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Any rejection or objection not listed below has been withdrawn.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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/27/2026 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 § 112
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.
Claims 1-2, 5-8, 10, 12-13, 27-28, 30-33, 48-50 are 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.
The term “inhalation session” in claims 1-2, 5-8, 10, 12-13, 27-28, 30-33, 48-50 is a relative term which renders the claim indefinite. The term “inhalation session” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of inhalation session is unclear as no definition of the time frame is given in the specification and one of ordinary skill in the art would not know what would be considered a time frame of a session. Is this considered the time frame for a breath? The specification informs us this is not required to be a single breath as one can sip water between inhales(example 3). Or just the length of time a patient takes to inhale both dosages? For instance an inhalation session could be two days if it takes two days to inhale both dosages.
For the purposes of examination the broadest reasonable interpretation of inhalation session was taken to mean any time frame wherein two dosages are taken.
Claim Rejections - 35 USC § 103- Modified Due to Amendments
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, 12-13, 27-28, 30-33 and 48-50 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (Jackson et al., US 20040018989 A1, 2004-01-29, previously provided) 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]. The reference also teaches “The FPF of at least 50% of the particles of the invention is less than about 5.6 um. For example, but not limited to, the FPF of at least 60%, or 70%, or 80%, or 90% of the particles is less than about 5.6 um.”[0042] This helps to teach claim 1, 27, 30, 48-49.
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 12 and 50.
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 and inhalation session (all claims), and UPDRS (all claims) and twice a day(claims 27-28, 30-33, 49-50).
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.
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). For the purposes of examination the broadest reasonable interpretation of inhalation session was taken to mean any time frame wherein two dosages are taken. This helps teach claims 1, 9, 10, 13, 27-28, 30-33, 49-50.
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(including than once a day) 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(including than once a day). 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. Additionally, However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
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, 12-13, 27-28, 30-33 and 48-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 64-81 of copending Application No. 19/350,337 in view of over Jackson (Jackson et al., US 20040018989 A1, 2004-01-29, previously provided) in view of Wright et al. (GB 2454480 A, 07/11/2007, previously provided).
The application ‘337 claims:
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This helps to teach claims 1-2, 5-8, 10, 12-13, 27-28, 30-33 and 48-50.
The application ‘337 does not teach specifically OFF episodes (all claims), specifically at least two capsules and inhalation session (all claims), inhalation device (all claims) and twice a day(claims 27-28, 30-33, 49-50).
The secondary references teach 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 to have modified application ‘337 with Jackson and 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(including than once a day) 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(including than once a day). 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. Additionally, However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 05/27/2026 have been fully considered but they are not persuasive.
The applicant argues that the two capsule system is unobvious because of impermissible hindsight and because it relies on art that lead away from the claimed invention. This is not persuasive because:
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Just because the references preferred a single capsule and multiple dosages were not the preferred embodiment does not make them less obvious to one of ordinary skill in the art. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994).
In response to the argument that there is no motivation to combine the two to arrive at the claimed two dosages; there is the motivation as described for one would be motivated to do this to allow for smaller dosages if desired. For instance one could then have half a dose instead of a full dose if desired without requiring separate packaging.
The applicant also argues that the ‘wherein clauses’ give unexpected results and patentable weight. This argument was not persuasive because unexpected results should be compared to the closet prior art to determine if they are truly unexpected and commensurate in scope with the claims. An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). The comparison of a placebo and general “rescue therapy” that is taken orally as mentioned in Example 3 is not considered the closet prior art since the inhalation references used in the 103 rejection are considered closer art. Unexpected results, for example a demonstration that two capsules instead of one capsule is required to achieve the UPDRS score is needed to be persuasive. Otherwise it is unclear what is causing this effect. Perhaps, one capsule would achieve this score just as well as two. In addition unexpected results must be commensurate in scope with the claims it is unclear if any number of capsules more than 2 would give the same results filled with any diameter less than 5.6 um. Additionally, However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Conclusion
Claims 1-2, 5-8, 10, 12-13, 27-28, 30-33 and 48-50 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR HASTINGS whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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