Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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.
DETAILED ACTION
Claims 1-22 are pending in the instant application.
Priority
This application is a Continuation of Application 17553916 (now US11897951), filed on 18/398367 which claims priority to the provisional application 63167925 filed on 3/30/2021 and on the European application EP203066121 filed on 12/18/2020.
Information Disclosure Statement
The information disclosure statement (IDS) dated 5/24/2024 complies with the provisions of 27 CFR 1.97, 1.98, and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Notice
Applicant is advised that should claim 2 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 2, 20
In the instant case, claim 20 differs from claim 2 solely in the dependency. However, as noted in the 112(d) rejection of claim 19 (of which claim 20 depends), this fails to establish a further limitation that claim 2 lacks. As such, despite a difference in wording, claims 2 and 20 are substantial duplicates.
Claim 13, 14-15
Similarly, should claim 13 be found allowable, claims 14 and 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Claims 13-15 fail to add any structure. These claims do not describe a method of treating disease, instead they describe an intended use for the polypeptide, whilst not changing the structure of the polypeptide of claim 1. Thus claims 13-15 are substantial duplicates.
Objections to the Claims
Claim 12 contains a typo, replace “composition for according to claim 1” to “composition according to claim 1.”
Claim 17 refers to “a host or host cells” where the specification (instant pg 5, paragraph 4) makes clear the host is non-human, therefor, claim 17 should recite a “non-human host or host cell.”
Correction is required. See MPEP § 608.01(m).
Claim Rejections – 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-22 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 1
Regarding claim 1, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “wherein the polypeptide comprises … at least three ISVDs”, and the claim also recites “wherein the polypeptide … consists of at least three ISVDs” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Furthermore, the use of “consists of at least three ISVDs” excluded the possibility of an optional “peptidic linker(s)” recited later in the claim. Dependent claims 2-22 fail to cure these deficiencies, thus are also rendered indefinite.
Claim 2, 20
Regarding claims 2 and 20, it is unclear what “pharmaceutically active polypeptides or compounds” is referring to. The instant specifications fail to provide a definition for the phrase “pharmaceutically active,” thus it cannot be determined what the metes and bounds of “pharmaceutically active” polypeptides or compounds are.
Claim 7
Regarding claim 7, the phrase "such as," recited twice, renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if “such as human serum albumin” is a further limitation of “serum albumin” or merely exemplary. Similarly, it is unclear if “such as IgG” is limiting or just exemplary type of immunoglobulin.
Claim 13-15
Claims 13-15 is drawn to a method comprising “for use as a medicament” or “for use in the treatment”. The method of claims 13-15 lack any positive steps towards completing the claimed method (e.g. “comprising administering the polypeptide of claim 1 to a subject in need thereof”). Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: “[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon” was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). See MPEP § 2173.05(q).
Claim Rejections – 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 19
Claim 19 is drawn to a composition comprising no other components other than the polypeptide described in parent claim 1. Thus claim 19 fails to further limit parent claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections – 35 USC § 112(a)
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 1-2, 4, 6-9, and 11-22 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.
All except 3, 5, 10
Claims 1, 4, 9, and 12 are drawn to CDRs or sequences comprising CDRs that optionally containing variable amino acids. The art recognizes that the CDRs define the binding properties of an antibody and that even single amino acid changes to this region can completely abrogate the binding specificity of an antibody (Kussie 1994 and Chen 1995). Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such mutations with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions. The art recognizes that the binding region of an ISVD (a.k.a. VHH) is defined by three CDRs (Muyldermans 2001). Thus applicant has failed to meet the written description of variable CDRs with the ISVDs wherein the binding to IL-6, TNFα, and human serum albumin is preserved. Dependent claims 2, 4, 6-9, and 11-22 fail to cure these deficiencies, thus are also rendered indefinite.
Claim Rejections – 35 USC § 103
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.
Claims 1-2, 4, 6-11, and 13-22 are rejected under 35 U.S.C. 103 as being unpatentable over Buyse (WO2017081320) in view of Kolkman (WO2007104529).
Claim 1
Regarding claim 1, Buyse teaches a polypeptide comprising three immunoglobulin single variable domains (ISVDs), optionally linked via two linkers (pg 38, paragraph 2). Buyse teaches that such polypeptides may be directed against the same antigen, two different antigens, or three different antigens (pg 38, paragraph 3). Buyse teaches a nucleotide sequence that encodes the polypeptide and a composition comprising the polypeptide (pg 31, paragraph 1). Buyse teaches an ISVD that binds TNFα comprising the CDRs of instant SEQ ID NOs: 9, 13, and 17 (SEQ ID NO: 40; pg 50, paragraph 4), shown below. Buyse teaches ISVDs targeting TNFα (abstract) are useful in treating autoimmune diseases such as rheumatoid arthritis (pg 2, paragraph 7).
instant_9.13.17 -------------------------GFTFSTADMG--------------RISGIDGTTY- 19
Buyse_40 DVQLVESGGGVVQPGGSLRLSCTASGFTFSTADMGWFRQAPGKGREFVARISGIDGTTYY 60
********** **********
instant_9.13.17 --------------------------------------PRYADQWSAYDY---------- 32
Buyse_40 DEPVKGRFTISRDNSKNTVYLQMNSLRPEDTALYYCRSPRYADQWSAYDYWGQGTLVTVS 120
************
instant_9.13.17 -- 32
Buyse_40 SA 122
Buyse does not teach an ISVD that binds IL-6, nor the CDR sets of instant SEQ ID NOs: 6, 10, and 14; nor SEQ ID NOs: 8, 12, and 16.
Kolkman teaches a single variable domain antibody or fragment (pg 16, paragraph 3) that binds IL-6 comprising the CDR sets of instant SEQ ID NOs: 6, 10, and 14; and SEQ ID NOs: 8, 12, and 16 (SEQ ID NO: 446; pg 36, paragraph 4), shown below.
instant_6.10.14 -------------------------GRTFSNYAMA--------------VISYAGGRTY- 20
Kolkman_446 AVQLVDSGGGLVQAGDSLRLSCAASGRTFSNYAMAWFRQAPGKEREFVAVISYAGGRTYY 60
********** **********
instant_6.10.14 --------------------------------------VDSPLIATHPRGYDY------- 35
Kolkman_446 ADSVKGRFTISRDNAKNTVYLQMNSLKPEDTAVYYCAAVDSPLIATHPRGYDYWGQGTQV 120
***************
Kolkman also teaches the CDR set of instant SEQ ID NOs: 8, 12, and 16 (SEQ ID NO: 429; pg 36, paragraph 4), wherein there is a 1-amino acid difference from SEQ ID NO 12.
instant_8.12.16 -----------------------------GFTLAYYAIG--------------CISGSVG 17
Kolkman_429 GGGSAVQLVESGGGLVQPGGSLRLSCAASGFTLAYYAIGWFRQAPGKEREGVSCISSSVG 180
********** ***.***
instant_8.12.16 TTY---------------------------------------SSWFDCGVQGRDLGNEYD 38
Kolkman_429 TTYYSDSVKGRFTISRDNAKNTVYLQMNSLKPEDTAVYYCVRSSWFDCGVQGRDLGNEYD 240
*** ******************
instant_8.12.16 Y----------- 39
Kolkman_429 YRGQGTQVTVSS 252
*
Kolkman also teaches that the IL-6 binding domains can be combined with TNF-a binding domains may create a synergistic effect in the treatment of disease (pg 217, paragraphs 1-2). Kolkman teaches ISVDs targeting IL-6 (abstract) are useful in treating autoimmune diseases such as rheumatoid arthritis (pg 2, paragraph 1).
It would’ve been obvious to generate an ISVD against TNF-α and IL-6 by linking the two ISVDs targeting TNF-α from Kolkman to those of Buyse targeting IL-6 because Kolkman teaches that this combination will have an additive or synergistic effect in treating disease, and both references teach that their ISVD’s are useful in treating autoimmune diseases such as rheumatoid arthritis.
Claims 2, 19, 20
Regarding claims 2, 19, and 20, Buyse teaches the polypeptide being part of a pharmaceutical composition, combined with one or more therapeutic compounds or peptides (pg 27, paragraph 3), and may also pharmaceutically acceptable carrier such as a diluent, excipient, or adjuvant (pg 44, paragraph 8).
Claim 4
Regarding claim 4, Buyse teaches a peptide that with 98.6% sequence identity with instant SEQ ID NO: 5 (SEQ ID NO: 40), shown below.
instant_5 EVQLVESGGGVVQPGGSLRLSCTASGFTFSTADMGWFRQAPGKGREFVARISGIDGTTYY 60
Buyse_40 DVQLVESGGGVVQPGGSLRLSCTASGFTFSTADMGWFRQAPGKGREFVARISGIDGTTYY 60
:***********************************************************
instant_5 DEPVKGRFTISRDNSKNTVYLQMNSLRPEDTALYYCRSPRYADQWSAYDYWGQGTLVKVS 120
Buyse_40 DEPVKGRFTISRDNSKNTVYLQMNSLRPEDTALYYCRSPRYADQWSAYDYWGQGTLVTVS 120
*********************************************************.**
instant_5 S- 121
Buyse_40 SA 122
*
Buyse does not teach ≥90% sequence similarity to instant SEQ ID NOs: 2 and 4.
Kolkman teaches a peptide that comprises 94.0% sequence identity with instant SEQ ID NO: 2 (SEQ ID NO: 446), shown below.
instant_2 DVQLVESGGGVVQPGGSLRLSCAASGRTFSNYAMAWFRQAPGKEREFVAVISYAGGRTYY 60
Kolkman_446 AVQLVDSGGGLVQAGDSLRLSCAASGRTFSNYAMAWFRQAPGKEREFVAVISYAGGRTYY 60
****:****:** *.********************************************
instant_2 ADSVKGRFTISRDNAKNTVYLQMNSLRPEDTALYYCAAVDSPLIATHPRGYDYWGQGTLV 120
Kolkman_446 ADSVKGRFTISRDNAKNTVYLQMNSLKPEDTAVYYCAAVDSPLIATHPRGYDYWGQGTQV 120
**************************:*****:************************* *
instant_2 TVSS-------------------------------------------------------- 124
Kolkman_446 TVSSGGGGSGGGSEVQLVESGGGLVQPGNSLRLSCAASGFTFSSFGMSWVRQAPGKGLEW 180
****
Kolkman also teaches a peptide that comprises 95.7% sequence identity with instant SEQ ID NO: 4 (SEQ ID NO: 429), shown below.
instant_4 ----EVQLVESGGGVVQPGGSLRLSCAASGFTLAYYAIGWFRQAPGKEREGVSCISGSVG 56
Kolkman_429 GGGSAVQLVESGGGLVQPGGSLRLSCAASGFTLAYYAIGWFRQAPGKEREGVSCISSSVG 180
*********:*****************************************.***
instant_4 TTYYADSVKGRFTISRDNAKNTVYLQMNSLRPEDTALYYCVRSSWFDCGVQGRDLGNEYD 116
Kolkman_429 TTYYSDSVKGRFTISRDNAKNTVYLQMNSLKPEDTAVYYCVRSSWFDCGVQGRDLGNEYD 240
****:*************************:*****:***********************
instant_4 YRGQGTLVTVSS 128
Kolkman_429 YRGQGTQVTVSS 252
****** *****
Claims 6-8
Regarding claims 6-8, Buyse teaches adding on one or more moieties that influence the pharmacokinetic or pharmacodynamic properties of the polypeptide, such as its half-life (pg 27, paragraph 3). Buyse teaches several example structures that include optional linkers joining the polypeptide to a half-life extending binding domain, such as an ISVD against human serum albumin (pg 73, Table C-2, See legend). Buyse also teaches that the half-life of a nanobody may be increased by attaching a further amino acid sequence targeting human serum albumin (pg 180, paragraph 3).
Claims 9-10
Regarding claims 9-10, Kolkman teaches a single variable domain antibody or fragment that binds human serum albumin comprising the CDRs of instant SEQ ID NOs: 7, 11, and 15 (SEQ ID NO: 157), shown below.
instant_7.11.15 -------------------------GFTFRSFGMS--------------SISGSGSDTL- 20
Kolkman_157 AVQLVESGGGLVQPGNSLRLSCAASGFTFRSFGMSWVRQAPGKEPEWVSSISGSGSDTLY 60
********** **********
instant_7.11.15 --------------------------------------GGSLSR----------- 26
Kolkman_157 ADSVKGRFTISRDNAKTTLYLQMNSLKPEDTAVYYCTIGGSLSRSSQGTQVTVSS 115
******
Claim 11
Regarding claim 11, Kolkman teaches 92.7% sequence identity to instant SEQ ID NO: 3 (SEQ ID NO: 157), shown below.
instant_3 EVQLVESGGGVVQPGGSLRLSCAASGFTFRSFGMSWVRQAPGKGPEWVSSISGSGSDTLY 60
Kolkman_157 AVQLVESGGGLVQPGNSLRLSCAASGFTFRSFGMSWVRQAPGKEPEWVSSISGSGSDTLY 60
*********:****.*************************** ****************
instant_3 ADSVKGRFTISRDNSKNTLYLQMNSLRPEDTALYYCTIGGSLSRSSQGTLVTVSS 115
Kolkman_157 ADSVKGRFTISRDNAKTTLYLQMNSLKPEDTAVYYCTIGGSLSRSSQGTQVTVSS 115
**************:*.*********:*****:**************** *****
Claims 13-15, 21-22
Regarding claims 13-15, 21, and 22, Kolkman teaches using the single variable domain antibody or fragment to treat inflammatory or autoimmune disease, such as rheumatoid arthritis (pg 270, claim 65). Similarly, Buyse also teaches that ISVDs that bind TNF are effective in treating inflammation, specifically in rheumatoid arthritis (pg 2, paragraph 7).
Claim 16
Regarding claim 16, Buyse teaches a nucleic acid encoding the ISVD (pg 80, claim 39).
Claim 17
Regarding claim 17, Buyse teaches a host cell comprising the nucleic acid encoding the ISVD (pg 81, Claim 41).
Claim 18
Regarding claim 18, Buyse teaches a method of producing the ISVD comprising a host cell expressing the nucleic acid encoding the ISVD, and a purification step that isolates the expressed ISVD (pg 81, claim 42).
In sum, it would have been obvious for one of ordinary skill in the art to combine the teachings of Buyse and Kolkman achieving an ISVD that binds IL-6, TNF-α, and human serum albumin that is effective in treating rheumatoid arthritis. One of ordinary skill in the art would have had a reasonable expectation of success because Kolkman disclosed that polypeptides targeting multiple antigens, specifically IL-6 and TNF-α, are an effective strategy in designing medicaments against inflammatory disease, and both references disclosed that the half-life of an ISVD can be increased by attaching a human serum albumin-binding domain.
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.
US11897951
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US11897951. Although the claims at issue are not identical, they are not patentably distinct from each other as described in the claim-by-claim analysis below.
Regarding instant claim 1-3, the reference claims the same polypeptide and/or composition comprising the same sets of CDRs (claim 1-3).
Regarding instant claim 4-5, the reference claims the same VH regions (claim 4).
Regarding instant claim 6, the reference claims the polypeptide comprises another group optionally joined by a linker (claim 6).
Regarding instant claim 6-11, the reference teaches the same sequences for the half-life extending anti-human serum albumin immunoglobulin (claim 8-12).
Regarding instant claim 12, the reference claims the polypeptide comprises SEQ ID NO: 1 (claim 13).
Regarding instant claim 13-15, 21-22, the reference claims treating an autoimmune disease such as rheumatoid arthritis comprising administering the polypeptide (claims 17-18).
Regarding instant claim 16-17, the reference claims a nucleic acid encoding the polypeptide (claim 14) and a host cell comprising said nucleic acid (claim 15).
Regarding instant claim 18, the reference claims a method of making the polypeptide comprising expressing the nucleic acid and isolating the polypeptide (claim 16).
Regarding instant claims 2 and 19-20, the reference claims a composition comprising the polypeptide and an adjuvant (claim 2).
Allowable Subject Matter
The ISVD comprising instant SEQ ID NOs: 8, 12, and 16 (instant claim 3 part b; instant claim 5 part b) was not found in the prior art. The closest prior art is that of Kolkman (WO2007104529, SEQ ID NO: 429), shown below.
Claim 3, 5
instant_8.12.16 -----------------------------GFTLAYYAIG--------------CISGSVG 17
Kolkman_429 GGGSAVQLVESGGGLVQPGGSLRLSCAASGFTLAYYAIGWFRQAPGKEREGVSCISSSVG 180
********** ***.***
instant_8.12.16 TTY---------------------------------------SSWFDCGVQGRDLGNEYD 38
Kolkman_429 TTYYSDSVKGRFTISRDNAKNTVYLQMNSLKPEDTAVYYCVRSSWFDCGVQGRDLGNEYD 240
*** ******************
instant_8.12.16 Y----------- 39
Kolkman_429 YRGQGTQVTVSS 252
*
Claim 12
A sequence that was 90% identical to instant SEQ ID NO: 1, wherein the CDR regions were preserved (instant claim 12) was also not found in the prior art. The closest prior art to instant SEQ ID NO: 1 is Gscwind (US20130078247, SEQ ID NO: 429), shown below with the CDR regions of the three ISVDs underlined.
instant_1 DVQLVESGGGVVQPGGSLRLSCAASGRTFSNYAMAWFRQAPGKEREFVAVISYAGGRTYY 60
Gschwind_465 DVQLVESGGGLVQPGGSLRLSCAASGRTFSSYAMAWYRQAPGKEREYVAAIRWSGGTAYY 60
**********:*******************.*****:*********:**.* ::** :**
instant_1 ADSVKGRFTISRDNAKNTVYLQMNSLRPEDTALYYCAAVDSPLIATHPRGYDYWGQGTLV 120
Gschwind_465 ADSVKGRFTISRDNAKNTVYLQMNSLRPEDTAVYYCANR-APDTRLAPYEYDHWGQGTLV 119
********************************:**** :* * **:*******
instant_1 TVSSGGGGSGGGSEVQLVESGGGVVQPGGSLRLSCAASGFTFRSFGMSWVRQAPGKGPEW 180
Gschwind_465 TVSSGGGGSGGGSEVQLVESGGGLVQPGNSLRLSCAASGFTFSSFGMSWVRQAPGKGLEW 179
***********************:****.************* ************** **
instant_1 VSSISGSGSDTLYADSVKGRFTISRDNSKNTLYLQMNSLRPEDTALYYCTIGGSLSRSSQ 240
Gschwind_465 VSSISGSGSDTLYADSVKGRFTISRDNAKTTLYLQMNSLRPEDTAVYYCTIGGSLSRSSQ 239
***************************:*.***************:**************
instant_1 GTLVTVSSGGGGSGGGSEVQLVESGGGVVQPGGSLRLSCAASGFTLAYYAIGWFRQAPGK 300
Gschwind_465 GTLVTVSSGGGGSGGGSEVQLVESGGGLVQPGGSLRLSCAASGFALDYYAIGWFRQAPGK 299
***************************:****************:* *************
instant_1 EREGVSCISGSVGTTYYADSVKGRFTISRDNAKNTVYLQMNSLRPEDTALYYCVRSSWFD 360
Gschwind_465 EREGVSCISSSDGITYYADSVKGRFTISRDNSKNTVYLQMNSLRPEDTAVYYCATDSGGY 359
*********.* * *****************:*****************:***. .*
instant_1 CGVQGRDLGNEYDYRGQGTLVTVSSGGGGSGGGSEVQLVESGGGVVQPGGSLRLSCTASG 420
Gschwind_465 --IDYDCMGLGYDYWGQGTLVTVSS----------------------------------- 382
:: :* *** **********
instant_1 FTFSTADMGWFRQAPGKGREFVARISGIDGTTYYDEPVKGRFTISRDNSKNTVYLQMNSL 480
Gschwind_465 ------------------------------------------------------------ 382
instant_1 RPEDTALYYCRSPRYADQWSAYDYWGQGTLVKVSSA 516
Gschwind_465 ------------------------------------ 382
It is understood in the art that any changes to the CDR regions are unpredictable, thus there was no guidance to arrive at the specific CDR set of SEQ ID NOs: 8, 12, and 16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/
Supervisory Patent Examiner, Art Unit 1675
Prosecution Insights