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 .
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
A date of 01/27/2022 has been used for priority.
Information Disclosure Statement
The information disclosure statement filed 11/30/2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the reference Yang 2021 was not provided. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Interpretation
Claims 18-25 are composition claims and thus are not limited by intended use. Since the specification does not indicate what is specifically required in an alcohol, a cooling agent and an organic acid to make the composition effective for regulating sexual functions, protecting cardiovascular and cerebrovascular systems, promoting regeneration of liver cells, preventing and/or treating tumors, and improving immunity and sleep quality the claims are interpreted as any combination of these ingredients would have these effects once optimized.
Claims 1-3, 5 and 10-17 recite “regulating sexual functions, protecting cardiovascular and cerebrovascular systems, promoting regeneration of liver cells, preventing and/or treating tumors, and improving immunity and sleep quality of an individual”. Due to the unclear grammar of the “and”s and “or”s in this list the scope of the claims is unclear. The broadest reasonable interpretation has been taken for examination of the claims. The broadest reasonable interpretation is to interpret all the limitations in the alternative.
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 1-3, 5 and 10-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for regulating sexual functions, protecting cardiovascular and cerebrovascular systems, promoting regeneration of liver cells, preventing and/or treating tumors, and improving immunity and sleep quality that using compositions 1-7, does not reasonably provide enablement for regulating sexual functions, protecting cardiovascular and cerebrovascular systems, or regulating sexual functions, protecting cardiovascular and cerebrovascular systems, promoting regeneration of liver cells, preventing and/or treating tumors, and improving immunity and sleep quality that are related to dysregulation of parasympathetic nerve signaling pathway using any compositions other than 1-7. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
[In re Sichert, 196 USPQ 209 (CCPA 1977)]
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely , or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).[1]
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to a method of regulating sexual functions, protecting cardiovascular and cerebrovascular systems, promoting regeneration of liver cells, preventing and/or treating tumors, and improving immunity and sleep quality of an individual, said method comprising administering to the individual a composition comprising 1 vol.% to 99 vol.% of at least one alcohol, 0.05 ppm to 500 ppm of at least one cooling agent, and 150 ppm to 30,000 ppm of at least one organic acid. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites the fact that while Applicant demonstrated the use of compositions 1-7 in several human trials , nowhere in the specification did applicant demonstrate the use of various combinations of ratios such as very high alcohol and low cooling agent(e.g. 99% Vol alcohol and 0.05 ppm cooling agent) or the whole broad range of all alcohols, organic acids and cooling agents claims for instance menthone was not used in a combination of the instant claims. Given that such compounds and compositions would have contrasting chemical and/or physical reactivity and given the nature of the invention, the examiner maintains that applicant has yet to enable the use of various compounds and compositions for the methods of the instant invention. For example, high (e.g 99%) alcohols concentrations are known in the art to be toxic and carcinogenic which is the opposite of promoting regeneration of liver cells, preventing and/or treating tumors(López-Lázaro, Miguel, A local mechanism by which alcohol consumption causes cancer, Oral Oncology 62 (2016) 149–152). Further, the predictability of treating the conditions of the instant claims are unpredictable for example the predictability of treating cancer (tumors) is relatively low given that the various types of cancers have different causative agents, involve different cellular mechanisms, and consequently, differ in treatment protocol. It is known (see Jin et al., Nature Reviews Drug Discovery | Volume 22 | March 2023 | 213–234) in the current art that the challenge of cancer treatment has been to target specific therapies to pathogenetically distinct tumor types, to maximize efficacy and minimize toxicity. In fact, the courts have made a distinction between mechanical elements, which function the same in different circumstances, yielding predictable results, and chemical and biological compounds, which often react unpredictably under different circumstances. Nationwide Chem. Corp. v. Wright, 458 F. supp. 828, 839, 192 USPQ 95, 105(M.D. Fla. 1976); Aff’d 584 F.2d 714, 200 USPQ 257 (5th Cir. 1978); In re Fischer, 427 F.2d 833, 839, 166 USPQ 10, 24(CCPA 1970). Thus, the physiological activity of a chemical or biological compound is considered to be an unpredictable art. Thus, given that applicant has failed to demonstrate treatment of various conditions utilizing various compositions encompassed by instant claim 1 and in light of the challenge in treating various types of biological conditions, the examiner maintains that applicant has not enabled the breadth of the claims.
2. The breadth of the claims
The claims are thus very broad insofar as they recite “a method of regulating sexual functions, protecting cardiovascular and cerebrovascular systems, promoting regeneration of liver cells, preventing and/or treating tumors, and improving immunity and sleep quality of an individual, said method comprising administering to the individual a composition comprising 1 vol.% to 99 vol.% of at least one alcohol, 0.05 ppm to 500 ppm of at least one cooling agent, and 150 ppm to 30,000 ppm of at least one organic acid”. While such “treatment” might theoretically be possible for regulating sexual functions, protecting cardiovascular and cerebrovascular systems, promoting regeneration of liver cells, preventing and/or treating tumors, and improving immunity and sleep quality that are related to dysregulation of parasympathetic nerve signaling pathway using compositions 1-7, as a practical matter it is nearly impossible to achieve a treatment for all instant conditions listed with the same compositions of instant claim 1 especially given the divergent structures of said compounds and divergent compositions of claim 1.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for the use of all combinations of instant claim 1 for use for all conditions of instant claim 1. No reasonably specific guidance is provided concerning useful therapeutic protocols for all of the disclosed combinations other than for compositions 1-7 (Pages 13-39).
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that every instantly claimed composition could be predictably used for the treatment of every single condition claimed as inferred by the claims and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Since every disease and disorder has its unique chemical pathway of expression, diagnosis and treatment of individual diseases and condition cannot be predicted a priori but must be determined from case to case by painstaking experimental study and when the above factors are weighed together, one of ordinary skill in the art would be burdened with undue ''painstaking experimentation study'' to determine which compositions of instant claim 1 treats which diseases/conditions. For example, chemical modification of biomolecules may alter the biological property that is important in the use of that particular, and also other properties such as solubilities in aqueous media, binding affinities etc. Thus variety of compounds encompassed by compositions of claim 1 will have different biological properties. Considering variety of compounds covered by claim 1 and the multitude of different diseases to be treated, this is a very large degree of experimentation.
Genetech, 108 F.3d at 1366 states that “a patent is not a hunting Iicense. It is not a reward for search, but compensation for its successful conclusion'' and ''[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.''
[1] As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.
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 1-3, 5 and 10-17 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.
Claims 1-3, 5 and 10-17 recite “regulating sexual functions, protecting cardiovascular and cerebrovascular systems, promoting regeneration of liver cells, preventing and/or treating tumors, and improving immunity and sleep quality of an individual”. Due to the unclear grammar of the “and”s and “or”s in this list the scope of the claims is unclear. For example it is unclear if the claims are meant to read as:
A list of alternative treatments a) in combination with treatment b) and c): 1) a) regulating sexual functions, protecting cardiovascular and cerebrovascular systems, promoting regeneration of liver cells, preventing and/or treating tumors, and b) improving immunity and c) sleep quality
A list of a combination of treatments all occurring together: 2) a) regulating sexual functions and protecting cardiovascular and cerebrovascular systems and promoting regeneration of liver cells and preventing (and/or treating) tumors, and improving immunity and sleep quality
Or if they are all meant to read in the alternative
Thus the scope of the claim is unclear. A claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined. That is, where the elements of a claim have two or more plausible constructions such that the examiner cannot readily ascertain positional relationship of the elements, the claim may be rendered indefinite. See, e.g., Ex parte Miyazaki, 89 USPQ2d 1207 (Bd. Pat. App. & Inter. 2008) (precedential) and Ex parte Brummer, 12 USPQ2d 1653 (Bd. Pat. App. & Inter. 1989).
Improper Markush Grouping
Claims 1-3, 5 and 10-17 rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of: regulating sexual functions, protecting cardiovascular and cerebrovascular systems, promoting regeneration of liver cells, preventing and/or treating tumors, and improving immunity and sleep quality of an individual is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: these are unrelated conditions that share no one common structure or use.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5 and 10-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over WEI (Wei et al., CN-106729187-A, CN-106729187-A, 2017-05-31, English Translation) in view of Rachdaoui ( Rachdaoui et al., Effects of Alcohol on the Endocrine System, Endocrinol Metab Clin North Am. 2013 September ; 42(3): 593–615).
The reference Wei teaches “A composition with anti-drunkenness, hangover relief, and health-preserving functions and its preparation method” (page 1) and “In this application context, the present invention provides a new product for "frequent drinkers" or "those who are not good at drinking but have to drink for social occasions", especially by making it into an alcoholic beverage, which can minimize the harm of alcohol to the body when consumed and help those who drink excessively to recover their health as quickly as possible”[0005]. The reference also teaches “The combination of lily bulb, bamboo leaf, poria cocos, lotus seed, amla fruit, and stir-fried gardenia can calm the mind and soothe the nerves, clear heat and cool the blood, and reduce the damage of alcohol to the cardiovascular and nervous systems during drinking”[0009] and reference claim 1 “A composition with anti-drunkenness, hangover-relieving, and health-preserving functions, characterized in that the raw materials include the following components in the indicated weight ratios: 80-120 parts of kudzu flower, 80-120 parts of Japanese raisin tree fruit, 60-100 parts of stir-fried gardenia fruit, 60-100 parts of amla fruit, 40-60 parts of light bamboo leaf, 40 60 parts of dandelion, 40-60 parts of imperata root, 40-60 parts of stir-fried radish seed, 40-60 parts of mulberry leaf, 40-60 parts of peppermint, 40-60 parts of licorice root, 40-60 parts of monkey head mushroom, 40-60 parts of coix seed, and lotus seed. 40-60 parts of seeds, 40-60 parts of Poria cocos, 30-50 parts of Platycodon grandiflorus, 30-50 parts of roasted malt, 30-50 parts of chicken gizzard lining, 30-50 parts of guava, 20-40 parts of chrysanthemum, 20-40 parts of Buddha's hand, 20-40 parts of rose, 20-40 parts of lily, 20-40 parts of Angelica dahurica, 20-40 parts of mulberry, 20-40 parts of Polygonatum sibiricum (processed with wine), 20-40 parts of oyster shell, 20-40 parts of maca, 10-20 parts of jujube, 10-20 parts of Cordyceps militaris, and 10-20 parts of stevia leaves”(reference claim 1).
The reference Wei teaches “The composition with anti-drunkenness and hangover-relieving health-preserving functions according to claim 1 is characterized in that: the composition is an alcoholic preparation made from the above-mentioned raw materials using conventional methods”(reference claim 2) and “The method for preparing the composition with anti-drunkenness, hangover relief, and health-preserving functions as described in claim 2 or 3 is characterized in that: the raw materials comprise the following components in the indicated weight ratios: 80-120 parts of kudzu flower, 80-120 parts of Japanese raisin tree fruit, 60-100 parts of stir-fried gardenia fruit, 60-100 parts of amla fruit, 40-60 parts of light bamboo leaf, 40-60 parts of dandelion, 40-60 parts of Imperata cylindrica root, 40-60 parts of stir-fried radish seed, 40-60 parts of mulberry leaf, 40-60 parts of peppermint, 40-60 parts of licorice root, 40-60 parts of monkey head mushroom, and 40-60 parts of coix seed. The ingredients are: lotus seeds (40-60 parts), poria cocos (40-60 parts), platycodon grandiflorus (30-50 parts), roasted malt (30-50 parts), chicken gizzard lining (30-50 parts), guava (30-50 parts), chrysanthemum (20-40 parts), citron (20-40 parts), rose (20-40 parts), lily (20-40 parts), angelica dahurica (20-40 parts), mulberry (20-40 parts), polygonatum odoratum (20-40 parts), oyster (20-40 parts), maca (20-40 parts), jujube (10-20 parts), cordyceps militaris (10-20 parts), and stevia leaves (10-20 parts). The preparation method includes the following steps: A. Extraction of active pharmaceutical ingredients: The above-mentioned active pharmaceutical ingredients are extracted with water and the extract is concentrated to obtain a concentrated extract. B. Granulation and drying: Pea starch is added to the concentrated extract obtained in step A, granules are formed and dried to obtain gel granules; C. Extraction of Baijiu: Place the gel particles obtained in step B into Baijiu, extract 3-5 times with ultrasound, filter, and obtain the original liquor.” (reference claim 4). The reference also teaches “The method for preparing the composition with anti-drunkenness and hangover-relieving health-preserving functions according to any one of claims 4-7 is characterized in that: a flavoring agent is added to the original wine obtained in step C, the mixture is allowed to stand and clarify, and the supernatant is taken and bottled to obtain the finished product” (reference claim 8) and “The preparation method of the composition with anti-drunkenness and hangover-relieving health function according to claim 8 is characterized in that: the specific operation method of adding flavoring agent to the original wine, letting it stand to clarify, and taking the supernatant to bottle to obtain the finished product is as follows: malic acid, citric acid, steviol glycoside, menthol and edible flavoring are added to the original wine in proportions of 3-6 g/L, 1-4 g/L, 0.5-2 g/L, 1-2 g/L and 0.1-0.3 g/L respectively, mixed thoroughly, left to stand at room temperature for 3-5 days to clarify, and the supernatant is taken to obtain the finished product” (reference claim 9).
Claims 18-25 are composition claims and thus are not limited by intended use. Since the specification does not indicate what is specifically required in an alcohol, a cooling agent and an organic acid to make the composition effective for regulating sexual functions, protecting cardiovascular and cerebrovascular systems, promoting regeneration of liver cells, preventing and/or treating tumors, and improving immunity and sleep quality the claims are interpreted as any combination of these ingredients would have these effects once optimized.
This helps to teach claims 18-25.
The reference Wei does not teach the specific volumes and concentrations of the compositions of all claims or the other health conditions of claims 1-3, 5 and 10-17.
The reference Rachdaoui teaches “These alcohol-induced hormonal dysregulations affect the entire body and can result in various disorders such as stress abnormalities, reproductive deficits, body growth defect, thyroid problems, immune dysfunction, cancers, bone disease and psychological and behavioral disorders” (abstract) and “Heavy alcohol drinking increases the risk of cardiovascular and liver disease, metabolic disturbances, nutritional deficiencies, cancers (i.e. mouth, stomach, colon, liver and breast cancer), neurobiological disorders and fetal abnormalities5”(page 2). The reference also teaches “Numerous studies in both, humans and animal models, showed that chronic exposure to alcohol induces alterations in the activity of clock genes resulting in severe desynchronizations of physiological clock systems such as sleep, body temperature, blood pressure and hormonal secretions; and vice versa clock genes influence alcohol use and abuse behavior107”(page 11).
This helps to teach claims 1-3, 5 and 10-17.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified Wei with Rachdaoui to get the instant invention because one would be motivated to preserve health functions and optimize for health benefits including reducing the damage of alcohol to the cardiovascular and nervous systems as taught by Wei and reducing the damage of alcohol to sexual functions, liver function, the body by causing cancer, immune and sleep function as these are major health functions or systems that can be damaged by alcohol consumption(Rachdaoui). Thus it would be obvious to combine the two references because Wei teaches a method of improving health function due to alcohol damage and Rachdaoui teach bodily systems alcohol can damage. One of ordinary skill in the art would have a reasonable expectation of success because one would try and improve health functions by routine optimization of the composition of Wei to maximize health function that alcohol may damage as known in the art (Rachdaoui) . One would also have a reasonable expectation of success because the ranges of the compositions of the instant claims are very large. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955.)
Conclusion
Claims 1-3, 5 and 10-25 are rejected.
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627