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 .
Applicant’s amendments file 7/24/2026 have been entered.
Claims 1, 3-4, 7, 8, 12-22 are pending.
The outstanding rejection under 35 USC 103a is withdrawn in view of the amendments filed 7/24/2026 as the claims recite the limitation that epinephrine is the only active in the composition.
Applicant’s remarks filed 7/24/2026 with regard to the outstanding obvious double patenting rejections are acknowledged. Accordingly, the outstanding double patenting rejection is maintained.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3, 4, 7, 8, 12-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,039,710 (710). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘710 teaches a nasal composition comprising epinephrine, and other components in the similar range of what is recited in the claims. ‘710 does not expressly teach the exact same weight percentage of the components as what is recited in the claims.
It would have been obvious to one of ordinary skill in the art at the time of filing to adjust the weight percent of the herein claimed components.
One of ordinary skill in the art would have been motivated to adjust the weight percent of the herein claimed components. The optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). As the weight percent range of the components disclosed by ‘710 encompasses that of the instant claims, prima facie obviousness exists.
Claims 1, 3, 4, 7, 8, 12-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,617,637 (‘637). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘637 teaches a liquid composition comprising epinephrine, and other components in the similar range of what is recited in the claims (see claims 2, 7, 12). ‘637 does not expressly teach the exact same weight percentage of the components as what is recited in the claims.
It would have been obvious to one of ordinary skill in the art at the time of filing to adjust the weight percent of the herein claimed components.
One of ordinary skill in the art would have been motivated to adjust the weight percent of the herein claimed components. The optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). As the weight percent range of the components disclosed by ‘637 encompasses or as similar to that of the instant claims, prima facie obviousness exists.
Claims 1, 3, 4, 7, 8, 12-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,966,925 (‘925). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘925 teaches a liquid composition comprising epinephrine, and other components in the similar range of what is recited in the claims (see claims 1, 5, 9, 10). ‘925 does not expressly teach the exact same weight percentage of the components as what is recited in the claims.
It would have been obvious to one of ordinary skill in the art at the time of filing to adjust the weight percent of the herein claimed components.
One of ordinary skill in the art would have been motivated to adjust the weight percent of the herein claimed components. The optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). As the weight percent range of the components disclosed by ‘925 encompasses or being similar to that of the instant claims, prima facie obviousness exists.
Claims 1, 3, 4, 7, 8, 12-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,973,781 (‘781). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘781 teaches a liquid composition comprising epinephrine, and other components in the similar range of what is recited in the claims (see claims 1-4). ‘781 does not expressly teach the exact same weight percentage of the components as what is recited in the claims.
It would have been obvious to one of ordinary skill in the art at the time of filing to adjust the weight percent of the herein claimed components.
One of ordinary skill in the art would have been motivated to adjust the weight percent of the herein claimed components. The optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). As the weight percent range of the components disclosed by ‘781 being similar to that of the instant claims, it is prima facie obvious to optimize the amount and weight percentage of the excipients to give rise optimal stability, solubility, and bioavailability of the composition.
Claims 1, 3, 4, 7, 8, 12-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,571,384 (‘384). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘384 teaches a liquid composition comprising epinephrine, and other components in the similar range of what is recited in the claims (see claims 10, 15, 16). ‘384 does not expressly teach the exact same weight percentage of the components as what is recited in the claims.
It would have been obvious to one of ordinary skill in the art at the time of filing to adjust the weight percent of the herein claimed components.
One of ordinary skill in the art would have been motivated to adjust the weight percent of the herein claimed components. The optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). As the weight percent range of some components (e.g., epinephrine) disclosed by ‘384 encompasses that of the instant claims, prima facie obviousness exists. For the weight percentage of other components that is very similar to that of the instant claims, it is prima facie obvious to optimize the amount and weight percentage of the excipients to give rise optimal stability, solubility, and bioavailability of the composition.
Claims 1, 3, 4, 7, 8, 12-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/723,722 (‘722) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘722 teaches a composition comprising epinephrine and the same ingredients, in a scope that is narrower than that of the instant application. Therefore, ‘722 reads on the instant application. Accordingly, this is an anticipatory type of double patenting rejection.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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