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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-4, 11, 25, 60-61, 142-143, 145 and 150-158) in the reply filed on May 22, 2026 is acknowledged. Applicant’s election without traverse of the different species in claims 2, 3, 4, 11, 25, 60 and 61 in the reply filed on May 22, 2026 is also acknowledged. Claims 148 and 149 are withdrawn from further consideration.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 14, line 37 to page 15, line 7 of the specification. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the terms “ETOXICLEARTM”, “PIERCETM”, “TOXINERASERTM”, “PURKINETM” and “DETOXI-GELTM” which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 60-61, 142-143, 145 and 150-158 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claim 1, and claims 60-61, 142-143, 145 and 150-158 which depend from claim 1, recite a method of purifying an inter-alpha inhibitor protein (IαIp) in a blood product material comprising applying the blood product material to a column comprising an endotoxin-binding agent. While the specification generally describes the endotoxin-binding agent as being a molecule that can or is known to bind an endotoxin, such as a lipopolysaccharide, and recites some specific commercially available endotoxin binding agents including “ETOXICLEARTM”, “PIERCETM”, “TOXINERASERTM”, “PURKINETM” and “DETOXI-GELTM” (see lines 32-37 on page 14, lines 1-8 on page 15 and lines 18-31 on page 23 of the instant specification) as being useful in the instant invention, the specification only provides specific examples and data for the use of either “ETOXICLEARTM” or “DETOXI-GELTM” as the endotoxin-binding agent used in the method for purifying an inter-alpha inhibitor protein (IαIp) in a blood product material. Examples 1, 5 and 6, and tables 2, 7 and 9 in the specification provide evidence that the endotoxin-binding agent “ETOXICLEARTM” can be used successfully to purify an inter-alpha inhibitor protein (IαIp) in a blood product material. Examples 2, 3 and 4, and tables 3, 4 and 5 in the specification provide evidence that the endotoxin-binding agent “DETOXI-GELTM” can be used successfully to purify an inter-alpha inhibitor protein (IαIp) in a blood product material. No other examples or data is provided in the specification for using other endotoxin-binding agents for purifying an inter-alpha inhibitor protein (IαIp) in a blood product material besides “ETOXICLEARTM” and “DETOXI-GELTM”. Therefore, while general assertions are made in the specification that other types of endotoxin-binding agents can be used in the method for purifying an inter-alpha inhibitor protein (IαIp) in a blood product material, it is unclear to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention as encompassed by the phrase “an endotoxin-binding agent”.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 11, 25, 60-61, 142-143, 145 and 150-158 are 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.
On line 5 of claim 1, the phrase “the biological material” lacks antecedent basis since the phrase “biological material” in claim 1 has been replace by the phrase “blood product material”.
Claim 2 contains the trademark/trade name ETOXICLEARTM. 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/trade name is used to identify/describe an endotoxin-binding agent and, accordingly, the identification/description is indefinite.
On line 7 of claim 60, the phrase “the column” lacks antecedent basis since lines 4-5 of claim 60 recite “an anion-exchange chromatography support”, not an anion-exchange chromatography column.
On lines 1-2 of claim 151, the phrase “a high salt elution buffer” is indefinite since it is not clear what concentration of a salt constitutes being a high salt elution buffer. See this same problem in claims 152 and 155-157 which depend from claim 151.
On line 4 of claim 158, the phrase “the yield” lacks antecedent basis.
Inventorship
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.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action since none of the prior art of record teaches or fairly suggests a method for purifying an inter-alpha inhibitor protein (IαIp) from a blood product material comprising combining the blood product material with a loading buffer, applying the blood product material comprising the IαIp to a column comprising an endotoxin-binding agent, wherein the endotoxin-binding agent comprises ETOXICLEARTM, separating a flow through comprising the blood product material that does not bind to the endotoxin-binding agent, and applying an elution buffer to the column and collecting an eluate comprising the IαIp. The closest prior art to Lim et al (US 2011/0190194 which corresponds to WO 2009/154695, both submitted in the IDS filed on July 27, 2023) teaches of a method for purifying an inter-alpha inhibitor protein (IαIp) from a blood product material comprising applying the blood product material comprising the IαIp to a chromatography column comprising an anion-exchange ligand such as diethylaminoethane (DEAE) or a quaternary amine (Q), applying a wash buffer having a pH of between 3.3 and 2.9 or lower to the column to allow a flow through comprising the blood product material that does not bind to the anion-exchange ligand, and applying an elution buffer to the column and collecting an eluate comprising the IαIp, but does not teach or fairly suggest using an endotoxin-binding agent comprising ETOXICLEARTM as the column material in the method for separating and purifying IαIp in a blood product material. The prior art reference to Hofinghoff et al (WO 2023/089503) teaches of using an ETOXICLEARTM column for separating inter-alpha inhibitor proteins (IαIp) from a sample (see paragraphs 0080-0081, 0093-0094 and 0108-0109 in Hofinghoff et al), but this reference is not prior art with regards to the instant claims since the earliest priority filing date of Hofinghoff et al, which is November 16, 2021, is after the earliest priority filing date of the instant application, which is November 16, 2020.
Claims 2-4, 11, 25, 60-61, 142-143, 145 and 150-158 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph and/or under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims for the same reasons as set forth above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Zurbriggen et al (US 2023/0250133) who teach of a method for purifying a protein of interest using an affinity chromatography matrix and washing with buffer solutions; Sun et al (US 2008/0064860) who teach of a method for isolating a protein by binding the protein to a medium, contacting the medium with one or more wash solutions, and then eluting the protein from the medium with an elution solution; Lim et al (US 2023/0055086) who teach of a method for quantifying inter-alpha inhibitor protein and pre-alpha inhibitor protein in sample; and Hofinghoff et al (WO 2023/089503) who teach of a method for purifying inter-alpha-inhibitor protein (Iαp) and pre-alpha inhibit protein (PαI) from a cryo-poor plasma sample using different anion-exchange resins including an ETOXICLEARTM column (see paragraphs 0080-0081, 0093-0094 and 0108-0109 in Hofinghoff et al). It is noted that Hofinghoff et al is not prior art with regards to the instant claims since the earliest priority filing date of Hofinghoff et al, which is November 16, 2021, is after the earliest priority filing date of the instant application, which is November 16, 2020.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 June 24, 2026
Prosecution Insights