DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-20 are pending and will be examined on the merits.
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Note: Both claims 1 and 2 as well as the Specification contain recitations of lytic domain amino acid sequences without sequence identifiers clearly identifying each individual sequence.
Example:
“… a peptide selected from KFAKFAKKFAKFAKK, KFAKFAKKFAKFAKKF, KFAKFAKKFAKFAKKFA, KFAKFAKKFAKFAKKFAK, KFAKFAKKFAKFAKKFAKF and KFAKFAKKFAKFAKKFAKFA (SEQ ID NOs.:1-6) …”
Potential correction:
“… a peptide selected from KFAKFAKKFAKFAKK (SEQ ID NO: 1), KFAKFAKKFAKFAKKF (SEQ ID NO: 2), KFAKFAKKFAKFAKKFA (SEQ ID NO: 3), KFAKFAKKFAKFAKKFAK (SEQ ID NO: 4), KFAKFAKKFAKFAKKFAKF (SEQ ID NO: 5) and KFAKFAKKFAKFAKKFAKFA (SEQ ID NO: 6) …”
Note: Sequences reciting amino acid sequences not immediately followed by sequence identifiers are in claims 1 and 2 as well as ¶¶ 0007, 0008, 0009, 0058, 0091, 0092, 0095-0097, and 0337 of the Specification and the claim objections to claims 1 and 2 and the objection to the Specification are due to this issue.
Claim Objections
Claim 20 is objected to because of the following informalities: Claim 20 contains the language “…. of an antibody that binds to 33 or CD70….”. Applicant appears to have written “33” in place of “CD33”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 13 is 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 13 recites the limitation “… wherein the lytic domains linked to the Heavy (H) chain or Light (L) chain, have an identical amino acid sequence or a different amino acid sequence.” The claim is rendered indefinite by virtue of the fact that the terms “an identical amino acid sequence” and “a different amino acid sequence” are both singular but are describing a plurality of lytic domains, making it unclear which lytic domains are being compared.
Suggested correction: “… wherein the lytic domains linked to the Heavy (H) chain or Light (L) chain have identical amino acid sequences or different amino acid sequences.”
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 16 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.
Regarding claim 16—claim 16 attempts to further limit claim 1 by stating that the lytic domains of claim 1 are joined to the antibody HC or LC “by a peptide sequence or a non-peptide linker or spacer”. This does not further limit claim 1 because the lytic domains will always be joined by a linker that is either peptidic or not peptidic.
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 § 102
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.
(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.
Claim(s) 1-2, 10-12, 14-15 and 17-20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Leuschner (Leuschner, et al., US 2009/026941A1; Published 10/29/2009).
Leuschner teaches on the subject of fusion constructs and methods of using such constructs in the treatment of hyperproliferative disorders such as cancers (Leuschner, Abstract). Leuschner teaches that the fusion constructs of Leuschner comprise: 1) a first domain that is a lytic domain that is directly or indirectly toxic to a cell and 2) a second domain that is a targeting or binding domain that targets a cell (Leuschner, ¶ 0051-0052). Regarding claims 1-2 and 17, Leuschner teaches that the lytic domains of the fusion constructs of Leuschner comprise the sequence KFAKFAKKFAKFAKK (same as instant SEQ ID NO: 1) (Leuschner, ¶ 0052) and the targeting/binding domains of the fusion constructs of Leuschner are antibodies that target the tumor-associated antigen CD70 (Leuschner, ¶ 0064). Regarding claims 14-15 and 20 specifically, Leuschner teaches that first and second lytic domains attached to the NH and carboxy termini of the binding moiety that is an antibody and, as such, would always be at the NH or COOH terminus of the HC or LC and always would be immediately joined to the HC or LC via a covalent bond that forms a contiguous amino acid sequence (Leuschner, ¶ 0015).
Regarding claims 10-12, Leuschner teaches that the fusions of Leuschner comprise additional lytic domains such as a third, fourth, fifth, sixth, seventh, etc… (note: the embodiments with four or more lytic domains will always have at least one lytic domain per HC or LC) (Leuschner, ¶ 0018). Regarding claims 17 and 18, Leuschner teaches pharmaceutical compositions comprising the fusion constructs of Leuschner and further comprising an anti-cell proliferative agent (Leuschner, ¶ 0019).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-12, 14-15 and 17-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Leuschner (Leuschner, et al., US 20090269341A1; Published 10/29/2009) as applied to claims 1-2, 10-12, 14-15 and 17-20 above and in further consideration of the Leuschner reference.
The teachings of Leuschner are discussed above.
Leuschner does not teach that the fusion construct of Leuschner comprises lytic domains bound to the amino and carboxy termini of the heavy and light chains of the anti-CD70 antibody targeting moiety of Leuschner as described in any one of instant claims 3-9.
In addition to the teachings of Leuschner discussed above, Leuschner also teaches that the position of the anti-CD70 antibody targeting moiety of Leuschner relative to the position(s) of the lytic domains (at C or N termini) affects the cell killing activity of the fusion constructs of Leuschner (Leuschner, ¶ 0084) as well as assay conditions for determining the cytotoxicity of the fusion constructs of Leuschner (Leuschner, ¶ 0087; ¶ 179-201).
It would be prima facie obvious to one of ordinary skill in the art to start with Leuschner’s teachings of fusion constructs comprising multiple lytic domains linked to the binding domain (e.g., two, three, four, five, six, etc…. see Leuschner, ¶ 0018) at the C an N termini of the antibody’s HC and LC coupled with Leuschner’s teachings that the relative position(s) of the lytic domain(s) to the anti-CD70 antibody targeting domain and arrive at an anti-CD70 antibody/lytic domain fusion construct comprising lytic domains bound to the amino and carboxy termini of the heavy and light chains of the anti-CD70 antibody targeting moiety of Leuschner as described in any one of instant claims 3-9 by routine experimentation. One of ordinary skill in the art would be motivated to do this in order to optimize both the number and position(s) of the lytic domains fused to the anti-CD70 antibody targeting moiety of Leuschner. It is well known in the art that an antibody comprises two heavy chains and two light chains and that each of these chains contains one amino terminus and one carboxy terminus and, as such, an antibody has a total of eight termini available for placement of a lytic domain. Leuschner’s teachings regarding the varying number lytic domains and Leuschner’s teachings that the relative position(s) of the lytic domain(s) affects cytotoxicity creates a natural motivation for one of skill in the art to optimize both the number and relative position(s) of the lytic domain(s) present on the anti-CD70 fusion construct of Leuschner. One of ordinary skill in the art would have a reasonable expectation of success starting with Leuschner’s teachings of fusion constructs comprising multiple lytic domains linked to the binding domain (e.g., two, three, four, five, six, etc…. see Leuschner, ¶ 0018) at the C an N termini of the antibody’s HC and LC coupled with Leuschner’s teachings that the relative position(s) of the lytic domain(s) to the anti-CD70 antibody targeting domain affects construct cytotoxicity and arrive at an anti-CD70 antibody/lytic domain fusion construct comprising lytic domains bound to the amino and carboxy termini of the heavy and light chains of the anti-CD70 antibody targeting moiety of Leuschner as described in any one of instant claims 3-9 by routine experimentation because: 1) Leuschner teaches that the anti-CD70 fusion constructs of Leuschner are permitted to comprise multiple lytic domains per antibody (e.g., two, three, four, five, six, etc….), creating a motivation to optimize the number of lytic domains present in the anti-CD70 fusion construct of Leuschner, 2) Leuschner teaches that the position(s) of the lytic domain(s) (i.e., at the N or C termini) affects construct cytotoxicity, creating a motivation to optimize the position(s) of lytic domain(s) present in the anti-CD70 fusion construct of Leuschner and 3) routine optimization of multiple parameters simultaneously is routine in the art using tools such as design of experiments (DoE) and response surface modeling (RSM) and is within the purview of one of skill in the art. Additionally, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 1-43 of U.S. Patent No. 8,318,899 B2 ;
Claims 1-57 of U.S. Patent No. 8,546,535 B2;
Claims 1-35 of U.S. Patent No. 9,255,134 B2;
Claim 1-31 of U.S. Patent No. 9,492,563 B2;
Claim 1-47 of U.S. Patent No. 9,586,996 B2;
Claim 1-28 of U.S. Patent No. 10,233,214 B2;
Claim 1-20 of U.S. Patent No. 10,729,740 B2;
all in view of Leuschner (Leuschner, et al., US 20090269341 A1; Published 10/29/2009).
All of the reference patents above are directed to fusion constructs comprising one or more lytic domains comprising the sequence KFAKFAKKFAKFAKK (same as instant SEQ ID NO: 1) covalently fused to the N and C termini of peptidic binding moieties that bind to a specific antigen combined with at least one additional anti-proliferative agent. The binding agent of the ‘899, ‘535 and ‘134 reference patents is luteinizing releasing hormone (LHRH), the binding agents of the ‘563 and ‘214 reference patents are CD19 or CD20 antibody and the binding agent of the ‘740 and ‘996 reference patents is a HER2/neu antibody.
The reference patents do not teach that the binding agent of the fusion constructs of the reference patents is a CD70 antibody. The reference patents do not teach that the fusion construct of the reference patents comprises lytic domains bound to the amino and carboxy termini of the heavy and light chains of the binding moiety of the reference patents as described in any one of instant claims 3-9.
Leuschner teaches on the subject of fusion constructs and methods of using such constructs in the treatment of hyperproliferative disorders such as cancers (Leuschner, Abstract). Leuschner teaches that the fusion constructs of Leuschner comprise: 1) a first domain that is a lytic domain that is directly or indirectly toxic to a cell and 2) a second domain that is a targeting or binding domain that targets a cell (Leuschner, ¶ 0051-0052). Leuschner teaches that the lytic domains of the fusion constructs of Leuschner comprise the sequence KFAKFAKKFAKFAKK (same as instant SEQ ID NO: 1) (Leuschner, ¶ 0052). Leuschner teaches that anti-CD70 antibodies (target CD70), anti-CD19 antibodies (target CD19), anti-CD20 antibodies (target CD20), anti-HER2 antibodies (target HER2) and LHRH (targets LHRH-R) are all permissible targeting/binding domains for directing the fusion constructs of Leuschner to cells for targeted killing (Leuschner, ¶ 0061-0067). Leuschner teaches that first and second lytic domains attached to the NH and carboxy termini of the binding moiety that is an antibody and, as such, would always be at the NH or COOH terminus of the HC or LC and always would be immediately joined to the HC or LC via a covalent bond that forms a contiguous amino acid sequence (Leuschner, ¶ 0015).
Leuschner teaches that the fusions of Leuschner comprise additional lytic domains such as a third, fourth, fifth, sixth, seventh, etc… (note: the embodiments with four or more lytic domains will always have at least one lytic domain per HC or LC) (Leuschner, ¶ 0018). Leuschner teaches pharmaceutical compositions comprising the fusion constructs of Leuschner and further comprising an anti-cell proliferative agent (Leuschner, ¶ 0019). Leuschner also teaches that the position of the binding/targeting moiety of Leuschner relative to the position(s) of the lytic domains (at C or N termini) affects the cell killing activity of the fusion constructs of Leuschner (Leuschner, ¶ 0084) as well as assay conditions for determining the cytotoxicity of the fusion constructs of Leuschner (Leuschner, ¶ 0087; ¶ 179-201).
It would be prima facie obvious to one of ordinary skill in the art to start with the binding domain-lytic domain fusion constructs of the reference patents and substitute the anti-CD70 antibody binding domain of Leuschner in place of any of the binding domains of the reference patents to form fusion constructs comprising the anti-CD70 antibody of Leuschner linked to one or more lytic domains of the reference patents. One of ordinary skill in the art would be motivated to do this in order to better treat hyperproliferative diseases expressing CD70. One of ordinary skill in the art would have a reasonable expectation of success starting with the binding domain-lytic domain fusion constructs of the reference patents and substituting the anti-CD70 antibody binding domain of Leuschner in place of any of the binding domains of the reference patents to form fusion constructs comprising the anti-CD70 antibody of Leuschner linked to one or more lytic domains of the reference patents because Leuschner teaches that anti-CD70 antibodies, anti-CD19 antibodies, anti-HER2 antibodies, anti-CD20 antibodies and LHRH are all acceptable targeting domains for directing the fusion constructs to hyperproliferative cells for targeted killing.
It would be prima facie obvious to one of ordinary skill in the art to start with the reference patents’ teachings of fusion constructs comprising multiple lytic domains linked to the binding domain at the C an N termini of the targeting domain coupled with Leuschner’s teachings that the relative position(s) of the lytic domain(s) to the targeting domain affects cytotoxicity of the fusion construct and arrive at an anti-CD70 antibody/lytic domain fusion construct comprising lytic domains bound to the amino and carboxy termini of the heavy and light chains of the anti-CD70 antibody targeting moiety of the reference patents and Leuschner as described in any one of instant claims 3-9 by routine experimentation. One of ordinary skill in the art would be motivated to do this in order to optimize both the number and position(s) of the lytic domains fused to the anti-CD70 antibody targeting moiety of the reference patents and Leuschner. It is well known in the art that an antibody comprises two heavy chains and two light chains and that each of these chains contains one amino terminus and one carboxy terminus and, as such, an antibody has a total of eight termini available for placement of a lytic domain. Leuschner’s teachings regarding the varying number lytic domains and Leuschner’s teachings that the relative position(s) of the lytic domain(s) affects cytotoxicity creates a natural motivation for one of skill in the art to optimize both the number and relative position(s) of the lytic domain(s) present on the anti-CD70 fusion construct of Leuschner. One of ordinary skill in the art would have a reasonable expectation of success starting with the reference patents’ teachings of fusion constructs comprising multiple lytic domains linked to the binding domain (e.g., two, three, four, five, six, etc…. see Leuschner, ¶ 0018) at the C an N termini of the antibody’s HC and LC coupled with Leuschner’s teachings that the relative position(s) of the lytic domain(s) to the anti-CD70 antibody targeting domain affects cytotoxicity of the fusion construct and arrive at an anti-CD70 antibody/lytic domain fusion construct comprising lytic domains bound to the amino and carboxy termini of the heavy and light chains of the anti-CD70 antibody targeting moiety of Leuschner as described in any one of instant claims 3-9 by routine experimentation because: 1) the reference patents teach that the fusion constructs of the reference patents are permitted to comprise multiple lytic domains per antibody (e.g., two, three, four, five, six, etc….), creating a motivation to optimize the number of lytic domains present in the fusion constructs of the reference patents, 2) Leuschner teaches that the position(s) of the lytic domain(s) (i.e., at the N or C termini) affects cytotoxicity of the fusion construct, creating a motivation to optimize the position(s) of lytic domain(s) present in the fusion construct of the reference patents and 3) routine optimization of multiple parameters simultaneously is routine in the art using tools such as design of experiments (DoE) and response surface modeling (RSM) and is within the purview of one of skill in the art. Additionally, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
Conclusion
Claims 1-20 are rejected.
Claims 1-2 and 20 is objected to.
The Specification is objected to.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sydney Van Druff whose telephone number is (571)272-2085. The examiner can normally be reached 10 am - 6 pm.
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/SYDNEY VAN DRUFF/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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