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 .
Claim Status
Claims 202-214 and 216-222 are pending. Claims 1-201 and 215 have been cancelled.
Election/Restrictions
Applicant’s election without traverse of the invention of Group II directed to claims 213-216 in the reply filed on 22 December 2025 is acknowledged.
Claims 202-212 and 217-221 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 213, 214, 216 and 222 are hereby examined, and the requirement is deemed proper and is therefore made FINAL.
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings (e.g., Figure 19) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification, for example in Table 2, are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claim 213 is objected to for failing to italicize the limitation Cannabis.
Appropriate action is advised.
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.
The claimed invention as encompassed by claims 213, 214, 216 and 222 are directed to a natural phenomenon without significantly more.
Claim(s) recite(s) a method for testing nucleic acids to determine the presence or absence of a variation at a polymorphic site within a low-recombination region or an allele in linkage disequilibrium with the polymorphic site in said region and is thus considered a natural phenomenon as the method merely correlates variation with location in the Cannabis genome.
This judicial exception (JE) is not integrated into a practical application because testing for this naturally occurring phenomenon does not add any meaningful limitation to the presence or absence of said naturally occurring phenomenon.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the JE. In light of the absence of a practical application and additional elements to amount to significantly more than the JE the instant method precludes anyone that is skilled in the art from testing nucleic acids in a Cannabis plant for the presence of absence of variations at polymorphic sites or alleles in linkage disequilibrium in low-recombination regions.
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 213, 214, 216 and 222 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 method to detect SEQ ID NO: 146, does not reasonably provide enablement for a method to test the genus of variations in polymorphic sites as broadly claimed. 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 In re Wands (8 USPQ2d 1400 (CAFC 1988)), the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation". These factors include: (a) the quantity of experimentation; (b) the amount of guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the predictability of the prior art; (g) the breadth of the claims; and (h) the relative skill in the art. The factors are analyzed in turn for the instant case as follows:
Here, the claims are broadly drawn to a method comprising testing nucleic acids from a Cannabis plant to determine the presence or absence of a variation at any conceivable polymorphic site within a low-recombination region in the Cannabis genome or an allele in linkage disequilibrium with the polymorphic site within the low-recombination region, wherein the low recombination region is in chromosome CM010796.2 from about 40 megabases to about 42.5 megabases and wherein the polymorphic site is a PRR7 gene.
Meanwhile, the specification teaches that PRR7 expression decreases in photoperiod plants upon transition to flowering while its expression remains constant in autoflowering plants (e.g., see p. 13 and Figure 5).
The specification teaches that a cross between a photosensitive plant MOT19P06/Tangerine Dream and an autoflowering plant BAT1804/Blue Dream Auto (p. 33).
The specification suggests the genetic underpinning of the autoflowering trait is located in a 20 MB region that has undergone very little recombination with photosensitive genotypes and that further crossing experiments provided evidence for a significantly reduced linkage region with a minimum size of about 0.75 Mb to a maximum size of about 2.5 Mb within the 20 Mb region (p. 36; see also p. 37, ¶ 1).
The specification teaches that of 1172 genes located in a 20 MB low recombination region in chromosome CM010796.2 a subset of 14 genes were identified as actively expressed in both autoflowering and photoperiod sensitive plants with PRR7 located within 0.75 MB and 2.5 MB linkage regions (p. 41, last ¶ bridging p. 42).
PRR7 is homologous to Arabidopsis PRR7 and is known to involved in the circadian clock and with mutant flowering phenotypes (p. 42, ¶ 1). Non-functional PRR7 gene in Cannabis display the same autoflowering phenotype as Arabidopsis PRR7 mutants (p. 45, last ¶).
The specification teaches the predicted mutational affects on PRR7 protein is severe strongly indicating non-functional PRR7 protein is causative of day length neutral phenotype (p. 44, last ¶). These mutants display similar phenotypes as compared to Arabidopsis PRR7 mutants and that its early downregulation suggests it as a likely candidate for controlling flowering time (p. 45 ¶ 1; see also p. 48, last ¶; p. 51, last ¶). The specification teaches no other clock genes have been identified in the linkage region and no mutations have been identified in other clock genes such that PRR7 likely regulates other clock genes and represses flowering (p. 51, last ¶).
However, aside from teaching a method to determine the presence of a limited number of variations at polymorphic sites in a particular low-recombination region, the specification fails to teach the methods as broadly claimed wherein any variation at any polymorphic site whatsoever is tested.
Here, the claims encompass testing a vast genus of nucleic acids yet the specification only teaches a limited number of variations at polymorphic sites and on a particular chromosome and in a particular region of said chromosome.
This guidance is critical in light of the state of the art: Leckie et al teach that prr7 single mutants have a slight effect on flowering time and do no significantly disrupt the circadian rhythms of CCA1 and that it is a splice mutation in csPRR37 that causes autoflowering (2024, The Plant Journal, 118:2020-2036; p. 2030, col. 1, last ¶ bridging col. 2; see also p. 2021, col. 1, last ¶ bridging col. 2).
Therefore and aside from testing for PRR7, the skilled artisan would be unable to predictably use the methods as claimed to determine the presence or absence of other variations at other polymorphic sites as broadly claimed.
Thus, in light of the breadth of the claims, the lack of working examples, the lack of guidance and the state of the art, the skilled practitioner would be unable to predictably use the method as broadly claimed without resorting to impermissible undue trial and error experimentation.
Claims 213, 214, 216 and 222 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 213, 214, 216 and 222 are broadly drawn to a method comprising testing nucleic acids from a Cannabis plant to determine the presence or absence of a variation at a polymorphic site within a low-recombination region in the Cannabis genome or an allele in linkage disequilibrium with the polymorphic site within the low-recombination region, wherein the low recombination region is in chromosome CM010796.2 from about 40 megabases to about 42.5 megabases and wherein the polymorphic site is a PRR7 gene.
Here, the claims are broadly drawn to a method comprising testing nucleic acids from a Cannabis plant to determine the presence or absence of a variation at any conceivable polymorphic site within a low-recombination region in the Cannabis genome or an allele in linkage disequilibrium with the polymorphic site within the low-recombination region, wherein the low recombination region is in chromosome CM010796.2 from about 40 megabases to about 42.5 megabases and wherein the polymorphic site is a PRR7 gene.
Meanwhile, the specification describes that PRR7 expression decreases in photoperiod plants upon transition to flowering while its expression remains constant in autoflowering plants (e.g., see p. 13 and Figure 5).
The specification describes that a cross between a photosensitive plant MOT19P06/Tangerine Dream and an autoflowering plant BAT1804/Blue Dream Auto (p. 33).
The specification suggests the genetic underpinning of the autoflowering trait is located in a 20 MB region that has undergone very little recombination with photosensitive genotypes and that further crossing experiments provided evidence for a significantly reduced linkage region with a minimum size of about 0.75 Mb to a maximum size of about 2.5 Mb within the 20 Mb region (p. 36; see also p. 37, ¶ 1).
The specification describes that of 1172 genes located in a 20 MB low recombination region in chromosome CM010796.2 a subset of 14 genes were identified as actively expressed in both autoflowering and photoperiod sensitive plants with PRR7 located within 0.75 MB and 2.5 MB linkage regions (p. 41, last ¶ bridging p. 42).
PRR7 is homologous to Arabidopsis PRR7 and is known to involved in the circadian clock and with mutant flowering phenotypes (p. 42, ¶ 1). Non-functional PRR7 gene in Cannabis display the same autoflowering phenotype as Arabidopsis PRR7 mutants (p. 45, last ¶).
The specification describes the predicted mutational effects on PRR7 protein is severe strongly indicating non-functional PRR7 protein is causative of day length neutral phenotype (p. 44, last ¶). These mutants display similar phenotypes as compared to Arabidopsis PRR7 mutants and that its early downregulation suggests it as a likely candidate for controlling flowering time (p. 45 ¶ 1; see also p. 48, last ¶; p. 51, last ¶). The specification describes no other clock genes have been identified in the linkage region and no mutations have been identified in other clock genes such that PRR7 likely regulates other clock genes and represses flowering (p. 51, last ¶).
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
However, aside from describing a method to determine the presence of a limited number of variations at polymorphic sites in a particular low-recombination region, the specification fails to describe determining the presence or absence of a representative number of species from the broad genus of any variant at any polymorphic site whatsoever.
Here, the claims encompass testing a vast genus of nucleic acids yet the specification only teaches a limited number of variations at polymorphic sites and on a particular chromosome and in a particular region of said chromosome. In fact, the methods as claimed would preclude virtually anyone from testing for variations at polymorphic sites in the Cannabis genome.
The Federal Circuit has clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material." Id.
Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus." Id. See MPEP 2163.
Applicant should note that the written description requirement serves to warn an innocent purchaser of the infringement of a patent, and conversely requires the patentee to distinguish the invention in the disclosure, and thus prevents the inventor from practicing upon the credulity or fears of other persons or from pretending that the invention is more than what it is. see Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115.
Here, the instant specification has described a method to determine nucleic acid variations in particular genes rather than a method to test all variations in the Cannabis genome such that a skilled artisan would not be of the opinion that Applicant was in possession of methods as broadly claimed.
As such, these claims are “reach through” claims in which Applicant has only described a starting material and at least one method step, but has not described the resulting product such that the genus of products that can be produced by the recited method steps and materials is so large that one of skill in the art would not readily envision the members of the claimed genus. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)).
A description of a representative number of variants at polymorphic sites is critical in light of the state of the art: Leckie et al describe that prr7 single mutants have a slight effect on flowering time and do no significantly disrupt the circadian rhythms of CCA1 and that it is a splice mutation in csPRR37 that causes autoflowering (p. 2030, col. 1, last ¶ bridging col. 2; see also p. 2021, col. 1, last ¶ bridging col. 2).
Therefore and aside from testing for PRR7, the skilled artisan would not be of the opinion that Applicant possesses the methods as broadly claimed to determine the presence or absence of other variations at other polymorphic sites as broadly claimed.
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.
(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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Barrera et al (Pub. No. US 2024/0049666 A1).
Instant claim 1 is drawn to a method comprising testing nucleic acid from a Cannabis plant to determine the presence or absence of a variation at a polymorphic site within a low-recombination region in the plant or an allele in linkage disequilibrium with the polymorphic site within said region.
Barrera et al claim a method of plant breeding to develop an autoflower value phenotype by screening and selecting for a plant comprising an allele conferring said phenotype by using various markers (see claims 1, 2, 3 and 4).
Therefore, a method comprising testing nucleic acid from a Cannabis plant to determine the presence or absence of a variation at a polymorphic site within a low-recombination region in the plant or an allele in linkage disequilibrium with the polymorphic site within said region is anticipated by Barrera et al.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Barrera et al (Pub. No. US 2024/0130311 A1).
Instant claim 1 is drawn to a method comprising testing nucleic acid from a Cannabis plant to determine the presence or absence of a variation at a polymorphic site within a low-recombination region in the plant or an allele in linkage disequilibrium with the polymorphic site within said region.
Barrera et al claim a method of plant breeding to develop an autoflower value phenotype by screening and selecting for a plant comprising an allele conferring said phenotype by using various markers (see claims 1, 2, 3 and 4).
Therefore, a method comprising testing nucleic acid from a Cannabis plant to determine the presence or absence of a variation at a polymorphic site within a low-recombination region in the plant or an allele in linkage disequilibrium with the polymorphic site within said region is anticipated by Barrera et al.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 213, 214, 216 and 222 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barrera et al (Pub. No. US 2024/0049666 A1) in view of Nakamichi et al (2020, Bioscience, Biotechnology, and Biochemistry, 84(5):970-979) and McKernan (Pub. No. US 2016/0177404 A1).
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Instant claims 213, 214, 216 and 222 are drawn to a method comprising testing nucleic acid from a Cannabis plant to determine the presence or absence of a variation at a polymorphic site within a low-recombination region in the plant or an allele in linkage disequilibrium with the polymorphic site within said region, wherein the region is an about 20 megabase region in chromosome 5 and wherein the polymorphic site in in an endogenous PRR7 gene.
Barrera et al that the autoflower trait in Cannabis where plants flower based on age rather than length of day allows for a more consistent crop in terms of growth, yield and harvest times as compared with day-length sensitive varieties (¶ 0003 and 0004).
Barrera et al claim a method of plant breeding to develop an autoflower value phenotype by screening and selecting for a plant comprising an allele conferring said phenotype by using various markers (see claims 1, 2, 3 and 4).
Barrera et al teaches detection of a marker and/or other linked marker can be used to identify, select and/or produce plants having the autoflower phenotype and/or to eliminate plants from breeding programs or from planting that do not have the autoflower phenotype and it is known that markers may be in linkage disequilibrium (¶ 0031; see also ¶ 0061).
Barrera et al does not teach an about 20 megabase region in chromosome 5 or a polymorphic site in in an endogenous PRR7 gene
Nakamichi et al teaches that it was known in the art that PRR7 promotes flowering (p. 971, col. 2) while McKernan teaches sequencing of the Cannabis sativa and Indica genomes (see Abstract; see also ¶ 0036).
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to modify the method of Barrera et al to determine the presence or absence of a variation at a polymorphic site PRR7 because said gene is known to be involved in autoflowering, the importance or which is discussed supra.
One would have a reasonable expectation of success in doing so because both the Cannabis genome sequence was available as was the sequence for the PRR7 gene. Thus one would be able to reasonable determine if said gene contained a polymorphic site.
As one would be detecting the presence of the PRR7 gene, it follows that the polymorphic site in the gene must be in the low recombination region as claimed.
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.
Claim 213 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,002,546 B2 (referred to herein as ‘546). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 213 is drawn to a method comprising testing nucleic acid from a Cannabis plant to determine the presence or absence of a variation at a polymorphic site within a low-recombination region in the plant or an allele in linkage disequilibrium with the polymorphic site within said region.
Meanwhile, ‘546 claims a method for producing a Cannabis plant having a day length neutral phenotype comprising testing nucleic acid to determine the presence or absence of an allele that is in linkage disequilibrium with a variation in a polymorphic site of the UPF2 gene (see claim 1).
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the method as claimed because ‘546 claims a method which is a species within the genus of the instantly claimed methods.
Conclusion
No claim is allowed.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662