DETAILED ACTION
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 .
Status of the Claims
Claims 16-43 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/18/2024, have been received and entered into the instant application. As reflected by the attached, completed copies of form PTO-1449, the Examiner has considered the cited references to the extent that they comply with the provisions of 37 C.F.R. §1.97, §1.98, and MPEP §609.
Priority
This application filed on 03/18/2024, is a 371 of PCT/EP2022/075782, filed on 09/16/2022, which claims benefit of EPO Application No. EP21382845.2, filed on 09/20/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
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.
Claims 16-43 are rejected under 35 U.S.C. 103 as being unpatentable over Virgili-Bernado et al (hereinafter “Virgili-Bernado”, WO2017084752A1, published 05/26/2017).
By way of a background, Applicants disclose that through their invention, Applicants surprisingly and unexpectedly discovered the oxadiazaspiro compounds of their invention as selective σ1 receptor agonist, which display neuroprotection activity (see, e.g., pages 1-4 of the specification).
Independent claim 16 is directed to a method for providing neuroprotection and/or treating motoneuron degeneration with an oxadiazaspiro compound of formula (I):
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Similar to the Applicants’ invention (see discussions above), Virgili-Bernado relates to oxadiazaspiro compounds with great affinity for σ1 receptors and use of the compounds for treating σ1 related diseases or disorders (see page 5). σ1 receptor is known for its neuroprotective activity (see pages 1-2). Specifically, Virgili-Bernado (see page 25), teaches oxadiazaspiro compound of formula (IZ):
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, which is identical to the claimed compound of formula (I). Virgili-Bernado (see pages 200-218), teaches compounds recited in instant claims 34-35. For example, Virgili-Bernado on page 200, teaches 12-ethyl-8- isopentyl-4-oxa-8,12-diazadispiro[ 2.1.5.3 ]tridecan-13-one, as compound 1 (identical to 1st compound recited in instant claim 34), and on page 215, teaches (S)-9-(4-fluorobenzyl)-2,4-dimethyl-1-oxa-4,9-diazaspiro[5.5]undecan-3-one, as compound 89 (identical to 1st compound recited in instant claim 34). Virgili-Bernado teaches σ1 receptor agonist activity of exemplary compounds recited in instant claims 34-35 (see pages 221-227).
Accordingly, at the time of the instant invention, a person skilled in the art would have understood that Virgili-Bernado envisioned a method for providing neuroprotection with a σ1 receptor agonist exemplified by the an oxadiazaspiro compound disclosed by Virgili-Bernado. An artisan of the ordinary skill would have envisaged a method for providing neuroprotection with a σ1 receptor agonist exemplified by the an oxadiazaspiro compound disclosed by Virgili-Bernado, in the disclosures of Virgili-Bernado.
One skilled in the art would have had a reasonable expectation that the administration of a σ1 receptor agonist compound of Virgili-Bernado to a subject in need thereof, would provide neuroprotection in the subject.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Regarding claims 37-42, the recited dosing regimes are result effective variables that would have been routinely determined and optimized in the pharmaceutical art. For example, Virgili-Bernado (see page 167), states:
“Generally, an effective administered amount of a compound of the invention will depend on the relative efficacy of the compound chosen, the severity of the disorder being treated and the weight of the sufferer. However, active compounds will typically be administered once or more times a day for example 1, 2, 3 or 4 times daily, with typical total daily doses in the range of from 0.1 to 1000 mg/kg/day.”
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
Regarding claim 43, Virgili-Bernado (see page 166), states:
“Another aspect of the invention refers to a pharmaceutical composition which comprises a compound according to the invention as described above according to general formula I or a pharmaceutically acceptable salt or steroisomer thereof, and a pharmaceutically acceptable carrier, adjuvant or vehicle. The present invention thus provides pharmaceutical compositions comprising a compound of this invention, or a pharmaceutically acceptable salt or stereoisomers thereof together with a pharmaceutically acceptable carrier, adjuvant, or vehicle, for administration to a patient.”
Thertefore, claims 16-43 are obvious over Virgili-Bernado.
Claims 16-43 are rejected under 35 U.S.C. 103 as being unpatentable over Modol-Caballero et al (hereinafter “Modol-Caballero”, Frontiers in Cellular Neuroscience, 2018, 11(431), 1-11), in view of Virgili-Bernado (WO2017084752A1, published 05/26/2017).
The corresponding teachings of Virgili-Bernado is disclosed above, and are hereby incorpoaretd into the instant rejections.
Regarding claims 16-43, Modol-Caballero (see, e.g., Figure 1), teaches a method for using a σ1 receptor agonist (PRE084), to provide neuroprotection in motoneuron (MN) under chronic excitotoxicity by DL-threo-b-hydroxyaspartic acid (THA).
Modol-Caballero differs from the claimed invention only insofar as Modol-Caballero is not explicit in disclosing an oxadiazaspiro compound of the claimed invention, as a σ1 receptor agonist.
However, the claimed invention would have been obvious over Modol-Caballero, because at the time of the instant invention, an oxadiazaspiro compound of the claimed invention was known in the art as a σ1 receptor agonist. For example, Virgili-Bernado teaches an oxadiazaspiro compound of the claimed invention as a σ1 receptor agonist that can be employed for providing neuroprotection and treating σ1 related diseases or disorders (see discussions above).
Accordingly, at the time of the instant invention, a person skilled in the art would have found it obvious to administer a σ1 receptor agonist (e.g., oxadiazaspiro compound of Virgili-Bernado), to a subject in need of neuroprotection, with a reasonable expectation of providing neuroprotection in the subject.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
The skilled artisan would have found it obvious to substitute one known element (a σ1 receptor agonist of Virgili-Bernado, i.e., oxadiazaspiro compound) for another (a σ1 receptor agonist of Modol-Caballero, i.e., PRE084), for the predictable result of providing neuroprotection in a subject in need thereof (Modol-Caballero).
The use of simple substitution of one known element for another to obtain predictable results as a requirement of a prima facie case of obviousness has been deemed as proper (please see MPEP § 2143). In the instant case, the one known element is a σ1 receptor agonist and the predictable results is providing neuroprotection. It is therefore reasonable to conclude that the strength of correlation between the σ1 receptor agonism and providing neuroprotection, gives rise to a reasonable expectation of success.
Therefore, claims 16-43 are obvious over Modol-Caballero and Virgili-Bernado.
MPEP 2143(e) states: The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Non-Statutory Obviousness-Type 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.
Claims 16-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims U.S. Patent Nos: 1) 10,927,128; and 2) 11,649,248.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and claims of the reference U.S. patents are similarly drawn to oxadiazaspiro compounds.
For example, the claims of the instant invention are drawn to a method for providing neuroprotection and/or treating motoneuron degeneration with an oxadiazaspiro compound of formula (I), whereas, the claims of the U.S. Patent No. 10,927,128 (‘128 patent) are drawn to an oxadiazaspiro compound of Formula (I), a process for preparing the oxadiazaspiro compound and a method for using the oxadiazaspiro compound. ‘128 patent claim 17, recites 12-ethyl-8- isopentyl-4-oxa-8,12-diazadispiro[ 2.1.5.3 ]tridecan-13-one, which is the same compound recited in instant claim 34 on page 8.
Although the ‘128 patent is not explicit in claiming a method for neuroprotection, the claimed invention would have been obvious over the ‘128 patent. This is because the ‘128 patent (see, e.g., column 1, lines 5-11 and 35-45), discloses the oxadiazaspiro compounds as σ1 receptor agonists and σ1 receptor is known for neuroprotective activity.
A patent’s "disclosure may be used…to answer the question whether claims merely define an obvious variation of what is earlier disclosed and claimed." AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust, 112 USPQ2d 1001, 1012 (Fed. Cir. 2014) (quoting In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008).
In the instant case, since the ‘128 patent (see discussions above), discloses the oxadiazaspiro compounds as σ1 receptor agonists and σ1 receptor is known for neuroprotective activity, these aspects of the instant claims are, therefore, obvious over the ‘128 patent.
The AbbVie court explicitly noted that the Federal Circuit has “repeatedly approved examination of the disclosed utility of the invention claimed in an earlier patent to address the question of obviousness” and that “a later expiring patent is not patentably distinct from an earlier expiring patent if it merely claims a disclosed utility of the earlier claimed invention." Id. For example, when the claims in a later-expiring patent "merely recite methods of administering" the compositions claimed in the earlier patent, they are not patentably distinct over the claims of the earlier expiring patent." Id. (quoting Pfizer, Inc. v. Teva Pharms. USA, Inc., 86 USPQ2d 1001, 1008 (Fed. Cir. 2008)).
Furthermore, for double patenting of previously disclosed, but newly claimed utility, please see Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010).
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
Conclusions
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S 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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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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