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 . The rejections from the Office Action of 11/21/2025 are hereby withdrawn. New grounds for rejection are presented below.
Claim Objections
Claim 65 is objected to because of the following informalities:
Claim 65 – Please put the word “and” back between elements c and d.
Claim 65 – Please delete the comma at the end of the claim that is before the period.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The “processing means” of Claim 65 are interpreted as invoking 35 USC 112(f). Corresponding structure is disclosed on Page 6 of the instant Specification as at least a computer.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 65 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the abstract idea of a mathematical and/or mental activity algorithm for evaluating whether spectral data from a sample from an adult subject indicates the need for surfactant.
This judicial exception is not integrated into a practical application because no use for the algorithm result is recited.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited spectroscope would have been required to produce the spectral data needed to implement the algorithm. The recited processing means amounts to the recitation of a general-purpose computer for implementing the algorithm and does not serve to amount to the recitation of significantly more than the abstract idea itself (see Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014))
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1, 3-5, 8, 12, 35, 39-40, 42, 48, 51-52, 55-56, 60, 65, and 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verder et al. (US 20160103143 A1)[hereinafter “Verder”] and Schousboe et al. (WO 2019068843 A1)[hereinafter “Schousboe”].
Regarding Claim 1, Verder discloses a method for treating a human subject likely to benefit from administration of surfactant [Abstract – “The present invention concerns methods and tools for analysing biomarkers useful for diagnosing an individual, in particular a newborn, with a respiratory disease, especially a newborn suffering from respiratory distress syndrome (RDS). The method and tools of the invention can in one embodiment be used for very rapidly detecting the ratio between lecithin and sphingomyelin in very small body fluid samples, e.g. gastric aspirate of a newborn. The invention is thus useful for obtaining a rapid treatment of RDS by administration of surfactant.”], the method comprising the steps of:
a) providing a sample obtained from said subject [See Fig. 1 and Paragraph [0032] – “Step 1) includes providing a sample of gastric aspirate.”],
b) determining in the sample of a) using suitable analysis means, an amount of at least a first compound and optionally at least a second compound, wherein the first compound is different than the second compound, wherein the first compound is lecithin or saturated lecithin, and the second compound is sphingomyelin [See Fig. 1 and Paragraph [0034] – “Step 4) comprises extracting chemical information (lecithin and sphingomyelin concentration and/or activity) from spectral signatures through chemometrics algorithm (multivariate data analysis).”];
c) obtaining a concentration of the first compound and/or a ratio between the first compound and the second compounds of b) [See Fig. 1 and Paragraph [0035] – “Step 5) comprises obtaining an L/S ratio”];
d) correlating the concentration of c) with a control concentration, wherein a concentration lower than or equal to the control concentration is indicative of ARDS of the subject benefiting from administration of surfactant, and/or correlating the ratio of c) with a control ratio, wherein a ratio equal to or lower than the control ratio is indicative of ARDS of the subject benefiting from administration of surfactant [See Fig. 1:
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], and
e) administering surfactant, or one or more components thereof, to said subject identified as likely to benefit from administration of surfactant [See Fig. 1 (“Early administration of surfactant”) and Paragraph [0035] – “Step 5) comprises obtaining an L/S ratio and optionally a recommended treatment regime.”].
Verder fails to disclose that the human subject is an adult subject. However, Schousboe discloses the consideration of applying such a technique to an adult subject [Page 14 lines 13-25 – “In one embodiment, the method is used to determine a concentration of lecithin or saturated lecithin on a sample derived from said subject, usually newborn, to determine whether the subject suffers from RDS. In another embodiment, the method is used to determine an L/S ratio based on a sample derived from said subject, usually a newborn, to determine whether the subject suffers from RDS. The sample may be a gastric aspirate sample, an amniotic fluid sample, a blood sample or an oropharyngeal secretion sample. The concentration of lecithin or saturated lecithin can be compared to a control value, and/or the L/S ratio can be compared to a control ratio, as described in co-pending application entitled "Fetal maturity lung test" filed by the same applicant and having the same filing date as the present application, thereby indicating whether the subject suffers from Respiratory Distress Syndrome. If the subject suffers from RDS, treatment is administered - in this particular case, a therapeutically amount of surfactant is administered to the subject.”Item 26 of Schousboe – “wherein the subject is a human being, such as a newborn, a premature newborn, an infant, a child, or an adult.”]. It would have been obvious to apply such a technique to an adult in order to effectively combat the negative effects of respiratory distress syndrome.
Regarding Claim 3, Schousboe discloses that the first compound (lecithin or saturated lecithin) can be measured as dipalmitoylphosphatidylcholine (DPPC)[Page 24 lines 11-12 – “Lecithin was measured as dipalmitoylphosphatidylcholine (DPPC).”]. It would have been obvious to measure DPPC as the first compound because this would have been an effective manner of measuring lecithin or saturated lecithin.
Regarding Claim 4, Verber discloses that the subject is suffering from a disease or a condition that can cause ARDS [Abstract – “The present invention concerns methods and tools for analysing biomarkers useful for diagnosing an individual, in particular a newborn, with a respiratory disease, especially a newborn suffering from respiratory distress syndrome (RDS).”Paragraph [0011] – “If the L/S ratio is less than about 2.0, this is an indication of that the fetal lungs are deficient [9].”]. It would have been obvious to apply such a technique to an adult (per Verder) in order to effectively combat the negative effects of respiratory distress syndrome.
Regarding Claim 5, Verber discloses that the subject is suffering from a disease or a condition is selected from the group consisting of pneumonia, such as viral or bacterial pneumonia, acute inhalation injury [Paragraph [0004] – “The onset of RDS is shortly after birth, and is manifest by tachypnea, tachycardia, chest wall retractions (recession), expiratory grunting, nasal flaring and cyanosis during breathing efforts. As the disease progresses, the newborn may develop ventilatory failure (rising carbon dioxide concentrations in the blood), and prolonged cessations of breathing (“apnea”). Whether treated or not, the clinical course for the acute disease lasts about 2 to 5 days. During the first days the condition of the patient worsens and requires more support. Despite major advances in care, RDS remains the most common single cause of death in the first month of life. Complications include metabolic disorders (acidosis, low blood sugar), patent ductus arteriosus, low blood pressure, chronic lung changes, and intracranial hemorrhage. The disease is frequently complicated by prematurity and its additional defects in other organ function.”Paragraph [0005] – “The characteristic histopathology seen in babies who die from RDS was the source of the name “hyaline membrane disease”. Waxy-appearing layers of hyaline membrane line the collapsed alveoli of the lung. In addition, the lungs show bleeding, over-distention of airways and damage to the lining cells.”], radiation-induced lung injury, aspiration, pulmonary embolism, atelectasis, emphysema, cystic fibrosis, chronic obstructive pulmonary disease, lung contusion, chest trauma, near-drowning, sepsis, shock, trauma, cardiopulmonary bypass, transfusion-related acute lung injury, burns, and increased intracranial pressure. It would have been obvious to apply such a technique to an adult (per Verder) in order to effectively combat the negative effects of respiratory distress syndrome.
Regarding Claim 8, Verber discloses that the sample is a lung epithelial lining fluid sample, a tracheal secretion sample, an oropharyngeal secretion sample, a gastric aspirate sample [See Fig. 1 and Paragraph [0032] – “Step 1) includes providing a sample of gastric aspirate.”], a bronchoalveolar lavage sample, a pleural fluid sample, or a blood sample.
Regarding Claim 12, the combination would disclose producing the sample by i. homogenising and diluting said sample in a first volume of a first solution, thereby obtaining a homogenous sample; ii. centrifuging the homogenous sample of step i) to obtain a pellet comprising lamellar bodies and a supernatant; iii. optionally discarding the supernatant and optionally resuspending the pellet in a second volume of a second solution, thereby obtaining a sample for analysis; and iv. determining the amount of the first compound, and the amount of the second compound, using analysis means [Producing the sample for analysis per Page 7 line 1 to Page 10 line 35 of Schousboe].
Regarding Claim 35, Verber discloses that the analysis means is an infrared spectrometer, such as a Fourier transformed infrared (FTIR) spectrometer [Paragraph [0032] – “Step 2) comprises applying the sample to the instrument; placing a multi frequency infrared (IR) light beam through the sample; measures molecular light absorbance/luminescence in the infrared light frequency spectra; passing the raw absorbance spectrum data passed to processing unit.”Paragraph [0033] – “Step 3) comprises processing raw data by Fourier Transform (FT) algorithm to produce light absorption wavelength.”].
Regarding Claim 39, Verber discloses determining the amount of a third compound [Paragraph [0054] – “While the present invention aims at determining the ratio between a first and a second compound, such as lecithin and sphingomyelin respectively, further compounds or groups of compounds can be quantified either for analytical purposes or in order to compensate for background spectral noise. Thus in one embodiment the invention also concerns determining the amount of a third, fourth, fifth or further compound, such as a compound selected from the group consisting of phosphatidylglycerol, hemoglobin, apo-hemoglobin, hem and porphyrin. In particular, the third compound is hemoglobin.”].
Regarding Claim 40, Verber discloses that said third compound is selected from the group consisting of phosphatidylglycerol, hemoglobin, apo-hemoglobin, heme and porphyrin, preferably the third compound is phosphatidylglycerol or hemoglobin [Paragraph [0054] – “While the present invention aims at determining the ratio between a first and a second compound, such as lecithin and sphingomyelin respectively, further compounds or groups of compounds can be quantified either for analytical purposes or in order to compensate for background spectral noise. Thus in one embodiment the invention also concerns determining the amount of a third, fourth, fifth or further compound, such as a compound selected from the group consisting of phosphatidylglycerol, hemoglobin, apo-hemoglobin, hem and porphyrin. In particular, the third compound is hemoglobin.”].
Regarding Claim 42, Verber discloses the step of subtracting the amount of the third compound from the amount of the first compound, thus obtaining a background corrected amount of the first compound, and/or comprising the step of subtracting the amount of the third compound from the amount of the second compound, thus obtaining a background corrected amount of the second compound, and/or comprising the step of subtracting the amount of the third compound from the amount of both the first compound and the second compound, thus obtaining a background corrected amount of both the first compound and the second compound [Paragraphs [0054]-[0056]].
Regarding Claim 48, Verber discloses that the method has a time-to-result of less than 10 minutes, such as about 5 minutes [Paragraph [0060]].
Regarding Claim 51, Verber discloses that the control ratio is between 1.0 and 10.0 + 0.5 [See Fig. 1:
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Regarding Claim 52, Verber discloses that the control ratio is between 2.0 and 5.0 + 0.5 [See Fig. 1:
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Regarding Claim 55, Schousboe discloses that such a method can have a specificity of 50% or more, such as 60% or more, such as 70% or more, such as 80% or more, such as 90% or more [Page 26 lines 6-9 – “Sensitivity and specificityThe present method shows a sensitivity of 91 % and a specificity of 79% based on 72 neonate GAS. By comparison, diagnosis on a cut-off value (control ratio) for the US ratio of 3.0 and DPPC contents alone has a sensitivity of 93% and a specificity of 74%.”].
Regarding Claim 56, Schousboe discloses that such a method has a sensitivity of 50% or more, such as 60% or more, such as 70% or more, such as 80% or more, such as 90% or more [Page 26 lines 6-9 – “Sensitivity and specificityThe present method shows a sensitivity of 91 % and a specificity of 79% based on 72 neonate GAS. By comparison, diagnosis on a cut-off value (control ratio) for the US ratio of 3.0 and DPPC contents alone has a sensitivity of 93% and a specificity of 74%.”].
Regarding Claim 60, Schousboe discloses that a concentration equal to or less than 25 uM + 0.5 uM indicates that the subject is likely to benefit from administration of surfactant [Page 11 lines 33-35 – “A concentration of lecithin or saturated lecithin equal to or less than 49.0 umol/L ± 0.5 umol/L is indicative of the subject suffering from RDS. In this case, the subject may be treated as is known in the art, for example as described herein.”]. It would have been obvious to apply such a technique to an adult (per Verder) in order to effectively combat the negative effects of respiratory distress syndrome.
Regarding Claim 65, Verder discloses a system for predicting a likelihood of a human subject benefitting from administration of surfactant based on a sample obtained from said subject [Abstract – “The present invention concerns methods and tools for analysing biomarkers useful for diagnosing an individual, in particular a newborn, with a respiratory disease, especially a newborn suffering from respiratory distress syndrome (RDS). The method and tools of the invention can in one embodiment be used for very rapidly detecting the ratio between lecithin and sphingomyelin in very small body fluid samples, e.g. gastric aspirate of a newborn. The invention is thus useful for obtaining a rapid treatment of RDS by administration of surfactant.”], comprising:
a spectroscope for measuring spectral data from said sample, and processing means [Fig. 1 – FTIR Spectrometer] configured for:
a) determining a first activity and/or a first concentration of a first compound and optionally a second activity and/or a second concentration of a second compound in said sample by analysing said spectral data, wherein the first compound is lecithin or saturated lecithin and the second compound is sphingomyelin [See Fig. 1 and Paragraph [0032] – “Step 1) includes providing a sample of gastric aspirate.”Paragraph [0034] – “Step 4) comprises extracting chemical information (lecithin and sphingomyelin concentration and/or activity) from spectral signatures through chemometrics algorithm (multivariate data analysis).”];
b) optionally calculating a ratio between the first activity and the second activity b) and/or the first concentration and the second concentration [See Fig. 1 and Paragraph [0035] – “Step 5) comprises obtaining an L/S ratio”];
c) correlating said first and/or second concentration with a control concentration and/or correlating said ratio with a control ratio, wherein a concentration lower than or equal to the control concentration is indicative of the subject benefitting from administration of surfactant and/or a ratio equal to or lower than the control ratio is indicative of the subject benefitting from administration of surfactant [See Fig. 1:
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See Fig. 1 (“Early administration of surfactant”) and Paragraph [0035] – “Step 5) comprises obtaining an L/S ratio and optionally a recommended treatment regime.”]; and
d) indicating whether the ratio is equal to or lower than the control ratio, wherein a ratio equal to or lower than a predefined value is indicative of the subject benefitting from administration of surfactant, and/or indicating whether the concentration is equal to or lower than the control concentration, wherein a concentration equal to or lower than a predefined value is indicative of the subject benefitting from administration of surfactant, wherein the first compound is lecithin or saturated lecithin, and the second compound is sphingomyelin [See Fig. 1:
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See Fig. 1 (“Early administration of surfactant”) and Paragraph [0035] – “Step 5) comprises obtaining an L/S ratio and optionally a recommended treatment regime.”].
Verder fails to disclose that the human subject is an adult subject. However, Schousboe discloses the consideration of applying such a technique to an adult subject [Page 14 lines 13-25 – “In one embodiment, the method is used to determine a concentration of lecithin or saturated lecithin on a sample derived from said subject, usually newborn, to determine whether the subject suffers from RDS. In another embodiment, the method is used to determine an L/S ratio based on a sample derived from said subject, usually a newborn, to determine whether the subject suffers from RDS. The sample may be a gastric aspirate sample, an amniotic fluid sample, a blood sample or an oropharyngeal secretion sample. The concentration of lecithin or saturated lecithin can be compared to a control value, and/or the L/S ratio can be compared to a control ratio, as described in co-pending application entitled "Fetal maturity lung test" filed by the same applicant and having the same filing date as the present application, thereby indicating whether the subject suffers from Respiratory Distress Syndrome. If the subject suffers from RDS, treatment is administered - in this particular case, a therapeutically amount of surfactant is administered to the subject.”Item 26 of Schousboe – “wherein the subject is a human being, such as a newborn, a premature newborn, an infant, a child, or an adult.”]. It would have been obvious to apply such a technique to an adult in order to effectively combat the negative effects of respiratory distress syndrome.
Regarding Claim 71, Verber discloses that the surfactant, or one or more components thereof, is dipalmitoylphosphatidylcholine (DPPC), phosphatidylcholine, phosphatidylglycerol, cholesterol, surfactant protein A, surfactant protein B, surfactant protein C and/or surfactant protein D [Paragraph [0008] – “In addition to DPPC which constitutes about 40%, the surfactant complex comprises about 40% other phospholipids, about 5% surfactant-associated proteins (SP-A, B, C and D) and additionally cholesterol and trace amounts of other substances.”].
Claim(s) 7 and 72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verder et al. (US 20160103143 A1)[hereinafter “Verder”], Schousboe et al. (WO 2019068843 A1)[hereinafter “Schousboe”], and Kassab et al. (US 20210330753 A1)[hereinafter “Kassab”].
Regarding Claim 7, Kassab fails to disclose that said disease is caused by an influenza virus or a coronavirus, such as wherein the disease is caused by a betacoronavirus such as SARS, MERS, or COVID-19.
However, Kassab discloses that surfactants are effective in treating such diseases [Title – METHODS OF TREATING COVID-19 MEDIATED LUNG DAMAGE USING SURFACTANTS AND NATURAL ANTIBODIES]. It would have been obvious to evaluate such a patient for potential surfactant use in order to effectively combat the negative effects of respiratory distress syndrome.
Regarding Claim 72, Verber fails to disclose that said surfactant is a synthetic surfactant, an animal-derived surfactant, or a combination of a synthetic surfactant and an animal-derived surfactant. However, Kassab discloses the use of such surfactants in treating pulmonary conditions [Abstract – “Disclosed is a method of treating respiratory viruses including coronaviruses such as SARS-CoV-2 using surfactant, surfactant protein A and/or surfactant protein D. The surfactant and surfactant protein treatment can be used in combination with immunoglobulin M administered intravenously. Surfactant proteins used in these embodiments, especially surfactant protein D, can be harvested from an exogenous source such as pigs, as they show improved resilience against viruses.”]. It would have been obvious to use such a surfactant in order to effectively combat the negative effects of respiratory distress syndrome.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verder et al. (US 20160103143 A1)[hereinafter “Verder”], Schousboe et al. (WO 2019068843 A1)[hereinafter “Schousboe”], and Glassberg Csete et al. (US 20200384034 A1)[hereinafter “Glassberg Csete”].
Regarding Claim 10, Verber fails to disclose that the sample is a bronchoalveolar lavage sample and wherein the bronchoalveolar lavage sample is obtained less than 72 hours after intubation of the subject, such as less than 48 hours after intubation of the subject, such as less than 24 hours after intubation of the subject, such as less than 12 hours after intubation of the subject.
However, Glassberg Csete discloses the use of such a test with regards to assessing cardiopulmonary function [Abstract – “The described invention provides compositions and methods for treating a susceptible subject at risk of pulmonary complications of an acute lung injury caused by a severe infection with a respiratory virus and for restoring lung function to donor lungs.”Paragraph [0315] – “According to some embodiments, the method further comprises obtaining a bronchoalveolar lavage fluid (BALF) sample from the subject and from the healthy control”]. It would have been obvious to produce the sample in such a manner in order to assess the need for a surfactant.
Regarding the timing for doing so, Verber discloses that surfactant treatment should begin as early as possible when needed [Paragraph [0012] – “A therapeutic standard procedure in very preterm infants has been to start with nCPAP, and, as surfactant is better administered early than late [6,10,11], to give surfactant during a short intubation as soon as clinical symptoms and an increasing oxygen requirement indicate moderate to severe RDS [6,12]. … Preferably the diagnosis and treatment should start immediately after birth. The present state of the art methods requires time-consuming laboratory tests to be performed thus delaying diagnosis and onset of medication of those in need thereof [15].”]. It would have been obvious to obtain the sample as soon as possible in the event that the need for intubation is necessary. It would have been obvious to apply such a technique to an adult (per Verder) in order to effectively combat the negative effects of respiratory distress syndrome.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verder et al. (US 20160103143 A1)[hereinafter “Verder”], Schousboe et al. (WO 2019068843 A1)[hereinafter “Schousboe”], and Abbas et al. (US 20180363032 A1)[hereinafter “Abbas”].
Regarding Claim 34, the combination would disclose that step b) comprises the steps of: i. adding an additive to the sample, homogenising and centrifuging the sample to create a first supernatant, discarding the first supernatant and diluting said sample in a volume of a solution, thereby obtaining a homogenous sample; ii. centrifuging the homogenous sample of step i) to obtain a pellet comprising lamellar bodies and a second supernatant: iii. discarding the second supernatant and drying the homogenous sample; and iv. determining the amount of the first compound, and the amount of the second compound, using analysis means [Producing the sample for analysis per Page 7 line 1 to Page 10 line 35 of Schousboe, the use of the vortex being a first centrifuging.].
The combination fails to disclose that the additive is tris-(2-carboxyethyl)fosfin, (TCEP). However, Abbas discloses that TCEP is known to be an effective reducing agent [Paragraph [0032] – “Useful reducing agents that can be utilized herein can include, for example tris(2-carboxyethyl)phosphine (TCEP), tris(2-carboxyethyl)phosphine hydrochloride (TCEP-HCl), other compositions including TCEP, any reducing agent containing one or more hydroxyl or carboxyl groups, or combinations thereof. In some embodiments, TCEP or TCEP-HCl can be utilized.”]. Its use in diluting the sample would have been obvious for that reason.
Response to Arguments
Applicant argues:
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Examiner’s Response:
The corresponding rejections under 35 USC 112 are hereby withdrawn.
Applicant argues:
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Examiner’s Response:
The Examiner respectfully disagrees. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited spectroscope would have been required to produce the spectral data needed to implement the algorithm.
Applicant argues:
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Examiner’s Response:
The Examiner respectfully disagrees. Schousboe discloses the consideration of applying such a technique to an adult subject [Page 14 lines 13-25 – “In one embodiment, the method is used to determine a concentration of lecithin or saturated lecithin on a sample derived from said subject, usually newborn, to determine whether the subject suffers from RDS. In another embodiment, the method is used to determine an L/S ratio based on a sample derived from said subject, usually a newborn, to determine whether the subject suffers from RDS. The sample may be a gastric aspirate sample, an amniotic fluid sample, a blood sample or an oropharyngeal secretion sample. The concentration of lecithin or saturated lecithin can be compared to a control value, and/or the L/S ratio can be compared to a control ratio, as described in co-pending application entitled "Fetal maturity lung test" filed by the same applicant and having the same filing date as the present application, thereby indicating whether the subject suffers from Respiratory Distress Syndrome. If the subject suffers from RDS, treatment is administered - in this particular case, a therapeutically amount of surfactant is administered to the subject.”Item 26 of Schousboe – “wherein the subject is a human being, such as a newborn, a premature newborn, an infant, a child, or an adult.”]. It would have been obvious to apply such a technique to an adult in order to effectively combat the negative effects of respiratory distress syndrome.
Applicant’s argument is not convincing because the Schousboe discloses a list [Item 26 of Schousboe – “wherein the subject is a human being, such as a newborn, a premature newborn, an infant, a child, or an adult.”] that could not be limited to only a pregnant woman or neonate subject. An “infant,” for example, can not be pregnant. By listing “newborn” (i.e., neonate) alongside “infant” alongside “child,” one having ordinary skill in the art would have understood the application of such a technique extends past only neonate subjects. One having ordinary skill in the art would have understood that, like the other recited types of subjects, Schousboe was considering application of such a technique with regards to an actual adult as a subject.
Applicant argues:
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Examiner’s Response:
The Examiner respectfully disagrees. Although it is appreciated that there is a difference between immature, neonate lungs and mature, child and adult lungs, Schousboe discloses the consideration of applying such a technique to an adult subject [Page 14 lines 13-25 – “In one embodiment, the method is used to determine a concentration of lecithin or saturated lecithin on a sample derived from said subject, usually newborn, to determine whether the subject suffers from RDS. In another embodiment, the method is used to determine an L/S ratio based on a sample derived from said subject, usually a newborn, to determine whether the subject suffers from RDS. The sample may be a gastric aspirate sample, an amniotic fluid sample, a blood sample or an oropharyngeal secretion sample. The concentration of lecithin or saturated lecithin can be compared to a control value, and/or the L/S ratio can be compared to a control ratio, as described in co-pending application entitled "Fetal maturity lung test" filed by the same applicant and having the same filing date as the present application, thereby indicating whether the subject suffers from Respiratory Distress Syndrome. If the subject suffers from RDS, treatment is administered - in this particular case, a therapeutically amount of surfactant is administered to the subject.”Item 26 of Schousboe – “wherein the subject is a human being, such as a newborn, a premature newborn, an infant, a child, or an adult.”]. It would have been obvious to apply such a technique to an adult in order to effectively combat the negative effects of respiratory distress syndrome.
Applicant’s argument is not convincing because the Schousboe discloses a list [Item 26 of Schousboe – “wherein the subject is a human being, such as a newborn, a premature newborn, an infant, a child, or an adult.”] that could not be limited to only a pregnant woman or neonate subject. An “infant,” for example, can not be pregnant. By listing “newborn” (i.e., neonate) alongside “infant” alongside “child,” one having ordinary skill in the art would have understood the application of such a technique extends past only neonate subjects. One having ordinary skill in the art would have understood that, like the other recited types of subjects, Schousboe was considering application of such a technique with regards to an actual adult as a subject.
Applicant argues:
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Examiner’s Response:
Glassberg is not relied on as disclosing such.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20050153373 A1 – Reagents And Methods Useful For Detecting Diseases Of The Breast
US 20200400558 A1 – FETAL LUNG MATURITY TEST
US 20180119131 A1 – METHOD OF RNA ISOLATION FROM CLINICAL SAMPLES
US 20140330246 A1 – Intrauterine Fetal Growth Restriction - The Biochemical Rationale Of Treatment Modalities Including Extraperitoneal Transamniotic Fetal Supplements
US 20210322421 A1 – COMPOSITIONS AND METHODS FOR THE TREATMENT OF SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV-2) INFECTION
US 20230223150 A1 – METHODS AND SYSTEMS FOR PREDICTING ARDS
US 4944941 A – Methods And Compositions For The Treatment Of Lung Conditions
US 20200326354 A1 – LAMELLAR BODY PURIFICATION FOR DIAGNOSIS AND TREATMENT OF A DISEASE OR DISORDER
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE ROBERT QUIGLEY whose telephone number is (313)446-4879. The examiner can normally be reached 9AM-5PM EST.
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/KYLE R QUIGLEY/Primary Examiner, Art Unit 2857