DETAILED ACTION
Disposition of Claims
Claims 1-20 were pending. Claims 6-7 and 10 have been cancelled. Amendments to claims 1, 5, 8, 11-13, 15-16, and 18 are acknowledged and entered. New claim 21 is acknowledged and entered. Claims 1-5, 8-9, and 11-21 will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US20230277651A1, Published 09/07/2023.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
The Power of Attorney filed on 12/31/2025 is acknowledged and entered.
Optional Authorization to Initiate Electronic Communications
The Applicant’s representative may wish to consider supplying a written authorization in response to this Office action to correspond with the Examiner via electronic mail (e-mail). This authorization is optional on the part of the Applicant’s representative, but it should be noted that the Examiner may not initiate nor respond to communications via electronic mail unless and until Applicant’s representative authorizes such communications in writing within the official record of the patent application. A sample authorization is available at MPEP § 502.03, part II. If Applicant’s representative chooses to provide this authorization, please ensure to include a valid e-mail address along with said authorization.
Response to Arguments
Applicant's arguments filed 12/23/2025 regarding the previous Office action dated 09/03/2025 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Claim Objections
(Objection withdrawn.) The objection to Claim 5 is withdrawn in light of the amendments to said claim.
(Objection withdrawn.) The objection to Claim 16 is withdrawn in light of the amendments to said claim.
(New objection.) Claim 17 is objected to because of the following informalities: “SARS-CoV-2/CoViD-19 viral antigen” should be amended to remove “/CoViD-19”.
Appropriate correction is required.
(New objection.) Claim 21 is objected to because of the following informalities: the definition of the abbreviations “SARS CoV-2”, “MERS CoV”, and “SARS” are not provided. For clarity, it is requested that the first recitation of an abbreviation within a claim set be preceded by its full-length name (e.g. … severe acute respiratory syndrome coronavirus type 2 (SARS CoV-2)...). Additionally, “H1N1” and “H5N1” are specific subtypes of influenza A virus, so while their abbreviations need not be preceded by their full-length name, it is suggested that said viruses have further identifying information to ensure it is clear that these are influenza A virus subtypes (e.g. “…influenza A virus subtype H1N1, influenza A virus subtype H5N1…” or “wherein the influenza A virus is of a subtype of H1N1 or H5N1”.)
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b); Second Paragraph
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claims 1 and 18 and dependent claims 2-17 and 19-20 thereof are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claim 5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claims 6-7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the cancellation of said claims.
(Rejection maintained and extended – necessitated by amendment.) Claims 11-13 remain 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 11 is drawn to the method of Claim 5, which has been amended to recite only “coronavirus” and remove the species of “SARS CoV-2”, “SARS CoV”, and “MERS CoV”. Therefore, the antecedent basis of “SARS CoV-2” in line 1 is unclear.
One suggestion is to rewrite the claim along the lines of the following:
“11. The method of Claim 5, wherein the coronavirus is SARS-CoV-2, the blood product is serum or plasma, and the immunization effective amount is about 5 mL to about 450mL.”
Claims 12-13 are rejected for similar reasoning.
Additionally, claim 12 still provides for “antigen-specific immunoglobulin”, which does not have clear antecedent basis in claim 5 or claim 1. It is suggested that claim 12 be amended along the lines of the following:
“12. The method of Claim 5, wherein the coronavirus is SARS-CoV-2, the blood product is serum or plasma, and the immunization effective amount is about one picogram per kilogram per day to about four grams per kg per day of purified antiviral immunoglobulins.”
Finally, claim 13 refers to “from a type of virus infection”. The antecedent basis of this is unclear, as it is unclear if the subjects recovered from the same type of virus infection (e.g. SARS CoV-2 infection) or from a similar type of infection (e.g. SARS CoV infection, MERS CoV infection, etc.) One suggestion is to amend claim 13 along the lines of the following:
“13. The method of Claim 5, wherein the coronavirus is SARS-CoV-2; the blood product is serum or plasma, wherein the serum or plasma is from either 1) a single subject who has recovered from a SARS CoV-2 infection or is 2) pooled serum or plasma from multiple subjects who have recovered from SARS CoV-2 infection; and the immunization effective amount is administered one or more times.”
For at least these reasons, claims 11-13 remain rejected on the grounds of being indefinite.
(Rejection withdrawn.) The rejection of Claim 15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
(Rejection withdrawn.) The rejection of Claims 16-17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection maintained and extended – necessitated by amendment.) Claim 18 and dependent claims 19-20 thereof remain 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.
In light of the amendments to claim 18 at lines 3-4, the blood product is recited as having “immunoglobulins” (plural) within said blood product against said virus. However, later recitation of “immunoglobulins” refers to them in the singular or plural. See e.g. “administering a therapeutically effective amount of one or more immunoglobulins and/or one or more soluble receptors corresponding to each immunoglobulin, and wherein administering a therapeutically effective amount of one or more immunoglobulins and/or one or more soluble receptors corresponding to each immunoglobulin comprises…” has unclear antecedent basis as first the claim goes from reciting a blood product with multiple immunoglobulins against said virus, then the claim recites one (singular) or more (plural) immunoglobulins but it is not clear that said one or more immunoglobulins are the same as those which are against the virus. Further wording throughout the claim confounds what is actually meant to happen within the method, as it is unclear now where the blood product now has one or more soluble receptors, as the blood product of lines 3-4 only recites having immunoglobulins.
One suggestion is to amend the claim along the lines of the following:
“18. A method of treating an infection from a virus, the method comprising the steps of:
1) obtaining an amount of at least one blood product from at least a first patient, wherein the blood product has one or more immunoglobulins against the virus and/or one or more soluble receptors corresponding to said immunoglobulins; and
2) administering a therapeutically effective amount of the at least one of blood product obtained from the at least first patient to at least a second patient with an infection from the same type of virus,
wherein said administering effectuates the humoral immune system of the at least a second patient to treat the virus, and
wherein the at least one blood product is irradiated prior to administration to the second subject.”
In light of the amendments to claim 18, the antecedent basis of certain limitations in dependent claims 19 and 20 becomes unclear, as it appears as though claim 18 already refers to anti-virus specific immunoglobulin, unless the anti-virus specific immunoglobulin is any virus, not just the virus causing the infection within the preamble of claim 18. Similarly, the “free virus”, “virus-infected cells”, and “virus progression” in claim 20 does not clearly refer back to the singular virus causing the infection. One suggestion would be to amend the method of claim 18 to recite a specific virus, then update the dependent claims accordingly. One suggestion is to cancel claim 19. Another suggestion is to amend claims 19 and 20 along the lines of the suggestions for claim 18:
“19. The method of claim 18, wherein step 2) comprises administration of a therapeutically effective amount at least two immunoglobulins against the virus.”
“20. The method of claim 18, wherein effectuating the humoral immune system of the at least a second patient comprises effectuating a targeted response against said virus causing said infection by 1) neutralizing and/or destroying free virions of said virus, and/or cells infected by said virus, and/or 2) alleviating progression of infection from said virus.”
For at least these reasons, claim 18 is rejected on the grounds of being indefinite. Claims 19-20 are also rejected for depending upon claim 18, but not clarifying the metes and bounds of claim 18.
(New rejection – necessitated by amendment.) Claim 21 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 21 recites the broad recitation of “influenza A virus”, and the claim also recites “H1N1”, “H5N1”, “avian flu virus”, and “influenza A virus”, which are narrower statements of the broader range/limitation of “influenza virus”.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. One suggestion is to have the more narrow statements in a dependent claim which further limits this claim.
One suggestion to amend this claim is to show that claim 21 also further limits claim 5, in that certain viruses further limit the broader genus of viruses recited in dependent claim 5. One suggestion is to amend the claim along the lines of the following:
“21. The method of Claim 5, wherein the coronavirus is selected from the group consisting of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), Middle East respiratory syndrome coronavirus (MERS-CoV), or severe acute respiratory syndrome coronavirus (SARS CoV); wherein the influenza virus is an influenza A virus selected from the group consisting of avian influenza virus, H1N1, or H5N1; and wherein the herpesvirus is varicella zoster virus (VZV or chickenpox virus.)”
For at least these reasons, claim 21 is rejected on the grounds of being indefinite.
Claim Rejections - 35 USC § 112(d); Fourth Paragraph
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claim 10 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn in light of the cancellation of said claim.
(New rejection – necessitated by amendment.) Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In light of the amendments to claim 18, claim 18 already recites immunoglobulins that are against the virus, and it is not clear that with these amendments that claim 19 further limits claim 19. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim 1 is drawn to a method of inhibiting an infection from a virus, the method comprising:
a) obtaining purified antiviral immunoglobulins from a blood product from a first subject wherein the blood product has immunoglobulins against the virus, and
b) administering an immunization effective amount of the purified antiviral immunoglobulins to a second subject who is at risk of becoming infected with the virus or a similar type of virus, wherein the viral infection in the second subject is inhibited.
Further limitations on the method according to Claim 1 are wherein the first subject has recovered from an infection by the virus, or has been immunized against the virus (claim 2); wherein inhibiting a viral infection comprises preventing a viral infection (claim 3); wherein the blood product is irradiated prior to administration to the second subject (claim 4); wherein the virus is a coronavirus (CoV), human immunodeficiency virus (HIV), influenza A H1N1 virus, influenza A H5N1 virus, Powassan virus (POWV), Zika virus (ZIKV), chikungunya virus (CHIKV), dengue virus (DENV), West Nile virus (WNV), herpesvirus, norovirus (NoV), parvovirus, human papillomavirus (HPV), respiratory syncytial virus (RSV), influenza virus, severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), Middle East respiratory syndrome coronavirus (MERS-CoV), avian flu virus (AIV), Ebola virus (EBOV), influenza A virus (IAV), SARS virus (SARS CoV), hepatitis virus, measles virus (MeV), rubella virus (RuV), chickenpox virus (varicella zoster virus or VZV), or yellow fever virus (YFV)(claim 5), wherein the coronavirus is SARS-CoV-2, the blood product is serum or plasma, and the immunization effective amount is about 5 mL to about 450mL (claim 11), wherein the coronavirus is SARS-CoV-2, the blood product is serum or plasma, and the immunization effective amount is about one picogram per kilogram per day to about four grams per kg per day of purified antiviral immunoglobulins (claim 12), wherein the coronavirus is SARS-CoV-2; the blood product is serum or plasma, wherein the serum or plasma is from either 1) a single subject who has recovered from a SARS CoV-2 infection or is 2) pooled serum or plasma from multiple subjects who have recovered from SARS CoV-2 infection; and the immunization effective amount is administered one or more times (claim 13), wherein the coronavirus is selected from the group consisting of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), Middle East respiratory syndrome coronavirus (MERS-CoV), or severe acute respiratory syndrome coronavirus (SARS CoV); wherein the influenza virus is an influenza A virus selected from the group consisting of avian influenza virus, H1N1, or H5N1; and wherein the herpesvirus is varicella zoster virus (VZV or chickenpox virus)(claim 21); wherein the immunoglobulins comprise at least one of immunoglobulin G (IgG), immunoglobulin M (IgM), immunoglobulin A (IgA), immunoglobulin E (IgE), and immunoglobulin D (IgD) and fragments thereof (claim 8), wherein the immunoglobulins and/or fragments thereof are selected from the group consisting of antibody binding fragment Fab, antibody subclasses IgGl,IgG2, IgG3, IgG4, and combinations thereof (claim 9); wherein a blood product obtained from the first subject is administered to a plurality of subjects at risk of contracting the same or similar type of virus (claim 14); further comprising administering conventional vaccination (claim 15); further comprising administering a chimeric or engineered form of an antibody (claim 16), and wherein the engineered form of the antibody is an Fc component fused with a SARS-Cov-2 viral antigen in place of Fab (claim 17).
Claim 18 is drawn to a method of treating an infection from a virus, the method comprising the steps of:
1) obtaining an amount of at least one blood product from at least a first patient, wherein the blood product has one or more immunoglobulins against the virus and/or one or more soluble receptors corresponding to said immunoglobulins; and
2) administering a therapeutically effective amount of the at least one of blood product obtained from the at least first patient to at least a second patient with an infection from the same type of virus,
wherein said administering effectuates the humoral immune system of the at least a second patient to treat the virus, and
wherein the at least one blood product is irradiated prior to administration to the second subject.”
Further limitations on the method of Claim 18 are wherein step 2) comprises administration of a therapeutically effective amount at least two immunoglobulins against the virus (claim 19); and wherein effectuating the humoral immune system of the at least a second patient comprises effectuating a targeted response against said virus causing said infection by 1) neutralizing and/or destroying free virions of said virus, and/or cells infected by said virus, and/or 2) alleviating progression of infection from said virus (claim 20).
Claim Rejections - 35 USC § 112(a); First Paragraph
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection maintained in part – necessitated by amendment.) Claims 18-20 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods of inhibiting viral infection through the use of purified, isolated immunoglobulins from a blood product from a first subject wherein the blood product has anti-viral immunoglobulins against said virus, does not reasonably provide enablement for inhibiting viral infection using any of the blood products claimed from a first subject wherein the blood product has anti-viral immunoglobulins against any virus. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Note that the rejection is withdrawn with respect to claims 1-17 in light of the amendments to the claims.
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). See also MPEP § 2164.01(a) and § 2164.04. 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:
Nature of the invention/Breadth of the claims. Claim 18, with the amendments, is drawn to a method of treating an infection from a virus, the method comprising the steps of:
obtaining an amount of at least one blood product from at least a first patient wherein the blood product has immunoglobulins against the virus and
administering the at least one of blood product obtained from the at least first patient to at least a second patient with the same type of virus,
wherein administering the at least one blood product obtained from the at least first patient to the at least a second patient with the same type of virus comprises administering a therapeutically effective amount of one or more immunoglobulins and/or one or more soluble receptors corresponding to each immunoglobulin, and
wherein administering a therapeutically effective amount of one or more immunoglobulins and/or one or more soluble receptors corresponding to each immunoglobulin comprises enabling reconstitution of a humoral immune system of the at least a second patient to treat the virus, wherein the blood product is irradiated prior to administration to the second subject. The breadth of the claims reads upon delivering any type of “blood product” to any second subject “with the same type of virus”; it is not clear that said second subject must be infected with/by said virus. The blood product from the first subject may be of any species (e.g. the first subject is a mouse, the second subject is a human), and may be any component of said blood sample (e.g. any component of blood, such as serum, plasma, one or more immunoglobulins (antibodies, such as IgG, IgM, IgA, IgE, IgD, or fragments or subclasses thereof; ¶[0029]) with or without their corresponding soluble receptors or fragments thereof.) The claim notes the blood product is “irradiated prior to administration to the second subject”; however, it is not clear what type of irradiation the blood product is exposed to (e.g. ionizing or non-ionizing radiation, wherein ionizing radiation (e.g. radiation that can remove electrons from atoms) includes X-rays, gamma rays, alpha rays, and beta rays; while non-ionizing radiation (e.g. radiation that can move atoms but not break bonds) includes light waves, infrared waves, microwaves, and radio waves) and if said irradiation is meant to neutralize any pathogens within said blood product. The administering step can be in any manner, including, but not limited to, oral, subdermal, intradermal, intramuscular, nasal, ocular, transdermal, or topical. The “immunoglobulins” of claim 18, lines 8-9 is not clearly referring back to the immunoglobulins against the virus of line 4, so it is unclear in the method if the “one or more immunoglobulins and/or one or more soluble receptors corresponding to each immunoglobulin” are referencing back to the same anti-viral immunoglobulins. The subject may be any subject, including human or non-human, within any population or demographic (e.g. age, health status, geographic region, sex, etc.) Dependent claim 20 does not make it clear that the “free virus” or cells infected by virus, or the viral progression alleviated are all caused by the same virus of the preamble of claim 18.
The analysis of the “State of the prior art/Predictability of the art”, the “Working examples”, the “Guidance in the specification”, and the “Amount of experimentation necessary” is still applicable to claims 18-20. As it was presented in a previous Office action, it will not be repeated herein.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not entirely persuasive.
Applicant argues that the amendments to the claims are now in line with what the Office had indicated as being enabled. While that is true with respect to some of the claims, claims 18-20 remain rejected for the reasons noted supra and in the previous Office action as the amendments to the claims still generate ambiguity as to the virus-specific immunoglobulins recited in line 4 of the claim and the use of “one or more immunoglobulins and/or one or more soluble receptors corresponding to each immunoglobulin” at lines 8-11 and whether or not the latter is referencing only the former. It is suggested that claims 18-20 be amended in line with the previous suggestions set forth supra to aid in overcoming the 35 USC 112a and b rejections.
For at least these reasons, the arguments were not persuasive with respect to claims 18-20, and the rejection is maintained with respect to these claims.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claims 1-3, 5-8, 10-13, 15, and 18-20 under 35 U.S.C. 102(a)(2) as being anticipated by Shen et. al. (Shen C, et. al. JAMA. 2020 Apr 28;323(16):1582-1589.; hereafter “Shen”) is withdrawn in light of the amendments to the claims.
(New rejection – necessitated by amendment.) Claims 1-3, 5, 8-9, 11-13, 14, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bloch et. al. (Bloch EM, et. al. J Clin Invest. 2020 Jun 1;130(6):2757-2765.; hereafter “Bloch”.)
The Prior Art
Bloch teaches severe acute respiratory syndrome coronavirus 2 (SARS–CoV-2), the cause of coronavirus disease 2019 (COVID-19), has spurred a global health crisis, and that at the time there were no proven options for prophylaxis for those who have been exposed to SARS–CoV-2, nor therapy for those who developed COVID-19. Bloch teaches immune (i.e., “convalescent”) plasma refers to plasma that is collected from individuals following resolution of infection and development of antibodies via apheresis to isolate and purify the plasma component, and that passive antibody administration through transfusion of convalescent plasma may offer the only short-term strategy for conferring immediate immunity to susceptible individuals (entire document; see abstract; Fig. 1; instant claims 1, 5, 21.) Bloch teaches in Figure 1 that the individual donating the plasma would have to have no evidence of illness and therefore have recovered from the SARS CoV-2 infection (Fig. 1; instant claim 2). Bloch teaches the dosage for prophylactic prevention of SARS CoV-2 would be variable, depending on the titer of the antibodies in the plasma (p. 2761, rt. Col., ¶3; instant claim 3). Bloch teaches assessment for the detection of different antibody subclasses, such as analysis of IgM, IgG, IgA, and IgG3 (p. 2760, “Antibody testing”; instant claims 8-9). Bloch estimates that the typical dosage for a patient in need would be about a single unit of 250 mL of plasma with an antibody titer of 1:64 or greater, but the dosage could vary by body weight, and that in previous scenarios about 5 mL/kg of plasma at a titer of 1:160 or greater was utilized during the SARS CoV epidemic, and that plasma could be aliquoted into smaller amounts for children so they could be dosed by body weight (p. 2761, “Optimal dosing and transfusion.”, instant claims 11-13, 14).
For at least these reasons, Bloch teaches the limitations of instant claims 1-3, 5, 8-9, 11-13, 14, and 21, and anticipates the invention encompassed by said claims.
(New rejection – necessitated by amendment.) Claims 1-3, 5, 13-14, 16-17, and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zion et. al. (US20210346490A1, Priority 04/10/2020; hereafter “Zion”.)
The Prior Art
Zion teaches the generation of a SARS CoV-2 receptor binding domain (RBD) fragment from the spike (S) protein fused to a human Fc fragment for use in relation to therapeutics to treat the 2019 Novel Coronavirus (COVID-19)(entire document; see abstract.) Zion teaches the RBD-Fc antibody can be given to SARS CoV-2 antibody-naïve patients to produce antibodies to SARS CoV-2 to enable the patients to become convalescent plasma donors (entire document; see abstract). Zion teaches that the immunogenic compositions described may be used in methods of treatment or prophylaxis of SARS CoV-2 (¶[0018-0021]), and that convalescent sera from individuals who contracted virus and recovered from the virus was previously used therapeutically or as a prophylactic vaccine in the context of influenza A virus (¶[0107]; instant claims 1-3, 5, 13, 16-17, 21). Zion teaches their methods can be used with antibody amplification treatment (AAT) to increase the anti-SARS CoV-2 antibody in the extracted sera so that the number of patients that can be treated with the isolated antibodies can be increased (¶[0121]; instant claim 14). Zion teaches the antibodies that can be generated in a mammal, such as a human, include IgG1, IgG2, IgG3, and IgG4, along with IgA and IgM (¶[0130]).
For at least these reasons, Zion teaches the limitations of 1-3, 5, 13-14, 16-17, and 21, and anticipates the invention encompassed by said claims.
Claim Rejections - 35 USC § 103
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 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.
(New rejection – necessitated by amendment.) Claims 4, 15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bloch as applied to claims 1-3, 5, 8-9, 11-13, 14, and 21 above, and over Zion as applied to claims 1-3, 5, 13-14, 16-17, and 21 above, and further in view of Picker (Picker SM. Blood Transfus. 2013 Jul;11(3):343-8. Epub 2013 Mar 14.; hereafter “Picker”) and Gasparyan et. al. (Gasparyan AY, et. al. J Korean Med Sci. 2020 May 11;35(18):e176.; hereafter “Gasparyan”.)
The Prior Art
The teachings of Bloch and Zion have been set forth supra. While Bloch and Zion both teach the use of convalescent plasma to prophylactically treat a person at risk for developing a SARS CoV-2 infection, and teach that isolation of plasma is done through techniques known in the art, such as apheresis, and that heat-inactivation of plasma is performed before many in vitro studies, neither explicitly teach the irradiation of the plasma before the use in another subject. However, such a method was known in the art, as taught by Picker. Further, the suggestion of including commercially available vaccines against heterologous antigens was also suggested in addition to the use of convalescent plasma treatments of Zion and Bloch, as it was noted that certain vaccines decreased the incidence of acquiring SARS CoV-2 infection, as noted by Gasparyan.
Picker teaches current strategies to reduce the risk of transmissible, transfusion-associated infections rely on donor deferral and testing procedures, filtration or gamma irradiation of blood products to reduce the number of pathogens and viable donor leucocytes promoting adverse transfusion reactions in the recipient (entire document; see p. 343, “Pathogen load of blood products”.)
Gasparyan teaches that in the early stages, the fight against SARS CoV-2 infection was based on strategies to boost immune responses to the infection, including trained immunity (the concept of cross-reactive or enhanced activity against a heterologous pathogen through vaccination with a commercial vaccine, such as BCG (p. 4, ¶1)) and the use of convalescent sera (pp. 5-6).
Given the teachings of Zion and Bloch, a skilled artisan would be apprised as to the use of convalescent sera to prophylactically treat an at-risk patient and to aid in the prevention of said patient from acquiring a SARS CoV-2 infection. It would be obvious to pre-treat the plasma of the convalescent patient to ensure it did not comprise bloodborne pathogens, such as the use of gamma-irradiation, given the teachings of Picker. A skilled artisan would be apprised as to the fact that the methods of treatment with SARS CoV-2 convalescent sera would aid in inhibiting viral infection by neutralizing and/or destroying any free, circulating SARS CoV-2 virus in said at-risk patient. Furthermore, additional methodologies, such as the use of heterologous, commercial vaccines to elicit trained immunity, would be obvious to a skilled artisan to try, given the teachings of Gasparyan, which teach the use of convalescent sera and trained immunity to inhibit the spread of SARS CoV-2. Therefore, given the combined teachings of Zion, Bloch, Gasparyan, and Picker, arriving at the limitations of instant claims 4, 15, and 18-20 would be obvious to a skilled artisan.
It would have been obvious to one of ordinary skill in the art to modify the methods taught by Zion or Bloch in order to pre-treat the convalescent sera, thereby ensuring the sera was pre-treated and pre-cleared for any bloodborne pathogen. One would have been motivated to do so, given the suggestion by Picker that it was common to irradiate sera before infusion into a recipient. There would have been a reasonable expectation of success, given the knowledge that the use of convalescent sera and trained immunity to treat or prevent SARS CoV-2 were both suggested modalities for this newly emerging infection, as taught by Picker. Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
No claims are 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.
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/RACHEL B GILL/
Primary Examiner, Art Unit 1671