DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 23, 2026 has been entered. By this amendment, claim 1 is amended and claims 1-9 and 12-22 are now pending in the application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the perpendicular, non-invasive, insulated transducer arrays applied to a region of the subject’s torso must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 and 12-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The originally-filed disclosure fails to provide adequate written description for the embodiment as presently claimed. The disclosure fails to provide adequate written description for a method of treating acute respiratory distress syndrome in a subject comprising applying an AEF to a region of the subject’s torso, wherein the AEF is applied via perpendicular, non-invasive, insulated transducer arrays, wherein the subject does not have a viral infection, wherein a frequency of the AEF is between 50 kHz and 10 MHz, and wherein the intensity of the AEF is 0.1 V/cm to 20 V/cm. The only disclosure of a perpendicular transducer array is found in paragraph [0011] and is described in relation to applying AEF to a dish of cells. There is no disclosure of applying AEF to a torso of a subject using perpendicular, non-invasive, insulated transducer arrays. As such, the claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Palti et al. (U.S. 2016/0346536), herein Palti, in view of Deshpande et al. (“Pseudomonas Aeruginosa Induced Cell Death in Acute Lung Injury and Acute Respiratory Distress Syndrome”, Int. J. Mol. Sci. 2020, 21, 5356.). Regarding claim 1, Palti discloses a method of treating a subject comprising applying an alternating electric field (AEF) (“allow for electric fields generation in mice “, paragraph [0198]) to a region of the subject's torso (“The four insulated electrodes were attached to the skin using hydrogel after mouse depilation”, paragraph [0197]), wherein the AEF is applied via perpendicular, non-invasive, insulated transducer arrays (“The electrode pairs were placed so as to create two perpendicular field directions at the center of the animal body.”, paragraph [0197]), wherein the subject does not have a viral infection (Palti is disclosed as treating bacterial infections and not viral infections), wherein a frequency of the AEF is between 50 kHz and 10 MHz (“When the field intensity is 20 V/cm, the magnitude of the Force acting on a dipole of 3000 debyes inside dividing bacteria as a function of field frequency is depicted in FIG. 38A for P. aeruginosa, which peaks at about 2 MHz”, paragraph [0191]), and wherein the intensity of the AEF is 0.1 V/cm to 20 V/cm (“When the field intensity is 20 V/cm, the magnitude of the Force acting on a dipole of 3000 debyes inside dividing bacteria as a function of field frequency is depicted in FIG. 38A for P. aeruginosa, which peaks at about 2 MHz”, paragraph [0191]). However, while Palti discloses treating a bacterial infection in a patient, including treating an infection caused by Pseudomonas Aeruginosa (“In vivo experiments were also performed on Pseudomonas aeruginosa strain PAO1 in lungs of infected mice”, paragraph [0195]), it fails to disclose treating acute respiratory distress syndrome (ARDS) in the patient. Deshpande teaches that “Pseudomonas Aeruginosa is an important opportunistic pathogen responsible for the cause of acute lung injury and acute respiratory distress syndrome” (see Abstract, lines 1-2). It would have been obvious to one having ordinary skill in the art before the effective filing date to utilize the invention of Palti to treat acute respiratory distress syndrome in the subject through its treatment of Pseudomonas Aeruginosa infection, as it is taught by Deshpande that Pseudomonas Aeruginosa infection causes ARDS and, thus, the treatment of Pseudomonas Aeruginosa results in the treatment for the ARDS associated with the bacteria.
Regarding claim 2, because Palti does not disclose the subject as being diagnosed as having cancer, it is considered to satisfy the claim limitation.
Regarding claim 3, Palti discloses administering to the subject a therapeutic drug for treating ARDS or the cause of ARDS (“The combined effect of electric fields and antibiotics was tested using Ceftazidime, an agent recommended by the infectious disease society of America for the treatment of hospital acquired pneumonia.”, paragraph [0205]).
Regarding claim 4, Palti discloses that the therapeutic drug is selected from the group consisting of neuromuscular blockage agents, p-adrenergic agonists, neutrophil elastase inhibitors, antibiotics (Ceftazidime is an antibiotic, (“The combined effect of electric fields and antibiotics was tested using Ceftazidime, an agent recommended by the infectious disease society of America for the treatment of hospital acquired pneumonia.”, paragraph [0205]), diuretics, bronchodilators, anti-inflammatory agents, inhaled pulmonary vasodilators, IL-6 inhibitors, surfactants, inhaled nitric oxide, antioxidants, and protease inhibitors.
Regarding claims 5 and 6, Palti discloses the invention substantially as claimed, but fails to disclose administering respiratory support to the subject, wherein the respiratory support is oxygen therapy, high flow oxygen therapy (HFNO), or hyperbaric oxygen therapy. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Palti in view of Deshpande to include administering oxygen therapy, high flow oxygen therapy (HFNO), or hyperbaric oxygen therapy, as it is well known in the art to administer oxygen therapy, high flow oxygen therapy (HFNO), or hyperbaric oxygen therapy to patients suffering from ARDS or pneumonia to ensure appropriate oxygenation of body tissues.
Regarding claim 7, Palti discloses that the AEF is applied to a region of the subject's upper torso (“Field intensities within lungs were measured “, paragraph [0202], where the area of the lungs is considered to satisfy the BRI for “upper torso”).
Regarding claim 8, Palti discloses that the AEF is applied to a lung of the subject (“Field intensities within lungs were measured “, paragraph [0202]).
Regarding claim 9, Palti discloses that the AEF is applied for at least 24 hours (“Application of electric fields began 3 hours after infection and was maintained for 48 h with two brief stops daily for monitoring the physical condition of the mice. “, paragraph [0204]).
Regarding claim 15, because Palti does not disclose the subject having a tumor, it is considered to satisfy the claim limitation.
Claims 12-14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Deshpande, as applied to claims 1-9 and 15 above, and further in view of DiLorenzo (U.S. 2021/0322718, previously cited). Regarding claim 12, Palti in view of Deshpande provides the invention substantially as claimed, but fails to disclose diagnosing the subject with ARDS by chest X-ray, blood work, CAT imaging, symptoms, oxygen saturation measurements, or echocardiogram. DiLorenzo teaches diagnosing the subject with ARDS by chest X-ray, blood work, CAT imaging, symptoms, oxygen saturation measurements, or echocardiogram (“FIG. 59 depicts a set of biomarkers related to the physiological state elements affected by and involved in the pathogenesis of at least one of acute respiratory distress syndrome (ARDS)”, paragraph [0554]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Palti in view of Deshpande to include diagnosing the subject with ARDS by chest X-ray, blood work, CAT imaging, symptoms, oxygen saturation measurements, or echocardiogram, as taught by DiLorenzo, as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 13, the recitation “the subject presents symptoms of ARDS” fails to further define the claimed method over that of the prior art because it is directed to the subject to which the method is applied rather than further limitations any patentable aspect of the method itself. Because the method of Palti is capable of being applied to a subject who presents symptoms of ARDS, Palti is considered to satisfy the claim limitation.
Regarding claim 14, the recitation “said symptoms comprise one or more of severe shortness of breath, difficulty breathing, low blood pressure, or extreme tiredness, or wherein the subject presents lung fibrosis or cytokine storm” fails to further define the claimed method over that of the prior art because it is directed to the subject to which the method is applied rather than further limitations any patentable aspect of the method itself. Because the method of Palti is capable of being applied to a subject who presents symptoms comprising one or more of severe shortness of breath, difficulty breathing, low blood pressure, or extreme tiredness, or wherein the subject presents lung fibrosis or cytokine storm, Palti is considered to satisfy the claim limitations.
Regarding claim 16, Palti in view of Deshpande provides the invention substantially as claimed, but fails to disclose an initial step of determining a PaO2/FiO2 ratio for the subject, wherein the PaO2/FiO2 ratio of the subject is 300 mmHg or less. DiLorenzo teaches an initial step of determining a PaO2/FiO2 ratio for the subject (“Biomarkers (478) is represented by a set of parameters, which comprises but is not limited to…PaO2/FIO2 (482) which is the partial pressure of oxygen divided by the fractional intake of oxygen”, paragraph [0556]), wherein the PaO2/FiO2 ratio of the subject is 300 mmHg or less (“In patients with ARDS, The PaO2/FIO2 (482) is usually <=300 mmHg, and in moderate ARDS, PaO2/FIO2 (482) drops to 100 to 200 mmHg, and in severe ARDS, PaO2/FIO2 (482) is <100 mmHg.”, paragraph [0552]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Palti in view of Deshpande to include an initial step of determining a PaO2/FiO2 ratio for the subject, wherein the PaO2/FiO2 ratio of the subject is 300 mmHg or less, as taught by DiLorenzo, as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claims 17 and 18, Palti in view of Deshpande and DiLorenzo provides the invention substantially as claimed, but fails to disclose that the AEF is applied until the PaO2/FiO2 ratio of the subject has increased by 50% or 50 mmHg. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Palti in view of Deshpande and DiLorenzo to apply the AEF until the PaO2/FiO2 ratio of the subject has increased by 50% or 50 mmHg, as it is known to apply treatment stimulation until such a time as diagnostic treatment criteria are met.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Deshpande, as applied to claims 1-9 and 15 above, and further in view of Stenzler (U.S. 2015/0328256, previously cited). Regarding claim 19, Palti in view of Deshpande provides the invention substantially as claimed, but fails to disclose an initial step of determining neutrophil to lymphocyte ratio (NLR) for the subject. Stenzler teaches a method for treating diseases and disorders, including ARDS (“Exemplary respiratory diseases or disorders treated by way of the present method include…ARDS”, paragraph [0068]), including determining neutrophil to lymphocyte ratio (NLR) for the subject for determining the effectiveness of the treatment (“As can be seen in Table 1, during days 1-14, 13 animals from the control group and 5 animals from the treatment group were identified as TP. The table shows values recorded for all 4 parameters determining TP/TN for all TP animals. Temperature, clinical score, white blood count, neutrophil/lymphocyte ratio were also included.”, paragraph [0140]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Palti in view of Deshpande to include an initial step of determining neutrophil to lymphocyte ratio (NLR) for the subject, as taught by Stenzler, to effectively treat the ARDS and as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 20, Palti in view of Deshpande and Stenzler fails to disclose that the AEF is applied until the NLR is below 3.5 or has decreased by at least 0.2. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Palti in view of Deshpande and Stenzler to apply the AEF until the NLR is below 3.5 or has decreased by at least 0.2, as it is known to apply treatment stimulation until such a time as diagnostic treatment criteria are met.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Deshpande as applied to claims 1-9 and 15 above, and further in view of Meduri et al. (“Effect of Prolonged Methylprednisolone Therapy in Unresolving Acute Respiratory Distress Syndrome”, previously cited). Palti in view of Deshpande provides the invention substantially as claimed, but fails to disclose that the therapeutic drug is the glucocorticoid methylprednisolone. Meduri teaches that Acute Respiratory Distress Syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure without a previous effective pharmacological therapeutic protocol (page 159, column 2, lines 1-11). Meduri teaches that prolonged methylprednisolone therapy is effective in improving lung injury score (LIS) and multiple organ dysfunction syndrome (MODS) and results in reduction of mortality caused by ARDS (page 163, column 1, lines 8-24). It would have been obvious to one having ordinary skill in the art before the effective filing date to combine prolonged methylprednisolone therapy, as taught by Meduri, with the ARDS treatment of Palti in view of Deshpande, in order to improve LIS and MODS and reduce mortality caused by ARDS.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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