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 .
Detailed Action
Claims 1-19 are currently pending.
Election/Restriction
Applicant’s election without traverse of Group I (Claims 1-4 and 18-19, drawn to compositions comprising TDP-43 inhibitors) and the elected species
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in the reply filed on 5/27/2026 is acknowledged.
Claims 5-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group II or unelected species, there being no allowable generic or linking claim. Thus, Claims 1-4 and 18-19 are being examined on the merits herein.
Specification
The specification is objected to because the claimed compounds of Claim 4 are numbered as follows: nTRD013, nTRD025, nTRD027 throughout the specification. However, the tested compounds of Figure 2 and recited in the brief descriptions lack the “0”. For example, nTRD27 is listed in Figure 2, but nTRD027 is recited in the specification. Standardization of the compound names is required.
Claim Interpretation
Regarding Claim 18, written instructions are not given patentable weight in this case. Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). In King Pharma, the court found that the relevant determination is whether the "instruction limitation" has a "new and unobvious functional relationship" with the known method of administering the drug with food. Id. The court held that the relationship was non-functional because "[i]nforming a patient about the benefits of a drug in no way transforms the process of taking the drug with food." Id. That is, the actual method of taking a drug with food is the same regardless of whether the patient is informed of the benefits. Id. "In other words, the ‘informing’ limitation ‘in no way depends on the method, and the method does not depend on the ‘informing’ limitation.’" Id. (citing In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)); see also In re Kao, 639 F.3d 1057, 1072-73, 98 USPQ2d 1799, 1811-12 (Fed. Cir. 2011). See MPEP 2112.01 (III).
Regarding Claim 19, the recitation “pharmaceutical composition comprising a composition” is interpreted to limit the composition of Claim 1 to the scope of a composition that is pharmaceutically acceptable for administration to a patient. No additional, specific agent is required by the claim language of Claim 19.
Claim Objections
Claim 2 is objected to because inhibiting is repeated in the following recitation: “of inhibiting inhibiting TDP-43”.
Claims 18-19 are objected to because “a composition” should instead read “the composition” in both claims.
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 1-4 and 18-19 are 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.
Applicant depicts four structures in Claim 4 and throughout the specification which are capable of inhibiting TDP-43. However, the scope of applicant’s claims encompass any small molecule without structural limitation as well as antibodies and mimetic peptides. The scope of the claim set is broader than even those broad genera; Claim 1 encompasses any agent at all capable of “inhibiting TDP-43 activity”. Again, applicant only reduces to practice four compounds which do not share a common structure. Pages 3-4 depict said compounds. However, applicant fails to describe in adequate detail how the function of inhibiting TDP-43 activity is achieved through a particular structure or motif; therefore, no structure-function relationship is offered so as to convey to one of skill in the art that applicant had possession of the entire scope of small molecules capable of the activity claimed. The functionalities listed in Claim 2 are also not drawn to a particular structure nor is a structure-function relationship established.
Larsen (WO2017066705) teaches hundreds of small molecule compounds which are claimed to inhibit activity of TDP-43 (Fig. 1A; Page 189, Example 27; Page 191, Example 29; Claims 1, 33, and 59-60 ). The breadth of small molecule compounds known in the art are not contemplated in the instant disclosure. Further, the broad genus of antibodies and mimetic peptides lack written description. No representative array of these structures is provided to ascertain what antibodies and peptides exhibit the activity as claimed or what required features are present in such agents to achieve the broad aims of inhibiting TDP-43 activity.
Regarding Claim 4, the phrase “structurally similar compound” does not limit the scope of the claim to any particular structure. No bounds or limits are placed on what the term “similar” might mean and, therefore, may encompass a vast array of compounds which are not described in detail to convey applicant’s possession of any compound that might be considered “similar”. Again, no structure-function relationship is established between any compound that may be “similar” to the disparate four compounds of Claim 4 and the ability of said similar compounds to inhibit TDP-43 as claimed.
Therefore, applicant at the time of filing the invention did not have possession of the scope of Claims 1-4, particularly Claims 1-3 describing broad functional genera. Claims 18-19 are rejected by virtue of dependency.
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 2 and 4 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 2 recites “engaging a pocket within the TDP-43”. It is unclear what engaging means in the context of the pocket. Does engaging refer to activation through direct binding or through some mechanism triggered by binding another pocket or site on the TDP-43? Does engaging mean binding and blocking some other substrate? It is unclear what limitation the term “engaging” imposes on the desired activity of the agent or if some structural requirement with respect to engaging said pocket is imposed.
Claim 2 recites “the RNA binding domain (RRM)”. “the” lacks antecedent basis, making the term ambiguous. Applicant explains on Page 1 of the specification that “two RNA recognition motifs (RRM1 and RRM2)” are present in TDP-43. Does “the” RRM refer to one of or both of these distinct domains? It is not clear from the construction of the claim.
Claim 4 recites no less than four times “a structurally similar compound”. When referring to the elected species
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, for example, does “structurally similar” require the same cyclic components? Same linkages? Does such a phrase allow for variation up to the point that only a single cycle or functional group is shared between the elected species and what might be considered a “structurally similar” compound? The metes and bounds are unclear. For the purpose of compact prosecution, the genus of Claim 4 is interpreted to be limited to the drawn structures.
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
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larsen (WO2017066705).
Larsen teaches compounds “for TDP-43 Inhibition” (Page 189). TDP-43 inclusions, an activity resulting from TDP-43, are treated and inhibited with exemplary small molecule compounds (Page 189, Example 27). TDP-43 aggregation is also inhibited (Page 191, Example 29). Pharmaceutical compositions specifically are claimed for the inhibition of TDP-43 inclusion formation activity comprising small molecules of the following formulae:
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and
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(Claims 1, 33, and 59-61).
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Francois (ACS Chem. Biol. 2019, 14, 2006−2013; published June 16, 2019; 5/31/2024 IDS).
Francois teaches “Computational in silico docking and biochemical experiments identified a compound, 6-(3-(4-fluorobenzyl)-3-(hydroxymethyl) piperidin-1-yl)pyrazine-2-carboxamide (hereafter designated as rTRD01 [
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] for RRM TDP-43 RNA disruptor 01) that bound to TDP-43 in the micromolar range. As it is critical for TDP-43 to maintain normal nucleic acid binding activity in the cell, we tested rTRD01 for its ability to bind normal and disease-linked nucleic acids. rTRD01 was able to reduce TDP 43 interactions with disease-linked nucleic acid while not interfering with a TDP-43 canonical substrate (UG rich binding sequence) in vitro. Finally, rTRD01 reduced ALS-like locomotor phenotypes in a Drosophila model” (Page 2007). The small molecule disrupted DNA binding via modulation of RRM and restored motor impairment in ALS models as required by Claim 2.
The pharmaceutical agent is taught to be included in a composition comprising buffer; “50 nM of labeled protein was mixed with a range of concentrations of rTRD01 in PBST buffer.” (Page 2011).
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, 3, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen (WO2017066705) in view of Bauer (Pharmaceutical Packaging Handbook (1st ed.). CRC Press. eBook 2016. pp iii-iv, 23.)
Larsen teaches compounds “for TDP-43 Inhibition” (Page 189). TDP-43 inclusions, an activity resulting from TDP-43, are treated and inhibited with exemplary small molecule compounds (Page 189, Example 27). TDP-43 aggregation is also inhibited (Page 191, Example 29). Pharmaceutical compositions specifically are claimed for the inhibition of TDP-43 inclusion formation activity comprising small molecules of the following formulae:
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and
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(Claims 1, 33, and 59-61).
Larsen does not teach a kit comprising pharmaceutical packaging and instructions for use.
Bauer teaches “Packaging provides containment, protection, and safe delivery of products everywhere health care is needed and makes possible the availability and use of drugs, vaccines and medical devices in hostile environments” (Page iii). “[L]abeled packaging, defined as the label, carton, insert, or electronic media such as a CD or other digital forms of information that is part of the package, provides the health care professional and the patient with the most complete set of instructions, warnings, cautions, and side effects for the product” (Page 23).
One seeking to preserve a composition as taught in Larsen would find it obvious to form a kit comprising packaging containment of the composition and instructions because Bauer teaches packaging provides protection and makes drugs with instructions for use by providers and patients available in hostile environments. One would expect success in doing so because Bauer teaches broadly and does not preclude any particular therapeutic agent from being packaged. (Although Bauer teaches providing instructions for use, where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP 2112.01 (III).)
Claims 1-3 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Francois (ACS Chem. Biol. 2019, 14, 2006−2013; published June 16, 2019; 5/31/2024 IDS) in view of Ansel (Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. 10th. Wolters Kluwer Health. 2013. Page 102) and Bauer (Pharmaceutical Packaging Handbook (1st ed.). CRC Press. eBook 2016. pp iii-iv, 23.)
Francois teaches “Computational in silico docking and biochemical experiments identified a compound, 6-(3-(4-fluorobenzyl)-3-(hydroxymethyl) piperidin-1-yl)pyrazine-2-carboxamide (hereafter designated as rTRD01 [
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] for RRM TDP-43 RNA disruptor 01) that bound to TDP-43 in the micromolar range. As it is critical for TDP-43 to maintain normal nucleic acid binding activity in the cell, we tested rTRD01 for its ability to bind normal and disease-linked nucleic acids. rTRD01 was able to reduce TDP 43 interactions with disease-linked nucleic acid while not interfering with a TDP-43 canonical substrate (UG rich binding sequence) in vitro. Finally, rTRD01 reduced ALS-like locomotor phenotypes in a Drosophila model” (Page 2007). The small molecule disrupted DNA binding via modulation of RRM and restored motor impairment in ALS models as required by Claim 2.
Francois does not teach a pharmaceutically acceptable composition of the composition of Claim 1 or kit thereof comprising pharmaceutical packaging and instructions for use.
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).
Bauer teaches “Packaging provides containment, protection, and safe delivery of products everywhere health care is needed and makes possible the availability and use of drugs, vaccines and medical devices in hostile environments” (Page iii). “[L]abeled packaging, defined as the label, carton, insert, or electronic media such as a CD or other digital forms of information that is part of the package, provides the health care professional and the patient with the most complete set of instructions, warnings, cautions, and side effects for the product” (Page 23).
Therefore, one of skill in the art seeking to administer the Francois drug to achieve the therapeutic effects of rTRD01 would find it obvious to formulate a pharmaceutical composition comprising agents to “solubilize, suspend, thicken, dilute, emulsify, stabilize, preserve, color, flavor, and fashion” the agent before the effective filing date of the examined invention. One of skill in the art would expect success in formulating some form of pharmaceutical composition because Ansel broadly teaches drugs are seldom administered alone but given as part of a formulation. Further, one seeking to preserve such a composition would find it obvious to form a kit comprising packaging containment of said composition and instructions because Bauer teaches packaging provides protection and makes drugs with instructions for use by providers and patients available in hostile environments. One would expect success in doing so because Bauer teaches broadly and does not preclude any particular therapeutic agent from being packaged. (Although Bauer teaches providing instructions for use, where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP 2112.01 (III).)
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:
Claims 1-3 and 18-19 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-20 of copending Application No. 18287427 (hereinafter referred to as Arizona) in view of Bauer (Pharmaceutical Packaging Handbook (1st ed.). CRC Press. eBook 2016. pp iii-iv, 23.).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a composition or pharmaceutical composition comprising an inhibitor of TDP-43 activity selected from an antibody, mimetic peptide, or small molecule.
Arizona teaches agents for inhibiting other protein activity in addition to TDP-43, but said additional activity is encompassed within the scope of the instant claim set. Selectivity is not a feature of the examined claims or agents described therein.
Arizona teaches methods of use which require the compositions as claimed in the instant application.
Regarding instant Claim 2, Arizona Claim 15 describes treating motor neuron disease thereby “mitigating motor impairment in a subject suffering” from said motor-affecting disease.
Arizona fails to teach a kit with instructions as described in Claim 18.
Bauer teaches “Packaging provides containment, protection, and safe delivery of products everywhere health care is needed and makes possible the availability and use of drugs, vaccines and medical devices in hostile environments” (Page iii). “[L]abeled packaging, defined as the label, carton, insert, or electronic media such as a CD or other digital forms of information that is part of the package, provides the health care professional and the patient with the most complete set of instructions, warnings, cautions, and side effects for the product” (Page 23).
One seeking to preserve a composition as taught in Arizona would find it obvious to form a kit comprising packaging containment of the composition and instructions because Bauer teaches packaging provides protection and makes drugs with instructions for use by providers and patients available in hostile environments. One would expect success in doing so because Bauer teaches broadly and does not preclude any particular therapeutic agent from being packaged. (Although Bauer teaches providing instructions for use, where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP 2112.01 (III).)
Since both applications teach compositions comprising an inhibitor of TDP-43 activity, 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 Arizona.
This is a provisional nonstatutory double patenting rejection.
NONPROVISIONAL:
Claims 1-3 and 18-19 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-11 of U.S. Patent No. 11147795 (hereinafter referred to as Arizona) in view of Bauer (Pharmaceutical Packaging Handbook (1st ed.). CRC Press. eBook 2016. pp iii-iv, 23.).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a small molecule inhibitor of TDP-43 activity capable of mitigating locomotor dysfunction.
Arizona teaches small molecule inhibitors of TDP-43 toxicity, toxicity being an activity thereof, as follows:
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Arizona teaches methods of use which require the compounds as claimed in the instant application.
Arizona does not teach compositions explicitly; however, Claims 7-9 of Arizona teach administering additional agents. An artisan of ordinary skill in the art would find it obvious to formulate the two agents in a pharmaceutical composition because a single dose is advantageous for ease of administration as compared to two separate doses. The artisan would expect success in doing so because “further…administering” suggests that the coadministration of the agents is safe and effective for treating the claimed diseases.
Arizona fails to teach a kit with instructions as described in Claim 18.
Bauer teaches “Packaging provides containment, protection, and safe delivery of products everywhere health care is needed and makes possible the availability and use of drugs, vaccines and medical devices in hostile environments” (Page iii). “[L]abeled packaging, defined as the label, carton, insert, or electronic media such as a CD or other digital forms of information that is part of the package, provides the health care professional and the patient with the most complete set of instructions, warnings, cautions, and side effects for the product” (Page 23).
One seeking to preserve a composition as taught in Arizona would find it obvious to form a kit comprising packaging containment of the composition and instructions because Bauer teaches packaging provides protection and makes drugs with instructions for use by providers and patients available in hostile environments. One would expect success in doing so because Bauer teaches broadly and does not preclude any particular therapeutic agent from being packaged. (Although Bauer teaches providing instructions for use, where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP 2112.01 (III).)
Since both claim sets teach TDP-43 activity inhibitors in the form of small molecules, 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 Arizona.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
Prosecution Insights