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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group 1 in the reply filed on 3/10/2026 is acknowledged.
Claims 4-8, 10-13, 15, 22-24, 26-29, 31, 35, and 40-67 have been cancelled.
Claims 1-3, 9, 14, 16-21, 25, 30, 32-34, and 36-39 are pending.
Claims 36-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-3, 9, 14, 16-21, 25, 30, and 32-34, drawn to a liquid therapeutic hyperimmune globulin composition comprising human plasma derived IgG, are examined on merits.
Information Disclosure Statement
The information disclosure statement (s) (IDS) submitted on 11/30/2022 and 12/16/2022 are/is considered by the examiner and initialed copies/copy of the PTO-1449 are/is enclosed.
Claim Objections
1. Claim 1, 3, and 9 are objected to for these phrases recited in the claims as
“…titer between 250-2500 per mg/ml of IgG”, and
“….neutralization activity IC50 between 1.5-15 per mg/ml of IgG,
which meanings are not clear. Does it mean the IgG concentration is between 250mg -2500 mg per mL? If so, correction should be made by deleting word “per” in the phrase, or making clarification using the phrases one skilled in the art would understand and used commonly.
2. Claim 1, 3, 19, and 21 are objected to for including word “titre”. Word titer (American English) and titre (British English) are alternative spellings for the same scientific term. However, the instant application has been filed in US Patent Office and applied for US patent. Using American English spelling titer would be proper. Amendment is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 9, 14, 16-21, 25, 30, and 32-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without inventive concept/Significantly more.
The claims are directed to
a liquid therapeutic hyperimmune globulin composition comprising human plasma derived immunoglobin with a purity of at least 97% of total protein content and having a SARS-Cov-2 antibody titer between 250-2500 mg/ml of IgG….
The specification teaches preparing and method for obtaining hyperimmune plasma from human convalescent donor (entire document). The specification teaches method comprising the step of selecting plasma donors who had SAR-CoV-2 infection, collecting plasma, and obtaining the hyperimmune globulin from the plasma and determining anti-SARS-CoV-2 IgG titer by ELISA and activity by neutralizing antibody assay, and then forming a liquid therapeutic hyperimmune globulin composition comprising the plasma (example 1-5).
The liquid therapeutic hyperimmune globulin from human plasma containing human IgG from human patient or donor is from the naturally existed plasma from human donor and does not markedly difference from naturally occurring product since the genetic materials such as cells and IgG has not be altered, therefore, the hyperimmune globulin is not sufficient to qualify as patent-eligible practical application that is something difference than a Judicial Exception (abstract ideas, laws of nature/natural principle, natural phenomena, and Natural Products).
The following inquiries are used to determine whether a claim is drawn to patent-eligible subject matter:
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter?
Answer is Yes, all of the claims are directed to a composition of matter.
Step 2A. Is the claim directed to a law of nature, a natural product or an abstract idea (judicially recognized exception) and does the claim recite additional elements that integrate the judicial exception into a practical application?
Answer is Yes, the claims recite natural product but the additional elements do not integrate the judicial exception into a practical application.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception?
Answer is No. The composition does not provide additional element that amount to significantly more than the judicial exception.
Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter
For more information and analysis, applicant is also directed to the new 2014 Guidance under 35 USC § 101 on the website below (Example 3 and 7 in particular):
Determine Subject Matter Eligibility of Claims Reciting or Involving Law of Nature, Natural Phenomena, & Natural Products, Issued Dec, 2014 and revised May, 2016 and Jan, 2019 at http://www.uspto.gov/patents/law/exam/examguide.jsp
Claim Rejections - 35 USC § 102
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 –
102(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2,16-18, 19-20, and 32-34 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mondou et al (US20230235025, filed on May 27, 2020).
The applied reference has a common applicant Grifols Worldwide Operation Limited with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Mondou et al disclose human convalescent plasma containing anti-SARS-CoV-2 IgG contained antibodies as a liquid therapeutic hyperimmune globulin in a composition used for treating Covid-19 infection (entire document, abstract). Mondou et al disclose the human plasma having IgG Normalized titer range between 250-2500 mg/ml or ELISA titer 1: 25,000-250,000, and neutralizing activity IC50 range at 1.5-15 mg/ml of IgG or 1:150-1500 (table 3 and [0155-0164]), which meet the limitation of claimed IgG titer and neutralizing activity titer set forth in claims 1-2 and 19-20. Mondou et al characterize the hyperimmune globulin having 97%-100% IgG of the total proteins, where are almost entirely as monomers and dimers and content of IgM is less than 0.01mg/ml and IgA is less than 0.04 mg/ml (example 4, [0151-154]), which meet the limitation set forth in claims 16-18 and 32-34.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claim 1-2, 3, 9, 14, 16-18, 19-20, 21, 25, 30, and 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mondou et al (US20230235025, filed on May 27, 2020).
The teaching of Mondou et al on hyperimmune globulin from human plasma derived immunoglobulin (IgG) including IgG antibody content, ranged dilution titers, and ranged neutralization activity titers are set forth above.
Although the reference does not specify the numbers within the ranges as claimed in the dependent claims, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to further concentrate the IgG from the same plasma to have dilution titer at 300-2,200 mg/ml or 50,000 -200,000 dilution ratio, which would have neutralizing activity between 1.8-12/mg/ml or 2000-1,250 the with expected result. In order to increase the treatment efficacy and effectiveness based on the teaching of Mondou et al, one of ordinary skill in the art before the effective filing date of was made would have been motivated with reasonable expectation of success to do so because Mondou et al have shown the ranges of concentration of the human plasma derived IgG and its neutralization activation and the ranges of Mondou include the claimed concentration and activity as in claims 3, 9, 21 and 25. Therefore, the reference teaches and suggests each and every limitation of the claims and the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention was made, absent unexpected results.
Regarding with the human plasma derived IgG content is between 5-20% (w/v), in order to meet the requirement of the treating Covid 19 in patients, one skilled in the art would have a reasonable expectation of success to optimize the IgG concentration comprising at 5-20% w/v as claimed by e.g. adding 5g of the IgG to 100ml liquid (pharmaceutically acceptable buffer) to arrive at current invention without unexpected result.
Applicant is directed to See MPEP 2144.05: Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions:
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim,541 F.2d 257, 191 USPQ 90 (CCPA 1976); Inre Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362,1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of “50to 100 Angstroms” considered prima facie obvious in view of prior art reference teaching that “forsuitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100Angstroms].” The court stated that “by stating that‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.”).
(A)prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330,65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951(Fed. Cir. 2005) (claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention).However, if the reference’s disclosed range is so broad as to encompass a very large number of possible distinct compositions, this might present a situation analogous to the obviousness of a species when the prior art broadly discloses a genus. Id. See also In re Baird, 16 F.3d 380, 29 USPQ2d 1550(Fed. Cir. 1994); In re Jones, 958 F.2d 347, 21USPQ2d 1941 (Fed. Cir. 1992); MPEP § 2144.08.
Training material 102/103 workshop:
MPEP § 2144.05(II)(B) has been revised to state that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lei Yao, whose telephone number is (571) 272-3112. The examiner can normally be reached on 8:00am-6:00pm Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEI YAO/Primary Examiner, Art Unit 1642
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