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 .
This is the First Office Action on the Merits of US 18/728,814 filed on 07/12/2024 which is a 371 of PCT/US2023/010549 filed on 01/11/2023 which claims US priority benefit of US Provisional 63/266,718 filed on 01/12/2022.
Claims 1-13 are pending and under examination.
Information Disclosure Statement
The IDS statements filed on 02/09/2026, 03/17/2026, 04/15/2025, and 07/12/2024 have been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 2, 6 and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 is indefinite because it recites the “dry powder of claim 1, wherein the vasoactive intestinal peptide is up to 300 µg for treatment session”. However, claim 1 does not recite a treatment session or a unit dose but rather just recites a dry powder “comprising, an inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide…” Thus, the term “up to 300 µg for treatment session” does not have sufficient antecedent basis in the claims.
Claim 6 recites the limitation "the diketopiperazine" in line 1. There is insufficient antecedent basis for this limitation in the claim because claim 6 depends from claim 4 which does not recite a diketopiperazine. Claim 5 recites diketopiperazine.
Claim 13 recites the phrase: “wherein the inhalable pharmaceutical formulation is manufacture in the dose is to be administered at least once a day”. The claim is indefinite because it is unclear what structure of inhalable formulation is required by this phrase.
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims are drawn to an inhalable dry powder pharmaceutical for treating lung disease, the formulation comprising vasoactive intestinal peptide, a derivative thereof, or an analog thereof. Claims require the critically essential element of a genus of functional therapeutic vasoactive intestinal peptides, derivatives thereof, or analogs thereof that are claimed by function and without sufficient structural limitations correlated to the required function..
While showing possession of a functional vasoactive intestinal peptide, neither the specification nor the state of the prior art provide a sufficient number of species of derivatives or analogs of a functional vasoactive intestinal peptide so that one of ordinary skill in the art would be able to envision whether a given such derivative or analog structure would possess the required functional properties.
For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. The MPEP states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not a sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
The Court of Appeals for the Federal Circuit has recently held that a "written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as be structure, formula [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 1997 U.S. App. LEXlS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original). To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these.
In addition, the state of the prior art does not provide a representative set of species of such therapeutic vasoactive intestinal peptides, derivatives thereof, or analogs thereof to show possession of the claimed genus. On the contrary, the state of the art shows that the correlation of amino acid sequence structure of a therapeutic peptide in unpredictable in how it may relate to the functional properties of the peptide. For example, Onoue et al disclose testing VIP derivatives for effectiveness treating acute airway inflammation showed unpredictability regarding specific VIP derivatives. (See Peptides 2012 Vol 35: pages 182-189). Also, Igarashi et al disclose the development of analogs of human Vasoactive Intestinal Peptides for therapeutic methods. (See entire document; Fig 1 & legend). Igarashi et al disclose that determining whether a given analog has the required therapeutic activity must be determined by experimentation. (See FIG2 and legend).
In the instant case, the single species of the 28 amino acid VIP peptide which was commercially available (see instant Specification, para 0069, lines 1-4), do not adequately support the claimed genus because the specification does not provide common identifying characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these.
Although the claims may recite some functional characteristics, the claims lack written description because there is not a sufficient disclosure of a correlation between function and structure of functional derivatives and analogs of the VIP peptide. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus. While having written description of the commercially available 28 amino acid Vasoactive Intestinal Peptide (VIP) described as being purchased from American Peptide Company (see instant Specification, para 0069, lines 1-4), the specification does not provide sufficient descriptive support for the myriad of VIP peptide derivatives and analog compounds embraced by the claims. Given this lack of description of representative species encompassed by the genus of the claim, the specification does not sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants were in possession of the entire scope of the claimed invention.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claims 1, and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Costello et al (US2020/147180).
Claim interpretation: Claims must be given their broadest reasonable interpretation during examination. Because claim 1 recites the elements of “one or more amino acids, one or more antioxidants, and/or a pharmaceutically acceptable carrier or excipient, in the alternative, claim 1 is construed to only require either “one or more amino acids”, “one or more antioxidants”, or a pharmaceutically acceptable carrier or excipient”. Therefore, the limitations of claims 3-10 regarding the pharmaceutically acceptable carrier (claims 3-6) or the one or more amino acids or antioxidants (claims 7-10) are not required for applying the prior art because, as written, these elements are not required of the claims.
Regarding claim 1, Costello et al discloses an inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide formulated for lung delivery (para 0100, 0101), and the pharmaceutically acceptable carrier or excipient diketopiperazine. (See para 0057.) Claims 3-4 and 7-10 are met by Costello et al as explained above under claim interpretation.
Regarding claims 5, Costello et al teaches the pharmaceutically acceptable carrier is a diketopiperazine. (See para 0015).
Regarding claims 6, Costello et al teaches the diketopiperazine is fumaryl diketopiperazine, or succinyl diketopiperazine. (See para 0015).
Thus, as presently written, Costello et al anticipates claims 1 and 3-10.
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.
Claim(s) 1-10, 12-13 is/are rejected under 35 U.S.C. 102(102(a)(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Klapproth et al (WO-2021/152119, published 08/05/2021; IDS ref).
Claim interpretation: Claims must be given their broadest reasonable interpretation during examination. Because claim 1 recites the elements of “one or more amino acids, one or more antioxidants, and/or a pharmaceutically acceptable carrier or excipient, in the alternative, claim 1 is construed to only require either “one or more amino acids”, “one or more antioxidants”, or a pharmaceutically acceptable carrier or excipient”. Therefore, the limitations of claims 3-10 regarding the pharmaceutically acceptable carrier (claims 3-6) or the one or more amino acids or antioxidants (claims 7-10) are not required for applying the prior art because, as written, these elements are not required of the claims.
Regarding claim 1, Klapproth et al discloses a dry powder for treating lung disease comprising, an inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide, one or more amino acids, one or more antioxidants, and/or a pharmaceutically acceptable carrier or excipient. (See Abstract; pages 3-5.) Klapproth et al is titled: Human Anti-Inflammatory Peptides for the Inhalatory Treatment of Inflammatory Pulmonary Diseases”. Klapproth et al particularly teaches the use of human VIP (aka aviptadil) vasoactive intestinal peptide being the “widely distributed human 28 amino acid neuropeptide” having the amino acid sequence His-Ser-Asp-Ala-Val-Phe-Thr-Asp-Asn-Tyr-Thr-Arg-Leu-Arg-Lys-Gin-Met-Ala-Val-Lys-Lys. Tyr-Leu-Asn-Ser-Ile-Leu-Asn (ref SEQ ID NO: 1). Klapproth et al teaches an inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide, one or more amino acids, one or more antioxidants, and/or a pharmaceutically acceptable carrier or excipient. (See page 51, para 4.). Klapproth et al recites:
Inhalatory administration in asthma treatment is commonly effected through metered-dose inhalers, respectively dry-powder inhalers. Thus, the present application refers also to a peptide according to the invention in the prophylaxis or treatment of asthma by inhalatory administration.
Klapproth et al teaches dry powder formulation in an inhalable form. (Page 37, para 1; see last sentence which recite aviptidil (aka VIP).
Regarding claim 2, Klapproth et al teaches the vasoactive intestinal peptide is up to 300 µg for treatment session. (Page 51, para 2).
Regarding claim 3, Klapproth et al teaches the pharmaceutically acceptable carrier is a sugar is mannitol and sorbitol. (See page 44, para 1.)
Regarding claim 4, Klapproth et al teaches mannitol. (See page 44, para 1.)
Regarding claims 5-6, Klapproth et al, the limitations of claims 5-6 regarding the pharmaceutically acceptable carrier are not required for applying the prior art because, as written, these elements are not required of the claims.
Regarding claim 7, Klapproth et al teaches the amino acids leucine, and methionine. (See page 43, para 1.)
Regarding claim 8, are leucine and methionine. (See page 43, para 1.)
Regarding claim 9, Klapproth et al teaches the amino acid methionine. (See page 43, para 1.)
Regarding claim 10, Klapproth et al teaches the one or more antioxidants including: ascorbic acid, methionine and carotenoids. (See page 43, para 1-2; page 42, para 2.)
Regarding claim 12, Klapproth et al teaches an inhalable pharmaceutical formulation comprising vasoactive intestinal peptide in a dose of up to 200 µg, mannitol, leucine, and methionine, for the treatment of edema in a subject. (See page 43, para 1, reciting methionine, leucine as preferred amino acids; page 51, para 2-3; page 44, para 1 recites mannitol; ref claim 6 recites edema).
Regarding claim 13, Klapproth et al formulation for administration at least once a day.(See para bridging pages 50-51; 64, Example 18.)
Thus, Klapproth et al anticipates claims 1-10, and 12-13 for reasons provided above. In the alternative, Klapproth et al renders obvious the claims 1-10, and 12-13 because it would have been obvious for one of ordinary skill in the art to apply the preferred embodiments disclosed in Klapproth et al to arrive at the presently claimed dry powder formulation of VIP and excipients as presently claimed.
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.
Claim interpretation: Claims must be given their broadest reasonable interpretation during examination. Because claim 1 recites the elements of “one or more amino acids, one or more antioxidants, and/or a pharmaceutically acceptable carrier or excipient, in the alternative, claim 1 is construed to only require either “one or more amino acids”, “one or more antioxidants”, or a pharmaceutically acceptable carrier or excipient”. Therefore, the limitations of claims 3-10 regarding the pharmaceutically acceptable carrier (claims 3-6) or the one or more amino acids or antioxidants (claims 7-10) are not required for applying the prior art because, as written, these elements are not required of the claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10744280 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claim 21 recites an inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide. Patented claim 6 recites the pharmaceutically acceptable carrier diketopiperazine.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11623052. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claim 20 recites an inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide. Patented claim 16 recites the pharmaceutically acceptable carrier diketopiperazine.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10421729. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claim 6 recites method of making microcrystalline diketopiperazine particles suitable for pulmonary administration as a dry powder comprising: a) forming diketopiperazine particles in a suspension having a bimodal distribution in the particle sizes which range from about 0.05 pm to about 10 pm; b) atomizing the suspension using a spray dryer under an air or gas stream, and c) reforming particles by spray-drying into a dry powder comprising the microcrystalline diketopiperazine particles having hollow spheres.an inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide. Patented claim 19 recites the pharmaceutically agent is vasoactive intestinal peptide.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 10745359. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claim 6 recites an inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide comprising the pharmaceutically acceptable carrier diketopiperazine. Patented claim 7 recites a dry powder suitable for pulmonary administration.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11192862 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claim 7 recites an inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide and the pharmaceutically acceptable carrier diketopiperazine. Patented claim 3 recites a surfactant.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12679811 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claim 7 recites an inhalable dry powder pharmaceutical formulation and patented claim 6 recites vasoactive intestinal peptide and the pharmaceutically acceptable carrier diketopiperazine.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10376587 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claim 12 recites an inhalable dry powder pharmaceutical formulation and patented claim 10 recites vasoactive intestinal peptide and the pharmaceutically acceptable carrier diketopiperazine.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10603383 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claim 12 recites an inhalable dry powder pharmaceutical formulation for deep lung inhalation and patented claim 8recites vasoactive intestinal peptide and the pharmaceutically acceptable carrier diketopiperazine.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11433135 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claim 1 recites an inhalable pharmaceutical formulation for lung inhalation and the pharmaceutically acceptable carrier diketopiperazine and patented claim 7 recites vasoactive intestinal peptide. Patented claims 15-16 recite dry powder.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10342938 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claims 8 and 16 recite an inhalable pharmaceutical formulation for lung inhalation and vasoactive intestinal peptide and the pharmaceutically acceptable carrier diketopiperazine.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US 12447293 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claim 2 recites an inhalable pharmaceutical formulation for lung inhalation and vasoactive intestinal peptide. Patented claim 3 recites the pharmaceutically acceptable carrier diketopiperazine.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. US 11998683 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claim 16 recites an inhalable pharmaceutical formulation for lung inhalation and vasoactive intestinal peptide. Patented claim 6 recites the pharmaceutically acceptable carrier diketopiperazine.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. US 9339615 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claims 4 and 14 recites a dry inhalable pharmaceutical formulation for lung inhalation and vasoactive intestinal peptide. Patented claims 8 and 18 recite the pharmaceutically acceptable carrier diketopiperazine.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. US 9446133 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claim 10 recites vasoactive intestinal peptide and the pharmaceutically acceptable carrier fumaryl diketopiperazine (FDKP). Patented claims 15 and 16 recite an inhalation system for delivering a dry powder medicament to a pulmonary tract.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. US 11241549 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claims 6, 13, and 21 recite vasoactive intestinal peptide and patented claim 7 recites the pharmaceutically acceptable carrier fumaryl diketopiperazine (FDKP). Patented claim 19 recites an inhalable dry powder medicament.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US 10751488 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claims13 recites an inhalable dry powder pharmaceutical vasoactive intestinal peptide and patented claim 17 recites the pharmaceutically acceptable carrier diketopiperazine.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. US 10201672 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, patented claims 6 and 18 recites an inhalable dry powder pharmaceutical vasoactive intestinal peptide and patented claim 23 recites the pharmaceutically acceptable carrier diketopiperazine.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. US 9511198 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the instant claims.
Regarding instant claims 1, and 3-10, patented claim 10 recites an inhalable dry powder comprising a pharmaceutical vasoactive intestinal peptide and the pharmaceutically acceptable carrier diketopiperazine for treating a pulmonary tract.
Thus, patented claim 10 anticipates instant claims 1, and 3-10.
Claims 1, and 3-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. US Application 19/022809. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of copending claims render obvious the instant claims.
Regarding instant claims 1, and 3-10, copending claim 7 recites pharmaceutical vasoactive intestinal peptide and pharmaceutically acceptable carrier diketopiperazine. Copending claim 8 recites and inhalable dry powder form.
One of ordinary skill in the art would have been motivated to combine the elements of patented claims to arrive at the presently claimed invention for the rationale of producing an inhalable treatment form of vasoactive intestinal peptide for treating lung conditions. It would have been obvious for one of ordinary skill in the art to combine the pharmaceutically acceptable carrier diketopiperazine with the inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide because these are preferred embodiment of the patented claims.
This is a provisional rejection because the copending claims are not yet patented.
Claims 1, and 3-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. US Application 19/284257. Although the claims at issue are not identical, they are not patentably distinct from each other because copending claims anticipate instant claims 1, and 3-10.
Regarding instant claims 1, and 3-10, copending claim 17 recites a pulmonary drug delivery system comprising a dry powder unit dose of a pharmaceutical vasoactive intestinal peptide and pharmaceutically acceptable carrier diketopiperazine.
Thus, copending claim 17 anticipates instant claims 1, and 3-10.
This is a provisional rejection because the copending claims are not yet patented.
Conclusion
No claim is allowed.
Related prior art which may be applied in a future office action if appropriate:
Lee et al "Dry powder inhaler for pulmonary drug delivery: human respiratory system, approved products and therapeutic equivalence guideline." (Journal of Pharmaceutical Investigation 2018 Vol 48 No 6 2018: 603-616; IDS ref).
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CATHERINE S. HIBBERT
Primary Examiner
Art Unit 1658
/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658
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