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 .
DETAILED ACTION
Applicant’s preliminary amendment filed on June 23, 2025 is acknowledged. Claims 4, 7, 9, 12-13, 16-18, 24, and 27-30 have been amended. Claims 5-6, 8, 14-15, 19-23, and 31-36 have been canceled. Claims 1-4, 7, 9-13, 16-18, and 24-30 are currently pending.
Election/Restriction
2. REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-4, 7, 9, and 24-29, drawn to a pharmaceutical agent comprising bacteria.
Group II, claim(s) 10-13 and 16-18, drawn to a method of making a paste with a bacteria.
Group III, claim(s) 30, drawn to a method of preventing or treating a disease.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Group I lack unity of invention because even though the inventions of these groups require the technical feature of a pharmaceutical agent comprising bacteria, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Dixit, WO 2018/218159 A1; Published: 11/29/18.
Dixit discloses therapeutically effective amounts of a pharmaceutical composition or a previously frozen fecal microbe composition. In one aspect, a fecal microbiota preparation comprises an isolated or purified population of live non-pathogenic fecal bacteria (i.e. Bifidobacterium adolescentis, Prevotella, Veillonella)(see paragraphs 0074-75; 102) at least about 1011 cells or spores (see paragraph 0100). The therapeutic composition can be provided together with a pharmaceutically acceptable carrier to include excipient (see paragraph 0115; meets claim 9).
During a telephone conversation with Mi Cai on October 28, 2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-4, 7, 9, and 24-29. Affirmation of this election must be made by applicant in replying to this Office action. Claims 10-13, 16-18 and 30 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claims 1-4, 7, 9, and 24-29 are under examination.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on June 23, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
Claim Objections
4. Claim 29 is objected to for relying on Tables 1-4. MPEP 2173.05(s) (Reference to Figures or Tables) discloses that where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. See MPEP § 608.01(m).
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.
5. Claim 28 is rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 28 is drawn in part to a solid dosage form, pharmaceutical agent, or pharmaceutical composition, wherein the bacteria are of the species Lactococcus lactis cremoris, optionally the Lactococcus lactis cremoris is Lactococcus lactis cremoris Strain A (ATCC designation number PTA-125368); the bacteria are of the species Veillonella parvula, optionally the Veillonella parvula is Veillonella parvula (ATCC designation number PTA-125691); the bacteria are of the species Prevotella histicola, optionally the Prevotella histicola is Prevotella histicola Strain B 50329 (NRRL accession number B 50329); or the bacteria are of the species Bifidobacterium animalis, optionally the Bifidobacterium animalis is Bifidobacterium animalis ssp. lactis (ATCC designation number PTA-125097).
Because it is not clear that cell lines possessing the properties of Lactococcus lactis cremoris Strain A (ATCC designation number PTA-125368), Veillonella parvula (ATCC designation number PTA-125691), Prevotella histicola Strain B 50329 (NRRL accession number B 50329), and Bifidobacterium animalis ssp. lactis (ATCC designation number PTA-125097) are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the claims require the use of a suitable deposit for patent purposes a deposit in a public repository is required. Without a publicly available deposit of the above Lactococcus lactis cremoris Strain A (ATCC designation number PTA-125368), Veillonella parvula (ATCC designation number PTA-125691), Prevotella histicola Strain B 50329 (NRRL accession number B 50329), and Bifidobacterium animalis ssp. lactis (ATCC designation number PTA-125097), one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the cell line is an unpredictable event.
Applicant’s referral to the deposit of Lactococcus lactis cremoris Strain A (ATCC designation number PTA-125368), Veillonella parvula (ATCC designation number PTA-125691), Prevotella histicola Strain B 50329 (NRRL accession number B 50329), and Bifidobacterium animalis ssp. lactis (ATCC designation number PTA-125097) on pages 18-19 of the specification is an insufficient assurance that all required deposits have been made and all the conditions of 37 CFR 1.801-1.809 have been met.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by the International Depository Authority under the provisions of the Budapest Treaty and that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application. These requirements are necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR 1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring: (a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request; (b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application; (c) the deposits will be maintained in the public repository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and (d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the repository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of biological material not made under the Budapest Treaty must be filed in the application and must contain: 1) The name and address of the depository; 2) The name and address of the depositor; 3) The date of deposit; 4) The identity of the deposit and the accession number given by the depository; 5) The date of the viability test; 6) The procedures used to obtain a sample if test is not done by the depository; and 7) A statement that the deposit is capable of reproduction. As well as a statement that removes restrictions to provide access to this strain upon granting of a patent has not made, either in the instant Specification, nor in Applicant's Remarks.
One of the critical conditions of Deposit is defined in 37 CFR 1.808 requires that the deposit of biological material be made under two conditions: (A) access to the deposit will be available during pendency of the patent application making reference to the deposit to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C. 122, and (B) with one exception, that all restrictions imposed by the depositor on the availability to the public of the deposited biological material be irrevocably removed upon the granting of the patent. Upon making this statement, the rejection under 35 USC 112, first paragraph will be withdrawn. This rejection can be obviated through perfection of the Deposit and amendment of the claims to clearly set forth the Deposited strains.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the Lactococcus lactis cremoris Strain A (ATCC designation number PTA-125368), Veillonella parvula (ATCC designation number PTA-125691), Prevotella histicola Strain B 50329 (NRRL accession number B 50329) and Bifidobacterium animalis ssp. lactis (ATCC designation number PTA-125097) described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant’s possession at the time the application was filed.
Applicant’s attention is directed to In re Lundack, 773 F.2d.1216, 227 USPQ (CAFC 1985) and 37 CFR 1.801-1.809 for further information concerning deposit practice.
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.
6. Claim 3 is 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 3 is rendered vague and indefinite by the use of “(e.g., powder)”. Parenthesis are viewed in the same manner as ‘such as’, which is exemplary language and is not permitted in a claim. The ambiguity of scope is not clear as the Office does not know clearly what is included and what is to be excluded. As written, it is impossible to determine the metes and bounds of the claimed invention.
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.
7. Claims 1-4, 7, 9, and 24-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,090,341 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn to a pharmaceutical agent comprising bacteria, wherein the bacteria in the pharmaceutical agent are present at a total cell count (TCC) of at least 1x1011 cells/gram of the pharmaceutical agent.
The patented claims are drawn to a pharmaceutical composition formulated for oral administration comprising bacteria (i.e. freeze-dried) comprising Veillonella parvula strain B (at least 1x106) and a pharmaceutically acceptable carrier within an enteric coating (coated tablet or capsule). As it pertains to claims 3, 4, 7 and 9, it would have been obvious to one of skill in the art to add an excipient and cryoprotectant (such as sucrose and dextran), because it is the most reliable and widely used methods for long-term preservation of pathogenic microbial strains; as evidenced by Andreasen et al., WO 2014/083169 A1; Published:6/5/14. The amount by which the agent is to be present is a matter of routine optimization.
8. Claims 1-4, 7, 9, and 24-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,792,314 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn to a pharmaceutical agent comprising bacteria, wherein the bacteria in the pharmaceutical agent are present at a total cell count (TCC) of at least 1x1011 cells/gram of the pharmaceutical agent.
The patented claims are drawn to a pharmaceutical composition formulated for oral administration comprising Bifidobacterium animalis ssp. Lactis strain A (at least 7.5x1010) and a pharmaceutically acceptable carrier within an enteric coating (coated tablet or capsule). As it pertains to claims 3, 4, 7, and 9 it would have been obvious to one of skill in the art to add a an excipient and cryoprotectant (such as sucrose and dextran), because it is one of the most reliable and widely used methods for long-term preservation of pathogenic microbial strains; as evidenced by Andreasen et al., WO 2014/083169 A1; Published:6/5/14. The amount by which the agent is to be present is a matter of routine optimization.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
9. Claim(s) 1-4, 7, 9, 24-27, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dixit, WO 2018/218159 A1; Published: 11/29/18.
Independent claim 1 is drawn to a pharmaceutical agent comprising bacteria, wherein the bacteria in the pharmaceutical agent are present at a total cell count (TCC) of at least 1x1011 cells/gram of the pharmaceutical agent.
Dixit discloses therapeutically effective amounts of a pharmaceutical composition or a previously frozen fecal microbe composition. In one aspect, a fecal microbiota preparation comprises an isolated or purified population of live non-pathogenic fecal bacteria (i.e. Bifidobacterium adolescentis, Prevotella, Veillonella)(see paragraphs 0074-75; 102; meets limitations of claim 1, 27, 29). A pharmaceutically active or therapeutic effective dose comprises at least about 1011 cells or spores (see paragraph 0100; meets limitations of claims 1-2). The therapeutic composition can be provided together with a pharmaceutically acceptable carrier to include excipient (see paragraph 0115; meets claim 9). Moreover, Dixit discloses that said composition comprises a cryoprotectant comprising sucrose (@ 5-10%) (see paragraph 0080-81; meets claims 3, 4, 7). In one aspect, a pharmaceutical composition is formulated as a geltab, pill, microcapsule, capsule, or tablet, as well as an enteric coated capsule (see paragraph 0092; meets claims 24-26).
Since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
10. Claim(s) 1-2, 9, and 24-29 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Cook et al., US 2016/0317653 A1; Published: 11/3/16.
Independent claim 1 is drawn to a pharmaceutical agent comprising bacteria, wherein the bacteria in the pharmaceutical agent are present at a total cell count (TCC) of at least 1x1011 cells/gram of the pharmaceutical agent.
Cook et al. disclose a composition comprising Veillonella parvula, Bifidobacterium animalis (see paragraph 0052, 61; meets limitation of claim 1 & 27-29). The preparations comprising the lactic acid bacterial populations are in a pharmaceutical composition. Said preparation may contain non-cellular materials, a bacterial supplement, binder, filler, vitamin, mineral, or combination thereof. Additional ingredients include ingredients to improve handling like preservatives, antioxidants, flavorings and the like (see paragraph 0081). Pharmaceutical or nutritional products are formulated such that a single administered dose or consumed unit contains at least about 1×104 colony forming units (cfus) of the bacteria (see paragraph 0083; meets claim 1-2). Such dosage forms include tablet and capsule forms (meets claim 24). Can be a free-flowing powder and an enteric coating (see paragraph 0090; meets claim 25-26). Material that can be used in enteric coatings includes, for example, alginic acid, cellulose acetate phthalate, plastics, waxes, shellac, and fatty acids (e.g., stearic acid, palmitic acid) (see paragraph 0092; meets claims 25-26). For example, a composition can be administered in a solid or liquid form. Examples of solid dosage forms include but are not limited to discrete units in capsules or tablets, as a powder or granule, or present in a tablet conventionally formed by compression molding (see paragraph 0095; meets claim 24). The composition further comprises conventional excipients (see paragraph 0096; meets claim 9).
Since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Conclusion
11. No claim is allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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, Gary B Nickol can be reached at 571-272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 November 13, 2025
/BRIAN GANGLE/Primary Examiner, Art Unit 1645