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 .
1. Formal Matters
A. Applicant’s election without traverse of Group I in the reply filed on 11/21/25 is acknowledged. Therefore, this restriction is deemed proper and is made FINAL.
B. Claims 1-14, 16, 19 and 20 are pending. Claims 19 and 20 are withdrawn as being drawn to a non-elected invention. Claims 1-14 and 16 are the subject of this Office Action.
2. Claim Objections
A. Though it is clear from the specification, for clarity of claim 1, it is suggested that the recited “fragment” be written as “an antigen-binding fragment”.
C. Though not incorrect, for clarity it is suggested that claim 1 be amended to recite “an” anti-IL-4R antibody to indicate that more than one is known in the prior art.
3. Claim Rejections - 35 USC § 112(a) – written description
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 7 and 8 are rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
These are genus claims. The claims are drawn to fusion proteins comprising a “variant thereof” of an Fc region fragment or “derived from” human IgG4. No definition of “derived from” could be found in the specification. With regard to the definition of “variant”, the specification states –
[0035] …In addition, as used herein, the term “Fc domain variant” may refer to a form which is different from the wild type Fc domain in terms of glycosylation pattern, or has a high glycosylation as compared with the wild type Fc domain, or has a low glycosylation as compared with the wild type Fc domain, or a deglycosylated form. In addition, an aglycosylated Fc domain is included therein. The Fc domain or a variant thereof may be adapted to have an adjusted number of sialic acids, fucosylations, or glycosylations, through culture conditions or genetic manipulation of a host.
[0036] …In addition, the Fc domain variant may be in a form in which some amino acids of the Fc domain are substituted with other amino acids.
Therefore, these variants could have one or more amino acid substitutions, deletions, insertions and/or additions to the wild-type Fc region and, in theory, every residue could be altered. While the specification does provide some guidance, it is noted that, due to the recitation of “may refer to” and “may be adapted”, this does not limit the types of changes that can be made to the Fc region. Thus, the scope of the claims includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between/among genus members is permitted. The specification and claims only provide minimal guidance as to what changes should be made. Structural features that could distinguish compounds in the genus from others in the protein class are missing from the disclosure. No common structural attributes identify the members of the genus.
Neither the specification nor the claims describe any variants or derivatives so, turning to the prior art, Arduin teaches L234A/L235A and N297A (Abstract). In further support of the small genus of Fc variants (i.e. changes in only a few residues), the post-filing reference Wilkinson teaches numerous in Tables 4, 5 and 6; however, nearly all require L234, L235 or N297.
Given this, the general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, the known Fc mutations, alone, are insufficient to describe the genus. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, Applicant was not in possession of the claimed genus at the time the invention was made.
4. Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
A. Claims 1, 2, 4 and 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gomez et al. in view of Hakimi et al. further in view of Hartman et al. and further in view of Stevens et al. (U.S. Patent No. 7,605,237 – cited on the IDS filed 1/17/23).
The claims are essentially drawn to a fusion protein comprising an FceRIa ECD and a fragment of an anti-IL-R4 antibody.
Regarding claim 1, Gomez (Introduction) teaches the role of FceRI in allergies and asthma and that it is “a viable target for the development of biologics that act to inhibit or attenuate the activation of mast cells and basophils”. The Introduction further states that an anti-IgE monoclonal antibody (omalizumab) reduces FceRI surface expression. In addition, Gomez teaches that DARPins can be used to in inhibit FceRI-IgE interactions. Finally, and most pertinently, Gomez teaches that fusion proteins which can co-aggregate FceRI can also be used.
Gomez does not specifically teach FceRIa, nor the involvement of an anti-ILR4 antibody. However, Hakimi (Abstract) teaches that it is the a subunit alone (i.e. without the b and/or g subunit) of FceRI that binds IgE with high affinity and that cell lines comprising a chimeric a subunit have been produced which can be used as “a means of identifying therapeutic agents which may be effective in the treatment/management of allergic diseases.”
Neither Gomez nor Hakimi teach the IgE ECD. However, Hartman does teach the role of the ECD in intracellular processing and surface expression of the claimed receptor (last sentence of the Abstract).
None of Gomez, Hakimi, or Hartman teach an anti-IL-4R antibody. However, the CDRs of claim 4 are of the IL-4R antibody dupilumab, which is taught by Stevens et al. and is used to treat allergic diseases (column 5, line 63 to column 6, line 7). In re Kerkhoven (205 USPQ 1069, CCPA 1980) summarizes:
"It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for the same purpose in order to form a combination that is to be used for the very same purpose: the idea of combining them flows logically from their having been individually taught in the prior art."
Regarding claim 2, it would have been obvious to have included an immunoglobulin Fc region since this is the region that binds to immune cells via Fc receptors in order to trigger effector functions, making this fusion pharmaceutically active. See, for example, the first full paragraph on page 5 of Gomez, who teaches the inhibitory effects of IgG Fc on mast cells.
Regarding claim 7, it would have been obvious to have used one or both of the claimed structural formulas since linking the IgE ECD with an IL-4R antibody is what produces a fusion protein. Given the small number of possible combinations, it would have been obvious to tried them all since, under KSR, it’s now apparent “obvious to try” may be an appropriate test in more situations than we previously contemplated. When there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try may show that it was obvious under § 103 (KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007), 82 USPQ2d 1385, 1397 (2007); 550 U.S. 398 (2007)).
Regarding claims 7 and 8, the term “variant thereof” and “derived from” are not clearly defined in the specification of claims; therefore, any Fc region of the prior art can be considered derived from IgG4 since there are no limits to the number and types of alterations that can be made. Furthermore, claim 7 only requires a fragment, which can be as little as a single amino acid.
Regarding claim 9, though none of the references teaches combining two or more fusions into a dimer, it would have been obvious to have optimized antibody stoichiometry for treatment since, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 454, 105 USPQ 223,235, (CCPA 1955). Furthermore, "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and, therefore, obvious) and E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1006 (Fed. Cir. 2018) (“it is not inventive to discover the optimum or workable ranges by routine experimentation.”).
Regarding claims 10-13, Hakimi teaches vectors, host cells (p22079, right column, under “Vector Construction” and “Cell Culture and DNA Transfection”.
Regarding claim 14, Gomez teach the use of omalizumab (page 2), which requires a pharmaceutical composition. It is also evident from the entire context of the reference that pharmaceutical compositions would be used to treat the conditions taught. Similarly, as discussed above in this rejection, However, Hakimi (Abstract) essentially teaches pharmaceutical compositions in stating “a means of identifying therapeutic agents which may be effective in the treatment/management of allergic diseases.”
B. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gomez et al. in view of Hakimi et al. further in view of Hartman et al., further in view of Stevens et al. and further in view of Ma et al. (U.S. Patent No. 10,195,272).
The teachings of Gomez, Hakimi, Hartman and Stevens are discussed in rejection A of this section. None teaches a fragment of SEQ ID NO:2. However, given the fact that the limitation “fragment” is used, which can read on as little as a single amino acid, it would be expected that the IgE of Gomez would meet this limitation regardless of whether or not the reference taught instant SEQ ID NO:2, as it would be expected that both would have at least a single amino acid in common. However, to provide further support, claim 3 is rejected in view of Ma since the patent teaches SEQ ID NO:2 in its entirety was known at the time of the instant invention.
Patent No. 10195272
GENERAL INFORMATION
APPLICANT: THE NEMOURS FOUNDATION
TITLE OF INVENTION: ADOPTIVE T-CELL THERAPY USING FceRI-BASED CHIMERIC ANTIGEN
TITLE OF INVENTION: RECEPTORS FOR TREATING IgE-MEDIATED ALLERGIC DISEASES
FILE REFERENCE: 45009_0044_01_US_540015
CURRENT APPLICATION NUMBER: US/15/084,192A
CURRENT FILING DATE: 2016-03-29
PRIOR APPLICATION NUMBER: US 15/058,286
PRIOR FILING DATE: 2016-03-02
PRIOR APPLICATION NUMBER: US 62/127,024
PRIOR FILING DATE: 2015-03-02
NUMBER OF SEQ ID NOS: 37
SEQ ID NO 1
LENGTH: 180
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 100.0%; Score 996; Length 180;
Best Local Similarity 100.0%;
Matches 180; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VPQKPKVSLNPPWNRIFKGENVTLTCNGNNFFEVSSTKWFHNGSLSEETNSSLNIVNAKF 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 VPQKPKVSLNPPWNRIFKGENVTLTCNGNNFFEVSSTKWFHNGSLSEETNSSLNIVNAKF 60
Qy 61 EDSGEYKCQHQQVNESEPVYLEVFSDWLLLQASAEVVMEGQPLFLRCHGWRNWDVYKVIY 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 EDSGEYKCQHQQVNESEPVYLEVFSDWLLLQASAEVVMEGQPLFLRCHGWRNWDVYKVIY 120
Qy 121 YKDGEALKYWYENHNISITNATVEDSGTYYCTGKVWQLDYESEPLNITVIKAPREKYWLQ 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 YKDGEALKYWYENHNISITNATVEDSGTYYCTGKVWQLDYESEPLNITVIKAPREKYWLQ 180
C. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gomez et al. in view of Hakimi et al. further in view of Hartman et al., further in view of Stevens et al. and further in view of either (1) VIB or (2) Progen Co., Ltd.
Progen is cited as KR20190084885 on the PCT/ISA/237 filed 1/17/23. On the IDS filed 1/17/23, in lieu of the KR document, Applicants cited US 20210070833. On the PTO-892 accompanying this Office Action, a machine translation of the KR document is cited and used in this and all rejections below. In addition, the PTO-892 also includes the English language equivalent of the KR document, cites as CA 3086222A1).
The teachings of Gomez, Hakimi, Hartman and Stevens are discussed in rejection A of this section. None teach the use of a food. However, VIB teach the use of edible antibodies to treat GI disorders as they resist degradation. Though the instant fusion is not comprised of antibodies per se, they are both directed to proteins/peptides and would have the same potential problem of being degraded when administered orally. Therefore, it would have been obvious to have used the method of VIB in order to produce proteins which would be orally stable.
Claim 14 of Progen teaches the use of a food composition comprising a polypeptide dimer for treating allergic symptoms.
D. Claim 1-4 and 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over Progen Co., Ltd. in view of Stevens et al.
Claim 1 of Progen teaches a polypeptide dimer comprising two monomers of FceRI1-ECD, which reads on instant claims 1 and 9. Claim 1 of Progen further recites a modified Fc region, which reads on instant claim 2. Furthermore, regarding claim 2, it would have been obvious to have included an immunoglobulin Fc region since this is the region that binds to immune cells via Fc receptors in order to trigger effector functions, making this fusion pharmaceutically active. In addition, the Fc modification also reads on “Fc region variant” in claim 7 and “derived from” in claim 8. Claim 2 of Progen reads on instant claim 3 (the sequence comparison was used based on US 2021/0070833 - cited on the IDS filed 1/17/23).
Progen does not teach an anti-IL-4R antibody. However, the CDRs of claim 4 are of the IL-4R antibody dupilumab, which is taught by Stevens et al. and is used to treat allergic diseases (column 5, line 63 to column 6, line 7). In re Kerkhoven (205 USPQ 1069, CCPA 1980) summarizes:
"It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for the same purpose in order to form a combination that is to be used for the very same purpose: the idea of combining them flows logically from their having been individually taught in the prior art."
Regarding instant claim 7, it would have been obvious to have used one or both of the claimed structural formulas since linking the ECD with an IL-4R antibody is what produces a fusion protein. Given the small number of possible combinations, it would have been obvious to tried them all (see KSR cited above). Furthermore, the hinge of Progen can be considered a linker.
Claims 10-13 are met by claims 9-11 and 15 of Progen and column 5, lines 37-44 of Stevens. Claim 14 is met by claim 12 of Progen and claim 4 of Stevens. Claim 16 is met by claim 14 of Progen.
SEQ ID NO:2
Sequence 1, US/16958861A
Publication No. US20210070833A1
GENERAL INFORMATION
APPLICANT: GI INNOVATION INC.
TITLE OF INVENTION: EXTRACELLULAR DOMAIN OF ALPHA SUBUNIT OF IGE FC RECEPTOR,
TITLE OF INVENTION: PHARMACEUTICAL COMPOSITION COMPRISING SAME AND METHOD FOR
TITLE OF INVENTION: PRODUCING SAME
FILE REFERENCE: Q255662
CURRENT APPLICATION NUMBER: US/16/958,861A
CURRENT FILING DATE: 2020-09-03
PRIOR APPLICATION NUMBER: PCT/KR2019/000274
PRIOR FILING DATE: 2019-01-08
PRIOR APPLICATION NUMBER: KR 10-2018-0002248
PRIOR FILING DATE: 2018-01-08
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 1
LENGTH: 180
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
ALIGNMENT:
Query Match 100.0%; Score 996; Length 180;
Best Local Similarity 100.0%;
Matches 180; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VPQKPKVSLNPPWNRIFKGENVTLTCNGNNFFEVSSTKWFHNGSLSEETNSSLNIVNAKF 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 VPQKPKVSLNPPWNRIFKGENVTLTCNGNNFFEVSSTKWFHNGSLSEETNSSLNIVNAKF 60
Qy 61 EDSGEYKCQHQQVNESEPVYLEVFSDWLLLQASAEVVMEGQPLFLRCHGWRNWDVYKVIY 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 EDSGEYKCQHQQVNESEPVYLEVFSDWLLLQASAEVVMEGQPLFLRCHGWRNWDVYKVIY 120
Qy 121 YKDGEALKYWYENHNISITNATVEDSGTYYCTGKVWQLDYESEPLNITVIKAPREKYWLQ 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 YKDGEALKYWYENHNISITNATVEDSGTYYCTGKVWQLDYESEPLNITVIKAPREKYWLQ 180
5. Nonstatutory 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.
A. Claims 1-4 and 7-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7 of copending Application No. 18/549,558 (reference application) in view of Stevens et al. (U.S. Patent No. 7,605,237). Although the claims at issue are not identical, they are not patentably distinct from each other
The instant claims are drawn to a fusion comprising an FceRIa-ECD and IL-4Ra antibody fragment. The methods of treating claims are currently withdrawn, but may be rejoined if the product claims are allowable. However, it is noted that the instant application is not a DIV of ‘558 and, therefore, does not receive safe-harbor protection. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
More specifically, the copending claims are drawn to pharmaceutical compositions comprising a fusion protein comprising an FceRIa-ECD dimer. Instant claim 1 recites a fusion of the ECD with a fragment of an anti-IL-4Ra antibody, which is not claimed in the copending application. However, both the ECD and the antibody are known to be involved in the treatment of allergic diseases and Stevens teaches dupilumab, for this purpose (column 5, line 63 to column 6, line 7). Dupilumab comprises the 6 CDRs of instant claim 4. In re Kerkhoven (205 USPQ 1069, CCPA 1980) summarizes:
"It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for the same purpose in order to form a combination that is to be used for the very same purpose: the idea of combining them flows logically from their having been individually taught in the prior art."
Though the instant claims do not recite a pH, any pH around physiological levels would have been obvious since these fusions/compositions are to be used in vivo for treatment.
Instant claim 2 is obvious over copending claim 4, which recites a modified Fc region. In addition, the modified Fc region of the instant claims is generic to claim 5 of the copending application. The ECD recited in claim 7 of the copending application (SEQ ID NO:1) is identical to instant SEQ ID NO:2 recited in claim 3. Copending claim 7 recites a modified Fc region, which is recited in instant claim 2.
Regarding instant claim 7, it would have been obvious to have used one or both of the claimed structural formulas since linking the ECD with an IL-4R antibody is what produces a fusion protein. Given the small number of possible combinations, it would have been obvious to tried them all (see KSR cited above). Furthermore, the hinge of the copending claims can be considered a linker.
Regarding instant claims 7 and 8, since there is no clear definition of “variant thereof” or “derived from”, there are no limitations to the number and types of alterations that can be made to the Fc region (including of human IgG4). Therefore, these claims are generic to any Fc region including that of claim 5 of the copending application.
Regarding claims 10-13, it would have been obvious given the ECD and antibody sequences to have used the encoding polynucleotides in an expression system to produce the dimer as this technique is one of the cornerstones of pharmacology.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
B. Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/549,558 (reference application) in view of Stevens et al. (U.S. Patent No. 7,605,237) and further in view of either (1) VIB or (2) Progen. Although the claims at issue are not identical, they are not patentably distinct from each other.
The teachings of the copending application and Stevens are discussed in rejection A of this section. Neither teaches the use of a food. However, VIB teach the use of edible antibodies to treat GI disorders as they resist degradation. Though the instant fusion is not comprised of antibodies per se, they are both directed to proteins/peptides and would have the same potential problem of being degraded when administered orally. Therefore, it would have been obvious to have used the method of VIB in order to produce proteins which would be orally stable.
Claim 14 of Progen teaches the use of a food composition comprising a polypeptide dimer for treating allergic symptoms.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
C. Claims 1-4 and 7-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 9 of copending Application No. 19/294,680 (reference application) in view of Stevens et al. (U.S. Patent No. 7,605,237). Although the claims at issue are not identical, they are not patentably distinct from each other.
Currently, the instant claims are drawn to a fusion comprising an FceRIa-ECD and IL-4Ra antibody fragment. The methods of treating claims are currently withdrawn, but may be rejoined if the product claims are allowable. However, it is noted that the instant application is not a DIV of ‘680 and, therefore, does not receive safe-harbor protection. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
More specifically, the copending claims are drawn to methods of treating allergic conditions by administering an FceRIa-ECD dimer. Instant claim 1 recites a fusion of the ECD with a fragment of an anti-IL-4Ra antibody, which is not claimed in the copending application. However, both the ECD and the antibody are known to be involved in the treatment of allergic diseases and Stevens teaches dupilumab, for this purpose (column 5, line 63 to column 6, line 7). Dupilumab comprises the 6 CDRs of instant claim 4. In re Kerkhoven (205 USPQ 1069, CCPA 1980) summarizes:
"It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for the same purpose in order to form a combination that is to be used for the very same purpose: the idea of combining them flows logically from their having been individually taught in the prior art."
Copending claim 1 recites a modified Fc region, which is recited in instant claim 2. The ECD recited in claim 2 of the copending application (SEQ ID NO:1) is identical to instant SEQ ID NO:2 recited in claim 3. It is also noted that both claims are drawn to a “fragment thereof”, further reading on each other.
Regarding instant claim 7, it would have been obvious to have used one or both of the claimed structural formulas since linking the ECD with an IL-4R antibody is what produces a fusion protein. Given the small number of possible combinations, it would have been obvious to tried them all (see KSR cited above). Furthermore, the hinge of the copending claims can be considered a linker.
Regarding instant claims 7 and 8, since there is no clear definition of “variant thereof” or “derived from”, there are no limitations to the number and types of alterations that can be made to the Fc region (including of human IgG4). Therefore, these claims are generic to any Fc region including that of claim 3 of the copending application (SEQ ID NO:2).
Regarding claims 10-13, it would have been obvious given the ECD and antibody sequences to have used the encoding polynucleotides in an expression system to produce the dimer as this technique is one of the cornerstones of pharmacology.
Regarding claim 14, copending claim 1 recites treating, which would require a pharmaceutical composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
D. Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/294,680 (reference application) in view of Stevens et al. (U.S. Patent No. 7,605,237) and further in view of either (1) VIB or (2) Progen. Although the claims at issue are not identical, they are not patentably distinct from each other.
The teachings of the copending application and Stevens are discussed in rejection C of this section. Neither teaches the use of a food. However, VIB teach the use of edible antibodies to treat GI disorders as they resist degradation. Though the instant fusion is not comprised of antibodies per se, they are both directed to proteins/peptides and would have the same potential problem of being degraded when administered orally. Therefore, it would have been obvious to have used the method of VIB in order to produce proteins which would be orally stable.
Claim 14 of Progen teaches the use of a food composition comprising a polypeptide dimer for treating allergic symptoms.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
6. Conclusion
A. Claims 1-4, 7-14 and 16 are not allowable.
B. SEQ ID NO:7 and 8 are free of the prior art; therefore, claims 5 and 6 are objected to since they depend from a rejected base claim, but are otherwise allowable.
Advisory information
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/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647