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 .
Terminal Disclaimer
The terminal disclaimer filed on 11/18/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 17/892,436 and 18/989,671 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Rejections
The prior rejection of claims 1 and 3-6 under 112(b) is withdrawn as Applicant has defined the formulation as consisting of thus clarifying the components allowed in the formation.
The prior double patenting rejections over application 17/892,436 and 18/989,671 are withdrawn as a result of Applicant filing terminal disclaimers.
Examiner’s Note
Applicant's amendments and arguments filed 11/18/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 11/18/2025, it is noted that claim 1 is amended and no new matter or claims have been added.
New Rejection:
The following rejection is newly applied based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 112 (b)
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 5 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 5 contains the limitation of “further comprising sinapultide”. Instant claim 1 is directed to a formulation consisting of components i)-v). It is unclear how sinapultide can be both excluded due to consisting of language and also be required to be present (further comprising). For compact prosecution and examination purposes claim 5 will be examined as requiring the additional ingredient sinapultide.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 contains the limitation of further comprising sinapultide, wherein instant claim 1 contains consisting of language. Thus claim 5 does not further limit claim 1 as it introduces an additional ingredient which is not allowed by the consisting of langue in instant claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments.
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 (previously applied) in view of US 6,211,162.
Regarding claims 1 and 6, the limitation of a spray-dried, respirable, dry powder particle surfactant formulation for pulmonary delivery consisting of: 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 from 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), thus meeting consisting of language wherein palmitic acid is at 0 parts. 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 composition as the ‘531 publication teaches a range of the ingredients, thus teaching an optimizable parameter. Regarding the limitation of spray-dried, it is a product by process limitation. MPEP 2113 - “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The ‘312 patent teaches the powder product containing the claimed ingredients and thus would meet the “spray dried” limitation absent factual evidence to the contrary.
The ‘312 patent does not specifically teach “wherein at least 40% or more of the dry powder particles have a fine particle fraction of less than 5.6 um and 30% or more has an FPF of greater than 3.4 um (claim 1).
The ‘162 patent teaches treating respiratory infections by pulmonary administration (abstract). To achieve deposition particles in the lower respiratory tract it is desirable to have particle size controlled and adjusted (column 3, lines 1-11). The formulation is taught to have particles from 0.1 to 10 microns in diameter and inhaled into the lungs (column 4, lines 25-40) preferably 1-5 um (column 4, lines 60-67). The composition is taught to be formed by lyophilization (column 12, lines 55-67, column 23, lines 1-15, column 16, lines 15-30).
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.
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 powder size range taught by the ‘162 patent and optimize as the ‘312 patent is directed to a pulmonary powder formulation to be delivered to the lungs through inhalation and the ‘162 patent teaches a formulation sized to be delivered to the lungs wherein the size is taught as an optimizable parameter to determine the delivery area in the lungs. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘312 patent and the ‘162 patent are directed to compositions in particle form which are delivered to the lungs and are formed by lyophilization.
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 spray dried, 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). The composition is taught to be spray dried (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 ‘509 publication teaches the pulmonary surfactant preparation, fatty acids can be present [0012] and is not required by the claims of the ‘509 publication (claims 1-5). Thus the ‘509 publication teaches the fatty acids such as palmitic acid may be present but are not required and therefore meets the instant claim limitation.
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 from the group consisting of trehalose, lactose, hydrogenated starch hydrolysate or sugar alcohol at 10 to 30% (claim 1) specifically lactose (claim 6).
The ‘509 publication does not specifically teach wherein at 40% or more of the dry powder particles have a fine particle fraction less than 5.6 um and wherein at least 30% or more of the dry powder particles have a FPF of less than 3.4 um (claim 1).
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 composition [0013]. Examples of sugars are taught to include lactose [0036]. The particle size is taught to be at least 1 um, preferably between 2-15 um wherein the distribution of particle size is taught to be selected to permit optimal deposition to the targeted sites [0046].
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 composition 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”.
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 particle sizes taught by the ‘503 publication for the powder taught by the ‘509 publication because the ‘509 publication teaches the composition in powder form to be pulmonary delivery and the ‘503 publication teaches a particle size range for lung delivery wherein the particle size is taught to be an optimizable parameter in order to obtain the desired delivery site. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘503 and the ‘509 publication are directed to particles formed by spray drying. 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
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52
363
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(column 21, lines 60-65), which corresponds to SEQ ID NO: 9 per the instant specification:
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(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”.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: The ‘312 patent
Applicant argues the ‘312 patent does not disclose or suggest spray dried formation. Lyophilization and spray drying are fundamentally different processes. One of ordinary skill would not recognize the process are interchangeable, while lyophilization preserves the structure but may yield less uniform particle without post processing.
In response, regarding the limitation of spray-dried, it is a product by process limitation. MPEP 2113 - “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The ‘312 patent teaches the powder product containing the claimed ingredients and thus would meet the “spray dried” limitation absent factual evidence to the contrary. Applicant has presented no evidence to the contrary. Applicant’s arguments may not take the place of factual evidence wherein factual evidence is required.
Applicant argues the ‘312 patent does not disclose or suggest a formation consisting of the claimed components without additional ingredients. The ‘312 patent formations include additional components such as fatty acids (e.g. palmitic acid) or fatty alcohols (e.g. cetyl alcohol). These are not mere optional additives as the ‘312 patent teaches them as required components (see e.g. claim 1). One of ordinary skill would not be motivated to eliminate the components and retain efficacy as doing so would lack a reasonable expectation of success in producing a functional respirable powder for pulmonary delivery.
In response, 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), thus meeting consisting of language wherein palmitic acid is at 0 parts. A dry powder is taught as formed (column 16, lines 25-40).
Applicant argues the ‘312 patent does not disclose or suggest a formulation herein at least 40% or more of the dry powder particle have a fine particle fraction of less than 5.6 and wherein at least 30% or more of the dry powder particles have a FPF of less than 3.4 um. The ‘312 patent provides no motivation to switch to spray drying as it is focused on lyophilization advantages and would require substantial redesign.
In response, the ‘162 patent teaches treating respiratory infections by pulmonary administration (abstract). To achieve deposition particles in the lower respiratory tract it is desirable to have particle size controlled and adjusted (column 3, lines 1-11). The formulation is taught to have particles from 0.1 to 10 microns in diameter and inhaled into the lungs (column 4, lines 25-40) preferably 1-5 um (column 4, lines 60-67). The composition is taught to be formed by lyophilization (column 12, lines 55-67, column 23, lines 1-15, column 16, lines 15-30). 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 powder size range taught by the ‘162 patent and optimize as the ‘312 patent is directed to a pulmonary powder formulation to be delivered to the lungs through inhalation and the ‘162 patent teaches a formulation sized to be delivered to the lungs wherein the size is taught as an optimizable parameter to determine the delivery area in the lungs. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘312 patent and the ‘162 patent are directed to compositions in particle form which are delivered to the lungs and are formed by lyophilization.
Applicant argues the ‘312 patent lists lactose but prefers sucrose/mannitol in examples. Selecting lactose would be non-obvious.
In response, “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).” (see MPEP 2123). Further, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).” (see MPEP 2141.02).
103: The ‘503 publication in view of the ’139 publication
Applicant argues the ‘503 publication surfactant formations which contain unclaimed components such as palmitic acid and calcium chloride which are excluded by the claimed “consisting of”.
In response, Applicant is referred to the modified rejection above. Regarding the limitation of wherein all components of the dry powder particles amount to 100 weight percent and the consisting of language is met by the ‘509 publication teaching each of the claimed ingredients present to form a dry powder as discussed above. The ‘509 publication teaches the pulmonary surfactant preparations; fatty acids can be present [0012] and is not required by the claims of the ‘509 publication (claims 1-5). Thus the ‘509 publication teaches the fatty acids such as palmitic acid may be present but are not required and therefore meets the instant claim limitation.
Applicant argues the newly claimed particle size range.
In response, the ‘503 publication teaches powder formulations which are useful for pulmonary administration to the respiratory tract of a patient (abstract). The particle size is taught to be at least 1 um, preferably between 2-15 um wherein the distribution of particle size is taught to be selected to permit optimal deposition to the targeted sites [0046]. 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 particle sizes taught by the ‘503 publication for the powder taught by the ‘509 publication because the ‘509 publication teaches the composition in powder form to be pulmonary delivery and the ‘503 publication teaches a particle size range for lung delivery wherein the particle size is taught to be an optimizable parameter in order to obtain the desired delivery site. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘503 and the ‘509 publication are directed to particles formed by spray drying. 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”.
Applicant argues the ‘509 publication describes preferred preparations, specifically the failure of the prior surfactant treatment and alleges to provide surfactant preparations that overcome the prior failures. The preferred preparations containing phospholipids, pulmonary surfactant proteins, fatty acid, preferably palmitic, and calcium chloride. The preferred preparation is confirmed by all examples, which requires a surfactant, a surfactant protein, palmitic acid and calcium chloride dihydrate. One skilled in the art must infer based on the teachings of the ‘509 publication that only preparations which comprise DPPC, POPG, palmitic acid, calcium chloride dihydate and rSP-c as prepared in the examples are suitable. The instant claims require NaCl, an excipient such as lactose, not present in the ‘509 publication and does not include palmitic acid.
In response, “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).” (see MPEP 2123). Further, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).” (see MPEP 2141.02). Regarding the limitation of wherein all components of the dry powder particles amount to 100 weight percent and the consisting of language is met by the ‘509 publication teaching each of the claimed ingredients present to form a dry powder as discussed above. The ‘509 publication teaches the pulmonary surfactant preparations; fatty acids can be present [0012] and is not required by the claims of the ‘509 publication (claims 1-5). Thus the ‘509 publication teaches the fatty acids such as palmitic acid may be present but are not required and therefore meets the instant claim limitation. Additionally the ‘509 publication clearly teaches the preparations to include sodium salts such as sodium chloride [0012] and the addition of an excipient (claim 4). The ‘139 publication teaches lactose as a known excipient pulmonary formulation (abstract, [0040]). Thus the limitations of the instant claim are obvious over the prior art.
Applicant argues replacing calcium chloride with NaCl.
In response, as discussed above a publication is not only as good as the preferred embodiments and examples. The 509 publications clearly teach the preparations to include sodium salts such as sodium chloride [0012].
Applicant argues the ‘503 and ‘139 publication relate to the rapid systemic administration of active agents via the pulmonary system. They need to get through the lung and into the blood stream. In contrast the ‘509 publication is not related to the rapid systemic delivery of a drug to a patient with a condition outside of lungs. Rather it is related to a dry powder formulation that will treat surfactant deficiencies in the alveoli, particular in newborn and infants. The different is systemically delivered vs delivered to alveoli. Applicant argues no reasonable expectation of success in the proposed combination of all three references.
In response, the ‘509 publication is directed to pulmonary surfactant preparations for treatment of pulmonary diseases (abstract) wherein additional excipients are used (claim 1) wherein the formulation is a dry powder (Example 1). The ‘503 publication teaches powder formulations for pulmonary administration to the respiratory tract (abstract) wherein the formulation is spray dried powder [0006] and an excipient is taught to include sugar [0011] such as lactose [0036]. The ‘139 publication teaches pulmonary delivery (abstract) of particles containing excipients such as lactose and fatty acids [0040]. Thus the ‘509 publication, the ‘503 publication and the ‘139 publication are all directed to compositions of dry powder formulations which are delivered to the pulmonary system containing excipients. 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 composition 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.
Applicant argues claim 5 recites sinapulitide. While the ‘509 publication teaches sinapultide, incorporating it without palmitic acid or CaCl2 would still require non-obvious modification.
In response, Applicant’s arguments regarding palmitic acid and CaCl2 are addressed above as first presented.
Applicant argues claim 6. The ‘503 publication and the ’139 publication list lactose among options but selecting it for the ‘509 publication surfactant is non obvious at it would alter the formation in unpredictable ways.
In response, it appears Applicant is arguing unexpected results however has not presented any data. Applicant’s arguments cannot take the place of factual evidence wherein factual evidence is required. Thus the ‘509 publication, the ‘503 publication and the ‘139 publication are all directed to compositions of dry powder formulations which are delivered to the pulmonary system containing excipients. 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 composition 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.
Applicant argues the ‘683 patent also does not cure the defects and it fails to teach or suggest that which is fundamentally missing from the other reference.
In response, Applicant’s arguments are addressed as first presented.
Conclusion
No claims are allowed.
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.
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.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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