DETAILED ACTION
Status of Application
The amendments, response, Declaration under 37 C.F.R. 1.131 and eTD filed on 04 March 2026 are acknowledged and have been considered in their entireties. Claims 2-20 are new, thus, claims 1-20 are pending and subject to examination on the merits.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04 March 2026 has been considered by the examiner. See initialed and signed PTO/SB/08.
Withdrawal of Previous Rejection(s)
Claim 1 is rejected under 35 U.S.C. 102(e) as being anticipated by Teschner et al. (US 20100330071 – cited on IDS, document 14) is withdrawn in view of the Declaration filed under 37 C.F.R. 1.131 on 04 March 2026, which establishes conception and reduction of practice prior to 27 May 2009.
The 12 non-statutory double patenting rejections over US Patents: 9468675, 9708391, 10208106, 10875906, 11136350, 11891431, 8993734, 8772462, 8921520, 8889838, 8940877 and 12545703 (previously cited as co-pending application 17473910) are withdrawn in view of the Terminal Disclaimer filed 04 March 2026. Said disclaimer is proper and has been accepted and recorded.
New Rejection – Necessitated by Amendments
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 4-5 and 7-11 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The claims recite “at least about 85%” or at “at least about 90%”. However, the term “at least” requires quantities equal to or greater than a specific quantity such as 85% or 90%, whereas the term “about” permits values lower than 85% or 90%. As such, the metes and bounds of the claim are unclear.
Claims 4-5 and 7-11 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The claims recite the term “about”, which renders the claimed values indefinite. While the specification at paragraph 0171 (PG-Pub) recites various interpretations of the term “about”, they are also unclear and inconsistent. On the one hand, the specification describes “about” as: “As used herein, the term “about” denotes an approximate range of plus or minus 10% from a specified value.” Thus, the value is not definite as +/- 10% because it is only an approximation. In the same paragraph, the term is recited as being the exact value; or it could be range of at or about the specified value: “As used herein, “about” refers to a range of at or about the specified value.”
This interpretation of indefiniteness for the term “about” absent a definitive definition has been recently reaffirmed as indefinite by the courts. See Enviro Tech Chemical Servs., Inc. v. Safe Foods Corp. (Fed. Circ., May 4th, 2026).
Maintained Rejection(s)
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-3, 6-11, 14-18 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Condie et al. (US 4136094 – cited on IDS) as evidenced by Teschner et al. (US 8772462 – cited herein).
Condie et al. teach methods of removing proteins from plasma composition by contacting said plasma composition with finely divided silico dioxide which bind unwanted proteins, specifically, Aerosil 380, and separating the silicon dioxide from composition – See Example 1. Condie et al. does not recognize that said silicon dioxide binds serine proteases FXIa or FXIIa or serine protease zymogen FXI or FXII.
Teschner et al. evidences finely divided silicon dioxide (such as Aerosil’s) bind serine proteases such as FXIa and FXIIa and zymogens FXI and FXII in plasma derived compositions (See Col. 16, lines 15-36; Example 1).
Regarding the use of Teschner et al. as the evidentiary reference, MPEP 2131.01(III) and 2124; 2112(II) are all relevant as explained below.
“Also note that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date.” 2131.01(III)
“Inherent feature need not be recognized at the time of the invention” 2112(II)
“In certain circumstances, references cited to show a universal fact need not be available as prior art before applicant’s filing date. In re Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA 1962). Such facts include the characteristics and properties of a material or a scientific truism” MPEP 2124.
Thus, while Condie et al. did not recognize at the time that the methods of removing unwanted proteins from plasma compositions by contacting said composition with Aerosil (finely divided silicon dioxide) would result in the binding/removal of serine proteases, Teschner et al. evidences the scientific fact the contacting with Aerosil would also result in binding/reduction of serine proteases FXIa/FXIIa and/or their zymogens FXI/FXII from the composition.
Regarding claim 2, the plasma-derived target protein is IgG or albumin – See Example 1.
Regarding claim 3, the final IgG composition comprises at least 10% - See Example 1, Col. 6 to Col. 7.
Regarding claim 6, the silicon dioxide is fumed silica – See claims 1 and 15; Examples.
Regarding claim 7, 20g/L of SiO2 is added as the final concentrations.
Regarding claim 8-9, the pH of the SiO2 is 7.37-7.83 for the first contact step with silicon dioxide and is a pH of 7.14-7.62 for the second step (See Example 1, Steps 2 and 3). As indicated above, the term “about” is indefinite and a definitive value cannot be ascertained therefrom. As such, the pH’s of Condie meet these limitations.
Regarding claim 10-11, the conductivity of the contacting is 11.4 mS for the first contacting and 11.6 mS for the second contacting (See Example 1, Steps 2 and 3).
Regarding claims 14-15, the IgG and Albumin compositions are diafiltered against glycine-saline buffer (See Buffer#5 in Table II and Steps 7 and 12 in Example 1).
Regarding claim 16, said formulation is for intravenous injection (See Title, claim 1 and Example 2).
Regarding claims 17 and 18, the method comprises both anion and cation exchange chromatography – See Example 1, Claim 1D and 1F.
Applicants Remarks and Examiner’s Rebuttal:
Applicant’s traverse the rejection of record and state that Teschner et al. does not evidence inherently that contacting Aerosil under the high-pH and conductivity conditions of Condie et al. will result in binding or reduction of serine proteases. This is because in Example 5 and Table 24, Teschner recreate the conditions of Condie and demonstrate the highest amount of serine protease was eluted from the Aerosil under these conditions (e.g. pH 7.5 and conductivity 77.88 mS/cm) – See Remarks, pp. 6-7.
The Examiner has considered these remarks but do not find them convincing because even the tiniest amount of binding, which clearly still occurs as exemplified by Teschner’s Table 24, is enough to mee the limitations of the claim. This is because there is no specific value attached to how much reduction of the serine protease or zymogen thereof is required. So, as noted, even the most minute fraction meets the limitations of the claims and thus the rejection is maintained.
New Rejection – Necessitated by IDS
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-14, 16-17 and 19-20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Bertolini et al. (WO 98/05686 – cited on new IDS filed 04 March 2026) as evidenced by Teschner et al. (US 8772462 – cited on previous PTO-892).
Bertolini et al. teach:
Regarding claims 1-2 and 6, a method of purifying immunoglobulin from plasma comprising contacting said plasma composition with fumed silica, either Aerosil 200 or 380, a pH of either 5.2 or 7.2 and a conductivity of 6 to 12 mS/cm (See p. 8, line 20 to p. 9, line 2; also see Example 1, Table 1). Additional conductivities tested were 9.0, 1.2 and 0.6 mS/cm (See Table 2). The use of said Aerosil was to bind and remove lipoproteins.
Teschner et al. evidences finely divided silicon dioxide (such as Aerosil’s) bind serine proteases such as FXIa and FXIIa and zymogens FXI and FXII in plasma derived compositions (See Col. 16, lines 15-36; Example 1) and that they bind these components in significant quantities at lower pH’s such as 6.0 and lower conductivities, which was demonstrated by lower amidolytic activity measured by substrate CS2166 – See Example 4 and Table 23.
Regarding the use of Teschner et al. as the evidentiary reference, MPEP 2131.01(III) and 2124; 2112(II) are all relevant as explained below.
“Also note that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date.” 2131.01(III)
“Inherent feature need not be recognized at the time of the invention” 2112(II)
“In certain circumstances, references cited to show a universal fact need not be available as prior art before applicant’s filing date. In re Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA 1962). Such facts include the characteristics and properties of a material or a scientific truism” MPEP 2124.
Thus, while Bertolini et al. did not recognize at the time that the methods of removing unwanted serine protease or zymogens thereof from plasma compositions by contacting said composition with Aerosil (finely divided silicon dioxide) would result in the binding/removal of serine proteases, Teschner et al. evidences the scientific fact the contacting with Aerosil would also result in binding/reduction of serine proteases FXIa/FXIIa and/or their zymogens FXI/FXII from the composition.
Regarding claims 3-5, the IgG content has a loss of less than 5% (See Example 1, lines 29-32).
Regarding claim 7, the amount of silicon dioxide added is 200mg Aerosil(200)/g protein (See Example 1, lines 29-32).
Regarding claims 8-9, as noted, the pH for binding was carried out either at pH 7.2 or pH 5.2 (See Example 1).
Regarding claims 10-11, the conductivities tested included those of 0.6 mS/cm – See Example 1, Table 2.
Regarding claims 12-13, the rate of hydrolysis of various substrates will inherently be significantly low and in the ranges of these claims given the binding and removal of proteases and nearly pure IgG compositions obtained as taught in Example 1; this is also evidenced by Teschner et al. in Example 4.
Regarding claims 14 and 19, a stabilizing agent is added to the composition prior to a viral inactivation step (See 10, lines 17-19).
Regarding claim 16, the formulation is suitable for intravenous administration – See p. 1, lines 5-9.
Regarding claim 17, the method utilizes anion exchange chromatography – See claim 1 and Examples 2 and 3.
Regarding claim 20, a 500 nM filter was utilized for filtration – See p. 22, lines 13-18.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action.
In addition, Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 04 March 2026 prompted the new ground(s) of rejection presented in this Office action.
Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a) and MPEP § 609.04(b). 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 SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 07 May 2026
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