DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-36 are pending in this application.
This office action is in response to applicants response filed on 7/1/2026.
The present application claims the benefit to U.S. Provisional Patent Application Serial Numbers 63/709,816, 63/709,821, 63/709,823, 63/709,850, and 63/709,859 all of which filed on October 21, 2024.
Election/Restrictions
Applicant’s election of Claims 1-17, drawn to a composition comprising Pro-hIFN alpha 2b, acetylated Pro-hIFN alpha 2b and/or a mixture thereof in the reply filed on 7/1/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 18-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention (VEGF-C), there being no allowable generic or linking claim.
Information Disclosure Statement
Information disclosure statements filed 7/1/2026, 4/6/2026, 3/9/2026, 12/18/2026, 12/11/2025 and 10/17/2025 have been identified and the documents considered. There are three notations on the IDS. First, if the document has been identified and considered, it is initialed. In the case that the document could not be located, it has been crossed off of the IDS. A search of the prior references as well as those submitted with this application were scanned. Those lined through and not noted could not be found in the cases. As these appear to be missing from the file, it would be remedial to include a copy and a new 1449 with their listing in the response. References not in English were crossed off and so noted. Third, for document listed as a Search reports and office actions, these have been considered but have been crossed off of the Form 1449. The corresponding signed and initialed PTO Form 1449 has been mailed with this action. Initials indicate that the document has been considered even if the reference is lined through. In the case that only an English abstract was identified, this is indicated.
Drawings
Figure 5 is objected to under 37 CFR 1.83(a) because they fail to show any details as described in the specification. Specifically, figure 5 is a schematic of a method of use of P-IFN-A2b. However, the details are indiscernible as the writing in the central figure is gray on gray and in the last s fuzzy. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). A proposed drawing correction or corrected drawings are required in reply to the Office action to avoid abandonment of the application. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-6, 7 and 10 are objected to because of the following informalities: in claim 1, Pro-hIFN alpha 2b is an abbreviation. On its first occurrence, Pro-hIFN alpha 2b should be spelled out in full. Although claims are allowed abbreviations, if an abbreviation is not spelled out in upon first use in a claim, MPEP §2429 states that Applicant only use abbreviations that are specifically defined in "WIPO Standard ST.25 (1998)" or that are well known and would be clear to someone who had not read the invention description. Pro appears to be proline, IFN is interferon. Hence, the spelling should be proline human interferon alpha 2 b (Pro-hIFN alpha 2b).
It is noted that using “and/or” in claim 1 is a bit redundant with “mixture thereof” such that only “or” is necessary. This is true of claims 2-5. The claims establish that the acetylated positions can be one or more. There is no reason to thereafter recite and/or.
In claim 6, E. coli should be italicized. This is true of claim 7 and 10.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 12 and 15-17 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.
Claim 12 is vague in reciting “below”. The term “below” is a relative one not defined by the claim, no single set of conditions is recognized by the art as being “below” and because the specification does not provide a standard for ascertaining the requisite degree, the metes and bounds of this claim cannot be established. It is not clear to what if the pH must be below 6.9 or 7.4. The claim does not indicate against what the pH must be below.
Claims 15 -17 are unclear by reciting “overall quantitative relative ration of “the Pro1-acetylated Pro-hIFN alpha 2b to acetylated Lys50 Pro-hIFN alpha 2b”. First, this recitation lacks antecedent basis for recitation of “the Pro1-acetylated Pro-hIFN alpha 2b”. Secondly, it is not clear if the ratio is within a single molecule or multiple hIFN molecules are in the composition and they are all unique. Claim 15 seems to refer to individual molecules but there is only reference to “said acetylated pro-hIFN alpha 2b”. Claims 16 and 17 refer to ratios that are themselves ratios and hence this also seems to reference a compound with multiple hIFN molecules. However, the claims are unclear by reference to “said acetylated Pro-hIFN alpha 2b”.
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.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al (CN 101883780, including translation).
Multiple references teach compositions comprising Pro-hIFN alpha 2B. Wu et al teach this composition (abstract and ¶ 0014). Claims 2-5, 13 and 15-17 limit the composition if the choice were the acetylated Pro-hIFN alpha 2b. As the art is not so limited, claims 2-5, 13 and 15-17 only describe what is required if the acetylated version were chosen.
¶0032-0033 of Wu et al teach such a process wherein coli supernatant, fermentation, inclusion bodies and denatured and then refolded pro-IFN alpha 2B is taught as recited in claims 6-10. The protein is further purified by anion exchange chromatography (see e.g. ¶0048). The pH is at 7 as recited in claims 11 and 12.
The IFN is part of a pharmaceutical composition (see ¶0024).
Conclusion
No claims allowed.
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/MARIA MARVICH/Primary Examiner, Art Unit 1634
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