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 . 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.
Election/Restrictions
Applicant’s election of intratracheal administration of an exogenous surfactant, vascular administration of rhodamine to patients under mechanical ventilation in the phone call with Eric Bleich, applicant’s representative, on 11 Feb, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant elected treating pulmonary edema with mechanical ventilation with tracheal administration of an exogenous surfactant and vascular administration of rhodamine. A search was conducted for this invention, and a reference rendering it obvious was found. As a result, claims 44-47, 49, 50, and 61 were examined, and claims 48 and 51-60 were withdrawn from consideration.
Claims Status
Claims 44-61 are pending.
Claims 48 and 51-60 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11 Feb, 2026.
Claim Interpretation
Claim 50, and applicant’s elected formulations comprise an exogenous surfactant. Applicants have not defined this term, so the dictionary definition (produced outside the organism or system, Merriam Webster online dictionary) is used (MPEP 2111.01(I)). Note that this reads on any formulation where the surfactant in the formulation is not isolated from the patient, even if the patient does make the surfactant, such as recombinant surfactant protein C. For surfactant complexes, such as the rhodamine/albumin complexes of Perlman (US 20160067210, cited by applicant), this is interpreted as being exogenous if any component of the surfactant is not isolated from the patient.
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.
Claims 44-47, 49, 50, and 61 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 44, and claims dependent on it, require a surface tension lowering component, while claim 50 states that it can be a rhodamine dye. A surfactant (i.e. a surface lowering agent) is a chemical with a hydrophobic section and a hydrophilic section (Liu et al, Curr. Opin. Colloid Interface. Sci. (2020) 45 p14-27, p14, 1st column, 1st paragraph). Rhodamine dyes are a family of triphenylmethane dyes where each ring has a charged or hydrophilic moiety on it (note the example of paragraph 44). Applicant’s prior work shows that rhodamine, by itself, does not lower surface tension (Perlman, US 20160067210, cited by applicant, paragraph 68), and converting a rhodamine to a surfactant in the prior art requires adding a hydrophobic moiety (McWilliams et al, Pure Appl. Chem. (2020) 92(2) p265-274, reaction scheme, table 1, p269, center of page). As applicant has stated in their claims that rhodamine is a surface tension lowering component, a property it does not have, it is unclear what applicant means by the phrase “surface tension lowering component.”
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.
Claim(s) 44-47, 49, 50, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over (Perlman, US 20160067210, cited by applicant) in view of Le Tourneau et al (J. Natl. Cancer Inst. (2009) 101 p708-720).
Perlman discusses rhodamine dyes to reduce aveolar surface tension (title), to reduce aveolar edema liquid (paragraph 19) during mechanical ventilation (paragraph 20), applicant’s elected patient population. This requires albumin (paragraph 68), either from the patient or administered with the rhodamine. This can be administered by the vasculature (paragraph 106), corresponding to part (ii) of claim 44. A mention is made of the benefits of tracheal instillation of an exogenous surfactant, such as Survanta, providing effects similar to that of the rhodamine (paragraph 84), step (i) of claim 44.
The difference between this reference and the examined claims is that this reference does not discuss both step (i) and step (ii) of examined claim 44 used together, nor does it discuss their timewise relationship.
Le Tourneau et al state that the main goal of the phase 1 clinical trial is to establish the dose and/or dose schedule for new drugs or drug combinations (abstract), to avoid unnecessary exposure of patients to subtherapeutic doses while preserving safety and maintaining rapid accrual (p708, 1st column, 2nd paragraph). A number of different experimental designs for establishing these numbers are mentioned (fig 2, p711, top of page). This reference discusses optimizing the dose schedule.
It is considered obvious to combine two moieties used for the same purpose (MPEP 2144.06(I)); in this case, the tracheal administration of exogenous surfactant formulation with vascular administration of rhodamine. This is a combination of known elements (the administration of each formulation separately) yielding expected results (lower surface tension in the avelolar space).
Furthermore, it would be obvious to optimize the dose and dose schedule of the combination, to avoid unnecessary exposure of patients to subtherapeutic doses while preserving safety and maintaining rapid accrual, as discussed by Le Tourneau et al. As every drug and drug combination must have these parameters optimized, a person of skill in the art would reasonably be experienced in this optimization, leading to a reasonable expectation of success.
Perlman renders obvious tracheal administration of an exogenous surfactant and vascular administration of rhodamine, rendering obvious claims 44, 49, and 50.
Le Tourneau et al renders obvious optimizing the dose schedule, rendering obvious claims 45-47 and 50.
Perlman renders obvious mechanical ventilation, rendering obvious claim 61.
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.
first rejection
Claims 44-47, 49, 50, and 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 12, and 13 of U.S. Patent No. 10,391,151 in view of Le Tourneau et al (J. Natl. Cancer Inst. (2009) 101 p708-720).
Competing claim 1 describes a method of reducing ventilation injury (i.e. on a ventilator or will be placed on a ventilator) of a patient with aveolar flooding, comprising administering a surfactant protein C. Competing claim 2 specifies that the material can be natural, recombinant, or synthetic, and competing claim 3 gives non-natural variants of the protein (i.e. exogenous). Competing claim 12 specifies tracheal administration, while competing claim 13 specifies vascular administration.
The difference between the competing claims and the examined claims is that this reference does not discuss both vascular and airway administration together, nor does it discuss their timewise relationship.
Le Tourneau et al state that the main goal of the phase 1 clinical trial is to establish the dose and/or dose schedule for new drugs or drug combinations (abstract), to avoid unnecessary exposure of patients to subtherapeutic doses while preserving safety and maintaining rapid accrual (p708, 1st column, 2nd paragraph). A number of different experimental designs for establishing these numbers are mentioned (fig 2, p711, top of page). This reference discusses optimizing the dose schedule.
It is considered obvious to combine two moieties used for the same purpose (MPEP 2144.06(I)); in this case, the tracheal administration of exogenous surfactant formulation with vascular administration of rhodamine. This is a combination of known elements (the administration of each formulation separately) yielding expected results (lower surface tension in the avelolar space).
Furthermore, it would be obvious to optimize the dose and dose schedule of the combination, to avoid unnecessary exposure of patients to subtherapeutic doses while preserving safety and maintaining rapid accrual, as discussed by Le Tourneau et al. As every drug and drug combination must have these parameters optimized, a person of skill in the art would reasonably be experienced in this optimization, leading to a reasonable expectation of success.
second rejection
Claims 44-47, 49, 50, and 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 19, and 22 of U.S. Patent No.9,693,990 in view of Le Tourneau et al (J. Natl. Cancer Inst. (2009) 101 p708-720).
Competing claim 1 describes a method of reducing ventilation injury (i.e. on a ventilator or will be placed on a ventilator) of a patient with aveolar flooding, comprising administering a rhodamine dye. Competing claim 19 specifies tracheal administration, while competing claim 22 specifies vascular administration.
The difference between the competing claims and the examined claims is that this reference does not discuss both vascular and airway administration together, nor does it discuss their timewise relationship.
Le Tourneau et al state that the main goal of the phase 1 clinical trial is to establish the dose and/or dose schedule for new drugs or drug combinations (abstract), to avoid unnecessary exposure of patients to subtherapeutic doses while preserving safety and maintaining rapid accrual (p708, 1st column, 2nd paragraph). A number of different experimental designs for establishing these numbers are mentioned (fig 2, p711, top of page). This reference discusses optimizing the dose schedule.
It is considered obvious to combine two moieties used for the same purpose (MPEP 2144.06(I)); in this case, the tracheal administration of exogenous surfactant formulation with vascular administration of rhodamine. This is a combination of known elements (the administration of each formulation separately) yielding expected results (lower surface tension in the avelolar space).
Furthermore, it would be obvious to optimize the dose and dose schedule of the combination, to avoid unnecessary exposure of patients to subtherapeutic doses while preserving safety and maintaining rapid accrual, as discussed by Le Tourneau et al. As every drug and drug combination must have these parameters optimized, a person of skill in the art would reasonably be experienced in this optimization, leading to a reasonable expectation of success.
third rejection
Claims 44-47, 49, 50, and 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, and 5 of U.S. Patent No. 9,504,796 in view of Le Tourneau et al (J. Natl. Cancer Inst. (2009) 101 p708-720).
Competing claim 1 describes a method of treating edema, comprising administering a rhodamine dye. Competing claim 2 specifies ventilator injury. Competing claim 4 specifies tracheal administration, while competing claim 5 specifies vascular administration.
The difference between the competing claims and the examined claims is that this reference does not discuss both vascular and airway administration together, nor does it discuss their timewise relationship.
Le Tourneau et al state that the main goal of the phase 1 clinical trial is to establish the dose and/or dose schedule for new drugs or drug combinations (abstract), to avoid unnecessary exposure of patients to subtherapeutic doses while preserving safety and maintaining rapid accrual (p708, 1st column, 2nd paragraph). A number of different experimental designs for establishing these numbers are mentioned (fig 2, p711, top of page). This reference discusses optimizing the dose schedule.
It is considered obvious to combine two moieties used for the same purpose (MPEP 2144.06(I)); in this case, the tracheal administration of exogenous surfactant formulation with vascular administration of rhodamine. This is a combination of known elements (the administration of each formulation separately) yielding expected results (lower surface tension in the avelolar space).
Furthermore, it would be obvious to optimize the dose and dose schedule of the combination, to avoid unnecessary exposure of patients to subtherapeutic doses while preserving safety and maintaining rapid accrual, as discussed by Le Tourneau et al. As every drug and drug combination must have these parameters optimized, a person of skill in the art would reasonably be experienced in this optimization, leading to a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658