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 .
DETAILED ACTION
The amendment filed May 9, 2024 is acknowledged and has been entered. Claims 1 and 3-6 have been amended. Claims 2, 7, 10, 17, 20-21 and 24 have been canceled.
Claims 1, 3-6, 8-9, 11-16, 18-19, 22-23 and 25-27 are pending and under examination.
Information Disclosure Statement
The information disclosure statements have been considered.
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.
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 his invention.
Claims 1, 5-6, 8-9, 11-16, 18-19, 22-23 and 25-27 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
“[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.
For a claim 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). “[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.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention. For example, the Federal Circuit has found that possession of a mouse antibody heavy and light chain variable regions provides a structural "stepping stone" to the corresponding chimeric antibody, but not to human antibodies. Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875 (Fed. Cir. 2011).
The teachings of the specification and the claimed invention:
The nature and scope of the claimed invention at issue is a genus of methods of treating and preventing cancer comprising:
administering to a subject a genus of peptides comprising an altered amino acid sequence relative to an amino acid sequence of e.g., SEQ ID NO: 4 that comprises deletion; substitution, or addition of one to several amino acids in the amino acid sequence and having a CTL induction activity.
Accordingly, the claims encompass methods of using any derivative peptide not limited to any particular structure having a CTL induction activity to treat or prevent cancer.
The instant specification discloses examples of specific WT1 killer peptides such as a peptide consisting of SEQ ID NO:2, that can be used to treat a cancer expressing WT1 (see Figures and Examples), but does not disclose variants of such a peptide comprising an altered amino acid sequence relative to an amino acid sequence of e.g., SEQ ID NO: 4 that comprises deletion; substitution, or addition of one to several amino acids in the amino acid sequence that treats or prevents cancer in general.
State of the Art
With respect to the claimed genus of derivatives of SEQ ID NO:2, it is noted that the genus of derivatives is widely diverse and one could not immediately envision, recognize or predict the structure of analogs or derivatives of SEQ ID NO:2 which have a CTL induction activity which would have anti-tumor activity, from those that would not. For example, Burrows et al (TRENDS in Imm, 27(1):11-16, 2006) disclose that peptides with viral and tumor antigens are targets for CTL recognition, but that specific peptides are required to obtain CTL activity towards a specific antigen (see Table 1), such that having CTL induction activity alone would not be expected to endow a peptide the ability to treat cancer as claimed. Notably, Burrows et al establishes that specific peptides are required for each antigen, such that one also would not be immediately envision, recognize or predict the structure of analogs or derivatives of SEQ ID NO:2 that have a CTL induction activity.
Accordingly, derivatives of SEQ ID NO:2 are widely diverse and one of skill in the art would not be able to recognize that which derivatives of SEQ ID NO:2 would have CTL induction activity or anti-tumor activity, except for the instantly claimed peptide consisting of the amino acid sequence of SEQ ID NO:2.
Claim Analysis
The nature and scope of the claimed invention is set forth above.
The claims encompass structurally diverse “derivatives of SEQ ID NO:2” that must also have anti-tumor activity and CTL induction activity.
Notably, one of skill in the art would not consider the disclosure of peptide consisting of the amino acid sequence of SEQ ID NO:2 as representative of the claims because these genera include members which do not share the same structural or functional attributes. Accordingly, one of skill in the art would reasonably conclude that applicant was not in possession of the claimed “derivatives of SEQ ID NO:2” that must also have anti-tumor activity and CTL induction activity.
To further explain why the claims which recite structurally and functionally diverse “derivatives” with anti-tumor activity and CTL induction activity are not adequately described, it is noted that it is well-established in the art that there is a high degree of unpredictability in modeling and predicting agents which will bind to any particular protein. For example, according to Tame (J. Comput. Aided Mol. Des. 1999 Mar; 13 (2): 99-108), computational approaches to design or select drug reagents which bind protein targets are hindered by the complexity of the physical chemistry that underlies weak, non-covalent interactions between protein targets (e.g., a cell surface receptor) and small molecule ligands (e.g., peptides); see entire document (e.g., the abstract). In addition, Dixon (Proteins. 1997; Suppl 1: 198-204) points out that the evaluation (scoring) of potential solutions is still an area that needs improvement, especially when predicting protein-protein interaction because of limitations associated with reproducing the geometry of the complex; see entire document (e.g., the abstract). While there are many additional reasons that predictions based upon the results of such modeling approaches are inaccurate, it is noted that Lensink et al. (Proteins. 2007; 69: 704-718) reviewed the performance accuracy of various different methods for predicting protein-protein interaction, reporting that significant numbers of "incorrect" determinations were made in blind analyses (i.e., without knowledge of the “correct” answer); see entire document (e.g., page 706, Table I). Lensink et al. concludes accordingly that their results "do not reveal a striking breakthrough in docking performance", despite some encouraging progress (page 717, column 1); and given such predictive inaccuracies, Lensink et al. adds that “current scoring methods are probably not sensitive enough” (abstract).
As such, while the specification describes a peptide consisting of the amino acid sequence of SEQ ID NO:2 as having CTL induction activity and anti-tumor activity, such a peptide is not representative of the respective genera, as a whole, since there is no disclosure of a correlation between any one particularly identifying (i.e., substantial) structural feature, which is shared by these species and other members of their respective genera, and any one functional feature also shared by at least most of the other members of their respective genera.
Consequently, the skilled artisan could not immediately envision, recognize or distinguish at least most of the members of the genera of “derivatives” to which the claims are directed; and therefore, the specification would not reasonably convey to the skilled artisan that Applicant had possession of the claimed invention at the time the application was filed.
Claims 1, 3-6, 8-9, 11-16, 18-19, 22-23 and 25-27 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for using methods such as treating cancer that express WT1 by administering peptide consisting of the amino acid sequence of SEQ ID NO:2 and a claimed immunomodulator does not reasonably provide enablement for using the full scope of the claimed methods such as preventing cancers or treating cancers that do not express WT1 . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term "undue experimentation," it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors, which have been outlined in the Federal Circuit decision of In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), include, but are not limited to, the nature of the invention, the state of the prior art, the relative skill of those in the art, the amount of direction or guidance disclosed in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, the breadth of the claims, and the quantity of experimentation which would be required in order to practice the invention as claimed. See also Ex parte Forman, 230 USPQ 546 (BPAI 1986).
The amount of guidance, direction, and exemplification disclosed in the specification, as filed, would not be sufficient to enable the skilled artisan to make and/or use the claimed invention at the time the application was filed without undue and/or unreasonable experimentation.
With respect to preventing all cancers, it is noted that preventing hyperproliferative disorders, including cancers and tumors, i.e., keeping individuals free of any such disorders indefinitely, is an intractable proposition, if not now wholly impossible, given, for example, that cancers are widely heterogeneous diseases, having widely varying pathologies and etiologies, and with causes that are multifactorial and as yet only partially characterized and poorly understood. It is generally recognized that a disease cannot be prevented unless and until its causes are fully appreciated and understood to a degree that it becomes possible to intercede effectively to block its onset or development by any cause. Notably, in this case, the specification presents merely prophetic examples that the recited compositions would be effective to prevent cancers. As such, the specification, which lacks any specific non-general guidance, direction, and exemplification that is reasonably commensurate in scope with the intended use of preventing cancer, would not reasonably enable the artisan to prevent such diseases without undue and/or unreasonable experimentation.
Furthermore, there is no disclosure of testing using any model to determine if any of the claimed methods as claimed can prevent cancers in any mammal or treat all cancers; again, the assertion that the invention is useful is based solely upon merely prophetic examples. Notably, the specification merely presents evidence that a peptide consisting of the amino acid sequence of SEQ ID NO:2 and a claimed immunomodulator can treat cancers expressing WT1 antigen. Accordingly, the specification, which lacks any specific non-general guidance, direction, and exemplification that is reasonably commensurate in scope with the intended use of preventing cancer and treating call cancers, would not reasonably enable the artisan to prevent such diseases without undue and/or unreasonable experimentation because one would need to determine how to use the claimed methods to prevent and treat all cancers. Obviously, such experimentation would be considered undue and/or unreasonable because decades of research has been carried out to identify viable treatments of cancer, and that research continues to this day.
Applicant is reminded that reasonable correlation must exist between the scope of the claims and scope of enablement set forth.
In deciding In re Fisher, 166 USPQ 18, 24 (CCPA 1970), the Court indicated the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. “Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Genentech Inc. v. Novo Nordisk A/S, 42 USPQ2d 1001, 1005 (CA FC 1997).
In conclusion, upon careful consideration of the factors used to determine whether undue experimentation is required, in accordance with the Federal Circuit decision of In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988), the amount of guidance, direction, and exemplification disclosed in the specification, as filed, is not deemed sufficient to have enable the skilled artisan to make and/or use the claimed invention at the time the application was filed without undue and/or unreasonable experimentation.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 3, 8-9, 11-13, 16, 18-19, 22-23 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2006/0217297-A, (Sugiyama et al, IDS), WO 2016/141312 A1 (Gajewski et al) and Koido et al (Clin. Cancer Res. 2014 Aug 15; 20 (16): 4228-39, IDS).
Sugiyama et al discloses a cancer vaccine comprising a peptide monomer and peptide dimer comprising WT1 antigen peptides consisting of 7-30 amino acids, each of which includes at least one cysteine residue at, e.g., their N-termini; see entire document (e.g., the abstract and page 8). Sugiyama et al discloses the monomeric units (peptides) of the peptide dimer are adjoined to one another via a disulfide bond forming between the cysteine residues (see, e.g., the abstract). Sugiyama et al discloses an exemplary WT1 antigen peptide for use in the vaccine is a peptide consisting of an amino acid sequence that is identical to the amino acid sequence of SEQ ID NO: 4 (as set forth by the instant application); see, e.g., paragraph [0015]; SEQ ID NO: 44 and that the peptide can be used in producing the peptide dimer. Sugiyama et al discloses the vaccine is administered to mammals afflicted with WT1-expressing cancer in order to elicit an anticancer immune response in the mammals (see, e.g., paragraphs [0023] and [0075]). Sugiyama et al discloses teaches the vaccine is suitably used to treat ovarian cancer (paragraph [0074]). Sugiyama et al discloses teaches the vaccine is administered in compositions with an adjuvant, i.e., administered simultaneously (see, e.g., paragraph [0072]).
Sugiyama et al does not expressly disclose administering an immunomodulator of claims 1, 8-9, 11-13, 16, 18-19, 22-23 and 25 to enhance the anticancer immune response.
Gajewski et al discloses that small molecule β-catenin inhibitors can be combined in methods of treating cancer, such as ovarian cancer, with peptides, antibodies, antibody fragments, etc. that target one or more cancer cell or tumor markers or components, such as WT1, PD-1, PD-L1, 4-1BB and TLR7 to enhance an anti-tumor response (see pages 24 and 26-28).
Koido et al discloses treating WT1 expressing cancers in human patients by administering to the patients dendritic cells pulsed with WT1 antigen peptides; see entire document (e.g., the abstract). Koido et al discloses although WT1-CTLs were generated by vaccination with DC/WT1-I/II and were detected in the circulation of the vaccinated patients in this study, these CTLs may not act against the tumor and suggests that this may be in part due to the presence of Tregs in the tumor environment, which act to suppress the anti-tumor immune response (see, e.g., the abstract). Moreover, Koido et al. suggests that the interaction of PD1 on the surface of activated CTLs with PD-L1 on the surface of tumor cells may provide a mechanism by which tumor cells escape destruction by the patient’s immune system (see, e.g., the abstract). Accordingly, Koido et al. suggests administering to the patients inhibitory antibodies that bind to PD1 or PD-L1 since such immune checkpoint blockade has been successfully used in treating cancer (see, e.g., the abstract and page 4237).
Accordingly, it would have been prima facie obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to have produced a cancer vaccine for treating a WT1-expressing cancer, such as a WT1-expressing ovarian cancer, in a mammal comprising a peptide monomer and peptide dimer comprising the peptide disclosed by Sugiyama et al, which is identical to the amino acid sequence of SEQ ID NO: 4 (as set forth by the instant application, and to have used the vaccine to treat cancer in a mammal (e.g., a human) in combination (together or separately) with one or more of the immunomodulators of Gajewski et al and Koido et al to enhance the antitumor response. One would have been motivated to do so before the effective filing date of the claimed invention in order to improve the treatment method of Sugiyama et al. The peptide vaccines and immunomodulators were both useful to treat cancer and, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See logic of In re Kerkhoven, 626 F.2d 848, 850, 205 USPQ 1069, 1072, (CCPA 1980) and MPEP § 2144.06.
Accordingly, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the reference.
Claims 1, 3, 8-9, 11-16, 18-19, 22-23 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2006/0217297-A, (Sugiyama et al, IDS), WO 2016/141312 A1 (Gajewski et al) and Koido et al (Clin. Cancer Res. 2014 Aug 15; 20 (16): 4228-39, IDS), as applied to claim 1, 3, 8-9, 11-13, 16, 18-19, 22-23 and 25-27 above, and further in view of WO 2015/176033 A1 (Feltquate et al).
The above 103 discloses and suggests that which is set forth in the above rejection but does not expressly teach the use of the anti-PD-1 antibody Pembrolizumab or PD-L1 antibody Durvalumab.
Feltquate et al discloses anti-PD-1 antibody Pembrolizumab and PD-L1 antibody Durvalumab and their use in treating cancer; see entire document (e.g., the abstract and pages 13 and 16).
Accordingly, it would have been prima facie obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to use the anti-PD-1 antibody Pembrolizumab and/or PD-L1 antibody Durvalumab for the PD1 and/or PD-L1 antibody of Koido in the methods suggested above because these were known antibodies that inhibit PD1 and PD-L1. One would have been motivated to do so before the effective filing date of the claimed invention in order to improve the treatment methods suggested above.
Claims 1, 3-4, 8-9, 11-13, 16, 18-19, 22-23 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2006/0217297-A, (Sugiyama et al, IDS), WO 2016/141312 A1 (Gajewski et al) and Koido et al (Clin. Cancer Res. 2014 Aug 15; 20 (16): 4228-39, IDS), as applied to claim 1, 3, 8-9, 11-13, 16, 18-19, 22-23 and 25-27 above, and further in view of EP1103564-A1, A1 (Sugiyama et al 2001, IDS).
The above 103 discloses and suggests that which is set forth in the above rejection but does not expressly teach a peptide comprising the amino acid sequence of SEQ ID NO: 2 (as set forth by the instant application).
Sugiyama et al (2001) discloses WT1 antigen peptides for inclusion in a WT1-expressing cancer vaccine including in particular a peptide comprising the amino acid sequence of SEQ ID NO: 5, which is identical to the amino acid sequence of SEQ ID NO: 2 (as set forth by the instant application); see, e.g., the section entitled, “Best Mode for Carrying Out the Invention” (paragraph [0017]).
Accordingly, it would have been prima facie obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to have produced, as suggested above a cancer vaccine for treating a WT1-expressing cancer in a mammal comprising a peptide dimer comprising the peptide disclosed by Sugiyama et al. (2006), which is identical to the amino acid sequence of SEQ ID NO: 4 (as set forth by the instant application), adjoined via a disulfide bond to a cysteine residue added to the N-terminus of the peptide described by Sugiyama et al. (2001), a peptide which then would have an amino acid sequence that is identical to the amino acid sequence of SEQ ID NO: 2 (as set forth by the instant application) except for the additional cysteine residue at the N-terminus because such a dimer peptide would have CTL induction activity towards WT1 expressing cancers. Notably the peptide dimer suggested by the prior art is indistinguishable from the compound of formula (3) as depicted by the claims of the instant application. Clearly the methodology necessary to produce such a dimer was well within the grasp of the artisan of ordinary skill in the art before the effective filing date of the claimed invention since, for example, Sugiyama et al. (2006) teaches a monomer peptide containing two or more cysteine residues can be also synthesized and purified using conventional methodology and then used to construct a peptide dimer as described.One ordinarily skilled in the art before the effective filing date of the claimed invention would have been motivated to do so in order to further develop the method suggested by the prior art and ultimately to improve treating the cancer in the mammal.
Claims 1, 3, 5-6, 8-9, 11-16, 18-19, 22-23 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2006/0217297-A, (Sugiyama et al, IDS), WO 2016/141312 A1 (Gajewski et al) and Koido et al (Clin. Cancer Res. 2014 Aug 15; 20 (16): 4228-39, IDS), as applied to claim 1, 3, 8-9, 11-13, 16, 18-19, 22-23 and 25-27 above, and further in view of U.S. Patent Application Publication No. 2012/0045465-A1 (Sugiyama et al 2012, IDS).
The above 103 discloses and suggests that which is set forth in the above rejection but does not expressly teach further administering to the mammal a WT1 helper peptide or more particularly a peptide consisting of SEQ ID NO: 18.
U.S. Patent Application Publication No. 2012/0045465-A1 (Sugiyama 2012) discloses the importance of helper T cells specific to a cancer antigen to effectively induce an anticancer immune response involving cancer antigen-specific CTLs; see entire document (e.g., paragraph [0004]). Sugiyama (2012) discloses that administering WT1 antigen helper peptides in conjunction with WT1 antigen killer peptides, which activate CTLs, is beneficial because the WT1 antigen helper peptides function to activate helper T cells (CD4-positive T cells), which in turn function to maintain the CTL-mediated immune response against cancer cells in the mammal (see, e.g., paragraph [0078]). Sugiyama (2012) teaches a peptide consisting of an amino acid sequence identical to the amino acid sequence of SEQ ID NO: 18, as set forth in the instant application, is an example of a WT1 antigen helper peptide that is suitably used as suggested to treat WT1 expressing cancer (see, e.g., SEQ ID NO: 3).
Accordingly, it would have been prima facie obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to have administered to a mammal afflicted with a WT1-expressing cancer a cancer vaccine, as suggested in the above 103, in combination with a WT1 helper peptide or more particularly a peptide consisting of SEQ ID NO: 18, as suggested by Sugiyama (2012) because the helper peptide would activate helper T cells (CD4-positive T cells), which in turn function to maintain the CTL-mediated immune response against cancer cells in the mammal. One ordinarily skilled in the art before the effective filing date of the claimed invention would have been motivated to do so in order to further develop the method suggested by the prior art and ultimately to improve treating the cancer in the mammal.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571)272-9935. The examiner can normally be reached on M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached on (571)272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
May 21, 2026
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