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
This application is a 371 of PCT/EP2020/078938 filed 10/14/2020. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) based on EP 19203399.1 filed 10/15/2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Claims
Applicant’s amendment filed on 09/22/2025 is acknowledged.
Claims 27, 31-42 and 44-49 are pending. Claims 27, 31, 32, 34 and 41 are amended. Claim 28-30 and 43 are cancelled. New claims 45-49 are added. Claims 34, 35, 37, 39, 40 and 44 are withdrawn.
Claims 27, 31-33, 36, 38, 41, 42 and 45-49 (claim set filed 09/22/2025) and are examined on the merits herein.
Withdrawal of Rejections
The response and amendment filed on 09/22/2025 are acknowledged. All of the amendment and arguments have been thoroughly reviewed and considered.
For the purposes of clarity of the record, the reasons for the Examiner's withdrawal and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner's response to arguments section.
The previous claims 27-33, 36, 38, 41 and 42 rejections under 35 U.S.C. 112(b) have been withdrawn necessitated by amendment of claims 27 and 32 and cancellation of claim 28.
New Rejections
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 31, 38, 41 and 42 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 31 recites the limitation "the bacterial strain producing butyrate". There is insufficient antecedent basis for this limitation in the claim. Claim 31 is dependent on claim 27 which recites “bacterial strain consuming lactate and producing butyrate” and does not recite "bacterial strain producing butyrate”. It is not clear whether "the bacterial strain producing butyrate" is the same strain that can also consume lactate or an additional strain. The scope and boundaries of claim 31 are not certain making claim 31 indefinite.
Claim 38 recites “a butyrate producing bacterium” to be comprised in a consortium of bacteria according to claim 27. Claim 27 recites “ at least one bacterial strain consuming lactate and producing butyrate” and does not recite "bacterial strain producing butyrate”. It is not clear whether "a butyrate producing bacterium" is the same strain that can also consume lactate or an additional strain. The scope and boundaries of claim 38 are not certain making claims 38 indefinite.
Claim 41, dependent on claim 38, has the same issue. Claim 41 recites a “butyrate producing bacterium in a consortium of bacteria” wherein consortium comprises: bacterial strain consuming lactate and producing butyrate”. It is not clear whether "butyrate producing bacterium" is the same strain that can also consume lactate or an additional strain. Additionally, claim 41 recites comprising “optionally glycerol” in line 3 and “at least 5% of glycerol” in line 11. It is not clear whether “at least 5% of glycerol” is included in the composition of the claim or glycerol is optional. The scope and boundaries of claim 41 are not certain making claim 41 indefinite.
Claim 42, dependent on claim 41, does not resolve the issues mentioned above and is rejected.
Maintained/Modified Rejections
The following rejections are maintained and/or modified taking into consideration amendment
to claims filed on 09/22/2024.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 27, 31-33, 36, 38, 41, 42 and 45-49 are rejected under 35 U.S.C. 103 as being unpatentable over Duncan (Duncan et al. Appl. Environ. Microbiol., 2004, 70, 5810-5817) in view of Oh (Oh et al. J. Industr. Engineer. Chem., 2019, 75, 44-51 on record in IDS) and Chatila (US 20180117099 A1).
Regarding claims 27, 38 and 41, Duncan teaches identification of bacteria being able to consume lactate and produce butyrate in isolated human fecal samples. The identified bacterial species are: Eubacterium hallii and Anaerostipes caccae (Abstract, p. 5811, right column, 2nd paragraph). Duncan describes composition comprising Bifidobacterium adolescentis, starch utilizing and lactate producing bacteria, and one of the identified species consuming lactate and producing butyrate (Abstract). Duncan discloses that when Bifidobacterium adolescentis are co-cultured with Anaerostipes caccae or Eubacterium hallii, the lactate produced by Bifidobacterium adolescentis becomes undetectable and butyrate is produced (Abstract, Figure 3). Duncan mentions that these bacteria can prevent accumulation of lactate which can lead to neurotoxicity and cardiac arrythmia (Abstract, p. 5810, left column, 1st paragraph).
Duncan does not teach the composition to comprise glycerol, does not teach increase in butyrate production by glycerol and does not teach composition to be formulated using an enteric coating.
Oh teaches that glycerol supplemented with sugar facilitates production of butyric acid by Clostridium tyrobutyricum (Abstract). Oh describes that Clostridium species such as C. tyrobutyricum or C. thermobutyricum are known to produce butyrate as a main product (p. 44, left column). Oh mentions that in the presence of glycerol C. tyrobutyricum consumes glucose, glycerol and acetic acid to produce butyrate. Oh discloses that the presence of glycerol results in significant increase in the yield of produced butyrate for more than 10%, i.e. from 35.42 g/L in the absence of glycerol to 54.79 g/L in the presence of glycerol (Abstract).
Regarding the amount of glycerol, Oh teaches addition of 10 g/L glycerol initially and another 10 g/L after 24 h (p. 49, Figure 5) to the fermentation medium resulting in 2% glycerol in the medium. The amount of cell in the inoculum in Oh teaching is 2.5% in the medium (p. 45, left column, 4th paragraph). Since the specification describes addition of glycerol to either inoculum used to seed the culture medium or directly to the medium (p. 9, lines 26-27) and claims do not specify whether glycerol is added to cells or medium, the amount of glycerol added in Oh teaching relative to the amount of cells reads on the claimed 5% glycerol limitation. However, if the 5% glycerol is required to be in the fermentation medium, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the amount of glycerol is a result effective variable. One would have been motivated to optimize the amount of glycerol that would allow to reach high amount of produced butyrate. A skilled artisan would have reasonably expected success in this optimization because selection of medium component concentration is routine and conventional.
Chatila teaches a pharmaceutical composition for treatment or preventing food allergy comprising microbial consortium of viable gut bacteria and including bacterial strains producing butyrate (paragraphs 0006 and 0007). Chatila describes that the composition of microbial consortium can be formulated with enteric coating. Chatila mentions that enteric coating: “can control the location of where a microbial consortium is released in the digestive system. Thus, an enteric coating can be used such that a microbial consortium-containing composition does not dissolve and release the microbes in the stomach, which can be a toxic environment for many microbes, but rather travels to the small intestine, where it dissolves and releases the microbes in an environment where they can survive.” (paragraph 0353).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine teachings of Duncan and Oh and add butyrate producing bacteria and glycerol as described by Oh to the microbiota composition from Duncan teaching to increase butyrate production. One would have been motivated to make this combination because Oh teaches that butyrate is useful in various fields including food and pharmaceutical industry (p. 44, left column) and Oh demonstrated significant increase in butyric acid production in the presence of glycerol in fermentation medium. A skilled artisan would have reasonably expected success in this combination since Duncan and Oh teach producing butyrate by bacteria.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow Chatila teaching and formulate the bacterial composition for production of butyrate based on Duncan and Oh teaching with an enteric coating and use it as pharmaceutical composition. One would have been motivated to do that since Chatila teaches pharmaceutical composition that can be used to treat food allergy and discloses that enteric coating prevents microbes release in a toxic environment of stomach and allows composition to travel and be released in the small intestine where microbes can survive. A skilled artisan would have reasonably expected success in this combination because Duncan, Oh and Chatila teach bacteria producing butyrate. Thus, Duncan, Oh and Chatila teachings render claims 27, 38 and 41 obvious.
Regarding claim 31, Duncan teaches Anaerostipes caccae (elected species) as butyrate producing bacteria (Abstract). Thus, Duncan, Oh and Chatila teachings render claim 31 obvious.
Regarding claim 32, Duncan teaches Bifidobacterium adolescentis as lactate producing bacteria (Abstract). Chatila teaches addition of one or more probiotic microorganisms producing lactate of Bacillus, Lactobacillus and Bifidobacterium genera to the composition and describes multiple Lactobacillus species producing lactate (paragraph 0360). Chatila mentions that probiotics are clinically safe and exhibit a beneficial prophylactic and/or therapeutic effect on the host organism (paragraph 0360).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add Lactobacillus species described by Chatila as substitute or additional lactate producing strain to composition of bacterial strains based on Duncan and Oh reaching. One would have been motivated to make this combination because Chatila and Duncan teach bacteria with the same function of producing lactate and having beneficial prophylactic and/or therapeutic effect on the host organism as described by Chatila. A skilled artisan would have reasonably expected success in this combination since Duncan and Oh teachings provide composition of bacteria producing butyrate that require lactate and Chatila provides lactate producing bacteria. Thus, Duncan, Oh and Chatila teachings render claim 32 obvious.
Regarding claim 33, Duncan, Oh and Chatila do not teach Blautia hydrogenotrophica in the composition (Abstract). Thus, Duncan, Oh and Chatila teachings render claim 33 obvious.
Regarding claim 36 and 42, Duncan teaches that when Bifidobacterium adolescentis are co-cultured with Anaerostipes caccae or Eubacterium hallii, the lactate produced by Bifidobacterium adolescentis becomes undetectable and butyrate and acetate are detected as can be seen on Figure 3 (p. 5815). (Abstract, Figure 3). Thus, Duncan, Oh and Chatila teaching render claims 36 and 42 obvious.
Regarding claims 45-49, Duncan teaches Eubacterium hallii and Anaerostipes caccae to be lactate consuming and butyrate producing bacteria (Abstract). Thus, Duncan, Oh and Chatila teachings render claims 45-49 obvious.
Response to Arguments
Applicant's arguments filed 09/22/2025 have been fully considered but they are not persuasive.
In response to Applicant’s arguments (addressing p. 9 of the Remarks) that the prior art of Duncan, Oh and Capurso does not teach a composition formulated using enteric coating, these arguments are not persuasive because current rejection is based on combination of prior art of Duncan, Oh and Chatila as described in the rejection above. Chatila teaches enteric coating of the composition comprising consortium of bacteria including butyrate-producing bacteria and that formulation ensures the release of the microbial composition in the small intestine where microbes can survive providing motivation to add enteric coating to the microbial composition producing butyrate based on Duncan and Oh teachings. Therefore, the 35 U.S.C. 103 rejection is maintained and modified necessitated by amendment of claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 27, 31-33, 38, 41 and 45-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5 and 10 of U.S. Patent No. US 11219649 (Lacroix) in view of Oh (Oh et al. J. Industr. Engineer. Chem., 2019, 75, 44-51 on record in IDS) and Chatila (US 20180117099 A1).
Claim 27 of instant application is directed to a pharmaceutical and nutraceutical composition comprising at least one bacterial strain producing lactate, at least one bacterial strain consuming lactate and producing butyrate, butyrate and 5% glycerol, wherein production of butyrate is increased by at least 10% in the presence of glycerol and composition is formulated using enteric coating.
Regarding claim 27, claim 1 of Lacroix teaches a composition, comprising bacterial strains selected from the recited groups. Among these groups are groups A3 and A7 containing strains producing lactate and group A6 containing strains that consume lactate and produce butyrate. Additionally claim 1 recites composition to comprise end metabolites including butyrate. Claim 10 of Lacroix teaches a composition to be a pharmaceutical composition.
Lacroix does not teach the composition to comprise glycerol, increase in butyrate production by glycerol and does not teach composition to be formulated using an enteric coating
Oh teaches that glycerol supplemented with sugar facilitates production of butyric acid by Clostridium tyrobutyricum (Abstract). Oh describes that Clostridium species such as C. tyrobutyricum or C. thermobutyricum are known to produce butyrate as a main product (p. 44, left column). Oh mentions that in the presence of glycerol C. tyrobutyricum consumes glucose, glycerol and acetic acid to produce butyrate. Oh discloses that the presence of glycerol results in significant increase in the yield of produced butyrate for more than 10%, i.e. from 35.42 g/L in the absence of glycerol to 54.79 g/L in the presence of glycerol (Abstract).
Regarding the amount of glycerol, Oh teaches addition of 10 g/L glycerol initially and another 10 g/L after 24 h (p. 49, Figure 5) to the fermentation medium resulting in 2% glycerol in the medium. The amount of cell in the inoculum in Oh teaching is 2.5% in the medium (p. 45, left column, 4th paragraph). Since the specification describes addition of glycerol to either inoculum used to seed the culture medium or directly to the medium (p. 9, lines 26-27) and claims do not specify whether glycerol is added to cells or medium, the amount of glycerol added in Oh teaching relative to the amount of cells reads on the claimed 5% glycerol limitation. However, if the 5% glycerol is required to be in the fermentation medium, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the amount of glycerol is a result effective variable. One would have been motivated to optimize the amount of glycerol that would allow to reach high amount of produced butyrate. A skilled artisan would have reasonably expected success in this optimization because selection of medium component concentration is routine and conventional.
Chatila teaches a pharmaceutical composition for treatment or preventing food allergy comprising microbial consortium of viable gut bacteria and including bacterial strains producing butyrate (paragraphs 0006 and 0007). Chatila describes that the composition of microbial consortium can be formulated with enteric coating. Chatila mentions that enteric coating: “can control the location of where a microbial consortium is released in the digestive system. Thus, an enteric coating can be used such that a microbial consortium-containing composition does not dissolve and release the microbes in the stomach, which can be a toxic environment for many microbes, but rather travels to the small intestine, where it dissolves and releases the microbes in an environment where they can survive.” (paragraph 0353).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine teachings of Lacroix and Oh and add butyrate producing bacteria and glycerol as described by Oh to the microbiota composition from Lacroix teaching to increase butyrate production. One would have been motivated to make this combination because Oh teaches that butyrate is useful in various fields including pharmaceutical industry (p. 44, left column) and Oh demonstrated significant increase in butyric acid production in the presence of glycerol in fermentation medium. A skilled artisan would have reasonably expected success in this combination since Lacroix and Oh teach producing butyrate by bacteria.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow Chatila teaching and formulate the bacterial composition for production of butyrate based on Lacroix and Oh teaching with an enteric coating. One would have been motivated to do that since Chatila teaches that enteric coating prevents microbes release in a toxic environment of stomach and allows composition to travel and be released in the small intestine where microbes can survive. A skilled artisan would have reasonably expected success in this combination because Lacroix, Oh and Chatila teach bacteria producing butyrate. Thus, claims 1 and 10 of Lacroix, Oh and Chatila teachings render claim 27 obvious.
Claim 31 of instant application are drawn to bacterial strain producing butyrate which is Anaerostipes caccae (elected species). Claim 3 of Lacroix teaches the same bacterial species in group A6. Thus, claim 3 of Lacroix and Oh and Chatila teachings render claim 31 obvious.
Claim 32 of instant application is drawn to Lactobacillus genus (elected species) of bacterium producing lactate. Claim 3 of Lacroix teaches Lactobacillus rhamnosus in group A3. Thus, claim 3 of Lacroix and Oh and Chatila teachings render claim 32 obvious.
Claim 33 of instant application is directed to composition not comprising Blautia hydrogenotrophica. Although claim 3 of Lacroix recites Blautia hydrogenotrophica in group A9, the composition of claim 1 does not necessarily include all the recited groups since bacterial groups are selected from the recited groups. Thus, claim 1 of Lacroix and Oh and Chatila teachings render claim 33 obvious.
Claims 38 and 41 of instant application are directed to a method of producing butyrate comprising composition of claim 27 and the resulting composition as described in claim 27. Claim 5 of Lacroix teaches bacterial composition in claim 1 obtained by co-culturing of bacterial groups. As described above, claim 1 of Lacroix teaches groups A3 and A7 producing lactate, group A6 consuming lactate and producing butyrate and end metabolite butyrate. Oh teaches culturing a butyrate producing bacteria with glycerol supplementation that results in the increase in the yield of produced butyrate for more than 10%, i.e. from 35.42 g/L in the absence of glycerol to 54.79 g/L in the presence of glycerol (Abstract). As described above for claim 27, Oh teaches addition of 2% glycerol in the medium that reads on the at least 5% glycerol relative to bacterial cells. However, if the 5% glycerol is required to be in the fermentation medium, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the amount of glycerol is a result effective variable. One would have been motivated to optimize the amount of glycerol with reasonably expected success to reach high amount of produced butyrate and because selection of medium component concentration is routine and conventional.
Chatila teaches enteric coating for the bacterial pharmaceutical composition containing bacteria producing butyrate (paragraphs 006, 007, 0353).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine teachings of Lacroix, Oh and Chatila and add butyrate producing bacteria and glycerol as described by Oh to the microbiota composition from Lacroix teaching to increase butyrate production and formulate the bacterial composition with an enteric coating as taught by Chatila. One would have been motivated to make this combination because Oh demonstrated significant increase in butyric acid production in the presence of glycerol in fermentation medium and Chatila teaches that enteric coating prevents microbes release in a toxic environment of stomach and allows composition to travel and be released in the small intestine where microbes can survive. A skilled artisan would have reasonably expected success in this combination because Lacroix, Oh and Chatila teach bacteria producing butyrate. Thus, claims 1 and 5 of Lacroix and Oh and Chatila teachings render claims 38 and 41 obvious.
Claims 45-49 of instant application are directed to bacterial strain consuming lactate and producing butyrate of genus Eubacterium and selected from recited species or of genus Anaerostipes and is Anaerostipes caccae (elected species). Claim 3 of Lacroix teaches the same bacterial species in group A6, i.e. Anaerostipes caccae and three of the recited species for Eubacterium genus, i.e. Eubacterium limosum, Eubacterium hallii and Eubacterium ramulus. Thus, claim 3 of Lacroix, Oh and Chatila teachings render claims 45-49 obvious.
Therefore, since instant claims 27, 31-33, 38, 41 and 45-49 encompass the subject matter of the reference claims 1, 3, 5 and 10, they are rejected under obviousness double patenting.
Response to Arguments
Applicant's arguments filed 09/22/2025 have been fully considered but they are not persuasive.
In response to Applicant’s arguments (addressing p. 9-10 of the Remarks) that the claims of 11219649 and the prior art of Oh do not teach a composition formulated using enteric coating, these arguments are not persuasive because current double patenting rejection is based on combination of the claims of 11219649 and the prior art of Oh and Chatila, wherein Chatila teaches enteric coating of the composition comprising consortium of bacteria including butyrate-producing bacteria as described in the rejection above. Therefore, the double patenting rejection is maintained and modified necessitated by amendment of claims.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIOUBOV G KOROTCHKINA whose telephone number is (571)270-0911. The examiner can normally be reached Monday-Friday: 8:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G.K./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653