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
The instant application, filed 04/14/2023, is a 371 filing of PCT/US2021/055317, filed 05/15/2021, which claims domestic priority to U.S. provisional application numbers 63/093,140, and 63/093,102, both filed 10/16/2020.
Preliminary Amendments and Claim Status
The preliminary amendment filed on 04/14/2023 is acknowledged and entered.
Claims 7, 9, 13-15, 17-19, 21-26, 28, 43 are amended;
Claims 10-12, 20, 27, 29-42, 45, 46 and 48-60 are cancelled;
Claims 1-9, 13-19, 21-26, 28, 43, 44, and 47 are pending.
Information Disclosure Statement
The Information Disclosure Statement filed on 04/14/2023 is acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statement is considered.
The listing of references in the specification is not a proper information disclosure statement (for example see paragraphs [0010]). 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.
Restriction/Election
Applicant’s election without traverse of Group I (claims 1-9, 13, 14 and 21) drawn to a compound of formula (X) and a pharmaceutical composition thereof, in the reply filed on 11/18/2025 is acknowledged. Furthermore, Applicant’s elections of: i) compound A10 as a species of a compound of Formula (X), and ii) potassium channel activators as a species of additional therapeutic compound are hereby acknowledged.
In accordance with the MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP § 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species (Figure 1) does not make contribution over the prior art of record.
Figure 1. Elected Species
PNG
media_image1.png
142
300
media_image1.png
Greyscale
Figure 1. Compound A10, Applicant’s elected species
Status of Claims
Claims 1-9, 13-19, 21-26, 28, 43, 44, and 47 are pending in the instant application. Claims 3-5, 16-20, 22-26, 28, 43, 44, and 47 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 1, 2, 6-9, 13, 14, and 21 read on an elected invention and species and are therefore under consideration in the instant application.
Specification
The attempt to incorporate subject matter into this application by reference to define “scientific and technical terms… with meanings that are commonly understood by those of ordinary skill in the art” using a long list of references, for example in paragraphs [0042] and [0084], is ineffective because these publications have not been listed on an information disclosure statement, nor have copies of the publications been provided for the purposes of proper examination. Applicant is required to either amend the specification to specifically include the specific definitions to which the instant application is subject, or to provide the relevant passages from the reference publications within an information disclosure statement, and include them with the submissions of the instant application.
Specification is objected to for including chemical structures of varying quality on pages 33-81. Applicant is respectfully asked to represent the chemical structures in a singular, consistent format of sufficient resolution and image quality. For example, compound A1 and A2 are of very different image quality, as shown below:
PNG
media_image2.png
275
352
media_image2.png
Greyscale
Appropriate correction is required.
Drawings
The drawings filed on 04/14/2023 objected to under 37 CFR § 1.83(a) because they fail to show the data types as described in the instant specification.
The different data types are indistinguishable in Figures 4A/B. The original figures rely on color-coding of the data, a feature not available in the black and white drawings. The figures must be remade with shapes or line-types used to describe the different data points.
The different data types are indistinguishable in Figures 4A/B. The figures lack a figure key to describe the different data types. The figures must be remade with a figure key describing the different types of data found in the figures.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Claim 6 is subject to the following interpretation:
The claim recites, wherein “The compound of claim 1, wherein the compound is selected from a compound in Tables 1 and 2.” The claim is interpreted as depending on the limitations outlined in claim 1, which defines a compound of Formula (X); and encompassing all of the compounds found on pages 33-81 of the instant specification, as listed in Tables 1 and 2. This interpretation is to clarify the limitations of the claimed subject matter, which is presently in improper form. However, for the purposes of compact prosecution, the compounds are herein examined.
Claim Objections
Claim 1 is objected to for the use of images of low resolution within the claim limitations. for example in the definition of R9-R19
PNG
media_image3.png
179
266
media_image3.png
Greyscale
R22 and R23 are very difficult to distinguish due to the poor image quality used.
Claim 1 is further objected to for the recitation of “each R2′ to R3′ ” which should be corrected to “each R2′ and R3′ ” because there is no range between the integers 2 and 3.
Claim Rejections - 35 U.S.C. § 112 (a)
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, 2, 7-9, 13, 14, and 21 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 1, 2, 7-9, 13, 14, and 21 of the instant application are drawn to compounds having following substituents:
W is —C(R1)(R2)—, —C(O)—, —C(S)—, —O—, —S— or —N(R1)—
V is —C(R3)(R4)—, —C(O)—, —C(S)—, —O—, —S— or —N(R1)—
X1 to X13 are C, N, S or O
Y1 to Y5 are C, N, or O
Z1 to Z11 are C, N, or O
v is 0, 1, or 2
R1 to R4 are H, D, or (C1-C3) alkyl;
R5 to R8 are H, D, halo, (C1-C3)alkoxyl, or (C1-C3) alkyl
R9 to R19 are H, D, (C1-C3) alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, (C1-C3)alkoxyl,
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
n is an integer from 1 to 5
R20 to R23 are independently H, D or (C1-C3)alkyl;
R24 to R34 are optionally and independently selected from H, D, (C1-C3)alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, methoxy or
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R2′ and R3′ are H, D, (C1-C3) alkyl, (C1-C3)haloalkyl, (C1-C3)alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, (C1-C3)alkoxyl,
PNG
media_image5.png
94
250
media_image5.png
Greyscale
35 U.S.C. § 112(a) and the first paragraph of pre-AIA 35 U.S.C. § 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111,1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim’s enablement is not equally conclusive of that claim’s satisfactory written description"). The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert, denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaffv. Wells Bees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); EliLilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm.,927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). An application specification may show actual reduction to practice by describing testing of the claimed invention.
In the present case, the important factors leading to a conclusion of inadequate written description is the absence of any working example of the invention as claimed, and the lack of predictability in the art.
In the instant specification, there is no disclosure of compounds having the following claimed substituents:
W as —C(R1)(R2)—, —C(O)—, —C(S)—, —O—, —S—; 1-12 13-53 54-92
V as —C(R3)(R4)—, —C(S)—, —O—, —S— or —N(R1)—;
X4 as C, S or O
X5 as S or O
X6 as S or O
X7 as S or O
X10 as O
X11 as O
X12 as S, or O;
X13 as N, S, or O;
Y1 to Y3 as O
Y5 as C or O
Z1 to Z11 are C, N, or O
Z5 to Z8 as O
Z9 as N or O
Z10 as C or O
Z11 as N
v as 2
R1 as D, or (C1-C3) alkyl
R2 to R4 as H, D, or (C1-C3) alkyl
R5 as D, halo, (C1-C3)alkoxyl, or (C2-C3) alkyl
R6 as D, Chloro, Bromo, Iodo, (C1-C3)alkoxyl, or (C1-C3) alkyl
R9 as D, (C1-C3) alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, (C1-C3)alkoxyl,
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R10 as D, (C2-C3) alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, (C1-C3)alkoxyl,
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R11 as D, (C1-C3) alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, halo, cyano, hydroxyl, nitro, thiol, (C1-C3)alkoxyl,
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R12 as D, (C1-C3) alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, (C2-C3)alkoxyl,
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R13 as D, (C2-C3) alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, (C1-C3)alkoxyl,
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R14 as D, (C1-C3) alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, Chloro, Bromo, Iodo, cyano, hydroxyl, nitro, thiol, (C1-C3)alkoxyl,
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R15 as D, (C1-C3) alkyl, (C1-C3)haloalkyl, (C2-C3) alkenyl, Chloro, Bromo, Iodo, , hydroxyl, nitro, thiol, (C1-C3)alkoxyl,
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R16 as D, (C2-C3) alkyl, (C2-C3)haloalkyl, (C2-C3) alkenyl, Chloro, Bromo, Iodo, , hydroxyl, nitro, amino, thiol, (C1-C3)alkoxyl,
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R17 and R18 as D, (C1-C3) alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, (C1-C3)alkoxyl,
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R19 as D, (C2-C3) alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, (C1-C3)alkoxyl,
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R20 to R23 as D or (C2-C3)alkyl;
R24 to R34 are optionally and independently selected from H, D, (C1-C3)alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, methoxy or
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R24, R25, R26, R28, R33, and R34 as D, (C2-C3)alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, methoxy or
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R27 as D, (C2-C3)alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, methoxy or
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R30, R31, and R32 as D, (C2-C3)alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, Chloro, Bromo, Iodo, cyano, hydroxyl, nitro, thiol, amino, methoxy or
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R29 as D, (C2-C3)alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, Chloro, Bromo, Iodo, cyano, hydroxyl, nitro, thiol, amino, or
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R2′ as (C2-C3) alkyl, (C1-C3)haloalkyl, (C1-C3)alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, (C1-C3)alkoxyl,
PNG
media_image6.png
62
110
media_image6.png
Greyscale
PNG
media_image7.png
112
141
media_image7.png
Greyscale
R3′ as H, (C2-C3) alkyl, (C1-C3)haloalkyl, (C1-C3)alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, (C1-C3)alkoxyl,
n as 3 to 5
The instant specification (pages 33-81) teaches compounds which are characterized as having only the following substituents:
W is—N(R1)—;
V is —C(O)—,
X4 is N
X5 is C and N
X6 is C and N
X7 is C and N
X10 is C, N and S;
X11 is C, N and S;
X12 is C and N;
X13 is C
Y1 to Y3 are C and N
Y5 is N
Z5 to Z8 are C and N
Z9 is C
Z10 is N
Z11 is C and O
v is 0 and 1
R1 is H
R2 to R4 are not disclosed
R5 is H and CH3
R6 is H and Fluoro
R9 and R10 are H
R11 is H, CH3 , amino,
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R12 is H and OCH3
R13 is H, OCH3,
R14 is H, F, amino, and CHF2,
PNG
media_image8.png
108
141
media_image8.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R15 is H, F, CH3 cyano, amino,
PNG
media_image8.png
108
141
media_image8.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R16 is H, F, CH3, cyano, CHF2, CF3,
PNG
media_image8.png
108
141
media_image8.png
Greyscale
R17 and R18 are H
R19 is H and CH3
R20 to R23 are H and CH3
R24 to R34 are optionally and independently selected from H, D, (C1-C3)alkyl, (C1-C3)haloalkyl, (C1-C3) alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, methoxy or
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R24, R25, R26, R28, R33, and R34 are H and CH3
R27 is H, CH3,
PNG
media_image4.png
2
1
media_image4.png
Greyscale
PNG
media_image4.png
2
1
media_image4.png
Greyscale
R30, R31, and R32 are H, CH3, F
R29 is H, CH3, OCH3, F
n is 1, and 2
R2’ is H, CH3
R3’ is H, CH3
PNG
media_image5.png
94
250
media_image5.png
Greyscale
Therefore, the compounds described in the instant specification detail only a limited number of the total substituents claimed (see substituents 1-12, above). All working examples presented in the instant specification are related to the compounds containing a fraction of the total claimed substituents (see substituents 11-15, above).
There are no working examples in the instant specification for the wide range of substituents claimed, but for which evidence of possession has not been provided (see substituents 13-53, above). Thus the instant specification does not provide any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application.
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966(1997); In re Gosteli, 872 F.2d 1008, 1012,10 USPQ2d 1614, 1618 (Fed Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.") Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. For example, disclosure of only a method of making the invention and the function may not be sufficient to support a product claim other than a product-by-process claim. See, e.g., Fiers v. Revel, 984 F.2d at 1169, 25 USPQ2d at 1605; Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021.
Thus, since Applicant has not described in adequate detail methods to synthesize compounds containing the claimed substituents, or provided evidence that said compounds have been characterized, or that they exist, an ordinary skilled artisan could not completely envisage Applicants’ invention. Moreover, it is clear that the written description requirement has not been met since Applicant has not provided any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application. Thus, claims 1, 2, 7-9, 14, and 21 of the instant application are not supported by the instant specification and thus a rejection under 35 U.S.C. § 112 (a) for failing to comply with the written description requirement is proper.
Claim Rejections - 35 U.S.C. § 112 (b)
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, 2, 7-9, 14, and 21 are rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. More specifically, claim 1 recites, “each R5 to R8 is independently H, D, halo, (C1-C3)alkoxyl, or (C1-C3) alkyl.” However, substituents R7 and R8 are not described in any two-dimensional molecular formula. The omitted elements are R7 and R8, which renders claim 1 and all claims which depend on 1 incomplete.
Claims 2, 7-9, 14, and 21 depends on claim 1 and do not remedy the incompleteness of claim 1, and are thus dually rejected as incomplete.
Claim 6 is rejected under 35 U.S.C. § 112(b) for references to tables in the claims. As stated in MPEP § 2173.05 (s), claims should be complete to themselves and the reference to tables renders the claims incomplete. Claims which recite figures or tables are only permitted 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 the duplicating a drawing or table into a claim. It is suggested to amend claim 6 to list all of the desired compounds to be claimed.
Claim Rejections - 35 U.S.C. § 112 (d)
The following is a quotation of 35 U.S.C. § 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. § 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. § 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. § 112(d) or pre-AIA 35 U.S.C. § 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 6, the claim recites several compounds (found on pages 33-81 of the instant specification) in which either W or V is absent—such as in compound A1
PNG
media_image9.png
112
181
media_image9.png
Greyscale
on page 33 of the instant specification. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of W and V in claim 1, on which claim 6 is based. Specifically, W and V are defined only as being —C(R3)(R4)—, —C(O)—, —C(S)—, —O—, —S— or —N(R1)—, and not as being completely absent. For all the reasons set forth above, a compound wherein W or V are absent is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites several compounds (found on pages 33-65 of the instant specification) in which Y is pyrimidinyl—such as in compound A4
PNG
media_image10.png
128
190
media_image10.png
Greyscale
on page 44 of the instant specification. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of Y in claim 1, on which claim 6 is based. Specifically, Y is defined as being
PNG
media_image11.png
210
253
media_image11.png
Greyscale
, which does not allow for pyrimidinyl as a substituent
PNG
media_image12.png
60
52
media_image12.png
Greyscale
at position Y. For all the reasons set forth above, a compound wherein Y is pyrimidinyl is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites several compounds (found on pages 33-65 of the instant specification) in which Y is oxazoyl—such as in compound A29
PNG
media_image13.png
112
179
media_image13.png
Greyscale
on page 37 of the instant specification. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of Y in claim 1, on which claim 6 is based. Specifically, Y is defined as being
PNG
media_image14.png
132
147
media_image14.png
Greyscale
, which does not allow for oxazoyl
PNG
media_image15.png
50
43
media_image15.png
Greyscale
at position Y. Furthermore, the claim recites a phenyl group at position R3’, which is unsupported by the limitations of claim 1. Claim 1 recites “R3′ is independently H, D, (C1-C3) alkyl, (C1-C3)haloalkyl, (C1-C3)alkenyl, halo, cyano, hydroxyl, nitro, thiol, amino, (C1-C3)alkoxyl,” which does not provide sufficient support for a phenyl group at that position For all the reasons set forth above, a compound wherein Y is oxazoyl and R3’ is a phenyl group is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites several compounds (found on pages 33-65 of the instant specification) in which either W or V is SO2—such as in compound A88
PNG
media_image16.png
106
276
media_image16.png
Greyscale
on page 47 of the instant specification. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of W and V in claim 1, on which claim 6 is based. Specifically, W and V are defined only as being —C(R3)(R4)—, —C(O)—, —C(S)—, —O—, —S— or —N(R1)—, and not as being SO2. For all the reasons set forth above, a compound wherein either W or V are SO2 is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites several compounds (found on pages 33-65 of the instant specification) in which Y is an alkyl fragment (tert-butyl)—such as in compound A52
PNG
media_image17.png
82
163
media_image17.png
Greyscale
on page 41 of the instant specification. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of Y claim 1, on which claim 6 is based. Specifically, Y is not currently defined as being a substituted alkyl. For all the reasons set forth above, a compound wherein Z is piperidinyl is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites several compounds (found on pages 33-65 of the instant specification) wherein Z is piperidinyl—such as in compound A178
PNG
media_image18.png
119
271
media_image18.png
Greyscale
on page 62 of the instant specification. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of Z in claim 1, on which claim 6 is based. Specifically, Z is defined only as being
PNG
media_image19.png
144
166
media_image19.png
Greyscale
and not as being capable of being piperidinyl,
PNG
media_image20.png
76
93
media_image20.png
Greyscale
. For all the reasons set forth above, a compound wherein Z is piperidinyl is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 6, the claim recites several compounds (found on pages 33-65 of the instant specification) wherein Z is cyclopropyl—such as in compound A186
PNG
media_image21.png
87
265
media_image21.png
Greyscale
on page 64 of the instant specification. This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R27 in claim 1, on which claim 6 is based. Specifically, R27 is capable of being cyclopropyl based on the present limitations of the claim. For all the reasons set forth above, a compound wherein R27 is cyclopropyl is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
With respect to the example compounds included within the above rejections based on subject matter that is not within the scope of the claim on which it depends: the exemplary compounds are in no way a complete listing of the compounds within the claim. Over 300 unique compounds have been listed in claim 6. In the interest of brevity, only singular examples of the various substituents which contain subject matter that is not within the scope of claim 1 have been included so as to guide Applicant. To make the record clear, many more compounds listed in claim 6 are identified as including subject matter beyond that which is defined by claim 1. Applicant is expected to properly address every instance in which unsupported subject matter is included in all compounds in any forthcoming amendments to claim 6, based on the substituents identified herein. Particular attention should be paid to MPEP § 608.04, regarding new matter upon amendment of the instant dependent claim, as well as the independent claim.
Claim Rejections - 35 U.S.C. § 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.
Claims 1, 2, 6-9, and 21 are rejected under 35 U.S.C. § 102 (a)(1) and 102 (a)(2) as being anticipated by Evenseenko (WO 2019169135 A1, published September 6, 2019).
The instant claims are drawn to a compound of Formula (X) (see Figure 2b) and a pharmaceutical composition thereof.
Evenseenko teaches compositions and methods for modulating inflammatory and degenerative disorder (Title). Specifically, Evenseenko discloses CAS Registry Number: RN 457940-87-3. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 457940-87-3. Entered STN: 02 Oct 2002] (see Figure 2a below, and page 65, claim 5 column 2, row 3 of Evenseenko). Registry number 457940-87-3 is available as prior art as of 02 Oct 2002 (for the purposes of use as prior art under 35 U.S.C. § 102 (a)(1)), the date it was indexed into the REGISTRY database.
Registry number 457940-87-3 anticipates compounds of Formula (X) wherein:
W is —N(R1)—, wherein R1 is H
V is —C(O)—
Y is as shown in Figure 2d, wherein Y1-Y3 are C, v is 0, R14, R15, R17, and R18 are H, and R16 is CH3
X is as shown in Figure 2e, wherein X1 is N, X2 is S, X3 is C, R2’ is absent, and R3’ is H
Y3 are C, v is 0, R14, R15, R17, and R18 are H, and R16 is CH3
Z is as shown in Figure 2f, wherein Z5 is N, Z6-Z9 are C, R29-R32 are H, and R33 is absent
Figure 2. Comparison of the prior art compound with instantly claimed
PNG
media_image22.png
491
589
media_image22.png
Greyscale
Figure 2. a) CAS Registry Number: RN 457940-87-3 b) instantly claimed Formula (X); c) instantly claimed Formula (XA); d) instantly claimed Y; e) instantly claimed X; f) instantly claimed Z
Regarding claim 2, the compound taught by Evenseenko is represented by Formula (X-A, see Figure 2c), wherein X1 is N, X2 is S, X3 is C, R2’ is absent, and R3’ is H
Regarding claim 6, the compound taught by Evenseenko is compound A10 in Table 1 (page 35 of the specification).
Regarding claim 7, Evenseenko teaches a pharmaceutical composition of compound A10 (claim 12, paragraph [0093]).
Regarding claims 8, and 21, Evenseenko teaches a pharmaceutical composition of compound A10 comprising a pharmaceutically acceptable carrier (claim 12).
Regarding claim 9, Evenseenko teaches a pharmaceutical composition which dramatically inhibits Inflammation-induced degradation of cartilage matrix proteins (Figure 17). This is regarded as inherently treating inflammation and preventing joint degeneration. Regarding inherent properties, the courts have stated,
In re Reynolds, 443 F.2d 384, 170 USPQ 94 (CCPA 1971); In re Smythe, 480 F. 2d 1376, 178 USPQ 279 (CCPA 1973); Yeda Research and Dev. Co. v. Abbott GMBH & Co., 837 F.3d 1341, 120 USPQ2d 1299 (Fed. Cir. 2016) ("Under the doctrine of inherent disclosure, when a specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as adequate written description to support a subsequent patent application that explicitly recites the invention’s inherent properties." See MPEP § 2163.07 (a).
Thus, all compounds within Formula (X) inherently share the same properties. Therefore, the compounds detailed by Evenseenko are inherently capable to be used for the purposes of treating inflammation and preventing joint degeneration, although not explicitly taught in the reference.
See MPEP § 2128 “Printed Publications” as prior art. An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. § 102 (a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981): since this date represents the date that each compound entered the REGISTRY database on STN, this represents the date that each compound was made accessible to the public.
It is further noted that for the purposes of determining if a reference is a “printed publication,” MPEP § 2128 (I) states the following:
A reference is proven to be a "printed publication" "upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it." In re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA 1981) (quoting I.C.E. Corp. v. Armco Steel Corp., 250 F. Supp. 738, 743, 148 USPQ 537, 540 (SDNY 1966)) ("We agree that ‘printed publication’ should be approached as a unitary concept.
where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of pre-AIA 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 13 is rejected under 35 U.S.C. § 103 as being unpatentable over Evenseenko as applied to claims 1, 2, 6-9, and 21 above, and further in view of Tsantoulas and McMahon (Trends Neurosci. Volume 37, Issue 3, pages 146–158, published January 21, 2014).
Claim 13 is drawn to a pharmaceutical composition of Formula (X), further comprising an additional therapeutic compound, elected to be a potassium channel activator.
Evenseenko is as set forth above.
Evenseenko fails to teach wherein the composition further comprises a potassium channel activator.
The deficiencies of Evenseenko are remedied by Tsantoulas and McMahon, who teach that potassium channel activation is linked to inflammatory and mechanical pain phenotypes (Table 1). Specifically, the reference teaches potassium channel activators reduce inflammatory and mechanical pain by suppressing hyperexcitability of peripheral nociceptors (Kv7, BKCa, KATP, K2P, see Figure 2 of disclosure). Potassium channel activation polarizes sensory neurons, and limits pathological excitability that underlies inflammatory and mechanical pain. Finally, Tsantoulas and McMahon further disclose synergistic treatment strategies involvement potassium channel activators in combination with other drug classes to improve analgesic outcomes (page 185).
Regarding claim 13, a person of ordinary skill in the art following the teachings of Tsantoulas and McMahon would have been motivated to combine potassium channel activators with the compounds disclosed by Evenseenko, which treat inflammation, because both of types of compounds are directed to a common purpose, i.e., treating inflammation. According to MPEP 2144.06 (I), combining equivalents known for the same purpose is rendered obvious. The courts have said,
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
Motivated by the explicit teaching of Tsantoulas and McMahon that synergistic combinations with other drug classes may improve analgesic outcomes, a person of ordinary skill in the art would have been directly motivated to combine potassium channel activators with compounds known to treat inflammation by Evenseenko, as they are both directed to treating inflammation, thus rendering the claims prima facie obvious.
Claim 14 is rejected under 35 U.S.C. § 103 as being unpatentable over Evenseenko as applied to claims 1, 2, 6-9, and 21 above, and further in view of Sahil et al. (Int J Res Pharm Chem, Volume 1, Issue 4, pages 1184-1198, published 2011), hereinafter Sahil.
Claim 14 is drawn to a pharmaceutical composition of Formula (X), further comprising microspheres, wherein the composition is formulated for slow release delivery (see instant claim 14).
Evenseenko is as set forth above.
Evenseenko fails to teach wherein the composition further comprises microspheres, and wherein the composition is formulated for slow release delivery.
The deficiencies of Evenseenko are remedied by Sahil, who teaches the use of microspheres for delivering a therapeutic substance to a target site in a sustained-release controlled fashion (Abstract). Sahil reviews the various types of microspheres and the ways that drug efficacy is improved in a range of different conditions. Specifically teaches that inflammatory drug therapeutic efficacy has shown improvement upon use of controlled drug delivery and release systems Inc. microspheres (page 1188).
Accordingly, a person of ordinary skill in the art, prior to the filing date of the instant claims, would have found it obvious to modify the pharmaceutical composition taught by Evenseenko to treat inflammation, to include microspheres for slow release delivery, as taught by Sahil, in order to improve the efficacy of the pharmaceutical composition in treating inflammation.
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 1, 2, 6-8, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15-19 copending Application No. 18/561,253 (US 20240279608 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims define compounds which completely overlap in scope with the instantly claimed compounds, especially the elected species which is defined in claim 19 of the co-pending application (see page 57, column 2, row 1)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. If a notice of allowance is issued in the co-pending application 18/561,253, upon issue of the patent, the provisionary NSDP rejection over the co-pending application will convert to a NSDP rejection over the published patent.
Claims 1, 2, 6-9, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/858,121, (US 20250333423 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims define compounds which completely overlap in scope with the instantly claimed compounds, especially the elected species which is defined in claim 19 of the co-pending application (see co-pending specification, page 57, compound 6).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. If a notice of allowance is issued in the co-pending application 18/858,121, upon issue of the patent, the provisionary NSDP rejection over the co-pending application will convert to a NSDP rejection over the published patent.
Claims 1, 2, 6-9, 13, 14 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. US 11,420,964 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claim defines the compound that is the elected species (see claim 1).
Correspondence
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
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, Adam C. Milligan can be reached on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (571) 273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call +1 (800) 786-9199 (IN USA OR CANADA) or +1 (571) 272-1000.
/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623