibodies to a subject in an amount effective to treat an infectious disease. The disclosure fails to provide sufficient guidance pertaining to the infectious disease to be treated, the antibody specificity and titer required for treatment, the effector cell titer and specificity, and the administration of a suitable antiviral agent. With respect to the infectious disease target, the specification simply states that viral, bacterial, fungal, or parasitic diseases are all encompassed by the claim language. Viral diseases include but are not limited to those caused by Poxviridae, Herpesviridae, Adenoviridae, Papillomaviridae, Polyomaviridae, Parvoviridae, Hepadnaviridae, Retroviridae, Reoviridae, Filoviridae, Paramyxoviridae, Rhabdoviridae, Orthomyxoviridae, Bunyaviridae, Arenaviridae, Coronaviridae, Picornaviridae, Hepeviridae, Caliciviridae, Astroviridae, Togaviridae, Flaviviridae, Bornaviridae, and prions. Examples of viral diseases include, but are not limited to, herpesvirus, arenavirus, coronavirus, enterovirus, filovirus, flavivirus, hantavirus, rotavirus, arbovirus, Epstein-Barr virus, cytomegalovirus, infant cytomegalovirus, astroviruses, adenoviruses and lentiviruses. Diseases related to viral infections include infectious serial species (molluscum contagiosum), coronavirus, HTLV, HTLV-1, HIV/AIDS, human papilloma virus, herpesvirus, herpes, genital herpes, viral dysentery, colds, flu, measles, rubella, Chickenpox, mumps, gray myelitis, rabies, mononucleosis, ebola, respiratory syncytial virus (RSV), dengue, yellow fever, Lassa fever, viral meningitis, western Nile fever, parainfluenza, chickenpox, smallpox, dengue hemorrhagic fever, progressive multiple Progressive multifocal leukoencephalopathy, viral gastroenteritis, acute appendicitis, hepatitis A, hepatitis B, chronic hepatitis B, hepatitis C, chronic hepatitis C, hepatitis D, hepatitis E, hepatitis X, simple Herpes, shingles, meningitis, encephalitis, shingles, pneumonia, encephalitis, California serogroup viral, St. Louis encephalitis, Rift Valley fever, hand, foot and mouth disease, hendra virus, Japanese encephalitis, lymphocytic choroiditis, sudden rash, dorsal parasite virus, SARS, warts, and cerebellar disease, In one embodiment, the viral disease is caused by Coronaviridae and is SARS-CoV-2 (see spec., pp. 30-31).
Bacterial diseases may be caused by, for example, Acetobacter, Acinetobacter, Actinomyces, Agrobacterium, Anaplasma, Azorhizobia, Bacillus, Bacteriodes, Bartonella, Bordetella, Borrelia, Brucella, Burkkolderia, Calymmatobacterium, Campylobacter, Chlamydia, Chlamydophila, Clostridium, Corynebacterium, Coxiella, Ehrlichia, Enterobacter, Enterococcus, Escherichia, Francisella, Fusobacterium, Gardnerella, Haemophilus, Helicobacter, Klebsiella, Lactobacillus, Legionella, Listeria, Methanobacterium, Microbacterium, Micrococcus, Moraxella, Mycobacterium, Mycoplasma, Neisseria, Pasteurella, Peptostreptococcus, Porphyromonas, Prevotella, Pseudomonas, Rhizobium, Rickettsia, Rochalimaea, Rothia, Salmonella, Shigella,
Staphylococcus, Stenotrophomonas, Streptococcus, Treponema, Vibrio, Walbachia, and Yersinia. In one embodiment, the bacterial infection is a Streptococcus pneumoniae infection (see spec. p. 31).
Examples of fungal infections include, but are not limited to, aspergillosis, blastomycosis, candidiasis, coccidioidomycosis (Valley Fever), cryptococcosis, histoplasmosis, mucormycosis, Pneumocystis pneumonia (PCP), ringworm, sporotrichosis, and talaromycosis, In some embodiments, the fungal disease is caused by a Cryptococcus, Aspergillus, Candida, Coccidioides, Blastomyces, Ajellomyces, Histoplasma, Rhizopus, Apophysomyces, Absidia, Saksenaea, Rhizomucor pusillus, Entomophthora, Conidiobolus, Basidiobolus, Sporothrix, Pneumocystis jirovecii, Talaromyces marneffei, Asclepias, Fusarium, or Scedosporium fungus/species. In some embodiments, the fungal disease is caused by a fungal species including, but not limited to, Aspergillus fumigatus, Aspergillus flavus, Aspergillus niger, Aspergillus terreus, Blastomyces dermatitidis, Ajellomyces dermatitidis, Candida albicans, Candida auris, Candida glabrata, Candida parapsilosis, Candida rugosa, Candida tropicalis, Coccidioides immitis, Coccidioides posadasii, Cryptococcus neoformans, Cryptococcus gattii, Histoplasma capsulatum, Rhizopus stolonifer, Rhizopus arrhizus, Mucor indicus, Cunninghamella bertholletiae, Apophysomyces elegans, Absidia species, Saksenaea species, Rhizomucor pusillus, Entomophthora species, Conidiobolus species,
Basidiobolus species, Sporothrix schenckii, Pneumocystis jirovecii, Talaromyces marneffei, Asclepias albicans, Fusarium solani, Scedosporium apiospermum, and Rhizomucor pusillus (see spec., pp. 31-32).
Examples of parasitic infections include, but are not limited to, African trypanosomiasis, Amebiasis, Ascariasis, Babesiosis, Chagas Disease, Clonorchiasis, Cryptosporidiosis, Cysticercosis, Diphyllobothriasis, Dracunculiasis, Echinococcosis, Enterobiasis, Fascioliasis, Fasciolopsiasis, Filariasis, Free-living amebic infection, Giardiasis, Gnathostomiasis, Hymenolepiasis, Isosporiasis, Kala-azar, Leishmaniasis, Malaria, Metagonimiasis, Myiasis, Onchocerciasis, Pediculosis, Pinworm Infection, Scabies, Schistosomiasis, Taeniasis, Toxocariasis, Toxoplasmosis, Trichinellosis, Trichinosis, Trichuriasis, and Trypanosomiasis (see p. 32).
The disclosure fails to describe the structure, specificity, and titer of any given antibody that’s required for treatment. The disclosure is silent with respect to the identification of suitable target antigens and the molecular determinants modulating antigen-antibody binding interactions. The disclosure fails to provide any guidance with respect to the variable heavy and light chains of any given antibody. There is no discussion about those amino acid residues within the framework regions (FRs) and complementarity determining regions (CDRs) that are responsible for binding.
The disclosure fails to describe the genotype and phenotype of suitable effector cells. What types of effector cells are required for therapy (e.g., macrophages, T-helper cells, cytotoxic T-cells, regulatory T-cells, plasma cells, macrophages, natural killer (NK) cells, neutrophils, or other cell types? What is the specificity of these cell types and what is the titer required for a positive therapeutic outcome?
The disclosure also fails to describe the administration of any suitable agents that can treat the inordinate number of viral, bacterial, fungal, and parasitic diseases encompassed by the claims.
Finally, the specification fails to describe any suitable working embodiments. A brief example discussed utilizing convalescent plasma (CP) from SARS-CoV-2 patients in conjunction with effector cells. However, the specificity, affinity, and titer of the antibodies contained within the CP was not examined. Moreover, the specificity, affinity, titer, and genotype/phenotype of any given effector cell was also not provided. Additionally, the development of suitable adoptive immunotherapy regimens can be challenging (Busch et al., 2016; Chi et al., 2024).
Accordingly, when all the aforementioned factors are considered in toto, the skilled artisan would reasonably conclude that Applicants were not in possession of the claimed invention at the time of filing.
Enablement
Claims 1, 2, 4-7, 10, 11, and 16-18 are rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The claims are broadly directed toward a method of treating an infectious disease in a subject comprising administering effector cells comprising two or more antibodies to a subject in an amount effective to treat an infectious disease.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
1) The claim breadth encompasses the treatment of an inordinate number of bacterial, viral, fungal, and parasitic infections. Viral diseases include but are not limited to those caused by Poxviridae, Herpesviridae, Adenoviridae, Papillomaviridae, Polyomaviridae, Parvoviridae, Hepadnaviridae, Retroviridae, Reoviridae, Filoviridae, Paramyxoviridae, Rhabdoviridae, Orthomyxoviridae, Bunyaviridae, Arenaviridae, Coronaviridae, Picornaviridae, Hepeviridae, Caliciviridae, Astroviridae, Togaviridae, Flaviviridae, Bornaviridae, and prions. Examples of viral diseases include, but are not limited to, herpesvirus, arenavirus, coronavirus, enterovirus, filovirus, flavivirus, hantavirus, rotavirus, arbovirus, Epstein-Barr virus, cytomegalovirus, infant cytomegalovirus, astroviruses, adenoviruses and lentiviruses. Diseases related to viral infections include infectious serial species (molluscum contagiosum), coronavirus, HTLV, HTLV-1, HIV/AIDS, human papilloma virus, herpesvirus, herpes, genital herpes, viral dysentery, colds, flu, measles, rubella, Chickenpox, mumps, gray myelitis, rabies, mononucleosis, ebola, respiratory syncytial virus (RSV), dengue, yellow fever, Lassa fever, viral meningitis, western Nile fever, parainfluenza, chickenpox, smallpox, dengue hemorrhagic fever, progressive multiple Progressive multifocal leukoencephalopathy, viral gastroenteritis, acute appendicitis, hepatitis A, hepatitis B, chronic hepatitis B, hepatitis C, chronic hepatitis C, hepatitis D, hepatitis E, hepatitis X, simple Herpes, shingles, meningitis, encephalitis, shingles, pneumonia, encephalitis, California serogroup viral, St. Louis encephalitis, Rift Valley fever, hand, foot and mouth disease, hendra virus, Japanese encephalitis, lymphocytic choroiditis, sudden rash, dorsal parasite virus, SARS, warts, and cerebellar disease, In one embodiment, the viral disease is caused by Coronaviridae and is SARS-CoV-2 (see spec., pp. 30-31).
Bacterial diseases may be caused by, for example, Acetobacter, Acinetobacter, Actinomyces, Agrobacterium, Anaplasma, Azorhizobia, Bacillus, Bacteriodes, Bartonella, Bordetella, Borrelia, Brucella, Burkkolderia, Calymmatobacterium, Campylobacter, Chlamydia, Chlamydophila, Clostridium, Corynebacterium, Coxiella, Ehrlichia, Enterobacter, Enterococcus, Escherichia, Francisella, Fusobacterium, Gardnerella, Haemophilus, Helicobacter, Klebsiella, Lactobacillus, Legionella, Listeria, Methanobacterium, Microbacterium, Micrococcus, Moraxella, Mycobacterium, Mycoplasma, Neisseria, Pasteurella, Peptostreptococcus, Porphyromonas, Prevotella, Pseudomonas, Rhizobium, Rickettsia, Rochalimaea, Rothia, Salmonella, Shigella,
Staphylococcus, Stenotrophomonas, Streptococcus, Treponema, Vibrio, Walbachia, and Yersinia. In one embodiment, the bacterial infection is a Streptococcus pneumoniae infection (see spec. p. 31).
Examples of fungal infections include, but are not limited to, aspergillosis, blastomycosis, candidiasis, coccidioidomycosis (Valley Fever), cryptococcosis, histoplasmosis, mucormycosis, Pneumocystis pneumonia (PCP), ringworm, sporotrichosis, and talaromycosis, In some embodiments, the fungal disease is caused by a Cryptococcus, Aspergillus, Candida, Coccidioides, Blastomyces, Ajellomyces, Histoplasma, Rhizopus, Apophysomyces, Absidia, Saksenaea, Rhizomucor pusillus, Entomophthora, Conidiobolus, Basidiobolus, Sporothrix, Pneumocystis jirovecii, Talaromyces marneffei, Asclepias, Fusarium, or Scedosporium fungus/species. In some embodiments, the fungal disease is caused by a fungal species including, but not limited to, Aspergillus fumigatus, Aspergillus flavus, Aspergillus niger, Aspergillus terreus, Blastomyces dermatitidis, Ajellomyces dermatitidis, Candida albicans, Candida auris, Candida glabrata, Candida parapsilosis, Candida rugosa, Candida tropicalis, Coccidioides immitis, Coccidioides posadasii, Cryptococcus neoformans, Cryptococcus gattii, Histoplasma capsulatum, Rhizopus stolonifer, Rhizopus arrhizus, Mucor indicus, Cunninghamella bertholletiae, Apophysomyces elegans, Absidia species, Saksenaea species, Rhizomucor pusillus, Entomophthora species, Conidiobolus species,
Basidiobolus species, Sporothrix schenckii, Pneumocystis jirovecii, Talaromyces marneffei, Asclepias albicans, Fusarium solani, Scedosporium apiospermum, and Rhizomucor pusillus (see spec., pp. 31-32).
Examples of parasitic infections include, but are not limited to, African trypanosomiasis, Amebiasis, Ascariasis, Babesiosis, Chagas Disease, Clonorchiasis, Cryptosporidiosis, Cysticercosis, Diphyllobothriasis, Dracunculiasis, Echinococcosis, Enterobiasis, Fascioliasis, Fasciolopsiasis, Filariasis, Free-living amebic infection, Giardiasis, Gnathostomiasis, Hymenolepiasis, Isosporiasis, Kala-azar, Leishmaniasis, Malaria, Metagonimiasis, Myiasis, Onchocerciasis, Pediculosis, Pinworm Infection, Scabies, Schistosomiasis, Taeniasis, Toxocariasis, Toxoplasmosis, Trichinellosis, Trichinosis, Trichuriasis, and Trypanosomiasis (see p. 32).
2) The disclosure fails to provide adequate guidance with respect to the structure, specificity, and titer of any given therapeutic antibody that’s required for treatment. The disclosure is silent with respect to the identification of suitable target antigens and the molecular determinants modulating antigen-antibody binding interactions. The disclosure fails to provide any guidance with respect to the variable heavy and light chains of any given antibody. There is no discussion about those amino acid residues within the framework regions (FRs) and complementarity determining regions (CDRs) that are responsible for binding. In order to practice the claimed invention, the skilled artisan would need to know the specificity, structure, and titer of the antibody composition being administered.
3) The disclosure fails to provide adequate guidance with respect to the genotype and phenotype of suitable effector cells. What types of effector cells are required for therapy (e.g., macrophages, T-helper cells, cytotoxic T-cells, regulatory T-cells, plasma cells, macrophages, natural killer (NK) cells, neutrophils, or other cell types? What is the specificity of these cell types and what is the titer required for a positive therapeutic outcome? In order to practice the claimed invention, the skilled artisan would need to know the genotypic/phenotypic composition of the effector cell population.
4) The disclosure also fails to provide adequate guidance pertaining to the administration of any suitable agents that can treat the inordinate number of viral, bacterial, fungal, and parasitic diseases encompassed by the claims. Once again, in order to practice the claimed invention, the skilled artisan would need to know which compound to administer.
5) The disclosure fails to provide any working embodiments. A brief example discussed utilizing convalescent plasma (CP) from SARS-CoV-2 patients in conjunction with patient white blood cells (WBCs). However, the specificity, affinity, and titer of the antibodies contained within the CP was not examined. Moreover, the specificity, affinity, titer, and genotype/phenotype of any given effector cell was also not provided. Moreover, the development of suitable adoptive immunotherapy regimens can be challenging (Busch et al., 2016; Chi et al., 2024).
Accordingly, when all the aforementioned factors are considered in toto, the skilled artisan would reasonably conclude that undue experimentation would be required to practice the claimed invention.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. 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 are unsuccessful, the Examiner's supervisor, Janet L. Andres, Ph.D., can be reached at (571) 272-0867. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
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Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671
29 September, 2025