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 .
Claims 1-20 are pending in the application.
This action is in response to applicants' amendment dated November 11, 2025. Claims 1-10 and 16-20 have been amended.
Response to Amendment
Applicant's arguments filed November 11, 2025 have been fully considered with the following effect:
With regards to the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection, labeled paragraph 2) maintained in the last office action. The applicants failed to comment on the rejection of “prodrug”.
Claims 1-13 and 16-20 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 enablement requirement. The claim(s) contains 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, for reasons of record and stated above.
The applicants’ amendments are sufficient to overcome the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection, labeled paragraph 5) in the last office action, which is hereby withdrawn.
With regards to the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection, labeled paragraph 6) in the last office action, the applicant’s amendments and remarks have been fully considered but they are not persuasive. The applicants stated that the chemical names of the compounds of Tables 1, 2, and 3 were generated using the ChemOffice Professional software, which is a gold standard for the scientific community. However, the compounds of Tables 1, 2 and 3 exhibit the (R) species only. Whether ChemOffice Professional software provides the nomenclature of the species as an (R) species or an (S) species it does not provide for both. It is either one or the other, only one species is listed and not the other thus, there is no written description for both species. Additionally, the first 9 species in claim 12 are not present in Table 2 at all.
Claims 11-13 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, for reasons of record and stated above.
With regards to the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection, labeled paragraph 7) in the last office action, the applicant’s amendments and remarks have been fully considered but they are not persuasive. The applicants stated that “the specification is not required to enable every conceivable embodiment or to describe efficacy against each possible disease within a mechanistic class if the skilled artisan would reasonably predict similar outcomes based on disclosed data and common scientific understanding”. A single compound T1.1 was shown to modulate a downstream target (Homer 1a) and the upregulation of Homer 1a has been linked to the treatment of depression. The applicants further state that they have provided many adenosine derivatives which have been approved drugs and/or clinical candidates for a variety of disease, however, there is no indication of which species have been approved for use as a GPCR. Additionally, it was stated that they have cited a plethora of reviews and papers in the specification showing the therapeutic effects of adenosine derivatives. First, adenosine derivatives are not solely GPCR agonist and second a listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. However, since the claims are read in light of the specification the following specific diseases that have been identified to be affected by adenosine receptor (AR) subtypes modulators include arrhythmia, ischaemia, vasodilation, dementia, anxiety, pain, Parkinson’s disease, etc. However, diseases such as hypoxia, epilepsy, Alzheimer’s disease, heart failure, dyslipidemia, glaucoma, etc. have been linked with the modulation of adenosine receptors which are neither supported nor contemplated, thus the generalization of diseases where any and all cardiovascular diseases, nervous system disorders, neurodegenerative disorders, renal system disorders, pulmonary disorders, inflammatory disorders, endocrine disorders, cancer and visual disorders are included in the treatment with the compounds of claim 1 is not remotely enabled.
Claims 18 and 19 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 enablement requirement. The claim(s) contains 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, for reasons of record and stated above.
The applicant's amendments and arguments are sufficient to overcome the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections, labeled paragraph 8a), b), c), d), e), f), i), k), n), p), q) and aa) in the last office action, which are hereby withdrawn. However, with regards to the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections, labeled paragraph 8g), h), j), l), m), o), r), s), t), u), v), w), x), y) and z) of the last office action, the applicant’s amendments and remarks have been fully considered but they are not persuasive.
g) The applicants’ stated that they have amended claim 3 to clarify that R7, as defined in Claim 1, is further selected from Formulas IIA and IIB and they further state that this amendment makes explicit that R7 is first broadly defined in Claim 1 and then narrowed in Claim 3 to particular structural embodiments including the “-O-R11” and “-O-R12”. The applicants own claim language states that the definition of R7 is further Formula IIA and Formula IIB which is broader than the definition of R7 in claim 1 and thus lacks antecedent basis remains, i.e. "further" means to add more items, details, or points to something already stated, essentially saying "in addition" or "more so," often to expand on a list. A dependent claim must narrow the scope of the claim from which it depends not expand upon it.
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 applicant regards as the invention, for reasons of record and stated above.
h) The applicants’ stated that as amended, claim 3 now recites R11 and R12 as “independently selected from hydrogen, alkyl, amino acid residue, -C(O)R14, -C(O)NR14R15…”. However, the definition of Formula IIA and Formula IIB which previously corresponded to the variable R8 which has been deleted and the definition of R7 cannot be further substituted with alkyl, amino acid residue, -C(O)R14, or -C(O)NR14R15.
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 applicant regards as the invention, for reasons of record and stated above.
j) The applicants’ stated that as amended, R14 and R15 are independently defined to include “alkyl” directly, without reliance on R8. However, the definition of R8 never included “alkyl” but was defined as “lower alkyl”. The applicant’s specification states that “lower alkyl” refers to an alkyl that includes from one to six carbon atoms and thus is limited to C1-6 alkyl.
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 applicant regards as the invention, for reasons of record and stated above.
l) The applicants’ stated that as amended, R13 in claim 3 has been amended to clarify the grammar by reciting “a-CH2-Cl group” (and similarly for other substituents such as a-CH2OH, a-COOR16 and a-CONR16R17). However, claim 3 recites that the R7 which is the ring of Formula IIA is substituted by halo, alkyl, hydroxy, alkoxy, aryloxy, amino, mono- or di-substituted amino, acyl or sulfonyl which fails to include the moiety a-CH2-Cl group, as well as a-CH2OH, a-COOR16 and a-CONR16R17.
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 applicant regards as the invention, for reasons of record and stated above.
m) The applicants’ stated that as amended, R16 and R17 are independently defined to include “alkyl” directly, with optional substitution by a clear explicit list of substituents (halo, alkyl, hydroxy, alkoxy, aryloxy, amino, mono- or di-substituted amino, acyl or sulfonyl) and stated that they correspond to the variable R8 which is not so, R16 and R17 are substituents on two of the moieties within the definition of R13 which fails to include hydrogen or alkyl.
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 applicant regards as the invention, for reasons of record and stated above.
o) The applicants’ stated that they have amended claim 4 to clarify that R7, as defined in Claim 1, is further selected from Formulas IIA and IIB and they further state that this amendment makes explicit that R7 is first broadly defined in Claim 1 and then narrowed in Claim 4 to particular structural embodiments including the “-O-R11” and “-O-R12”. The applicants own claim language states that the definition of R7 is further Formula IIA and Formula IIB which is broader than the definition of R7 in claim 1 and thus lacks antecedent basis remains, i.e. "further" means to add more items, details, or points to something already stated, essentially saying "in addition" or "more so," often to expand on a list. A dependent claim must narrow the scope of the claim from which it depends not expand upon it.
Claim 4 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 applicant regards as the invention, for reasons of record and stated above.
r) The applicants’ stated that Claim 8 has now been amended to explicitly define R18 as “selected from aryl or heteroaryl, each substituted as defined in Claim 1. However, in claim 1 R6 is defined as alkynyl optionally substituted with one or more substituents selected from halo, lower alkyl, lower alkenyl, lower alkynyl, hydroxy, lower alkoxy, aryloxy, amino, mono- or di-substituted amino, acyl or sulfonyl.
Claim 8 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 applicant regards as the invention, for reasons of record and stated above.
The applicants’ stated that the remaining subpoints concern claims which are now canceled. However, since no claims have been canceled the rejections are herein maintained.
Claim 12 is vague and indefinite in that it is not known what is meant by the species on page 24, lines 7-9 i.e., (1S,2R,3S,4R,5S)-4-(2-([1,1'-biphenyl]-4-ylethyny1)-6-((((R)-2-amino-3-methylbutanamido)methyl)(4-hydroxy-3-methoxyphenethyl)amino)-9H-purin-9-yl)-2,3-dihydroxy-N-methylbicyclo[3.1.0]hexane-1-carboxamide which is a duplicate of the species on page 23, lines 13-15.
Claim 12 is vague and indefinite in that it is not known what is meant by the species on page 24, lines 10-12 i.e., (1S,2R,3S,4R,5S)-4-(2-([1, l'-biphenyl]-4-ylethynyl)-6-((((S)-2-amino-3-methylbutanamido)methyl)(4-hydroxy-3-methoxyphenethyl)amino)-9H-purin-9-yl)-2,3-dihydroxy-N-methylbicyclo[3.1.0]hexane-1-carboxamide which is a duplicate of the species on page 23, lines 16-18.
Claim 12 is vague and indefinite in that it is not known what is meant by the species on page 24, lines 13-15 i.e., (1S,2R,3S,4R,5S)-4-(2-([1,1'-biphenyl]-4-ylethyny1)-6-((acetamidomethyl)(4-hydroxy-3-methoxyphenethyl)amino)-9H-purin-9-yl)-2,3-dihydroxy-N-methylbicyclo[3.1.0]hexane-1-carboxamide which is a duplicate of the species on page 23, lines 19-21.
Claim 12 is vague and indefinite in that it is not known what is meant by the species on page 24, lines 16-18 i.e., (1S,2R,3S,4R,5S)-4-(2-([1,1'-biphenyl]-4-ylethynyl)-6-((4-hydroxy-3-methoxyphenethyl)(propionamidomethyl)amino)-9H-purin-9-yl)-2,3-dihydroxy-N-methylbicyclo[3.1.0]hexane-1-carboxamide which is a duplicate of the species on page 23, lines 22-24.
Claim 12 is vague and indefinite in that it is not known what is meant by the species on page 24, lines 19-21 i.e., N-(((2-([1,1'-biphenyl]-4-ylethynyl)-9-((1S,2R,3S,4R,5S)-3,4-dihydroxy-5-(methylcarbamoyl)bicyclo[3.1.0]hexan-2-yl)-9H-purin-6-yl)(4-hydroxy-3-methoxyphenethyl)amino)methy!)nicotinamide which is a duplicate of the species on page 23, lines 25-27.
Claim 12 is vague and indefinite in that it is not known what is meant by the species on page 24, lines 22-24 i.e., (1S,2R,3S,4R,5S)-4-(2-([1,1'-biphenyl]-4-ylethynyl)-6-((4-hydroxy-3-methoxyphenethyl)((2-phenylacetamido)methyl)amino)-9H-purin-9-yl)-2,3-dihydroxy-N-methylbicyclo[3.1.0]hexane-1-carboxamide which is a duplicate of the species on page 23, lines 28-30.
Claim 12 is vague and indefinite in that it is not known what is meant by the species on page 24, lines 25-27 i.e., (1S,2R,3S,4R,5S)-4-(2-([1,1'-biphenyl]-4-ylethyny1)-6-((((R)-2-amino-3-phenylpropanamido)methyl(4-hydroxy-3-methoxyphenethyl)amino)-9H-purin-9-yl)-2,3-dihydroxy-N-methylbicyclo[3.1.0]hexane-1-carboxamide which is a duplicate of the species on page 24, lines 1-3.
Claim 12 is vague and indefinite in that it is not known what is meant by the species on page 24, lines 28-30 i.e., (1S,2R,3S,4R,5S)-4-(2-([1,1'-biphenyl]-4-ylethynyl)-6-((((S)-2-amino-3-phenylpropanamido)methyl)(4-hydroxy-3-methoxyphenethyl)amino)-9H-purin-9-yl)-2,3-dihydroxy-N-methylbicyclo[3.1.0]hexane-1-carboxamide which is a duplicate of the species on page 24, lines 4-6.
Claim 12 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 applicant regards as the invention, for reasons of record and stated above.
In view of the amendment dated November 11, 2025, the following new grounds of rejection apply:
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 1-13 and 16-20 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. The amendment to claim 1 where the definition of R8 has been deleted and the definition has been incorporated into the definition of R2, R5 and R7 where the hydrogen, alkyl, heteroalkyl, aryl, arylalkyl, heteroaryl, heteroaylalkyl, cycloalkyl, and bicycloalkyl are each substituted with one or more substituents selected from halo, alkyl, hydroxy, alkoxy, aryloxy, amino, mono- or di-substituted amino, acyl or sulfonyl. The definition of the substituents which previously corresponded to the variable R8 includes the moieties alkyl, alkoxy, mono- or di-substituted amino, acyl or sulfonyl which are not described in the specification with respect to the compounds of Formula I. Alkyl is limited to lower alkyl in the definition of R-8; alkoxy is limited to lower alkoxy; mono- or di-substituted amino is limited to alkylamino, dialkylamino or diarylalkylamino; acyl and sulfonyl are not defined by R8.
Applicant is required to cancel the new matter in the reply to this Office action.
Claims 1-13 and 16-20 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. The amendment to claim 1 where the definition of R8 has been deleted and the definition has been incorporated into the definition of R6 where the hydrogen, halogen, alkyl, alkenyl, alkynyl, heteroalkyl, aryl, arylalkyl, heteroaryl, heteroaylalkyl, cycloalkyl, and heterocycloalkyl, wherein each of the foregoing groups is optionally substituted with one or more substituents selected from halo, lower alkyl, lower alkenyl, lower alkynyl, hydroxy, lower alkoxy, aryloxy, amino, mono- or di-substituted amino, acyl or sulfonyl. The definition of the substituents which previously corresponded to the variable R8 includes the moieties mono- or di-substituted amino, acyl or sulfonyl which are not described in the specification with respect to the compounds of Formula I. Mono- or di-substituted amino is limited to alkylamino, dialkylamino or diarylalkylamino; acyl and sulfonyl are not defined by R8.
Applicant is required to cancel the new matter in the reply to this Office action.
Claim 20 is 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. The amendment to claim 20 where the process of producing a compound of Formula I which comprises reacting a “purine derivative” with a “bicyclohexane derivative” are not described in the specification with respect to the compounds of Formula I.
Applicant is required to cancel the new matter in the reply to this Office action.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 and 16-20 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 pre-AIA the applicant regards as the invention. The following reasons apply:
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the definition of R2, R5 and R7 is hydrogen substituted with one or more substituents selected from halo, alkyl, hydroxy, alkoxy, aryloxy, amino, mono- or di-substituted amino, acyl or sulfonyl.
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the definition of R6 is hydrogen or halogen substituted with one or more substituents selected from halo, lower alkyl, lower alkenyl, lower alkynyl, hydroxy, lower alkoxy, aryloxy, amino, mono- or di-substituted amino, acyl or sulfonyl.
Claim 2 recites the limitation "heterocycloalkyl" in the definition of R2. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "isopropyl" in the definition of R3. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "alkyl" in the definition of R4. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 is vague and indefinite in that it is not known what is meant by “as defined in Claim 1 within the definition of R4.
Claim 3 recites the limitation "
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" in the definition of R7. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 is vague and indefinite in that it is not known what is meant by “substituted as defined in Claim 1” in the definition of R14 and R15 and again in the definition of R16 and R17.
Claim 4 recites the limitation "
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" in the definition of R7. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "Formula IIIB" in the definition of R7. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 is vague and indefinite in that it is not known what is meant by “each substituted as defined in Claim 1” in the definition of R18.
Claim 9 recites the limitation "-CH2-OH" in the Formula VIA and Formula VIB. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "-CH2-OH" in the Formula VII. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "-C(=O)-OH" in the Formula VII. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "dicyclopropylmethyl" in the 2 species on page 6 and the first 7 species on page 7 with respect to R2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "dicyclobutylmethyl" in the last 6 species on page 7 and the first 3 species on page 8 with respect to R2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 is vague and indefinite in that it does not end with a period indicating the end of the claim.
Claim 13 recites the limitation “hydroxymethyl” in the 5 species on page 12, the 10 species on page 13 and the 3 species on page 14 with respect to substituents on R7. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 is vague and indefinite in that it does not end with a period indicating the end of the claim.
Claim 18 is vague and indefinite in that it is not known what is meant by “defined in any of the claim 1”.
Claim Objections
The applicants have placed a status identifier on claims 14 and 15 as “(Withdrawn)”. Cancellation of these claims or other appropriate action is required in response to this final action.
Claims 4 and 19 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only.
Conclusion
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 BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624