DETAILED ACTION
Any rejection or objection not listed below has been withdrawn.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/21/2025 has been entered.
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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The date of 4/21/2014 was used for priority.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/21/2025 is being considered by the examiner.
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.
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.
Claims 1-2, 5-8, 10-13, 27-28, and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (Jackson et al., US 20040018989 A1, 2004-01-29) in view of Wright et al. (GB 2454480 A, 07/11/2007, previously provided).
The reference Jackson teaches “In order to obtain dry particles of particular physical and chemical characteristics, in vitro characterization tests can be carried out on the finished dry particles, and the process parameters adjusted accordingly, as described above. Particles containing 90 wt % L-Dopa, 8 wt % DPPC and 2 wt % sodium chloride produced using this method had a VMGD of 14 .mu.m measured by Rodos at 1 bar and a VMGD of 11 .mu.m at 2 bar, FPF(5.6) of 70%. In this manner, the desired aerodynamic diameter, geometric diameter, and particle density could be obtained for these particles in real-time, during the production process” [0119] and “Without wishing to be held to a particular interpretation of the invention, it is believed that a salt, such as NaCl, provides a source of mobile counter-ions. It is believed that the addition of a small salt to particles that have local areas of charge on their surface will reduce the amount of static present in the final powder by providing a source of mobile counter-ions that would associate with the charged regions on the surface. Thereby the yield of the powder produced is improved by reducing powder agglomeration, improving the Fine Particle Fraction (FPF) and emitted dose of the particles and allowing for a larger mass of particles to be packed into a single receptacle. As seen in Table 1, particles comprising L-Dopa and either trehalose or DPPC, with the addition of sodium chloride, show an increased yield of approximately 50-60 fold”[0028]. The reference also teaches “In a specific example, dry powder from a dry powder inhaler receptacle, e.g., capsule, holding 25 mg nominal powder dose having at 95% L-Dopa load, i.e., 23.75 mg L-Dopa, could be administered in a single breath. Based on a conservative 4-fold dose advantage, the 23.75 mg delivered in one breath would be the equivalent of about 95 mg of L-Dopa required in oral administration. Several such capsules can be employed to deliver higher doses of L-Dopa. For instance a size 4 capsule can be used to deliver 50 mg of L-Dopa to the pulmonary system to replace (considering the same conservative 4-fold dose advantage) a 200 mg oral dose”[0078] and “The method of the invention includes delivering to the pulmonary system an effective amount of a medicament such as, for example, a medicament described above. As used herein, the term "effective amount" means the amount needed to achieve the desired effect or efficacy. The actual effective amounts of drug can vary according to the specific drug or combination thereof being utilized, the particular composition formulated, the mode of administration, and the age, weight, condition of the patient, and severity of the episode being treated. In the case of a dopamine precursor, agonist or combination thereof it is an amount which reduces the Parkinson's symptoms which require therapy. Dosages for a particular patient are described herein and can be determined by one of ordinary skill in the art using conventional considerations, (e.g. by means of an appropriate, conventional pharmacological protocol). For example, effective amounts of oral L-Dopa range from about 50 milligrams (mg) to about 500 mg. In many instances, a common ongoing (oral) L-Dopa treatment schedule is 100 mg eight (8) times a day”[0085]. The reference also teaches “In one example, at least 80% of the mass of the particles stored in the inhaler receptacle is delivered to a subject's respiratory system in a single, breath-activated step. In another embodiment, at least 1 milligram of L-Dopa is delivered by administering, in a single breath, to a subject's respiratory tract particles enclosed in the receptacle. Preferably at least 10 milligrams of L-Dopa is delivered to a subject's respiratory tract. Amounts as high as 15, 20, 25, 30, 35, 40 and 50 milligrams can be delivered”[0080]. This helps to teach claim 1, 27, 30.
The reference Jackson teaches “The invention has numerous advantages. The particles of the invention are useful in treating all stages of Parkinson's disease, e.g., ongoing management of the disease, as well as providing rescue therapy. The particles have a high content of L-Dopa and, therefore, the amount of drug that can be contained and administered from a given inhaler capsule is increased, thereby reducing the number of puffs required to deliver a clinically effective dose. The methods of the invention result in forming dry, non-sticky particles in high yields, minimizing material losses and manufacturing costs. The particles have aerodynamic and dispersive properties that render them useful in pulmonary delivery, in particular delivery to the deep lung”[0013] and “Patients exhibit increasingly marked swings in Parkinson's disease symptoms, ranging from a return to classic Parkinson's disease symptoms, when plasma levels fall, to the so-called dyskinesis, when plasma levels temporarily rise too high following L-Dopa administration”[0003]. This helps to teach claim 1, 5, 27, 31.
The reference Jackson teaches “The particles can be fabricated with a rough surface texture to reduce particle agglomeration and improve flowability of the powder. The spray-dried particles have improved aerosolization properties. The spray-dried particle can be fabricated with features which enhance aerosolization via dry powder inhaler devices, and lead to lower deposition in the mouth, throat and inhaler device”[0071] and “ Administration of particles to the respiratory system can be by means such as known in the art. For example, particles are delivered from an inhalation device such as a dry powder inhaler (DPI). Metered-dose-inhalers (MDI), nebulizers or instillation techniques also can be employed” [0073]. This helps to teach claim 11-12.
The reference Jackson teaches “It is also found that even with as many as six to ten L-Dopa doses a day, plasma L-Dopa levels can still fall dangerously low, and the patient can experience very severe Parkinson's disease symptoms. When this happens, additional L-Dopa is administered as intervention therapy to rapidly increase brain dopamine activity”[0005]. This helps to teach claim 13.
The reference Jackson does not teach specifically OFF episodes (all claims), specifically at least two capsules (all claims), and UPDRS (all claims).
The reference Wright teaches “A composition comprising levodopa (L-dopa) for the treatment of diseases and disorders of the central nervous system, such as Parkinson's disease, wherein the composition is administered via pulmonary inhalation and provides a therapeutic effect within 10 minutes of administration,” (abstract) and “The present invention seeks to provide a way of providing “rescue therapy" in the treatment of Parkinson's disease in which particles of L-dopa are delivered to the pulmonary system. Rescue therapy normally refers to non-surgical medical treatment in life-threatening situations. However, despite the unpleasantness of Parkinson's disease, the symptoms are not life threatening and this patent would therefore appear to relate to "rescue" from off-period symptoms”( pages 4-5 lines 30-5). This helps teach claim 1, 2, 5, 8 and 27. Wright teaches a dose of levodopa of up to 35 mg (reference claim 3). Wright also teaches “In one embodiment of the invention, at least about 90% of the particles of L-dopa have a particle size of 5 μm or less,” (page 16, line 1) and “ The term "ultrafine particle dose" (UFPD) is used herein to mean the total mass of active material delivered by a device which has a diameter of not more than 3 μm,” (page 17, lines 10-15). This helps teach claims 3, 4, 29 and 30.
Wright also teaches “In one embodiment of the invention, at least about 90% of the particles of L-dopa have a particle size of 5 μm or less,” (page 16, line 1) and “ The term "ultrafine particle dose" (UFPD) is used herein to mean the total mass of active material delivered by a device which has a diameter of not more than 3 μm,” (page 17, lines 10-15). This helps to teach claims 8, 9, 10, and 11.
Wright teaches “An inhaler device as claimed in claim 15, wherein the device is a dry powder inhaler, a pressurized metered dose inhaler or a nebulizer,” (reference claim 16) This helps to teach claim 12.
Regarding claims 6, 7, 13, 32 and 33, Wright et al. teaches administration of the levodopa as rescue therapy. Therefore, one having ordinary skill in the art would administer the levodopa to the pulmonary system anytime the symptoms arise, regardless the number of times and how long the symptoms last.
Additionally, Wright teaches “In one embodiment, the dose is preferably provided in a blister or capsule which is to be dispensed using a dry powder inhaler device,” (page 10, lines 10-15) and “A composition as claimed in any one of the preceding claims, wherein doses of the levodopa composition are to be administered to the patient as needed,”(reference claim 5), and “A composition as claimed in any one of preceding claims, wherein doses may be administered sequentially, with the effect of each dosing being assessed by the patient before the next dose is administered to allow self-titration and optimisation of the dose”( reference claim 6). This helps teach claim 9, 10, 13 and 27.
Wright also teaches “lt is a further aim of the present invention to reduce "off-periods" experienced by the patient as much as possible and, if possible, to avoid such off-periods altogether,” (page 5, lines 15-20). This helps to teach claim 27.
It would be prima facie obvious to the person having ordinary skill in the art before the effective filing date of the instant invention to have modified Jackson with Wright because both teach inhalation of fine levodopa particles for the treatment of Parkinson's disease. One would have understood OFF episodes as taught by Wright could be treated by rescue therapy as taught by Jackson with reasonable expectation of success because Jackson and Wright teach rescue therapy. Therefore, one having ordinary skill in the art would administer the levodopa to the pulmonary system anytime the symptoms arise, regardless the number of times and how long the symptoms last with a reasonable expectation of success. One would be motivated to do so to treat the symptoms. It would be prima facie obvious to the person having ordinary skill in the art before the effective filing date of the instant invention to administer at least two capsules because Jackson teaches multiple doses and to administer them as needed. One would have a reasonable expectation of success in doing this since multiple dosages have been taught in the reference and one would be motivated to do this to allow for smaller dosages if desired. [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.) There would be a reasonable expectation that treatment of “off-periods” with levodopa would improve UPDRS since UPDRS includes “off-period” occurrences and duration in its calculation. Thus, it would be a reasonable expectation when treating the same disease with the same chemical using the similar method and doses that the UPDRS rating would improve a similar amount. Furthermore, the same reasoning can be used for the improvement in “off” hours and dyskinesis.
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 1-2, 5-8, 10-13, 27-28, and 30-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 8545878 B1 and over claims 1-14 of U.S. Patent No. 8685442 B1 in view of Jackson (Jackson et al., US 20040018989 A1, 2004-01-29) in view of Wright et al. (GB 2454480 A, 07/11/2007, previously provided).
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The patent ‘878 B1 claims:
The patent ‘442 B1 claims:
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The specification teaches the use of the invention for the treatment of Parkinson disease page 1. A compound claim can be used to reject a method claim if the utility is disclosed in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F. 3d 1381, 1385 (CAFC 2010). See also MPEP § 804(II)(B)(2)(a).
This helps to teach claims 1-2, 5-8, 10-13, 27-28, and 30-33.
The patent ‘878 B1 and patent ‘442 B1 do not teach not teach specifically OFF episodes (all claims), specifically at least two capsules (all claims), UPDRS (all claims), the specific compositions and amounts(all claims).
The secondary references further teaches that all needed changes would be obvious as outlined in the 103 rejection (which is incorporated herein by reference).
It would be prima facie obvious to the person having ordinary skill in the art before the effective filing date of the instant invention to have modified patent ‘878 B1 and patent ‘442 B1 with Jackson and Wright because all teach inhalation of fine levodopa particles for the treatment of Parkinson's disease. One would have understood OFF episodes as taught by Wright could be treated by rescue therapy as taught by Jackson with reasonable expectation of success because Jackson and Wright teach rescue therapy. Therefore, one having ordinary skill in the art would administer the levodopa to the pulmonary system anytime the symptoms arise, regardless the number of times and how long the symptoms last with a reasonable expectation of success. One would be motivated to do so to treat the symptoms. It would be prima facie obvious to the person having ordinary skill in the art before the effective filing date of the instant invention to administer at least two capsules because Jackson teaches multiple doses and to administer them as needed. One would have a reasonable expectation of success in doing this since multiple dosages have been taught in the reference and one would be motivated to do this to allow for smaller dosages if desired. [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.) There would be a reasonable expectation that treatment of “off-periods” with levodopa would improve UPDRS since UPDRS includes “off-period” occurrences and duration in its calculation. Thus, it would be a reasonable expectation when treating the same disease with the same chemical using the similar method and doses that the UPDRS rating would improve a similar amount. Furthermore, the same reasoning can be used for the improvement in “off” hours and dyskinesis.
Response to Arguments
Applicant's arguments filed 10/21/2025 have been fully considered but they are not persuasive.
The applicant argues that the reference Wright does not make up for the deficiency of the reference Jackson. This argument is not persuasive because Wright was used to link rescue therapy with off-period symptoms. The reference Jackson teaches “The invention has numerous advantages. The particles of the invention are useful in treating all stages of Parkinson's disease, e.g., ongoing management of the disease, as well as providing rescue therapy”[0013]. Since Jackson teaches rescue therapy it would be obvious that it would be used to treat off-period symptoms in view of Wright.
As for the limitation of at least two capsules are required; Wright teaches the dose is preferably delivered in a capsule and self-titrations of multiple doses can be given sequentially(reference claims 5-6). One would have a reasonable expectation of success in doing this since multiple dosages have been taught in the reference and one would be motivated to do this to allow for smaller dosages if desired. Since the general conditions are disclosed simply changing or optimizing the dosing schedule is obvious and not inventive. [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.). The applicant also argues that multiple doses sequentially administered is not the same as two capsules used at the same time. This argument is not persuasive because the claim does not require the capsules be administered at the same time and additionally even if they are administered at the same time this would not be any different than one large dose thus is not inventive and would have been obvious to one of ordinary skill in the art.
As for the UPDRS limitation, while not specifically taught by either reference it is a result of an obvious method. Thus one would have a reasonable expectation that the obvious method would also result in the same improvement. Thus, it would be a reasonable expectation when treating the same disease with the same chemical using the similar method and doses that the UPDRS rating would improve a similar amount. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph).
The applicant argues that there is no motivation to combine the two references because they have significantly different dosages. This argument is not persuasive because the references just teach a range of dosages that can be used to treat OFF episodes. One of ordinary skill in the art would find it obvious that any of these dosages could be used to treat OFF episodes and that they would find it obvious that they could be supplied as self-titrations of multiple doses for better personal treatment.
The applicant also argues there is no reason to combine the two reference to treat OFF episodes at the claimed dose and administration methods. This argument is not persuasive because Jackson teaches rescue therapy it would be obvious that it would be used to treat off-period symptoms in view of Wright. It is also not persuasive because Jackson teaches “The invention has numerous advantages. The particles of the invention are useful in treating all stages of Parkinson's disease, e.g., ongoing management of the disease, as well as providing rescue therapy”[0013]. Thus a person of ordinary skill in the art would find it obvious to treat all stages of the disease including OFF episodes with the formula and dosages of Jackson.
The applicant argues that the double patenting rejections are not obvious because of the differences in composition of the capsule shell, however, no limitations are given in the instant claims to remove those difference in compositions from being included.
Conclusion
Claims 1-2, 5-8, 10-13, 27-28 and 30-33 are rejected.
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.
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/A.A.S./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627