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 .
Status of the Claims and Response to Restriction Requirement
Claims 1-38 are pending as of the response filed 01/02/2026. Applicant’s election of Group II claims 9-36 and 38, without traverse in the response filed 01/02/2026 is acknowledged. Claims 1-8 and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election of a species of cell membrane permeable prodrug or derivative of cysteine, glutamylcysteine, glutathione, as glutathione monoethyl ester is acknowledged. Claims 9-36 encompass the elected species. Claim 38 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Therefore, claims 9-36 have been examined to the extent to which they are readable on the above identified elected species.
Because Applicant did not distinctly and specifically point out the supposed errors in the election of species requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
This application claims priority to PRO 63/373,708 filed 08/27/2022. The subject matter of claims 9-36 are supported by the ‘708 provisional application and accordingly, have an effective filing date of 08/27/2022.
Information Disclosure Statement
The information disclosure statements submitted on 04/03/2024 and 09/30/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 13, 21-23, 26, 33 are objected to because of the following informalities:
In claim 13, the claim has a grammatical error and is read as follows –
“The method of claim 12, further comprising selecting at least one injection of said at least two or more injections [[is ]]from an intravenous bolus injection, continuous intravenous infusion, subcutaneous injection, intramuscular injection, intrathecal injection, intraosseous injection, autoinjection, or implantation.
In claim 21, line 2 and line 3, the “and or” should read “and/or”.
In claim 22, line 3, line 5 and line 6, the “and or” should read “and/or”.
In claim 23, line 3, line 5, the “and or” should read “and/or”.
In claim 26, line 2, the “and or” should read “and/or”.
In claim 33, line 2, the “and or” should read “and/or”.
Appropriate correction is required.
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 9-36 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.
Regarding claim 9, the claim recites “administering an at least one injectable formulation of an at least one cell membrane permeable prodrug or derivative of cysteine, glutamylcysteine, glutathione, or a combination thereof to a patient or subject”. It is not clear if the limitation “prodrug or derivative of” refers to just cysteine or also applies to glutamylcysteine and glutathione. This renders the scope of the claim indefinite.
For the purpose of applying prior art, claim 9 has been interpreted to read “administering an at least one injectable formulation of an at least one cell membrane permeable prodrug or derivative of selected from the group consisting of cysteine, glutamylcysteine, glutathione, or a combination thereof to a patient or subject”.
Claims 9-36 depend either directly or indirectly from claim 9 and are similarly rejected.
Additionally, claim 9 recites “at least one cell membrane permeable prodrug or derivative of”. A prodrug is any compound which is pharmaceutically active in vivo when it undergoes metabolic degradation (a functional classification), while a derivative of a compound is a chemically modified analogue of said compound (a structural classification). The instant specification discloses some species of derivatives (Paras. [0013]-[0015]) mostly directed to esters and acyl derivatives. The instant specification states that the glutathione derivatives act as prodrugs (Para. [0013]) (it appears that the term derivative and prodrug stand for the same compounds, which causes some ambiguity regarding the claim scope). The instant specification does not provide a distinction or limiting definition of the terms “prodrug” and “derivative”. The full scope of the compounds – possible prodrugs and derivatives encompassed by the claim has not been defined. Therefore the metes and bounds of the claim are indefinite.
Moreover, dependent claims 15-18, 21, 24-28, recite “further comprising administering the at least one injectable formulation to”. It is unclear if the at least one injectable formulation is administered a second time OR if the dependent claim just refers back to the step of administering the at least one injectable formulation of claim 9.
For the purpose of applying prior art, claims 15-18, 21, 24-28 are interpreted to include just one administration of the at least one injectable formulation of claim 9.
Claim Interpretation
Given the broadest reasonable interpretation in light of the specification, claims 15-18, 21-22, 24-31, 33-36 have been construed as – the sole active step of administering the at least one injectable formulation of an at least one cell membrane permeable prodrug or derivative selected from the group consisting of cysteine, glutamylcysteine, glutathione, or a combination thereof to a patient or subject as in the method of claim 9, results in said effected treatments. The subject population is broad and can be any subject wherein said administration leads to increase in intracellular glutathione levels.
Moreover, in instances where the claims recite multiple effected treatments as a result of administering the at least one injectable formulation of claim 9, the method is interpreted to require only one of said multiple options.
For instance, in claim 15 that recites,
“The method of claim 9, further comprising administering the at least one injectable formulation to:
treat, prevent, or reduce cellular damage and tissue damage from oxidation; treating, preventing, or reducing cellular damage and tissue damage from ischemia; treat, prevent, or reduce cellular damage and tissue damage from surgery; treating, preventing, or reducing cellular damage and tissue damage from injury; or treat, prevent, or reduce the effects of stress”,
only one of these multiple treatment effects needs to be achieved with said administration of the injectable formulation by the prior art, to render it anticipated or obvious.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 9-12, 14-18, 20-22, 24-31 and 33-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meister (US 4,710,489 A, date of patent 01 December 1987, in the IDS).
Regarding instant claims 9 and 11, Meister teaches a method for increasing intracellular glutathione levels by administering an alkyl monoester of glutathione in animals whereby said ester is transported into said cells (i.e., is cell membrane permeable) and hydrolyzed intracellularly to glutathione (Col. 3, Lns. 14-26; Claim 1). Meister teaches the ester to be an ethyl monoester of glutathione (Claim 1; Claim 3) (i.e., the instantly elected species of cell membrane permeable prodrug or derivative). Meister teaches the esters are typically administered by injection (Col. 5, Lns. 1-2; Claim 5).
According to MPEP § 2131.02(III), “A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)).” In the instant case, a person of ordinary skill in the art can clearly envisage an injectable formulation of the ethyl monoester of glutathione (the instantly elected species of cell membrane permeable prodrug or derivative) for use in a method for increasing intracellular glutathione levels by administering an alkyl monoester of glutathione to the animals. Therefore, the disclosure of Meister anticipates the limitations of instant claim 9 and claim 11.
Regarding instant claim 10, Meister anticipates the method of instant claim 9. Meister teaches in example 2 the administration of the monoester to mice resulted in substantial increase in the levels of intracellular glutathione in the liver and kidney (Col. Lns. 26-56; Fig 2(a); Fig. 2(b)). Meister teaches the effects observed with glutathione monomethyl ester and glutathione monoethyl ester were about the same (Col. Lns. 54-56). The figures 2(a) and (2(b) show about 500% and 300% increase in glutathione levels between 4 and 6 hours after administration of the monoester. This satisfies the limitation of increase in glutathione levels by more than 1%.
Regarding instant claim 12, Meister anticipates the method of instant claim 9. Meister teaches the suggested dosage of the ester is administered one to six times a day (Col. 5, Lns. 17-20). Therefore, the disclosure of Meister anticipates the limitations drawn to administering two or more injections of said at least one injectable formulation of an at least one cell membrane permeable prodrug or derivative of cysteine, glutamylcysteine, glutathione, or a combination thereof.
Regarding instant claim 14, Meister anticipates the method of instant claim 9. Meister teaches the esters of glutathione are typically administered by injection after dissolution in water (Col. 5, Lns. 1-7). Therefore, the disclosure of Meister anticipates the limitations of instant claim 14.
Regarding instant claim 20, Meister anticipates the method of instant claim 9. Meister teaches one can monitor glutathione level in the patient or use other parameters of effectiveness depending on the nature of the toxicity being treated (“monitor” is construed as measuring the levels before, during, and after treatment to assess the therapeutic efficacy, or the impact of interventions) (Col. 5, Lns. 14-16). Therefore, the disclosure of Meister anticipates the limitations of instant claim 20.
Regarding instant claims 15-18, 21-22, 24-31, 33-36, Meister anticipates the method of instant claim 9. Meister teaches the method provides for efficiency and rapidly increasing cellular glutathione levels for any purpose for which elevated glutathione levels are desired (Col.3, Lns. 1-7). Meister teaches methods for increasing radiation resistance of an animal comprising: administering a substantially pure monomethyl or monoethyl ester of glutathione (Claim 7). Meister teaches methods for effective detoxification of drugs, including acetaminophen (Col.1, Lns. 58-61; Claim 15; Claim 17; Fig. 3).
The limitations of claims 15-18, 21-22, 24-31, 33-36, with respect to
further comprising administering the at least one injectable formulation to: treat, prevent, or reduce cellular damage and tissue damage from oxidation; treating, preventing, or reducing cellular damage and tissue damage from ischemia; treat, prevent, or reduce cellular damage and tissue damage from surgery; treating, preventing, or reducing cellular damage and tissue damage from injury; or treat, prevent, or reduce the effects of stress;
further comprising administering the at least one injectable formulation to treat, prevent, or reduce aging and or symptoms of aging; treats, reduces, or prevents oxidative damage associated with aging; increases levels of glutathione that decline with age; or a combination thereof;
further comprising administering the at least one injectable formulation to: treat, prevent, or reduce thiol sensitive disorders; or treat, prevent, or reduce symptoms associated with homocystinuria and or hepatic disease;
further comprising administering the at least one injectable formulation to treat or reduce symptoms associated with inborn errors of metabolism and or enzyme deficiency and or enzyme inefficiency in at least one enzyme selected from glutamate cysteine ligase, glutathione synthase, cystathionine-beta-synthase, cystathionase, methionine synthase, or a combination thereof;
further comprising administering the at least one injectable formulation to treat amino acid deficiencies in patients with peptide and or amino acid gastrointestinal malabsorption issues and related gastrointestinal conditions, and or providing amino acid supplementation;
further comprising administering the at least one injectable formulation for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants requiring total parenteral nutrition, and or of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require total parenteral nutrition, and or for providing a more complete profile of amino acids for protein synthesis, and or for treating an otherwise hepatoxic acetaminophen overdose;
further comprising administering the at least one injectable formulation to treat, prevent, or reduce in the body DNA oxidative damage, lipid oxidative damage, protein oxidative damage, or a combination thereof;
further comprising administering the at least one injectable formulation to increase DNA repair, enhance healing from a wound or injury, reduce cellular apoptosis, reduce impaired fertility, or a combination thereof;
further comprising administering the at least one injectable formulation to repair or restore mitochondrial function and or mitochondrial respiration; and/or increase the number of mitochondria; and/or treat at least one mitochondrial disease and or improve a redox imbalance thereof;
further comprising administering the at least one injectable formulation to treat, prevent, or reduce damage from radiation exposure; treat, prevent, or reduce toxicity associated with chemotherapy; or a combination thereof;
further comprising administering the at least one injectable formulation to at least one of treat, prevent, or reduce symptoms of scurvy; treat, prevent, or reduce symptoms of anemia and or sickle cell anemia; treat, prevent, or reduce eye disease; or treat, prevent, or reduce hearing loss or inner ear disease;
wherein administering the at least one injectable formulation causes changes in nitric oxide levels or bioavailability, nitric oxide signaling, or a combination thereof;
wherein administering the at least one injectable formulation protects neurons, nerves, and/or the brain;
further comprising administering the at least one injectable formulation to treat/adjunctively treat neurological disease, including at least one of Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, traumatic brain injury, or a combination thereof;
wherein administering the at least one injectable formulation reduces viral or retroviral expression, infectivity, and or infection, and or reduces bacterial infectivity and or infection, or a combination thereof;
wherein administering the at least one injectable formulation treats at least one inflammatory condition selected from sepsis, septic shock, systemic inflammatory response syndrome, lupus, or rheumatoid arthritis;
wherein administering the at least one injectable formulation treats and or prophylactically prevents oxidative damage associated with oxygen gas toxicity in patients, scuba divers, pilots, and astronauts receiving supplemental oxygen gas administration and or nitrox gas administration;
wherein administering the at least one injectable formulation treats/adjunctively treats or counters exposure to toxic agents, venomous agents, poisonous agents, and biothreat agents;
are related to the treatment effects obtained by the sole step of administering the at least one injectable formulation to a subject. Meister anticipates the step of administering an alkyl monoester of glutathione in animals by injection, for increasing intracellular glutathione levels whereby said ester is transported into said cells (i.e., is cell membrane permeable) and hydrolyzed intracellularly to glutathione (Col. 3, Lns. 14-26; Claim 1). Meister anticipates the instantly elected species of cell membrane permeable prodrug or derivative, glutathione monoethyl ester (Claim 1; Claim 3). Therefore, practicing the method of Meister in said subjects would have necessarily resulted in the intended treatment benefits.
According to MPEP 2112.02 (II), “The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 154, 163 {(CCPA 1957}. However, when the claim recites using an old composition or structure and the “use’” is directed to a result or property of that composition or structure, then the claim is anticipated”. In re May, S74 F.2d 1082, 1090, 197 USPO 601, 607 (CCPA 1978). In the instant case, Meister as such anticipates the claims. Therefore, the limitations of instant claims 15-18, 21-22, 24-31, 33-36, are held unpatentable.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 9, 11 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robinson et al. (Parenteral Glutathione Monoester Enhances Tissue Antioxidant Stores, October 1992, hereinafter Robinson).
Regarding instant claims 9 and 13, Robinson teaches the administration of glutathione monoethyl ester (GSH-ME) in rats via an intravenous (IV) bolus significantly increased the liver, renal and ileal mucosal glutathione levels (Abstract; Pg. 414, first column, third full paragraph; Pg. 415, first column, last paragraph; TABLE 1). Robinson teaches glutathione monoesters are more lipid soluble and are transported into cells more easily than glutathione (Pg. 413, second column, last paragraph). Robinson teaches the GSH-ME solutions were prepared on the morning that they were used (Pg. 414, second column, first full paragraph).
Therefore, the disclosure of Robinson anticipates the limitations of instant claims 9, 11 and 14.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 9 and 30-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zeevalk et al. (Characterization of intracellular elevation of glutathione (GSH) with glutathione monoethyl ester and GSH in brain and neuronal cultures: Relevance to Parkinson's disease, 17 October 2006, hereinafter Zeevalk, in the IDS).
Regarding instant claims 9 and 30-32, Zeevalk teaches Parkinson's disease (PD) is associated with loss of total glutathione (GSH) which may contribute to progressive cell death (Abstract). Zeevalk teaches administration of the monoethyl ester of GSH (GEE) (i.e., the instantly elected species of cell membrane permeable prodrug or derivative), but not GSH (1–10 mM, 24 h) produced a dose-dependent elevation in GSH (Abstract). Zeevalk teaches elevation of GSH with GEE protected neurons from oxidative stress (Abstract) (satisfies the limitations of instant claim 30). Zeevalk teaches rats were administered 0.1-50 mg/kg/day GEE via a cannula placed into the left cerebral ventricle (icv) for 28 days (Abstract) (i.e., delivered directly to the brain and the cerebrospinal fluid (CSF) system, which satisfies the limitations of instant claim 32). Zeevalk concludes that the ethyl ester of GSH but not GSH per se can elevate intracellular GSH, that brain elevation of GSH requires central delivery of the ethyl ester and that this elevation provides neuroprotection against oxidative stress or chronic mitochondrial impairment (Pg. 519, second column, last paragraph).
Therefore, the disclosure of Zeevalk anticipates the limitations of instant claims 9 and 30-32.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 9 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leeuwenburgh et al. (Glutathone and Glutathione Ethyl Ester Supplementation of Mice Alter Glutathione Homeostasis during Exercise, 1998, hereinafter Leeuwenburgh, in the IDS).
Regarding instant claims 9 and 23, Leeuwenburgh teaches a study that examined the effect of glutathione (GSH) and glutathione ethyl ester (GSH-E) (i.e., the instantly elected species of cell membrane permeable prodrug or derivative) supplementation on GSH homeostasis and exercise-induced oxidative stress (Abstract). Leeuwenburgh teaches acute GSH and GSH-E supplementation improve endurance performance and prevent muscle lipid peroxidation during prolonged exercise (Abstract). Leeuwenburgh teaches the GSH ethyl ester was injected intraperitoneally in mice before exercise (Pg. 2421, second column, first full paragraph). Leeuwenburgh teaches supplementation with GSH-E demonstrated some unique effects that may substantiate its antioxidant potential during exercise (Pg. 2425, second column, second full paragraph). Leeuwenburgh teaches it is beneficial for the cell to increase GSH levels to protect against reactive oxygen species (ROS) (Pg. 2420, second column, continued paragraph).
Therefore, the disclosure of Leeuwenburgh anticipates the limitations of instant claims 9 and 23.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Meister (US 4,710,489 A, date of patent 01 December 1987, in the IDS) in view of Robinson et al. (Parenteral Glutathione Monoester Enhances Tissue Antioxidant Stores, October 1992, hereinafter Robinson).
The teachings of Meister are set forth in the anticipation rejection above and incorporated herein by reference.
Regarding instant claim 13, Meister anticipates the method of instant claim 12. Meister do not teach selecting at least one injection of said at least two or more injections from an intravenous bolus injection, continuous intravenous infusion, subcutaneous injection, intramuscular injection, intrathecal injection, intraosseous injection, autoinjection, or implantation.
Robinson teaches the administration of glutathione monoethyl ester (GSH-ME) in rats via an intravenous (IV) bolus significantly increased the liver, renal and ileal mucosal glutathione levels (Abstract; Pg. 414, first column, third full paragraph; Pg. 415, first column, last paragraph; TABLE 1).
Given the teachings of Meister and Robinson, it is prima facie obvious to select a suitable route of administration to exert the intended therapeutic effect, with a reasonable expectation of success.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Meister (US 4,710,489 A, date of patent 01 December 1987, in the IDS) in view of Cuenod et al. (US 2009/0297494 A1, 03 December 2009, hereinafter Cuenod).
The teachings of Meister are set forth in the anticipation rejection above and incorporated herein by reference.
Regarding instant claim 19, Meister anticipates the method of instant claim 18. Meister do not teach further comprising gene/genetic sequencing or detecting genetic mutations in, and or measuring levels of, and or measuring levels of activity of, one or more enzymes involved in and or related to the metabolism of cysteine, glutamylcysteine, glutathione, or a combination thereof.
Cuenod teaches the expression of genes and activity of proteins involved in regulating the intracellular glutathione (GSH) level and/or GSH oxidative stress-related gene expression as well as plasmatic levels of amino acids are perturbed in patients affected by Schizophrenia (Para. [0010]). Cuenod teaches determining the presence of at least one polymorphism and/or at least one combination of polymorphisms of at least one copy of a gene involved in regulating the intracellular glutathione (GSH) level and/or GSH-oxidative stress-related gene expression in a human being, especially genes encoding glutamate-cysteine ligase (GCL), and glutathione synthetase (GSS) will help the diagnosis of a mental disorder or a predisposition therefor (Abstract; Para. [0013]; Para. [0228]).
Given the teachings of Meister and Cuenod, it would have been prima facie obvious to assess glutathione-related enzymes through genetic sequencing and activity measurement in order to diagnose predisposition and/or progression of certain mental disorders, such as Schizophrenia. The motivation being to screen for modulators of the mental disorder, thereby aiding in effective treatments (Para. [0011]).
Conclusion
Claims 9-36 are rejected.
Claims 13, 21-23, 26, 33 are objected to.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached 9:00-5:30pm EDT.
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 on (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.
/PADMAJA S RAO/Examiner, Art Unit 1627