DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Election
1) Applicant’s election filed 06/04/26 in response to the species election requirement mailed 04/09/26 is acknowledged. Applicant has elected the composition species comprising an amino acid sequence at least 80-95% identical to SEQ ID NO: 67. Because Applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as an election without traverse. M.P.E.P § 818.03(a).
Status of Claims
2) Claims 1-36 have been canceled via the preliminary amendment filed 12/16/24.
New claims 37-46 have been added via the preliminary amendment filed 12/16/24.
Claims 37-46 are pending.
Claims 39, 40, 42, 43, 45 and 46 are withdrawn from consideration as being directed to a non-elected species. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
Claims 37, 38, 41 and 44 are examined on the merits.
Information Disclosure Statements
3) Six of Applicant’s information disclosure statements all filed 08/14/24 and the one filed 06/04/26 are acknowledged. The information referred to therein has been considered and a signed copy of the same is attached to this Office Action.
Substitute Specifications
4) Applicant’s substitute specifications filed 03/19/26 and 12/16/24 are acknowledged.
Drawings
5) Acknowledgment is made of Applicant’s drawings filed 08/14/24.
Sequence Listing
6) Acknowledgment is made of Applicant’s sequence listing which has been entered on 12/16/24.
Priority
7) This non-AIA application filed 08/14/2024 is a continuation of U.S application 17371762 filed 07/09/2021, now US patent 12084519, which is a continuation of U.S application 15475664 filed 03/31/2017, now US patent 11091563, which is a continuation of U.S application 14665542 filed 03/23/2015, now US patent 9,834,616, which is a divisional of U.S. application 13/566,524 filed 08/03/2012, now US patent 9,023,352, which claims priority to the provisional application 61/514,949 filed 08/04/2011, which is a continuation-in-part of U.S. application 12/889,511 filed 09/24/2010, now US patent 8,349,326, which is a continuation-in-part of U.S. application 12/032,744 filed 02/18/2008, now US patent 8,865,169, which claims priority to the provisional application 60/890,626 filed 02/20/2007.
Oath/ Declaration
8) The instant application having new claims filed with the application does not appear be a continuation, but a continuation-in-part application. The new claims contain new subject matter relative to the prior application(s) to which priority is claimed. A new oath or declaration along with the surcharge set forth in 37 CFR 1.16(f) re-designating the application as a continuation-in-part application is needed. See paragraphs 9(b) and 11 of this Office Action.
Objection(s) to Substitute Specification
9) The instant specification is objected to for the following reason(s):
(a) The use of trademark recitation(s) has been noted in the instant specification. For example, see Example 6 for ‘Tween 20’. All trademark recitations should be capitalized wherever they appear. See M.P.E.P 608.01(V) and Appendix l. Although the use of trademarks is permissible in patent applications, the propriety nature of the marks should be respected and every effort made to prevent their use in any manner, which might adversely affect their validity as trademarks. It is suggested that Applicants examine the whole specification to make similar corrections to trademark recitations, wherever such recitations appear.
(b) 37 CFR 1.75(d)(1) provides, in part, that ‘the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description.’ 35 U.S.C § 132 states that no amendment shall introduce new matter into the disclosure of the invention.
New claim 37, as set forth, includes the limitations: “the VHH polypeptide or the functional binding fragment thereof binds to Clostridium difficile toxin B comprises .... an amino acid sequence comprising at least 80% sequence identity to the amino acid sequence set forth in SEQ ID NO: 67, wherein the VHH polypeptide further comprises ..... CDRs .... comprising the amino acid sequences of the CDRs in the amino acid sequence set forth in SEQ ID NO: 67 ....”, which lack descriptive support and antecedent basis in the as-filed specification. The as-filed specification lacks antecedent basis and descriptive support for the claimed VHH or a functional binding fragment thereof comprising an amino acid sequence at least 80% identical to SEQ ID NO: 67 and comprising the CDRs of SEQ ID NO: 67 (but not required to comprise the frameworks from SEQ ID NO: 67) and retaining the capacity to bind to Clostridium difficile toxin B. Applicants have not pointed to parts of the original as-filed specification that provide descriptive support and antecedent basis in the as-filed specification.
Rejection(s) under 35 U.S.C § 112 (Pre-AIA ), 1st Paragraph or 35 U.S.C § 112(a)
10) The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), first paragraph:
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 the invention.
The following is a quotation 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.
11) Claim 37 and the dependent claims 38, 41 and 44 are rejected under 35 U.S.C § 112 (pre-AIA ), first paragraph or 35 U.S.C § 112(a), 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. This is a new matter rejection.
New claim 37, as set forth, includes the limitations: “the VHH polypeptide or the functional binding fragment thereof binds to Clostridium difficile toxin B comprises .... an amino acid sequence comprising at least 80% sequence identity to the amino acid sequence set forth in SEQ ID NO: 67, wherein the VHH polypeptide further comprises ..... CDRs .... comprising the amino acid sequences of the CDRs in the amino acid sequence set forth in SEQ ID NO: 67 ....”, which lack descriptive support in the as-filed specification. The as-filed specification lacks descriptive support for the claimed VHH or a functional binding fragment thereof comprising an amino acid sequence at least 80% identical to SEQ ID NO: 67 and comprising the CDRs of SEQ ID NO: 67 (but not required to comprise the frameworks from SEQ ID NO: 67) and retaining the capacity to bind to Clostridium difficile toxin B. The functional binding fragment species of the claimed VHH having partial or modified frameworks that are encompassed within the scope of the claims which are required to bind to Clostridium difficile toxin B lack descriptive support in the as-filed specification. Applicants have not pointed to parts of the original as-filed specification that provide descriptive support in the as-filed specification. Therefore, the new limitations and the now claimed scope of the claim(s) constitute new matter.
Applicants are respectfully requested to point to the descriptive support in the specification as filed, for the new limitation(s) and the new scope, or alternatively, remove the new matter from the claim(s). Applicants should specifically point out the support for any amendments made to the disclosure. See MPEP 714.02 and 2163.06.
12) Claims 37, 38, 41 and 44 are rejected under 35 U.S.C § 112 (pre-AIA ), first paragraph or 35 U.S.C § 112(a) 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. This is a written description rejection.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). The analysis of whether the as-filed specification complies with the written description requirements calls for the Office to compare the scope of the claims with the scope of the description to determine whether Applicant has demonstrated possession of the full scope of the claimed invention at the time of the invention. In the instant application, an analysis of the scope of the claims and of the variant genus encompassed therein indicates the following.
New claim 37 is representative of the claimed invention. Claim 37 is drawn to a composition comprising a VHH polypeptide or functional binding fragment thereof, wherein the VHH polypeptide or the functional binding fragment thereof binds to Clostridium difficile toxin B and comprises an amino acid sequence comprising at least 80% sequence identity to the amino acid sequence set forth in SEQ ID NO: 67, the elected species, wherein the VHH polypeptide further comprises CDRs comprising the amino acid sequences of the CDRs in the amino acid sequence set forth in SEQ ID NO: 67, i.e., not required to comprise the frameworks from SEQ ID NO: 67. The limitation ‘further comprises ....’ appears to indicate that the CDRs are additional to SEQ ID NO: 167. The VHH polypeptide or the functional binding fragment thereof of claim 38 comprises at least 85% sequence identity to SEQ ID NO: 67, whereas the VHH polypeptide or the functional binding fragment thereof of claim 41 comprises at least 90% sequence identity to SEQ ID NO: 67. The VHH polypeptide or the functional binding fragment thereof of claim 44 comprises at least 95% sequence identity to SEQ ID NO: 67. Thus, the VHH polypeptide or a functional fragment thereof with up to 20%, up to 15%, up to 10%, or up to 5% non-identity to SEQ ID NO: 67 anywhere along its entire length in the claimed composition represents a huge genus encompassing structurally highly divergent species that are required to have the function of binding to Clostridium difficile toxin B. The amino acid sequences having up to 20% non-identity encompass structurally variable species having partial or modified frameworks, yet are required to bind to Clostridium difficile toxin B. Instant application intends anti-C. difficile toxin B- neutralizing functions for the claimed VHH composition. However, Applicants were not in possession of the variable genus and the full scope of the broadly claimed invention at the time of the invention.
The written description requirement can be met by describing the claimed subject matter to a person skilled in the art using sufficiently detailed, relevant identifying characteristics such as functional characteristics, and correlating those functional characteristics with a disclosed structure. See Enzo Biochem v. Gen-Probe, 323 F.3d 956, 964, 967, 968 (Fed. Cir. 2002). Sufficient description to show possession of a genus may be achieved by means of description of a representative number of species, defined by structure falling within the scope of the genus, or description of structural features common to members of the genus, which features constitute a substantial portion of the genus. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. Sufficient description to show possession of a genus may be achieved by means of description of a substantial number of the members or species of the recited genus, or alternatively describe a representative member of the recited genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would allow the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. A ‘representative number of species’ means that the species, which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, as in the instant case due to the structural variability, one must describe a sufficient number and variety of species to reflect the variation within the genus along with a correlation to the requisite function. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure ‘indicates that the patentee has invented species sufficient to constitute the gen[us].’ See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (‘[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated’). ‘A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when .... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.’ In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004). With respect to a representative number of species, see AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014). (Claims directed to a functionally defined genus of antibodies were not supported by
a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not
representative of the full variety or scope of the genus.").
In the instant application, the claimed large VHH genus encompasses structurally highly variable variant species comprising amino acid sequences having up to 5% to 20% sequence non-identity to SEQ ID NO: 67. Such a genus includes a large number of structurally highly divergent sequence species along the entire length of SEQ ID NO: 67 and having unspecified amino acid deletions, insertions, truncations, amino acid substitutions, additions and/or other modifications, yet the resultant species of variable structure are required to retain the Clostridium difficile toxin B-binding function and also the intended Clostridium difficile toxin B-neutralizing function. The as-filed specification discloses only one VHH comprising the amino acid sequence of SEQ ID NO: 67. To fulfill the written description requirements under 35 U.S.C § 112(a), the structure of a representative number and variety of up to 5% to 20% non-identical sequence species of SEQ ID NO: 67 must be identified and correlated with the recited requisite and the intended functions, i.e., the Clostridium difficile toxin B-binding as well as the Clostridium difficile toxin B-neutralizing functions. The amino acid sequences having up to 20% non-identity encompass functional binding fragment species having partial or modified frameworks, which are required to bind to Clostridium difficile toxin B. However, the as-filed specification fails to provide sufficient description or guidance as to which specific amino acids within SEQ ID NO: 67 that specifically bind to one or more contiguous or non-contiguous and/or conformational or non-conformational epitopes of Clostridium difficile toxin B should be retained or can be deleted, substituted, inserted, or modified such that the resultant at least 5% to 20% non-identical protein variant species would still retain the three dimensional structure, bind specifically to the Clostridium difficile toxin B species, and exert Clostridium difficile toxin B-neutralizing effects. This is important because there is no predictability that if one made such up to 5% to 20% non-identical variants with random modifications including insertions, deletions, substitutions and/or point mutations, one would retain Clostridium difficile toxin B-binding immunospecificity and the Clostridium difficile toxin B-neutralizing functions. This is also important because with respect to the immunospecificity of antibodies, Lederman et al. (Mol. Immunol. 28: 1171-1181, 1991 - Applicants’ IDS) taught that a single amino acid substitution in a common allele ablates binding of a monoclonal antibody. See the entire document. Li et al. (PNAS 77: 3211-3214, 1980 - Applicants’ IDS) taught of dissociation of immunoreactivity from other biological activities when constructing analogs. See entire document. Colman et al. (Res. Immunol. 145: 33-36, 1994 - Applicants’ IDS) taught that single amino acid changes in an antigen can effectively abolish antibody antigen binding. Abaza et al. (J. Protein Chem. 11: 433-444, 1992 - Applicants’ IDS) taught that single amino acid substitutions outside the antigenic site on a protein effect antibody binding. Furthermore, Skolnick et al. (Trends in Biotechnology 18: 34-39, 2000 - Applicants’ IDS) taught that a skilled artisan is well aware that assigning functional activities for any particular protein or a family of proteins based upon sequence homology is inaccurate, partly because of the multifunctional nature of proteins. See abstract; and page 34. Even in situations where there is some confidence of a similar overall structure between two proteins, only experimental research can confirm the artisan’s best guess as to the function of the structurally related protein. See abstract and Box 2. The instant specification fails to provide specific guidance regarding which specific amino acids within the claimed SEQ ID NO: 67 can be modified in such a way that the required Clostridium difficile toxin B-binding function and the intended Clostridium difficile toxin B-neutralizing function are maintained. Clearly, the instant disclosure does not allow one of skill in the art to visualize or recognize the structure of a representative number of the VHH species, the structure of which is correlated with the required Clostridium difficile toxin B-binding function and the intended Clostridium difficile toxin B-neutralizing functions. As such, which of the amino acid sequence variants are effective in binding and neutralizing the recited Clostridium difficile toxin B is unpredictable. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddles v. Baird, 30 USPQ2d 1481, 1483. In the instant case, the full breadth of the claims does not meet the written description provision of 35 U.S.C § 112(a). Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C § 112 is severable from its enablement provision. See page 1115. A mere idea of function is insufficient for written description.
"When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus" (Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)) [Emphasis added].
"A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus" (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) [Emphasis added].
Furthermore, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) decided Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which concerned the issue of adequate written description for claims drawn to antibodies. The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79.
In sum, in the instant application, Applicants were not in possession of the full breadth of the claimed genus and the full scope of the composition at the time of the invention. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. In the instant application, there is insufficient written description of the required structure-identifying information and the corresponding make-up of the claimed genus of VHH to demonstrate possession. Given the broadly claimed genus of VHH and the absence of sufficient disclosure of relevant identifying characteristics for the claimed genus having the recited requisite functions, the patentee must establish ‘a reasonable structure-function correlation’ either within the specification or by reference to the knowledge of one skilled in the art with functional claims. Clearly, the instant specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicants were not in possession of the full scope of the claimed invention at the time of filing. Instant claims do not meet the provision of 35 U.S.C § 112(a).
Rejection(s) under 35 U.S.C § 112 (Pre-AIA ), 2nd Paragraph or 35 U.S.C § 112(b)
13) 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.
14) Claims 37, 38, 41 and 44 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 inventor or a joint inventor, or for the pre-AIA the Applicants regard as the invention.
(a) New claim 37 is ambiguous and indefinite in the limitations: the VHH polypeptide or the functional binding fragment thereof ..... comprises .... an amino acid sequence comprising at least 80% sequence identity to the amino acid sequence set forth in SEQ ID NO: 67, wherein the VHH polypeptide “further comprises CDRs comprising the amino acid sequences of the CDRs in the amino acid sequence set forth in SEQ ID NO: 67”. Does it mean that the amino acid sequences of the CDRs in the amino acid sequence set forth in SEQ ID NO: 67 are further present in addition to an amino acid sequence comprising at least 80% sequence identity to the amino acid sequence set forth in SEQ ID NO: 67? One of ordinary skill in the art cannot understand in an unambiguous way the structural boundaries of the claimed ‘a VHH polypeptide or functional binding fragment thereof’ and thus the scope of the claim.
(b) Claims 38, 41 and 44, which depend from claim 37, are also rejected as being indefinite due to the indefiniteness identified above in the base claim(s).
Notice Re Prior Art Available under Both Pre-AIA and 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 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.
Rejection(s) under 35 U.S.C § 102
15) 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
16) Claims 37, 38, 41 and 44 are rejected under 35 U.S.C § 102(b) as being anticipated by Schmidt et al. (Clin. Vaccine Immunol. 23: 774-784, pre-published online 13 July 2016 - Applicants’ IDS).
The reference of Schmidt et al. is applied in this rejection since it qualifies as prior art under subsection (b) of 35 U.S.C § 102 due to the effective filing date of the instant application that is afforded to instant claims.
Schmidt et al. taught a composition comprising the toxin-neutralizing 5D VHH capable of neutralizing TcdB. See last two sentences of the paragraph bridging pages 774 and 775; 2nd paragraph under MATERIALS AND METHHODS; and the 1st sentence of page 775. Schmidt et al. taught the purified, engineered or synthetically generated element containing the 5D neutralizing VHH targeting TcdB and a composition or a therapeutic composition comprising the same. See 1st full paragraph of page 775 including the last two sentences therein; the 1st sentence of page 775; ‘Materials and Methods’ section on page 775 including the last two full paragraphs on page 775; ‘Results’ section on page 776 including the first full paragraph therein; Figure 1B; and the paragraph bridging pages 778 and 779. Since the 5D VHH of the prior art and the 5D VHH of the instant application are one and the same, the prior art 5D VHH is expected to necessarily have the same amino acid sequence as recited in instant claims, i.e., SEQ ID NO: 67, as is set forth at line 3 of page 85 of Applicants’ as-filed specification.
Claims 37, 38, 41 and 44 are anticipated by Schmidt et al.
17) Claims 37, 38, 41 and 44 are rejected under 35 U.S.C § 102(b) as being anticipated by Shoemaker et al. (US 20140294826 A1 - Applicants’ IDS) (‘826).
The reference of Shoemaker et al. is applied in this rejection since it qualifies as prior art under subsection (b) of 35 U.S.C § 102 due to the effective filing date of the instant application that is afforded to instant claims.
Shoemaker et al. (‘826) disclosed a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a purified recombinant engineered binding protein comprising the instantly recited SEQ ID NO: 67 or the SEQ ID NO: 87 comprising therein the instantly recited SEQ ID NO: 67. Shoemaker et al. (‘826) taught a composition comprising the neutralizing 5D VHH that binds to and neutralize Clostridium difficile toxin-B. The 5D VHH of the prior art and the 5D VHH of the instant application are one and the same. See Examples 22 and 23; pages 108, 117 and 118; line 5 of section [0076]; sections [0108], [0109], [0111], [0112], [0230], [0232], [0236], [0279] and [0251], and the sequence alignments (A) and (B).
US-14-247-628-67 & 87
Sequences 67 & 87, Application US 14247628
Publication No. US 20140294826 A1
GENERAL INFORMATION
APPLICANT: Tufts University
APPLICANT: Shoemaker, Charles B.
TITLE OF INVENTION: Methods and compositions with a recombinant heteromultimeric neutralizing binding protein for treating toxin exposure
CURRENT APPLICATION NUMBER: US 14/247,628
CURRENT FILING DATE: 2014-04-08
NUMBER OF SEQ ID NOS: 163
SEQ ID NO: 67
LENGTH: 135
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: The sequence has been designed and synthesized
US-14-247-628-67
Query Match 100%; Score 705; Length 135; Best Loc Similarity 100%;
Matches 135; Conservative 0; Mismatches 0; Indels 0; Gaps 0.
Qy 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
Qy 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
Qy 121 TQVAVSSEPKTPKPQ 135
|||||||||||||||
Db 121 TQVAVSSEPKTPKPQ 135
SEQ ID NO 87
LENGTH: 453
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: The sequence has been designed and synthesized
US-14-247-628-87
Query Match 100%; Score 705; Length 453; Best Loc Similarity 100%;
Matches 135; Conservative 0; Mismatches 0; Indels 0; Gaps 0.
Qy 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 168 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 227
Qy 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 228 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 287
Qy 121 TQVAVSSEPKTPKPQ 135
|||||||||||||||
Db 288 TQVAVSSEPKTPKPQ 302
Claims 37, 38, 41 and 44 are anticipated by Shoemaker et al. (‘826).
Double Patenting Rejection(s)
18) 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 C.F.R 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
19) Claims 37, 38, 41 and 44 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 18, 21, 24, 11 and 1 of US 12,084,519 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other because the identified claims of the ‘519 patent, drawn to a composition comprising an amino acid sequence comprising SEQ ID NO: 67 comprising 3 CDRs and 4 framework regions or a functional binding fragment thereof which binds to Clostridium difficile toxin B, read on and anticipate instant claims. See the sequence alignment set forth below:
US-17-371-762A-67
Filing date in PALM: 2021-07-09
Sequence 67, US 17371762A
Patent No. 12084519
GENERAL INFORMATION
APPLICANT: Trustees of Tufts College
TITLE OF INVENTION: Methods, compositions and kits for treating a subject using a recombinant heteromultimeric neutralizing binding protein
CURRENT APPLICATION NUMBER: US/17/371,762A
CURRENT FILING DATE: 2021-07-09
PRIOR APPLICATION NUMBER: 15/475,664
PRIOR FILING DATE: 2017-03-31
PRIOR APPLICATION NUMBER: 14/665,542
PRIOR FILING DATE: 2015-03-23
PRIOR APPLICATION NUMBER: 13/566,524
PRIOR FILING DATE: 2012-08-03
PRIOR APPLICATION NUMBER: 61/514,949
PRIOR FILING DATE: 2011-08-04
PRIOR APPLICATION NUMBER: 12/889,511
PRIOR FILING DATE: 2010-09-24
PRIOR APPLICATION NUMBER: 12/032,744
PRIOR FILING DATE: 2008-02-18
PRIOR APPLICATION NUMBER: 60/890,626
PRIOR FILING DATE: 2007-02-20
NUMBER OF SEQ ID NOS: 112
SEQ ID NO: 67
LENGTH: 135
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: The sequence has been designed and synthesized
Query Match 100%; Score 705; Length 135; Best Local Similarity 100%;
Matches 135; Conservative 0; Mismatches 0; Indels 0; Gaps 0.
Qy 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
Qy 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
Qy 121 TQVAVSSEPKTPKPQ 135
|||||||||||||||
Db 121 TQVAVSSEPKTPKPQ 135
20) Claims 37 and 38 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 16, 1 and 5 of US 12077575 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other because the identified claims of the ‘575 patent, drawn to a pharmaceutical formulation comprising a binding agent comprising h5D VHH having binding specificity for an epitope of Clostridium difficile toxin B and comprising SEQ ID NO: 1 or SEQ ID NO: 9 having at least 85.8% sequence identity to the instantly claimed SEQ ID NO: 67, read on and anticipate instant claims. See the sequence alignments (A) and (B) set forth below:
(A)
US-17-616-134-1
Sequence 1, US 17616134
Patent No. 12077575
GENERAL INFORMATION
APPLICANT: FENG, Hanping
APPLICANT: YANG, Zhiyong
APPLICANT: YU, Hua
APPLICANT: ZHANG, Yifan
APPLICANT: ZHANG, Yongrong
TITLE OF INVENTION: HUMANIZED TETRA-SPECIFIC OCTAVALENT ANTIBODY AGAINST CLOSTRIDIUM DIFFICILE TOXIN A AND B
CURRENT APPLICATION NUMBER: US/17/616,134
CURRENT FILING DATE: 2021-12-02
PRIOR APPLICATION NUMBER: US 62/856,493
PRIOR FILING DATE: 2019-06-03
NUMBER OF SEQ ID NOS: 39
SEQ ID NO: 1
LENGTH: 127
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Humanized VHH peptide monomer 5D
Query Match 85.8%; Score 605; Length 127; Best Local Similarity 90.6%;
Matches 115; Conservative 6; Mismatches 6; Indels 0; Gaps 0.
Qy 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
:|||:||||||||||||||||| |||||||||||||||| ||||||||||||||||||||
Db 1 EVQLLESGGGLVQPGGSLRLSCAASGFTLDYYGIGWFRQAPGKEREAVSYISASARTILY 60
Qy 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
||||||||||||||:|| :|||||||: ||||||||||||||||||||||||||||||:|
Db 61 ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARRRFSASSVNRWLADDYDVWGQG 120
Qy 121 TQVAVSS 127
| | |||
Db 121 TLVTVSS 127
(B)
US-17-616-134-9
Sequence 1, US 17616134
Patent No. 12077575
GENERAL INFORMATION
APPLICANT: FENG, Hanping
APPLICANT: YANG, Zhiyong
APPLICANT: YU, Hua
APPLICANT: ZHANG, Yifan
APPLICANT: ZHANG, Yongrong
TITLE OF INVENTION: HUMANIZED TETRA-SPECIFIC OCTAVALENT ANTIBODY AGAINST CLOSTRIDIUM DIFFICILE TOXIN A AND B
CURRENT APPLICATION NUMBER: US 17/616,134
CURRENT FILING DATE: 2021-12-02
PRIOR APPLICATION NUMBER: US 62/856,493
PRIOR FILING DATE: 2019-06-03
NUMBER OF SEQ ID NOS: 39
SEQ ID NO: 9
LENGTH: 559
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: hAH3-h5D heavy chain of FZ003 binding agent
Query Match 85.8%; Score 605; Length 599; Best Local Similarity 90.6%;
Matches 115; Conservative 6; Mismatches 6; Indels 0; Gaps 0
Qy 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
:|||:||||||||||||||||| |||||||||||||||| ||||||||||||||||||||
Db 143 EVQLLESGGGLVQPGGSLRLSCAASGFTLDYYGIGWFRQAPGKEREAVSYISASARTILY 202
Qy 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
||||||||||||||:|| :|||||||: ||||||||||||||||||||||||||||||:|
Db 203 ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARRRFSASSVNRWLADDYDVWGQG 262
Qy 121 TQVAVSS 127
| | |||
Db 263 TLVTVSS 269
21) Claims 37, 38 and 41 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 8, 7, 5 and 1 of US 10961299 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other because the identified claims of the ‘299 patent, drawn to a pharmaceutical formulation comprising a binding agent comprising 5D VHH having binding specificity for an epitope of Clostridium difficile toxin B and comprising SEQ ID NO: 1 or SEQ ID NO: 44 having at least 93.5% sequence identity to the instantly claimed SEQ ID NO: 67, read on and anticipate instant claims. See the sequence alignments (C) and (D) set forth below:
(C)
US-15-548-901-1
Sequence 1, US 15548901
Patent No. 10961299
GENERAL INFORMATION
APPLICANT: FENG, Hanping
TITLE OF INVENTION: TETRA-SPECIFIC, OCTAMERIC BINDING AGENTS AND ANTIBODIES AGAINST CLOSTRIDIUM DIFFICILE TOXIN A AND TOXIN B
CURRENT APPLICATION NUMBER: US 15/548,901
CURRENT FILING DATE: 2017-08-04
PRIOR APPLICATION NUMBER: US 62/113,046
PRIOR FILING DATE: 2015-02-06
NUMBER OF SEQ ID NOS: 67
SEQ ID NO: 1
LENGTH: 127
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Codon-optimized VHH peptide monomer 5D
Query Match 93.5%; Score 659; Length 127; Best Local Similarity 100%;
Matches 127; Conservative 0; Mismatches 0; Indels 0; Gaps 0.
Qy 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
Qy 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
Qy 121 TQVAVSS 127
|||||||
Db 121 TQVAVSS 127
(D)
US-15-548-901-44
Sequence 44, US 15548901
Patent No. 10961299
GENERAL INFORMATION
APPLICANT: FENG, Hanping
TITLE OF INVENTION: TETRA-SPECIFIC, OCTAMERIC BINDING AGENTS AND ANTIBODIES AGAINST CLOSTRIDIUM DIFFICILE TOXIN A AND TOXIN B
CURRENT APPLICATION NUMBER: US 15/548,901
CURRENT FILING DATE: 2017-08-04
PRIOR APPLICATION NUMBER: US 62/113,046
PRIOR FILING DATE: 2015-02-06
NUMBER OF SEQ ID NOS: 67
SEQ ID NO: 44
LENGTH: 599
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Codon-optimized VHH peptide monomer 5D
Query Match 93.5%; Score 659; Length 599; Best Local Similarity 100%;
Matches 127; Conservative 0; Mismatches 0; Indels 0; Gaps 0.
Qy 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 143 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 202
Qy 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 203 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 262
Qy 121 TQVAVSS 127
|||||||
Db 263 TQVAVSS 269
22) Claims 37, 38, 41 and 44 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 4, 1, 12 and 9 of US 11091563 B2 (Applicants’ IDS). Although the conflicting claims are not identical, they are not patentably distinct from each other because the identified claims of the ‘563 patent, drawn to a pharmaceutical composition comprising a binding protein comprising the VHH that specifically binds to Clostridium difficile toxin B and comprising SEQ ID NO: 67 or SEQ ID NO: 87 having 100% sequence identity to the instantly claimed SEQ ID NO: 67, read on and anticipate instant claims. See the sequence alignments (E) and (F) set forth below:
(E)
US-15-475-664-67
Sequence 67, US 15475664
Patent No. 11091563 B2
GENERAL INFORMATION
APPLICANT: Tufts University
APPLICANT: Shoemaker, Charles B.
APPLICANT: Feng, Hanping
TITLE OF INVENTION: Methods, compositions and kits for treating a subject using a recombinant heteromultimeric neutralizing binding protein
CURRENT APPLICATION NUMBER: US/15/475,664
CURRENT FILING DATE: 2017-03-31
PRIOR APPLICATION NUMBER: US 14/665,542
PRIOR FILING DATE: 2015-03-23
PRIOR APPLICATION NUMBER: 61/514,949
PRIOR FILING DATE: 2011-08-04
PRIOR APPLICATION NUMBER: 12/889,511
PRIOR FILING DATE: 2010-09-24
PRIOR APPLICATION NUMBER: 12/032,744
PRIOR FILING DATE: 2008-02-18
PRIOR APPLICATION NUMBER: 60/890,626
PRIOR FILING DATE: 2007-02-20
NUMBER OF SEQ ID NOS: 112
SEQ ID NO: 67
LENGTH: 135
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: The sequence has been designed and synthesized
Query Match 100.0%; Score 705; Length 135; Best Local Similarity 100%;
Matches 135; Conservative 0; Mismatches 0; Indels 0; Gaps 0.
Qy 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
Qy 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
Qy 121 TQVAVSSEPKTPKPQ 135
|||||||||||||||
Db 121 TQVAVSSEPKTPKPQ 135
(F)
US-15-475-664-87
Sequence 87, US 15475664
Patent No. 11091563 B2
GENERAL INFORMATION
APPLICANT: Tufts University
APPLICANT: Shoemaker, Charles B.
APPLICANT: Feng, Hanping
TITLE OF INVENTION: Methods, compositions and kits for treating a subject using a recombinant heteromultimeric neutralizing binding protein
CURRENT APPLICATION NUMBER: US/15/475,664
CURRENT FILING DATE: 2017-03-31
PRIOR APPLICATION NUMBER: US 14/665,542
PRIOR FILING DATE: 2015-03-23
PRIOR APPLICATION NUMBER: 61/514,949
PRIOR FILING DATE: 2011-08-04
PRIOR APPLICATION NUMBER: 12/889,511
PRIOR FILING DATE: 2010-09-24
PRIOR APPLICATION NUMBER: 12/032,744
PRIOR FILING DATE: 2008-02-18
PRIOR APPLICATION NUMBER: 60/890,626
PRIOR FILING DATE: 2007-02-20
NUMBER OF SEQ ID NOS: 112
SEQ ID NO: 87
LENGTH: 453
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: The sequence has been designed and synthesized
Query Match 100%; Score 705; Length 453; Best Local Similarity 100%;
Matches 135; Conservative 0; Mismatches 0; Indels 0; Gaps 0
Qy 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 168 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 227
Qy 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 228 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 287
Qy 121 TQVAVSSEPKTPKPQ 135
|||||||||||||||
Db 288 TQVAVSSEPKTPKPQ 302
23) Claims 37, 38, 41 and 44 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 4, 1, 18 and 15 of US 9834616 B2 (Applicants’ IDS). Although the conflicting claims are not identical, they are not patentably distinct from each other because the identified claims of the ‘616 patent, drawn to a composition comprising a binding protein comprising the VHH that specifically binds to Clostridium difficile toxin B and comprising SEQ ID NO: 67 having at least 100% sequence identity to the instantly claimed SEQ ID NO: 67, read on and anticipate instant claims. See the sequence alignment set forth below:
Sequence 67, US 14665542A
Patent No. 9834616 B2
GENERAL INFORMATION
APPLICANT: Tufts University
APPLICANT: Shoemaker, Charles B.
APPLICANT: Feng, Hanping
TITLE OF INVENTION: Methods, compositions and kits for treating a subject using a recombinant heteromultimeric neutralizing binding protein
CURRENT APPLICATION NUMBER: US 14/665,542A
CURRENT FILING DATE: 2015-03-23
PRIOR APPLICATION NUMBER: 61/514,949
PRIOR FILING DATE: 2011-08-04
PRIOR APPLICATION NUMBER: 12/889,511
PRIOR FILING DATE: 2010-09-24
PRIOR APPLICATION NUMBER: 12/032,744
PRIOR FILING DATE: 2008-02-18
PRIOR APPLICATION NUMBER: 60/890,626
PRIOR FILING DATE: 2007-02-20
NUMBER OF SEQ ID NOS: 112
SEQ ID NO: 67
LENGTH: 135
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: The sequence has been designed and synthesized
Query Match 100.0%; Score 705; Length 135; Best Local Similarity 100%;
Matches 135; Conservative 0; Mismatches 0; Indels 0; Gaps 0.
Qy 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
Qy 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
Qy 121 TQVAVSSEPKTPKPQ 135
|||||||||||||||
Db 121 TQVAVSSEPKTPKPQ 135
24) Claims 37, 38, 41 and 44 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1, 4, 9 and 19 of US 9023352 B2 (Applicants’ IDS). Although the conflicting claims are not identical, they are not patentably distinct from each other because the identified claims of the ‘352 patent, drawn to a formulation comprising a binding protein comprising having binding specificity for an epitope of Clostridium difficile toxin B and comprising SEQ ID NO: 87 which comprises an amino acid sequence having 100% sequence identity to the instantly claimed SEQ ID NO: 67, read on and anticipate instant claims. See the sequence alignment set forth below:
US-13-566-524C-87
Sequence 87, Application US 13566524C
Patent No. 9023352
GENERAL INFORMATION
APPLICANT: Tufts University
APPLICANT: Shoemaker, Charles B.
APPLICANT: Feng, Hanping
TITLE OF INVENTION: Methods, compositions and kits for treating a subject using a recombinant heteromultimeric neutralizing binding protein
CURRENT APPLICATION NUMBER: US 13/566,524C
CURRENT FILING DATE: 2012-08-03
PRIOR APPLICATION NUMBER: 61/514,949
PRIOR FILING DATE: 2011-08-04
PRIOR APPLICATION NUMBER: 12/889,511
PRIOR FILING DATE: 2010-09-24
PRIOR APPLICATION NUMBER: 12/032,744
PRIOR FILING DATE: 2008-02-18
PRIOR APPLICATION NUMBER: 60/890,626
PRIOR FILING DATE: 2007-02-20
NUMBER OF SEQ ID NOS: 112
SEQ ID NO: 87
LENGTH: 453
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: The sequence has been designed and synthesized
US-13-566-524C-87
Query Match 100%; Score 705; Length 453; Best Loc Similarity 100%;
Matches 135; Conservative 0; Mismatches 0; Indels 0; Gaps 0.
Qy 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 168 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 227
Qy 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 228 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 287
Qy 121 TQVAVSSEPKTPKPQ 135
|||||||||||||||
Db 288 TQVAVSSEPKTPKPQ 302
25) Claims 37, 38, 41 and 44 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 7 and 1 of US 10,202,441 B2 (Applicants’ IDS). Although the conflicting claims are not identical, they are not patentably distinct from each other because the identified claims of the ‘441 patent, drawn to a pharmaceutical composition comprising one or more of the amino acid sequences of SEQ ID NO: 164, SEQ ID NO: 167, SEQ ID NO: 172 and SEQ ID NO: 173, each of which comprises therein an amino acid sequence that is 99.6% identical to the instantly recited SEQ ID NO: 67 and therefore read on and anticipate instant claims. See one exemplary sequence alignment set forth below:
US-15-191-739-164
Sequences 164
Application US 15191739
Patent No. 10202441
GENERAL INFORMATION
APPLICANT: Tufts University
APPLICANT: Shoemaker, Charles B.
TITLE OF INVENTION: Methods, compositions and kits for treating a subject using a recombinant neutralizing binding protein
CURRENT APPLICATION NUMBER: US 15/191,739
CURRENT FILING DATE: 2016-06-24
PRIOR APPLICATION NUMBER: 61/920,825
PRIOR FILING DATE: 2013-12-26
PRIOR APPLICATION NUMBER: PCT/US14/72340
PRIOR FILING DATE: 2014-12-24
NUMBER OF SEQ ID NOS: 174
SEQ ID NO: 164
LENGTH: 135
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: The amino acid was designed and synthesized
US-15-191-739-164
Query Match 99.6%; Score 702; Length 135; Best Local Similarity 99.3%;
Matches 134; Conservative 1; Mismatches 0; Indels 0; Gaps 0.
Qy 1 QVQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
|:||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QLQLVESGGGLVQPGGSLRLSCEASGFTLDYYGIGWFRQPPGKEREAVSYISASARTILY 60
Qy 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNAKNAVYLQMNSLKREDTAVYYCARRRFSASSVNRWLADDYDVWGRG 120
Qy 121 TQVAVSSEPKTPKPQ 135
|||||||||||||||
Db 121 TQVAVSSEPKTPKPQ 135
Conclusion
26) No claims are allowed.
Correspondence
27) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (ET). If attempts to reach the Examiner by telephone are unsuccessful, her Supervisor Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
28) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
August, 2026
Prosecution Insights