DETAILED ACTION
Status of Claims
The amendment submitted May 19, 2026 has been entered.
Claims 1-2, 5-8 and 18 are pending and under consideration.
Claims 9-17 are cancelled by Applicant.
Claims 1, 5 are presently amended.
Claims 3-4 and 18 are withdrawn as explained below in the Election/Restriction section.
Claims 1-2, and 5-8 are under consideration in the instant office action as explained below in the Election/Restriction section
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
This application is a 371 National Phase Application of PCT/CA2020/051755 filed December 18, 2020, which claims the benefit of priority to United States Provisional Application 62/949678 filed December 18, 2019.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9 and 17, drawn to a method of treating cancer in a patient comprising the step of administering to said patient at least one compound of formula I in the reply filed on October 7, 2025 is acknowledged.
Applicant’s election without traverse of the compound of claim 2 (shown below) as a species of a compound of formula (I) and lymphoma as a species of cancer in the reply filed on October 7, 2025 likewise acknowledged.
The elected species reads on claims 1 where each Y is independently selected by N and CH, Z is a heteroaryl optionally substituted with one or more RA or R4 substituents, where R2 is L-aryl and L is C1 alkylene, and where W is N(R1)(R3), and wherein when R1 and R3 are attached to a nitrogen atom optionally they join together with the nitrogen atom to form a 6 membered ring, optionally substituted with one RA, where RA is NR1R3 and R1 and R3 are hydrogen. The elected species is also known as UM171 as per page 39, paragraph [00148].
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The elected species also reads on claims 2, 5, 6, 7, 8, 9, and 17.
The Examiner notes that claims 9 and 17 are cancelled.
Claims 3-4, 18 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 7, 2025.
Claims 1-2, and 5-8 are under consideration and the subject of this Office Action.
Information Disclosure Statement
No additional information disclosure statements were submitted.
WITHDRAWN REJECTIONS
The examiner withdraws rejections to claims 1-2, 5-9, and 17 under 35 U.S.C. 112(a) for failing to comply with written description based on amendments made by Applicant and cancellation of claims 9 and 17.
The examiner withdraws rejections to claim 5 under 35 U.S.C. 112(b) based on amendments made by Applicant.
MAINTAINED/MODIFIED REJECTIONS
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 and 5-8 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
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 include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.01 (a).
Upon consideration of the factors discussed below, the examiner concludes that one skilled in the art could not practice the invention without being burdened with undue experimentation based on the information provided by the applicant.
A discussion of these factors they relate to the pending claims follows.
Breadth of Claims and Nature of Invention
Claims 1-2 and 5-8 are directed to “a method of treating cancer in a patient comprising the step of administering to said patient at least one compound of formula I”
Applicant has not explicitly provided a definition for treating cancer, nor has Applicant provided a definition for cancer.
Consequently, as per MPEP 2111, “the pending claims must be "given their broadest reasonable interpretation consistent with the specification."
As per MPEP 2111.01, I: “Under a broadest reasonable interpretation (BRI), words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. The ordinary and customary meaning of a term may be evidenced by a variety of sources, including the words of the claims themselves, the specification, drawings, and prior art.”
Cancer is a broad class of heterogenous diseases for which there exists no general treatment or prevention. Hanahan explains that “there are more than 100 distinct types of cancer, and subtypes of tumors can be found within specific organs” (Hanahan, Douglas, and Robert A. Weinberg. "The Hallmarks of Cancer." Cell 100, no. 1 (2000): 57-70).
Below, the Examiner provides teachings from prior art related to types of cancers and specific mutations pertinent to instant invention by example only.
Van den Bent teaches that H3 K27M-mutant diffuse glioma is a type of cancer based on a K27 mutation (van den Bent, M., Saratsis, A.M., Geurts, M. and Franceschi, E., 2024. H3 K27M-altered glioma and diffuse intrinsic pontine glioma: Semi-systematic review of treatment landscape and future directions. Neuro-oncology, 26(Supplement_2), pp.S110-S124).
Van den Bent teaches that “H3 K27M-mutant diffuse glioma is a recently identified brain tumor associated with poor prognosis. As of 2016, it is classified by the World Health Organization as a distinct form of grade IV glioma. Despite recognition as an important prognostic and diagnostic feature in diffuse glioma, radiation remains the sole standard of care and no effective systemic therapies are available for H3K27M mutant tumors.”
Van den Bent further teaches that “The presence of the H3 K27M mutation is associated with dismal survival, although the reported prognostic magnitude relative to gliomas without the H3 K27M mutation depends on many variables.38–43 Although the H3 K27M mutation was discovered in DIPG and is often thought to be a pediatric disease, young adult patients are also affected. Reports indicate up to 90% of pediatric DIPG cases are H3 K27M-mutant. Among adults with DMG, the H3 K27M mutation occurs in 15%–60% of cases. In a study of young adult and adult patients with thalamic tumors, the mutation was absent in all patients over the age of 50, whereas 91% of patients under the age of 50 (range, 17–46 years) were H3 K27M-mutant.”
Van den Bent further teaches that “Despite the prevalence of small molecules for a variety of cancers, few compounds are being evaluated in DIPG and H3 K27M-mutant-exclusive populations.”
In terms of PRC2, Wang teaches that “Polycomb repressive complex 2 (PRC2) is known to regulate gene expression and chromatin structure as it methylates H3K27, resulting in gene silencing. Studies have shown that PRC2 has dual functions in oncogenesis that allow it to function as both an oncogene and a tumor suppressor. Because of this, nuanced strategies are necessary to promote or inhibit PRC2 activity therapeutically (Wang, M.S., Sussman, J., Xu, J.A., Patel, R., Elghawy, O. and Rawla, P., 2024. Pharmacological advancements of PRC2 in cancer therapy: a narrative review. Life, 14(12), p.1645).”
“Within PRC2, EZH2 serves as the catalytic subunit that mediates PRC2’s identity as a histone methyltransferase.”
Therefore, Wang teaches the relationship between PRC2 and EZH2 and cancer, and the nuances required to promote or inhibit PRC2 activity based on its dual function as oncogene and tumor suppressor.
Wang further teaches “Amongst the core subunits, EZH2 has been of particular interest within the literature due to its contribution toward drug resistance, and its overexpression is linked with both oncogenic and tumor suppression effects [2]. For example, the overexpression of EZH2 is common within non-small-cell lung carcinoma (NSCLC) [13,14], colorectal cancer (CRC) associated with claudin-23 (CLDN23) and Runt-related transcription factor 3 (RUNX3) [15,16], aggressive forms of breast cancer [17,18,19,20], Ras signaling-based pancreatic cancer [21,22], and hormone-refractory prostate cancer [23,24].”
Eich teaches that “EZH2 is overexpressed in numerous tumor entities including melanoma, ovarian, breast, endometrial, bladder, renal cell, lung, and liver cancer, and is associated with aggressive disease, leading to its classification as an oncogene. In prostate cancer, EZH2 is significantly overexpressed in metastatic disease compared with localized cancer and benign prostatic tissue at both the transcript and protein levels. Furthermore, EZH2 plays a role in prostate cancer cell proliferation and depending on its phosphorylation status acts as a coactivator for transcription factors like the androgen receptor (Eich, M.L., Athar, M., Ferguson III, J.E. and Varambally, S., 2020. EZH2-targeted therapies in cancer: hype or a reality. Cancer research, 80(24), pp.5449-5458).”
Eich further teaches that “EZH2 inhibition alone may not be highly effective in certain tumors, however, and combination with other drugs and immunotherapies may prove beneficial in cancers that are not sensitive to EZH2 inhibition alone…. Although our ability to predict EZH2 sensitivity is improving, more work is required to develop highly predictive biomarkers for EZH2 therapeutic response. ”
Volkel teaches that “A large set of experimental data have established that EZH2 acts as a key player in tumorigenesis. However, the molecular mechanisms involved in EZH2 dysregulation in cancer appear to be diverse. EZH2 overexpression is mainly found in solid tumors and activating mutations are found in B-cell lymphomas while inactivating mutations are often identified in myelodysplastic syndromes and myeloproliferative neoplasms. Finally, a missense mutation in the gene encoding histone H3.3 (H3F3A) inhibiting EZH2 activity is present at high frequencies in pediatric gliomas. Thus, EZH2 functions as an oncogene in solid tumors and lymphomas whereas it behaves like a tumor suppressor gene in myeloid disorders and in pediatric glioblastomas. The oncogenic role of EZH2 mainly depends on its ability to repress gene expression programs via H3K27 methylation and chromatin compaction. However, studies in certain cancers revealed that the oncogenic function of EZH2 could also result of its action as a PRC2-independent transcriptional activator. Then, EZH2 could be involved in cancer through multiple mechanisms and could be regulated by different pathways depending on cellular context and cancer type. A better understanding of the regulatory network involving EZH2 is consequently required for the development of novel anti-cancer therapeutic strategies (Völkel, P., Dupret, B., Le Bourhis, X. and Angrand, P.O., 2015. Diverse involvement of EZH2 in cancer epigenetics. American journal of translational research, 7(2), p.175).”
Consequently, Völkel demonstrates the unpredictability associated with EZH2, whose function shows high variability.
On page 35, paragraph [00125], Applicant defines subject as "subject" or "patient" is intended to mean humans and non-human mammals such as primates, cats, dogs, swine, cattle, sheep, goats, horses, rabbits, rats, mice and the like.”
Consequently, it is reasonable to conclude that the claims are broad with respect to the patient population, cancer, and aim of treating.
The state of the prior art
The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification. See MPEP § 2164.05 (a).
To the best knowledge of the examiner, there is no general pharmaceutical agent capable of treating all types of cancer.
Particularly, UM171 is not known to be a general treatment for cancer.
Applicant has provided no support suggesting UM171 is capable of treating such broad range aside from the leukemias tested.
In particular, Applicant has provided no support suggesting UM171 can be used in pediatric patients or has the required properties for treating brain cancers such as H3 K27M-mutant diffuse glioma, a cancer with poor prognosis whose patient population is predominantly pediatric, which currently has no effective chemotherapeutic options as aforementioned by example only.
The role of EZH2 and PRC2 mutation is also highly variable. As aforementioned, for EZH2, the regulatory network is complex and is still not well-understood. PRC2 is known to have dual functions and can either suppress or promote tumors; therefore, also is highly variable and unpredictable. Applicant has provided no guidance or support demonstrating the nuances of the compounds claimed to actually being effective in treating cancer based on a K27 mutation, EZH2 mutation or PRC2 mutation.
Therefore, it is reasonable to conclude that the current state of the art is highly unpredictable, indicating that more details, working examples and guidance would be required to practice the invention as disclosed
(D) The level of one of ordinary skill
The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the relevant time. Factors that may be considered in determining the level of ordinary skill in the art may include: (A) "type of problems encountered in the art;" (B) "prior art solutions to those problems;" (C) "rapidity with which innovations are made;" (D) "sophistication of the technology; and" (E) "educational level of active workers in the field. In a given case, every factor may not be present, and one or more factors may predominate." In re GPAC, 57 F.3d 1573, 1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995); Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed. Cir. 1986); Environmental Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983). See MPEP § 2141.03 (I)
The invention described pertains to medicine, veterinary medicine and pharmacology. One of ordinary skill would be a person with training in oncology, pharmacology, biochemistry or a related technical discipline.
(E) The level of predictability in the art
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The "amount of guidance or direction" refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling.
The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. See MPEP § 2164.03.
Consequently, technologies involving physiological activity as opposed to mechanical or electrical inventions are generally regarded as being unpredictable sciences.
As aforementioned, cancer is an unpredictable, complex and heterogenous disease, including the cancers associated with specific mutations relevant to instant invention based on the evidence provided above.
Based on these culminative factors, it is reasonable to conclude that predictability in the art is extremely low.
Consequently, the applicant would need to provide more details, working examples and guidance in order for the claimed invention to be enabling based on the scope and nature of the claimed invention.
The existence of working examples
The applicants’ working examples are directed towards:
Chemistry examples for synthesis of compounds (pages 41-56).
In vitro testing for instant compounds for AML3.
Whole Genome CRISPR/Cas9 Screen and methodology for UM171 of OCI-AML5 or OCI-AML1 cell lines.
PK assays for bioavailability for oral and intravenous delivery in mice for UM681 and UM729).
Western Blot and Flow cytometry-based analysis for H3K27 acetylation in response to UM171 (Fig.3(B)).
Western Blot analysis for KBTBD4 knockdown (Fig. 3 (D)).
Antineoplastic effects of UM171 and UM681 on cancerous cell lines specific to leukemias (AML, APL, etc.)(Table 1, page 25) (in vitro, IC50 data)
Antineoplastic effect of UM171 on cell proliferation from AML patients (Table 2, page 26, IC50 data).
However, there are no examples supporting the method can be used to treat all types of cancers. All examples are focused on leukemias. Additionally, despite the diverse range of compounds recited in claim 1, the working examples are directed towards only 2-3 key compounds. There is no additional data provided suggesting the data can be extrapolated from leukemias towards treating the broad range of heterogenous cancers and patient populations claimed, including brain cancers and pediatric patients.
It is also known that there are significant challenges translating in vitro studies to all biological subjects in a clinical setting and that not all in vitro studies can be directly translated to the clinical setting depending on the cancer type. Therefore, it is also not reasonable to suggest Applicant’s invention can be used to treat cancer in all subjects.
On this basis and the prior discussion, the working examples are both not commensurate with the scope of protection sought and are not enabling.
One ordinarily skilled in the art would unable to simply translate the evidence provided by the applicant to treat the cancers in the subjects as claimed using the broad range of compounds claimed without undue experimentation.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
As aforementioned, the quantity of experimentation depends on the prior art, the predictability of the art, and the direction provided by the inventor, which are factors that were already discussed.
In order for one ordinarily skilled in the art to practice the invention as disclosed, some attributes one would require, but are not limited to:
Data supporting the broad and diverse class of compounds claimed is effective in treating the broad and heterogenous class of cancers claimed, including brain cancers.
Treatment regimen, dosing schedules, and guidance based on patient populations such as pediatric patients for the diverse cancers claimed.
Support that in vitro data can be extrapolated to clinical models, particularly for cancers where in vitro models are not known to translate well.
Consequently, the examiner concludes that one ordinarily skilled in the art would require undue experimentation in order to practice invention based on the details provided and scope of invention defined in Claims 1-2, and 5-8.
Consequently, Claims 1-2, and 5-8 remain rejected for lacking enablement.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 5-8 remain rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kang et al (US-PGPUB 2019/0093081A1).
Regarding claims 1-2 and 5, Kang teaches methods for treating cancer in a patient comprising administering UM171.
Kang specifically teaches treating a subject having glioblastoma through administering UM171 as a stem cell mobilizing agent (claims 1-25) and paragraph [0220].
Regarding claims 6-7, Kang teaches “wherein said patient is a human or an animal,” and “wherein said animal is a mouse.”
Kang specifically teaches at paragraph [0046], “In some embodiments of the above aspects, the subject is a mammal. In some embodiments, the subject is a human.”
Example 5 of Kang at paragraph [0456] additionally teaches where the subject is a mouse, and where the treatment is delivered via IV meeting the limitations of claim 8.
Therefore, Claims 1-2, 5-8 remain rejected as being anticipated by Kang.
Claims 1-2 and 5-8 remain rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sauvageau et al (USPN 9,757,378 B2).
Regarding claims 1-2, and 5, Sauvageau teaches methods for treating cancer in a patient comprising administering UM171.
Sauvageau specifically teaches “In another aspect, the present invention provides a method for inhibiting or eliminating AML initiating cells in a subject, said method comprising administering to said subject an effective amount of a pharmaceutically acceptable agonist of the Aryl hydrocarbon Receptor (AhR).”
Therefore, Sauvageau teaches methods for treating AML in a subject.
The elected species UM171 and its pharmaceutically acceptable salt is taught as compounds 40 and 41 (column 27), which is an aryl hydrocarbon receptor defined on column 2, lines 20-30. Consequently, Sauvageau meets the limitations of claims 1-2 and 5.
Regarding claims 6-7, Sauvageau teaches “wherein said patient is a human or an animal,” and “wherein said animal is a mouse.”
Example 5 of Sauvageau (column 71,lines 44-67) and Fig 4A teaches where the patient is a mouse.
Regarding claim 8, Sauvageau teaches “wherein said compound is formulated for an administration orally, intramuscularly, intravenously or subcutaneously.”
Specifically, “In the method for inhibiting or eliminating AML initiating cells, and/or for preventing or inhibiting MRD, in a subject of the present invention, the pharmaceutically acceptable AhR agonist may be formulated into a pharmaceutical composition.
Such compositions may be prepared in a manner well known in the pharmaceutical art. Supplementary active compounds can also be incorporated into the compositions. As used herein “pharmaceutically acceptable carrier” or “excipient” or “diluent” includes any and all solvents, buffers, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents, and the like that are physiologically compatible. The carrier can be suitable, for example, for intravenous, parenteral, subcutaneous, intramuscular, intracranial, intraorbital, ophthalmic, intraventricular, intracapsular, intraspinal, intrathecal, epidural, intracisternal, intraperitoneal, intranasal or pulmonary (e.g., aerosol) administration (see Remington: The Science and Practice of Pharmacy by Alfonso R. Gennaro, 2003, 21st edition, Mack Publishing Company)(column 54, lines 14-34).”
Additionally, Fig. 4A shoes where “AML cells from 6 primary human AML samples were injected untreated into the tail vein of sublethally irradiated NSG mice at 4 different doses (column 38, lines 1-11).”
Therefore, Claims 1-2, 5-8 remain rejected as being anticipated by Sauvageau.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure as disclosed in the prior Office Action. Rossi et al (US-PGPUB 2019/0119642 A1) disclose methods and compositions relating to expanding, enriching, and/or maintaining a population of hematopoietic stem cells ex vivo containing UM171. Sauvageau No. 2 (USPN 10,647,718 B2) and Sauvageau No. 3 (USPN 9,409,906 B2) additionally report the use of UM171 and similar analogues in treating diseases involving hematopoietic stem cells.
Response to Arguments
The Remarks of May 19, 2026 have been fully considered but are not fully persuasive for the reasons below.
35 USC 112(a)
Applicant’s Arguments:
“Regarding the rejections of claims 1, 2, 5-9 and 17 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, the Applicant submits that claim 1 has been amended as enclosed herewith to remove recitation of "a prodrug" and "at least one cell expanding factor", and former claims 9 and 17 have been deleted. Reconsideration and withdrawal of the Examiner's rejection are earnestly solicited.”
Examiner’s Response:
The examiner acknowledges the amendments made by Applicants, which have overcome the written description rejection. However, Applicant is reminded that Claims 1-2, and 5-8 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. Applicant has not submitted any arguments to address the enablement rejection as set forth by the Examiner, and has failed to address the comprehensive Wands factor analysis provided by the Examiner as is the standard test for enablement. Please see MPEP 2164.01 for further details.
As per MPEP 2164.05, “Once the examiner has weighed all the evidence and established a reasonable basis to question the enablement provided for the claimed invention, the burden falls on applicant to present persuasive arguments, supported by suitable proofs where necessary, that one skilled in the art would be able to make and use the claimed invention using the application as a guide. In re Brandstadter, 484 F.2d 1395, 1406-07, 179 USPQ 286, 294 (CCPA 1973).”
Consequently, the burden falls on Applicant to address the Wands factors and provide appropriate arguments and/or evidence.
As per MPEP 2164.05: “To overcome a prima facie case of lack of enablement, applicant must present argument and/or evidence that the disclosure would have enabled one of ordinary skill in the art to make and use the claimed invention at the time of filing. This does not preclude applicant from providing a declaration after the filing date which demonstrates that the claimed invention works. However, the examiner should carefully compare the steps, materials, and conditions used in the experiments of the declaration with those disclosed in the application to make sure that they are commensurate in scope; i.e., that the experiments used the guidance in the specification as filed and what was well known to one of skill in the art at the time of filing. Such a showing also must be commensurate with the scope of the claimed invention, i.e., must reasonably enable the full scope of the claimed invention. See Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021).”
Consequently, Applicant is further reminded that any arguments and/or support must demonstrate enablement commensurate with the full scope of the claimed invention.
Therefore, the rejection is maintained and Applicant is invited to submit an proper response and/or evidence to overcome the rejection.
35 USC 102
Applicant’s Arguments:
“In these regards, it is respectfully submitted that both documents relate to the expansion of stem cells ex-vivo and then inject the expanded population into the patient. The present claims relate to a method of treatment where the compounds perform their action in vivo. The technical problem solved by the present invention is therefore completely different to that of Kang et al. or Sauvageau et al., and both documents are not enabling disclosures for the treatment as claimed herein. The claims are novel over the cited art and reconsideration, and withdrawal of the Examiner's rejections are earnestly solicited.”
Examiner’s Response:
The examiner respectfully disagrees.
Applicant is reminded as per MPEP 211: “During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification."
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “method of treatment involving the expansion of stem cells ex-vivo and then injected the expanded population into the patient”) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
As recited in claim 1, Applicant’s claims are directed towards “a method of treating cancer in a patient comprising the step of administering to the said patient at least one compound of formula I.”
Applicant is further reminded of the use of comprising. Specifically, as per MPEP 2111.03 “the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) ("[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended."). Invitrogen Corp. v. Biocrest Manufacturing, L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003).
Therefore, both Kang and Sauvageau anticipate the claims as set forth in the rejection as stated above as there is no requirement for the method as claimed to be ex vivo, nor has Applicant provide any evidence showing Kang and Sauvageau are not enabled as prior art references. To this aim, based on broadest reasonable interpretation, Kang and Sauvageau meet the limitations of the instant claims and therefore, anticipate the instant invention.
Applicant is advised to consult MPEP 2121.01 for more details on what constitutes an “enabling disclosure.”
Applicant is further advised to consult MPEP 2152.06 for what is required to overcome a 35 USC 102 rejection. Presently, Applicant has failed to provide a sufficient response nor has Applicant amended claims accordingly to render instant invention free of prior art.
Therefore, for these reasons, Applicant’s arguments remain unpersuasive and the rejections are maintained.
Conclusion
Claims 1-2, 5-8 are under consideration and are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN L. LADD whose telephone number is (703)756-5313. The examiner can normally be reached M-Th, 7:00 am to 5:30 pm EST.
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, James H. Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.L.L./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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