Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The amendment filed 18 June 2026 has been received, entered and considered. The following information has been made of record in the instant amendment:
1. Claims 4-5, and 8 have been canceled.
2. No new Claims have been added.
3. Claim 1 has been amended.
4. Remarks drawn to rejections under 35 USC 103, and double patenting.
Claims 1-3, 6-7 and 9-12 are pending in the case.
The following rejections are necessitated by Applicant's amendment filed 18 June 2026 wherein the limitations in pending claim 1 have been amended.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 negated 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-3, 6-7, and 9-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Steiner et al (US 6,652,885; of record) as evidenced by Schukmann (US 20070240708; of record) and by Iwanij et al (J. Biol. Chem., 1990, 265, 21302-21308; of record) and further in view of Williams et al (American Journal of Physiology-Heart and Circulatory Physiology, 1994, 267:2, H796-H803; of record) and Gulyaev et al (Pharmaceutical Research, 1999, 16(10), 1564-1569; of record).
Steiner teaches an inhaler which contains a dry powder which is in the form of microparticles including a pharmaceutical carrier (col. 10, lines 35-51; part of the limitation of claim 1 regarding inhalation device, microparticles, and limitation of claim 3). The microparticles have a diameter of about 5mm (col. 12, lines 65-67; as in claim 1). The active agent to be delivered can be a vasoactive agent (col. 5, lines 6-11). This can be formulated in combination with diketopiperazine (col. 6, lines 8-30; as in claim 1). The diketopiperazine is 2,5-diketopiperazines as in claims 2, and 10, and can be used as salts as in claim 12 (col. 6, lines 39-40; col. 7, lines 50-67).
According to Steiner the range of loading of the drug to be delivered is typically between about 0.01% and 90%, depending on the form and size of the drug to be delivered and the target tissue. The appropriate dosage can be determined (col. 11, lines 4-12). One of ordinary skill in the art can use this teaching as a guide and adjust the amount of the vasoactive agent to be in the range as in claim 7.
Schukmann teaches that dry powder inhaler has been known for a long time, and the device contains a cartridge. Therefore, the inhaler device of Steiner should have a cartridge (para 0002; as in claim 9).
According to Iwanij lung does not have antibody receptor, and therefore the said active agent does not bind to receptors in the lung (Abstract; as in claim 11).
Steiner et al does not teach prostaglandin and polysorbate 80 as ingredients in its composition as in claim 1.
Williams et al teaches that the prostaglandin PGI2 is a potent vasodilator (page H796, left col., first paragraph; limitations of claims 1 and 6). In view of this teaching and that of Steiner regarding the use of vasodilators as active agents in combination with 2,5-diketopiperazines it would be obvious to one of ordinary skill in the art at the time the invention was made to use a prostaglandin including PGI2 as vasoactive agents in the inhaler of Steiner.
Gulyaev teaches that nanoparticles of the drug doxorubicin coated with polysorbate 80 enhanced the concentration of the drug in the brain and other organs (; Abstract; Tables 1 and 2; polysorbate 80 as in claim 1). Even though Gulyaev teaches nanoparticle formulation of a drug as a nasal spray solution, one of ordinary skill in the art, in view of Gulyaev would have a reasonable expectation of success in enhancement of the concentration of the instant labile active agent like prostaglandin in combination with polysorbate and diketopiperazine when administered as a dry powder formulation using an inhalation device as in claim 1.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, diketopiperazine is known to be formulated in an inhaler as a microparticle having a diameter of about 5mm along with a vasodilator (Steiner). Prostaglandin including PGI2 are potent vasodilators, and the amount of the active agent can be adjusted (Williams), and polysorbate 80 is known to enhance drug concentrations in the brain and other organs (Gulyaev). Thus, it is obvious to arrive at the invention in claims 1-3, 6-7, and 9-12 in view of the combined teachings of the prior art.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made over the combined teachings of the prior art. Product improvement is the motivation. In addition, Steiner teaches that its invention provides methods and compositions for facilitated transport of biologically active agents across biological membranes (col. 3, lines 14-17). Gulyaev provides the motivation to include polysorbate 80 as an ingredient in combination with a diketopiperazine and the labile active agent.
Response to Applicant’s Remarks
Applicant has traversed the rejection of claims 1-3, 6-7 and 9-12 under 35 USC 103 of record arguing that Claim 1 is amended to recite that the labile active agent is delivered to systemic arterial circulation to avoid or reduce contact with peripheral tissues, venous, or hepatic metabolism. This is tied to the inhalation delivery that is not disclosed in any of the cited references. None of the cited references recognize that degradation in peripheral tissue, venous circulation, or the liver prior to systemic distribution represents a limiting factor in therapeutic efficacy. In the absence of recognition of this problem, there is no reason a person of ordinary skill would have modified the cited systems to achieve the claimed delivery path.
Steiner does not teach or suggest avoidance of peripheral tissue contact, venous degradation or hepatic exposure. It is concerned only about introducing drugs into the blood stream and not about what subsequently happens to the drug. Steiner does not describe or analyze hepatic exposure timing. There is no evidence in the cited references that would lead to a conclusion that all diketopiperazine-based inhalation systems or all pulmonary systems necessarily avoid or reduce peripheral, venous or hepatic interactions.
Steiner, Schukman, Iwanji and Williams make no mention of polysorbate 80. Steiner and Gulyaev operate in distinct technological domains. Steiner teaches diketopiperazine for pulmonary delivery, while Gulyaev teaches polymer nanoparticles for intravenous administration and targets the blood brain barrier. Gulyaev’s use of polysorbate 80 is limited to coating intravenous nanoparticles to alter systemic biodistribution. There is no suggestion that such surfactant use would be applicable to or beneficial for inhaled diketopiperazine microparticles, or that it would produce the claimed arterial delivery profile while reducing contact with degradation pathways.
The presently claimed system achieves a greater therapeutic effect with lower systemic exposure. This is unexpected because conventional pharmacological principles would predict that increased therapeutic effect requires increased systemic exposure. The present disclosure demonstrates that by delivering the active agent to the systemic arterial circulation, degradation pathways are avoided, thereby increasing drug delivery despite lower overall exposure. For these reasons the cited references fail to render the instant claims obvious. (Remarks-pages 4-6).
Applicant’s arguments are not persuasive. Independent claim 1 is drawn to a system comprising the recited components. The limitation regarding the greater therapeutic effect is intended result. The components are delivered via inhalation.
Steiner teaches an inhaler which contains a dry powder in the form of microparticles including a pharmaceutical carrier. The microparticles have a diameter of about 5mm. The active agent to be delivered can be a vasoactive agent. This can be formulated in combination with diketopiperazine. The diketopiperazine is 2,5-diketopiperazines can be used as salts.
Williams et al teaches that the prostaglandin PGI2 is a potent vasodilator. In view of this teaching and that of Steiner regarding the use of vasodilators as active agents in combination with 2,5-diketopiperazines it would be obvious to one of ordinary skill in the art at the time the invention was made to use a prostaglandin including PGI2 as vasoactive agents in the inhaler of Steiner. Gulyaev teaches the use of polysorbate 80 for in combination with microparticles enhances the drug concentration in other organs, not just the brain. The components taught by Steiner, Williams, and Gulyaev which can be included in a powder form in the inhaler device comprises the system as in claim 10. Applicant agrees that Steiner diketopiperazine for pulmonary delivery, which means that the diketopiperazine and the other claimed components can be provided as system for inhalation.
Even though not important since claim 10 is not to a method, the claim recites inhalation formulation, which indicates that the composition which has the labile active agent is delivered via inhalation to avoid or reduce contact with peripheral tissue, venous or hepatic metabolism. From Steiner’s teaching it is obvious that a dry powder composition can be delivered via inhalation. Therefore, a dry powder composition comprising all of the claimed components can also be delivered via inhalation. Since this is obvious from the teachings of the prior art, using the claimed system for administration via inhalation, which is obvious from the teachings of the prior art, should also deliver the labile active agent to systemic arterial circulation to avoid or reduce contact with peripheral tissue, venous, or hepatic metabolism, and should achieve a greater therapeutic effect.
It is true that Gulyaev teaches polymer nanoparticles for intravenous administration and targets the blood brain barrier, and Gulyaev’s use of polysorbate 80 is limited to coating intravenous nanoparticles to alter systemic biodistribution. However, one of ordinary skill in the art, in view of Gulyaev, will recognize that the polysorbate can be included as a component along with the other claimed components as a powder inhalation composition to make the claimed system. It does not mean that the polysorbate 80 taught Gulyaev should be used only as a coating for intravenous administration. When the combined teachings of the prior art suggest the claimed system for administering to a labile active agent via inhalation, the effect seen by the inventors as in claim 1 should be seen since claim 1 is also drawn to the same step of inhalation. Applicant has not convincingly shown that this is not the case.
The combined teachings of the prior art do render the instant claims obvious. The rejection is maintained.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 6-7, and 9-12 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7, 9-11, 13-18 and 20 of U.S. Patent No. 8,372,804 (‘804), and as being unpatentable over claims 1-4 and 6 of U.S. Patent No. 11,304,992 (‘992)in view of Steiner et al (US 6,652,885; of record and newly cited necessitated by amendment) as evidenced by Schukmann (US 20070240708; of record and newly cited necessitated by amendment) and by Iwanij et al (J. Biol. Chem., 1990, 265, 21302-21308; of record and newly cited necessitated by amendment) and further in view of Williams et al (American Journal of Physiology-Heart and Circulatory Physiology, 1994, 267:2, H796-H803; newly cited necessitated by amendment).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claim 1 is drawn to a system comprising a dry powder inhalation device comprising a formulation of microparticles comprising a diketopiperazine and a labile active agent which is prostaglandin, wherein about 35% to about 75% of the microparticles have a diameter of less than 5.8 micrometer. Dependent claims recite limitations drawn to diketopiperazine, carrier or excipient, specific labile active agent, amount of labile active agent, the system comprising a cartridge, fumaryl substituted diketopiperazine and salts thereof, and the active agent does not bind to receptors in the lung.
Claims 1 and 13 of ‘804 is drawn to the use of an inhaler having a diketopiperazine and a hormone. Dependent claims 2-7, 9-11, 14-18 and 20 of ‘804 recite limitations drawn to substitutions on the diketopiperazine, carrier or excipients. These same limitations are seen in the instant claims.
Claim 1 of ‘992 is drawn to a powder composition comprising fumaryl substituted 2,5-diketopiperazine or acceptable salt and an antiviral compound. Dependent claims 2-4 and 6 are drawn to diameter of the particles being less than 5.8 micrometer, wt. percent of the antiviral and the amount of the composition provided.
The teachings of the secondary references set forth above. Steiner teaches a composition comprising the diketopiperazine in powder form including a vasodilator as an additional component. Williams teaches that PGI2 is a vasodilator, and Gulyaev teaches the use of polysorbate 80 as a drug carrier.
The claims of ‘804 differ from the instant claims in that the instant claims are drawn to an inhalation device comprising the claimed composition and a hormone, whereas the claims of ‘804 use the same device comprising the claimed components in a method. The claims of ‘992 are drawn to a composition that has an antiviral as an active agent, whereas the instant device can include several other active agents.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to arrive at the claimed system in view of the secondary references.
In the instant case ‘804 and ‘992 teach the inhalation system applicant claims. Although the claims of '804 and ‘992 use the same device comprising the claimed components in a method, and use a hormone and an antiviral as active agent, one of ordinary skill in the art would readily recognize that the claimed inhalation device could be arrived at in view of '804 and ‘992 in view of the secondary references with a reasonable expectation of success. The use of known members of classes of agents in devices taught in the prior art is not seen to render the instantly claimed device unobvious over the art. Once the general scheme has been shown to be old, the burden is on the applicant to present reason or authority for believing that the claimed device cannot be made.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 6-7, and 9-12 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of copending Application No. 18/434,301 (‘301). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claim 1 is drawn to a system comprising a dry powder inhalation device comprising a formulation of microparticles comprising a diketopiperazine and a labile active agent which is a prostaglandin, wherein about 35% to about 75% of the microparticles have a diameter of less than 5.8 micrometer. Dependent claims recite limitations drawn to diketopiperazine, carrier or excipient, amounts, the system comprising a cartridge, fumaryl substituted diketopiperazine and salts thereof, and the active agent does not bind to receptors in the lung.
Claim 1 of ‘301 is drawn to a delivery system which is a dry powder inhaler and a cartridge, wherein the powder comprises substituted 2,5-diketopiperazine and prostaglandin as an active agent and wherein dosage of the dry powder is 0.01-3mg and about 35% to about 75% of the microparticles have a diameter of less than 5.8 micrometer. Independent claim 4 is drawn to an inhaler device having the limitations of claim 1 and further recites dosage for the prostaglandin. Independent claim 12 is drawn to a method of use of the inhalation device comprising the same components. Dependent claims 2-3, 5-11, 14-17 are drawn to limitations that are seen in the instant claims.
The copending claims of ‘031 differ from the instant claims in that instant claim 1 does not recite a dosage, whereas claim 1 of ‘031 recites a dosage.
Although the claims of '031 teach the use of prostaglandin as the active agent in combination with the 2,5-diketopiperazine, one of ordinary skill in the art at the time the invention was made would readily recognize that the inhaler system taught by '031 can be modified to arrive at the in the instant invention with a reasonable expectation of success.
One of ordinary skill in the art would have reasonably expected that the instant composition would have same or substantially similar beneficial therapeutic effects and usefulness based on the reasonable expectation that structurally similar species usually have similar properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214, and if the claimed invention and the structurally similar prior art species share any useful property, that will generally be sufficient to motivate an artisan of ordinary skill to make the claimed species. In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904, as noted in MPEP 2144.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Applicant’s Remarks
Regarding the double patenting rejections of record applicant has stated that addressing the rejections is deferred until there is otherwise allowable subject matter in the instant application, and requests that the rejection be held in abeyance until claims are allowable in the present application.
The filing of a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s/patents claims is necessary. Since neither has been made of record the rejection(s) are being maintained.
Conclusion
1. Pending claims 1-3, 6-7, and 9-12 are rejected.
2. Claims 4-5 and 8 have been canceled.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
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