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 .
Status of Claims
Claims are 3-4, 7, 10, 16, 19-21, 23-24, 26-28, 38, and 40 are amended. Claims 5-6, 8-9, 11-15, 17-18, 22, 25, 31-33, 36-37, 39, and 41-45 are cancelled. Claims 1-4, 7, 10, 16, 19-21, 23-24, 26-30, 34-35, 38, and 40 are currently pending and under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The claims have an earliest effective filing date of 09/27/2020, corresponding to provisional application 63/083,981.
Information Disclosure Statement
The Information Disclosure Statement filed on 02/25/2025 has been considered.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 7, 10, 16, 19-21, 23-24, 38, and 40 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Butterweck et al (US20120076779, published 03/29/2012).
Regarding claims 1, 20, 24 and 40 Butterweck et al teach a formulation of immunoglobulins at a concentration of 60g/L (mg/ml) (Butterweck et al, pg. 32, paragraph 0354) including 250 mM proline (Butterweck et al, pg. 4, paragraph 0100) wherein the formulation is at pH 5.7 (Butterweck et al, pg. 8, paragraph 0200). Regarding claim 40, it is noted that 5.7 is at least 5.5, at least 5.6, or at least 5.7. Regarding claims 20 and 24, it is noted that Butterweck et al does not state that an additional buffer or glucose is required.
Regarding claims 2, 16, and 19, Butterweck et al teach the formulation can additionally include a stabilizer (Butterweck et al, pg. 2, paragraph 0028), including an example with .15g/L (mg/ml) polysorbate 80 (Butterweck et al, pg. 51, paragraph 0510). Regarding claim 19, it is noted that .15 mg/mL is between .1 and .4.
Regarding claim 3, claim 1 is discussed above. Butterweck et al teach the immunoglobulins can be IgG (Butterweck et al, pg. 2, paragraph 0037).
Regarding claim 4, claim 1 is discussed above. Butterweck et al teach the immunoglobulins can come from a human (Butterweck et al, pg. 2, paragraph 0041). It is noted that humans are mammalian.
Regarding claim 7, claim 1 is discussed above. It is noted that 5.7 is in the range from 5.6 to about 5.8.
Regarding claim 10, claim 1 is discussed above. It is noted that 60mg/mL is in the range of about 60mg/mL to about 250 mg/mL.
Regarding claim 21, the method of claim 1 is discussed above. Additionally, Butterweck et al disclose various suitable buffers that can be included in the formulation (Butterweck et al, pg. 53, paragraph 0531).
Regarding claim 23, the method of claim 1 is discussed above. Additionally, Butterweck et al teach the formulation at 95% purity (Butterweck et al, pg. 25, paragraph 0301).
Regarding claim 38, the method of claim 1 is discussed above. Additionally, Butterweck et al teach the formulation can be administered intravenously or intramuscularly (Butterweck et al, pg. 23, paragraph 0284).
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.
Claim(s) 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Butterweck et al (US20120076779, published 03/29/2012).
Regarding claims 26 and 27 Butterweck et al teach a formulation of immunoglobulins at a concentration of 60g/L (mg/ml) (Butterweck et al, pg. 32, paragraph 0354) including 250 mM proline (Butterweck et al, pg. 4, paragraph 0100) wherein the formulation is at pH 5.7 (Butterweck et al, pg. 8, paragraph 0200). It is noted that Butterweck et al do not teach the formulation comprising 200mM of proline or .3mg/mL of polysorbate 80. However, Butterweck et al do teach the concentration of proline in a range from 200mM to 300mM.
Furthermore, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Claim(s) 26-30 and 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butterweck et al (US20120076779, published 03/29/2012) in view of Lee et al (Lee et al Nature Microbiology Vol 5 2020 1185-1191, published 10/2020).
Butterweck et al is discussed in detail above. Butterweck et al teach a formulation comprising immunoglobulins, proline, and polysorbate 80 wherein the formulation has a pH of 5.7. Butterweck et al do not teach a formulation comprising immunoglobulins, proline, and polysorbate 80 wherein the formulation has a pH of 5.7 wherein the immunoglobulins specifically bind SARS-CoV-2. This deficiency is remedied by Lee et al.
Lee et al. teach that SARS-CoV-2 antibodies can be used in vaccines (Lee et al, pg. 1185, Abstract). Based upon the teachings of Lee et al, one of ordinary skill in the art would have been motivated to improve SARS CoV-2 vaccines.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of Butterweck et al and Lee et al to arrive at a formulation comprising immunoglobulins, proline, and polysorbate 80 wherein the formulation has a pH of 5.7 wherein the immunoglobulins specifically bind SARS-CoV-2. One of ordinary skill in the art would have been motivated to do so, because Butterweck et al teach a formulation comprising immunoglobulins, proline, and polysorbate 80 wherein the formulation has a pH of 5.7. Furthermore based on the teachings of Lee et al, one of ordinary skill in the art would have been motivated to treat SARS-CoV-2 with an antibody-based vaccine. As such one of ordinary skill in the art would have been motivated to modify the teachings of Butterweck et al, which teaches an antibody vaccine formulation, to further include SARS-CoV-2 antibodies because there would have been a reasonable expectation that the resultant invention, which comprises a SARS-CoV-2 vaccine, is effective in treating SARS-CoV-2. The invention of Butterweck et al and Lee et al meet the limitations of claims 28, 34, and 35.
Butterweck et al do not teach a formulation comprising immunoglobulins, proline, and polysorbate 80 wherein the formulation has a pH of 5.7 wherein the immunoglobulins specifically bind influenza A. This deficiency is remedied by Lee et al.
Lee et al. teach that Influenza A antibodies can be used in vaccines (Lee et al, pg. 1188, Column 2, paragraph 3). Based upon the teachings of Lee et al, one of ordinary skill in the art would have been motivated to improve influenza A vaccines.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of Butterweck et al and Lee et al to arrive at a formulation comprising immunoglobulins, proline, and polysorbate 80 wherein the formulation has a pH of 5.7 wherein the immunoglobulins specifically bind influenza A. One of ordinary skill in the art would have been motivated to do so, because Butterweck et al teach a formulation comprising immunoglobulins, proline, and polysorbate 80 wherein the formulation has a pH of 5.7. Furthermore based on the teachings of Lee et al, one of ordinary skill in the art would have been motivated to treat Influenza A with an antibody-based vaccine. As such one of ordinary skill in the art would have been motivated to modify the teachings of Butterweck et al, which teaches an antibody vaccine formulation, to further include Influenza A antibodies because there would have been a reasonable expectation that the resultant invention which comprises an influenza A vaccine is effective in treating influenza A. The invention of Butterweck et al and Lee et al meet the limitations of claims 29 and 30.
Therefore the claims as a whole were prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention, as evidenced by the references.
Conclusion
No claim is allowed
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/J.K.D./Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642