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 Claims
Claims 1-20 are pending in the instant application.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 12/04/2023, 05/03/2024 and 02/05/2026 were considered by the Examiner.
Claim Objections
Claim 1 is objected to because of the following informality:
It is recommended that Applicant amend the claim to spell out the first abbreviation of alpha 7 nACHR, as in the title of the invention.
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 1-2, 8-15 and 18-20 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 instant claims 1 and 11 recite the limitation “α7 nAChR modulator”, which offers no structural limitations. The claimed modulators are described completely functionally by what they do as opposed to what they are. The specification does not provide clear guidance on all the structures that do or do not meet the limitations of the claims (e.g. the recitation “α7 nAChR modulator” is a structure/function relationship instead of a defined limitation such as listed structure element alternatives that fulfill the desired function). One would not conclude that Applicant was in possession of every α7 nAChR modulator (a genus) that meets the limitations of claims 1 and 11, including those yet to be discovered. It is also not clear from the specification which functionalities are responsible for the claimed functional limitations. The functional limitations are rather specific but there are no structural limitations present in the claims. The instant invention does disclose the specific modulator of (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane, for which there is written support for. However, it is not clear from the specification which functionalities are capable of carrying out the specific functional properties required by the instant claims. The specification does not decode the physical structures required to carry out the rather specific functional limitations of the claims, nor does the body of the prior art teachings.
Claims 2, 8-10, 12-15 and 18-20 do not resolve the issue of written description above, and as such, are also rejected under 112(a).
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.
Claim 11 is 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation "the improvement" in line 4. There is insufficient antecedent basis for this limitation in the claim.
It is recommended that Applicant amend the claim to recite to remove “In” in line 1 of the claim and replace “the improvement” with “the method” in line 4. It is further recommended that Applicant replace
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 (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.
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) 1-3 and 8 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kalman et al (US 2010/0125063 A1).
Regarding claim 1, Kalman teaches a method of prevention, treatment or delay of progression of an anxiety disorder in a patient in need thereof comprising administering to said patient an effective amount of one or more nicotinic acetylcholine alpha 7 receptor agonist (claim 11). Kalman teaches that the effective dosage of the active ingredient may vary depending on the particular compound or pharmaceutical composition employed, the mode of administration, the severity of the condition being treated. Kalman further teaches that a physician, clinician or veterinarian of ordinary skill can readily determine and prescribe the effective amount to prevent, counter or arrest the progress of the condition (paragraph [0123]).
Regarding claim 2, as seen above, Kalman teaches that the α7 nAChR modulator is a nicotinic acetylcholine alpha 7 receptor agonist.
Regarding claim 3, Kalman teaches that the particularly preferred nicotinic acetylcholine alpha 7 receptor agonist is (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane (paragraph [0051]).
Regarding claim 8, Kalman teaches that the preferred route of administration is orally, in capsules (paragraph [0015]-[0016]).
Claim Rejections - 35 USC § 103
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.
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) 1-11 and 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kalman et al (US 2010/0125063 A1) in view of Stein et al (Lancet. 2008 Mar 29;371(9618):1115-25).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Regarding claim 1, Kalman teaches a method of prevention, treatment or delay of progression of an anxiety disorder in a patient in need thereof comprising administering to said patient an effective amount of one or more nicotinic acetylcholine alpha 7 receptor agonist (claim 11). Kalman teaches that the effective dosage of the active ingredient may vary depending on the particular compound or pharmaceutical composition employed, the mode of administration, the severity of the condition being treated. Kalman further teaches that a physician, clinician or veterinarian of ordinary skill can readily determine and prescribe the effective amount to prevent, counter or arrest the progress of the condition (paragraph [0123]).
Regarding claim 2, as seen above, Kalman teaches that the α7 nAChR modulator is a nicotinic acetylcholine alpha 7 receptor agonist.
Regarding claim 3, Kalman teaches that the particularly preferred nicotinic acetylcholine alpha 7 receptor agonist is (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane (paragraph [0051]).
Regarding claim 8, Kalman teaches that the preferred route of administration is orally, in capsules (paragraph [0015]-[0016]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art is deemed to anticipate instant claims 1-3 and 8 where anticipation is the epitome of obviousness. In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974)).
The prior art does not specify the exact dosage amount of (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane that is used in the method.
The prior art also does not specify the exact type of acute anxiety to be treated or that the patient is a female.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, regarding the dosage amounts of claims 4-7, Kalman teaches that the compound is administered in an effective amount. Kalman further teaches that The effective dosage of each of the active ingredients employed in the invention may vary depending on the particular compound or pharmaceutical composition employed, the mode of administration, the severity of the condition being treated. Thus, the dosage regimen the invention is selected in accordance with a variety of factors including the route of administration and the renal and hepatic function of the patient. A physician, clinician or veterinarian of ordinary skill can readily determine and prescribe the effective amount of the single active ingredients required to prevent, counter or arrest the progress of the condition. Optimal precision in achieving concentration of the active ingredients within the range that yields efficacy without toxicity requires a regimen based on the kinetics of the active ingredients availability to target sites. This involves a consideration of the distribution, equilibrium, and elimination of the active ingredients (paragraph [0123]).
As such regarding claims 4-7, one of ordinary skill in the art would have been motivated by these teachings to optimize the dosage amounts of (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane. See MPEP 2144.05:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was “unexpectedly good”); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
As for the limitations concerning the specific type of anxiety and gender of the patient, Stein teaches that social anxiety is the most common anxiety disorder (abstract). Stein also teaches that the lifetime prevalence of social anxiety disorder is 12.1%, with higher prevalence in females (page 1115, right column, paragraph 2).
Regarding claims 9-11 and 14, as Kalman teaches a method of treating anxiety with a nicotinic acetylcholine alpha 7 receptor agonist, one of ordinary skill in the art would have been motivated to alter the method to include females with social anxiety disorder as Stein teaches that social anxiety is the most common anxiety disorder and that it has a higher prevalence in females.
Regarding claim 15, as seen above, Kalman teaches that the α7 nAChR modulator is a nicotinic acetylcholine alpha 7 receptor agonist.
Regarding claim 16, Kalman teaches that the particularly preferred nicotinic acetylcholine alpha 7 receptor agonist is (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane (paragraph [0051]).
Regarding the dosage amounts of claims 17 and 20, Kalman teaches that the compound is administered in an effective amount. Kalman further teaches that The effective dosage of each of the active ingredients employed in the invention may vary depending on the particular compound or pharmaceutical composition employed, the mode of administration, the severity of the condition being treated. Thus, the dosage regimen the invention is selected in accordance with a variety of factors including the route of administration and the renal and hepatic function of the patient. A physician, clinician or veterinarian of ordinary skill can readily determine and prescribe the effective amount of the single active ingredients required to prevent, counter or arrest the progress of the condition. Optimal precision in achieving concentration of the active ingredients within the range that yields efficacy without toxicity requires a regimen based on the kinetics of the active ingredients availability to target sites. This involves a consideration of the distribution, equilibrium, and elimination of the active ingredients (paragraph [0123]).
As such regarding claims 17 and 20, one of ordinary skill in the art would have been motivated by these teachings to optimize the dosage amounts of (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane. See MPEP 2144.05:
Regarding claim 18, Kalman teaches that the preferred route of administration is orally, in capsules (paragraph [0015]-[0016]).
Regarding claim 19, Stein teaches that individuals with social anxiety experience symptoms such as heart racing, sweating and trembling (page 115, left column, paragraph 2). Kalman is silent regarding " heart racing, sweating and trembling". However: "heart racing, sweating and trembling " will inevitably flow from the teachings of the prior art (see above rejection), since the same compound ((R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane) is being administered to the same subjects (a subject suffering from social anxiety). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding heart racing, sweating and trembling ", by practicing the method taught by the prior art: "the administration of (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane to a patient suffering from social anxiety", one will also be " art racing, sweating and trembling,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“heart racing, sweating and trembling ") of the method taught by the prior art ("the administration of (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane to a patient suffering from social anxiety").
MPEP 2112 I states: “[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.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kalman et al (US 2010/0125063 A1) in view of Stein et al (Lancet. 2008 Mar 29;371(9618):1115-25), as applied to claims 1-11 and 14-20 above, and in further view of Melaragno et al (Focus Vol. 19, No. 2, Spring 2021).
The 103 rejection of claims 1-11 and 14-20 over Kalman and Stein is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Neither Kalman nor Stein explicitly teach that (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane is to be administered about 2 hours prior to the individual experiencing an acute anxiety-inducing setting. Kalman does teach that the compound can be administered at difference time intervals (paragraph [0088]) and different times during the course of therapy (paragraph [0121]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not explicitly teach that (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane is to be administered about 2 hours prior to the individual experiencing an acute anxiety-inducing setting.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Melaragno teaches that medications to be used in social anxiety disorder treatment should be administered 1-2 hours before a situation (page 154, right column, paragraph 2).
Regarding claims 12-13, as Kalman teaches that (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane can be administered at different times during the course of therapy, one of ordinary skill in the art would have been motivated to administer (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane 2 hours before an anxiety inducing situation as Melaragno teaches that medications to be used in treatment of a social anxiety disorder should be administered 1-2 hours before an anxiety inducing situation.
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 1-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6, 8, 10-17, 19, 21-22, 24-25 and 70-71 of copending Application No. 18/249,920 (reference application) in view of Kalman et al (US 2010/0125063 A1), Stein et al (Lancet. 2008 Mar 29;371(9618):1115-25) and Melaragno et al (Focus Vol. 19, No. 2, Spring 2021).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application claims a method of treatment of an individual suffering from public speaking anxiety or a symptom thereof, the method comprising administering to the individual (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane (claim 1). The copending application also claims that the individual suffers from public speaking anxiety as presenting symptom of social anxiety disorder (claim 2). The copending application also claims dosage amounts for the compounds (Claims 21-22). The instant claims are deemed to be variants of the subject matter of copending Application No. 18/249,920 for the same reasons as under 35 USC 103.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Correspondence
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699