DETAILED ACTION
Claims 1-26 are pending. Of these, claims 3-6, 9-11, and 17-26 are withdrawn as directed to a nonelected invention. Therefore, claims 1-2, 7-8, and 12-16 are under consideration on the merits.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/28/24, 9/13/24, and 3/28/25 was filed prior to the mailing date of a first Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
Election/Restrictions
Applicant’s election of Group I, claims 1-16, is acknowledged. The election having been made without traverse, the restriction requirement is still considered proper and is made FINAL.
Applicant’s election of phospholipid and lactose as the species of first and second pharmacologically acceptable excipient is acknowledged. The elections having been made without traverse, the election of species requirement is still considered proper and is made FINAL.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
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, 7-8, and 12-16 are rejected under 35 U.S.C. 103 as unpatentable over Xu et al. (US Pat. Pub. 2022/0016126; of record in IDS).
As to claims 1-2, 7-8, and 12-16, Xu discloses a powdered pharmaceutical composition for dry powdered inhalation comprising a PDE5 inhibitor such as vardenafil, sildenafil, tadalafil, or avanafil, the composition additionally comprising at least one carrier comprising fine lactose particles (the elected species of second pharmacologically acceptable excipient of claims 14-16), and wherein lecithin also may be used as a carrier (paragraphs 50, 53, and 66-67 and claims 1 and 2-3 of Xu). The skilled artisan would recognize that lecithin comprises phospholipids, which is the elected species of first pharmacologically acceptable excipient of claim 1, and would further recognize that one of the phospholipids found in lecithin is phosphatidylcholine (claim 8). Xu further singles out lactose as a suitable carrier for vardenafil formulations for pulmonary administration because it does not react with vardenafil (paragraph 63). Xu also teaches that the aerodynamic geometry of the particles depends on particle geometry, density, and volume diameter, wherein a small spherical particle having high density will behave as a bigger particle that is poorly transported in the lower airways, and that the aerodynamic diameter can be improved by altering the shape of the particles by means of various processes (paragraph 44).
Regarding claims 2, 7, and 15, the vardenafil may be present in the amount of at least 2 wt%, which substantially overlaps the recited range of claim 2 (paragraph 50 and claim 4 of Xu), and the carrier excipients may be used in the amount of about 1 wt% to about 95 wt%, which allows for amounts of the phospholipid and lactose that are within the recited ranges of claims 2, 7, and 15 (paragraph 62). “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art.” MPEP 2144.05(I). Additionally, discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 12, the vardenafil and the excipient base form particles as can be seen in Figure 7B, and Xu teaches that the lactose carrier particles may have a diameter of about 2-150 microns or less than 7 microns, and further teaches that the active particles may have a size much smaller than that of the carrier particles (paragraph 63), which allows for the combination of active and carrier to possess size ranges within the range of claim 12. Additionally, discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As to claims 1-2, 7-8, and 12-16, Xu does not further expressly disclose a specific embodiment wherein the PDE5 inhibitor is vardenafil and the first and second excipients are the elected species, i.e., phospholipid and lactose. Nor does Xu expressly disclose that the particles have a shape that is one of those recited by claim 13, such as a solid spherical shaped form.
As to claims 1-2, 7-8, and 12-16, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the teachings of Xu by selecting vardenafil as the active and a combination of phospholipid-comprising lecithin and lactose as the carrier excipients, because Xu expressly teaches that the PDE5 inhibitor active may be selected from a list that includes vardenafil and that the one or more carrier excipients may be selected from a list that includes lecithin and lactose and specifically calls out lactose as a carrier that is well suited for use with vardenafil because it does not react with this active, such that the proposed combination is merely the combining of known elements according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." (325 U.S. at 335, 65 USPQ at 301). MPEP § 2144.07.
Regarding claim 13, it further would have been prima facie obvious to select a particle shape such as a solid or hollow spherical shape, because Xu teaches that the shape of a particle, including its sphericity, is a result effective variable that affects its aerodynamic behavior and its ability to be transported in the airways as discussed above, such that the skilled artisan would have had a motivation to test spherical particles for their suitability for inhalation, and Xu further teaches that different processes are known which can be used to alter the particle shape. There would have been a reasonable expectation of success at arriving at a solid or hollow spherical shape because the skilled artisan would have been optimizing the particle to perform the same function as the particles of the present claims, i.e., to serve as particles that are suitable for dry powder inhalation for delivery of vardenafil to a subject.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 7-8, and 12-16 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over claims 1-14 of US Pat. Appl. No. 19/203,219, and in view of Xu et al. (US Pat. Pub. 2022/0016126) where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a pharmaceutical composition for dry powder inhalation comprising an active compound in the amount of 1-50 wt% and a first excipient such as phospholipid such as dipalmitoyl phosphatidylcholine in the amount of 50-99 wt% and a second excipient that is lactose, wherein the composition is in the form of a particle having a particle size of 50 nm to 5 microns and is in the shape of a solid spherical form.
Although the reference claims do not specify that the active is vardenafil, it would have been prima facie obvious to incorporate vardenafil as the active, because Xu expressly teaches that vardenafil is suitable for incorporation into powders for dry inhalation comprising phospholipids and lactose as carriers, such that the skilled artisan reasonably would have expected that vardenafil could be delivered in the dry inhalation powder comprising phospholipids and lactose as carriers that is recited by the reference claims.
Although the reference claims do not specify the amount of the lactose second excipient, it would have been prima facie obvious to select amounts within the 70-99.995 wt% range recited by the claims, because the reference claims recite amounts of the first excipient and active that read on the presently claimed ranges such that the skilled artisan readily could have envisaged that the remaining ingredient, i.e., the second excipient lactose, could be used in amounts within the claimed range. Additionally, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Claims 1-2, 7-8, and 12-16 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over claims 1-16 of US Pat. Appl. No. 18/932,803, and in view of Xu et al. (US Pat. Pub. 2022/0016126) where indicated below.
The teachings of the cited secondary references are relied upon as discussed above1-16
The reference claims recite a pharmaceutical composition for dry powder inhalation comprising the PDE5 inhibitor sildenafil in the amount of 1-99 wt% and a first excipient such as phospholipid such as dipalmitoyl phosphatidylcholine in the amount of 1-99 wt% and a second excipient that is lactose in the amount of 70-99.995%, wherein the composition is in the form of a finely divided particle having a particle size of 50 nm to 10 microns and is in the shape of a solid spherical, hollow spherical, or solid polyhedron form.
Although the reference claims do not specify that the active is vardenafil, it would have been prima facie obvious to incorporate vardenafil instead of, or in addition to, sildenafil, because Xu expressly teaches that both sildenafil and vardenafil are PDE5 inhibitors suitable for incorporation into powders for dry inhalation comprising phospholipids and lactose as carriers, such that the skilled artisan reasonably would have expected that vardenafil could be delivered in the dry inhalation powder comprising phospholipids and lactose as carriers that is recited by the reference claims.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Claims 1-2, 7-8, and 12-16 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over claims 1-16 of US Pat. Appl. No. 18/931,074 and in view of Xu et al. (US Pat. Pub. 2022/0016126) where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a pharmaceutical composition for dry powder inhalation comprising the PDE5 inhibitor tadalafil in the amount of 1-99 wt% and a first excipient such as phospholipid such as dipalmitoyl phosphatidylcholine in the amount of 1-99 wt% and a second excipient that is lactose in the amount of 70-99.995%, wherein the composition is in the form of a finely divided particle having a particle size of 50 nm to 10 microns and is in the shape of a solid spherical, hollow spherical, or solid polyhedron form.
Although the reference claims do not specify that the active is vardenafil, it would have been prima facie obvious to incorporate vardenafil instead of, or in addition to, tadalafil, because Xu expressly teaches that both tadalafil and vardenafil are PDE5 inhibitors suitable for incorporation into powders for dry inhalation comprising phospholipids and lactose as carriers, such that the skilled artisan reasonably would have expected that vardenafil could be delivered in the dry inhalation powder comprising phospholipids and lactose as carriers that is recited by the reference claims.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Claims 1-2, 7-8, and 12-16 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over claims 1-16 of US Pat. Appl. No. 18/931,072 and in view of Xu et al. (US Pat. Pub. 2022/0016126) where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a pharmaceutical composition for dry powder inhalation comprising the PDE5 inhibitor avanafil in the amount of 1-99 wt% and a first excipient such as phospholipid such as dipalmitoyl phosphatidylcholine in the amount of 1-99 wt% and a second excipient that is lactose in the amount of 70-99.995%, wherein the composition is in the form of a finely divided particle having a particle size of 50 nm to 10 microns and is in the shape of a solid spherical, hollow spherical, or solid polyhedron form.
Although the reference claims do not specify that the active is vardenafil, it would have been prima facie obvious to incorporate vardenafil instead of, or in addition to, avanafil, because Xu expressly teaches that both avanafil and vardenafil are PDE5 inhibitors suitable for incorporation into powders for dry inhalation comprising phospholipids and lactose as carriers, such that the skilled artisan reasonably would have expected that vardenafil could be delivered in the dry inhalation powder comprising phospholipids and lactose as carriers that is recited by the reference claims.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GAREN GOTFREDSON/Examiner, Art Unit1619
/GENEVIEVE S ALLEY/Primary Examiner, Art Unit 1617
Prosecution Insights