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 of PCT/EP2021/084089, filed Dec. 3, 2021 and claims foreign priority to EP20211730.5, filed Dec. 3, 2020 with the European Patent Office.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Mar. 25, 2026 and Apr. 22, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 5-16 and 18-22 are currently pending.
Applicant’s election without traverse of Group I, claim 1-7 and 15-16, and the compound
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, in the reply filed on Dec. 2, 2025 is acknowledged. Claims 5, 7, 15 and 21 read on the elected invention. Claims 20 and 22 are newly added and dependent upon withdrawn claim 8 and are therefore also withdrawn.
Claims 5, 7, 15 and 21 are active and subject to examination.
Claims 6, 8-14, 16, 18-20 and 22 are withdrawn.
Claim Rejections – Withdrawn – Overcome by Amendment
The rejection of claims 1-5, 7 and 15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn.
The rejection of claims 1-5 and 7 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention is withdrawn.
The rejection of claims 1-5 under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention is withdrawn.
The rejection of claim(s) 1-5 and 7 under 35 U.S.C. 102(a)(1) as being anticipated by Nakamura et al. (US 20180015077 A1) is withdrawn.
The rejection of claim(s) 1-5 under 35 U.S.C. 102(a)(1) as being anticipated by Grabowski et al. (Biochemical Pharmacology, Volume 154, August 2018, Pages 148-160) is withdrawn.
The rejection of claim(s) 1-5 under 35 U.S.C. 102(a)(1) as being anticipated by Rodinovskaya et al. (Journal of Combinatorial Chemistry, Vol. 10, Issue 2, Feb. 13, 2008, p. 313-322) (of record, IDS 09/04/2025, NPL cite no. 2) is withdrawn.
The rejection of claim(s) 1-5 under 35 U.S.C. 102(a)(1) as being anticipated by Andersson et al. (Journal of Medicinal Chemistry, Vol 55/Issue 17, July 23, 2012, p. 7706-7718) is withdrawn.
The above rejections were overcome by Applicant’s amendments to the claims.
Claim Rejections – 35 USC § 112(a) – Previously Presented
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.”
The rejection of claims 15 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention is maintained.
Response to Arguments
The Applicant does not specifically traverse the rejection of claim 15 under 35 U.S.C. 112(a) and only mentions claim 5 and claim 8 (Remarks, p. 49). Claim 15 was not amended to have the limited scope as in claim 5. The rejection of claim 15 is therefore maintained.
Reiterated Rejection
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement is distinct from the enablement requirement; this was first pointed out by the court in In re Ruschig, 379 F.2d 990, 154 USPQ 118 (CCPA 1967), and clarified in Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 19 USPQ2d 1111 (Fed. Cir. 1991). The issue of whether the claimed subject matter is adequately supported/described by the specification, is a question of fact. Id. at 1563, 19 USPQ2d at Il 16.
When considering whether the claimed subject matter complies with the written description requirement, Applicants' disclosure should be read in light of the knowledge possessed by those skilled in the art.
"[T]he disclosure in question must be read in light of the knowledge possessed by those skilled in the art, and that knowledge can be established by affidavits of fact composed by an expert, and by referencing to patents and publications available to the public... "
In re Lange, 644 F.2d 856, 863, 209 USPQ 288, 294 (CCPA 1981). see also, In re Alton, 76
F.3d 1168, 37 USPQ2d 1578 (Fed. Cir. 1996).
Applicants enjoy the presumption that their patent application is valid and all statements contained therein are accurate; it is the PTO's burden to demonstrate why any of Applicants claims should be rejected or why any of Applicant's statements should be doubted.
"it is incumbent upon the Patent Office, whenever a rejection... is made, to explain why it doubts the truth or accuracy of any statement in a supporting disclosure and to back up assertions of its own with acceptable evidence or reasoning which is inconsistent with the contested statement. Otherwise, there would be no need for the applicant to go to the trouble and expense of supporting his presumptively accurate disclosure. "
In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA 1971). The court has made it clear that such challenges apply to written description rejections:
"we are of the opinion that the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims."
In re Wertheim, 191 USPQ 90, 97 (CCPA 1976).
If successful in presenting such evidence and argument, the burden then shifts to the Applicant to provide evidence that would convince one to the contrary that the disclosure as a whole provides written description support for the claimed subject matter.
The Claimed Invention
Claim 15 is directed towards a kit comprising the compound of claim 1 and a PARP inhibitor.
Claim 15 is directed towards a kit comprising the compound of claim 1 and a PARP inhibitor, and limits the ALC1 allosteric inhibitor to a compound of formula (I):
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The Supporting Disclosure
In the background of the invention, the Applicant summarizes the role of ALC1 in the poly-ADP-ribose polymerase (PARP) pathways and its implication in proliferative diseases (Specification, p. 1-4).
In the summary of the invention, the Applicant states that the present invention relates to an allosteric inhibitor of ALC1, which binds to an allosteric binding pocket formed by an amino acid stretch spanning amino acid residues 101 to 219 of SEQ ID NO: 1. The Applicant describes that the invention relates to compounds of formula (I):
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The Applicant also states that the invention relates to bifunctional compounds comprising the allosteric inhibitor and an E3 ligase ligand. The Applicant further provides pharmaceutical compositions comprising the ALC1 inhibitor (ALC1i) and a method of treating or ameliorating a proliferative disease in a patient comprising administering an ALC1i (Specification, p. 4-7).
The Applicant provides the structures of about 278 ALC1 inhibitors in Figure 10. Not all tested ALC1 inhibitors are shown in Figure 10. For example, ALC1i-117 is not shown in Figure 10. Figure 21 shows the suppliers of each compound employed by the Applicant.
In the detailed description of the invention, the Applicant describes certain embodiments and concepts pertaining to the invention, including in silico docking procedures, descriptions of the compounds of formula (I), certain PARP inhibitors, and methods of using the compound in combination with PARP inhibitors (pages 10-50). The Experimental section describes different assays employed by the Applicant to evaluate the ability of the compounds to inhibit ALC1i (pages 50-56). The primary method was a nucleosome sliding assay using purified components from which the IC50 for each compound was estimated.
Regarding claim 4, the Applicant only presents a few specific species for R1, for example carboxylic acids or esters or amides, as the hydrogen bond donating group (e.g. p. 21). The Applicant presents only a few specific species for R3, for example, H, =O, -OH, ester groups and alkyls.
The Written Description Requirement for Genus Claims
The MPEP states that the disclosure must support the full scope of the claimed genus:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
MPEP § 2161.01.
The State of the Art, Relevant facts and Applicants Lacking Disclosure
High throughput screening (HTS) is a common strategy in the art to identify enzyme inhibitors. For example, the Applicant cites Abbott et al. (Mol Cancer Ther (2020) 19 (8): 1598–1612)) on page 3 of the specification, where the first inhibitors of ALC1 were identified by a HTS of ALC1 ATPase activity. These inhibitors have varied structures and core features (see Abbott, Figure 3, displayed in the prior office action). It is unclear what binding pocket these inhibitors act through.
The Applicant only describes allosteric inhibitors of formula (I), which have varied potency for inhibition of ALC1. In Fig. 11, the IC50 of the compounds ranges from greater than 250 micromolar, 25 to 250 micromolar, and less than 25 micromolar (Fig. 11; Specification, p. 9). Applicant has not described a representative number of species falling within the genus, nor has the Applicant disclosed the structural features common to the members of the genus so that one of ordinary skill in the art could visualize or recognize members of the genus. Applicant’s own data establish that the recited structure does not correlate with the recited function across the claim scope. As shown in Fig. 11, compounds of formula (I) range from potent inhibitors to compounds with no meaningful inhibition, and the specification does not identify which structural features within formula (I) distinguish the former from the latter.
Accordingly, the specification does not reasonably convey to one skilled in the art that the inventors had possession of the full scope of claim 15 at the time the Application was filed.
Claim Rejections – 35 USC § 102 – New Grounds of Rejection Necessitated by Amendment
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.”
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “11-(3,4-Dichlorophenyl)-13-(difluoromethyl)-8-thia-3,5,10-triazatricyclo[7.4.0.02,7]trideca-1(9),2(7),10,12-tetraene-4,6-dione” (PubChem, PubChem CID 20417160, First published Dec. 5, 2007) (herein “PubChem”).
Claim 5 is directed towards an allosteric ALC1 inhibitor compound of formula (I):
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The preamble is not a limitation because it merely recites a purpose or intended use (see MPEP 2111.02(II)).
PubChem teaches a compound falling within the genus of formula (I), wherein X is S, R1 and R2 together form uracil, R3 is difluoromethyl, A is C, R4 is H and R5 is phenyl substituted with two Cl substituents:
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PubChem, p. 2.
Therefore, claim 5 is anticipated.
Claim Rejections – 35 USC § 103 – New Grounds of Rejection Necessitated by Amendment
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.”
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5, 7 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reichelt et al. (WO2006010568A2) in view of McCurdy & Cohen (Bioisosterism, DrugDesignOrg, Feb. 2007, p. 1-138).
Claim 5 is directed towards an allosteric inhibitor of ALC1 having the structure of formula (I):
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For example, a compound of formula (I) is:
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(claim 21).
Reichelt teaches a compound largely similar to the compounds of formula (I) including the exemplified species above:
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Reichelt, Spec., Translation, p. 27, Compound 10d.
Reichelt teaches that this compound is a TNFα inhibitor of formula 1a:
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Id., p. 8.
Reichelt teaches such compounds are useful for the treatment of diseases such as “chronic inflammatory diseases, autoimmune diseases, cardiovascular diseases, viral diseases and especially retroviral diseases such as the acquired immunodeficiency syndrome (AIDS) and cancer, especially degeneration of the hematopoietic system.” (Id., p. 10).
While compound of Reichelt differs from the claimed compound of formula (I) in that the phenyl is substituted with methoxy instead of a halogen, one of ordinary skill in the art would have a reasonable expectation of success to substitute methoxy for a halogen because it is well known in the art that methoxy is an equivalent substituent (isosteric) to halogen.
For example, McCurdy & Cohen teach that methoxy is equivalent to halogens (methoxy is equivalent to F and Cl which are equivalent to Br):
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McCurdy & Cohen, p. 11-12.
A rejection based on close structural similarity is founded on the expectation that compounds similar in structure will have similar properties:
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979)
MPEP § 2144.09.
Therefore, claim 5 was prima facie obvious at the time of filing.
Claim 7 is directed towards a pharmaceutical composition comprising an allosteric inhibitor of ALC1 of claim 5 and a pharmaceutically acceptable excipient.
Reichelt teaches pharmaceutical compositions comprising compounds equivalent to the compounds of claim 5 together with a pharmaceutically acceptable excipient: “If appropriate, the compounds according to the invention can be formulated together with further active compounds and with excipients customary in pharmaceutical compositions” (Reichelt, Spec., Translation, p. 10).
Therefore, claim 7 was prima facie obvious at the time of filing.
Claim 21 is directed towards the ALC1 inhibitor according to claim 5, wherein the inhibitor has the structure:
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The rejection of claim 5 is incorporated herein by reference. Therefore, claim 21 was prima facie obvious at the time of filing.
Claim(s) 5, 7, 15 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reichelt et al. (WO2006010568A2) in view of McCurdy & Cohen (Bioisosterism, DrugDesignOrg, Feb. 2007, p. 1-138), as applied to claims 5, 7 and 21 above, and further in view of Kroger et al. (Inflammation, Vol. 20, No. 2, 1996, p. 203).
The rejection of claims 5, 7 and 21 above are incorporated herein by reference.
Claim 15 is directed towards a kit of parts comprising separately packaged PARPi and an ALC1i or a composition comprising a PARPi and an ALC1i, wherein the ALC1i has a structure of formula (I):
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The ALC1i is fully defined by the structure of formula (I). Reichelt teaches compounds falling within formula (I) of claim 15, including, but not limited to:
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Reichelt, Spec., Translation, p. 27, Compound 10d;
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Id., Compounds 4-6.
Reichelt teaches such compounds are TNF-alpha inhibitors useful for the treatment of diseases such as “chronic inflammatory diseases, autoimmune diseases, cardiovascular diseases, viral diseases and especially retroviral diseases such as the acquired immunodeficiency syndrome (AIDS) and cancer, especially degeneration of the hematopoietic system.” (Id., p. 10).
Reichelt teaches that such compounds can be included in compositions together with further active compounds: “If appropriate, the compounds according to the invention can be formulated together with further active compounds and with excipients customary in pharmaceutical compositions” (Reichelt, Spec., Translation, p. 10). Reichelt teaches that such pharmaceutical compositions can exhibit synergy and have enhanced therapeutic effectiveness:
The compounds according to the invention are also suitable in the context of combination therapies with already known active compounds for the treatment of the abovementioned diseases. In this case, surprising synergy effects are to be used to increase the therapeutic effectiveness of the substances according to the invention. The combination may be to offer a single pharmaceutical composition comprising at least one of the compounds of the present invention in combination with one or more of the following, or simultaneously or temporally displaced to the patient, several agents containing one or more of the following active ingredients administered.
Id., p. 11.
While Reichelt does not teach that the additional agent is a PARP inhibitor, one of ordinary skill in the art would have a reasonable expectation of success to formulate a compound of formula (I) such as those taught by Reichelt in combination with PARP inhibitors because it is commonly known in the art that PARP inhibitors exhibit synergistic effects with TNF-alpha inhibitors.
For example, Kroger teaches that the combined application of a TNF-alpha inhibitor with a PARP inhibitor caused a powerful synergistic inhibition of arthritis:
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Kroger, Abstract.
The compound’s function as an ALC1 inhibitor is not necessary to show obviousness (“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” (MPEP § 2112)).
Therefore, claim 15 was prima facie obvious at the time of filing.
Claim Rejections – 35 USC § 103 – Previously Presented
The rejection of claim(s) 15 under 35 U.S.C. 103 as being unpatentable over Andersson et al. (Journal of Medicinal Chemistry, Vol 55/Issue 17, July 23, 2012, p. 7706-7718) and further in view of Chang et al. (US 20110097329 A1) is maintained.
Response to Arguments
The Applicant argues that Andersson does not teach a compound of claim 5 (Remarks, p. 56). These arguments were fully considered but are not persuasive. Claim 15 does not depend upon claim 5 and claims a different compound of formula (I) than claim 5. The compound of Andersson is a compound of formula (I) as in claim 15, as shown below and in the prior office action.
The Applicant argues that a potential use for treating a proliferative disease is not mentioned in Andersson (id.). These arguments were fully considered but are not persuasive. Andersson teaches that PARP inhibitors have utility in the treatment of cancer (Andersson, Abstract). Nonetheless, Andersson is not being asserted alone, but is asserted in combination with Chang, who teaches that PARP14 inhibitors have utility in the treatment and prevention of proliferative diseases:
The invention further provides kits containing one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10) of the pharmaceutical compositions described herein. The kits may further contain materials to aid in the administration of the pharmaceutical agents (e.g., a syringe). The kits may contain one or more doses of a pharmaceutical agent provided by the invention. The kits may further contain instructions for administering the pharmaceutical compositions to a subject having a stress granule-related disorder or cancer, or a subject that has a high probability of developing (a high propensity) for developing a stress granule-related disorder or cancer.
Chang, Specification, paragraph [0147] (cited in the last office action).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The Applicant argues that Chang does not refer to small molecule compounds that allosterically inhibit ALC1 and that Andersson generally relates to providing compounds suitable for studying the function of proteins and not ARTD7 inhibitors for medical use (Remarks, p. 56). These arguments were fully considered but are not persuasive. Andersson teaches that a compound of formula (I) (compound 10) is a selective PARP14 inhibitor. As shown above, Andersson teaches that PARP14 inhibitors have a medical use in the treatment of cancer. One of ordinary skill in the art would have a reasonable expectation of success to include this compound (an ALC1i) in a kit of parts comprising a separately packaged PARPi and the ALC1i because kits comprising one or more PARP inhibitors are commonly known in the art for the treatment of cancer, as shown by Cheng. The compound’s function as an ALC1 inhibitor is not necessary to show obviousness (“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” (MPEP § 2112)). Nor is it necessary to show that Andersson used a PARP14 inhibitor for a medical purpose because the medical purpose of PARP14 inhibitors was commonly known in the art at the time of filing. Similarly, Applicant has extrapolated data from an in silico screen and in vitro enzymatic testing to a medical use. In vivo or other data is not necessary to establish a medical use.
Reiterated Rejection
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. (Journal of Medicinal Chemistry, Vol 55/Issue 17, July 23, 2012, p. 7706-7718) and further in view of Chang et al. (US 20110097329 A1).
Claim 15 is directed towards a kit of parts comprising separately packaged PARPi and an ALC1i or a composition comprising a PARPi and an ALC1i, wherein the ALC1i has a structure of formula (I):
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Andersson teaches a compound of formula (I) as a PARP14 (ARTD8) inhibitor:
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Andersson, p. 7710;
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Andersson, p. 7711.
While Andersson does not teach that the compound is an allosteric inhibitor of ALC1, this is an inherent property of the compound. This compound is disclosed in the specification as ALCi-61 (Figure 10), which is shown to have ALC1 inhibitory activity in Fig. 23.
One of ordinary skill in the art would have a reasonable expectation of success to include this compound (compound 10) in a kit of parts comprising a separately packaged PARPi and the ALC1i because kits comprising one or more PARP inhibitors are commonly known in the art.
For example, Chang teaches kits containing one or more PARP inhibitors:
The invention further provides kits containing one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10) of the pharmaceutical compositions described herein. The kits may further contain materials to aid in the administration of the pharmaceutical agents (e.g., a syringe). The kits may contain one or more doses of a pharmaceutical agent provided by the invention. The kits may further contain instructions for administering the pharmaceutical compositions to a subject having a stress granule-related disorder or cancer, or a subject that has a high probability of developing (a high propensity) for developing a stress granule-related disorder or cancer.
Chang, Specification, paragraph [0147];
In each of these methods, compositions, and kits, the one or more PARP inhibitor(s) may selectively decrease (e.g., at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 99%, or even 100% decrease) the expression (e.g., mRNA and/or protein) and/or one or more (e.g., 1, 2, 3, 4, or 5) activities of one or more (e.g., 1, 2, 3, 4, 5, 6, 7, or 8) of PARP1, PARP2, PARP5A, PARP5B, PARP7, PARP8, PARP14, and PARP16.
Chang, Specification, paragraph [0014].
Therefore, claim 15 was prima facie obvious at the time of filing.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Conclusion
No claim is found to be 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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