DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 1, 2025 has been entered.
Election/Restrictions
To summarize the election, the applicant elected the species where the respirable, dry powder particle surfactant formulation is that of claimed formulation number 72 and a pediatric patient population with respiratory distress syndrome, without traverse. The specification indicates that formulation 72 contains SEQ ID No. 9 as the SP-B surfactant protein (see page 74). This will be construed as the elected surfactant protein in the elected formulation since the claims and specification have been clarified.
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.
Claim 24 is 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 24 recites a formulation that is followed by a parenthetical collection of numbers separated by colons. If the parenthetical recitation is to be ratios of components, then they constitute a narrow limitation after a broader limitation that recites components not required by the parent claim. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Interpretation
The claim amendment appears to add context to the recitation of “SP-B” in claim 24. In previous office actions, an issue concerning the clarity and scope was raised due to the specification employing “SP-B” when referencing the full protein and then varying between reciting this same acronym alone or employing SP-B derivative, SP-B analogue, SP-B fragment, and SP-B peptide when referencing a derivative, analogue, fragment, or peptide thereof. Since the specification has been amended and claim 1 now recite “a SP-B surfactant protein… selected from the group consisting of: SEQ ID NOS: 1-16 or an amino acid sequence homologous thereto with at least 90% identity at the amino acid level” , the “SP-B” of claim 24 is viewed as a referencing a surfactant protein within this scope.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5-6, 15-16, 18-21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Häfner et al. (previously cited) in view of Eistetter (previously cited), Blizzard et al. (previously cited), Clarke (previously cited), Notter et al. (previously cited), Walther et al. (previously cited), and Egan et al. (previously cited) as evidenced by Cunningham et al. (previously cited).
Häfner et al. teach a dry particle for inhalation of pulmonary surfactant (abstract and paragraph 15). The particle is envisioned to include phospholipids in combination with excipients as well as pulmonary surfactant protein B (SP-B) or surfactant protein C (SP-C), or one of their derivatives (see claim 4). Preferable phospholipids are a combination of dipalmitoyl- phosphatidylcholine (DPPC) and palmitoyl- oleyl-phosphatidylglycerol sodium (POPG-Na) at a ratio that ranges from 7:3 to 3:7 (see paragraph 11; instant claim 20). The desired pulmonary surfactant protein is more specifically taught present at 0.5 to 3 wt% (see paragraph 12). An example is provided composed of 69.3 wt% DPPC, 24.8 wt% POPG-Na, 2 wt% calcium chloride, 2.5 wt% palmitic acid, and 1.4 wt% recombinant SP-C (see examples 1; instant claims 1-2 and 20). Sodium chloride is taught as an alternative to calcium chloride (see paragraph 23). Häfner et al. further the teach the preparation of their dry particles via a spray drying of lyophilization procedure as detailed in WO 97/26863 authored by Eistetter (see paragraph 13). The teachings of Eistetter detail that their process generates particles at 1 to 5 mm in size that permits inhalation administration (see page 2 lines 66-77). They do not exemplify the SEQ ID No. 9 as a derivative of SP-B, the presence of sodium chloride, hydrogenated starch hydrolysate (HSH), SD-30, or the instantly recited proportions for each of the components of instant claim 24/formulation 72. While treatment of various pulmonary conditions, including acute respiratory distress syndrome, is taught, a pediatric human patient population is not explicitly detailed (see paragraph 15).
Blizzard et al. teach the inclusion of HSH in dry particulate pharmaceutical formulations administrable by inhalation in order to improve their chemical and physical stability (see paragraphs 5 and 7-8). The proportion of this component is at least 5 wt% and polyalditol is named as an envisioned variety composed of a blend of sorbitol maltitol, and higher order polyols (see paragraphs 10-14). They further teach obtaining a fine particle fraction less than 3.3 mm of at least 30% from spray draying the HSH containing mixture (see paragraphs 40 and 61). Blizzard et al. further teach that an aerodynamic diameter of 1 to 5 mm permits the particles to escape inertia and gravitational deposition in the oropharyngeal region to instead land in airways, particularly the deep lung (see paragraph 51).
Clarke teaches the use of HSH in pharmaceutical preparations (see paragraph 83). SD-30 is one of two particular varieties that are named (see paragraph 85). Cunningham et al. detail that SD-30 is a polyglycitol (see paragraph 5). Clarke also teaches the usefulness of polyalditol and HSH in the same capacity (see paragraph 83).
Notter et al. teach derivatives of SP-B for treating pulmonary disfunction due to surfactant deficiency (see paragraphs 14 and 65). One variety they exemplify is called Super Mini-B and has a sequence that fully matches instant SEQ ID NO. 9 (see paragraph 75, SEQ ID NO. 13, and example 3).
Walther et al. teach that Super Mini-B proteins yield superior oxygenation over SP-B when administered to a mammalian animal (see abstract, page 6 first column, and figure 14).
Egan et al. teach the treatment of acute respiratory distress syndrome and respiratory distress syndrome by administering a phospholipid in combination with SP-B or a protein that functions like SP-B (see page 3 lines 1-21 and claim 1). This condition is characterized by a deficiency in the quantity of lung surfactant (see page 1 lines 20-23; instant claim 1). The patient population is individuals that are at least one week old and a group of interest is pediatric patients (see page 4 lines 13-16 and claims 6-7; instant claims 17-18). A set of tested patients of interest were divided into age groups of less than one year, 1-5 years, 6-13 years, and greater than 13 years (see page 7 lines 15-16; instant claim 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the dry particles as Häfner et al. teach via the process of Eistetter because they state to do so and the result would be particles sized as Eistetter teach. While Eistetter does not state which type of diameter they recite, the fact that they teach the 1 to 5 mm sizing to be particularly suited for inhalation delivery and Blizzard et al. teach this same numerical range for aerodynamic diameter that is well suited to inhalation delivery to the lung, the artisan of ordinary skill would have viewed the size of Eistetter to be an aerodynamic diameter and/or found it obvious to generate this size from spray dry production as well as the preferred fine particle fraction of at least 30% smaller than 3.3 mm Blizzard et al. teaches. Within this production scheme, it would have been obvious to employ the example of Häfner et al. as a starting point for specific formulations within their scope and adjust the relative proportions of the DPPC and POPG-Na in the exemplified composition within the range that is taught. This range overlaps with that instantly claimed, thereby rendering it obvious (see MPEP 2144.05; instant claim 20). It also would have been obvious to employ a derivative of SP-B, namely the Super Mini B derivative of SP-B, in place of SP-C in the composition because Häfner et al. teaches the inclusion of SP-B, SP-C, and/or their derivatives. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g. specific SP-B derivative vs. generic SP-B derivative) and as the application of the same technique to a similar product in order to yield the same improvement. Here Notter et al. detail the utility of the Super Mini B protein and Walther et al. highlight its superior performance over SP-B, thereby rendering obvious its selection amongst known derivatives of SP-B. Routine work by the artisan of ordinary skill within the teachings of Häfner et al. that embrace a proportion of lung surfactant protein greater than 3 wt% would have been obvious and produces a range of proportions that overlap the “about 5 wt%” instantly claimed (see MPEP 2144.05; instant claim 5). Further, the exchange of sodium chloride for the calcium chloride in the product also would have been obvious because Häfner et al. teach the two salts as alternatives. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The addition of HSH in the dry particle formulation would have been obvious as the application of the same technique to a similar product in order to yield the same improvement that is taught by Blizzard et al. Further, selecting polyglycitol (SD-30) as the HSH would have been obvious because it was a known variety taught along with polyalditol by Clarke that is employed in pharmaceutical formulations (see instant claims 6 and 21). This choice would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The particle size distribution as well as proportions for the DPPC, POPG-Na, SP-B derivative SEQ ID No: 9, sodium chloride, and SD-30 meet, are close to, or overlap/embrace the ranges that are instantly claimed. Due to this proximity and the lack of evidence of the criticality of the selection of any of the claimed values, they are obvious in light of the prior art teachings and as a matter of routine work/design choice by the artisan. Given the teaching by Häfner et al. to administer their composition to treat acute respiratory distress syndrome (ARDS), it would follow to employ this resulting composition in this manner. More specifically, treating ARDS in a pediatric patient population, as delineated by Egan et al., by administering the modified composition of Häfner et al. would have been obvious because they teach the treatment of this condition with a combination of SP-B derivative and phospholipid which are the components provided by the modified Häfner et al. composition. Therefore claims 1-2, 5-6, 15-16, 18-21, and 24 are obvious over Häfner et al. in view of Eistetter, Blizzard et al., Clarke, Notter et al., Walther et al. and Egan et al. as evidenced by Cunningham et al.
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 1-2, 5-6, 15-16, 18-19, 20, and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/999039 (reference application) in view of Blizzard et al., Clake, and Häfner et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite treating respiratory distress syndrome in the same patient population with a respirable dry powder comprising SP-B. The SP-B is recited in the copending claims to have a sequence that matches instant SEQ ID No: 9. In addition, DPPC, POPG, and NaCl at proportions that meet the instant limitations are present in the particles. The presence of hydrogenated starch hydrolase is not detailed in the copending claims.
Blizzard et al. teach the inclusion of HSH in dry particulate pharmaceutical formulations administrable by inhalation in order to improve their chemical and physical stability (see paragraphs 5 and 7-8). The proportion of this component is at least 5 wt% and polyalditol is named as an envisioned variety composed of a blend of sorbitol maltitol, and higher order polyols (see paragraphs 10-14). They further teach obtaining a fine particle fraction less than 3.3 mm of at least 30% from spray draying the HSH containing mixture (see paragraphs 40 and 61). Blizzard et al. further teach that an aerodynamic diameter of 1 to 5 mm permits the particles to escape inertia and gravitational deposition in the oropharyngeal region to instead land in airways, particularly the deep lung (see paragraph 51).
Clarke teaches the use of HSH in pharmaceutical preparations (see paragraph 83). SD-30 is one of two particular varieties that are named (see paragraph 85). Cunningham et al. detail that SD-30 is a polyglycitol (see paragraph 5). Clarke also teaches the usefulness of polyalditol and HSH in the same capacity (see paragraph 83).
Häfner et al. teach a dry particle for inhalation of pulmonary surfactant (abstract and paragraph 15). The particle is envisioned to include phospholipids in combination with excipients as well as pulmonary surfactant protein B (SP-B) or surfactant protein C (SP-C), or one of their derivatives (see claim 4). Preferable phospholipids are a combination of dipalmitoyl- phosphatidylcholine (DPPC) and palmitoyl- oleyl-phosphatidylglycerol sodium (POPG-Na) at a ratio that ranges from 7:3 to 3:7 (see paragraph 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to size the particles of the copending claims according to Blizzard et al. for superior deposition control and add HSH at the taught proportions in the dry particle formulation as the application of the same technique to a similar product in order to yield the same improvement that is taught by Blizzard et al. Further, selecting polyglycitol (SD-30) as the HSH would have been obvious because it was a known variety taught along with polyalditol by Clarke that is employed in pharmaceutical formulations. This choice would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. It additionally would have been obvious the select POPG-Na as the POPG to include in light of Häfner et al. who teach its suitability in dry respirable particles containing SP-B. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The range of proportions for the SP-B peptide, POPG-Na, HSH, and NaCl overlaps with that instantly claimed, thereby rendering the claimed ranges obvious (see MPEP 2144.05). While not provided by a single lineage of claims, it would have been obvious to administer the modified composition of the copending claims to treat the pediatric patients with the condition they recite because the suggest to do so. Therefore claims 1-2, 5-6, 15-16, 18-19, 20, and 24 are obvious over claims 1-14 of copending Application No. 18/999039 (reference application) in view of Blizzard et al., Clake, and Häfner et al.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed October 1, 2025 have been fully considered. In light of the amendment to the claims, the objection to the specification is hereby withdrawn. A slightly different configuration of prior art previously cited is reapplied to the claims and their adjusted scope. The amendment did not address all the issues raised under 35 UCSC 112(b). The remaining issue is still detailed in the rejection above.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615