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 .
The examiner of record has changed to Richard Grant Peckham. Examiner can be reached at (703) 756-4621 during regular business hours (CST).
DETAILED ACTION
Response to Amendment
The amendment filed 6/30/2025 has been entered. Newly amended Claims 1, 8, 10-13, 15-16, 19, 24-26, 28, 30, and 34-42 are pending in the application.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Restriction Requirement
The restriction requirement stands. Claim 24 as amended embraces the elected species. It is therefore rejoined for examination herein. Claim 13 remains withdrawn.
The scope of search and examination was extended to the following compound:
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wherein the R1 of examined formula (I) is C1-alkyl with carbon being replaced by oxygen.
Response to Applicant’s Arguments
Applicant argues that the cited art no longer reads over Claim 1 because of the newly added limitation. However, this new limitation is in conflict with several similar wherein clauses which describe a different scope and are not amended. This issue renders the claim and the limitations to formula (I) unclear. Therefore, the same art is applied to the amended claims. For further explanation and interpretation see Claim Rejections - 35 USC § 112(b) section below.
Claim Objections
Claims 1, 8, 10, 24, 30, 35, 40, and 42 are objected to because of the following informalities:
Claims 1, 8, 10, and 24 recite variables implicitly; e.g., R2-R5 to represent R2, R3, R4, and R5. All such variables must be depicted explicitly.
Claim 30 recites “comprising administering a compound” twice.
Claim 30: Remove the comma after non-melanoma.
Claims 35 and 40 recite “and cancer” and should instead read “or cancer”.
Claim 42 should read “or cancer related to” and “or T-cell lymphoma” instead of “and”. Alternatively the list is preceded by “the cancer is selected from cancer related to…” instead of “the cancer is related to”.
Claim 42 recites “and” before stomach despite this embodiment not being the last item in a listing.
Appropriate correction is required.
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 30, 34, 35-36, and 40-42 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 improving immune system related applications and treating diseases mediated by enhancing Notch, does not reasonably provide enablement for the methods not mediated by Notch enhancement or are instead mediated by the inhibition thereof. 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.
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The nature of the invention (1) and breadth of the claims (6)
The nature of the invention and breadth of Claims 30, 34, 35-36, and 40-42 is the treatment of any disease without limitation comprising administering Compounds of Claim 1 or 25 (see Claim Rejections - 35 USC § 112(b)).
Page 116 of the specification provides that the term "treating" or "treatment" refers to one or more of (1) inhibiting the disease; for example, inhibiting a disease, condition or disorder in an individual who is experiencing or displaying the pathology or symptomatology of the disease, condition or disorder (i.e., arresting further development of the pathology and/or symptomatology); and (2) ameliorating the disease; for example, ameliorating a disease, condition or disorder in an individual who is experiencing or displaying the pathology or symptomatology of the disease, condition or disorder (i.e., reversing the pathology and/or symptomatology) such as decreasing the severity of disease; and (3) slowing down disease progression..
The state of the prior art (2) and the predictability or lack thereof in the art (3)
The state of the prior art is clear even with regard to cancers that are mediated in any form by Notch.
Vazquez (Rev Med Virol. 2018;28:e1988. 1-16.) teaches of the “dual behavior of the Notch pathway as activator or suppressor of neoplasia in virus‐related cancers” (Abstract). The same nature is reiterated in the Conclusion of Page 12. Regarding particular diseases of Claim 42, “The Notch pathway…plays a critical role in [hepatocellular carcinoma] HCC because activation of the pathway has been described in 30% to 90% of human HCC tumors, promoting tumor cell migration, invasion, and metastasis” (Page 4). Further, “NOTCH2 pharmacologic inhibition has been shown to trigger the viral lytic cycle, killing the [Epstein Barr virus] EBV‐positive transformed cells. Also, siRNA‐mediated NOTCH3 knockdown enhances the sensitivity of EBV‐associated nasopharyngeal cancer to the chemotherapeutic drug cisplatin, supporting NOTCH inhibition as a therapeutic approach in EBV‐positive tumors (Page 8). Several cancerous diseases are not expected to be treated via Notch enhancement but rather the opposite mechanism. Several claimed diseases are not expected to be treated in view of the art. Further, it is unclear what diseases may or may not be treated with the claimed compounds because of the tumor promoting and suppressing properties of Notch described in Vazquez. The art does not enable generic treatment of any disease, merely Notch-mediated diseases, or even the particular cancers as claimed whose pathway is described above.
The amount of direction or guidance present (4) and the presence or absence of working examples (5)
Applicant describes several in vitro assays wherein at least T-cell leukemia (RPMI 8402) and lymphoma (HH) among other cancers are assessed against select compounds (Specification: Starting Page 73). Activity is shown in said cancer lines but applicant fails to demonstrate or explicate in the disclosure how such cancers mediated by Notch inhibition or not by Notch at all would be expected to be treated by the methods as claimed. The mechanistic explanations of Vazquez are not contradicted or resolved by the disclosure with respect to non-enabled cancers.
The quantity of experimentation needed (7)
The quantity of experimentation needed is extremely difficult, novel, and undue experimentation; the ability of the compounds of Claims 1 and 25 to treat any disease, or cancers, or even those specific diseases mediated by a mechanism opposite to the one disclosed or bolster immune system applications not specifically mediated by Notch enhancement is nearly impossible to determine and not at all enabled by the experiments disclosed in the specifications of the application.
One of skill in the art would be tasked with 1) determining which diseases, beyond merely cancers or hyperproliferative diseases, and what immune system applications are mediated by Notch which is known in the art to promote cancer as well as suppress and 2) which compounds out of the vast genus of general formula (I) which lacks clear delineation or direction with respect to a distinct core or recognizable structure would be effective as Notch enhancers as described let alone efficacious therapeutic treatments. The art is not definitive with respect to the role of Notch in the large scope of diseases claimed by applicant.
The level of the skill in the art (8)
The level of skill in the art is high. However, one of even the highest skill, if such an artisan were able to discern what compounds are encompassed by the extremely broad and indefinite genus of formula (I) (see Claim Rejections - 35 USC § 112(b)) and those listed in Claim 25, would not be able to readily determine which compounds, even if exhibiting the desired Notch enhancement, would be applicable to the unlimited list of diseases claimed by applicant. The artisan would also struggle to treat the claimed species of disease—mediated by Notch inhibition—with enhancers and not expect tumor promotion instead of the desired suppression.
Thus, the specification fails to provide sufficient support of the broad use of the claimed compounds in the broad claim methods of treating diseases and improving immune system applications.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 8, 10-12, 15-16, 19, 24-26, 28, 30, and 34-42 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites the new limitation:
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but does not remove or modify the following limitation describing a different scope of R1:
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.
Therefore, two sets of metes and bounds are established: 1) where heteroatomic replacement must occur and 2) where the replacement “can” occur or is optional. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claims 8, 10-12, 15-16, 19, 24, 26, 28, 30, and 34-36, 38, and 42 are rejected by virtue of dependency. Claim 15 in particular restricts the presence of heteroatoms altogether, conflicting with the narrower scope and potentially raising a 35 USC 112d issue if unresolved. The second of the two metes and bounds, wherein the limitation is optional, is used to determine the broadest reasonable scope of the claims.
Claim 1 recites the following:
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but does not remove or modify the option of R1 being substituted with the substituent groups which are unacceptable as replacements at a “terminal position”. A single-radical substituent is necessarily terminal and therefore may circumvent the above proviso through alternative interpretation of a compound. The conflicting limitations are not resolved. Claims 8, 10-12, 15-16, 19, 24, 26, 28, 30, 34-38, and 42 are rejected by virtue of dependency.
Claims 1 and 38 are amended to include tables of numbers. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). See MPEP 2173.05 (s). Applicant does not reference a figure or table but instead a list of numbers alleged to represent an array of compounds. No structures are presented nor are universal compound structure names provided. It is unclear what compounds are being excluded by the extensive lists in the cited claims. The unclear provisos do not serve to further limit the claims, and the broadest reasonable scope of search and examination is unaffected by said provisos. Claims 8, 10-12, 15-16, 19, 24, 26, 28, 30, 34-37, and 42 are rejected by virtue of dependency. It is requested that a table of structures be included or at least the names of the structures are provided for clear examination.
Claims 1 and 38 contain tables with columns headed by “CAS”. It is assumed that “CAS” in each case is a reference to the registered trademark “CAS Registry Number” (Serial No. 73709416; trademark information supplied in document named “CAS Registry Trademark”). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe compounds and, accordingly, the identification/description is indefinite. Claims 8, 10-12, 15-16, 19, 24, 26, 28, 30, 34-37, and 42 are rejected by virtue of dependency.
Claim 1 depicts the undefined variable “Z1/2” in the structure of formula (Ib). The group is interpreted to be “Z1 and Z2…together”. All variables must be explicitly defined. Claims 8, 10-12, 15-16, 19, 24, 26, 28, 30, 34-38, and 42 are rejected by virtue of dependency.
Claims 1 and 13 recite ambiguous parentheticals like
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or
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. It is unclear whether the preceding limitations are only applicable to each respective subgenus or what purpose each parenthetical serves with respect to the definitions of the formula. Claims 8, 10-12, 15-16, 19, 24, 26, 28, 30, 34-38, and 42 are rejected by virtue of dependency.
Claim 13 recites “said cyclic residue” in (iv). However, no less than two cyclic residues are described in (ii) and (iii). The antecedent basis of the claim is ambiguous.
Claim 25 is amended to depict several tables which show labeled and labeled compounds. It is unclear whether the unnamed blank slots are to be interpreted as claimed compounds which happen to be unnamed or not as claimed compounds at all despite their depiction. For example, Table 23
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depicts multiple rows which are blank; however, the structures of each unnamed cell are discernable from referencing the A row and B column. Blank cells are interpreted as being merely unlabeled embodiments included in the scope of the broadest reasonable interpretation of the claim. Claims 39-41 are rejected by virtue of dependency.
Claim 30 recites “treating diseases comprising” followed by a list. Comprising language is nonlimiting. Therefore, every listed disease and disease NOT listed are encompassed by the broadest reasonable scope of the claim. If applicant intended to describe a Markush group, said groups are by their nature closed. “selected from the group consisting of” is appropriate language for a closed list, not comprising. 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. In contrast, the court noted the phrase "group consisting of" is a closed term, which is often used in claim drafting to signal a "Markush group" that is by its nature closed. See MPEP 2111.03.
Claims 34 and 41 recite “deploying…therapeutic immune system-related applications”. The phrasing is unclear. Applicant must amend the claim to give clear meaning to the phrase. The limitation is interpreted as the compound being used in any immune system context.
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.
Claim Rejections - 35 USC § 102
Claims 1, 8, 10-12, 15-16, 19, 24-26, 28, 30, 34-36, and 38-41 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Reinmueller (WO2017158190, 9/08/2021 IDS).
Reinmueller teaches V150 on Page 19:
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in which the following definitions of examined formula (I) apply: R1 is a bridged C10tricycloalkyl; R2, R3, R4, and R5 are H; X1, X2, X3, and X4 are CR8 wherein R8 is H; Z1 and Z2 are together oxo; and Y is OC2alkyl. Also, V150 reads on the cell of instant Claim 25, Table 7, A Row 14, B Col 4. The compounds are used for “enhancing Notch signaling”, treating Notch-related diseases including particular cancers, and for immunotherapy (i.e., “immune system-related treatment”) in cancer (Abstract; Pages 23 and 41). Compositions comprising the compound and a carrier are envisaged; water as a carrier for example is “suitable for human medicine” as claimed (Pages 27-28).
Claims 1, 8, 10-12, and 37-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cid (WO2009033702).
Cid teaches the following compound in Description 24 of Page 31:
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in which the following definitions of examined formula (I) apply: R1 of examined formula (I) is C1-alkyl with carbon being replaced by heteroatomic oxygen; R2, R3, R4, and R5 are H; X1, X2, X3, and X4 are CR8 wherein R8 is H; Z1 and Z2 are together oxo; and Y is OC1alkyl.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 8, 10-12, 15-16, 19, 24-26, 28, 30, 34-36, and 38-42 are rejected under 35 U.S.C. 103 as being unpatentable over Reinmueller (WO2017158190, 9/08/2021 IDS) in view of Hayward (Seminars in Cancer Biology 14 (2004) 387–396).
Reinmueller teaches V150 on Page 19:
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in which the following definitions of examined formula (I) apply: R1 is a bridged C10tricycloalkyl; R2, R3, R4, and R5 are H; X1, X2, X3, and X4 are CR8 wherein R8 is H; Z1 and Z2 are together oxo; and Y is OC2alkyl. Also, V150 reads on the cell of instant Claim 25, Table 7, A Row 14, B Col 4. The compounds are used for “enhancing Notch signaling”, treating Notch-related diseases including particular cancers, and for immunotherapy (i.e., “immune system-related treatment”) in cancer (Abstract; Pages 23 and 41). Compositions comprising the compound and a carrier are envisaged; water as a carrier for example is “suitable for human medicine” as claimed (Pages 27-28).
Hayward teaches “Notch1 but not Notch2 can downregulate expression of the HPV E6/E7 genes in cervical cancer cells” (Page 391, 5. Andeovirus, human…). HPV is an immune system-related ailment as viruses are associated and combatted with immune system mechanisms.
Therefore, one of skill in the art seeking to treat the particular cancer implicated with Notch signaling before the filing date of the examined invention would find it obvious to administer the Notch enhancer V150 to a patient with cervical cancer and expect successful treatment because Notch1 can downregulate HPV viral genes in said cancer.
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.
PROVISIONAL:
1. Claims 1, 8, 10-12, 15-16, 19, 24-26, 28, 30, and 34-42 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 18-20, 22-28, and 30-52 of copending Application No. 16938475 (hereinafter referred to as Xeniopro) in view of Hayward (Seminars in Cancer Biology 14 (2004) 387–396).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to Notch enhancers of similar formulae, the same embodiments, compositions comprising a carrier, and methods of treatment of the same diseases including non-melanoma skin cancer. See Claim 51 of Xeniopro for specific embodiments anticipating examined Claims 1, 8, 10-12, 15-16, 19, 24-26, and 37-38.
Xeniopro fails to teach treatment of cancers mediated by a virus.
Hayward teaches “Notch1 but not Notch2 can downregulate expression of the HPV E6/E7 genes in cervical cancer cells” (Page 391, 5. Andeovirus, human…). HPV is an immune system-related ailment as viruses are associated and combatted with immune system mechanisms.
Therefore, one of skill in the art seeking to treat the particular cancer implicated with Notch signaling before the filing date of the examined invention would find it obvious to administer the Notch enhancers of Xeniopro to a patient with HPV cervical cancer and expect successful treatment because Notch1 can downregulate HPV viral genes in said cancer.
Since both applications teach the same Notch enhancers and similar genera thereof as well as compositions and methods, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Xeniopro.
This is a provisional nonstatutory double patenting rejection.
2. Claims 1, 8, 10-12, 15-16, 19, 24-26, 28, 30, and 34-42 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-21 of copending Application No. 19308117 (hereinafter referred to as Xeniopro).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to overlapping genera of formula (I), the same embodiments, compositions with a carrier, and methods of treating cervical cancers and T-cell lymphomas (T-cells are a part of the immune system, i.e., immune system related). See Claims 9 of Xeniopro and instant 25 for shared embodiments. Particularly the very first of Table 6 in each:
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(Instant).
Since both applications teach the same embodiment and compositions for the same uses, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Xeniopro.
This is a provisional nonstatutory double patenting rejection.
NONPROVISIONAL:
1. Claims 1, 8, 10-12, 15-16, 19, 24, 26, 28, 30, 34-38, and 42 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-15 of U.S. Patent No. 10772876 (hereinafter referred to as Xeniopro) in view of Ansel (Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. 10th. Wolters Kluwer Health. 2013. Page 102) and Hayward (Seminars in Cancer Biology 14 (2004) 387–396).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to overlapping formula (I) and methods of administering the Notch enhancers to patients in immunotherapy contexts to treat cancers including non-melanoma skin cancer.
Formulae (I) are shown below:
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(Instant).
Xeniopro applies to the instant in that its R1 is an alkyl or cyclic group which is also optionally substituted with the same groups; R2-R5 are also H or halogen or alkyl, etc.; X is an aryl or heteroaryl, wherein the Z substituent reads on several embodiments of R8-R11 of including halogen, hydrocarbyls, etc.; Y is O, reading on Z1 and Z2 together forming an oxo; and R6 can be hydroxyl or alkoxyl as required of the instant Y group.
Methods of Xeniopro require compounds enclosed therein, rendering the instant formula (I) genus obvious.
Xeniopro fails to teach compositions with carriers and treatment of viral cancers.
Ansel teaches “Drug substances are seldom administered alone; rather they are given as part of a formulation in combination with one or more nonmedicinal agents that serve varied and specialized pharmaceutical functions. Selective use of these nonmedicinal agents, referred to as pharmaceutical ingredients or excipients, produces dosage forms of various types. The pharmaceutical ingredients solubilize, suspend, thicken, dilute, emulsify, stabilize, preserve, color, flavor, and fashion medicinal agents into efficacious and appealing dosage forms” (Page 102). Therefore, one of skill in the art motivated to not administer the drugs alone, would find it obvious and expect success in forming an agent or carrier to suspend, dilute, emulsify, etc. the Notch enhancer in a composition for human/animal suitability.
Hayward teaches “Notch1 but not Notch2 can downregulate expression of the HPV E6/E7 genes in cervical cancer cells” (Page 391, 5. Andeovirus, human…).
Therefore, one of skill in the art seeking to treat the particular cancer implicated with Notch signaling before the filing date of the examined invention would find it obvious to administer the Notch enhancers of Xeniopro to a patient with HPV cervical cancer and expect successful treatment because Notch1 can downregulate HPV viral genes in said cancer.
Since both claim sets teach overlapping genera of Notch enhancers for the same use, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Xeniopro.
2. Claims 1, 8, 10-12, 15-16, 19, 24-26, 28, 30, and 34-42 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 30 of U.S. Patent No. 11591289 (hereinafter referred to as Xeniopro) in view of Ansel (Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. 10th. Wolters Kluwer Health. 2013. Page 102).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to genera of overlapping Notch enhancers used to treat cancers and proliferative disorders mediated or caused by viral infection and other similar embodiments like Kaposi’s sarcoma and cervical cancer.
Regarding the common Notch enhancers, several of the same embodiments are taught between Claim 23 of Xeniopro and instant 25; e.g.,
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(Instant).
Methods of Xeniopro require compounds enclosed therein, rendering the instant formula (I) genus obvious.
Xeniopro fails to teach compositions with carriers.
Ansel teaches “Drug substances are seldom administered alone; rather they are given as part of a formulation in combination with one or more nonmedicinal agents that serve varied and specialized pharmaceutical functions. Selective use of these nonmedicinal agents, referred to as pharmaceutical ingredients or excipients, produces dosage forms of various types. The pharmaceutical ingredients solubilize, suspend, thicken, dilute, emulsify, stabilize, preserve, color, flavor, and fashion medicinal agents into efficacious and appealing dosage forms” (Page 102). Therefore, one of skill in the art motivated to not administer the drugs alone, would find it obvious and expect success in forming an agent or carrier to suspend, dilute, emulsify, etc. the Notch enhancer in a composition for human/animal suitability.
Since both claim sets teach Notch enhancers to be administered for the treatment of the same diseases, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Xeniopro.
3. Claims 1, 8, 10-12, 15-16, 19, 24-26, 28, 30, and 34-42 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-29 of U.S. Patent No. 12600696 (hereinafter referred to as Xeniopro).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to genera od Notch enhancers comprising several overlapping embodiments and compositions thereof comprising a carrier.
Regarding the common Notch enhancers, several of the same embodiments are taught between Claim 23 of Xeniopro and instant 25; e.g.,
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98
314
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(Xeniopro) and
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168
172
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(Instant).
Regarding the claims directed to compositions of matter, In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). See MPEP 804 (II) (B) (1). Columns 154-156 teach the use of the compounds for treating viral disease in immune system-related applications. Treatment of cervical cancer is also taught. Therefore, administration to achieve the uses is obvious.
Since both claim sets teach the same Notch enhancers, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Xeniopro.
Conclusion
No claim is allowable.
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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