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 .
Election/Restrictions
Applicant’s election with traverse of HLA-A*02:01, Formula (5) and Glioma in the reply filed on 6/18/26 is acknowledged.
The traversal is on the ground(s) that the Examiner did not provide the required grounds to support distinctness and reasons for insisting on election. The Applicants argue that the Examiner simply provided a conclusion without further information.
This is not found persuasive because the species are considered mutually exclusive and patentably distinct because they recite different patient population, different cancers having distinct etiologies and pathologies and distinct peptide species that have different amino acid sequence. Thus, the respective species do not overlap in scope and examination of one species would not necessarily establish the applicability or patentability of the other species.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 1-21 are pending.
Claims 1-4 and 14-21 read on the elected species and are under consideration.
Claim Objections
Claim 1 is objected to because of the following informalities: “CTLs” should be completely spelled out the first time it appears followed by the acronym in parenthesis.
Claim 16 is objected to because of the following informalities: “of” is repeated.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-4 and 14-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for inducing a WT1 specific cellular immune response, in particular the activation of WT1 specific CD8 positive cytotoxic T cells with SEQ ID NO: 2 and Formula (5), does not reasonably provide enablement for treatment or preventing a cancer with SEQ ID NO: 2 (or altered peptide thereof). The instant specification is also not enabled to activation of a WT1 specific CD8 positive cytotoxic T cells with an altered peptide of SEQ ID NO: 2. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
As stated in MPEP 2164.01(a), “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.”
The factors to be considered when determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, were described in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) as:
1. the nature of the invention;
2. the breadth of the claims;
3. the state of the prior art;
4. the relative skill of those in the art;
5. the predictability or unpredictability of the art;
6. the amount of direction or guidance presented [by the inventor];
7. the presence or absence of working examples; and
8. the quantity of experimentation necessary [to make and/or use the invention.
(1) The Nature of the Invention
Claim 1 is drawn to a method of treating or preventing a cancer in an HLA-A*02:01….. positive subject comprising administering a pharmaceutical composition comprising a peptide comprising the amino acid sequence of SEQ ID NO: 2 or an altered peptide thereof having an ability to induce CTLs or a pharmaceutically acceptable salt. Claim 15 claim the composition comprising Formula (4) or Formula (5).
(2) The Breadth of the claims
The claims will be given its broadest reasonable interpretation. The applicable rule for interpreting the claims is that “each claim must be separately analyzed and given its broadest reasonable interpretation in light of and consistent with the written description.” See MPEP 2163(II)(1), citing In re Morris, 127 F.3d 1048, 1053-1054; 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). The instant specification states that “preventing cancer” means preventing development of the cancer in a subject who has not yet developed any cancer [PGPUB0101]. The instant specification states that “treating a cancer” includes completely or partially inhibiting progression of a cancer and at least partially reducing one or more symptoms of cancer [PGPUB0101]. The instant specification includes blood cancers, or solid cancers [PGPUB0104]. The instant specification defines “altered peptide” refers to a peptide consisting of an amino acid sequence that has one or several amino acid residues altered in the amino acid sequence of the peptide, for example 1-9 [PGPUB0091].
In view of this rule, Claim 1 is drawn to prevention and treatment of all cancer types with SEQ ID NO: 2 or “altered” peptides thereof having any number of altered residues.
(3) The state of the prior art and (5) The predictability or unpredictability of the art
The instant application is enabling for inducing a WT1 specific cellular immune response, in particular the activation of WT1 specific CD8 positive cytotoxic T cells with SEQ ID NO: 2 and Formula (5). However, the art is not enabling for treating and preventing all cancers with SEQ ID NO: 2 or an altered peptide thereof. There was no art found that supported preventing or treating all cancers with a single peptide or combination of peptides.
As indicated in the 102 rejection below, WT1 derived peptides including SEQ ID NO: 2 and Formula (4) and (5) were known to elicit a WT specific cellular immune response. However, the art did not establish that all cancers can be prevented or treated.
For example, the Merck Manual (<Lynch Syndrome - Oncology - Merck Manual Professional Edition> accessed 8/8/26) teaches Lynch syndrome is an autosomal dominant disorder responsible for some cases of colorectal cancer. The hereditary cancer is confers a lifetime increased risk of colorectal cancer and endometrial cancer (in women) despite an absence of environmental triggers. Therefore, it would be unlikely and require undue experimentation to determine if immune activation alone would prevent colorectal cancer in subjects with Lynch syndrome.
The prior art establishes that WT1 directed immune activation with the claimed peptides and provides a framework for therapeutic vaccination. However, the prior art does not establish whether this immune activation could prevent or treat all cancer types.
Therefore, the state of the art at the time of the application is that the etiology and treatment of all cancers is not well understood and complex. Adding to the complexity are the many different types of cancers known in the art. It is noted that pharmaceutical and biological art is generally unpredictable requiring each embodiment to be individually assessed for physiological activity. Furthermore, the claimed cancers have distinct etiologies and pathologies. Given this fact, historically the development of new drugs has been difficult and time-consuming. Adding to the unpredictability is that many treatment options may show promise in animal models, but may fail to show therapeutic improvement in clinical trials. There is no absolute predictability, even in view of the high level of skill in the art.
(4) The relative skill of those in the art
MPEP 2141.03 states (in part)” A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner’s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the skill in the art high with respect to physicians and scientists. The level of skill in the art (physicians and scientists) would be high.
(6) The amount of direction or guidance presented (by the inventor) and (7) The presence or absence of working examples
The instant application provided sufficient guidance for inducing a WT1 specific cellular immune response, in particular the activation of WT1 specific CD8 positive cytotoxic T cells with SEQ ID NO: 2 and Formula (5). The instant specification identifies the specific peptides, provides concentrations and conditions used in PBMCs, identified relevant HLA types and assays for evaluating the WT1 immune response.
However, the specification does not provide sufficient guidance for achieving prevention and treatment of all cancers. It does not provide specific guidance on which subjects should be selected for preventative treatment, which cancer types are to be prevented, the prophylactic regimen (dosing, length of treatment etc). The specification does not provide a working example of actually treating or preventing any cancer. There was no example of a reduction or inhibition of tumor growth or increased survival.
(8) The quantity of experimentation necessary (to make and/or use the invention)
Owing to the factors listed above, especially in points 6 and 7, the amount of experimentation needed will be extensive in view of the lack of guidance by the inventor. MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
In conclusion, the instant application is enabled for inducing a WT1 specific cellular immune response, in particular the activation of WT1 specific CD8 positive cytotoxic T cells with SEQ ID NO: 2 and Formula (5).
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 15 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 15 is rejected because it does not depend from any claim. The claim was amended to remove the claim number from which it depends, so it is unclear what claim is should depend from. For purposes of examination, it is interpreted to depend from claim 1.
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 14-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ban et al. (WO2020/204173, published 10/8/2020, cited on IDS). Please note that the English language equivalent of the reference is US Patent Application Publication US2022/0241409. The US publication is relied upon in the rejection below as the English translation.
With respect to claims 1-4 and 14-19, Ban et al. teach compounds useful as a vaccine adjuvant for a cancer vaccine (Abstract). Ban et al. claims a pharmaceutical composition comprising Formula (4):
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wherein the bond between C-C is disulfide bond, or a pharmaceutically acceptable salt thereof, and a peptide represented by amino acid sequence of SEQ ID NO: 3 WAPVLDFAPPGASAYGSL (claim 22). Formula (4) of Ban et al. is identical to instantly claimed Formula (5). SEQ ID NO: 3 of Ban et al. is identical to instantly claimed SEQ ID NO: 2. Therefore, the pharmaceutical composition of Ban et al. is identical to instantly claimed pharmaceutical formulation. With respect to the limitation “a method of treating or preventing cancer in an HLA-A*02:01, Ban et al. teach treatment of prevention of cancer [0580-0582, 0556] Fig. 4 discloses the results of Test 6: a vaccine was prepared by adding a composition comprising Formula (4) and SEQ ID NO: 3 in an HLA-A*02:01 [0183]. The instant specification defines “subject” as humans and non-human animals [PGPUB0095]. This is consistent with the instant specification of definition of “preventing” which encompasses administration prior to the development of cancer and/or prior to the manifestations of symptoms. Accordingly, Ban et al. teach administration of the claimed pharmaceutical composition to the subject population for preventing cancer as required by the claim.
With respect to claims 20 and 21, Ban et al. teach the cancer is leukemia, multiple myeloma …glioma [PGPUB0556]. Glioma is associated with an elevated expression of WT1.
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 1-7 and 14-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. USPN 9,248,173. Although the claims at issue are not identical, they are not patentably distinct from each other because the USPN claims a composition comprising Formula (5) and SEQ ID NO:244. Formula (5) is identical to instantly claimed Formula (5) and SEQ ID NO: 244 is identical to instantly claimed SEQ ID NO: 2. The USPN claims inducing cytotoxic T cells against WT1 positive cancer, wherein the cancer is leukemia…and brain tumor (claims 1-27). MPEP 804 states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. In the instant case, the specification teaches treatment or prophylaxis of cancer with the claimed composition.
Claims 1-7 and 14-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. USPN 9,181,302.
Although the claims at issue are not identical, they are not patentably distinct from each other because the USPN claims a composition comprising Formula (5) and SEQ ID NO:244. Formula (5) is identical to instantly claimed Formula (5) and SEQ ID NO: 244 is identical to instantly claimed SEQ ID NO: 2. The USPN claims inducing cytotoxic T cells against WT1 positive cancer, wherein the cancer is leukemia…and brain tumor (claims 1-28). MPEP 804 states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. In the instant case, the specification teaches treatment or prophylaxis of cancer with the claimed composition.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA L MARTINEZ/Primary Examiner, Art Unit 1654
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