DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s election of Group I (drawn to a binding protein) in the reply filed on February 23, 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 1-20 are pending.
Claims 7-10 and 12-19 have been withdrawn under 37 CFR 1.142(b) as being drawn to nonelected inventions.
Claims 1-6, 11, and 20 are currently under consideration as they read on the elected invention.
3. claims 5 and 6 are objected to for following informality:
Claims 5 and 6 recite “at least one least one” in line 2. Appropriated correction is required.
4. 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.
5. Claims 4-6 and 20 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 4 recites “wherein the fusion protein further comprises at least one molecule modulating pharmacokinetics of the fusion protein selected optionally from a serum albumin….”.
Claim 5 recites “wherein the fusion protein further comprises at least one diagnostically active moiety, optionally wherein the at least one diagnostically active moiety is selected from the group consisting of a radionuclide…..”.
Claim 6 recites “optionally wherein the at least one therapeutically active moiety is selected from the group consisting of a monoclonal antibody….”
The word “modulating” in claim 4 is ambiguous as to the direction (positive or negative) of said modulating. The term “modulating” is not defined by the claims. The specification does not provide a standard form ascertaining the requisite degree and one of skill in the art would not be reasonably apprised the metes and bounds of the claim.
Further, the recitation of “optionally” in claims 4-6 renders the claims indefinite because it is not clear whether the limitations following the “optionally” are part of the claims.
6. 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.
7. Claims 1, 3-6, 11, and 20 are 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.
The claims are drawn to a binding protein for huma Her2 comprising an amino acid sequence with at least 97% identity to SEQ ID NO:1, wherein the binding protein has a binding affinity for Her2 of less than 0.5 nM after 24h incubation in serum as determined by ELISA, and is stable at temperatures of at least 64oC.
The specification discloses that the ubiquitin dimer of amino acid sequence of SEQ ID NO:16 was mutated in 13 specific positions with specific amino acid residues producing SEQ ID NO:1. The specification further disclose Her2 binding proteins shown in Figure 1 (SEQ ID NOs: 1-14). SEQ ID NO:2-14 appears to be variants of SEQ ID NO:1, they differ from SEQ ID NO:1 in specific positions with specific amino acid residues, see SEQ ID NOs: 1 and 2 alignments below:
RESULT 1
US-18-016-436-2
Query Match 99.6%; Score 773; DB 1; Length 152;
Best Local Similarity 99.3%;
Matches 151; Conservative 1; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MQIFVKTLTGKTITLEVEPSDTTENVKAKIQDKEGIPPDQQTLAFVGKQLEDGRTLSDYN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MQIFVKTLTGKTITLEVEPSDTTENVKAKIQDKEGIPPDQQTLAFVGKQLEDGRTLSDYN 60
Qy 61 IQKESTLWLYLTLRAAMRIFVKTHTGKTITLDVEPSDTIENVKAKIQDKEGIPPDQQRLI 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 IQKESTLWLYLTLRAAMRIFVKTHTGKTITLDVEPSDTIENVKAKIQDKEGIPPDQQRLI 120
Qy 121 WAGKQLEDGRTLSDYNIQEWSILHLVLRLRAA 152
||||||||||||||||||||:|||||||||||
Db 121 WAGKQLEDGRTLSDYNIQEWAILHLVLRLRAA 152
However, there is insufficient written description in the specification as-filed of a binding protein for human Her2 comprising an amino acid sequence with at least 97% identity to SEQ ID NO:1 as recited in the instant claims.
The claims encompass a genus of Her2 binding proteins that are at least 97% identical to SEQ ID NO:1 (152 amino acid residues) which allow 4.56 non-specified amino acid residues within SEQ ID NO:1 to be mutated to any or all amino acid residues.
The genus of the binding proteins for human Her2 are therefore extremely large. Applicant has disclosed only 14 binding proteins with specific amino acid sequences (see FIGURE 1 of the specification as-filed). Thus Applicant has disclosed only a limited species of the human Her2 binding proteins. The claimed binding protein comprising an amino acid sequence with at least 97% identity to SEQ ID NO:1 lack a common structure essential for their functions of having a binding affinity for Her2 of less than 0.5nM after 24h incubation in serum s determined by ELISA and is stable at temperatures of at least 64oC.
For example, Kim et al. (Computational and Structural Biotechnology Journal 2021, 19:1325-1334) teach that experimental approaches comprising repeated rounds of a library construction and screening have been most widely used but they are labor-intensive and time-consuming and almost impossible to specify the binding region especially for a target with a multi-domain protein with a large size (e.g. see 1st paragraph in the left col. in page 1325).
Kim et al. further teach that while computational methods have recently attracted a considerable attention with many advances, purely computational design of a protein binding with a desired epitope and binding affinity remains a challenge (e.g. see paragraph spanning left and right col. in page 1325).
Kim et al. estimated that effective design of Her2 binding should shar at least over 20% of the trastuzumab (anti-Her2 antibody) epitope and generated 30 docking models for the target site on Her2 domain IV, and enabled 30,000 designs (e.g. see right col. in page 1332).
Thus, it does not appear based upon the limited disclosure of the 14 human Her2 binding proteins having specific amino acid sequences alone that Applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the limited number of species disclosed and the extensive variation permitted within the genus of binding protein.
“Adequate written description requires a precise definition, such as by structure, formula, chemical name or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.” Regents of the University of California v. Eli Lilly and Co. 43 USPQ2d 1398 (Fed. Cir. 1997).
The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter of the claim. Id. 43 USPQ2d at 1406.
In the absence of disclosure of relevant, identifying characteristics of the human Her2 binding protein comprising at least 97% sequence identity to SEQ ID NO:1, there is insufficient written disclosure under 35 U.S.C. 112, first paragraph.
8. Claims 1, 3-6, 11, and 20 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a binding protein for huma Her2 comprising the amino acid sequence selected from the group consisting of SEQ ID NOs: 1-14), does not reasonably provide enablement for more. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention.
The claims are drawn to a binding protein for huma Her2 comprising an amino acid sequence with at least 97% identity to SEQ ID NO:1, wherein the binding protein has a binding affinity for Her2 of less than 0.5 nM after 24h incubation in serum as determined by ELISA, and is stable at temperatures of at least 64oC.
The specification discloses that the ubiquitin dimer of amino acid sequence of SEQ ID NO:16 was mutated in 13 specific positions with specific amino acid residues producing SEQ ID NO:1. The specification further disclose Her2 binding proteins shown in Figure 1 (SEQ ID NOs: 1-14). SEQ ID NO:2-14 appears to be variants of SEQ ID NO:1, they differ from SEQ ID NO:1 in specific positions with specific amino acid residues, see SEQ ID NOs: 1 and 2 alignments below:
RESULT 1
US-18-016-436-2
Query Match 99.6%; Score 773; DB 1; Length 152;
Best Local Similarity 99.3%;
Matches 151; Conservative 1; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MQIFVKTLTGKTITLEVEPSDTTENVKAKIQDKEGIPPDQQTLAFVGKQLEDGRTLSDYN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MQIFVKTLTGKTITLEVEPSDTTENVKAKIQDKEGIPPDQQTLAFVGKQLEDGRTLSDYN 60
Qy 61 IQKESTLWLYLTLRAAMRIFVKTHTGKTITLDVEPSDTIENVKAKIQDKEGIPPDQQRLI 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 IQKESTLWLYLTLRAAMRIFVKTHTGKTITLDVEPSDTIENVKAKIQDKEGIPPDQQRLI 120
Qy 121 WAGKQLEDGRTLSDYNIQEWSILHLVLRLRAA 152
||||||||||||||||||||:|||||||||||
Db 121 WAGKQLEDGRTLSDYNIQEWAILHLVLRLRAA 152
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The specification does not provide a sufficient enabling description of the claimed invention. The disclosure appears to show only 14 Her2 binding proteins that are highly homologous to each other but differ in specific positions with specific amino acid residues.
The instant claims encompass in their breadth any binding protein for human Her2 comprising an amino acid sequence with at least 97% identity to SEQ ID NO:1 (152 amino acids in length), allowing 4.56 amino acid residues within SEQ ID NO:1 that can be randomly mutated to any or all amino acid residues while maintaining the function of the recited binding affinity.
However, there does not appear to be sufficient guidance in the specification as field as to how the skilled artisan would make and use the claimed Her2 binding protein that is at least 97% identical to SEQ ID NO:1.
The state of the art at the time the invention was made recognized that making protein binders targeting Her2 can be unpredictable.
For example, Kim et al. (Computational and Structural Biotechnology Journal 2021, 19:1325-1334) teach that experimental approaches comprising repeated rounds of a library construction and screening for protein binders have been most widely used but they are labor-intensive and time-consuming and almost impossible to specify the binding region especially for a target with a multi-domain protein with a large size (e.g. see 1st paragraph in the left col. in page 1325).
Kim et al. further teach that while computational methods have recently attracted a considerable attention with many advances, purely computational design of a protein binding with a desired epitope and binding affinity remains a challenge (e.g. see paragraph spanning left and right col. in page 1325).
Kim et al. estimated that effective design of Her2 binding should shar at least over 20% of the trastuzumab (anti-Her2 antibody) epitope and generated 30 docking models for the target site on Her2 domain IV, and enabled 30,000 designs (e.g. see right col. in page 1332).
Given the extensive variation permitted by the instant claim language, the skilled artisan would not reasonably predict which amnio acid resides within SEQ ID NO:1 can be mutated to have the same function as the instant claimed invention.
It is unpredictable if functional activity will be shared by two polypeptides having less than 100% identity over the full length of their sequences. The specification does not appear to provide sufficient guidance as to which residues should or should not be changed within SEQ ID NO:1 to preserve the particular function of the recited binding affinity.
Consequently, the experimentation left to those skilled in the art to determine which binding protein for human Her2 that is at least 97% identical to SEQ ID NO:1 and the same function of having a binding affinity for Her2 of less than 0.5nM after 24h incubation in serum as determined by ELISA and is stable at temperatures of at least 64oC is unnecessarily, improperly, and extensive and undue.
9. 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.
10. 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.
11. Claims 1, 3-6, 11, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bosse-Doenecke et al. (US 2018/0030140).
The claims are drawn to a binding protein for huma Her2 comprising an amino acid sequence with at least 97% identity to SEQ ID NO:1 (152 amino acid residues), which allows amino acid modification in 4.56 residues (3%x152 aa=4.56). The round up of 4.56 amino acid residues would result in 5 amino acid residues
Bosse-Doenecke et al. teach a binding protein that binds human Her2 and comprising amino acid sequence of SEQ ID NO:71 that is 96.5% identical to the instant SEQ ID NO:1 (see sequence alignment below). The prior art SEQ ID NO:71 differ from the instant claims in 5 amino acid residues.
Instant SEQ ID NO:1 (Qy) alignment to prior art protein:
RESULT 20
US-15-549-022-71
(NOTE: this sequence has 1 duplicate in the database searched)
Sequence 71, US/15549022
Publication No. US20180030140A1
GENERAL INFORMATION
APPLICANT: Navigo Proteins GmbH
APPLICANT: BOSSE-DOENECKE, Eva
APPLICANT: KAHL, Mathias
APPLICANT: SETTELE, Florian
APPLICANT: KNICK, Paul
APPLICANT: LIEBSCHER, Markus
APPLICANT: FIEDLER, Erik
APPLICANT: HENNICKE, Julia
TITLE OF INVENTION: Novel binding proteins comprising a ubiquitin mutein and
TITLE OF INVENTION: antibodies or antibody fragments
FILE REFERENCE: 3073/8 PCT/US
CURRENT APPLICATION NUMBER: US/15/549,022
CURRENT FILING DATE: 2017-08-04
PRIOR APPLICATION NUMBER: EP15154150.5
PRIOR FILING DATE: 2015-02-06
PRIOR APPLICATION NUMBER: EP15169863.6
PRIOR FILING DATE: 2015-05-29
PRIOR APPLICATION NUMBER: PCT/EP2016/052345
PRIOR FILING DATE: 2016-02-04
NUMBER OF SEQ ID NOS: 80
SEQ ID NO 71
LENGTH: 408
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: OKT3 Mab NL 142628 Sequence
Query Match 96.5%; Score 749; Length 408;
Best Local Similarity 96.7%;
Matches 147; Conservative 1; Mismatches 4; Indels 0; Gaps 0;
Qy 1 MQIFVKTLTGKTITLEVEPSDTTENVKAKIQDKEGIPPDQQTLAFVGKQLEDGRTLSDYN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 23 MQIFVKTLTGKTITLEVEPSDTTENVKAKIQDKEGIPPDQQTLAFVGKQLEDGRTLSDYN 82
Qy 61 IQKESTLWLYLTLRAAMRIFVKTHTGKTITLDVEPSDTIENVKAKIQDKEGIPPDQQRLI 120
|||||||||||| ||||||| ||||||||||||||||||||||||||||||||||||||
Db 83 IQKESTLWLYLTWYAAMRIFVTTHTGKTITLDVEPSDTIENVKAKIQDKEGIPPDQQRLI 142
Qy 121 WAGKQLEDGRTLSDYNIQEWSILHLVLRLRAA 152
||||||||||||||||| ||:|||||||||||
Db 143 WAGKQLEDGRTLSDYNISEWAILHLVLRLRAA 174
Bosse-Doenecke et al. further teach a fusion protein comprising the Her-2 specific binding protein and a monoclonal antibody which is a pharmacokinetics modulating molecule or a diagnostically active component or an imaging agent (e.g. see [0001], [0014], [0055], [0059], and [0170]). Furthermore, Bosse-Doenecke et al. teach a pharmaceutical composition comprising the binding protein for human Her2 (e.g. see [0159] and claim 14).
Therefore, the reference teachings anticipate the instant invention.
12. 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.
13. Claims 1, 3-6, 11, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 7-15 of US 10,584,152 (the ‘152 Patent).
US-15-744-054A-19
(NOTE: this sequence has 1 duplicate in the database searched)
Sequence 19, US/15744054A
Patent No. 10584152
GENERAL INFORMATION
APPLICANT: Navigo Proteins GmbH
APPLICANT: Fiedler, Erik
APPLICANT: Meysing, Maren
TITLE OF INVENTION: NOVEL BINDING PROTEINS BASED ON DI-UBIQUITIN MUTEINS AND METHODS FOR GENERATION
FILE REFERENCE: 3073/10 PCT/US
CURRENT APPLICATION NUMBER: US/15/744,054A
CURRENT FILING DATE: 2018-01-11
PRIOR APPLICATION NUMBER: EP15177545.9
PRIOR FILING DATE: 2015-07-20
PRIOR APPLICATION NUMBER: PCT/EP2016/067216
PRIOR FILING DATE: 2016-07-19
NUMBER OF SEQ ID NOS: 45
SEQ ID NO 19
LENGTH: 152
TYPE: PRT
ORGANISM: Artificial sequence
FEATURE:
OTHER INFORMATION: Artificially synthesized Affilin-142628
Query Match 96.5%; Score 749; Length 152;
Best Local Similarity 96.7%;
Matches 147; Conservative 1; Mismatches 4; Indels 0; Gaps 0;
Qy 1 MQIFVKTLTGKTITLEVEPSDTTENVKAKIQDKEGIPPDQQTLAFVGKQLEDGRTLSDYN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MQIFVKTLTGKTITLEVEPSDTTENVKAKIQDKEGIPPDQQTLAFVGKQLEDGRTLSDYN 60
Qy 61 IQKESTLWLYLTLRAAMRIFVKTHTGKTITLDVEPSDTIENVKAKIQDKEGIPPDQQRLI 120
|||||||||||| ||||||| ||||||||||||||||||||||||||||||||||||||
Db 61 IQKESTLWLYLTWYAAMRIFVTTHTGKTITLDVEPSDTIENVKAKIQDKEGIPPDQQRLI 120
Qy 121 WAGKQLEDGRTLSDYNIQEWSILHLVLRLRAA 152
||||||||||||||||| ||:|||||||||||
Db 121 WAGKQLEDGRTLSDYNISEWAILHLVLRLRAA 152
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the claims in the ‘152 Patent are drawn to the same or nearly the same binding protein having the same or nearly the same identical amino acid sequences. As such, the claims in the ‘152 Patent would anticipate the instant invention.
14. Claims 1, 2-6, 11, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of US 11,813,336 (the ‘336 Patent).
Instant SEQ ID NO:3 (Qy) alignment:
RESULT 2
US-16-098-600C-43
Sequence 43, US/16098600C
Patent No. 11813336
GENERAL INFORMATION
APPLICANT: Navigo Proteins GmbH
APPLICANT: Haupts, Ulrich
APPLICANT: Liebscher, Markus
APPLICANT: Fiedler, Eric
TITLE OF INVENTION: TARGETED COMPOUNDS FOR THE SITE-SPECIFIC COUPLING OF
TITLE OF INVENTION: CHEMICAL MOIETIES COMPRISING A PEPTIDE LINKER
FILE REFERENCE: 3073/12 PCT/US
CURRENT APPLICATION NUMBER: US/16/098,600C
CURRENT FILING DATE: 2018-11-02
PRIOR APPLICATION NUMBER: PCT/EP2017/060650
PRIOR FILING DATE: 2017-05-04
PRIOR APPLICATION NUMBER: EP 17161514.9
PRIOR FILING DATE: 2017-03-17
PRIOR APPLICATION NUMBER: EP 16168255.4
PRIOR FILING DATE: 2016-05-04
NUMBER OF SEQ ID NOS: 81
SEQ ID NO 43 (SEQ ID NO:45)
LENGTH: 252
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Artificially synthesized Her2 specific fusion protein
146414
Query Match 97.2%; Score 753; Length 252;
Best Local Similarity 97.4%;
Matches 148; Conservative 1; Mismatches 3; Indels 0; Gaps 0;
Qy 1 MQIFVKTLTGKTITLEVEPSDTTENVKAKIQDKEGIPPDQQTLAFVGKQLEDGRTLSDYN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MQIFVKTLTGKTITLEVEPSDTTENVKAKIQDKEGIPPDQQTLAFVGKQLEDGRTLSDYN 60
Qy 61 IQKESTLWLYLTLRAAMRIFVKTHTGKTITLDVEPSDTIENVKAKIQDKEGIPPDQQRLI 120
|||||||||||| ||||||| ||||||||||||||||||||||||||||||||||||||
Db 61 IQKESTLWLYLTWYAAMRIFVTTHTGKTITLDVEPSDTIENVKAKIQDKEGIPPDQQRLI 120
Qy 121 WAGKQLEDGRTLSDYNISEWSILHLVLRLRAA 152
||||||||||||||||||||:|||||||||||
Db 121 WAGKQLEDGRTLSDYNISEWAILHLVLRLRAA 152
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the claims in the ‘336 Patent are drawn to the same or nearly the same binding protein having the same or nearly the same identical amino acid sequences. As such, the claim in the ‘336 Patent would anticipate the instant invention.
15. Claim 2 is objected as being dependent upon a rejected base claims 1, but would be allowable if rewritten in the independent form including all of the limitations of the base claim and any intervening claims.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN DAHLE whose telephone number is (571)272-8142. The examiner can normally be reached Mon-Fri 6:30am-4:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN W DAHLE/Primary Examiner, Art Unit 1641