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 preliminary amendments filed 1/16/2024 have been entered.
Claims 1, 3, 4, 7, 8, 12-22 are pending.
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, 4, 7, 8, 12-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US2015/0005356 (‘356) in view of Marple et al., Otolaryngol Head Neck Surg, 2004;130:131-41 and Remington, 17th Ed, 1985, pages 1478-1486. ‘356, Maple et al., and Remington are references of record in the parent application 16/007999.
‘356 teaches an intranasal composition comprising epinephrine, in an amounts ranging from 0.05 mg to 10mg, with a pH of 3-6 (see abstract, claim 18, [0075]-[0076]). ‘356 teaches that the delivery volume of a spray as 100-250 µL (see [0075]-[0076]). The examiner notes that 0.05 -10mg in 100 µL would be 0.05-10%w/w. ‘356 teaches excipients such as EDTA, sodium chloride (0.1-1.0%) as osmotic adjusting agent, propylene glycol, ethanol, glycerin, hydrochloric acid for adjusting pH, can be used to formulate the epinephrine composition (see [0047], [0053], [0054], [0059], [0100], [0103]). ‘356 teaches “In addition to enabling agents in both aqueous and powder intranasal formulations of the present invention, the composition may further contain preservatives, stabilizers, antioxidants, thickening agent, humectant, surfactants, mucoadhesive agents, colorants, one or more excipients or combinations thereof” (see [0080]).
‘356 does not expressly teach the use of sodium sulfite or BKC. ‘356 does not expressly teach the herein claimed amount of the components.
Marple et al. teaches benzalkonium chloride as commonly used preservatives for intranasal product with minimum toxicity and well-tolerated (see abstract and page 140, Conclusion).
Remington teaches sodium sulfite, sodium metasulfite, and ascorbic acid, as well-known antioxidant for aqueous systems (see page 1481, col. 2, 4th paragraph).
It would have been obvious to incorporate the herein claimed excipients, in the amount herein claimed, into the epinephrine intranasal composition.
One of ordinary skill in the art would have been motivated to incorporate the herein claimed excipients, in the amount herein claimed, into the epinephrine intranasal composition. Incorporating the well-known excipients, which are useful in aqueous systems and the epinephrine composition of ‘356, into the epinephrine composition would be reasonably expected to impart the beneficial effects such as inhibit oxidation and degradation of the composition and thereby increase the stability of the composition.
Furthermore, the optimization of result effect parameters (e.g., weight amount of the excipients) 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). In the instant case, the adjustment of the excipients amount would produce the optimal stability conditions (such as solubility, pH, oxidation inhibition, the antimicrobial effect) of the composition. The amount of epinephrine taught in ‘356 encompasses that of the instant claims and therefore prima facie case of obviousness exists.
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.
No claims are allowed.
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.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAN MING R HUI/ Primary Examiner, Art Unit 1627
Prosecution Insights