DETAILED ACTION
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 1-20 and 22-30 are pending in the present application.
Priority
The present application is a CON of 17/549,219 filed 13 December 2021, which is a CIP of 16/143,821 filed 27 September 2018, which is a CIP of 15/791,249 filed 23 October 2017, which is a CIP of 15/717,859 filed 27 September 2017, which is a CIP of 15/587,364 filed 4 May 2017, which claims benefit of 62/331,996 filed 5 May 2016.
Parent cases 16/143,821, 15/791,249, 15/717,859, 15/587,364 and 62/331,996 do not provide adequate written support for the limitation “the prodrug having a half-life of less than one minute”. The earliest filed case providing adequate written support is 17/549,219. Therefore, the effective filing date for the instant claims is 13 December 2021.
Response to Arguments
Applicant's arguments filed 29 October 2025 have been fully considered but they are not persuasive. Applicant asserts that by disclosing in a patent application a device that inherently performs a function or has a property, operates according to a theory or has an advantage, a patent application necessarily discloses that function, theory or advantage, even though it says nothing explicit concerning it. The application may later be amended to recite the function, theory or advantage without introducing prohibited new matter. Such is the case here. The Application was later amended to recite the properties and advantages of the ester of epinephrine having a half-life of less than one minute. The priority document's filing date can be used as the effective prior art date for subject matter disclosed within it that is also claimed in a later application.
The examiner respectfully argues that the parent applications recite an ester of epinephrine or a prodrug of epinephrine, such as dipivefrin, but do not limit the genus of prodrug or ester of epinephrine to those having a half-life of less than one minute. The parent applications do not provide any basis to limit the genus of compounds to those that have the instantly claimed property. The applications recite one example of an ester and prodrug of epinephrine, dipivefrin, but that is not a sufficient disclosure to then claim any ester of epinephrine having the instantly claimed half-life.
As evidenced by Almoazen et al. (WO 2018/089570 A1), the genus esters of epinephrine include numerous compounds that have a half-life of one minute or more ([0023], [0028]). Almoazen et al. further teach that the half-life can increase or decrease depending on how the atom in position R4 influences the ester group ([0023]).
Therefore, the recitation “a prodrug of epinephrine, such as dipivefrin” is not a sufficient disclosure to show that the Applicant had adequate written support for the genus of an ester of epinephrine having a half-life of less than one minute.
Claim Rejections - 35 USC § 102
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.
Claims 1-20 and 22-30 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Schobel ‘670 (WO 2019/067670 A1).
It is noted that the instant claims have an effective priority date of 13 December 2021. WO 2019/067670 A1 was published 4 April 2019 and is available as prior art.
Regarding instant claims 1-2, Schobel ‘670 disclose a pharmaceutical composition comprising a polymeric matrix; a pharmaceutically active component including dipivefrin (an ester of epinephrine) in the polymeric matrix; and an adrenergic receptor interacter (Examples 23-27; Claims 1, 37, 39-46).
Regarding the ester having a half-life of less than one minute, Schobel ‘670 discloses dipivefrin, which is the same ester as disclosed in the instant specification.
Regarding instant claims 3 and 7, Schobel ‘670 disclose that the composition is a film (Examples 23-27).
Regarding instant claims 4-6, Schobel ‘670 disclose that the pharmaceutical composition further comprises a permeation enhancer, wherein the permeation enhancer includes clove oil and Labrasol (Examples 23-27). Schobel ‘670 further disclose that the permeation enhancer includes phenylpropanoids, farnesol and linoleic acid (Claims 4-6).
Regarding instant claim 8, Schobel ‘670 disclose that the pharmaceutical composition is a film (Examples 23-27).
Regarding instant claims 9-12, Schobel ‘670 disclose that the phenylpropanoid is eugenol, eugenol acetate, cinnamic acid, cinnamic acid ester, cinnamic aldehyde, hydrocinnamic acid, chavicol, or safrole (Claims 9-12).
Regarding instant claims 13-18, Schobel ‘670 disclose that the adrenergic receptor interacter is a phytoextract including an essential oil extract of a leaf, flower bud or stem of a clove plant, or the phytoextract is synthetic or biosynthetic (Examples 23-27; Claims 13-18).
Regarding instant claim 19, Schobel ‘670 disclose that the phytoextract further includes 40-95% eugenol (Claim 19).
Regarding instant claim 20, Schobel ‘670 disclose that the adrenergic receptor interacter includes a terpenoid, terpene or a sesquiterpene (Claims 20).
Regarding instant claims 22-26, Schobel ‘670 disclose that the polymer matrix includes a polymer, including the instantly claimed polymers (Claims 21-26).
Regarding instant claim 27, Schobel ‘670 disclose that the pharmaceutical composition further comprises a stabilizer (Claim 27).
Regarding instant claim 28, Schobel ‘670 disclose that the polymeric matrix comprises a dendritic polymer or a hyperbranched polymer (Claim 28).
Regarding instant claim 29, Schobel ‘670 disclose that the pharmaceutical compositions comprise sodium citrate, citric acid, sodium metabisulfite, sodium bisulfite, glycerol, glycerol monoacetate, glycerol diacetate, glycerol triacetate, polysorbate, cetyl alcohol, propylene glycol, sorbitan monostearate, sorbitan monooleate, sorbitan monopalmitate, sucralose, sorbitol, mannitol, or xylitol (pg. 33, 35, 37-38, 41; Examples 23-27).
Regarding instant claim 30, Schobel ‘670 disclose a method of making a pharmaceutical composition comprising: combining an adrenergic receptor interacter with a pharmaceutically active component including epinephrine or its prodrug, and forming a pharmaceutical composition including the adrenergic receptor interacter and the pharmaceutically active component (Claim 29).
Response to Arguments
Applicant's arguments filed 29 October 2025 have been fully considered but they are not persuasive. Applicant asserts that the instant claims should have the benefit of the priority date of May 5, 2016. Accordingly, WO 2019/067670 A1 to Schobel is not prior art.
As discussed above, the examiner respectfully argues that the instant claims do not have adequate written support in the priority documents to limit the scope of the instant claims to esters of epinephrine having a half-life of less than one minute. Therefore, the instant claims do not get the benefit of the earlier filed application dates.
Claims 1, 3 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Almoazen et al. (WO 2018/089570 A1).
It is noted that the instant claims have an effective priority date of 13 December 2021. WO 2018/089570 A1 was published 17 May 2018 and is available as prior art.
Regarding instant claims 1 and 3, Almoazen et al. disclose a rapidly dissolving film comprising 4-(1-hydroxy-2-(methylamino)ethyl)-1,2-phenylene bis(2,2-dimethylpropanoate) (i.e., dipivefrin), formulated for sublingual or buccal administration ([0028]). The rapidly dissolving film comprises a drug, a water-soluble polymer, a plasticizer, a saliva stimulating agent, a surfactant and other fillers such as sweetening agents and flavors in case of bitter taste drugs ([0029], [0032]-[0040]).
Regarding instant claim 29, Almoazen et al. disclose that the plasticizer includes glycerol ([0033], [0039]); the saliva stimulating agent is preferably citric acid, and the sweetening agent is xylitol ([0036]).
Response to Arguments
Applicant's arguments filed 29 October 2025 have been fully considered but they are not persuasive. Applicant asserts that the instant claims should have the benefit of the priority date of May 5, 2016. Accordingly, WO 2018/089570 A1 (“Almoazen”) is not prior art.
As discussed above, the examiner respectfully argues that the instant claims do not have adequate written support in the priority documents to limit the scope of the instant claims to esters of epinephrine having a half-life of less than one minute. Therefore, the instant claims do not get the benefit of the earlier filed application dates.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 1-20, 22-28 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 and 27-28 of U.S. Patent No. 11,191,737. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a pharmaceutical composition comprising a polymeric matrix, an ester of epinephrine and an adrenergic receptor interacter. The instantly claimed permeation enhancers and adrenergic receptor interacters overlap significantly with US ‘737, including phenylpropanoid, linoleic acid, farnesol, eugenol, eugenol acetate, cinnamic acid, cinnamic acid ester, cinnamic aldehyde, hydrocinnamic acid, chavicol, safrole, phytoextract, essential oil extract of a clove plant, a terpene, and sesquiterpene. Also, US ‘737 claims the same polymers as instantly claimed, as well as stabilizer. It is noted that the esters of epinephrine according to US ‘737 will include the instantly claimed esters having a half-life of less than one minute.
Response to Arguments
Applicant states that they will address these rejections when the claims are deemed allowable. Therefore, the rejection is maintained.
Claims 1-20 and 22-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,233,309. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a pharmaceutical composition comprising a polymeric matrix; a pharmaceutically active component including an ester of epinephrine in the polymeric matrix; and an adrenergic receptor interacter. US ‘309 recites the same adrenergic receptor interacters, polymers and a stabilizer, as the instant claims. It is noted that the esters of epinephrine according to US ‘309 will include the instantly claimed esters having a half-life of less than one minute.
Response to Arguments
Applicant states that they will address these rejections when the claims are deemed allowable. Therefore, the rejection is maintained.
Claims 1-20 and 22-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 5-6 and 8-36 of copending Application No. 15/791,249 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition comprising a polymeric matrix, a pharmaceutically active component including epinephrine or its prodrug in the polymeric matrix, and an adrenergic receptor interacter or permeation enhancer. The ‘249 Application and the instant claims recite the same adrenergic receptor interacters and permeation enhancers, as well as the same polymers and a stabilizer. The ‘249 Application specifically claims that the active includes dipivefrin, which is an ester of epinephrine according to the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant states that they will address these rejections when the claims are deemed allowable. Therefore, the rejection is maintained.
Claims 1-20 and 22-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29, 31-40, 42-46, and 51-56 of copending Application No. 16/143,821 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition comprising a polymeric matrix, a pharmaceutically active component including a prodrug of epinephrine in the polymeric matrix, and an adrenergic receptor interacter or permeation enhancer. The ‘821 Application and the instant claims recite the same adrenergic receptor interacters and permeation enhancers, as well as the same polymers and a stabilizer. The ‘821 Application also specifically claims that the prodrug of epinephrine is dipivefrin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant states that they will address these rejections when the claims are deemed allowable. Therefore, the rejection is maintained.
Claims 1-20 and 22-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-50 of copending Application No. 17/549,219 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a pharmaceutical composition comprising a polymeric matrix; a pharmaceutically active component including a prodrug of epinephrine in the polymeric matrix, the prodrug having a half-life of less than one minute; and an adrenergic receptor interacter. The ‘219 Application further comprises a permeation enhancer, and recites the same adrenergic receptor interacters and permeation enhancers, as well as the same polymers and a stabilizer, as the instant claims. The ‘219 Application also specifically claims that the prodrug is dipivefrin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant states that they will address these rejections when the claims are deemed allowable. Therefore, the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached on 10:00 AM to 6:00 PM, Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached on (571) 272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.W.S/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616