DETAILED ACTION
Claims 1, 3-6 and 8-14 are currently pending. Claims 1 and 3-6 are currently under examination.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 09/25/2025 is acknowledged.
Claims 8-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/25/2025.
Applicant’s election without traverse of lactose, SP-B of SEQ ID NO: 9 as the surfactant protein and respiratory distress syndrome as the condition in the reply filed on 09/25/2025 is acknowledged.
No claims are withdrawn as a result of the species election.
Priority
The instant application is a continuation of 18/651,962, filed 05/01/2024, continuation of 17/151,873, filed 01/19/2021, continuation of 16/901,270, filed 06/15/2020, which is a continuation of PCT/US18/66435, filed 12/19/2018, which claims priority to provisional application 62/609,277, filed 12/21/2017.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 06/10/2025 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Claim Objections
Claims 1 is objected to because of the following informalities: the claims recite acronyms for a number of different recited components. While the specification delineates the names of the components that these abbreviations represent, the full name of the claimed component should appear in the claims prior to the use of an acronym. Appropriate correction is required.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 3-6 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 1 contains the limitation “dry powder particle surfactant formation for pulmonary delivery comprising” i), ii), iii), iv) and v) “wherein all components of the dry powder particles amount to 100 weight percent”. The instant claims have unclear metes and bounds as it is unclear if additional ingredients may be included in the particles outside the specifically recited i-v ingredients in view of the comprising language. The instant claim states all components of the dry powder particle amount to 100 weight percent, however it is unclear if it is only ingredients i-iv to be 100% in the particles or if additional ingredients are allowed, wherein anything present in the particles is 100%. The instant claim therefore has unclear metes and bounds.
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 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 7,582,312.
Regarding claims 1 and 6, the limitation of a respirable, dry powder particle surfactant formulation for pulmonary delivery comprising: i) at least 30% DPPC by weight of the particle, at least 10% POPG by weight of the particle, 0.1 to 3% NaCl by weight of the particle, an excipient selected form the group consisting of any one or more of trehalose, lactose or sugar alcohol and 1-10% by weight of the particle of a surfactant proteins elected form the group couniting of SP-A. SP-B, or any active fragments thereof wherein all components of the dry powder particles amount to 100 weight percent is met by the ‘312 patent lung surfactant formulations through solvent dissolution and lyophilization (abstract). Lung surfactants are taught to include SP-A, SP-B, SP-C or SP-D (column 7, lines 10-20). A preferred SP-B mimetic is KL4 peptide (column 7, lines 45-60). Phospholipids are taught to include DPPC and POPG (column 9, lines 35-60). Other excipients are taught to include lactose and salts such as NaCl (column 10, lines 30-42). The composition is taught to include 1 part KL4, 20-100 parts DPPC; 0 to 50 parts by weight of POPG and 0-25 parts of palmitic acid (column 12, line 65 to column 13, line 5). A dry powder is taught as formed (column 16, lines 25-40). As MPEP 2144.05 recites “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 optimization”. It would have been prima facie obvious to one of ordinary skill in the art to optimize the DPPC, POPG, NaCl and SP-B amounts in the powder compristion as the ‘531 publication teaches a range of the ingredients, thus teaching an optimizable parameter.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to follow the teachings of the ‘312 patent to arrive at the instant invention. It would have been obvious to do so because the ‘312 patent disclose inhalable formulations comprising a combination of phospholipids including DPPC and POPG and in addition a surfactant protein for improved delivery and absorption of the active agent. The ‘312 patent teach that the surfactant proteins include KL4 (sinaplulide). The dry powder formulations also may comprise excipients such as lactose and NaCl. As such it would have been obvious to one of ordinary skill in the art to have taken guidance from the ‘312 patent and prepared a dry powder formation comprising the components with a reasonable expectation of success as they are taught by the ‘312 patent as an effective formation for pulmonary delivery. One of ordinary skill in the art would have been more than motivated to combine a phospholipid and surfactant protein in a formulation to improve the drug delivery and lung health in a patient in need thereof. All of the claimed elements were known in the prior art and one of ordinary skill in the art would have combined the elements as claimed by known methods to yield predictable results to one of ordinary skill in the art at the time of the invention.
Claim(s) 1 and 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0091509 (Applicant provided) in view of US 2016/0317503 (Applicant provided) and US 2003/0129139 (Applicant provided).
Regarding claim 1, the limitation of a respirable, dry powder particle surfactant formulation for pulmonary delivery is met by the ‘509 publication teaching pulmonary surfactant preparations for treatment of chronic pulmonary diseases in mammals (abstract). The composition is taught to be in the form of a dried loose powder (example 1).
Regarding the limitation of at least 30% DPPC by weight of the particle and at least 10% POPG by weight of the particle is met by the ‘509 publication teaching the composition contains preferred phospholipids of dipalmitoylphosphatidylcholine (DPPC) and palmitoyloleylphosphatidylglycerol (POPG) in a ratio of 7:3 to 3:7 [0011] wherein the phospholipids may be present from 80-95% [0012].
Regarding the limitation of about 0.1-3% NaCl is met by the ‘509 publication teaching preparations can contain electrolytes such as sodium chloride present at 0-3% [0012].
Regarding the limitation of about 1% to about 10% by weight of the particle of a surfactant protein is met by the ‘509 publication teaching the composition to include suitable pulmonary surfactant proteins such as the elected SP-B ([0011] or claim 4) present at 0.5 to 3 wt% [0012].
Regarding the limitation of further comprising an excipient is met by the ‘509 publication teaching further excipients (claim 4).
Regarding the limitation of wherein all components of the dry powder particles amount to 100 weight percent is met by the ‘509 publication teaching each of the claimed ingredients present to form a dry powder as discussed above. The use of comprising language does not limit the listed ingredients i-v to be the only ingredient present.
Regarding claim 5, the limitation of further comprising sinapultide is met by the ‘509 publication teaching modified derivatives of pulmonary surfactant proteins are also understood and include preferably sinapultide. The pulmonary surfactant proteins are taught to be used in mixtures [0011].
The ‘509 publication does not specifically teach the excipient is selected form the group consisting of trehalose, lactose, hydrogenated starch hydrolysate or sugar alcohol (claim 1) specifically lactose (claim 6).
The ‘503 publication teaches powder formulations which are useful for pulmonary administration to the respiratory tract of a patient (abstract). The formulation is taught to be a spray dried powder containing an active agent [0006]. The dry powder formulation comprises the active agent, a phospholipid, a salt and an additional excipient which includes a sugar [0011]. DPPC and sodium chloride are taught as included in the compristion [0013]. Examples of sugars are taught to include lactose [0036].
The ‘139 publication teaches particulate composition for delivering a drug to the pulmonary system (abstract). The particle can include other excipients which include lactose and fatty acids [0040]. The particle includes phospholipids such as DPPC [0041] which can be present from about 10 to about 80 weight % [0043]. Formulations are taught to include 60% DPPC, 20% BSA and 10 wt% lactose [0065].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use lactose as an excipient in the inhalable particles taught by the ‘509 publication because the ‘139 publication and the ‘503 publication teach the use of lactose in inhalable powders. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘509 publication teaches the use of excipients in the formulation which includes phospholipids such as DPPC and the ‘139 publication and the ‘503 publication teach the use of lactose in inhalable powders which include an active agent and DPPC. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success in using lactose in the compristion taught by the ‘509 publication because the ‘509 publication teaches the use of excipient which include fatty acids and the ‘139 publication teaches excipients include fatty acids and lactose thus teaching the interchangeability of excipients in an inhalable phospholipid powder containing particle compositions. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the amount of DPPC, POPG, SP-B, Lactose and NaCl in the powered formulation as the ‘509 publication and the ‘139 publication teaches ranges for each of the claimed ingredients known to be used in inhalable particles, thus are taught as optimizable parameters. As MPEP 2144.05 recites “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 optimization”.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0091509 in view of US 2016/0317503 and US 2003/0129139 as applied to claims 1 and 5-6 above, and further in view of US 8,563,683 (Applicant provided).
As mentioned in the above 103(a) rejection, all the limitations of claims 1 and 5-6 are taught by the combination of the ‘509 publication, the ‘503 publication and the ‘139 publication.
Regarding claim 4, the limitation of wherein the surfactant protein is about 5% by weight of the particle is met by the ‘509 publication teaching the composition to include suitable pulmonary surfactant proteins such as the elected SP-B ([0011] or claim 4) present at 0.5 to 3 wt% [0012].
The combination of references does not specifically teach wherein the surfactant protein is selected from the group consisting of SEQ ID NOS: 1-21 (claim 3), specifically SEQ ID NO: 9 (claim 4).
The ‘683 patent teaches a synthetic lung surfactant composition that contain one or more phospholipase resistant phosphor-glycerol derivatives, surface active proteins or peptides. Uses of the surfactant compositions of the present invention to treat endogenous surfactant dysfunctional or deficient lung tissues (abstract). The surface-active synthetic peptide of this invention can be related in primary sequence to the regions of surfactant proteins SP-B. Particularly preferred amphipathic peptides of this invention are those related to the regional or full-length sequence of human or animal SP-B including dimer forms which may be used in synthetic lung surfactants with lipid analogs as single peptides or in combination with added synthetic peptides related to the regional or full sequences of SP-C or SP-A (column 12, lines 4-20). Peptide family correspond go Mini B family incorporates functionally relevant features of native SP-B (column 20, lines 35-50). Exemplary peptides that correspond to the peptides of SEQ ID NO: 1 include SEQ ID NO: 13
PNG
media_image1.png
52
363
media_image1.png
Greyscale
(column 21, lines 60-65), which corresponds to SEQ ID NO: 9 per the instant specification:
PNG
media_image1.png
52
363
media_image1.png
Greyscale
(page 18, Table B).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the Mini B family of peptides as taught by the ‘683 patent for the SP-B taught by the ‘509 publication because the ‘509 publication teaches derivatives of the SP-B derivatives of interest to be used in the formation and the ‘683 patent teaches the use of the functionally relevant features of the native SP-B, thus providing motivation and reasonable expectation of success in using the peptides taught by the ‘683 patent in the formulation of the ’509 publication. It would have been prima facie obvious to one of ordinary skill in the art to optimize the amount of surfactant protein in the composition taught by the combination of references as the ‘509 publication teaches a range of surfactant proteins. As MPEP 2144.05 recites “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 optimization”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-4 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, 15-16, 18-21 and 24 of copending Application No. 17/892,436 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘436 application are directed to powders comprising DPPC, POPG, NaCl and SP-B surfactant in overlapping range, wherein he surfactant protein may be SEQ ID NO: 9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-4 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-8 of copending Application No. 18/989,671 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘671 application are directed to powders comprising DPPC, POPG, NaCl and SP-B surfactant in overlapping range, wherein he surfactant protein may be SEQ ID NO: 9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613