DETAILED ACTION
Claims 195-197 are currently pending in the instant application and are rejected.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim 195 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,682,928. Although the claims at issue are not identical, they are not patentably distinct from each other because conflicting claim 1 claims:
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which corresponds to the formula X of Applicant’s instant claim 195 wherein Y is sulfur; Z is nitrogen; R8 and R9 together with the atom to which they are attached, for a heterocycloalkyl group; and R10 is hydrogen. While the conflicting claim 1 is a product claim, the specification of the ‘928 patent provides on column 44 that the present inventions provides methods of using the compounds of formulas I-XXVI for treating disorders involving a GAGAA receptor including the treatment of status epilepticus.
With regard to obviousness-type double patenting of a method claim over a patented composition, the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent.
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
Pfizer, 518 F3d 1353 at 1363 (Fed. Cir. 2008).
Geneva, 349 F3d at 1386 (Fed. Cir. 2003).
One skilled in the art would thus be motivated to prepare products embraced by the ‘928 patent to arrive at the instant products with the expectation of obtaining additional beneficial products would be useful in treating status epilepticus. The instant claimed invention would have been suggested to one skilled in the art and therefore, the instant claimed invention would have been obvious to one skilled in the art.
Claim Rejections - 35 USC § 112
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 195-197 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’s amendment filed 13 September 2023 cancels the pending claims and adds claims 195-197 which have the added phrases of “increasing pre-synaptic inhibition without depressing all GABAS receptors by” and “wherein the compound increases neuronal inhibition by acting at interneuron terminals and regulating neuronal firing.” The remarks filed on 13 September 2023 by Applicant’s representative provides:
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The as filed specification paragraph [0384], page 246, discussing the compound NTP-2014 provides:
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which does not support the new claim language. The compound NTP-2014 is found in paragraph [0579], page 299, as
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which is:
not within the formula X as instantly claimed in claim 195 and does not correspond to the species as found in claims 196-197. There is no disclosure of the phrases “increasing pre-synaptic inhibition without depressing all GABAS receptors by” and “wherein the compound increases neuronal inhibition by acting at interneuron terminals and regulating neuronal firing” in regards to formula X or the species found in the instant method claims.
The specification does not describe a method of treating status epilepticus in a patient in need thereof comprising increasing pre-synaptic inhibition without depressing all GABA receptors by administering a compound of formula X:
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, including:
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and
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or pharmaceutically acceptable salts thereof wherein the compound increases neuronal inhibition by acting at interneuron terminals and regulating neuronal firing.
In addition, based on the original disclosure one of skill in the art would not recognize that Applicant possessed this discovery.
As per MPEP § 2163-II.A.3.(b): With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4 (Fed. Cir. 2007) (citing MPEP § 2163.04 which provides that a "simple statement such as ‘applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘___’ in the application as filed’ may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported."); see also MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure."); and MPEP § 2163.04 ("If applicant amends the claims and points out where and/or how the originally filed disclosure supports the amendment(s), and the examiner finds that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of the filing of the application, the examiner has the initial burden of presenting evidence or reasoning to explain why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims."). The inquiry into whether the description requirement is met is a question of fact that must be determined on a case-by-case basis. AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1297, 111 USPQ2d 1780, 1788 (Fed. Cir. 2014) ("Whether a patent claim is supported by an adequate written description is a question of fact."); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) ("Precisely how close [to the claimed invention] the description must come to comply with Sec. 112 must be left to case-by-case development."); In re Wertheim, 541 F.2d at 262, 191 USPQ at 96 (inquiry is primarily factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure).
The examiner could not locate support for such a limitation of “increasing pre-synaptic inhibition without depressing all GABAS receptors by” and “wherein the compound increases neuronal inhibition by acting at interneuron terminals and regulating neuronal firing” in regards to the treatment of status epilepticus with formula X, or the species of claims 196 and 197, nor does there appear to be a written description of the limitation in the application as filed. See Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007) (holding that "[MPEP] § 2163.04 (I)(B) as written is a lawful formulation of the prima facie standard for a lack of written description rejection."). There is no literal support for the limitations in the new claims added 13 September 2023 and one of skill in the art would not recognize that Applicant possessed the claim scope. Thus, claims 195-197 are rejected.
Claim Rejections - 35 USC § 102
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 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.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 195-197 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by WO 2007/047447.
WO 2007/047447 discloses the compounds of examples 14 (page 82):
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and claim 2, page 113, bumetanide dibenzylthioamide, which correspond to the compounds of claims 195 and 196.
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and
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which corresponds to instant claims 195 and 197. Additionally, these compounds correspond to the formula X wherein Y is sulfur; Z is nitrogen; R10 is H; and R8 and R9 are each alkyl or alkaryl. Page 2 provides a discussion on status epilepticus. Page 74 provides the methods of treatment including the treatment of status epilepticus with the compounds of the prior art invention.
While the prior art reference fails to expressly teach “increasing pre-synaptic inhibition without depressing all GABAS receptors by” and “wherein the compound increases neuronal inhibition by acting at interneuron terminals and regulating neuronal firing.” These results would occur inherently upon administering the same composition to the same patient population. While the prior art reference does not describe the effect of its methods on status epilepticus, the prior art does provide the administering the same compound as instantly claimed to the same population (one with status epilepticus), which would inherently increase pre-synaptic inhibition without depressing all GABAS receptors and the compound would increase neuronal inhibition by acting at interneuron terminals and regulating neuronal firing. The prior art does provide the compounds of the instant claims for the treatment of status epilepticus, the same compounds administered to treat the same disease to the same population as treating is defined on page 72 of the prior art reference to be reducing the severity of the disorder or the disorder is partially or entirely eliminated. Therefore, the patient population would be one with status epilepticus. Additionally, in regards to “increasing pre-synaptic inhibition without depressing all GABAS receptors by” and “wherein the compound increases neuronal inhibition by acting at interneuron terminals and regulating neuronal firing” these characteristics would necessarily be derived from employing the instantly claimed method. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01(II).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 26 February 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600