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 .
Application Status
2. Applicant’s amendment and response, submitted November 30, 2025, has been reviewed by the examiner and entered of record in the file.
3. Claims 17, 18, and 20 are amended, claim 19 is canceled, and claim 37 is newly added.
4. Claims 17, 18, and 20-37 are under examination and are the subject of this office action.
Information Disclosure Statement
5. The information disclosure statements (IDS) submitted on January 14, 2026, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner, please refer to the signed copy of Applicant’s PTO-1449 forms, attached herewith.
Previous Claim Rejections - 35 USC § 112(b)
6. Claims 17 -36 were previously rejected as being indefinite regarding the term “ameliorating” and the recitation of “determining the QOL based upon the administering.”
7. In view of Applicant’s amendments to claims 17 and 18, the previous indefinite rejections are withdrawn.
8. Claim 20 was previously rejected regarding the limitation of “aged or geriatric equine.” In view of applicant’s amendment to delete the limitation of “aged or geriatric” and replace with “older than 15 years,” the previous indefiniteness rejection is withdrawn.
New Claim Rejections - 35 USC § 112(b)
9. 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.
10. Claims 17, 18 and 20-36 are newly 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.
These rejections are newly applied as a result of applicant’s amendment to the claims.
11. Claim 17 is unclear in the following aspects:
(a) Claim 17, as amended, recites the limitation “wherein… the ciclesonide or pharmaceutically acceptable salt thereof is administered via inhalation by the equine,” [emphasis added]. It is not clear if Applicant is intending to recite that the equine administers the inhaled ciclesonide or if the ciclesonide is administered via inhalation to the equine?
Clarification is requested.
12. Claims 18 and 20-36 are rejected as depending from and including the limitations of claim 17.
Previous Claim Rejections - 35 USC § 102
13. Claims 17, 18, and 21-36 were previously rejected under 35 U.S.C. 102(a)(2) as being anticipated by Albrecht et al., U.S. 2014179651 A1 (cited on Applicant’s IDS of October 12, 2022).
14. In view of Applicant’s amendment to claim 17 to exclude the patient population comprising an equine that is not suffering from an airway disease, the previous anticipation rejections of claims 17, 18 and 21-36 are withdrawn.
Previous Claim Rejections - 35 USC § 103
15. Claim 20 was previously rejected under 35 U.S.C. 103 as being unpatentable over Albrecht et al., U.S. 2014179651 A1, as applied to claims 17, 18, and 21-36 above, and further in view of Couetil et al., J Vet Intern Med 2016.
16. In view of Applicant’s amendments to the claims to eliminate the patient population of an equine that is not suffering from an airway disease, the previous obviousness rejection is withdrawn.
New Claim Rejections - 35 USC § 103
17. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
18. Claims 17 and 22 are newly rejected under 35 U.S.C. 103 as being unpatentable over Florine et al., WO 2014160956.
This rejection is newly applied as a result of Applicant’s amendments to the claims.
Claim 17 is drawn to a method of ameliorating quality of life (QOL) of an equine comprising administering ciclesonide or a pharmaceutically acceptable salt thereof to the equine, wherein the equine is not suffering from any airway disease, and the ciclesonide or pharmaceutically acceptable salt thereof is administered via inhalation by the equine.
Claim 22 is drawn to claim 17, wherein the ciclesonide or a pharmaceutically acceptable salt thereof is inhalable.
In view of a broadest reasonable interpretation of claim 17, the limitations of “ameliorating quality of life (QOL) of an equine,” and “determining QOL of the equine based upon the administering” are construed to mean:
“determining an amelioration rate of the equine over a time period of the administration of ciclesonide to the equine, comprising
determining a first QOL value for the equine based upon assessment of QOL parameters at a first point in time prior to a first administration of ciclesonide to the equine on Day 0, wherein the QOL parameters comprise assessing one or more of attitude of the equine, energy level of the equine, and social interaction of the equine with one or more human beings and/or one or more other equines;
determining a second QOL value for the equine based upon assessment of QOL parameters at a second point in time during administration of ciclesonide to the equine on Day 10 or Day 14; and
comparing the first QOL value with the second QOL value to determine an amelioration rate of the equine at the second point in time.”
19. Florine et al. teach a composition comprising a fusion protein and a glucocorticoid, specifically naming cicleosonide (Claim 21), intended for injection into an intra-articular space of a joint in a mammal, wherein the mammal is a horse (Claims 16 and 19) and its method of use in the treatment of joint injury or disease, comprising administering a therapeutically effective amount of the fusion protein/ciclesonide composition into an intra-articular space of a joint (see Claim 33). Treating joint injury or disease in a horse in need thereof embraces treatment of an equine that is not suffering from an airway disease. By virtue of mitigating inflammation and improving symptoms of intraarticular joint disease in a horse in need thereof, such that said horse is relieved of symptoms of joint disease including pain and inflammation, one is necessarily and inevitably improving QOL of said horse.
20. And, the fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
21. Florine et al. do not disclose the administration of a composition comprising ciclesonide or a pharmaceutically acceptable salt thereof to a horse via inhalation.
22. Yet, Florine et al. additionally suggest inhalation as a route of administration:
“The one or more fusion proteins or compositions thereof as disclosed herein may be administered by any route known in the art or described herein, for example, oral, parenteral (e.g., intravenously or intramuscularly), intra- peritoneal, rectal, cutaneous, nasal, vaginal, inhalant,”
[emphasis added] (see page 36, second paragraph).
23. Thus, one of skill in the art before the effective filing date of the claimed invention would have been motivated to administer the ciclesonide composition via an alternative route such as inhalation, as an inhalable composition is specifically named by Florine et al., with a reasonable expectation of success.
As such, claims 17 and 22 are prima facie obvious.
24. Claims 18 and 36 are newly rejected under 35 U.S.C. 103 as being unpatentable over Florine et al., WO 2014160956, as applied to claim 17, above, and further in view of Parker and Yeates, Equine Veterinary Journal 2011 (cited on Applicant’s IDS of October 12, 2022).
This rejection is newly applied as a result of Applicant’s amendment to the claims.
Claim 17 is addressed in detail, above.
Claim 18 is drawn to claim 17, wherein the method further comprises determining a QOL based upon the administering;
wherein the QOL of the equine is determined based upon an assessment value of the equine based upon one or more parameters, the one or more parameters selected from the group consisting of an assessed attitude of the equine, an assessed energy level of the equine, and an assessed social interaction of the equine with one or more human beings and/or one or more other equines.
Claim 21 is drawn to claim 17, wherein an amelioration rate of the equine is at least 40%, at least 45%, at least 50%, at least 60%, at least 65%, or at least 68% after five days of treatment compared to day 0, or the amelioration rate of the equine is at least 45%, at least 50%, at least 60%, at least 65%, or at least 68% after ten days of treatment compared to day 0.
Claim 36 is drawn to claim 17, wherein the determining QOL of the equine based upon the administering comprises determining an amelioration rate of the equine over a time period of the administration of ciclesonide to the equine, the determining the amelioration rate comprising: determining a first QOL for the equine based upon QOL parameters and at a first point in time prior to a first administration of ciclesonide to the equine, wherein the QOL parameters comprise one or more of attitude of the equine, energy level of the equine, and social interaction of the equine with one or more human beings and/or one or more other equines; determining a second QOL for the equine based upon the QOL parameters at a second point in time during administration of ciclesonide to the equine; and comparing the first QOL with the second QOL to determine an amelioration rate of the equine at the second point in time.
In view of a broadest reasonable interpretation of claims 18 and 36, the limitation of and “determining QOL of the equine based upon the administering” is construed to mean:
“determining an amelioration rate of the equine over a time period of the administration of ciclesonide to the equine, comprising
determining a first QOL value for the equine based upon assessment of QOL parameters at a first point in time prior to a first administration of ciclesonide to the equine on Day 0, wherein the QOL parameters comprise assessing one or more of attitude of the equine, energy level of the equine, and social interaction of the equine with one or more human beings and/or one or more other equines;
determining a second QOL value for the equine based upon assessment of QOL parameters at a second point in time during administration of ciclesonide to the equine on Day 10 or Day 14; and
comparing the first QOL value with the second QOL value to determine an amelioration rate of the equine at the second point in time.”
25. Florine et al. teach a composition comprising a fusion protein and a glucocorticoid, specifically naming cicleosonide intended for injection into an intra-articular space of a joint in a mammal, wherein the mammal is a horse (Claims 16, 19 and 21) and its method of use in the treatment of joint injury or disease, comprising administering a therapeutically effective amount of the fusion protein/ciclesonide composition (Claim 33). Treating joint injury or disease in a horse in need thereof embraces treatment of an equine that is not suffering from an airway disease. By virtue of mitigating inflammation and improving symptoms of intraarticular joint disease in a horse in need thereof, such that said horse is relieved of symptoms of joint disease including pain and inflammation, one is necessarily and inevitably improving QOL of said horse.
26. Florine et al. additionally suggests administration via inhalation.
27. Florine et al. are silent to the limitation of determining QOL of the horse based upon an assessment value of the horse (claim 18), or based upon determining an ameliorate rate of the horse over a period of time of the administration of ciclesonide to the horse (claim 36).
28. However, Parker teaches that assessing equine patients’ quality of life (QOL) is a core part of clinical decision making, yet there are a lack of validated methodologies for assessing QOL in equine veterinary medicine (see Summary and page 247, left column under “Discussion”). Parker discloses methods of identifying and assessing QOL in equine patients (and Tables 1-3 page 245), and teaches that QOL assessment is useful in diagnostic screening and can dictate treatment choices (page 247, left column under “Step 5: Making a decision”). Parker suggests that equine practitioners report and discuss QOL assessments in clinical case discussions and journals, for example (page 247, left column under “Discussion”).
29. Therefore, one of skill in the art would have been motivated before the effective filing date of the claimed invention to determine QOL in an equine patient receiving treatment of any kind, in this case following administration of ciclesonide to said equine, in order to better diagnose said equine and assess therapeutic benefit as well as recovery. It would have been prima facie obvious to one skilled in the art before the effective filing date of the claimed invention to assess and determine QOL in an equine patient following administration of ciclesonide to said equine, with a reasonable expectation of success.
30. Regarding claim 21, drawn to the improvement in the amelioration rate, the fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
As such, claims 18 and 36 are prima facie obvious.
31. Claim 20 is newly rejected under 35 U.S.C. 103 as being unpatentable over Florine et al., WO 2014160956 A2, as applied to claims 17, 18, and 21-36 above, and further in view of the webpage printout of Equisearch (2002).
This rejection is newly applied as a result of Applicant’s amendments to the claims.
Claim 17 is addressed in detail, above.
Claim 20 is drawn to claim 17, and limits wherein the equine is older than 15 years.
32. Florine et al. teach a composition comprising a fusion protein and a glucocorticoid, specifically naming cicleosonide intended for injection into an intra-articular space of a joint in a mammal, wherein the mammal is a horse (Claims 16, 19 and 21) and its method of use in the treatment of joint injury or disease, comprising administering a therapeutically effective amount of the fusion protein/ciclesonide composition (Claim 33). Treating joint injury or disease in a horse in need thereof embraces treatment of an equine that is not suffering from an airway disease. By virtue of mitigating inflammation and improving symptoms of intraarticular joint disease in a horse in need thereof, such that said horse is relieved of symptoms of joint disease including pain and inflammation, one is necessarily and inevitably improving QOL of said horse. Florine et al. additionally suggest administration via inhalation.
33. Florine et al. are silent to the administration of ciclesonide to an equine older than 15 years.
34. Yet, Equisearch teaches that progressive joint inflammation, also known as degenerative joint disease, mainly affects senior horses, wherein horses around the age of 15 are particularly at risk: “a metabolic shift that occurs around age 15, leading to an escalation of cell death within bone, cartilage, and fibrous tissue,” (page 3, second paragraph). Therefore a senior horse around the age of 15 years or older meets the limitation of a horse at risk of joint injury or disease and in need of a fusion protein and a glucocorticoid composition.
35. Therefore, one of skill in the art before the effective filing date of the claimed invention would have been motivated to administer ciclesonide for treating joint disease in a horse, wherein the horse is older than 15 years, and would reasonably expect successful amelioration in the quality of life of said horse, following said administration.
As such, claim 20 is prima facie obvious.
36. Claims 23-35 are newly rejected under 35 U.S.C. 103 as being unpatentable over Florine et al., WO 2014160956, in view of Albrecht et al., U.S. 2014179651 A1 (cited on Applicant’s IDS of October 12, 2022).
This rejection is newly applied as a result of Applicant’s amendments to the claims.
Claim 17 is addressed in detail, above.
Claim 23 is drawn to claim 17, wherein the ciclesonide or pharmaceutically acceptable salt thereof is in a liquid formulation. Claim 24 is drawn to claim 23, wherein the liquid formulation comprises one or more of the solvents water, ethanol, one or more hydrofluoroalkanes and/or one or more hydrofluoroolefins and optionally additional excipients. Claim 25 is drawn to claim 24, wherein the one or more hydrofluoroalkanes comprise HFA 227 and/or HFA 134a, and the one or more hydrofluoroolefins comprise HFO1234ze. Claim 26 is drawn to claim 23, wherein the liquid formulation comprises a solvent that is partially aqueous and partially ethanolic. Claim 27 is drawn to claim 26, wherein the solvent in the liquid formulation consists of a mixture of > 85%V/V ethanol and <15% V/V water, or consists of a mixture of 10% V/V water and 90% V/V ethanol.
Claim 28 is drawn to claim 17, wherein the ciclesonide or pharmaceutically acceptable salt thereof is administered via an equine inhaler device.
Claim 29 is drawn to claim 28, wherein the equine inhaler device comprises: a) a pressurized metered dose inhaler or an aqueous/ ethanolic droplet inhaler or an aerosol-generating inhalation device; and b) an adapter for equine use.
Claim 30 is drawn to claim 17, wherein the ciclesonide or pharmaceutically acceptable salt thereof is a partially ethanolic formulation and is administered via an equine inhaler device.
Claim 31 is drawn to claim 30, wherein the ciclesonide or pharmaceutically acceptable salt thereof is administered to the equine at a dose of at least 900mg ex inhaler, at least 1800mg ex inhaler, at least 2400mg ex inhaler, or at least 2700mg ex inhaler. Claim 32 is drawn to claim 30, wherein the ciclesonide or pharmaceutically acceptable salt thereof is administered to the equine at a dose of 100mg to 5000mg ex inhaler, 450mg to 2700mg ex inhaler, 900mg to 2400mg ex inhaler, or 900mg to 2700mg ex inhaler.
Claim 33 is drawn to claim 30, wherein the ciclesonide or pharmaceutically acceptable salt thereof is administered with less than 20 actuations per dose, or 12 actuations per dose, or 11 actuations per dose, or 10 actuations per dose, or 9 actuations per dose, or 8 actuations per dose, or 7 actuations per dose, or 6 actuations per dose, or 5 actuations per dose, or 4 actuations per dose, or 3 actuations per dose, or 2 actuations per dose, or 1 actuation per dose. Claim 34 is drawn to claim 17, wherein the ciclesonide or pharmaceutically acceptable salt thereof is administered in 1 to 3 doses per day, or in 1 to 2 doses per day. Claim 35 is drawn to claim 17, wherein the ciclesonide or pharmaceutically acceptable salt thereof is administered over an extended time period of at least 1 week, at least 2 weeks, at least 3 weeks, at least 4 weeks, at least 5 weeks, at least 6 weeks, at least 7 weeks, at least 8 weeks, at least 9 weeks, or at least 10 weeks or longer.
37. Florine et al. teach a composition comprising a fusion protein and a glucocorticoid, specifically naming ciclesonide and its method of use in the treatment of joint injury or disease in a horse (Claims 16, 19 and 21), comprising administering a therapeutically effective amount of the fusion protein/ciclesonide composition (Claim 33). Treating joint injury or disease in a horse in need thereof embraces treatment of an equine that is not suffering from an airway disease. By virtue of mitigating inflammation and improving symptoms of intraarticular joint disease in a horse in need thereof, such that said horse is relieved of symptoms of joint disease including pain and inflammation, one is necessarily and inevitably improving QOL of said horse.
38. Florine et al. additionally suggests administration via inhalation, but do not teach wherein the administration is conducted with an equine inhaler device.
39. Yet, Albrecht et al. teach the administration of inhalable ciclesonide via the Equine Inhaler device, RESPIMAT®, an inhalation device using the RESPIMAT® aerosol generating technology, (see Example 3), which meets the limitations of claims 28-30).
40. Florine et al. do not teach a liquid formulation or the components of claims 24-27.
41. Albrecht et al. teach that the RESPIMAT® inhaler is an inhalation device using the RESPIMAT® aerosol generating technology, which can be used to produce the inhalable aerosols/inhalants employed in Example 3 (page 8), from the active substance in the liquid formulation (inhalation solution), which meets the limitations of claim 23 (see paragraph [0019]). Albrecht et al teach that the liquid formulation comprising ciclesonide or the pharmaceutically acceptable salt thereof is:
“preferably an ethanolic formulation, which can be aerosolized to facilitate its inhalation. In a further aspect of the present invention the liquid formulation is partially ethanolic and partially aqueous. In a further aspect of the present invention the liquid formulation comprises one or more of the solvents: water, ethanol, hydrofluoroalkane(s) such as HFA 227 and HFA 134a, hydrofluoro- olefin(s) such as HFO-1234ze, and optionally additional excipients. HFA is short for hydrofluoroalkane and HFO is the abbreviation for hydrofluoroolefin.
“In a preferred aspect of the present invention the solvent of the liquid formulation comprises/consists of a mixture of ≥85% V/V ethanol and ≤15% V/V water, such as for example 10% V/V aqueous and 90% V/V ethanol.
In another preferred aspect of the present invention the solvent of the liquid formulation comprises a mixture of ethanol and water, whereby the proportion of ethanol is in the range of 85-100% V/V, preferably 90-95% V/V. Preferably the proportion of ethanol is 90% V/V ethanol,”
which meet the limitations of claims 24-27, 29 and 30 (see paragraphs [0015]-[0017]).
42. Florine et al. do not teach metered dosage, however, Albrecht et al. additionally teach that the commercially available RESPIMAT® is used to administer ciclesonide at a dose of 1687.5 mg (5 actuations, twice daily) or 2700 mg (8 actuations twice daily) horse (ex-RESPIMAT®) for 14 days per inhalation, which meets the limitations of claims 31-35 (See the study of Example 3).
43. As such, one skilled in the art before the effective filing date of the claimed invention would have been motivated to administer the inhalable ciclesonide composition of Florine et al. via the equine inhaler device disclosed by Albrecht et al., with a reasonable expectation of success. It would have been obvious to one of skill in the art before the effective filing date of the claimed invention to employ the formulation in the parameters and dosage regimen previously disclosed by Albrecht et al., for administration to a horse, as guided by Florine et al. with a reasonable expectation of success.
Therefore, claims 23-35 are prima facie obvious.
Response to Arguments
44. Applicant traverses the previous obviousness rejection of claim 17 based upon Florine in view of Parker. Applicant argues that Florine describes treatment of a joint injury or joint disease, where a medicament such as ciclesonide can be injected into an intra-articulated space of a joint in an animal to treat such joint injury or joint disease. Applicant argues that the methods described by Florine are in relation to direct administration via injection of the medicament to an injury or disease site within a joint and not administration via inhalation of the medicament in the manner as claimed.
Applicant argues that Parker (or Albrecht) cannot account for the deficiencies of Florine.
45. Applicant's arguments have been fully considered but they are not persuasive. A patent is prior art for all that it teaches. While the examiner concedes that Florine describes treatment of a joint injury or joint disease, where a medicament such as ciclesonide can be injected into an intra-articulated space of a joint, Florine also suggests that the ciclesonide compositon can be administered via inhalation (page 36, second paragraph). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.").
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) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have "relatively acceptable dimensional stability" and "some degree of flexibility," but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant’s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since "Gurley asserted no discovery beyond what was known in the art." 27 F.3d at 554, 31 USPQ2d at 1132.). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
And, “[e]ven if a reference discloses an inoperative device, it is prior art for all that it teaches” (Beckman Instruments v. LKB Produkter AB, 892 F.2d 1547 (Fed. Cir. 1989)). Therefore, “a non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 103” (Symbol Techs. Inc. v. Opticon Inc., 935 F.2d 1569 (Fed. Cir. 1991)). Therefore, Florine’s suggestion of inhalable ciclesonide constitutes prior art.
46. Claim 37 is rejected under 35 U.S.C. 103 as being obvious over Albrecht et al., U.S. 2014179651 A1 (cited on Applicant’s IDS of October 12, 2022), in view of Parker and Yeates, Equine Veterinary Journal 2011 (cited on Applicant’s IDS of October 12, 2022).
This rejection is newly applied as a result of Applicant’s amendment to the claims.
Claim 37 is drawn to a method of ameliorating quality of life (QOL) of an equine comprising administering ciclesonide or a pharmaceutically acceptable salt thereof to the equine and determining QOL of the equine based upon the administering;
and determining a QOL of the equine based upon the administering; wherein the QOL of the equine is determined based upon an assessment value of the equine based upon one or more parameters, the one or more parameters selected from the group consisting of an assessed attitude of the equine, an assessed energy level of the equine, and an assessed social interaction of the equine with one or more human beings and/or one or more other equines.
In view of a broadest reasonable interpretation of claim 37, the limitations of “ameliorating quality of life (QOL) of an equine,” and “determining QOL of the equine based upon the administering” are construed to mean:
“determining an amelioration rate of the equine over a time period of the administration of ciclesonide to the equine, comprising
determining a first QOL value for the equine based upon assessment of QOL parameters at a first point in time prior to a first administration of ciclesonide to the equine on Day 0, wherein the QOL parameters comprise assessing one or more of attitude of the equine, energy level of the equine, and social interaction of the equine with one or more human beings and/or one or more other equines;
determining a second QOL value for the equine based upon assessment of QOL parameters at a second point in time during administration of ciclesonide to the equine on Day 10 or Day 14; and
comparing the first QOL value with the second QOL value to determine an amelioration rate of the equine at the second point in time.”
47. Albrecht et al. teach the administration of ciclesonide for the treatment of airway disease in horses (see Example 3 at page 8). Note that while Albrecht et al. do not teach the inherent property of the instantly claimed method of administering ciclesonide to ameliorate quality of life (QOL), this result flows from the administration step itself. When ciclesonide is administered to treat airway/respiratory disease in a horse, the limitation of improving QOL is necessarily and inevitably present because following said treatment, the equine is able to breathe without distress. As a horse suffering from an airway disease meets the criteria of a horse in need of improving QOL (i.e., to help to breathe without distress), the claim as a whole is anticipated. MPEP § 2112 (II) states "there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)." Furthermore, Integra Life Sciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) makes clear that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products.
And it is noted that in the Specification, Applicant teaches that said ameliorating QOL in an equine refers to a therapeutic method involving the administration of a medicament (ciclesonide) to an equine, “whereby the poor general health condition of the equine is improved. This improvement of the general health condition may be accompanied by the treatment of a specific disease or disorder, such as a respiratory disease, in particular equine asthma,” (Specification page 3, lines 20-25).
48. Albrecht et al. are silent to the limitation of determining QOL of said horse based upon an assessment value of the horse.
49. However, Albrecht et al. teach that certain parameters are examined during the study. And, Parker teaches that assessing patients’ quality of life (QOL) is a core part of clinical decision making, yet there are a lack of validated methodologies for assessing QOL in equine veterinary medicine (see Summary and page 247, left column under “Discussion”). Parker discloses methods of identifying and assessing QOL in equine patients (and Tables 1-3 page 245), and teaches that QOL assessment is useful in diagnostic screening and can dictate treatment choices (page 247, left column under “Step 5: Making a decision”). Parker suggests that equine practitioners report and discuss QOL assessments in clinical case discussions and journals, for example (page 247, left column under “Discussion”).
50. Therefore, one of skill in the art would have been motivated before the effective filing date of the claimed invention to determine QOL in an equine patient receiving treatment of any kind, in this case following administration of ciclesonide to said horse, in order to better diagnose said horse and assess therapeutic benefit as well as recovery, with a reasonable expectation of success.
As such, claim 37 is prima facie obvious.
Previous Double Patenting Rejections
51. Claims 17, 18 and 21-36 were previously rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 9,918,995 B2.
52. In view of Applicant’s amendment to claim 17 to exclude the patient population comprising an equine that is not suffering from an airway disease, the previous double patenting rejections of claims 17, 18 and 21-36 are withdrawn.
53. Claims 17, 18 and 21-36 were previously rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,258,634 B2.
54. In view of Applicant’s amendment to claim 17 to exclude the patient population comprising an equine that is not suffering from an airway disease, the previous double patenting rejections of claims 17, 18 and 21-36 are withdrawn.
55. Claims 17, 18 and 21-36 were previously rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,441,597 B2.
56. In view of Applicant’s amendment to claim 17 to exclude the patient population comprising an equine that is not suffering from an airway disease, the previous double patenting rejections of claims 17, 18 and 21-36 are withdrawn.
New Double Patenting Rejections
57. 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).
58. 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).
59. 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.
60. 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.
61. Claims 37 is rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 9,918,995 B2.
This rejection is newly applied as a result of Applicant’s amendment to the claims.
62. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. 9,918,995 recite the following:
1. A method of treating an airway disease in equines comprising administering by inhalation to an equine having an airway disease an effective amount of ciclesonide or a pharmaceutically acceptable salt thereof or a composition comprising ciclesonide or a pharmaceutically acceptable salt thereof during a treatment period comprising a first portion and optionally a second portion, wherein the effective amount administered during the first portion of the treatment period comprises a daily dose of at least 5000 μg ex inhaler for consecutive days and the effective amount administered during the optional second portion of the treatment period comprises a daily dose of at least 100 μg to 5000 μg ex inhaler.
2. The method according to claim 1, wherein the airway disease is a pulmonary disease.
3. The method according to claim 1, wherein the airway disease is selected from the group consisting of: recurrent airway obstruction (RAO), summer pasture associated obstructive pulmonary disease (SPAOPD), and inflammatory airway disease (IAD).
4. The method according to claim 3, wherein the airway disease is RAO.
5. A method according to claim 1, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is in a liquid formulation.
6. A method according to claim 5, wherein said liquid formulation comprises one or more of the solvents water, ethanol, hydrofluoroalkanes, hydrofluoroolefin or excipients.
7. A method according to claim 6, wherein said hydrofluoroalkanes are HFA 227, HFA 134a, and combinations thereof.
8. A method according to claim 6, wherein said hydrofluoroolefin is HFO1234ze.
9. A method according to claim 5, wherein the solvent in said liquid formulation is partially aqueous and partially ethanol.
10. A method according to claim 9, wherein the solvent in said liquid formulation comprises of a mixture of ≥85% V/V ethanol and ≤15% V/V water.
11. A method according to claim 9, wherein the solvent in said liquid formulation comprises 10% V/V water and 90% V/V ethanol.
12. A method according to claim 5, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is administered via an inhaler device.
13. The method according to claim 12, whereby said inhaler device comprises: a. a pressurized metered dose inhaler or a aqueous/ethanolic droplet inhaler; and b. an adapter for equine use.
14. A method according to claim 5, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is a partially ethanolic formulation and is administered via an inhaler device.
15. A method according to claim 14, wherein the method includes both the first and second portions, and the effective amount administered during the second portion of the treatment period comprises a daily dose of at least 900 μg ex inhaler, at least 1800 μg ex inhaler, or at least 2700 μg ex inhaler.
16. The method according to claim 1, wherein the method includes both the first and second portions, and wherein the effective amount administered during the treatment period comprises a first dose administered twice daily for a period of 5-7 days during the first portion and a second dose administered once daily for a period of 5-7 days during the second portion.
17. The method according to claim 16, wherein the first dose is 2700 μg ex inhaler administered twice daily and the second dose is 3712.5 μg ex inhaler administered once daily.
18. The method according to claim 1, wherein the composition comprises a solution comprising 0.7-3.1 g ciclesonide/100 mL.
63. Instant claim 37 is described in detail, above.
64. Thus the claims of U.S. 9,918,995 recite the administration of ciclesonide for the treatment of airway disease in horses wherein ciclesonide is administered by inhalation via an inhaler device wherein the ciclesonide is in a liquid ethanolic formulation (inhalation solution), at a dosage amount and for a duration of time that overlaps the range recited in the instant claims. Regarding the U.S. 9,918,995 recitation of administering ciclesonide in a first and second portion, dose regimen optimization is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art. It would have been obvious for one of skill in the art to have chosen a dosage from among those previously recited in order to achieve a beneficial effect of the administration of ciclesonide in an equine in need thereof. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
65. While of U.S. 9,918,995 does not recite the inherent property of the instantly claimed method of administering ciclesonide to ameliorate quality of life (QOL), this result flows from the administration step itself. When ciclesonide is administered to treat airway/respiratory disease in a horse, the limitation of improving QOL is necessarily and inevitably present because following said treatment, the equine is able to breathe without distress. As a horse suffering from an airway disease meets the criteria of a horse in need of improving QOL (i.e., to help to breathe without distress), the claim as a whole is anticipated. MPEP § 2112 (II) states "there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)." Furthermore, Integra Life Sciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) makes clear that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products.
And it is noted that in the instant Specification, Applicant teaches that said ameliorating QOL in an equine refers to a therapeutic method involving the administration of a medicament (ciclesonide) to an equine, “whereby the poor general health condition of the equine is improved. This improvement of the general health condition may be accompanied by the treatment of a specific disease or disorder, such as a respiratory disease, in particular equine asthma,” (Specification page 3, lines 20-25).
66. Claim 37 is rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,258,634 B2.
This rejection is newly applied as a result of Applicant’s amendment to the claims.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. 10,258,634 recite the following:
1. A method of treating an airway disease in equines comprising administering to an equine an effective amount of ciclesonide or a pharmaceutically acceptable salt thereof or a composition comprising ciclesonide or a pharmaceutically acceptable salt thereof; wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered at a dose of 100 μg to 5000 μg ex inhaler.
2. The method of claim 1, wherein the airway disease is a pulmonary disease.
3. The method of claim 1, wherein the airway disease is selected from the group consisting of recurrent airway obstruction (RAO), summer pasture associated obstructive pulmonary disease (SPAOPD), and inflammatory airway disease (IAD).
4. The method according to claim 3, wherein the airway disease is RAO.
5. The method claim 1, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is inhalable.
6. The method of claim 1, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is in a liquid formulation.
7. The method of claim 6, wherein the liquid formulation comprises one or more solvents selected from the group consisting of water, ethanol, hydrofluoroalkanes, hydrofluoroolefin, and excipients.
8. The method of claim 7, wherein the hydrofluoroalkanes are HFA 227, HFA 134a, and combinations thereof.
9. The method of claim 7, wherein the hydrofluoroolefin is HFO1234ze.
10. The method of claim 6, wherein the solvent in the liquid formulation is partially aqueous and partially ethanol.
11. The method of claim 10, wherein the solvent in the liquid formulation comprises of a mixture of ≥85% V/V ethanol and ≤15% V/V water.
12. The method of claim 10, wherein the solvent in the liquid formulation comprises 10% V/V water and 90% V/V ethanol.
13. The method of claim 6, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered via an inhaler device.
14. The method of claim 13, wherein the inhaler device comprises: a. a pressurized metered dose inhaler or a aqueous/ethanolic droplet inhaler comprising the RESPIMAT® inhaler or another inhalation device using the RESPIMAT® aerosol-generating technology; and b. an adapter for equine use.
15. The method of claim 6, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is a partially ethanolic formulation and is administered via an inhaler device.
16. The method of claim 15, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered at a dose of at least 900 μg ex inhaler, at least 1800 μg ex inhaler, or at least 2700 μg ex inhaler.
17. The method of claim 16, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered at a dose of 450 μg to 2700 μg ex inhaler.
18. The method of claim 16, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered at a dose of 900 μg to 2700 μg ex inhaler.
19. The method of claim 6, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered with less than 20 actuations per dose.
20. The method of claim 19, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered with 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 actuations per dose.
21. The method of claim 20, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered using 8 or fewer actuations per dose.
22. The method of claim 6, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered in 1 to 3 doses per day.
23. The method of claim 22, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered in 1 to 2 doses per day.
24. The method of claim 6, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered over a time period of at least 1 week.
25. The method of claim 24, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered over a time period of at least 10 weeks.
26. A method according to claim 1, wherein the composition comprises a solution including 0.7-3.1 g ciclesonide/100 mL.
27. A method of treating an airway disease in equines comprising administering to an equine an effective amount of ciclesonide or a pharmaceutically acceptable salt thereof or a composition comprising ciclesonide or a pharmaceutically acceptable salt thereof; wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered at a dose of 1800 μg to 5000 μg ex inhaler.
67. Instant claim 37 is described in detail, above.
68. Thus the claims of U.S. 10,258,634 B2 recite the administration of ciclesonide for the treatment of airway disease in horses wherein ciclesonide is administered by inhalation via an inhaler device, specifically Respimat, wherein the ciclesonide is in a liquid ethanolic formulation (inhalation solution), at a dosage amount and for a duration of time that overlaps the range recited in the instant claims. And, discovery of an optimum value of a result effective variable in a known process, such as dose amount and duration is ordinarily within the skill of the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980),
69. Regarding the instantly claimed method of administering ciclesonide to ameliorate quality of life (QOL), this result flows from the administration step itself. When ciclesonide is administered to treat airway/respiratory disease in a horse, the limitation of improving QOL is necessarily and inevitably present because following said treatment, the equine is able to breathe without distress. As a horse suffering from an airway disease meets the criteria of a horse in need of improving QOL (i.e., to help to breathe without distress), the claim as a whole is anticipated. MPEP § 2112 (II) states "there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)." Furthermore, Integra Life Sciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) makes clear that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products.
And it is noted that in the instant Specification, Applicant teaches that said ameliorating QOL in an equine refers to a therapeutic method involving the administration of a medicament (ciclesonide) to an equine, “whereby the poor general health condition of the equine is improved. This improvement of the general health condition may be accompanied by the treatment of a specific disease or disorder, such as a respiratory disease, in particular equine asthma,” (Specification page 3, lines 20-25).
70. Claim 37 is rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,441,597 B2.
This rejection is newly applied as a result of Applicant’s amendment to the claims.
71. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. 10,441,597 recite the following:
1. A method of treating an airway disease in an equine comprising administering by inhalation to the equine an effective amount of ciclesonide or a pharmaceutically acceptable salt thereof or a composition comprising ciclesonide or a pharmaceutically acceptable salt thereof.
2. The method of claim 1, wherein the airway disease is a pulmonary disease.
3. The method of claim 1, wherein the airway disease is selected from the group consisting of: recurrent airway obstruction (RAO), summer pasture associated obstructive pulmonary disease (SPAOPD), and inflammatory airway disease (IAD).
4. The method of claim 1, wherein the airway disease is RAO.
5. The method of claim 1, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is inhalable.
6. The method of claim 1, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is in a liquid formulation.
7. The method of claim 6, wherein the liquid formulation comprises one or more of the solvents water, ethanol, hydrofluoroalkanes, hydrofluoroolefin or excipients.
8. The method of claim 7, wherein the one or more solvents include one or more hydrofluoroalkanes selected from the group consisting of HFA 227, HFA 134a, and combinations thereof.
9. The method of claim 7, wherein the one or more solvents include HFO1234ze.
10. The method of claim 7, wherein the liquid formulation is partially aqueous and partially ethanol.
11. The method of claim 7, wherein the liquid formulation comprises a mixture of ≥85% V/V ethanol and ≤15% V/V water.
12. The method of claim 7, wherein the liquid formulation comprises 10% V/V water and 90% V/V ethanol.
13. The method of claim 1, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered to the equine via an inhaler device.
14. The method of claim 13, whereby the inhaler device comprises: a. a pressurized metered dose inhaler or aqueous/ethanolic droplet inhaler; and b. an adapter for equine use.
15. The method of claim 1, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is a partially ethanolic formulation and is administered to the equine via an inhaler device.
16. The method of claim 13, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered to the equine at a dose selected from the group consisting of: at least 900 μg ex inhaler, at least 1800 μg ex inhaler, at least 2700 μg ex inhaler, and at least 2700 μg ex inhaler.
17. The method of claim 13, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered to the equine at a dose of 100 μg to 5000 μg ex inhaler.
18. The method of claim 13, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered to the equine with less than 20 actuations per dose, or 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 actuation per dose.
19. The method of claim 13, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered to the equine in 1 to 3 doses per day, or in 1 to 2 doses per day.
20. The method of claim 1, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered to the equine over an extended time period selecting from the group consisting of at least 1 week, at least 2 weeks, at least 3 weeks, at least 4 weeks, at least 5 weeks, at least 6 weeks, at least 7 weeks, at least 8 weeks, at least 9 weeks, and at least 10 weeks.
21. The method of claim 1, wherein the equine is a horse.
72. Instant claim 37 is described in detail, above.
73. Thus the claims of U.S. 10,441,597 B2 recite the administration of ciclesonide for the treatment of airway disease in horses wherein ciclesonide is administered by inhalation via an inhaler device wherein the ciclesonide is in a liquid ethanolic formulation (inhalation solution), at a dosage and a duration of time that overlap with Applicant’s instant claims. And, discovery of an optimum value of a result effective variable in a known process, such as dose amount and duration of administration is ordinarily within the skill of the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
74. While of U.S. 10,441,597 does not recite the inherent property of the instantly claimed method of administering ciclesonide to ameliorate quality of life (QOL), this result flows from the administration step itself. When ciclesonide is administered to treat airway/respiratory disease in a horse, the limitation of improving QOL is necessarily and inevitably present because following said treatment, the equine is able to breathe without distress. As a horse suffering from an airway disease meets the criteria of a horse in need of improving QOL (i.e., to help to breathe without distress), the claim as a whole is anticipated. MPEP § 2112 (II) states "there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)." Furthermore, Integra Life Sciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) makes clear that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products.
And it is noted that in the instant Specification, Applicant teaches that said ameliorating QOL in an equine refers to a therapeutic method involving the administration of a medicament (ciclesonide) to an equine, “whereby the poor general health condition of the equine is improved. This improvement of the general health condition may be accompanied by the treatment of a specific disease or disorder, such as a respiratory disease, in particular equine asthma,” (Specification page 3, lines 20-25).
New Claim Objections
This objection is newly applied as a result of the amendments to the claims.
75. Claim 22 is objected to because it recites that the ciclesonide or pharmaceutically acceptable salt thereof is inhalable. However, claim 22 is drawn to claim 17, which as amended, limits administration to inhalation. Therefore claim 22 is redundant. Appropriate correction is required.
Conclusion
76. Claims 17, 18 and 20-37 are pending in the application, and all claims stand rejected. No claim is presently allowed.
77. 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.
78. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628