DETAILED ACTION
Claims 1-4 and 6-21 are pending. Applicant has amended claim 1 and added new claims 12-21 in the response of 6/23/2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/23/2025 has been entered.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 5/30/2025 and 6/2/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the Examiner.
Claim Rejections - 35 USC § 103
(NEW Rejection)
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6-7 and 10-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cloutier et al US 6,521,212 issued February 10, 2003; Voswinckel, R., et al., Inhaled treprostinil is a potent pulmonary vasodilator in severe pulmonary hypertension, 25 EUROPEAN HEART J. 22 (2004) (Ex. 1007) (“Voswinckel JESC”); Robert Voswinckel, et al., Inhaled Treprostinil Sodium (TRE) For the Treatment of Pulmonary Hypertension, in Abstracts from the 2004 Scientific Sessions of the American Heart Association, 110 CIRCULATION III-295 (Oct. 26, 2004) (Ex. 1008) (“Voswinckel JAHA”); Atkins, P., Dry Powder Inhalers: An Overview, RESPIRATORY CARE • OCTOBER 2005 VOL 50 NO 10; Badesch et al. “Prostanoid Therapy for Pulmonary Arterial Hypertension,” JACC Vol. 43, No. 12 Suppl S June 16, 2004:56S–61S; and Goldsmith et al. “Inhaled Iloprost,” Drugs 2004; 64 (7): 763-773 with guidance and rebuttal evidence from Final Written Opinion IPR202 l -00406 in regards to Patent 10,716,793 B2 entered 7/19/2022.
Instant claim 1 is generally directed towards a method of treating pulmonary hypertension comprising: providing an inhalation device for treating pulmonary hypertension in a human suffering from pulmonary hypertension comprising a powder formulation of treprostinil or a pharmaceutically acceptable salt thereof and a dry powder inhaler configured to administer a single event dose of the powder formulation comprising treprostinil or a pharmaceutically acceptable salt thereof, wherein the single event dose comprises at least 45 micrograms of treprostinil or a pharmaceutically acceptable salt thereof delivered in 1 to 3 breaths, wherein the dry powder inhaler is configured to administer the entire single event dose in less than 5 minutes with at least 5 micrograms of treprostinil or a pharmaceutically acceptable salt thereof being inhaled per breath through coordinated actuation of the dry powder inhaler with each breath, and administering to a human suffering from pulmonary hypertension with the dry powder inhaler the single event dose comprising at least 45 micrograms of treprostinil or a pharmaceutically acceptable salt thereof in 1 to 3 breaths, wherein the human administers the entire single event dose with the dry powder inhaler in less than 5 minutes by inhaling at least 5 micrograms of treprostinil or a pharmaceutically acceptable salt thereof per breath by coordinating one actuation of the dry powder inhaler for each separate breath, and wherein administration of an additional single event dose in the same manner occurs at least 3 hours later.
The ’212 Patent describes methods of delivering a therapeutically effective amount of benzindene prostaglandin (also known as “UT-15”) by inhalation to treat pulmonary hypertension in a single dose event. Abstract, 2:16-18, 2:66- 3:5, 4:10-13, 4:41-54, 7:18-24. A POSA as of May 2006 would have readily understood that “UT-15” is synonymous with treprostinil sodium, and that treprostinil is an analog of benzindene prostaglandin. Specifically, the ’212 Patent discloses and claims “a method of treating pulmonary hypertension by inhalation of a benzindene prostaglandin” or a “pharmaceutically acceptable salt” thereof, 4, 11-12. The ’212 Patent further states that the “benzindene prostaglandin is delivered by inhalation to a patient in need thereof in a ‘therapeutically effective amount.’” 6:56-58. “A ‘therapeutically effective amount’ refers to that amount that has therapeutic effects on the condition intended to be treated or prevented.” 6:58- 61. The ’212 Patent explains that “[t]he precise amount that is considered effective for a particular therapeutic purpose will, of course, depend upon the specific circumstances of the patient being treated and the magnitude of effect desired by the patient’s doctor.” 6:66-7:2.
The ’212 Patent discloses that an inhaler may be used to deliver the benzindene prostaglandin. 5:30-32 (“Preferably, a nebulizer, inhaler, atomizer or aerosolizer is used, which forms droplets from a solution or liquid containing the active ingredient(s).”). A POSA as of May 2006 would have readily understood that an inhaler is an inhalation device.
The ’212 Patent discloses that “[i]t has been discovered that aerosolized UT15 has both greater potency and efficacy” for “attenuating chemically induced pulmonary hypertension” as compared to intravascular delivery. 8:5-8. The ’212 Patent quantifies this potency, teaching that “aerosolized UT-15 has a greater potency as compared to intravascularly administered UT-15, since the actual amount of UT-15 delivered via aerosolization delivery is only a fraction (10-50%) of the dosage delivered intravascularly.” 8:8-12.
Given these teachings, the successful sheep data, and the claims of the ’212 Patent, a POSA would have been motivated to look for data administering inhaled treprostinil in humans with PH and the doses used therein. A POSA would have been readily led to Voswinckel JESC, which discloses the effective administration of inhaled treprostinil for human patients with pulmonary arterial hypertension for 6 minutes on the OptiNeb® nebulizer of treprostinil solution at a concentrations of 16 to 64 µg/mL. See Methods.
Voswinckel JESC teaches that "patients inhaled solvent solution (placebo) (n=8) or treprostinil for 6 min (OptiNeb ultrasound nebulizer, Nebu-tec, Germany) in concentrations of 16, 32, 48, and 64 μg/ml (n=6, 6, 6, and 3 patients)." Ex. 1007, 7. Although this teaching shows administration to patients of inhaled solutions with particular concentrations of treprostinil, it does not disclose the amount of solution administered, which is necessary in order to calculate the amount of Treprostinil administered. Id. Petitioner directs us to the testimony of its declarants, Dr. Nicholas Hill and Dr. Igor Gonda, to understand how a person of ordinary skill in the art would have interpreted Voswinckel JESC's disclosure. Pet. 23 ( citing Ex. 1002 ,r 65; Ex. 1004 ,r 56). Dr. Gonda testifies that "in May 2006 ... nebulizers conventionally deliver[ ed] between 1 and 5 mL" of solution. Ex. 1004 ,r 56. Relying on Dr. Gonda's testimony as well as his own experience, Dr. Hill testifies that a person of ordinary skill in the art in 2006 would have understood that "nebulizers ... nebulize (i.e. aerosolize liquid) at least" 1 mL of solution. Ex. 1002 ,r 65. Multiplying Voswinckel JESC's 16, 32, 48, or 64 micrograms of Treprostinil per milliliter of solution by the 1 to 5 milliliters of solution in the testimony of Drs. Hill and Gonda, a person of ordinary skill in the art would have interpreted Voswinckel JESC as teaching the delivery of 16-80, 32-160, 48-240, or 64-320 micrograms of treprostinil. All of these ranges encompass an amount of at least 45 micrograms.
Given that ‘212 states the dose as result effective. Optimization of the dose would be obvious. According to the '212 patent, this method may be used to "treat[] pulmonary hypertension in a mammal." Id. at 14:9-12. Moreover, the '212 patent teaches "medical use" of its method in a "human." Id. at 7:4-5. The necessary dose to achieve "a particular therapeutic purpose will, of course, depend upon the specific circumstances of the patient being treated and the magnitude of the effect desired by the patient's doctor. Titration to effect may be used to determine proper dosage." Id. at 6:66-7:3. "[A]erosolized UT-15 has a greater potency as compared to intravascularly administered UT-15," so the '212 patent teaches delivering "only a fraction (10-50%) of the dosage delivered intravascularly" when using its inhalation delivery method. Id. at 8:8-12. Even at "high doses," however, the '212 patent teaches a lack of "significant non-lung effects, i.e., heart rate, cardiac output." Id. at 10:51-54.
Therefore a POSA would have known to optimize the dose for effect as noted by the ‘212 patent and arrive at the at least 45 microgram dose. A POSA would also have expected dosage to be dependent on the form, and one would know they would require routine optimization when switching dosage forms (liquid to solid) as absorption would most likely vary. Instant claims 10 requires 45-120 micrograms, and instant claim 12 requires 90-120 micrograms. Claim 19 varies the range again. Given the range in the art and the fact that the dose is a known variable to optimize all these claims are prima facie obvious.
A POSA would have known to increase patient compliance and convenience, it would be desirable to reduce the number of breaths required for delivery of treprostinil by inhalation. A POSA who understood the necessary amount of dosing for aerosolized delivery of treprostinil would then look to the art for the fewest number of breaths in which that delivery could occur.
Voswinckel JAHA discloses a low number of breaths for the aerosolized delivery of treprostinil specifically for treatment of pulmonary hypertension. Thus, a POSA would understand the ’212 Patent and Voswinckel JESC’s dosage teachings would be readily applicable to the breath disclosure of Voswinckel JAHA.
In particular, Voswinckel JAHA states “[p]atients received a TRE [inhaled treprostinil sodium] by use of the pulsed OptiNeb® ultrasound nebulizer (3 single breaths, TRE solution 600 µg/ml)” and further observes that “[t]olerability is excellent even at high drug concentrations and short inhalation times (3 breaths)” with “strong pulmonary selective vasodilatory efficacy with a long duration of affect following single acute dosing.” See EX1008, Methods, Conclusion. A POSA therefore would have applied the 3-breath delivery disclosure of Voswinckel JAHA to the teachings of the ’212 Patent to improve patient adherence to treatment. EX1002, ¶¶103, 104. Accordingly, a POSA reading the ’212 Patent and Voswinckel JESC and applying Voswinckel JAHA’s teachings to increase patient compliance and ease of use would have thought it obvious to administer treprostinil via inhalation in 3 breaths or less, thereby rendering the instant limitation obvious.
The above rationale explains how a POSA would arrive at treating pulmonary hypertension via an inhalation device using an effective single event dose of the formulation around 45 micrograms of treprostinil delivered in 1 to 3 breaths, wherein the inhaler is configured to administer the entire therapeutically effective single event dose in less than 5 minutes. These references do not disclose the multiple dosing timing of inhaled treprostinil, as required by claim 1 that requires “administration of an additional therapeutically single event dose in the same manner occurs at least 3 hours later.” The treatment of PH however is not curative, and a single dose is not the end of treatment with treprostinil. The references above teach that the switching from nebulized to inhaled treprostinil, but do not teach multiple dosing. Badesch and Goldsmith provide the teaching of showing that both treprostinil and iloprost are prostanoids (Badesch, Abstract), and when using inhaled iloprost one doses the drug 6 to 9 times a day for treatment of PH (Goldsmith, Abstract). Treprostinil has a half-life of 3h (Badesch, 58S, ¶2). Iloprost has a half-life of 20 to 25 minutes (Badesch, 58S, ¶7). Therefore one would know, using Iloprost as a guide, that when switching to Treprostinil the dosing interval will be longer in duration than that of Iloprost (every 2.67 to 4 hours). Therefore dosing Treprostinil, one would arrive at a dosing interval “at least 3 hours later” based on the substitution from inhaled iloprost to inhaled treprostinil as the half-life of treprostinil is longer. Thereby rendering the instant limitation to a dosing interval “at least 3 hours later” obvious.
The ’212 Patent further states “solid formulations, usually in the form of a powder, may be inhaled in accordance with the present invention.” Id., 5:37-39. And finally, claim 9 of the ʼ212 Patent is specifically directed to an inhaled powder formulation of treprostinil. Accordingly, a POSA would have readily understood the “inhaler” disclosed in the ’212 Patent could be used as a “dry powder inhaler,” as claimed, to deliver powder formulations.
Such dry powder inhalers were well known and “widely accepted” as of 2006. See Atkins, (October 2005 “Dry Powder Inhalers: An Overview”).
The ‘212 Patent states that solid formulations, usually in the form of a powder, may be inhaled in accordance with the present invention. In such case, the particles are preferably less than 10 micrometers in diameter, and more preferably, less than 5 micrometers in diameter. Meeting the limitation of claim 5. 5:39-4.
Claim 1 also requires no metacresol. Disclosed in the ’212 Patent, which has no disclosure requiring the presence of metacresol in the described formulation. EX1006, 5:25-29 (disclosing formulation of a “more preferred solution” that does not include metacresol), 8:39. A POSA would thus understand the ’212 Patent to disclose a formulation of UT-15 (i.e., treprostinil) that contains no metacresol. Meeting the limitations of instant claim 1. Moreover, Voswinckel JAHA teaches “Methods: In an open-label study a preservative free solution of inhaled TRE was applied to 17 patients with severe pulmonary hypertension during Swan-Ganz catheter investigation.” Given metacresol is a known preservative, one can conclude the Voswinckel JAHA reference excludes metacresol.
Claim Rejections - 35 USC § 103
Claims 1-4 and 6-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cloutier et al US 6,521,212 issued February 10, 2003; Voswinckel, R., et al., Inhaled treprostinil is a potent pulmonary vasodilator in severe pulmonary hypertension, 25 EUROPEAN HEART J. 22 (2004) (Ex. 1007) (“Voswinckel JESC”); Robert Voswinckel, et al., Inhaled Treprostinil Sodium (TRE) For the Treatment of Pulmonary Hypertension, in Abstracts from the 2004 Scientific Sessions of the American Heart Association, 110 CIRCULATION III-295 (Oct. 26, 2004) (Ex. 1008) (“Voswinckel JAHA”); Atkins, P., Dry Powder Inhalers: An Overview, RESPIRATORY CARE • OCTOBER 2005 VOL 50 NO 10; Badesch et al. “Prostanoid Therapy for Pulmonary Arterial Hypertension,” JACC Vol. 43, No. 12 Suppl S June 16, 2004:56S–61S; and Goldsmith et al. “Inhaled Iloprost,” Drugs 2004; 64 (7): 763-773 as applied to claims 1-4, 6-7 and 10-21 and in further view of Laliberte et al. “Pharmacokinetics and Steady-State Bioequivalence of Treprostinil Sodium (Remodulin®) Administered by the Intravenous and Subcutaneous Route to Normal Volunteers,” J Cardiovasc Pharmacol, Volume 44, Number 2, August 2004.
Claims 8 and 9 are inherent to the dose and physical properties of the drug itself, and the rejection of these claims specifically is not necessary as the dose of 45 micrograms of treprostinil (rendered obvious above) will achieve the desired PK required by the claims 8 and 9.
Regardless Laliberte shows the PK of Treprostinil, and that the Cmax of 1.4 ng/mL was achieved. Moreover one can see the rapid onset of the PK, and this would be expected based on the moving to inhaled Treprostinil as well.
Therefore, the PK discussed, which is inherent to the dose of claim 1, is obvious based on the art of record.
Response to Arguments: Applicant argues (Section I) the claim limitation to “at least 3 hours apart” and “at least 45 micrograms” renders the claims obvious. These limitations have been discussed and have been shown obvious based on the art of record. The art of record uses the combination of the PTAB decision with new references that fill in the gaps not adjudicated in the Final Written Decision. The combination renders the claims obvious.
In Section II of the arguments Applicant argues unexpected results in comparison to the prior art of JESC and JAHA. Applicant point out that the data provided by JESC is insufficient, “[t]his type of area between the curves (ABC) data provides no reasonable expectation of success that a given single event dose could provide greater efficacy for at least 3 hours compared to another single event dose because it does not identify any effect at a particular point in time.”
This is not convincing as the pharmacokinetics (PK) and pharmacodynamics (PD) are inherent to the properties of the drug, and do not change based on measurement. Therefore one could perform the art, JESC, and get more data and a better understanding of the PK/PD relationship, therefore suing this reference as a guide, for what it actually teaches, one would understand the PK. One must also note the conclusion of JESC states:
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The long-lasting effect is inherent to the PK, and the PK flows naturally from the dose. Given the dose is obvious based on the art, the duration of action is inherent. Therefore this argument is not persuasive.
Applicant makes a similar argument with respect to JAHA, Stating the data in the art is insufficient to make the 3 hours later conclusion. Again Applicant is misapplying what the reference teaches. One could simply practice the taught method and take more measurements and identify the PK/PD relationship and adjust the dose according to the ‘221 recommendation to achieve the efficacy. These 2 references teach methods of use, which one could repeat and understand the full picture of the drugs behavior in the human, and from the known art in combination with using a known titration (‘212) arrive at the optimal dose and timing. Therefore this argument is not persuasive.
Applicant argue the “dry powder” gives unexpected results, Section III. This argument appears to show an unexpected result with a true difference, but no claim drawn to “4 hours apart” is present. One would not expect the powder given in a higher dose to behave significantly different from the liquid formulation. As such this argument is persuasive, but no claim directed to the 4 hour result is present to examine.
Applicant argues in Section IV and V are also directed to a similar unexpected result, that the metacresol free formulation has unexpected properties and that the higher dose could be administered. It is unclear from the argument what is actually causing the unexpected property. Is it the higher dose of the powder alone, versus liquid solution? Is it that in combination with no metacresol? What is the required formulation to have the unexpected property? It seems the unexpected properties arrive from dry powder and metacresol free, and the result is a 4 hour duration. This argument is not clearly showing where the unexpected property comes from. Applicant would need to show that in a comparison to the prior art formualtions taken out to 4 or 5 hours and show the results. The data from the references are not sufficient, and the USPTO is not capable of running the experiment. As such without a proper comparison this argument is inconclusive.
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 1-4 and 6-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,357,782 in view of Cloutier et al US 6,521,212 issued February 10, 2003. The instant claims are similar however the dose range is overlapping and not anticipatory. The instant requires, comprises at least 45 micrograms of treprostinil or a pharmaceutically acceptable salt thereof delivered in 1 to 3 breaths while the ‘782 patent requires at least 15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable salt thereof in 1 to 3 breaths. Given the teaching of ‘212 shich states, dose as result effective. Optimization of the dose would be obvious. According to the '212 patent, this method may be used to "treat[] pulmonary hypertension in a mammal." Id. at 14:9-12. Moreover, the '212 patent teaches "medical use" of its method in a "human." Id. at 7:4-5. The necessary dose to achieve "a particular therapeutic purpose will, of course, depend upon the specific circumstances of the patient being treated and the magnitude of the effect desired by the patient's doctor. Titration to effect may be used to determine proper dosage." Id. at 6:66-7:3. "[A]erosolized UT-15 has a greater potency as compared to intravascularly administered UT-15," so the '212 patent teaches delivering "only a fraction (10-50%) of the dosage delivered intravascularly" when using its inhalation delivery method. Id. at 8:8-12. Even at "high doses," however, the '212 patent teaches a lack of "significant non-lung effects, i.e., heart rate, cardiac output." Id. at 10:51-54.
Therefore a POSA would have known to optimize the dose for effect as noted by the ‘212 patent and arrive at the at least 45 microgram dose. Given the range in the art and the fact that the dose is a known variable to optimize all these claims are prima facie obvious.
Conclusion
No claims allowed.
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/MICHAEL J SCHMITT/ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629