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
Claims 1-13 and 16-19 are pending in the instant application.
Priority
This application is a 371 of PCT/EP2021/060236, filed on 4/20/2021 which claims priority to the European application EP20170651.2 filed on 4/21/2020.
Information Disclosure Statement
The information disclosure statements (IDS) dated 10/20/2022, 12/15/2022, 9/27/2024, and 7/14/2025 comply with the provisions of 27 CFR 1.97, 1.98, and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Objections to the Claims
Claim 1 contains Interferon names outside of the semi-colon. Such as “SEQ ID NO: 1; (IFNa14)”. Please edit all entries such that the labels in parentheses are behind the semi-colon, like “SEQ ID NO: 1 (IFNa14);”
Claim 1, part (10) places the conjunction “or” in the wrong location. Please replace “; or (IFNa5) with “(IFNa5); or”.
Claim 2, line 1, uses the plural version of “claims” when it should be singular. Please replace “claims 1,” with “claim 1,”.
Claim 3 lacks the conjunction “or” or “and/or” between the last two list items of (B) and (C).
Claim 6, line 6 does not completely capitalize “SEQ ID NOs:”. Please replace “SEQ ID Nos.” with “SEQ ID NOs:”.
Claim 7, lines 4 and 5, do not completely capitalize “SEQ ID NOs:”. Please replace “SEQ ID Nos.” with “SEQ ID NOs:”.
Claim 12 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claim 12 has not been further treated on the merits.
Correction is required. See MPEP § 608.01(m).
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.
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 17 is 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 17
Claim 17 is drawn to a host cell comprising “at least one pharmaceutically acceptable excipient.” It is unclear if applicant is claiming that the host cell contains an internal or external excipient. For internal applications, applicant could be claiming the host cells are injected with an excipient (e.g. xylitol) or if they are claiming an inherent property of the host cell containing a pharmaceutical excipient (e.g. glucose). For external excipients, it is also unclear if they mean the solution media surrounding the host cells comprises an excipient. Because of these multiple interpretations, this claim is rendered indefinite.
Claim Rejections – 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-5, 13, and 17-19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2
Claim 2, option (v) fails to provide a further limitation over parent claim 1, option (5).
Claim 2, option (viii) fails to provide a further limitation over parent claim 1, option (8).
Claim 2, option (ix) fails to provide a further limitation over parent claim 1, option (9).
Claim 2, option (x) fails to provide a further limitation over parent claim 1, option (10).
Claim 3
Claim 3, option (B)(1)(2) fails to provide a further limitation over parent claim 1, option (10).
Claim 4
Claim 4, option (1) fails to provide a further limitation over parent claim 3, option (A)(1)(2).
Claim 4, option (2) fails to provide a further limitation over parent claim 3, option (A)(1)(3).
Claim 4, option (4) fails to provide a further limitation over parent claim 3, option (A)(2)(3).
Claim 4, option (10) fails to provide a further limitation over parent claim 3, option (C)(1)(2).
Claim 4, option (14) fails to provide a further limitation over parent claim 3, option (B)(1)(3).
Claim 4, option (15) fails to provide a further limitation over parent claim 3, option (B)(2)(3).
Claim 4, option (16) fails to provide a further limitation over parent claim 3, option (B)(1)(2)(3).
Claim 5
In claim 5, when the conjunction “and/or” is interpreted as “or” then the limitation “retains at least one of the substitutions” fails to provide a further limitation over parent claim 1 which requires at least one mutation.
Claim 13
Claim 13, by virtue of the language “optionally” is drawn to a composition comprising no other components other than the polypeptide described in parent claim 1. Thus claim 13 fails to further limit parent claim 1.
Claim 17
Claim 17, by virtue of the language “optionally” is drawn to a composition comprising no other components other than the polypeptide described in parent claim 10. Thus claim 17 fails to further limit parent claim 10.
Claim 18
Claim 18, by virtue of the language “optionally” is drawn to a composition comprising no other components other than the polypeptide described in parent claim 9. Thus claim 18 fails to further limit parent claim 9.
Claim 19
Claim 19, by virtue of the language “optionally” is drawn to a composition comprising no other components other than the polypeptide described in parent claim 10. Thus claim 19 fails to further limit parent claim 10.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 1, 3, 6-7, and 12 are directly objected to.
Claims 8-11 and 16 are objected to as being dependent upon an objected or rejected base claim, but would be allowable is rewritten in independent form, including all of the limitations of the base claim and any intervening claims.
The instant invention of claim 1 is allowable upon correction of the typos. The art of record is absent a motivation or suggestion to perform the particular mutations of the Interferon Alpha 2 performed by the inventor. While administering recombinant Interferon Alpha has been used to treat hepatitis B, these variants appended solubilizing moieties such as PEG to the native interferon as opposed to mutating the interferon sequences themselves (See Woo doi: 10.21037/atm.2017.03.69).
The closest prior art is that of Champion (US20190233536) who teaches K23R mutation of the native Interferon Alpha 2 as a component of an adenovirus-based treatment for cancer.
instant_1 CDLPQTHSLGSRRTLMLLAQMRKISLFSCLKDRHDFGFPQEEFGNQFQKAETIPVLHEMI 60
Champion_117 CDLPQTHSLGSRRTLMLLAQMRRISLFSCLKDRHDFGFPQEEFGNQFQKAETIPVLHEMI 60
**********************:*************************************
instant_1 QQIFNLFSTKDSSAAWDETLLDKFYTELYQQLNDLEACVIQGVGVTETPLMKEDSILAVR 120
Champion_117 QQIFNLFSTKDSSAAWDETLLDKFYTELYQQLNDLEACVIQGVGVTETPLMKEDSILAVR 120
************************************************************
instant_1 KYFQRITLYLKEKKYSPCAWEVVRAEIMRSFSLSTNLQESLRSKE 165
Champion_117 KYFQRITLYLKEKKYSPCAWEVVRAEIMRSFSLSTNLQESLRSKE 165
*********************************************
Importantly, Champion does not teach or suggest any of the mutations described in the instant claims.
Conclusion
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/
Supervisory Patent Examiner, Art Unit 1675