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 .
Election/Restrictions
Applicant’s response to the restriction/ election requirement from 11/13/2025 is acknowledged. Applicant has elected the invention of Group II, and as species- lung infections. Applicant has designated all claims of Group II (claims 43-50, 52-54, 56 and 65-67) to read on the elected group and species. 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)).
On further consideration of the art the restriction of species requirement is hereby withdrawn. The restriction/ election requirement is hereby MADE FINAL. Claims 43-50, 52-54, 56 and 65-67 are pending, and have been examined herewith across their breadth.
Claim Objections
Applicant’s independent claim 43 is directed to: “A method of improving breathing of a subject experiencing a breathing difficulty, said method comprises administering to a subject in need of such treatment an amount of glyceryltriacetate (GTA), the amount being effective to improve breathing in said subject.” The claim uses the word “comprises” in lieu of the grammatically appropriate transitional term “comprising”.
Appropriate correction is requested.
Claim Rejections - 35 USC § 112
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 43, 45, 52 and 53 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 43 recites the limitation "a subject" in line 2. There is insufficient antecedent basis for this limitation in the claim, because this is the second appearance of this claim term, i.e. the term should be “the subject”.
Claim 45 recites the limitation "a subject" in line 1. There is insufficient antecedent basis for this limitation in the claim, because claim 45 depends from claim 43, wherein the term is already claimed three times as “a subject”, “a subject”, and “said subject”.
Claim 52 recites the limitation "said compound" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 52 depends from claim 43, which recites “glyceryltriacetate (GTA)”, not “compound”.
Claim 53 recites the limitation "said compound" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 53 depends from claim 43, which recites “glyceryltriacetate (GTA)”, not “compound”.
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.
Claims 43-50, 52-54, 56 and 65-67 are rejected under 35 U.S.C. 103 as being unpatentable over US 20130266643 to Moffett (“Moffett”), and further in view of US 10765654 B2 to Jaworski (“Jaworski”), and Livan Delgado-Roche et al., Oxidative Stress as Key Player in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) Infection, Arch Med Res. 2020 Apr 30;51(5):384–387 (“Delgado-Roche”).
Claim interpretation
Applicant’s independent claim 43 is directed to: “A method of improving breathing of a subject experiencing a breathing difficulty, said method comprises administering to a subject in need of such treatment an amount of glyceryltriacetate (GTA), the amount being effective to improve breathing in said subject.”
With respect to the claim terms “improving breathing of a subject experiencing a breathing difficulty” and “the amount being effective to improve breathing in said subject” Applicant’s specification provides the following guidance:
-“[0018] Without being bound by theory, it is assumed that administration of GTA at high doses is effective to increase acetate blood level and tissue bioavailability and thereby enhance the subject's acetylation capability and overcome conditions that are associated with local acetate or acetyl-CoA deficiency, and that may benefit from an augmentation of the organism's acetylation powder.”
-“[0020] Without being bound by theory, the use of GTA at a dosage form comprising at minimum 1 gram GTA/day is believe to enrich the blood stream with acetate and enable cells to compensate for local deficiency of acetate or acetyl-coA. Normal circulating level of free acetate is relatively low, ˜50 μM (Mueller N. et al. Am J Clin Nutr (2020) 111: 545-54) and when 1 g GTA is hydrolyzed and spread in 10 L blood volume, it can increase acetate concentration by up to more than 20 folds. Cells can readily import acetate from the blood stream, which, in turn, will convert intracellularly to Acetyl-CoA by the enzyme ACSS2.
[0021] Therefore, the present disclosure provides a GTA compound for use in improving breathing of a subject, a composition comprising a GTA compound for improving breathing of a subject and a method for improving breathing of a subject, when the subject is experiencing a breathing difficulty, the GTA compound is used in an amount effective to improve breathing in said subject.”
-“[0026] The GTA used and formulated in an amount effective to achieve improvement in breathing. In some examples, the amount is at least 1 g per day. In some examples, the amount is any amount between 1 and 40 g a day. In some examples, the amount is any one of 1 g/day, 2 g/day, 3 g/day, 4 g/day, 5 g/day, 6 g/day, 7 g/day, 8 g/day, 9 g/day, 10 g/day, 11 g/day, 12 g/day, 13 g/day, 14 g/day, 15 g/day, 16 g/day, 17 g/day, 18 g/day, 19 g/day, 20 g/day, 21 g/day, 22 g/day, 23 g/day, 24 g/day, 25 g/day, 26 g/day, 27 g/day, 28 g/day, 29 g/day, 30 g/day, 31 g/day, 32 g/day, 33 g/day, 34 g/day, 35 g/day, 36 g/day, 37 g/day, 38 g/day, 39 g/day, 40 g/day or even more than 40 g/day.”
-“[0029] In some examples, the breathing difficulty is associated or is a result of reduced lung function and can be characterized by any one of or any combination of shortness of breath, cough, typically dry cough, wheezing and gasping breath, amount of air inhaled or exhaled during normal breathing; total amount of air exhaled per minute; total volume of air that can be exhaled after inhaling as much as one can; amount of air left in lungs after exhaling normally; amount of air left in the lungs after exhaling as much as one can; total volume of the lungs when filled with as much air as possible; amount of air exhaled forcefully and quickly after inhaling as much as one can; amount of air expired during the first, second, and third seconds of the FVC test; average rate of flow during the middle half of the FVC test; fastest rate that one can force air out of his/her lungs. maximal pressure that can be produced by the patient trying to inhale through a blocked mouthpiece; single-breath diffusing capacity for carbon monoxide (DLCO); and oxygen saturation and desaturation at rest and during exercise.
[0030] In some examples, the improvement in breathing can be determined by self-assessment, e.g. improvement in at least one of the above symptoms, namely, shortness of breath, cough, typically dry cough, wheezing and gasping breath.
[0031] In additional or other examples, the reduced lung function and independently the improvement in breathing can be determined from measuring lung/pulmonary function parameters.”
-“[0061] In some examples, the composition comprising GTA and the method of its administration are for treating any one of the above lung conditions, namely, any one of lung viral infection, lung bacterial infection, chronic obstructive pulmonary disease (COPD), chronic bronchitis, asthma, pulmonary edema, bronchiectasis, bronchiolitis, cystic fibrosis, pneumonia, pneumoconiosis, adult/acute respiratory distress syndrome (ARDS), acute lung injury (ALI), sepsis, eosinophilic pneumonia, tuberculosis, sarcoidosis, pulmonary fibrosis, idiopathic pulmonary fibrosis, lobectomy, lung cancer and pneumonectomy.”
-“Example 2—Treating Lung Cancer Patient with Breathing Difficulties
[0098] A 92 old male diagnosed with lung cancer (NSCLC) at advanced stage, was suffering from shortness of breath, he looked pale and could not walk more than ˜50 m without stopping for a rest. . . Within 2 days after he started taking GTA, the patient reported that he feels much better and felt breathing is much easier.”
-“Example 3—Treating SARS-Cov2 Infected Patients (COVID-19 Infection)
[0099] Eleven subjects, age 60-89 with various comorbidities, who were positive for COVID-19 infection by the PCR test and already developed respiratory-related symptoms of the disease. . . All the above 11 patients fully recovered from the disease without the need for other medication.”
-“Example 4—Treating Long-COVID (=Post-Corona) Patients with GTA Capsules
[0100] Long COVID is a range of symptoms that can last weeks or months after first being infected with the virus that causes COVID-19 or can appear weeks after infection. 5 Long-Covid subjects who recovered from COVID-19 infection (=became PCR negative) but still have significant breathing problems that compromised their daily physical activities. . . All the above 5 patients fully or almost fully recovered from their breathing problems within 5-10 days without the need for other medication.”
-“Example 5—Treating Asthmatic Patients with GTA Capsules
[0101] four chronic asthmatic subjects, who are receiving a state of the art treatment but still have breathing difficulties, especially under exercises. . . All 4 patients reported an outstanding improvement in their breathing, including giving up inhalation.”
-“Example 6—Treating a Bronchitis Patient with GTA Capsules
[0102] Male 51, doing sports 5 times a week, cycling, running, weight lifting, swimming. 87 KG, fat percentage 16%, smokes cigars about 5 per week, was suffering from bronchitis for several weeks. . . He reported immediately less to no coughing, improved breathing, did a 5 miles run, and in his own words: “never felt better on a run, less fatigue, no shortness of breath specifically on uphill run, lower hart rate throughout the run”.”
-“Example 7: Treating an Influenza-Virus Infected Patient (Swine-Flu Infection)
[0103] Subjects diagnosed with swine flu infection will be administered orally with softgel capsules filled with GTA at a daily dose of 12 ml, either 4 ml three times a day or 6 ml twice a day, during or immediately after meal. Treatment duration will be for around 5-12 days and it is expected that the treatment will result in the acceleration of patient's healing, compared to non-treated patients having swine flu infection.”
Claim rejections
Moffett discloses compositions comprising glyceryl-triacetate (GTA) for use in delivering non-glucose energy deriving metabolites during physical performance, which reduce lactate production and serve as thermogenic agents. (Abstract). Claim 1 of Moffett recites: “A method for increasing energy production in the heart and skeletal muscle of a human subject, said method comprising administering a liquid formula comprising about 0.5% v/v to about 5% v/v glyceryl-triacetate (GTA) or a food product comprising about 0.5% to about 10% w/w GTA to the human subject having about 99% to about 85% blood oxygen content and/or a blood lactate level of about 2 millimolar to about 20 millimolar, thereby increasing energy production in the heart and skeletal muscle of the human subject.” Claim 2 recites: “The method of claim 1, wherein increasing energy production comprises increasing ATP production from acetyl CoA.” Claim 7 recites “wherein the glyceryl-triacetate is contained in a capsule, pill or soft gel cap.” Claim 10 recites “wherein the liquid formula is orally administered”.
Per the specification of Moffett: “Glyceryl-triacetate (GTA) provides a rapid source of acetyl CoA synthesis for prolonged aerobic ATP regeneration. Accordingly, it is an object of the present invention to provide an immediate metabolic energy source in a liquid drink, energy bar, capsule, food product or transdermal patch containing GTA as a calorie source for increasing skeletal muscle metabolic energy levels during physical performance (e.g., medical, military and sports applications). Moreover, if glucose consumption is replaced with GTA prior to such physical performance, less lactate is produced in muscles, lactic acidosis is reduced and muscle fatigue is delayed and/or decreased, allowing for prolonged exertion.
[0008] In one aspect, the invention provides a method for increasing physical performance of a human subject, said method comprising administering a liquid formula comprising about 0.5% v/v to about 5% v/v glyceryl-triacetate to the human subject, thereby increasing physical performance in the human subject, wherein the increase in physical performance comprises increased ATP production from acetyl CoA. In other embodiments, the increase in physical performance comprises an increase in blood oxygen content or carbon dioxide output or a decrease in blood lactate levels.
[0009] In another aspect, the invention provides a method for increasing energy production in the heart and skeletal muscle of a human subject, said method comprising administering a liquid formula comprising about 0.5% v/v to about 5% v/v glyceryl-triacetate (GTA) to the human subject, thereby increasing energy production in the in the heart and skeletal muscle of the human subject. ”
Per definitions of Moffett:
“[0030] By "an effective amount" is meant the amount of a required agent or composition comprising GTA to ameliorate the symptoms of a disorder (e.g., lactic acidosis, muscle fatigue) to an untreated subject. The effective amount of GTA used to practice the present invention for varies depending upon the manner of administration, the age, body weight, and general health of the subject.
[0031] By "increasing physical performance" is meant an increase in blood oxygen content, carbon dioxide output, ATP production, a decrease in blood lactate levels (Poulos et al., 2011), or prolonged exercise capacity. Prolonged exercise capacity can be determined, for example, by monitoring endurance in a subject administered GTA or placebo, and/or monitoring endurance in a subject administered equal caloric amounts of sugar or GTA and in either case, determining that the subject can continue exercise for a longer duration without muscle fatigue and cramping following GTA administration.
. . .
[0035] The term "increase" as used herein generally means an increase by a statistically significant amount. However, for avoidance of doubt, "increase" means an increase by at least 5% as compared to a reference level, for example an increase by at least about 10%, or at least about 20%, or at least about 30%, or at least about 40%, or at least about 50%, or at least about 60%, or at least about 70%, or at least about 80%, or at least about 90% or up to and including a 100% increase (i.e. significantly above levels of detection), or any increase between 10-100% as compared to a reference level, as that term is defined herein.
[0036] As used herein, the term "standard" or "reference" refers to a measured physical parameter including but not limited to an amount of blood oxygen content, carbon dioxide output, lactic acid levels, glycogen levels or ATP production in a known sample against which another sample is compared. . .”
As was noted with respect to Applicant’s specification at [0029], improvement of breathing is manifested by improvement of oxygen saturation and desaturation at rest and during exercise, which is overlapping disclosure with Moffett at e.g. [0008], which recites increasing physical performance in the human subject, wherein the increase in physical performance comprises increased ATP production from acetyl CoA, and wherein, the increase in physical performance comprises an increase in blood oxygen content or carbon dioxide output or a decrease in blood lactate levels. Thus, this provides disclosure for a method of improving breathing of a subject experiencing a breathing difficulty, said method comprising administering to a subject in need of such treatment an amount of glyceryltriacetate (GTA), the amount being effective to improve breathing in said subject, per Applicant’s claims. Identity of terminology is not required. As the Federal Circuit holds, the elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990). See also MPEP 2131.
Even though Moffett does not specifically disclose the amount of GTA to be more than 1 g per day, it discloses nonetheless that it has to be an effective amount of a composition comprising GTA to ameliorate the symptoms of a disorder (e.g., lactic acidosis, muscle fatigue) to an untreated subject. The effective amount of GTA used to practice the present invention for varies depending upon the manner of administration, the age, body weight, and general health of the subject. Based on that disclosure, it would have been obvious to a person of skill in the art to optimize the amount of GTA to achieve improved breathing by increasing physical performance in the human subject, wherein the increase in physical performance comprises increased ATP production from acetyl CoA, and wherein the increase in physical performance comprises an increase in blood oxygen content or carbon dioxide output or a decrease in blood lactate levels. Doing so would have been specifically within the purview of the skilled artisan, as Moffett discloses very specific parameters on which result(s) is being followed, and what constitutes lactic acidosis, low blood oxygen content, and increased blood lactate levels. (See, e.g., [0043] Accordingly, compositions and methods of the invention decrease, delay or prevent lactic acidosis. A subject at risk for lactic acidosis, for example, is one having about 99% to about 85% blood oxygen content (e.g., about 99%, 98%, 97%, 96%, 95%, 94%, 93%, 92%, 91%, 90%, 89%, 88%, 87%, 86%, to about 85% blood oxygen content), and/or about 2 millimolar (mM) to about 20 mM blood lactate levels (e.g., about 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, to about 20 mM blood lactate levels) and/or undergoing physical performance.).
Moffett discloses administering GTA alone, or with other active ingredients. (“[0047] In other specific embodiments, GTA can be also used in combination with other energy facilitating metabolites including but not limited to L-carnitine, vitamins, amino acids, creatine and taurine.”).
Moffett discloses that the GTA is to be used in an effective amount to ameliorate the symptoms of a disorder (e.g., lactic acidosis, muscle fatigue) to an untreated subject ([0030]), which is broadly inclusive of any such disorder, to include of the lung, but it does not specifically recite specific disorders. The disclosure is so broad, however, as to mechanistically apply to any disease or disorder, where there is a need to increase ATP and decrease lactic acidosis and muscle fatigue, which is inclusive of a lung condition.
Moffett further does not specifically disclose administration by aerosol in a liquid carrier, by inhalation or insufflation of infusion, and the capsules being made of gelatin, starch, carrageenan or HPMC.
Jaworski relates to methods for treating a cancer, which include administering to a subject in need of treatment of a cancer, a glyceryltriacetate (GTA) compound in a therapeutically effective amount to treat the cancer. (col. 1, ll. 41-45). The cancer may be lung cancer. (col. 9, l. 50). Per Applicant’s specification ([0061]) and claims, a lung condition includes lung cancer. Per Jaworski GTA may be administered to the subject in an effective amount for treating cancer, wherein the biological effect may be the amelioration and or absolute elimination of symptoms resulting from the cancer. (col. 12, l. 56, col. 13- l. 6).
Regarding amounts, one administration of the GTA compound to the subject includes at least 0.01, 0.05, 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 grams of GTA per kg of the subject's body weight. The total amount of GTA compound administered to the subject in a single day is between 0.1 and 100 g/kg body weight. The GTA compound is administered to the subject in a pharmaceutical composition. (col. 2, ll. 15-28). This specifically discloses a GTA amount according to Applicant’s claims.
Jaworski further discloses administration by inhalation in the form of an aerosol spray with a suitable propellant, capsules and cartridges of e.g. gelatin for use in an inhaler or insufflator further formulated with starch, preparing aerosol delivery systems with techniques known in the art, parenteral administration by continuous infusion, and solutions in aqueous vehicles. (col. 17, ll. 27-56).
It would have been obvious to a person of skill in the art to combine the disclosure of Moffett and Jaworski in order to practice Applicant’s claimed invention with a reasonable expectation of success. Motivation to do so is first in view of the explicit teachings of Jaworski. Since Jaworski discloses utilizing GTA to treat lung cancer, which includes ameliorating or eliminating any of its symptoms, and in Applicant’s claimed pharmaceutically effective amounts, and with means of administration known in the art and according to Applicant’s claims, this disclosure necessarily includes improving breathing in a subject with lung cancer, wherein the subject has reduced lung function. Further motivation to do so is in order to increase ATP levels, oxidative phosphorylation, and blood oxygen, and to accordingly improve breathing in the lung cancer patient, for which there is disclosure in support in Moffett. Additional motivation to this end is also found in Jaworski also discloses that: “administration of a compound of the invention may increase acetyl CoA and shift cells from carrying out aerobic glycolysis processes (Warburg effect) to carrying out more oxidative phosphorylation processes. Such a switch may lead to generation of additional CO, by the cells and may result in hyperventilation by the subject to blow off the additional CO, that is produced. This shift to a higher level of oxidative phosphorylation may provide increased energy to a subject undergoing a treatment method of the invention with a compound of the invention, such as but not limited to GTA. Thus, in some aspects, the invention includes methods to increase energy in subjects through administration of such compounds, for example, a GTA compound.” (col. 10, ll. 41-54). Further motivation to do so is since both Moffett and Jaworski disclose some overlapping means of administration, and since Jaworski further discloses other means of administration according to Applicant’s claims.
Moffett does not explicitly disclose wherein said breathing difficulty is associated with a lung condition selected from lung inflammation or lung infection, and wherein said lung viral infection is an infection caused by a Coronavirus, per Applicant’s claims 48 and 50.
Delgado-Roche discloses by way of background that the “emergence of viral respiratory pathogens with pandemic potential, such as severe acute respiratory syndrome coronavirus (SARS-CoV), the pathogenic agent of Covid-19, represent a serious health problem worldwide. Respiratory viral infections are, in general, associated with cytokine production, inflammation, cell death, and other pathophysiological processes, which could be link with a redox imbalance or oxidative stress. . . The aim of the present work was to contribute with the understanding of the possible link between oxidative stress and the pathogenesis, severity and mortality risk in patients affected by SARS-CoV infection.” (Abstract).
Delgado-Roche reports that: “Experimental animal models of severe acute respiratory syndrome have shown an enhanced ROS levels and disturbance of antioxidant defense during SARS-CoV infection (13). Some authors suggest that the onset of severe lung injury in SARS-CoV infected patients depends on activation of the oxidative stress machinery that is coupled with innate immunity and activates transcription factors, such as NF-κB, resulting in an exacerbated proinflammatory host response (14).”
Regarding Oxidative Stress and SARS-CoV Infection, Delgado-Roche discloses that “Therefore, the authors suggest that ROS-activated NF-kB signal transduction pathway, induced by SARS-CoV 3CLpro, might be considered a key player in SARS-CoV pathophysiology. In addition, other SARS-CoV's protease, the 3a protein, has been associated with the activation of mitochondrial cell death pathways (intrinsic and extrinsic signaling). . . In the clinical setting, Shao and coworkers (23) observed an upregulation of mitochondrial genes and genes responding to oxidative stress in peripheral blood mononuclear cells (PBMC) of convalescent SARS-CoV patients. Some of these genes, including PRDX1, FTH1, and FOS are sensitive to oxidative stress, showed a remarkable elevation. In addition, stress response protein DNAJB1, differentiation-associated gene IFRD1, cytokine IL-1B, and other genes were overexpressed in PBMC of SARS-CoV infected patients. These results support the association between oxidative stress, inflammation and the pathogenesis of SARS-CoV infection (23).” (p. 385-386).
Accordingly, it would have been obvious to a person of skill in the art to combine the teachings of Moffett, Jaworski and Delgado-Roche with a reasonable expectation of success in order to practice Applicant’s claimed method of improving breathing in a subject with lung infection caused by coronavirus, by administering an effective amount of GTA. The skilled artisan would have been motivated to do so since patients infected with SARS-CoV have been reported to undergo oxidative stress linked to the pathology of the SARS-CoV infection in lung injury and since this oxidative stress has been associated with the activation of mitochondrial cell death pathways, per Delgado-Roche. Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to improve this oxidative phosphorylation carried out in the mitochondria by an effective amount of GTA, for the reasons of record of Moffett, e.g. to improve blood oxygen content and to improve cellular Acetyl-CoA levels and oxidative phosphorylation through the Krebs cycle. Further motivation to do so in view of Jaworski, which discloses GTA amounts for administration, which have been determined in the art for other conditions of lung injury.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627