DETAILED ACTION
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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I (SEQ ID 30), the species of CD138, and the species of SEQ 16 in the reply filed on 7/3/26 is acknowledged. Both species requirements are withdrawn.
Claims 31-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/3/26.
Claims 21-30 are under examination.
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 –
(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.
(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) 21-30 is/are rejected under 35 U.S.C. 102(a)(1-2) as being anticipated by Stover (US20200331966; form 892).
The applied reference has a common inventor with the instant application. See MPEP §2153 and §2154 for criteria for prior art exceptions.
Regarding claim 21, Stover teaches a composition comprising the polypeptide sequence TDVDYYREWSWTQV (SEQ ID NO: 14), wherein said polypeptide sequence masks the activity of a Type-I interferon (IFN) and wherein said composition further comprises a fusion protein which is fused to an antibody that binds to a tumor associated antigen (claim 1). This differs from the instant claim in that instant SEQ ID NO: 30 contains two glycine residues (GG) at the C-terminus of reference SEQ ID NO: 14. However, Stover also teaches the mask of SEQ ID NO: 14 that comprises these two C-terminal glycine residues (paragraphs 172 and 173). This anticipates each and every limitation of the instant claim.
Regarding claim 22, Stover claims a flexible peptide linker (claim 2).
Regarding claim 23, Stover claims a tumor associated protease cleavage site (claim 3).
Regarding claims 24-30, these are inherent properties of the polypeptide mask. A structurally identical sequence must possess the same properties. Chemical compounds and their properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)). Further, Stover also teaches these properties of the mask (claims 4-10).
Therefore, claims 21-30 are anticipated.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11136353. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Comparing instant claim 21 to reference claim 1, the claims solely differ in the sequence of the mask peptide where the instant mask contains an additional two residues (GG).
“The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)(‘[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.’); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (‘Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.’). See also MPEP § 2111.01. Further, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized ‘that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,’ but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first ‘determine how much of the patent disclosure pertains to the invention claimed in the patent’ because only ‘[t]his portion of the specification supports the patent claims and may be considered.’ The court pointed out that ‘this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.’’’ MPEP §804(II)(B)(1).
In this case, the reference claim explicitly states that the mask polypeptide “comprises” SEQ ID NO:14. It is a fair use of the specification to determine what else this sequence comprises, such material being an embodiment disclosed in the patent which provides support for the patent claim. The specification discloses that one specific embodiment of a polypeptide comprising SEQ ID NO: 14 at C22 which also contains the instantly claimed GG. The instantly claimed sequence is an obvious variant of the reference claims because the reference document teaches the instant sequence as an explicit embodiment encompassed by the reference claim.
Regarding claim 22, the reference claims a flexible peptide linker (claim 2).
Regarding claim 23, the reference claims a tumor associated protease cleavage site (claim 3).
Regarding claims 24-30, these are inherent properties of the polypeptide mask. A structurally identical sequence must possess the same properties. Chemical compounds and their properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)). Further, Stover also teaches these properties of the mask (claims 4-10).
Claims 21-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-11, and 13-20 of copending Application No. 17803392 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Comparing instant claim 21 to reference claim 9, the reference claim recites a fusion protein fused to an antibody (type-1 interferon…fused to the c-terminal of said antibody) where the antibody binds a tumor associated antigen (antibody which specifically binds to a CD138 antigen) and comprises a mask polypeptide (reference SEQ ID NO: 34). The reference mask comprises SEQ ID NO: 34, which is the first 14 amino acids of the instantly claimed 16 amino acid sequence, only differing in lacking the explicit GG residues.
“The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)(‘[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.’); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (‘Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.’). See also MPEP § 2111.01. Further, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized ‘that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,’ but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first ‘determine how much of the patent disclosure pertains to the invention claimed in the patent’ because only ‘[t]his portion of the specification supports the patent claims and may be considered.’ The court pointed out that ‘this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.’’’ MPEP §804(II)(B)(1).
In this case, the reference claim explicitly states that the mask polypeptide “comprises” SEQ ID NO:34. It is a fair use of the specification to determine what else this sequence comprises, such material being an embodiment disclosed which provides support for the reference claim. The specification discloses that one specific embodiment of a polypeptide comprising SEQ ID NO: 34 at paragraph 395 (SEQ ID NO: 30) which also contains the instantly claimed GG. The instantly claimed sequence is an obvious variant of the reference claims because the reference document teaches the instant sequence as an explicit embodiment encompassed by the reference claim.
Regarding claim 22, the reference claims a flexible peptide linker (claim 11).
Regarding claim 23, the reference claims the mask fused to the interferon by a flexible peptide (claim 13). The specification discloses an embodiment of this linker peptide is a tumor associated protease cleavage site (paragraph 469-470).
Regarding claims 24-30, these are inherent properties of the polypeptide mask. A structurally identical sequence must possess the same properties. Chemical compounds and their properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
US 11795198 does not claim the composition comprising an additional fused peptide.
US 12162958 claims the mask as SEQ ID NO: 15, which contains a C-terminal “S” rather than “GG”. As such, this is a structurally different mask.
Other than the art cited above, the prior art is generally deficient in teaching the instantly claimed mask protein. The art teaches similar peptides but which have an “S” rather than “GG”. See for example US 20100221212 and US20130101555 (form 892). Unlike merely adding additional residues as discussed above, replacing amino acids does not provide a predictable assumption that the masking properties would be preserved. The art of record does not provide a suggestion of replacing this terminal serine.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Weidner/ Primary Examiner, Art Unit 1675
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