DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Herein, “the previous Office action” refers to the Final Rejection filed 11/19/2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/19/2026 has been entered.
Priority
As detailed on the Filing Receipt filed 1/22/2026, the instant application claims priority to as early as 5/27/2013. At this point in prosecution, all claims are accorded the earliest claimed priority date.
Claim Status
Claim 8 is canceled.
Claims 1-7 and 9-12 are pending, and examined herein.
Withdrawn Rejections
The rejections of claims 1-7 and 9-12 under 35 USC § 103, as being unpatentable over combinations of Jameson, as evidenced Neligan, with Liu, Perkins and/or Peneff, are hereby withdrawn in view of Applicant’s persuasive arguments. See ‘Response to Arguments – Claim Rejections Under 35 USC § 103’ section for full details.
Response to Arguments - Claim Rejections Under 35 USC § 103
In the remarks filed 3/19/2026, Applicant traverses the rejections under 35 USC § 103 and presents supporting arguments.
Applicant alleges that the cited references do not provide a reasonable expectation of success in using an L/S ratio of <2 as a diagnostic tool to see if administration of treatment is needed, and particularly asserts that Jameson in fact teaches away from this feature in teaching that L/S ratios of <2 are not reliable predictors of RDS (pg. 7, para. 1 – pg. 8, para. 1).
Jameson does indeed teach that an L/S ratio of less than 2 does not reliably indicate that treatment with surfactant is necessary. Jameson also teaches that a ratio ≥2 is a reliable predictor of sufficient production of surfactant to prevent neonatal RDS and affirms the clinical utility of this threshold in avoiding unnecessary treatment, i.e., minimizing needless administration of surfactant (col. 1, lines 25-27; col. 2, lines 24-35). Jameson presents no alternative metric to L/S ratio for supporting a decision to administer surfactant, but rather treats administration of surfactant as a default treatment that is contraindicated by an L/S ratio of ≥2. The teachings of Jameson, taken together, indicate that treatment with surfactant is not necessary when the L/S ratio is ≥2 and may be necessary when the L/S ratio is <2.
Jameson specifically mentions administration of artificial surfactant as an available treatment option for newborn lung immaturity, and characterizes their own L/S ratio assessment method as “a convenient and accurate test for fetal… lung maturity… very valuable in the clinical management and prevention of RDS” (col. 1, lines 25-30). Jameson does not disparage, discredit or otherwise discourage administration of surfactant to a newborn individual on the basis of having an L/S ratio less than 2, and is not considered to ‘teach away’ from administration of surfactant based on the discussed L/S ratio threshold as claimed. The argument that Jameson teaches away from the cited feature, and so fails to provide a reasonable expectation of success, is found unpersuasive.
Applicant alleges that none of the cited references teaches methods that can be performed in less than 10 minutes. Applicant particularly notes that Liu demonstrates 10-minute prior centrifugation of all samples therein, and although teaching that phosphatidylglycerol can be detected in contaminated amniotic fluid (i.e., in absence of centrifugation to remove contaminants), does not teach the same regarding detection of the lecithin/sphingomyelin ratio in contaminated gastric aspirate, tracheal fluid, or hypopharyngeal secretion samples as claimed (pg. 8, para. 2 – pg. 9, para. 3).
This argument is found persuasive with respect to the outlined deficiency of Liu.
Applicant alleges that Jameson, Neligan and Perkins are completely silent regarding reduced sample preparation times, and do not provide guidance on how to reduce sample preparation time (pg. 9, para. 4).
Perkins in fact teaches that sample preparation steps can be a significant limiting factor on throughput in addition to spectral scan time (pg. A270, l. column), but does not further discuss sample preparation or suggest that such steps can be omitted. This argument is found persuasive with respect to a lack of remedial guidance in Jameson, Neligan and Perkins regarding the outlined deficiency of Liu.
Applicant notes that Peneff is applied for teachings regarding analysis of gastric aspirate and alleges that these teachings do not overcome the discussed deficiencies of the other references (pg. 11, para. 4).
This argument is found persuasive with respect to a lack of remedial teaching in Peneff regarding the outlined deficiencies of the other references.
The rejections of claims 1-7 and 9-12 under 35 USC § 103, as being unpatentable over combinations of Jameson, as evidenced Neligan, with Liu, Perkins and/or Peneff, are hereby withdrawn in view of at least Applicant’s above persuasive arguments regarding deficiencies of the cited art.
Reference of record Balint et al (Pediatric Research 12: 715-719; published 1978) discusses the predictive significance of measured lecithin composition in development of infantile respiratory distress syndrome (pg. 715, Abstract) and discloses measurement of phospholipids in uncentrifuged gastric and tracheal aspirate samples obtained from newborns (pg. 716, l. column). Balint specifically teaches that prior centrifugation of gastric and tracheal aspirate samples is unnecessary, pointing to their own findings and prior evidence (pg. 716, l. column). Balint also discusses conventional measurement of L/S ratio in amniotic fluid, gastric and tracheal aspirate samples (pg. 715, l. column; see titles of references 8-9 listed on pg. 718), and presents findings that fatty acid composition in amniotic fluid, gastric and tracheal aspirate samples is similar (pg. 716, l-r. columns and Table I).
Balint is considered highly relevant art, and its teachings may remedy the presented deficiencies of Jameson, Liu, Perkins and Peneff in combination. However, in determining obviousness of a claimed invention, the courts have held that prior art must be weighed in conjunction with secondary considerations which indeed may outweigh prior-art based evidence. In Ex parte Thompson, Appeal 2011-011620 (March 21, 2014; designated informative), for example, the Board wrote that “the Examiner's findings regarding the [prior art] teachings… are undisputed, as is their combinability… [but] that still does not obviate the requirement that this prior art-based evidence must be properly considered in conjunction with other evidence of secondary considerations”(Ex parte Thompson at pg. 13).
In addition to the above arguments regarding deficiencies of cited prior art, Applicant also presents an argument regarding a significant secondary consideration: solution of long-felt need. This argument is considered below.
Applicant alleges that the claimed method solves a long-felt need for treatment of surfactant in a neonate suffering from RDS as soon as possible, and points to supporting evidence in references of record Sweet et al 2017 (“[i]f RDS develops, and surfactant is given, the earlier in the course of the disease surfactant is given, the better the outcome” at pg. 112, r. column) and Sweet et al 2019 (“The overall aim is to… give surfactant as early as possible in the course of RDS once it is deemed necessary” at pg. 436, r. column) in support of long-felt need (pg. 10, para. 3 – pg. 11, para. 2).
The cited excerpts of the Sweet references provide evidence supporting consideration of administration of surfactant as early as possible, in the course of neonatal RDS, as a recognized long-felt need in the field of the invention. Review of prior art (including the cited references) indicates that collective performance of analysis in 10 minutes or less was not provided by another in the field, prior to the effective filing date of the claimed invention. Applicant presents a compelling case that the claimed invention, in further minimizing the total analysis time, provides a solution to this need.
This argument is found persuasive, and the claimed invention is considered nonobvious in light of the provided solution of an evidence-supported long-felt need. Therefore, new obviousness rejections incorporating the Balint reference have not been made.
Response to Arguments - Double Patenting
In the remarks filed 3/19/2026, Applicant requests reconsideration of the rejections on the ground of nonstatutory double patenting for the reasons presented with respect to the rejections under 35 USC § 103 (pg. 12, para. 2).
The arguments presented with respect to the rejections under 35 USC § 103 concern alleged points of distinction between the instant claims and teachings of Jameson (as evidenced by Neligan), Liu, Perkins and/or Peneff. They do not present alleged points of distinction between the instant claims and claims of the cited patents and/or copending patent application (US Patent Nos. 11,105,822 and 11,781,980; Application No. 17/999,985). They are consequently found unpersuasive with respect to the rejections on the ground of nonstatutory double patenting, and these rejections are maintained.
Applicant is encouraged to file appropriate Terminal Disclaimers and/or present alleged points of distinction between the instant claims and claims of the cited patents and/or copending patent application.
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.
Instant claims 1-7 and 9-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-10 and 12-13 of U.S. Patent No. 11,105,822 (issued 8/31/2021; hereafter, “‘822”). ‘822 shares joint inventors (Henrik Verder, Agnar Höskuldsson) and a common assignee (Sime Diagnostics) with the instant application. ‘822 issued from Application No. 14/893,822, of which the instant application is a Continuation.
This rejection is maintained from the previous Office action. This header has been revised solely to indicate the relationship of ‘822 to the instant application.
Correspondence is as follows:
Instant claim
Instant limitations
‘822 claim
Corresponding limitations
1
A method of treatment of respiratory distress syndrome (RDS) in a newborn individual, comprising:
1
A method of treatment of respiratory distress syndrome (RDS) in a newborn individual, comprising:
providing a body fluid sample obtained from a newborn subject, wherein:
collecting a body fluid sample obtained from a newborn subject, wherein:
the sample is gastric aspirate, tracheal fluid or hypopharyngeal secretion;
the sample is gastric aspirate, tracheal fluid or hypopharyngeal secretion;
determining, using a spectrometer, in the sample the activity and/or concentration of a first compound and a second compound, wherein the first compound is lecithin or saturated lecithin and the second compound is sphingomyelin;
determining, using a spectrometer, in the sample the activity and/or concentration of a first compound and a second compound, wherein the first compound is lecithin or saturated lecithin and the second compound is sphingomyelin;
obtaining a ratio between the first compound and the second compound;
obtaining a ratio between the first compound and the second compound;
correlating the ratio with a control ratio, wherein:
correlating the ratio with a control ratio, wherein:
a ratio differing from the control ratio is indicative of RDS of the subject;
a ratio differing from the control ratio is indicative of RDS of the subject;
identifying an individual with the ratio less than 2.0 ± 0.5;
identifying an individual with the ratio less than 2.0 ± 0.5;
administering a therapeutically effective amount of surfactant to the newborn subject with said ratio;
administering a therapeutically effective amount of surfactant to the newborn subject with said ratio;
wherein steps are collectively performed in less than 10 minutes.
wherein steps are collectively performed in less than 10 minutes.
2
determining an activity or concentration of a third compound
2
determining the amount of a third compound
3
the third compound is selected from phosphatidylglycerol, hemoglobin, apo-hemoglobin, heme and porphyrin
3
the third compound is selected from phosphatidylglycerol, hemoglobin, apo-hemoglobin, heme and porphyrin
4
the third compound is hemoglobin
4
the third compound is hemoglobin
5
subtracting the activity or concentration of the third compound from the activity or concentration of the first compound, thus obtaining a background corrected amount of the first compound
5
subtracting the amount of the third compound from the amount of the first compound, thus obtaining a background corrected amount of the first compound
6
subtracting the activity or concentration of the third compound from the activity or concentration of the second compound, thus obtaining a background corrected amount of the second compound
6
subtracting the amount of the third compound from the amount of the second compound, thus obtaining a background corrected amount of the second compound
7
subtracting the activity or concentration of the third compound from the activity or concentration of both the first and the second compound, thus obtaining a background corrected amount of both the first and the second compound
7
subtracting the amount of the third compound from the amount of both the first and the second compound, thus obtaining a background corrected amount of both the first and the second compound
9
the subject is a human infant born before 43 weeks gestation
9
the subject is a human infant born before 43 weeks gestation
10
the body fluid sample is directly
transferred from the subject to the spectrometer without intermediate sample
preparation
11
the body fluid sample is directly
transferred from the subject to the spectrometer without intermediate sample
preparation
11
the spectrometer is a Fourier transformed infrared
(FTIR) spectrometer
12
the spectrometer is a Fourier transformed infrared
(FTIR) spectrometer
12
the body fluid sample is gastric aspirate
13
the body fluid sample is gastric aspirate
Instant claims 1-3, 9 and 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-9, 11-12 and 15-16 of U.S. Patent No. 11,781,980 (issued 10/10/2023; hereafter, “‘980”). ‘980 shares an inventor (Henrik Verder) and a common assignee (Sime Diagnostics) with the instant application. This rejection is maintained from the previous Office action.
Correspondence is as follows:
Instant claim
Instant limitations
‘980 claim
Corresponding limitations
1
A method of treatment of respiratory distress syndrome (RDS) in a newborn individual, comprising:
11
A method of treatment of respiratory distress syndrome (RDS) in a newborn individual, comprising:
providing a body fluid sample obtained from a newborn subject, wherein:
providing a sample from said newborn individual, wherein:
the sample is gastric aspirate, tracheal fluid or hypopharyngeal secretion;
the sample is an oropharyngeal secretion sample or a gastric aspirate sample;
determining, using a spectrometer, in the sample the activity and/or concentration of a first compound and a second compound, wherein the first compound is lecithin or saturated lecithin and the second compound is sphingomyelin;
determining the amount of a first compound selected from lecithin and saturated lecithin and optionally the amount of sphingomyelin in the sample, using analysis means, wherein:
7
the analysis means is an infrared spectrometer;
obtaining a ratio between the first compound and the second compound;
11
obtaining a ratio between the first compound and sphingomyelin;
correlating the ratio with a control ratio, wherein:
11
correlating the ratio with a control ratio, wherein:
a ratio differing from the control ratio is indicative of RDS of the subject;
a ratio equal to or lower than the control ratio is indicative of the subject having RDS,
identifying an individual with the ratio less than 2.0 ± 0.5;
12
the control ratio is between 1.0 and 3.0 ± 0.5 (*see Note below);
administering a therapeutically effective amount of surfactant to the newborn subject with said ratio;
11
if the ratio is equal to or less than the control ratio, administering a therapeutically effective amount of surfactant to the newborn individual;
wherein steps are collectively performed in less than 10 minutes.
9
wherein the time-to-result of the method is between 5 and 60 minutes (**see Note below).
2
determining an activity or concentration of a third compound
8
determining the amount of a further compound
3
the third compound is selected from phosphatidylglycerol, hemoglobin, apo-hemoglobin, heme and porphyrin
16
the further compound is phosphatidylglycerol
9
the subject is a human infant born before 43 weeks gestation
11
(***see Note)
11
the spectrometer is a Fourier transformed infrared
(FTIR) spectrometer
15
the infrared spectrometer is a Fourier transformed infrared (FTIR) spectrometer
12
the body fluid sample is gastric aspirate
11
the sample is an oropharyngeal secretion sample or a gastric aspirate sample
Note: The portion of the specification of a reference patent that describes subject matter that falls within the scope of a reference claim may relied upon to properly construe the scope of that claim (MPEP 804 § II.B(1)). Alternatively, see “at once envisaged” rationale (MPEP 2131.02 § III).
* The reference specification describes embodiments wherein the control ratio is between 1.0 and 3.0 ± 0.5, “such as between… 2.0 ± 0.5” (col. 22, item 50).** The reference specification describes embodiments wherein the time-to-result is between 5 and 60 minutes, “such as 10 minutes or less” (col. 14, para. 3).*** The reference specification describes embodiments wherein the newborn is a human infant born “before 43 weeks gestation” (col. 20, items 28-32).
Additionally, instant claims 1-7 and 10-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 11, 35-36, 39-44, 48, 53, 69 and 71 of copending Application No. 17/999,985 (hereafter, “‘985”), in view of Jameson. ‘985 shares an inventor (Henrik Verder) and a common assignee (Sime Diagnostics) with the instant application. This rejection is maintained from the previous Office action.
The corresponding patent publication, US 2023/0223150, is used as reference for claims of the copending application. Correspondence is as follows:
Instant claim
Instant limitations
‘985 claim
Corresponding limitations
1
A method of treatment of respiratory distress syndrome (RDS) in a newborn individual, comprising:
1
A method for predicting the likelihood of acute respiratory
distress syndrome (ARDS) in an adult subject, comprising:
providing a body fluid sample obtained from a newborn subject, wherein:
providing a sample obtained from said subject, wherein:
the sample is gastric aspirate, tracheal fluid or hypopharyngeal secretion;
8
the sample is a tracheal secretion, an oropharyngeal secretion, or a gastric aspirate;
determining, using a spectrometer, in the sample the activity and/or concentration of a first compound and a second compound, wherein the first compound is lecithin or saturated lecithin and the second compound is sphingomyelin;
1
determining in the sample, using suitable analysis
means, the amount of at least a first and optionally at
least a second compound, wherein:
the first compound is lecithin or saturated lecithin,
and the second compound is sphingomyelin,
35
the analysis means is an infrared spectrometer,
41
the amount of the first, second and/or third
compound is determined by measuring the activity and/or
concentration of the compound(s);
obtaining a ratio between the first compound and the second compound;
1
obtaining a ratio between the first and second compounds;
correlating the ratio with a control ratio, wherein:
correlating the ratio with a control ratio, wherein:
a ratio differing from the control ratio is indicative of RDS of the subject;
a ratio differing from the control ratio is indicative of ARDS of the subject;
identifying an individual with the ratio less than 2.0 ± 0.5;
53
If the ratio is equal to or less than 2.0 ± 0.5, the subject is classified as having or likely to develop ARDS
administering a therapeutically effective amount of surfactant to the newborn subject with said ratio;
69
administering a treatment to a subject
having an increased likelihood of ARDS, wherein:
71
the treatment comprises administering surfactant
wherein steps are collectively performed in less than 10 minutes.
48
the time-to-result of the method is less than
10 minutes
‘985 does not disclose assessing RDS in a newborn subject.
Jameson discusses RDS, one of the most critical problems associated with the clinical management of premature newborns, and teaches that determination of the L/S ratio in samples of amniotic fluid or infant pulmonary effluent is the most widely accepted measure of lung maturity (col. 2, lines 15-18). Jameson exemplifies determination from infant tracheal lavage fluid, i.e., tracheal aspirate (col. 1, lines 34-35; col. 4, lines 13-19) using a spectrofluorometer (col. 4, lines 37-38). Jameson further teaches that newborns can be treated for RDS with administration of artificial surfactant (col. 1, lines 25-27).
2
determining an activity or concentration of a third compound
39
determining the amount of a third compound
3
the third compound is selected from phosphatidylglycerol, hemoglobin, apo-hemoglobin, heme and porphyrin
40
said third compound is selected from the group consisting of phosphatidylglycerol,
hemoglobin, apo-hemoglobin, heme and
porphyrin
4
the third compound is hemoglobin
preferably the third compound is phosphatidylglycerol or hemoglobin
5
subtracting the activity or concentration of the third compound from the activity or concentration of the first compound, thus obtaining a background corrected amount of the first compound
42
subtracting the amount of the
third compound from the amount of the first compound, thus
obtaining a background corrected amount of the first compound
6
subtracting the activity or concentration of the third compound from the activity or concentration of the second compound, thus obtaining a background corrected amount of the second compound
43
subtracting the amount of the
third compound from the amount of the second compound, thus obtaining a background corrected amount of the second
compound
7
subtracting the activity or concentration of the third compound from the activity or concentration of both the first and the second compound, thus obtaining a background corrected amount of both the first and the second compound
44
subtracting the amount of the
third compound from the amount of both the first and the second compound, thus obtaining a background corrected amount of both the first and the second compound
10
the body fluid sample is directly
transferred from the subject to the spectrometer without intermediate sample
preparation
11
the sample is directly transferred from the subject by a sampling means to an analysis means, without
intermediate sample preparation
11
the spectrometer is a Fourier transformed infrared
(FTIR) spectrometer
36
the analysis means is an FTIR spectrometer
12
the body fluid sample is gastric aspirate
8
the sample is a tracheal secretion, an oropharyngeal secretion, or a gastric aspirate
An invention would have been obvious to one of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, said practitioner would have applied the methodology of ‘985 to the prediction of RDS in newborns, because Jameson teaches the techniques of ‘985 (e.g., determination of L/S ratio, using a spectrometer, in tracheal secretion samples; assessment of the ratio; and administration of surfactant) are broadly applicable to clinically-critical assessment and treatment of RDS in newborns (col. 1, lines 25-27 and 34-35; col. 2, lines 15-18; col. 4, lines 13-19 and 37-38).
In this way instant claims 1-7 and 10-12 are not patentably distinct from claims of ‘985, in light of Jameson.
Conclusion
At this point in prosecution, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore C. Striegel whose telephone number is (571)272-1860. The examiner can normally be reached Mon-Fri 12pm-8pm ET.
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/T.C.S./Examiner, Art Unit 1685
/JESSE P FRUMKIN/Primary Examiner, Art Unit 1685 April 3, 2026