DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The application is the national stage entry of PCT/US2022/017499, which claims benefit to U.S. Provisional Application No. 63/152,747, filed February 23, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 14, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Status of the Claims
Claims 1-15 and 22-26 are under consideration in this office action.
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 12-13 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.
Claims 12-13 are rejected as vague and indefinite for reciting the terms “R6.5” and “HCD54” as the sole means of identifying the antibody. If R6.5 and HCD54 are commercial clone designation, using such designations as the only means to identify the particular antibody renders the claims indefinite because different laboratories may use the same laboratory designations to define completely distinct molecules. It is also well known in the art that molecule names can be altered, deleted, amended, or revised over time by inventors and authors. Hence, one of ordinary skill in the art and or competitors would be unable to discern structure of what is claims and the bounds of the claimed invention.
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 1-15 and 22-26 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.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
Claims 1-11, 14-15, and 22-26 are directed to a method of treating comprising administering an anti-ICAM1 antibody drug conjugate. The anti-ICAM1 antibody is only defined by its function, i.e. what it binds. Claims 12-13 are limited to an anti-ICAM1 antibody that is HCD54; because the structure of this antibody is unclear in view of the specification, these claims are included in the written description rejection. It is noted, that R6.5 is sufficiently described in the specification (pg 7).
Antibodies generally share certain characteristics such as Fc regions or hinge regions. However, these structures are not correlated with the binding function of the antibody. It is well established in the art that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three complementarity determining regions (CDRs) that provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity, which is characteristic of the immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences, which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites (see Almagro et al, Section 3 “Antibody Structure and the Antigen Binding Site” and Figure 1; instant PTO-892).
There is no way to a priori look at an antigen sequence (e.g., ICAM1) and envisage the combination of six CDRs that will bind that antigen. First, even highly related CDRs may not bind the same target. See for example Kussie (instant PTO-892), who demonstrates that a single amino acid change in the heavy chain of an antibody that binds p-azophenylarsonate (Ars) completely abrogates the ability of the antibody to bind Ars but adds the functionality of binding the structurally related p-azophenylsulfonate (see abstract). Second, even when provided with several related antibodies that bind the desired target, this does not represent the astronomical and potentially unknowable breadth of all possible amino acid sequences which will result in the desired binding properties. This is exemplified by the Court decision in Abbvie (Abbvie v Janssen 759 F.3d 1285 (Fed. Cir. 2014)), where Abbvie developed over 200 antibodies that shared 99.5% identity in the variable regions (pg 7) and which bound the target, but in no way allowed one to envisage the unique structure of Centocor’s antibodies which bound the same target but shared only 50% sequence similarity (see table on pg 11).
While the prior art teaches some understanding of the structural basis of antigen-antibody recognition, it is noted that the art is characterized by a high level of unpredictability, since the skilled artisan still cannot accurately and reliably predict the consequences of amino acid substitutions, insertions, and deletions in the antigen-binding domains.
According to the specification, the applicant has disclosed 2 species of anti-ICAM1 antibody, which are previously described in the art, although not clearly described in the specification. The specification does not provide adequate written description for the entire claimed genus of anti-ICAM1 antibodies, because one skilled in the art would be unable to immediately envision, recognize, or distinguish most of the members comprised within the genus claimed, specifically which heavy chain and light chain amino acid sequences should be combined to yield an antigen-binding region that is capable of binding ICAM1.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.
In the instant case, the specification provides insufficient direction or guidance concerning the relationship between the structure of the possible antibody to demonstrate possession of the breadth of the genus of anti-ICAM1 antibodies encompassed by the instant claim, especially in view of the unpredictability of such an endeavor. The prior art, as evidenced by Edwards et al., 2003 (instant PTO-892), teaches there is a substantially huge antibody diversity produced to one single antigen target. Edwards provides evidence that over 1000 antibodies, all different amino acid sequences, were generated towards one single protein antigen target (see abstract). Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
Applicant has not described the claimed invention sufficiently to show they had possession of the claimed genus of antibodies that bind ICAM1. 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. See University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 69 USPQ2d 1886 (Fed. Cir. 2004).
To provide adequate written description and evidence of possession of the claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the only factors present in the claims are a recitation of one generic, broad genus that encompassed a diverse and huge number of possible antibodies and other agents that bind the disclosed epitope. The specification does not provide a consistent structure for all of the possible antibodies and fails to provide a representative number of species for the claimed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of anti-ICAM1 antibody.
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only 2 species within the genus.
For claims drawn to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., high affinity, neutralization activity, competing with a reference antibody for binding), “[c]laiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011). An antibody described only by functional characteristic, such as antibody that binds ICAM1, without any known or disclosed correlation between that function and the structure of the sequence, is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the biomolecule of interest. In re Bell, 991 F.2d 781, 26 U.S.P.Q.2d 1529 (Fed. Cir. 1993). In re Deuel, 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995).
With the exception of specifically disclosed antibodies with specific CDRs, the skilled artisan cannot envision the detailed chemical structure of all of the encompassed antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. 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).
Therefore, claims 1-15 and 22-26 do not meet the written description requirement.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-15 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015151080, published October 8, 2015 (“Yongxin”; IDS from 3/14/2024).
Claim 1 is directed to a method of treating a subject with cancer comprising administering an anti-ICAM1 antibody drug conjugate. Other claims are further limited to various drugs and linkers.
Yongxin teaches antibody-drug conjugates comprised of an antibody, linkers, and cytotoxic agents [(pg 1, ln 4-9); pg 5, ln 10-20), as in the antibody-drug conjugate of instant claim 1 and the linker of instant claim 5. The antibody of Yongxin may be the anti-ICAM1 antibody Enlimomab pegol (pg 29, ln 13), as in claim 1. Enlimomab is known in the art to be R6.5, as evidenced by US Patent 5,324,510 (column 10, ln 21-26; IDS from 3/14/2024), therefore, Enlimomab teaches R6.5 of instant claims 12-13. The antibody of the antibody-drug conjugate of Yongxin may be a monoclonal antibody, Fab fragment, F(ab’)2 fragment, diabody, or single chain antibody (pg 24, ln 22-29), as in instant claim 10. The monoclonal antibody may be chimeric or humanized (pg 25, ln 23-26), as in instant claims 11 and 13.
Yongxin teaches that the antibodies are agent that are able to bind tumor cells that express ICAM1 (pg 33-34), as in the treatment of ICAM1-expressing cancer of instant claim 1. Yongxin teaches a method of treating cancer, including breast cancer, prostate cancer, ovarian cancer, melanoma, and lung cancer comprised of administering the antibody-drug conjugate (pg 36), as in instant claim 23. Yongxin teaches that the subject is human (pg 12, ln 6-8), as in instant claim 22.
Yongxin teaches that the antibody-drug conjugate maybe comprised of the drugs DM1, DM4 (pg 82, ln 7), MMAE, and MMAF (pg 54, ln 21-3)2, as in instant claims 2-4.
The linker of the antibody-drug conjugate of Yongxin may be the cleavable linkers Val-cit, SPDB, Sulfo-SPBD, or MC (pg 17, ln 19-pg 18, ln 3; pg 91, 9-16), as in instant claims 6-7. Yongxin also teaches that the linker may be the non-cleavable linker MMC (pg 17, ln 19-23), as in instant claims 8-9.
Yongxin teaches that the drug to antibody ratio is more than 4 (pg 4, ln 27-32), which overlaps with the ratio range in instant claim 14; in a specific embodiment, the drug/antibody ratio is 4.0 (pg 75), as in claim 15.
Although Yongxin teaches all the individual limitations of the claim, this reference does not explicitly set forth a specific embodiment comprised of the claimed combination for the antibody drug conjugate in a method of treating cancer. However, it would have been obvious to the ordinary artisan prior to the effective filing date of the claimed invention to arrive at the claimed antibody drug conjugate in the treatment of cancer and have a reasonable and predictable expectation of success. One of ordinary skill in the art would have been able to generate this preferred antibody drug conjugate via routine optimization of the method of Yongxin (see MPEP § 2144.05). This is because the artisan has good reason to pursue known options within their technical grasp to obtain predictable results.
Thus, because Yongxin teaches the antibody drug conjugate and the method of treating cancer, the burden is on the applicant to demonstrate that the method of treating cancer comprised of the claimed antibody drug conjugate is directed to unexpected results. Types of unexpected results include greater than expected results, superiority of a property shared with the prior art, presence of an unexpected property, or absence of an expected property (see MPEP 716.02(a)I.
Claims 1-15 and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over; IDS from 3/14/2024).
Claims 1-15 and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015151080, published October 8, 2015 (“Yongxin”) as applied to claims 1-15 and 22-23 above, and further in view of Wang et al, published online December 10, 2018 (instant PTO-892).
The teachings of Yongxin are discussed above; Yongxin does not teach a method for treating triple negative breast cancer (TNBC), as required by claims 24-26.
Wang et al teaches administration of doxorubicin (DOX) loaded cyanine 5.5 engineered mesoporous organosilica nanoparticles (PMOs) linked to an anti-ICAM1 antibody for the treatment of TNBC (Wang abstract). Wang et al also teaches that ICAM-1 is overexpressed in TNBC tissues and cell lines and its expression is closely related to the development and metastasis of TNBC (pg 631, column 1, para 2). Animals treated with DOX@PMO-CY5.5-ICAM1 had final tumor volumes of 464 mm3 compared to 1174 mm3 in untreated animals (pg 636, column 1, para 2 and Fig 5e), demonstrating that ICAM-1 targeted treatment strategies are efficacious for TNBC.
Given that Yongxin teaches a method of treating breast cancer comprised of the claimed antibody drug conjugate, and further given that Wang et al has identified the breast cancer subtype TNBC is responsive to anti-ICAM linked DOX@PMP-CY5.5, it would have been obvious to one of ordinary skill in the art to substitute the conjugate of Yongxin with the anti-ICAM loaded nanoparticle of Wang et al and have a reasonable expectation of success. This is because a known work in one field of endeavor may prompt variation of it for use in the same field (MPEP 2143.I.F). Such is the case here, where the ordinary artisan would apply the anti-ICAM1 antibody drug conjugate of Yongxin in the method of treating TNBC using anti-ICAM1 targeting taught by Wang et al. The motivation to do so comes from Wang et al, which teaches that anti-ICAM1 targeted therapy is a promising treatment strategy for TNBC (abstract). Furthermore, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses combining prior art elements according to known methods to yield predictable results; the combination is obvious unless its application is beyond that person's skill. It would have been within the technical grasp of the ordinary artisan to apply the antibody-drug conjugate in the method of Wang et al to obtain predictable results. Such amounts to combining prior art elements according to known methods to achieve predictable outcomes.
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 1-15 and 22-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 9, 11, 13, 15, and 17 of copending Application No. 17/637,305. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to overlapping subject matter: a method of treating a subject with cancer comprising administering the same anti-ICAM1 drug conjugate.
Claim 1 of ‘305 is directed to a method of treating pancreatic cancer comprising administering an antibody drug conjugate comprising and anti-ICAM1 antibody conjugate to a drug, which reads on in instant claim 1. Moreover, ‘305 teaches recite identical drugs, linkers, and antibody drug ratio (‘305 claims 2, 4-6, 9, 11, 13, 15, and 17), which reads on instant claims 2-15 and 22.
The scope of the instant claims fully overlaps with the reference claims, and thus, the and the claims of the two applications are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 22-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 9, 11, 13, 15, and 17 of copending Application No. 17/637,305 in view of Wang et al, published online December 10, 2018. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to overlapping subject matter: a method of treating a subject with cancer comprising administering the same anti-ICAM1 drug conjugate.
The teaching of the ‘305 claims are discussed above; these claims do not teach a method for treating triple negative breast cancer (TNBC), as required by claims 24-26.
Wang et al teaches administration of doxorubicin (DOX) loaded cyanine 5.5 engineered mesoporous organosilica nanoparticles (PMOs) linked to an ICAM1 antibody in the treatment of TNBC (Wang abstract). Wang et al teaches that ICAM-1 is overexpressed in TNBC tissues and cell lines and that its expression is closely related to the development and metastasis of TNBC (pg 631, column 1, para 2). The DOX@PMO-CY5.5-ICAM1 treated animals had final tumor volumes of 464 mm3 compared to 1174 mm3 in untreated animals (pg 636, column 1, para 2 and Fig 5e), demonstrating that ICAM-1 targeted treatment strategies are efficacious for TNBC.
Given that ‘305 claims teach a method of treating cancer comprised of the claimed antibody drug conjugate, and further given that Wang et al has identified the breast cancer subtype TNBC is responsive to anti-ICAM associated DOX@PMP-CY5.5, it would have been obvious to one of ordinary skill in the art to substitute the conjugate of ‘305 with the anti-ICAM loaded nanoparticle of Wang et al and have a reasonable expectation of success. This is because a known work in one field of endeavor may prompt variation of it for use in the same field (MPEP 2143.I.F). Such is the case here, where the ordinary artisan would apply the anti-ICAM1 antibody drug conjugate of ‘305 in the method of treating TNBC using anti-ICAM1 targeting taught by Wang et al. The motivation to do so comes from Wang et al, which teaches that anti-ICAM1 targeted therapy is a promising treatment strategy for TNBC (abstract). Furthermore, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses combining prior art elements according to known methods to yield predictable results; the combination is obvious unless its application is beyond that person's skill. It would have been within the technical grasp of the ordinary artisan to apply the antibody-drug conjugate in the method of Wang et al to obtain predictable results. Such amounts to combining prior art elements according to known methods to achieve predictable outcomes.
Conclusion
No claim is allowed.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675