DETAILED ACTION
Status of Claims
The amendment submitted April 4, 2023 has been entered.
Claims 14-30 are pending and under consideration.
Claims 1-13 are cancelled by Applicant.
Claims 14-30 are new.
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/JP2021/039490 filed October 26, 2021, which claims the benefit of priority to Japanese Patent Application No. JP2020-180455, filed on October 28, 2020.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d), and the certified copy has been filed.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
Eighty-two information disclosure statements (IDS) submitted on August 22, 2023; September 11, 2023; September 29, 2023; October 13, 2023; October 24, 2023; October 30, 2023; November 3, 2023; November 16, 2023; January 10, 2024; February 6, 2024; February 21, 2024; March 13, 2024; March 19, 2024; March 28, 2024; April 1, 2024; May 21, 2024; June 10, 2024; July 5, 2024; July 12, 2024; July 31, 2024; August 5, 2024; August 16, 2024; August 26, 2024; September 4, 2024; September 30, 2024; October 2, 2024; October 16, 2024; October 23, 2024; November 8, 2024; November 20, 2024; December 4, 2024; December 13, 2024; December 30, 2024; January 14, 2025; January 16, 2025; January 28, 2025; February 4, 2025; February 7, 2026; February 13, 2025; February 24, 2025; March 10, 2025; March 21, 2025; March 31, 2025; April 3, 2025; April 11, 2025; April 16, 2026; April 29, 2026; May 2, 2025; May 9, 2025; May 28, 2025; June 9, 2025; July 11, 2026; July 18, 2025; July 22, 2025; July 28, 2025; July 30, 2025; August 6, 2025; August 12, 2025; August 19, 2025; September 4, 2025; September 29, 2025; November 7, 2025; November 12, 2025; November 13, 2025; November 21, 2025; December 4, 2025; December 10, 2025; December 12, 2025; December 17, 2025; December 19, 2025; December 26, 2026; January 12, 2026; January 21, 2026; February 4, 2026; February 13, 2026; February 20, 2026; March 3, 2026; March 5, 2026; March 13, 2026; March 17, 2026; March 19, 2026; March 20, 2026 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
Abstract Objections
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract is less than 50 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
Claim 14- 30 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 the Invention
Claims 14-30 are directed towards “A method for treating a tumor, comprising administering 5-((2-(4-(1-(2-hydroxyethyl)piperidin-4-yl)benzamide)pyridin-4-yl)oxy)-6-(2-methoxyethoxy)-N-methyl-1H-indole-1-carboxamide represented by formula (I) or its pharmaceutically acceptable salt and a PD-1 antagonist to a patient in need thereof.”
Claim 15 is directed towards the administration of the antitumor agent and PD-1 antagonist.
Claim 16 is directed towards the pharmaceutically acceptable salt of the compound of formula (I).
Claim 17 is directed towards dosing amounts.
Claims 18-24 are directed towards wherein the PD-1 antagonist is an anti-PD-1 antibody and dosing amounts and schedules for the PD-1 antagonist.
Claim 25 is directed towards specific tumors “wherein the tumor is breast cancer, stomach cancer, non-small-cell lung cancer, bladder cancer, endometrial cancer, hepatocellular carcinoma, bile duct cancer, melanoma, esophageal cancer, colorectal cancer, renal cell carcinoma, head and neck cancer, pleural mesothelioma or Hodgkin's lymphoma.”
Claim 27 is directed towards wherein the tumor is breast cancer.
Claim 28 is directed towards wherein the breast cancer is “locally advanced breast cancer, metastatic breast cancer or recurrent breast cancer.”
Claims 29-30 are directed towards “wherein the breast cancer expresses FGFR.”
On page 21, paragraph [0032] of Applicant’s specification, Applicant explains that “The type of tumor to be treated by the pharmaceutical composition for treating a tumor of the disclosure is not particularly restricted…”
Cancer, including tumors 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).
The cancers cited are heterogenous and diverse in terms of origin, etiology, growth speed, molecular and genetic diversity, treatment plan, and disease progression.
Additional, tumors are not limited by Applicant to solely being cancerous.
The National Cancer Institute teaches that “Different body tissue types give rise to different tumors, both benign and malignant (“Tumor List,” National Cancer Institute SEER Training Modules, https://training.seer.cancer.gov/disease/categories/tumors.html, Accessed: February 13, 2026) and provides examples based on tissue, benign tumor and malignant tumors.
By example only, Johns Hopkins Medicine teaches that “There are more than 120 different types of brain tumors, lesions and cysts, which are differentiated by where they occur and what kinds of cells they are made of. Certain types of tumors are typically benign (noncancerous), while others are typically malignant (cancerous) (“Brain Tumor Types,” Johns Hopkins Medicine, https://www.hopkinsmedicine.org/health/conditions-and-diseases/brain-tumor/brain-tumor-types, Accessed: February 13, 2026).
Additionally, it is well-known that tumor heterogeneity is a challenge in cancer treatment.
El-Sayes teaches that “Despite great advances in cancer therapy, tumor heterogeneity continues to be a great barrier for the successful treatment of cancer. It has long been established that tumor heterogeneity is prevalent in most cancer patients and is a major driver of acquired resistance to all forms of cancer therapy (El-Sayes, Nader, Alyssa Vito, and Karen Mossman. "Tumor heterogeneity: a great barrier in the age of cancer immunotherapy." Cancers 13, no. 4 (2021): 806).”
El-Sayes also teaches that “Major challenges with universal cancer therapy have historically been attributed to the large number of subtypes of the disease and the biological differences associated with cancers arising in different parts of the body. While this locational diversity remains a challenge for unifying cancer treatment across various types, it has now become clear that even patients with phenotypically identical cancers often have dichotomous responses to treatment.”
El-Sayes further teaches that “Patients with the same type of malignancy may experience vastly different clinical outcomes, both before and after treatment. This interpatient heterogeneity is often seen in the clinic and is largely attributed to differences in somatic mutations acquired in the tumor.”
El-Sayes further teaches that “There is a plethora of innovative therapeutic approaches currently being developed for the treatment of cancer. Tumor heterogeneity acts as a major hurdle for treatment and a potentiator of acquired resistance regardless of the therapeutic approach or the type of cancer. Unlike primary resistance, acquired resistance can occur in patients that initially respond to therapy, resulting in a relapse after a period of tumor regression [33]. The mechanism of resistance caused by tumor heterogeneity is the same regardless of the treatment received. In a manner similar to that of natural selection, the composition of subpopulations in the tumor changes dynamically as a result of selective pressure exerted by therapeutic intervention and changes in the TME.”
By example only Marino teaches that “Molecular heterogeneity is a frequent event in cancer responsible of several critical issues in diagnosis and treatment of oncologic patients. Lung tumours are characterized by high degree of molecular heterogeneity associated to different mechanisms of origin including genetic, epigenetic and non-genetic source (Marino, Federica Zito, Roberto Bianco, Marina Accardo, Andrea Ronchi, Immacolata Cozzolino, Floriana Morgillo, Giulio Rossi, and Renato Franco. "Molecular heterogeneity in lung cancer: from mechanisms of origin to clinical implications." International journal of medical sciences 16, no. 7 (2019): 981).”
Marino further teaches that “Heterogeneity of molecular profile represents one of the most challenging issues in cancer, particularly in lung cancer, in the light of the resulting therapeutic implications. In lung cancer, different levels of molecular heterogeneity have been recognized including inter-patients, intra- and inter-tumour variability. Molecular heterogeneity between lung cancer patients with the same histotype represents a proven biological process resulting frequently in different treatment response for each individual patient.”
Marino teaches that “Tailored therapies based on the identification of molecular targets represent currently a well-established therapeutic scenario in the treatment of NSCLC patients, however short responses and development of resistance are frequently observed in daily clinical practice. Although the optimal efficacy of specific TKIs, a subset of NSCLC patients often shows a mixed response to treatment. Patient-specific response and resistance can originate not only from secondary aberrations induced by targeted therapy but also from intratumoral genetic heterogeneity.”
For breast cancer, Rivenbark teaches that “Breast cancer is noted for disparate clinical behaviors and patient outcomes, despite common histopathological features at diagnosis. Molecular pathogenesis studies suggest that breast cancer is a collection of diseases with variable molecular underpinnings that modulate therapeutic responses, disease-free intervals, and long-term survival. Traditional therapeutic strategies for individual patients are guided by the expression status of the estrogen and progesterone receptors (ER and PR) and human epidermal growth factor receptor 2 (HER2). Although such methods for clinical classification have utility in selection of targeted therapies, short-term patient responses and long-term survival remain difficult to predict (Rivenbark, A.G., O’Connor, S.M. and Coleman, W.B., 2013. Molecular and cellular heterogeneity in breast cancer: challenges for personalized medicine. The American journal of pathology, 183(4), pp.1113-1124).”
Rivenbark further explains that “If we accept the premise that every breast cancer is unique and reflects distinct qualitative and quantitative molecular traits, then knowledge of the entirety of molecular traits carried in any given breast cancer and patient is required for true personalized therapy to be realized…For current basic science, clinical, and translational researchers, the challenge is to evaluate large numbers of breast cancers (with known treatment and clinical response measures) to link specific qualitative or quantitative molecular traits with positive or negative responses to a variety of targeted and nontargeted drugs.”
Therefore, it is reasonable to conclude the claims are broad with respect to tumor and/or disease of treatment.
Applicant’s claims are also broadly directed towards PD-1 antagonists.
Specifically, on page 17, paragraph [0020] of Applicant’s specification, Applicant states that “The PD-1 antagonist of the disclosure may include any compound or biomolecule that blocks binding of PD-L1 expressed by cancer cells to PD-1 expressed on immunocytes (T cells, B cells or Natural Killer T (NKT) cells), or that blocks binding of PD-L2 expressed by cancer cells to PD-1 expressed on immunocytes.”
Therefore, is reasonable to conclude that the claims are broad with respect to PD-1 antagonist and/or combination therapy regimen.
Consequently, it is reasonable to conclude that the claims are broad with respect to tumor, pharmacological agent and combination therapy regimen.
The state of the prior art
The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). See Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021).
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 of the examiner’s knowledge, there is no general treatment available for treating all types of tumors in a patient using a compound of formula (I) and a PD-1 antagonist.
By example only, Khasraw teaches that “With the exception of few select cases (e.g., patients with Lynch syndrome) the neuro-oncology community is still awaiting evidence that PD-1 blockade can lead to meaningful clinical benefit in glioblastoma. This lack of progress in the field is likely to be due to multiple reasons, including inherent challenges in brain tumor drug development, the blood-brain barrier, the unique immune environment in the brain, the impact of corticosteroids, as well as inter- and intra-tumoral heterogeneity (Khasraw, M., Reardon, D.A., Weller, M. and Sampson, J.H., 2020. PD-1 Inhibitors: Do they have a Future in the Treatment of Glioblastoma?. Clinical Cancer Research, 26(20), pp.5287-5296).”
Khasraw teaches furthermore that “The scarcity of representative pre-clinical models has led to the initiation of clinical trials evaluating immunotherapies that have shown promise in other cancers without definitive pre-clinical rationale in GBM. Clinical trials are often initiated with uncontrolled, open label (unblinded), non-randomized, small sample size trials that have inherent selection and other biases. This in turn will have a high type I error rate, with ineffective therapies showing false positive results that may surreptitiously build the case to start larger studies.”
Sun also teaches that “Despite the potentially cure-like survival benefit, only a minority of patients are estimated to experience a positive response to PD-1/PD-L1 blockade therapy, and the primary or acquired resistance might eventually lead to cancer progression in patients with clinical responses (Sun, J.Y., Zhang, D., Wu, S., Xu, M., Zhou, X., Lu, X.J. and Ji, J., 2020. Resistance to PD-1/PD-L1 blockade cancer immunotherapy: mechanisms, predictive factors, and future perspectives. Biomarker research, 8(1), p.35).”
Sun further teaches that “Clinical evidence indicated that even for patients with tumors highly positive for PD-L1, more than 50% of them might not respond to PD-1/PD-L1 blockade [19]. Due to tumor heterogeneity and many other reasons, clinical responses vary largely across different tumor entities. The objective response rate was 30–45% in melanoma [20], 15–20% in NSCLC [21], 13% in head and neck carcinoma [22], and 22–25% in kidney cancer [23]. Besides, for most patients experiencing initial clinical response, acquired resistance remains another problem, which would lead to cancer progression or relapse after a few years.”
Sun further teaches that “Moreover, pancreatic cancer generally exhibits a lower mutation load compared with other solid tumors, and therefore, PD-1/PD-L1 blockade is usually ineffective for those patients and fails to improve their survival outcomes.”
Additionally, all of Applicant’s data regarding combination therapy are directed towards mouse cell lines and mouse antibodies. As aforementioned, patient selection is key towards clinical success.
Additionally, Mason-Osann teaches that “Combination therapy continues to be a valuable element of cancer treatment in the era of targeted therapies (1, 19, 20). Currently, preclinical strategies to identify new drug combinations often prioritize synergy (3–5); however, this approach may have drawbacks. First, synergy metrics do not assess absolute efficacy, therefore, synergy scores can prioritize combinations of drugs with little or no monotherapy activity, resulting in technically synergistic but weak treatments. This is a significant concern because synergy is most often observed among weak drugs (10). Second, synergy metrics are generally based on short-term assays and do not reveal response durability. Therefore, including other metrics, such as overall efficacy and durability of response may enhance the translational relevance of preclinical data (Mason-Osann, E., Pomeroy, A.E., Palmer, A.C. and Mettetal, J.T., 2024. Synergistic drug combinations promote the development of resistance in acute myeloid leukemia. Blood Cancer Discovery, 5(2), pp.95-105).”
Mason-Osann furthermore teaches that “The current data, supported by prior experiments and models (7, 11, 21, 22), suggest that combination strategies depending solely on synergy may compromise durability of response. In a synergistic combination, drugs depend on each other's activity to maximize effect; small losses in sensitivity to either component drug therefore produce a larger loss in sensitivity to the combination (Fig. 1A). This means that modest resistance to a single drug produces a large fitness benefit (Fig. 3D; Supplementary Fig. S5A), speeding the emergence of drug resistance…Together, these data have important implications for how to prioritize combinations in oncology. We have shown that synergistic drug combinations, while potentially useful to achieve high efficacy, contribute to the evolutionary pressure to develop drug resistance. Therefore, to identify regimens that produce durable clinical response, preclinical assessments of drug combinations should consider metrics beyond synergy, such as monotherapy activity, overall combination activity, and durability of response.”
Therefore, based on the references provided for tumor types, pharmacological agents (i.e: PD-1 antagonists) and combination therapy, it is reasonable to conclude that the current state of the art is unpredictable, indicating that more details, working examples and guidance would be required to practice the invention as disclosed for patients, tumors and conditions as claimed.
(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 and pharmacology. One of ordinary skill would be a person with training in oncology, medicine, immunology, 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, and tumors are additionally well-known in the art to be complex and heterogenous as cited above.
Additionally, there is unpredictability in terms of developing combination therapy regimens. PD-1 antagonists are not effective for all cancers and it is not well-supported that simply combining such pharmacological agents with a compound of formula (I) would necessarily result in treating the wide range of cancerous and non-cancerous tumors claimed. It is also known that patient selection is critical, and response to PD-1 can be highly variable. Resistance can occur, leading to relapse and accelerated disease progression.
Based on these cumulative factors, it is reasonable to conclude that predictability in the art is 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:
Page 22, paragraph [0036], Example 1, antitumor effects by combination of compound A and anti-mouse PD-1 antibody in mouse breast cancer cell line.
Page 25, paragraph [0049], Example 2, antitumor effects by combination of compound A and anti-mouse PD-1 antibody in mouse renal cell carcinoma cell line.
Page 27, paragraph [0059], Example 2, antitumor effects by combination of compound A and anti-mouse PD-1 antibody in mouse hepatocellular carcinoma cell line.
Consequently, Applicant has provided data for breast cancer, renal cell carcinoma and hepatocellular carcinoma; however, the studies are only limited to mouse cell lines. Additionally, only mouse PD-1 antibodies were studied. Consequently, Applicant has failed to demonstrate synergism between a compound of formula (I) and the broad range of PD-1 antagonists as claimed. Such data does not support whether such synergies would be actually effective in treating tumors in an actual patient as claimed, nor does such data take into account the complex tumor microenvironment that can complicate treatments as discussed above for various cancer types. It is uncertain whether Applicant’s methods would be able to mitigate against issues with drug resistance and if the synergies would be actually effective in treating the tumors as claimed on this basis.
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 be unable to simply translate the evidence provided by the applicant without undue experimentation across the full scope of the instant invention in terms of tumor, subject, and combination therapies claimed.
(F) 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:
Studies supporting that the method is general for all tumor types and cancer cells or studies across a broad range of tumor and/cancer cells, including actual human cell lines or preclinical and/or clinical models that extrapolate towards the tumors as claimed.
Studies for efficacy for the combination therapies claimed.
Studies exemplifying the broad range of PD-1 antagonist and combination therapies, and supporting that the synergism is actually effective.
Demonstration that the methods can actually be used to treat tumors in patients and/or correlation with the cancers as claimed.
Long-term studies verifying effectiveness of the treatment based on tendency for drug resistance to develop, especially as some synergies can actually accelerate drug resistance.
Guidance on biomarkers and patient selection as predictable measures of efficacy and actual treatment.
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 14-30.
Therefore, claims 14-30 are rejected for lacking enablement.
Conclusion
Claims 14-30 are under consideration and are rejected.
No claims are allowed.
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.
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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.
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/C.L.L./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622