DETAILED 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 .
Claim Status
The amended claim set filed on 15 October 2025 is acknowledged. Claims 76-81, 84-90, 92-98, 100, and 102-105 are currently pending. Of those, claims 76, 84-85, 89-90, 92, 96-98, and 100 are currently amended. Claims 102-105 are new, and no claims are withdrawn. Claims 82-83, 91, 99, and 101 are cancelled. Claims 76-81, 84-90, 92-98, 100, and 102-105 will be examined on the merits herein.
Response to Amendment
The Applicants’ arguments filed 15 October 2025 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 15 May 2025 will be referred to “NFOA”.
The substitute specification filed 15 October 2025 is acknowledged. The amendments have been reviewed and do not constitute new matter because the FIG. 2 description was copied from pg. 35 and other amendments are adding periods to paragraphs or fixing clear typographical errors (see MPEP 2163.07).
Priority
Claims 76 and 89 are currently amended to recite the subject matter previously recited in claims 82-83, 99, and/or 101. However, the subject matter of now-cancelled claims 83 and 101 was not supported in the priority documents, 62/976,792, GB 2004007.7, or GB 2007045.4. Because the subject matter previously recited in claims 83 and 101 has been incorporated into independent claims 76 and 89, the effective filing date of claims 76-81, 84-90, 92-98, 100, and 102-105 is 12 February 2021. See NFOA para. 3-6 for discussion of priority.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 15 October 2025 was filed after the mailing date of the NFOA on 15 May 2025. The submission is in compliance with the provisions of 37 CFR 1.97 because it was submitted with the appropriate fee. Accordingly, the information disclosure statement is being considered by the examiner.
Objection(s) and Rejection(s) Withdrawn
The objection to the specification is withdrawn in view of the substitute specification.
The objections and rejections to claims 82-83, 91, 99, and 101 are moot because those claims are cancelled.
The objection to claim 96 is withdrawn in view of the amendments to the claim.
The rejections of claims 90, 92, 96, and 98 under 35 U.S.C 112(b) are withdrawn in view of the amendments to the claims, except those noted below.
The rejection of claims 92-95 under 35 U.S.C. 112(d) is withdrawn in view of the amendments to the claims.
Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112(b)
Claim 90 remains rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 90 contains the trademark(s)/trade name(s) NUTRACEUTICAL® and PROBODY®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark(s)/trade name(s) is/are used to identify/describe “one or more biologically-active agent” and, accordingly, the identification/description is indefinite.
Applicant argues (Remarks, pg. 8-9) that the terms NUTRACEUTICAL® and PROBODY®, as used in the application, are well understood in the art.
This argument has been fully considered but is not found persuasive. The terms NUTRACEUTICALTM and PROBODY® are trademarks (live or otherwise) found in the Agency’s online “Trademark search” (see Figure 1 below). Thus, trademark(s) or trade name(s) cannot be used properly to identify any particular material or product and the claim fails to comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
PNG
media_image1.png
458
798
media_image1.png
Greyscale
PNG
media_image2.png
482
799
media_image2.png
Greyscale
Figure 1: Images taken from the USPTO “Trademark search” web page.
Claim Rejections - 35 USC § 102
Claims 76-81, 84, 87-90, 93-98, and 100 remain rejected under pre-AIA 35 U.S.C. 102(g) as being anticipated by Stanford et al. (WO 2007/071978 A1; herein “Stanford”) for the reasons of record and the reasons herein.
The following rejection has been amended to reflect the claim amendments.
Regarding claims 76-80, Stanford teaches a method of treating or preventing a condition in a subject comprising administering an immune modulator composition to a subject (pg. 20, lines 19-22), wherein the immune modulator composition comprises a killed (i.e., non-pathogenic and non-viable; pg. 69, lines 16-18) rough strain of Mycobacterium obuense (M. obuense) (pg. 8, lines 27-29). Stanford teaches that the composition(s) comprising M. obuense may be formulated for parenteral, oral, sublingual, or nasal routes (pg. 60, lines 3-5). Stanford also teaches that the immune modulator composition may be administered to a human subject with cancer, including those with brain, kidney, bladder, pancreas, and liver tumors (pg. 52, line 14 – pg. 53, line 9).
Regarding claims 81, 96, and 98, Stanford teaches that the M. obuense may be the strain deposited under the Budapest Treaty under Accession Number NCTC 13365 (Abstract and pg. 8, lines 20-26).
Regarding claim 84, Stanford teaches that the parenteral route may be an intravenous, subcutaneous, or intradermal route (pg. 60, lines 9-10).
Regarding claim 87, Stanford teaches that the composition may be administered at a dose of 108 – 109 organisms, i.e., M. obuense (pg. 59, lines 18-20).
Regarding claim 88, Stanford teaches the M. obuense modifies a cellular immune response (pg. 6, lines 28-30 and pg. 19, lines 23-26).
Regarding claims 89-91 and 93-97, Stanford teaches a method for treating or preventing an infection, including a viral infection (pg. 25, lines 5-6) in a subject, comprising administering an immune modulator composition comprising an adjuvant, wherein the adjuvant comprises a killed (i.e., non-pathogenic and non-viable; pg. 69, lines 16-18), whole cell, rough strain Mycobacterium obuense (M. obuense) and at least one antigen or antigenic determinant (i.e., biologically-active agents) (pg. 10, lines 1-3 and 15-19, pg. 23, lines 27-31, and pg. 63, lines 11-12). Stanford teaches that the composition(s) comprising M. obuense may be formulated for parenteral, oral, sublingual, or nasal routes (pg. 60, lines 3-5). Stanford also teaches that the immune modulator composition may be administered to a human subject with cancer, including those with brain, kidney, bladder, pancreas, and liver tumors (pg. 52, line 14 – pg. 53, line 9).
Regarding claim 90, Stanford teaches that the antigen or antigenic determinant may be cells, specifically Mycobacterium vaccae (pg. 10, lines 20-24) or Mycobacterium obuense (pg. 11, lines 1-4).
Regarding claim 100, Stanford teaches that the immune modulator composition comprising M. obuense may be co-administered with an antigen or antigenic determinant (i.e., biologically active agents) and that the adjuvant (M. obuense) and antigen or antigenic determinant may be administered in the same delivery vehicle (i.e., in the same composition via the same route) (pg. 23, lines 28-31 and pg. 60, lines 11-24).
A recitation of the intended use of the claimed invention (“treatment or prevention of a viral infection and/or the symptoms thereof in a human subject…wherein the viral infection is an infection caused by a coronavirus” as in claim 76 and “treatment or prevention of an infection and/or the symptoms thereof in a human subject at elevated risk of exposure to and/or severity of said infection…wherein the infection is an infection caused by a coronavirus” as in claim 89), and the specific coronaviruses in claims 77-79 and 93-95 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. The claims and the art both teach administering the same compositions to the same subject population (a population at risk of a coronavirus infection or viral, bacterial, protozoan, or fungal infection). If the prior art structure is capable of performing the intended use, then it meets the claim. When the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). See also MPEP 2111.02 for a discussion of intended uses in the preamble and MPEP 2112 for a discussion of inherency.
Response to Arguments
Applicant argues (Remarks pg. 9-10) that “the intention to treat or prevent coronavirus infection is a technical feature of the claims that give life and meaning to the claims.”
This argument has been fully considered but is not persuasive. Regarding the intended use of the claimed invention, “treatment or prevention of a viral infection and/or the symptoms thereof in a human subject…wherein the viral infection is an infection caused by a coronavirus” as in claim 76 and “treatment or prevention of an infection and/or the symptoms thereof in a human subject at elevated risk of exposure to and/or severity of said infection…wherein the infection is an infection caused by a coronavirus” as in claim 89, these elements do not limit the scope of the claimed subject population because a population in which an infection may be prevented encompasses all members of that population. This is contrasted with the limitation, “said human subject has one or more tumours”, which does limit the scope of the subject population. Furthermore, as stated in para. 47 of the NFOA, elements in the preamble 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. See also MPEP 2111.02 (“statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art.”) It is not apparent, based on the evidence of record, that the treatment or prevention of a viral infection and/or the symptoms thereof, wherein the viral infection is an infection caused by a coronavirus, results in a structural difference in the claimed composition or a manipulative difference in the method steps, and applicant has not presented any arguments otherwise. Because the prior art structure is substantially identical to the claimed composition, it is capable of the intended use and meets the claim, and the burden of proving that the prior art structure is not inherently capable of the intended use shifts to the Applicant (see MPEP 2112(V)).
Claim Rejections - 35 USC § 103
Claims 76-81, 84-90, 92-98, and 100 remain rejected and claim 102 is newly rejected under 35 U.S.C. 103 as being unpatentable over Stanford (WO 2007/071978 A1) in view of Gratieri et al (2013, Eur. J. Pharm. Sci.; herein “Gratieri”) and Liu et al. (2017, Antivir. Res.; herein “Liu”) for the reasons of record and the reasons herein.
The following rejection has been amended to reflect the claim amendments.
The teachings of Stanford regarding claims 76-81, 84, 87-90, 93-98, and 100 are set forth in the rejection under 35 U.S.C. 102 above.
However, Stanford does not teach a method comprising administering an immunomodulator via a microneedle device comprising a plurality of needles (as in claim 85), or a method wherein an immunomodulator is prepared for administration within a single-use pre-filed syringe, multi-use applicator, or jet injector (as in claim 86). Stanford also does not teach an antigen or antigenic determinant specific for, targeted to, and/or derived from a coronavirus (as in claim 92) or an antigen or antigenic determinant comprised within or delivered by any of the structures recited in claim 102.
Regarding claim 85, Gratieri teaches that microneedles can be used to deliver drugs by a minimally invasive, safe, and painless disruption of the skin barrier (section 3.2, para. 1-2). Of the different microneedle designs, Gratieri teaches that hollow microneedles, which deliver a drug directly to the skin in the same manner as a conventional needle, are the simplest way to enhance drug delivery to the skin (section 3.2, para. 2).
Regarding claim 86, Gratieri teaches that jet injectors are devices that propel drugs through the skin without the use of needles and may be used to deliver vaccines via intradermal, subcutaneous, or intramuscular routes (section 3.1, para. 1-2). Gratieri teaches that direct contact between antigens and skin antigen-presenting cells generates stronger systemic and mucosal immune responses at lower doses than those required for deeper injections (pg. 612, section 3.1, para. 3). Gratieri also teaches that other advantages of needle free devices are prevention of accidental needle sticks and eliminating the need for costly and hazardous “sharps” waste (section 3.1, para. 4).
Regarding claims 92 and 102, Liu teaches that the S or N proteins of SARS-CoV are antigens used in T-cell targeting vaccines and that vectors such as recombinant adenoviral vectors or plasmid vectors have been used as carriers for DNA encoding S or N genes in vaccines. These vaccines are able to induce SARS-CoV-specific T-cell responses that allow for protection against the virus (pg. 85, sections 3 and 3.1).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to combine the method of treating or preventing an infection taught by Stanford with the microneedle device or jet injector device taught by Gratieri to administer the compositions, thereby arriving at the invention of claim 85 or 86. The person of ordinary skill in the art would have been motivated to make the modification because, as taught by Gratieri, administration of drugs or vaccines to the skin requires lower doses to elicit a strong immune response compared to deeper injections. Also, jet injectors eliminate accidental needle sticks and don’t require costly disposal systems, and microneedles are minimally invasive and painless. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because microneedles and jet injectors are well known in the art as devices used to safely administer drugs or vaccines to subjects and elicit a strong immune response. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., administration of M. obuense to a subject, microneedles, jet injectors) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Alternately or in addition, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to combine the method of treating or preventing an infection taught by Stanford with a coronavirus antigen taught by Liu, thereby arriving at the invention of claims 92 and 102. The person of ordinary skill in the art would have been motivated to make the modification because the use of SARS-CoV-specific antigens in vaccines induces a SARS-CoV-specific T-cell response that is beneficial when protecting against SARS-CoV infection. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because the M. obuense of Stanford may be readily used as an adjuvant in combination with a viral antigen and the coronavirus antigens taught by Liu are known to induce T-cell responses beneficial in protection against the virus. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., administration of Mycobacterium sp. as an adjuvant in conjunction with an antigen and coronavirus antigens) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Response to Arguments
Applicant argues (Remarks, pg. 10-11) that the mechanism and efficacy of the claimed invention is supported by the studies of Stefan et al. and an unpublished clinical trial.
This argument has been fully considered but is not persuasive. In response to the teachings of the evidence relied upon by applicant, it is noted that the features upon which applicant relies (i.e., efficacy of the claimed composition) are not recited in the rejected claim(s). Applicant does not allege that the evidence of efficacy demonstrated unexpected results, and is therefore insufficient to prove nonobviousness. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally, because the Stefan et al. reference was published in 2024 and the data from the clinical trial is unpublished, it is not apparent that the efficacy of the composition was known before the effective filing date (2020-2021) of the claimed composition.
Applicant argues (Remarks, pg. 11) that Stanford does not indicate that the claimed composition would be appropriate to treat or prevent infection caused by a coronavirus in cancer patients, and that the secondary references do not overcome said deficiency.
This argument has been fully considered but is not persuasive. In response to applicant's argument that Stanford does not teach or suggest that the claimed composition is capable of treating or preventing a coronavirus infection in cancer patients, 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. See para. 23-26 above. Regarding the Gratieri and Liu references, the NFOA sets forth that Gratieri teaches microneedles and jet injectors for the delivery of drugs and that Liu teaches coronavirus antigens and carriers thereof; the NFOA did not rely on Gratieri or Liu to teach or suggest administering the composition of Stanford to the claimed subject population.
Double Patenting
Response to Arguments
Applicant argues (Remarks pg. 11-13) that the instant claims are not obvious over the cited application and patents and that the teachings of Stanford, Gratieri, and/or Liu fail to render the instant claims obvious over the claims of the ‘139 application and the cited patents.
This argument has been fully considered but is not persuasive. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
17/758,139
Claims 76-81, 84-85, 87-90, 92-98, and 100 remain provisionally rejected and claim 102 is newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 57-59, 60, 66, and 69-71 of copending Application No. 17/758,139 (‘139) in view of Stanford (WO 2007/071978 A1) and Liu (2017, Antivir. Res.). This is a provisional nonstatutory double patenting rejection.
The following rejection has been amended to reflect the amendments to the instant claims as well as the amendments to the ‘139 claims filed 1 October 2025.
Regarding instant claims 76-79 and 84-85, the ‘139 claims teach administering to a subject non-pathogenic non-viable Mycobacterium obuense (‘139 claim 60). The ‘139 claims also teach that the subject may have a tumor (‘139 claims 60 and 69-71) and that the non-pathogenic non-viable M. obuense is administered using a microneedle device comprising a plurality of microneedles, where the microneedles penetrate into the skin of the subject and deliver the non-pathogenic non-viable M. obuense into the skin (i.e., parenterally administered via intradermal injection) (‘139 claims 57-58 and 60).
Regarding instant claims 80 and 97, the ‘139 claims teach that the Mycobacterium is a rough variant and/or whole cell (‘139 claim 66).
Regarding instant claim 81 and 98, the ‘139 claims teach that the Mycobacterium maybe M. obuense deposited under NCTC 13365 (‘139 claim 58).
Regarding instant claims 89 and 93-95, the ‘139 claims teach a method comprising administering to a subject non-pathogenic non-viable Mycobacterium (‘139 claim 60) in conjunction with one or more biologically-active agents (‘139 claims 57-58). The ‘139 claims also teach that the subject may have a tumor (‘139 claims 60 and 69-71) and that the non-pathogenic non-viable M. obuense is administered using a microneedle device comprising a plurality of microneedles, where the microneedles penetrate into the skin of the subject and deliver the non-pathogenic non-viable M. obuense into the skin (i.e., parenterally administered via intradermal injection) (‘139 claims 57-58 and 60).
Regarding instant claim 90, the ‘139 claims teach that the one or more biologically-active agents may be a therapeutic drug, nutraceutical, cell, virus, lysate, vector, gene, mRNA, DNA, nucleic acid, protein, polypeptide, peptide, antibody, bispecific antibody, multi-specific antibody, ADC (antibody-drug conjugate), Fab fragment (Fab), F(ab')2 fragment, diabody, triabody, tetrabody, probody, single-chain variable region fragment (scFv), disulfide- stabilized variable region fragment (dsFv), or other antigen binding fragment thereof, optionally wherein said biologically-active agent is an antigen or antigenic determinant (‘139 claim 58).
Regarding instant claim 96, the ‘139 claims teach the Mycobacterium may be M. vaccae, M. vaccae deposited under NCTC 11659, M. vaccae deposited under ATCC 95051, M. paragordonae (strain 49061), M. parafortuitum, M. aurum, M. indicus pranii, M. w, M. kyogaense deposited under DSM 107316/CECT 9546, M. tuberculosis Aoyama B or H37Rv, and combinations thereof (‘139 claims 58 and 60).
A recitation of the intended use of the claimed invention (“treatment or prevention of a viral infection and/or the symptoms thereof in a subject…wherein the viral infection is an infection caused by a coronavirus” as in claim 76 and “treatment or prevention of an infection and/or the symptoms thereof in a human subject at elevated risk of exposure to and/or severity of said infection…wherein the infection is an infection caused by a virus, bacteria, protozoa and fungus, preferably wherein the virus is a coronavirus” as in claim 89), and the specific coronaviruses in claims 77-79 and 93-95 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. The instant claims and the ‘139 claims both teach administering the same compositions to the same subject population (a population at risk of a coronavirus infection or viral, bacterial, protozoan, or fungal infection). If the prior art structure is capable of performing the intended use, then it meets the claim. When the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). See also MPEP 2111.02 for a discussion of intended uses in the preamble and MPEP 2112 for a discussion of inherency.
Thus, instant claims 76-81, 84-85, 89-90, and 93-98 are anticipated by the ‘139 claims.
However, the ‘139 claims do not teach a non-pathogenic non-viable M. obuense that modifies a cellular immune response (as in instant claim 88) and does not teach an antigen or antigenic determinant specific for, targeted to and/or derived from a coronavirus (as in instant claim 92), a method in which the non-pathogenic non-viable Mycobacterium and/or one or more biologically-active agents are administered in the same composition via the same route or in separate compositions via a different route (as in instant claim 100), or an antigen or antigenic determinant comprised within or delivered by one or more of the structures recited in instant claim 102. The ‘139 claims are also silent on the dosage of M. obuense to be administered (as in instant claim 87).
Regarding instant claims 76-80, Stanford teaches a method of treating or preventing a condition in a subject comprising administering an immune modulator composition to a subject (pg. 20, lines 19-22), wherein the immune modulator composition comprises a killed (i.e., non-pathogenic and non-viable; pg. 69, lines 16-18) rough strain of Mycobacterium obuense (M. obuense) (pg. 8, lines 27-29). Stanford teaches that the composition(s) comprising M. obuense may be formulated for parenteral, oral, sublingual, or nasal routes (pg. 60, lines 3-5). Stanford also teaches that the immune modulator composition may be administered to a human subject with cancer, including those with brain, kidney, bladder, pancreas, and liver tumors (pg. 52, line 14 – pg. 53, line 9).
Regarding instant claims 81, 96, and 98, Stanford teaches that the M. obuense may be the strain deposited under the Budapest Treaty under Accession Number NCTC 13365 (Abstract and pg. 8, lines 20-26).
Regarding instant claim 84, Stanford teaches that the parenteral route may be an intravenous, subcutaneous, or intradermal route (pg. 60, lines 9-10).
Regarding instant claim 87, Stanford teaches that the composition may be administered at a dose of 108 – 109 organisms, i.e., M. obuense (pg. 59, lines 18-20).
Regarding instant claim 88, Stanford teaches the M. obuense modifies a cellular immune response (pg. 6, lines 28-30 and pg. 19, lines 23-26).
Regarding instant claims 89-91 and 93-97, Stanford teaches a method for treating or preventing an infection, including a viral infection (pg. 25, lines 5-6) in a subject, comprising administering an immune modulator composition comprising an adjuvant, wherein the adjuvant comprises a killed (i.e., non-pathogenic and non-viable; pg. 69, lines 16-18), whole cell, rough strain Mycobacterium obuense (M. obuense) and at least one antigen or antigenic determinant (i.e., biologically-active agents) (pg. 10, lines 1-3 and 15-19, pg. 23, lines 27-31, and pg. 63, lines 11-12). Stanford teaches that the composition(s) comprising M. obuense may be formulated for parenteral, oral, sublingual, or nasal routes (pg. 60, lines 3-5). Stanford also teaches that the immune modulator composition may be administered to a human subject with cancer, including those with brain, kidney, bladder, pancreas, and liver tumors (pg. 52, line 14 – pg. 53, line 9).
Regarding instant claim 90, Stanford teaches that the antigen or antigenic determinant may be cells, specifically Mycobacterium vaccae (pg. 10, lines 20-24) or Mycobacterium obuense (pg. 11, lines 1-4).
Regarding instant claim 100, Stanford teaches that the immune modulator composition comprising M. obuense may be co-administered with an antigen or antigenic determinant (i.e., biologically active agents) and that the adjuvant (M. obuense) and antigen or antigenic determinant may be administered in the same delivery vehicle (i.e., in the same composition via the same route) (pg. 23, lines 28-31 and pg. 60, lines 11-24).
Regarding instant claims 92 and 102, Liu teaches that the S or N proteins of SARS-CoV are antigens used in T-cell targeting vaccines and that vectors such as recombinant adenoviral vectors or plasmid vectors have been used as carriers for DNA encoding S or N genes in vaccines. These vaccines are able to induce SARS-CoV-specific T-cell responses that allow for protection against the virus (pg. 85, sections 3 and 3.1).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, to combine the method of administering non-pathogenic non-viable Mycobacterium via a microneedle device, alone or in conjunction with a biologically-active agent taught by the ‘139 claims with the dosage taught by Stanford and further combine with a coronavirus antigen and vector taught by Liu, thereby arriving at the invention of instant claims 76-81, 84-85, 87-90, 92-98, 100, and 102. The person of ordinary skill in the art would have been motivated to make the modification because Stanford teaches that M. obuense, specifically strain NCTC 13365, is an immune modulator. Additionally, the use of SARS-CoV-specific antigens in vaccines induces a SARS-CoV-specific T-cell response that is beneficial when protecting against SARS-CoV infection. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because the M. obuense of Stanford may be readily used as an adjuvant in combination with a viral antigen and the coronavirus antigens taught by Liu are known to induce T-cell responses beneficial in protection against the virus. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., administration of M. obuense to a subject, microneedles, administration of Mycobacterium sp. as an adjuvant in conjunction with an antigen, and coronavirus antigens) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
US 10,610,577 B2
Claims 76-81, 84-90, 92-98, and 100 remain rejected and claim 102 is newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 6-7 of U.S. Patent No. 10,610,577 (‘577) in view of Stanford (WO 2007/071978 A1), Gratieri (2013, Eur. J. Pharm. Sci.), and Liu (2017, Antivir. Res.).
Regarding instant claims 76-79 and 84, the ‘577 claims teach a method comprising administering to a human patient with a pancreatic neoplasia (i.e., one or more tumors) a heat-killed (i.e., non-pathogenic and non-viable) Mycobacterium obuense (‘577 claim 1). The ‘577 claims also teach that the heat-killed M. obuense is administered intradermally, i.e., parenterally (‘577 claim 1).
Regarding instant claims 80 and 97, the ‘577 claims teach that the heat-killed M. obuense is whole cell and a rough variant (‘577 claims 1 and 7).
Regarding instant claim 87, the ‘577 claims teach that the amount of heat-killed M. obuense administered is from 107 to 109 cells per dose (‘577 claim 2).
Regarding instant claims 89-90 and 93-96, the ‘577 claims teach the method comprising administering to a human patient with a pancreatic neoplasia (i.e., one or more tumors) a heat-killed M. obuense further comprises administering an anti-PD-L1 antibody (i.e., a biologically-active agent) (‘577 claim 1). The ‘577 claims also teach that the heat-killed M. obuense is administered intradermally, i.e., parenterally (‘577 claim 1).
Regarding instant claim 100, the ‘577 claims teach that the anti-PD-L1 antibody is administered intravenously, i.e., via a different administration route than the M. obuense administered intradermally, and may be administered separately, simultaneously or at different times (‘577 claims 1 and 6).
A recitation of the intended use of the claimed invention (“treatment or prevention of a viral infection and/or the symptoms thereof in a subject…wherein the viral infection is an infection caused by a coronavirus” as in claim 76 and “treatment or prevention of an infection and/or the symptoms thereof in a human subject at elevated risk of exposure to and/or severity of said infection…wherein the infection is an infection caused by a virus, bacteria, protozoa and fungus, preferably wherein the virus is a coronavirus” as in claim 89) 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. The instant claims and the ‘577 claims both teach administering the same compositions to the same subject population (a population at risk of a coronavirus infection or viral, bacterial, protozoan, or fungal infection). If the prior art structure is capable of performing the intended use, then it meets the claim. When the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). See also MPEP 2111.02 for a discussion of intended uses in the preamble and MPEP 2112 for a discussion of inherency.
Thus, instant claims 76-80, 84, 87, 89-90, 93-97, and 100 are anticipated by the ‘577 claims.
However, the ‘577 claims do not teach a non-pathogenic non-viable M. obuense that is the strain NCTC 13365 (as in instant claims 81 and 98) or modifies a cellular immune response (as in instant claim 88) and does not teach administration of an antigen or antigenic determinant specific for, targeted to and/or derived from a coronavirus (as in instant claim 92), or an antigen or antigenic determinant comprised within or delivered by one or more of the structures recited in instant claim 102.
The teachings of Stanford with respect to instant claims 76-81, 84, 87-91, 93-98, and 100 are set forth in the double patenting rejection over copending application 17/758,139 above (para. 61-68). Stanford also teaches that whole cell, rough strain M. obuense can be used in the treatment or prevention of cancers (pg. 11, lines 10-13 and 26-27 and pg. 14, lines 4-7) because of its ability to modulate a cellular immune response (pg. 52, lines 14-15). Specifically, M. obuense can upregulate Th1 response, downregulate Th2 response, or both (pg. 19, line 28 – pg. 20, line 9), which is useful when treating cancer because an unregulated increase in Th2 response is observed during cancer growth (pg. 52, line 21).
The teachings of Liu with respect to instant claims 92 and 102 are set forth in the double patenting rejection over copending application 17/758,139 above (para. 69).
Regarding claim 85, Gratieri teaches that microneedles can be used to deliver drugs by a minimally invasive, safe, and painless disruption of the skin barrier (section 3.2, para. 1-2). Of the different microneedle designs, Gratieri teaches that hollow microneedles, which deliver a drug directly to the skin in the same manner as a conventional needle, are the simplest way to enhance drug delivery to the skin (section 3.2, para. 2).
Regarding claim 86, Gratieri teaches that jet injectors are devices that propel drugs through the skin without the use of needles and may be used to deliver vaccines via intradermal, subcutaneous, or intramuscular routes (section 3.1, para. 1-2). Gratieri teaches that direct contact between antigens and skin antigen-presenting cells generates stronger systemic and mucosal immune responses at lower doses than those required for deeper injections (pg. 612, section 3.1, para. 3). Gratieri also teaches that other advantages of needle free devices are prevention of accidental needle sticks and eliminating the need for costly and hazardous “sharps” waste (section 3.1, para. 4).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to combine the method comprising administering M. obuense intradermally taught by the ‘577 claims with the microneedle device or jet injector device taught by Gratieri to administer the compositions, thereby arriving at the invention of claim 85 or 86. The person of ordinary skill in the art would have been motivated to make the modification because jet injectors and/or microneedles are beneficial devices for intradermal administration of drugs or vaccines because jet injectors eliminate accidental needle sticks and don’t require costly disposal systems, and microneedles are minimally invasive and painless. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because microneedles and jet injectors are well known in the art as devices used to safely administer drugs or vaccines to subjects and elicit a strong immune response. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., administration of M. obuense to a subject, microneedles, jet injectors) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Alternately or in addition, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to combine the method comprising administering non-pathogenic non-viable Mycobacterium obuense, alone or in conjunction with a biologically-active agent taught by the ‘577 claims using the M. obuense strain taught by Stanford and further combine with a coronavirus antigen taught by Liu, thereby arriving at the invention of claims 91-92. The person of ordinary skill in the art would have been motivated to make the modification because the use of SARS-CoV-specific antigens in vaccines induces a SARS-CoV-specific T-cell response that is beneficial when protecting against SARS-CoV infection. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because the M. obuense of Stanford may be readily used as an adjuvant in combination with a viral antigen and the coronavirus antigens taught by Liu are known to induce T-cell responses beneficial in protection against the virus. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., administration of Mycobacterium sp. as an adjuvant in conjunction with an antigen and coronavirus antigens) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
In the interest of space, the other highly-similar rejections are presented in an abbreviated from. The table lays out the support for each limitation of the instant claims (see row labels on the left of the table) in the claims of each patent (see column heaters at the top of the table).
‘578
‘952
‘002
‘584
‘405
‘532
76
1
1, 16-18
1, 19-20
1, 18-20
1, 9-10
1, 13-15
77
1
1
1
1
1
1
78
1
1
1
1
1
1
79
1
1
1
1
1
1
80
7
9
8
7
8
8
81
--
--
--
--
--
--
84
1
18
20
20
10
15
85
--
--
--
--
--
--
86
--
--
--
--
--
--
87
2
2
2
2
12
2
88
--
--
--
--
--
--
89
1
1, 16-18
1, 13-16, 19-20
1, 13-16, 18-20
1-4, 9-10, 17-18
1, 10-15
90
1
1
1, 13-16
1, 13-16
1-4, 17-18
1, 10-12
92
--
--
--
--
--
--
93
1
1
1, 13-16
1, 13-16
1-4, 17-18
1, 10-12
94
1
1
1, 13-16
1, 13-16
1-4, 17-18
1, 10-12
95
1
1
1, 13-16
1, 13-16
1-4, 17-18
1, 10-12
96
1
1
1
1
1
1
97
1, 7
1, 9
1, 8
1, 7
1, 8
1,8
98
--
--
--
--
--
--
100
1, 6
1, 16-20
1, 7, 19-20
1, 6, 18-20
1-4, 17-18
1, 13-15
102
--
--
--
--
--
--
US 10,610,578 B2
Claims 76-81, 84-90, 92-98, and 100 remain rejected and claim 102 is newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 6-7 of U.S. Patent No. 10,610,578 (‘578) in view of Stanford (WO 2007/071978 A1), Gratieri (2013, Eur. J. Pharm. Sci.), and Liu (2017, Antivir. Res.).
The teachings of the ‘578 claims relevant to and anticipating instant claims 76-80, 84, 87, 89-90, 93-97, and 100 are presented in the table above.
However, the ‘578 claims do not teach a non-pathogenic non-viable M. obuense that is the strain NCTC 13365 (as in instant claims 81 and 98) or modifies a cellular immune response (as in instant claim 88) and does not teach administration of an antigen or antigenic determinant specific for, targeted to and/or derived from a coronavirus (as in instant claim 92), or an antigen or antigenic determinant comprised within or delivered by one or more of the structures recited in instant claim 102.
The motivation and rationale for combining the teachings of the ‘578 claims, Stanford, Gratieri, and Liu are the same as that set forth in the double patenting rejection over US 10,610,577 B2 above (para. 85-88).
US 10,925,952 B2
Claims 76-81, 84-90, 92-98, and 100 remain rejected and claim 102 is newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 9, and 16-20 of U.S. Patent No. 10,925,952 (‘952) in view of Stanford (WO 2007/071978 A1), Gratieri (2013, Eur. J. Pharm. Sci.), and Liu (2017, Antivir. Res.).
The teachings of the ‘952 claims relevant to and anticipating instant claims 76-80, 84, 87, 89-90, 93-97, and 100 are presented in the table above.
However, the ‘952 claims do not teach a non-pathogenic non-viable M. obuense that is the strain NCTC 13365 (as in instant claims 81 and 98) or modifies a cellular immune response (as in instant claim 88) and does not teach administration of an antigen or antigenic determinant specific for, targeted to and/or derived from a coronavirus (as in instant claim 92), or an antigen or antigenic determinant comprised within or delivered by one or more of the structures recited in instant claim 102.
The motivation and rationale for combining the teachings of the ‘952 claims, Stanford, Gratieri, and Liu are the same as that set forth in the double patenting rejection over US 10,610,577 B2 above (para. 85-88).
US 10,994,002 B2
Claims 76-81, 84-90, 92-98, and 100 remain rejected and claim 102 is newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7-8, 13-16, and 19-20 of U.S. Patent No. 10,994,002 (‘002) in view of Stanford (WO 2007/071978 A1), Gratieri (2013, Eur. J. Pharm. Sci.), and Liu (2017, Antivir. Res.).
The teachings of the ‘002 claims relevant to and anticipating instant claims 76-80, 84, 87, 89-90, 93-97, and 100 are presented in the table above.
However, the ‘002 claims do not teach a non-pathogenic non-viable M. obuense that is the strain NCTC 13365 (as in instant claims 81 and 98) or modifies a cellular immune response (as in instant claim 88) and does not teach administration of an antigen or antigenic determinant specific for, targeted to and/or derived from a coronavirus (as in instant claim 92), or an antigen or antigenic determinant comprised within or delivered by one or more of the structures recited in instant claim 102.
The motivation and rationale for combining the teachings of the ‘002 claims, Stanford, Gratieri, and Liu are the same as that set forth in the double patenting rejection over US 10,610,577 B2 above (para. 85-88).
US 11,000,584 B2
Claims 76-81, 84-90, 92-98, and 100 remain rejected and claim 102 is newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-7, 13-16, and 18-20 of U.S. Patent No. 11,000,584 (‘584) in view of Stanford (WO 2007/071978 A1), Gratieri (2013, Eur. J. Pharm. Sci.), and Liu (2017, Antivir. Res.).
The teachings of the ‘584 claims relevant to and anticipating instant claims 76-80, 84, 87, 89-90, 93-97, and 100 are presented in the table above.
However, the ‘584 claims do not teach a non-pathogenic non-viable M. obuense that is the strain NCTC 13365 (as in instant claims 81 and 98) or modifies a cellular immune response (as in instant claim 88) and does not teach administration of an antigen or antigenic determinant specific for, targeted to and/or derived from a coronavirus (as in instant claim 92), or an antigen or antigenic determinant comprised within or delivered by one or more of the structures recited in instant claim 102.
The motivation and rationale for combining the teachings of the ‘584 claims, Stanford, Gratieri, and Liu are the same as that set forth in the double patenting rejection over US 10,610,577 B2 above (para. 85-88).
US 11,207,405 B2
Claims 76-81, 84-90, 92-98, and 100 remain rejected and claim 102 is newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-10, 12, and 17-18 of U.S. Patent No. 11,207,405 (‘405) in view of Stanford (WO 2007/071978 A1), Gratieri (2013, Eur. J. Pharm. Sci.), and Liu (2017, Antivir. Res.).
The teachings of the ‘405 claims relevant to and anticipating instant claims 76-80, 84, 87, 89-90, 93-97, and 100 are presented in the table above.
However, the ‘405 claims do not teach a non-pathogenic non-viable M. obuense that is the strain NCTC 13365 (as in instant claims 81 and 98) or modifies a cellular immune response (as in instant claim 88) and does not teach administration of an antigen or antigenic determinant specific for, targeted to and/or derived from a coronavirus (as in instant claim 92), or an antigen or antigenic determinant comprised within or delivered by one or more of the structures recited in instant claim 102.
The motivation and rationale for combining the teachings of the ‘405 claims, Stanford, Gratieri, and Liu are the same as that set forth in the double patenting rejection over US 10,610,577 B2 above (para. 85-88).
US 12,042,532 B2
Claims 76-81, 84-90, 92-98, and 100 remain rejected and claim 102 is newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8, and 10-15 of U.S. Patent No. 12,042,532 (‘532) in view of Stanford (WO 2007/071978 A1), Gratieri (2013, Eur. J. Pharm. Sci.), and Liu (2017, Antivir. Res.).
The teachings of the ‘532 claims relevant to and anticipating instant claims 76-80, 84, 87, 89-90, 93-97, and 100 are presented in the table above.
However, the ‘532 claims do not teach a non-pathogenic non-viable M. obuense that is the strain NCTC 13365 (as in instant claims 81 and 98) or modifies a cellular immune response (as in instant claim 88) and does not teach administration of an antigen or antigenic determinant specific for, targeted to and/or derived from a coronavirus (as in instant claim 92), or an antigen or antigenic determinant comprised within or delivered by one or more of the structures recited in instant claim 102.
The motivation and rationale for combining the teachings of the ‘532 claims, Stanford, Gratieri, and Liu are the same as that set forth in the double patenting rejection over US 10,610,577 B2 above (para. 85-88).
New Objection(s) and Rejection(s)
Claim Objections
Claim 96 is newly objected to because of the following informalities: the semicolon after “ATCC 95051” should be a comma to be consistent with the punctuation throughout the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
Claim 102 is newly rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 102, which depends upon claim 90, recites the limitation "a vehicle used for the delivery thereof" in line 2. There is insufficient antecedent basis for “thereof” in the claim. Additionally, the use of punctuation (i.e., the use of both commas and semicolons) in the claim makes it unclear if the elements are intended to be grouped together (e.g., a group of elements that the antigen or antigenic determinant is comprised within and a group of elements that are vehicles). In the interest of compact prosecution, the elements “an adenoviral vector, vaccinia vector, plasmid vector, mRNA, modified mRNA, stabilized mRNA, viral replicase, spike protein, spike fragment, envelope protein, membrane protein, nucleocapsid protein, subunit of a spike protein, or receptor binding domain of the subunit of a spike protein” are interpreted as elements capable of comprising or delivering the antigen or antigenic determinant of claim 90. Note that the elements of claim 102 are not limited to a specific organism or species, i.e., a spike protein is not limited to coronavirus spike proteins. Clarification is requested.
Claim Rejections - 35 USC § 103
Claim(s) 76-81, 84, 87-90, 92-98, 100, and 102-105 are newly rejected under 35 U.S.C. 103 as being unpatentable over Stanford (WO 2007/071978 A1) in view of Sahin et al. (2020, Nature; herein “Sahin”) and de Lusignan et al. (2020, J. Infect.; herein “de Lusignan”).
The teachings of Stanford regarding claims 76-81, 84, 87-90, 93-98, and 100 are set forth in the rejection under 35 U.S.C. 102 above (para. 19-27).
However, Stanford does not teach a method comprising administering an immunomodulator via a microneedle device comprising a plurality of needles (as in claim 85), or a method wherein an immunomodulator is prepared for administration within a single-use pre-filed syringe, multi-use applicator, or jet injector (as in claim 86). Stanford also does not teach an antigen or antigenic determinant specific for, targeted to, and/or derived from a coronavirus (as in claim 92) or an antigen or antigenic determinant comprised within or delivered by one of the structures recited in claim 102, a human subject with one or more tumors and is infected with a coronavirus (as in instant claim 103), or a human subject at elevated risk of exposure to and/or severity of coronavirus infection having one or more tumors that is a member of a household where one or more occupants has known or suspected coronavirus infection or is a healthcare or social care worker exposed to human subjects with known or suspected coronavirus infection (as in instant claims 104-105).
Regarding claim 92 and 102, Sahin teaches BNT162b1,a lipid nanoparticle comprising a modified mRNA encoding the receptor binding domain of the SARS-CoV-2 spike protein (Abstract). Sahin teaches that this composition, i.e., a biologically active agent, elicited a robust T cell response and neutralizing antibody response (Abstract).
Regarding claim 103, de Lusignan teaches that people undergoing treatment for cancer (i.e., may have one or more tumors) are associated with poorer outcomes when positive for COVID-19 (i.e., infected with a coronavirus) and that comorbidities such as cancer increases excess mortality rate from COVID-19 infection (pg. 787, left col., para. 1-3 and Abstract).
Regarding claims 104-105, de Lusignan teaches that, in patients with comorbidities, such as cancer, living in a household with greater than 5 other people significantly increases excess mortality rate (Table 3 and pg. 790, left col., para. 3). De Lusignan also teaches that household transmission is one of the ways that COVID-19 is spread, i.e., transmission occurs when a member of a household infected with COVID-19 transmits the infection to another member of a household (pg. 790, left col., para. 8).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to modify the method of administering M. obuense to patients with one or more tumors as is taught by Stanford by combining the M. obuense with the SARS-CoV-2 antigen taught by Sahin and administer the resulting composition to the subject population of cancer patients infected with COVID-19 and/or live in a household with a person infected with COVID-19, as taught by de Lusignan, thereby arriving at the claimed invention. The person of ordinary skill in the art would have been motivated to make the modification because de Lusignan teaches that the excess mortality rate is higher among patients with comorbidities living in households with five or more people and that excess mortality rate is higher among cancer patients than patients with other comorbidities. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because M. obuense of Stanford may be readily used as an adjuvant in combination with a viral antigen and the coronavirus antigens taught by Sahin are known to induce T-cell responses beneficial in protection against the virus. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., administration of Mycobacterium sp. as an adjuvant in conjunction with an antigen and coronavirus antigens, patients with cancer at high risk of coronavirus infection) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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 by telephone are unsuccessful, the examiner’s supervisor, DANIEL KOLKER can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BAILEY M MORGAN/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645