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 .
Applicant’s election with traverse of Group I, claims 1-15, in the reply filed on 15 January 2026 is acknowledged.
In response to applicant's argument that the prior art references does not pertain to prevention or treatment of infection by SARS-CoV-2, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Thus, the restriction requirement is deemed proper and final.
Claims 16-20 are withdrawn as being directed to a nonelected invention.
Claims 1-15 are presented for examination on the merits.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim 1 (and claims dependent thereon) are directed to a composition comprising natural products. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Effective January 7, 2019, subject matter eligibility determinations under 35 U.S.C. § 101 follow the procedure explained in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No.4, 50-57), which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Applicants are kindly asked to review this guidance as well as MPEP 2106.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on December 16, 2014 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)), Diamond v. Chakrabarty, 447 U.S. 303 (1980)) and Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S. 127 (1948)). (inter alia). See eg. MPEP 2106.04(b)
The Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and technological work", and are thus excluded from patentability because "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting Myriad, 133 S. Ct. at 2116, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this "exclusionary principle" is pre-emption. Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena; i.e., one may not patent every "substantial practical application" of an abstract idea, law of nature, or natural phenomenon, even if the judicial exception is narrow.
While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible.
Products of Nature: When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". Products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
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It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from its closest naturally occurring counterpart.
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When a claim recites a nature-based product limitation, examiners use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify product of nature exceptions.
The Markedly Different Characteristics Analysis
The markedly different characteristics analysis is part of Step 2A, because the courts use this analysis to identify product of nature exceptions. If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible. If the claim includes a nature-based product that does not exhibit markedly different characteristics from its closest naturally occurring counterpart in its natural state, then the claim is directed to a "product of nature" exception (Step 2A: YES), and requires further analysis in Step 2B to determine whether any additional elements in the claim add significantly more to the exception.
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Nature-based Product Claim Analysis
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Where the claim is to a nature-based product by itself, the markedly different characteristics analysis should be applied to the entire product.
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Where the claim is to a nature-based product produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. Where the claim is to a nature-based product in combination with non-nature based elements, the markedly different characteristics analysis should be applied only to the nature-based product limitation. For a product-by-process claims, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart.
The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.
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Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product.
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When there are multiple counterparts to the nature-based product, the comparison should be made to the closest naturally occurring counterpart. When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature).
Markedly changed characteristics can include structural, functional, chemical changes. In order to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at 2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.
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If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception.
The claims are directed to a composition comprising nature-based components (i.e. Sanguisorba officinalis Linne extract), which is not markedly different from its closest naturally-occurring counterpart because there is no indication that their combination or preparation has caused the nature-based product to have any characteristics that are markedly different from the closest naturally-occurring product and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The rationale for this determination is explained below:
Step 1: Determine if the claims are directed to one of the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: a process, machine, manufacture or composition of matter. YES, the claims are directed to a composition of matter, which is a statutory category within at least one of the four categories of patent eligible subject matter.
Step 2A: PRONG ONE: Evaluate whether the claim recites a Judicial Exception
(e.g., law of nature, natural phenomenon, or an abstract idea). YES, the claims are product claims reciting something that appears to be a nature-based product (i.e., a Sanguisorba officinalis Linne extract) which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products).
Note: with respect to extracts of natural products such as plants, the closest naturally-occurring counterpart is always the same compounds found in the extract, present in the non-isolated form in the source plant material. Extracts that are made simply by separating the extracted components from the non-extracted components, is a partitioning process that absent any specific chemical modification, merely separates the compounds leaving their activities unchanged.
Ingredients recited in the claims are natural products that would occur naturally; thus, the claims involve the use of judicial exceptions. There is no indication in the record of any markedly different characteristics (either structural or functional) of the composition as broadly claimed. For example, there is no evidence of record of a structural difference between the extract(s) in the claimed composition and that of their nature-based counterparts. Consequently, the claimed compositions are structurally the same as their closest naturally- occurring counterparts.
Nor is there any difference in functional characteristics. To show a marked difference, the characteristic(s) must be changed as compared it closest natural-occurring counterpart. For example, and assertion of changed functionality must be accompanied with evidence of a comparison of the claimed composition with its closest naturally-occurring counterpart and should apply to the full scope of the claim. Furthermore, inherent or innate characteristics of the naturally occurring counterpart cannot show a marked difference. Likewise, differences in the characteristics that came about or were produced independently of any effort or influence by Applicant cannot show a marked difference.
The recitation of specific amounts of the ingredients does not affect this analysis because it is well known and routine in the art to mix specific amounts of active ingredients with additional ingredients. Therefore, the claim is not meaningfully limited and does not amount to significantly more than each product of nature by itself. Finally, the claimed mixture is like the novel bacterial mixture of Funk Brothers, which was held ineligible because each species of bacteria in the mixture (like each component in the instantly claimed mixture) continued to have “the same effect it always had”, i.e., it lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117. While not discussed in the opinion, it is noted that several of the claims held ineligible in Funk Brothers recited specific amounts of the bacterial species in the mixture, e.g., claims 6, 7 and 13. Funk Brothers, 333 U.S. at 128 n.1.
Thus, there is no evidence of record to indicate that the claimed product is markedly different, structurally, chemically, functionally, than its closest naturally occurring counterpart.
PRONG TWO: Evaluate whether the judicial exception is integrated into a practical application. The claims are directed to a composition, not its practical use such as a particular treatment or prophylaxis for a disease or medical condition.
Thus the cited claims are directed to a judicial exception to patentable subject matter.
Step 2b: Determine whether the claim directed to a judicial exception provides an inventive concept. For example, the claims may recite additional elements that amount to significantly more than the judicial exception. In the instant case, NO, the claims are directed to an extract composition without any other components that could add significantly more to the exception. No other specific limitations other than what is well-understood, routine and conventional in the field at a high level of generality have been added to the claimed nature-based product (e.g., addition of well-known ingredients).
Thus, the claimed product is not eligible subject matter under current 35 USC 101 standards.
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 1-15 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 a composition for treating an infection by SARS-CoV- comprising a water extract of Sanguisorba officinalis Linne as an active ingredient (such as obtained by the method of extraction detailed in paragraph [79] of the specification, does not reasonably provide enablement for any and all extracts of Sanguisorba officinalis Linne for preventing or treating SARS CoV-2 infections. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples provided in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8USPQ2d 1400, 1404 (Fed. Cir. 1988).
Please note that the term "prevent" is an absolute definition which means to stop from occurring and, thus, requires a higher standard for enablement than does "treat", especially since it is notoriously well accepted in the medical art that the vast majority of afflictions/disorders suffered by mankind cannot be totally prevented with current therapies - including preventing such disorders as SARS CoV-2 infection (which clearly is not recognized in the medical art as being a totally preventable condition).
According, it would take undue experimentation without a reasonable expectation of success for one of art the art to provide and extract having the recited functional effect of preventing SARS CoV-2, as instantly claimed.
There is well-known unpredictability regarding natural product extracts and their e.g., pharmaceutical capabilities. The resulting compositions and thus functional properties of an extraction process are highly dependent on the particular steps of the extraction and the extraction solvent employed
Raskin et al. clearly establish the grave unpredictability of elucidating active ingredients from natural sources:
Multi-component botanical therapeutics also present unique challenges in identifying their active ingredients and in validating their clinical effects. Activity-guided fractionation and reconstitution experiments currently used to characterize compound interferences within a mixture are cumbersome and time consuming…..While chromatographic analysis is often employed to produce biochemical fingerprints used for product comparison…..in the absence of information about the identity of active ingredients, such analysis is hardly reliable, since chromatography provides an incomplete picture of the qualitative and quantitative comparison of a complex extract (p. 3426, col. 2 – p. 3427, col. 1) emphasis added.
Regarding the extraction solvent used to obtain the claims product with anti-SARS CoV-2 properties, it is well known in the art that polarity of solvents plays a key role in determining the final product obtained by an extraction. However, because many phytochemicals remain undiscovered, the skilled artisan has to make his/her best educated guess as to what types of phytochemicals will be successfully extracted with a solvent of a particular polarity. Oftentimes, unless the constituents in a particular natural product extract have been well evaluated and documented in the literature, the skilled artisan must adhere to trial and error protocols in order to quantitatively determine phytochemical constituents present in samples obtained from respective extraction procedures. These procedures are common when, for example, a natural product or part thereof has been documented in the literature as possessing some medicinal quality. The skilled artisan will attempt numerous extraction protocols in an attempt to isolate particular ingredient(s) that have medicinal efficacy. Typically, beginning with the first crude extraction, it is a guess as to whether or not the extract will possess certain phytochemical constituents. For example, unpredictability with regard to natural extracts due to their highly complex nature has been well documented. Revilla et al. (J. Agric. Food Chem. (1998), vol. 46, pp. 4592-4597) showed that the slightest variations in polarity of solvent and reaction time upon grape extraction provided respective products with unique characteristic properties (See tables 1, 2, 4, 5, 6 and 7 in Revilla). In turn, each product would possess varying pharmacological properties based upon their respective methods of extraction. Thus, the functional property of an extract of Sanguisorba officinalis Linne for preventing or treating SARS CoV-2 infections is not considered to be predictable because the type of extraction used to produce the extract would have a significant impact on the chemical characteristics of the extract.
The specification does not provide any specific guidance to show that any and all extracts of Sanguisorba officinalis Linne have the claimed functionality for preventing or treating SARS CoV-2 infections. An artisan would have to test every potential extraction technique with the virtually limitless number of solvents as well as every species of bee from every specific locale in order to determine if it is able to inhibit inflammation. This degree of experimentation clearly places an undue burden on the artisan of ordinary skill. The specification only provides testing data that the extract produced by the extraction procedures and variables disclosed in paragraph [78]. Given the wide range of possible resulting extracts that could potentially result from various extraction methods, the presence of a single example of an extract that possesses anti-SARS CoV-2 properties provides insufficient guidance to the person to practice the full scope of the claimed invention. Consequently, given the unpredictability of the art, the lack of guidance from the specification and the quantity of experimentation needed to practice the claimed invention, the claims are not considered to be enabled for every extract of Sanguisorba officinalis Linne that may have the ability inhibit SARS CoV-2 infection.
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 2, 3 and 10 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 2 is rendered vague and indefinite by the phrase “a variant thereof”. The phrase encompasses any possible variation in SARS-CoV-2 as well as other viruses which may be seen as a variant of SARS-CoV-2, and is thus considered vague and unclear. That is – how different can the variant be and still be within the scope of the term. This would also have some relevance to the Written Description requirement under 35 USC 112(a), since the specification has only shown efficacy against a particular variant.
Claim 10 is rendered vague and indefinite by the phrase “the Sanguisorba officinalis Linne extract is extracted from roots of Sanguisorba officinalis L., roots of Sanguisorba longifolia, or a mixture thereof”. It is unclear how an extract of Sanguisorba officinalis Linne may be obtained from the roots of Sanguisorba longifolia, which seems to be a different species.
Note on claim interpretation: For purposes of examination the claims are given their broadest reasonable interpretation (BRI). The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limited (see e.g., MPEP 2112). A composition of matter that is old in the art cannot be patented by one who discovers a previously unknown property of that composition. Titanium Metals Corp. of Am. v. Banner, 778 F.2d 775, 227 U.S.P.Q. (BNA) 773 (Fed. Cir. 1985).
Thus, the BRI of the claims is any composition comprising any Sanguisorba officinalis Linne extract as an active ingredient.
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 (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 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 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (2010).
Kim et al. reveals that a Sanguisorbae radix (Sanguisorba radix (Di Yu) is the dried root of Sanguisorba officinalis), extracted with methanol under ultrasonic conditions for 3 hours, reduced replication of various coronaviruses. The authors suggest that the mechanism of the Sanguisorbae radix extract may be the inhibition of RNA-dependent RNA polymerase or protease activity that is crucial for CoV RNA replication.
Thus, the reference discloses a liquid composition, suitable for pharmaceutical or health functional use, comprising Sanguisorbae officinalis extract extracted from roots of Sanguisorba officinalis using an alcohol as a solvent and is deemed to anticipated the cited claims.
Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (2016).
Liu et al. discloses a hot water extract of roots of Sanguisorba officinalis L. and thus discloses a liquid composition, suitable for pharmaceutical or health functional use, comprising Sanguisorbae officinalis extract extracted from roots of Sanguisorba officinalis using water as a solvent and is deemed to anticipate the cited claims.
Claims 1-9 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gawron et al. (2016).
Gawron et al. disclose various extracts, in liquid form, of Sanguisorba officinalis L. herbs obtained using methanol or water. The reference shows that water extraction yielded a higher content of polyphenols but a lower content of flavonoids with respect to methanol extraction. The methanolic extract has higher antioxidant activity than the aqueous extract.
Thus, the reference discloses a liquid composition, suitable for pharmaceutical or health functional use, comprising Sanguisorbae officinalis extract extracted from roots of Sanguisorba officinalis using water as solvent and is deemed to anticipate the cited claims.
Claims 1-5, 7-9 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. 2021.
Chen et al. disclose that 1,2,3,4,6-O-Pentagalloyl glucose (PGG), a natural polyphenol which can be isolated from Sanguisorba officinalis L, binds to the spike-RBD domain of SARS-CoV2, thereby hindering its interaction with the ACE2 receptor, and, in a composition comprising FBS-medium, suppresses infection of HEK 293 cells in vitro by the SARS-CoV-2 S-pseudotype lentivirus. The authors suggest that PGG may be developed as an effective anti-viral agent for external use, e.g., against COVID-19.
Thus the reference discloses a liquid composition, suitable for pharmaceutical or health functional use, comprising an extract of Sanguisorba officinalis L. (i.e., PGG) and is deemed to anticipate the cited claims.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655