DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 10-23 are pending in the instant invention. According to the Amendments to the Claims, filed May 21, 2024, claims 10-12 and 15 were amended, claims 1-9 were cancelled and claims 16-23 were added.
Status of Priority
This invention claims priority under 35 U.S.C. § 119(a-d) to: a) JP 2023-029739, filed February 28, 2023; and b) JP 2022-138548, filed August 31, 2022.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on December 4, 2025, is acknowledged: a) Group I - claims 10, 16-18 and 20-23; and b) substituted heteroaryl (MYT inhibitor) of formula (1) - p. 172, formula (2), shown to the right below, and hereafter referred to as 2-amino-1-(3-hydroxy-2,6-dimethylphenyl)-5,6-dimethyl-1H-pyrrolo-[2,3-b]pyridine-3-carboxamide, where R6 = -C(O)NHR8, wherein R8 = -H; R5 = -NR7R7, wherein each R7 = -H; R1 = -CH3; X = CR2, wherein R2 = -CH3; Y = N; Z = CR2, wherein R2 = -H; R3 = -CH3; and R4 = -CH3. Claims 10, 16-18 and 20-23 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
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Similarly, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Likewise, the inventor or joint inventor should further note that the elected species, shown to the right, was not found to be free of the prior art.
Moreover, the inventor or joint inventor should further note that claims 11-15 and 19 were withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking claim.
Thus, a first Office action and prosecution on the merits of claims 10, 16-18 and 20-23 is contained within.
Specification Objection - Disclosure
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the inventor’s or joint inventor’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility invention should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase Not Applicable should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR
DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A
COMPACT DISC.
(f) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art (including information disclosed under 37 CFR 1.97
and 1.98).
(g) BRIEF SUMMARY OF THE INVENTION.
(h) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(i) DETAILED DESCRIPTION OF THE INVENTION.
(j) CLAIM OR CLAIMS (commencing on a separate sheet).
(k) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(l) SEQUENCE LISTING (See MPEP § 2424 and 37 CFR 1.821-1.825).
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(b) above. Revisions should particularly include section headings (b-i), where applicable. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying the substituted heteroaryls represented by the formula (1).
The following title is suggested: SUBSTITUTED HETEROARYLS AS MYT1 INHIBITORS.
Appropriate correction is required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of formula (1) into the abstract, to overcome this objection.
Claim Objections
Claim 10 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b), and/or compliance with the Requirement for Restriction/Election of Species, mailed on October 7, 2025, the existing recitation should be replaced with the following recitation:
A method for treating cancer in a cancer patient, wherein the method comprises administering to the cancer patient in need thereof a combination of a chemotherapeutic agent and a therapeutically effective amount of a myelin transcription factor 1 (MYT1) inhibitor compound represented by the formula (1):
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(1)
or a pharmaceutically acceptable salt thereof,
wherein:
R1 is H, halogen, CN, C1-6 alkyl, C1-6 alkylene-C2-9 heterocyclyl, C1-6 alkylene-C1-9 heteroaryl, C2-6 alkenyl, C2-6 alkynyl, C(O)NR8R8, NR7R7, OR7, S(O)2R7A, S(O)2NR8R8, C3-8 cycloalkyl, C3-8 cycloalkenyl, C2-9 heterocyclyl, C6-10 aryl, C1-9 heteroaryl, or Q-R7B, wherein the C1-6 alkyl, C1-6 alkylene-C2-9 heterocyclyl, C1-6 alkylene-C1-9 heteroaryl, C2-6 alkenyl, C2-6 alkynyl, C3-8 cycloalkyl, C3-8 cycloalkenyl, C2-9 heterocyclyl, C6-10 aryl, and C1-9 heteroaryl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, (=NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl;
X is CR2 or N;
Y is CR2 or N;
Z is CR2 or N;
each R2 is independently H, halogen, CN, C1-6 alkyl, C1-6 alkylene-C2-9 heterocyclyl, C1-6 alkylene-C1-9 heteroaryl, C2-6 alkenyl, C2-6 alkynyl, C(O)NR8R8, NR7R7, OR7, S(O)2R7A, S(O)2NR8R8, C3-8 cycloalkyl, C3-8 cycloalkenyl, C2-9 heterocyclyl, C6-10 aryl, C1-9 heteroaryl, or Q-R7B, wherein each C1-6 alkyl, C1-6 alkylene-C2-9 heterocyclyl, C1-6 alkylene-C1-9 heteroaryl, C2-6 alkenyl, C2-6 alkynyl, C3-8 cycloalkyl, C3-8 cycloalkenyl, C2-9 heterocyclyl, C6-10 aryl, and C1-9 heteroaryl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; or
R1 and R2 of X, taken together with the carbon atoms to which they are attached, form a C3-6 cycloalkylene, wherein the C3-6 cycloalkylene is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, alkyl, alkenyl, alkynyl, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; or
R1 and R2 of Z, taken together with the carbon atoms to which they are attached, form a C3-6 cycloalkylene, wherein the C3-6 cycloalkylene is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, alkyl, alkenyl, alkynyl, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl;
each Q is independently C1-6 alkylene, C2-6 alkenylene, C2-6 alkynylene, C3-8 cycloalkylene, C3-8 cycloalkenylene, C2-9 heterocyclylene, C6-10 arylene, or C1-9 heteroarylene;
wherein each C1-6 alkylene, C2-6 alkenylene, and C2-6 alkynylene is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; and
wherein each C3-8 cycloalkylene, C3-8 cycloalkenylene, C2-9 heterocyclylene, C6-10 arylene, and C1-9 heteroarylene is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, alkyl, alkenyl, alkynyl, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl;
each R7B is independently C1-6 alkyl, C(O)NR8R8, NR7R7, OH, O(alkyl), S(O)2R7A, S(O)2NR8R8, C2-9 heterocyclyl, C6-10 aryl, or C1-9 heteroaryl;
wherein each C1-6 alkyl and O(alkyl) is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; and
wherein each C2-9 heterocyclyl, C6-10 aryl, and C1-9 heteroaryl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, alkyl, alkenyl, alkynyl, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl;
each R8 is independently H, C1-6 alkyl, alkylene-OC2-6 alkyl, C1-6 alkylene-C6-10 aryl, C3-8 cycloalkyl, C6-10 aryl, or C1-9 heteroaryl;
wherein each C1-6 alkyl, C1-6 alkylene, and alkylene-OC2-6 alkyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; and
wherein each C3-8 cycloalkyl, C6-10 aryl, and C1-9 heteroaryl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, alkyl, alkenyl, alkynyl, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; or
two R8, taken together with the nitrogen atom to which they are attached, form a C2-9 heterocyclyl;
R5 is H or NR7R7;
each R7 is independently H, C1-6 alkyl, C1-6 alkylene-C6-10 aryl, C1-6 alkylene-C1-9 heteroaryl, S(O)2R7A, C3-8 cycloalkyl, C2-9 heterocyclyl, C6-10 aryl, or C1-9 heteroaryl;
wherein each C1-6 alkyl and C1-6 alkylene is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; and
wherein each C3-8 cycloalkyl, C2-9 heterocyclyl, C6-10 aryl, and C1-9 heteroaryl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, alkyl, alkenyl, alkynyl, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; or
two R7, taken together with the nitrogen atom to which they are attached, form a C2-9 heterocyclyl;
R6 is C(O)R7A, C(O)NHR8, or S(O)2R7A;
R7A is C1-6 alkyl, C3-8 cycloalkyl, or C6-10 aryl;
wherein the C1-6 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; and
wherein the C3-8 cycloalkyl or C6-10 aryl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, alkyl, alkenyl, alkynyl, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl;
R3 is halogen or C1-6 alkyl, wherein the C1-6 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; and
R4 is halogen or C1-6 alkyl, wherein the C1-6 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl;
wherein the cancer patient is characterized as having a retinoblastoma 1 (RB1) gene mutation positivity, a decrease in expression of a retinoblastoma 1 (RB1) gene or protein, or positive expression of a hyperphosphorylated retinoblastoma 1 (RB1) protein.
Appropriate correction is required. See MPEP § 2173.02.
Claim 16 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 10, wherein the retinoblastoma 1 (RB1) gene mutation comprises a mutation causing insertion of at least one amino acid residue to the wild-type retinoblastoma 1 (RB1) protein, a mutation causing substitution of at least one amino acid residue to the wild-type retinoblastoma 1 (RB1) protein, a mutation causing deletion of at least one amino acid residue to the wild-type retinoblastoma 1 (RB1) protein, and/or a mutation causing addition of at least one amino acid residue to the wild-type retinoblastoma 1 (RB1) protein.
Appropriate correction is required. See MPEP § 2173.02.
Claim 17 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 10, wherein the retinoblastoma 1 (RB1) gene mutation is selected from the group consisting of a nonsense mutation, a frameshift mutation, a splice site mutation, a homozygous deletion, and a heterozygous deletion.
Appropriate correction is required. See MPEP § 2173.02.
Claim 18 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 10, wherein the retinoblastoma 1 (RB1) gene mutation is a mutation decreasing a function of retinoblastoma 1 (RB1).
Appropriate correction is required. See MPEP § 2173.02.
Claim 20 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 10, wherein:
R1 is C1-6 alkyl;
X is CR2;
Y is N;
Z is CR2;
R6 is C(O)NHR8;
R5 is NR7R7;
R3 is C1-6 alkyl; and
R4 is C1-6 alkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 21 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a) and/or 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
The method according to claim 10, wherein the compound represented by the formula (1) comprises an excess of the atropisomer represented by the formula (1A):
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(1A).
Appropriate correction is required. See MPEP § 2173.02.
Claim 22 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 10, wherein the compound represented by the formula (1) is a compound represented by the formula (2):
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(2)
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 23 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a) and/or 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
The method according to claim 10, wherein the chemotherapeutic agent is selected from the group consisting of an alkylating agent, an antibody-drug conjugate, an anticancer antibiotic, an antimetabolite, a mitosis inhibitor, a platinating agent, and a topoisomerase inhibitor, or a combination thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. § 112:
(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.
Method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient
Claims 20 and 22 are rejected under 35 U.S.C. § 112(a) because the specification, while being enabling for performing a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor compound represented by the formula (I) to the cancer patient, does not reasonably provide enablement for performing a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. A method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient, as recited in claims 20 and 22, respectively, has not been adequately enabled in the specification to allow any person having ordinary skill in the art, at the time this invention was made, to make and/or use (perform) a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor or joint inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. {See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986); and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988)}.
The above factors, regarding the instant invention, are summarized as follows:
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(a) Breadth of the claims - the breadth of the claims includes a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor compound represented by the formula (I), shown to the right, or a solvate thereof, to the cancer patient;
(b) Nature of the invention - the nature of the invention is performance of a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor compound represented by the formula (I), shown to the right above, or a solvate thereof, to the cancer patient;
(c) State of the prior art - Nature Reviews: Drug Discovery offers a snapshot of the state of the drug development art. Herein, drug development is stated to follow the widely accepted Ehrlich model which includes: (1) development of a broad synthetic organic chemistry program; (2) subsequent testing of compounds in an appropriate laboratory model for the disease to be treated; and (3) screening of compounds with low toxicity in prospective clinical trials (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205). Moreover, WO 22/213204, as provided in the file and cited on the IDS, illustrates the synthesis of substituted heteroaryls represented by the formula (1), and/or methods of use thereof {Fourtounis, et al. WO 22/213204, 2022};
(d) Level of one of ordinary skill in the art - the artisans performing the inventor’s or joint inventor’s method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor compound represented by the formula (I) to the cancer patient, or a solvate thereof, would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience;
(e) Level of predictability in the art - Synthetic organic chemistry is quite unpredictable (See In re Marzocchi and Horton 169 USPQ at 367 ¶3). Similarly, it is unclear based on the combination of the instant specification, and Fourtounis, et al. in WO 22/213204, as provided in the file and cited on the IDS, whether performance of the instantly recited method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient is enabled. Moreover, the following excerpt is taken from Vippagunta, et al., with respect to the synthesis of solvates of substituted heteroaryls represented by the formula (1) {Vippagunta, et al. Advanced Drug Delivery Reviews, 48, 2001, 18}:
Predicting the formation of solvates or hydrates of a compound and the number of molecules of water or solvent incorporated into the crystal lattice of a compound is complex and difficult. Each solid compound responds uniquely to the possible formation of solvates or hydrates and hence generalizations cannot be made for a series of related compounds. Certain molecular shapes and features favor the formation of crystals without solvent; these compounds tend to be stabilized by efficient packing of molecules in the crystal lattice, whereas other crystal forms are more stable in the presence of water and/or solvents. There may be too many possibilities so that no computer programs are currently available for predicting the crystal structures of hydrates and solvates.
(f) Amount of direction provided by the inventor - the invention lacks direction with respect to making and/or using (performing) a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient;
(g) Existence of working examples - the inventor or joint inventor has provided sufficient guidance to make and/or use (perform) a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor compound represented by the formula (I) to the cancer patient; however, the disclosure is insufficient to allow extrapolation of the limited examples to enable performing the instantly recited method for treating cancer of a cancer patient, the method comprising administering a combination of a chemo-therapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient. The specification lacks working examples of performing a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient.
Within the specification, [A]t least one specific operative embodiment or example of the invention must be set forth. The example(s) and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP § 608.01(p) and MPEP § 2173.05.
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(h) Quantity of experimentation needed to make or use the invention based on the content of the disclosure - predicting whether a recited compound, and/or solvate thereof, is in fact one that produces a desired physiological effect at a therapeutic concentration and with useful kinetics, is filled with experimental uncertainty, and without proper guidance, would involve a substantial amount of experimentation (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205-213). Similarly, the specification, as originally filed, including any references incorporated therein, fails to provide the necessary support required by 35 U.S.C. § 112(a) to enable performing the instantly recited method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient. Thus, it is unclear, based on the guidance provided by the specification, whether a solvate of a substituted heteroaryl represented by the formula (1), such as 2-amino-1-(3-hydroxy-2,6-dimethylphenyl)-5,6-dimethyl-1H-pyrrolo[2,3-b]pyridine-3-carboxamide dihydrate, shown to the left above, possesses utility as a therapeutic agent, useful in a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the invention was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {See In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
The determination that undue experimentation would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. (See In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404). These factual considerations are discussed comprehensively in MPEP § 2164.08 (scope or breadth of the claims), § 2164.05(a) (nature of the invention and state of the prior art), § 2164.05(b) (level of one of ordinary skill), § 2164.03 (level of predictability in the art and amount of direction provided by the inventor or joint inventor), § 2164.02 (the existence of working examples) and § 2164.06 (quantity of experimentation needed to make or use the invention based on the content of the disclosure).
Based on a preponderance of the evidence presented herein, the conclusion that the inventor or joint inventor is insufficiently enabled for making and/or using (performing) a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient, is clearly justified.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 10, 16-18 and 20-23 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 10 recites the functional limitation and/or physicochemical property, A method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient. wherein the cancer patient is characterized as having RB1 gene mutation positivity, a decrease in expression of an RB1 gene or protein, or positive expression of hyperphosphorylated RB1 protein, in lines 1-5 of the claim.
Similarly, the inventor or joint inventor should further note that the aforementioned recited functional limitation and/or physicochemical property of the patient administered thereto in the instantly recited method for treating cancer of a cancer patient renders the instant invention ambiguous, vague, incoherent, opaque and/or otherwise unclear to the examiner and fails to meet the statutory requirements of 35 U.S.C. § 112(b), since the recited limitation merely states a functional limitation and/or physicochemical property without providing any clarity regarding how the functional limitation and/or physicochemical property is imparted.
Likewise, the inventor or joint inventor should further note that the instantly recited functional limitation and/or physicochemical property does not appear to emanate from and/or does not appear to be an inherent or salient property of the patient administered thereto within the instantly recited method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient.
Next, the inventor or joint inventor should further note that the examiner is uncertain whether the instantly recited method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient, requires an additional unrecited component to be administered to the cancer patient to impart the recited functional limitation and/or physicochemical property.
Consequently, the inventor or joint inventor should further note that since the instantly recited method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient incorporates the aforementioned ambiguous, vague, incoherent, opaque and/or otherwise unclear recited functional limitation and/or physicochemical property, the instantly recited method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient is rendered indefinite under 35 U.S.C. § 112(b), since one of ordinary skill in the art may not reasonably determine the metes and bounds of the instantly recited method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient due to an inability to establish the metes and bounds encompassed by the recited functional limitation and/or physicochemical property.
Then, the inventor or joint inventor should further note that [A] claim which omits matter disclosed to be essential to the invention, as described in the specification or in other statements of record, may also be rejected under 35 U.S.C. § 112(a), as not enabling. {See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); and MPEP § 2164.08(c)}.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claim, to overcome this rejection.
Claims 20 and 21 are further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the phrase, optionally substituted, in claim 20, with regard to R1, R2, R3, R4, R7, R7A, R7B, R8, and/or Q, respectively, is a relative phrase which renders the claim indefinite. The phrase, optionally substituted, is not defined by the claims, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification defines the term, substituent, using a boiler plate list of functional groups, such as amino, alkoxy, etc., and further discloses that the substituents themselves may be further substituted; however, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the substituted heteroaryls represented by the formula (1) administered within the method for treating or preventing cancer of a cancer patient have been rendered indefinite by the use of the phrase, optionally substituted, with regard to R1, R2, R3, R4, R7, R7A, R7B, R8, and/or Q, respectively.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of the appropriate paragraphs 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103(a) 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.
Claims 10, 16-18 and 20-23 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Fourtounis, et al. in WO 22/213204, in view of Guarducci, et al. npj Breast Cancer, 38, 2018, 1-10.
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The inventor or joint inventor should note that the instant invention recites a method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient, shown to the left, where R6 = -C(O)NHR8, wherein R8 = -H; R5 = -NR7R7, wherein each R7 = -H; R1 = -C1-6 alkyl; X = CR2, wherein R2 = -C1-6 alkyl; Y = N; Z = CR2, wherein R2 = -H; R3 = -C1-6 alkyl; and R4 = -C1-6 alkyl, respectively, wherein the cancer patient is characterized as having a retinoblastoma 1 (RB1) gene mutation positivity, a decrease in expression of a retinoblastoma 1 (RB1) gene, or positive expression of a hyperphosphorylated retinoblastoma 1 (RB1) protein.
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Similarly, the inventor or joint inventor should further note that Fourtounis, et al. (WO 22/213204), as provided in the file and cited on the IDS, teaches a method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient, shown to the right, where R6 = -C(O)NHR8, wherein R8 = -H; R5 = -NR7R7, wherein each R7 = -H; R1 = -CH3; X = CR2, wherein R2 = -CH3; Y = N; Z = CR2, wherein R2 = -H; R3 = -CH3; and R4 = -CH3, respectively, wherein the cancer patent is a cancer patient overexpressing cyclin E1 (CCNE1) {method - p. 2, lines 4-21; and compound(s) - p. 40, no. 164, no. 165 and no. 166}.
Likewise, the inventor or joint inventor should further note that Guarducci, et al. [npj Breast Cancer, 38, 2018] teaches that modulation of cyclin E1 (CCNE1) and retinoblastoma 1 (RB1) activity, including overexpression of cyclin E1 (CCNE1) and down-regulation of retinoblastoma 1 (RB1), are alternative and/or concomitant events in the treatment of patients having hormone receptor-positive breast cancer [see Abstract and Introduction].
Next, the inventor or joint inventor should further note that the only difference between the instantly recited method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient and Fourtounis’s method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient is the instantly recited method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient comprises a cancer patient characterized as having a retinoblastoma 1 (RB1) gene mutation positivity, a decrease in expression of a retinoblastoma 1 (RB1) gene, or positive expression of a hyperphosphorylated retinoblastoma 1 (RB1) protein, whereas Fourtounis’s method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient comprises a cancer patient overexpressing cyclin E1 (CCNE1).
Then, the inventor or joint inventor should further note that in the chemical arts, it is widely accepted that [S]tructural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions or compounds, creates a prima facie case of obviousness. {See Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., No. 06-1329, slip op. at 9 (Fed. Cir. June 28, 2007) (quoting In re Dillon, 919 F.2d 688, 692 [16 USPQ2d 1897] (Fed. Cir. 1990) (en banc)); and In re Papesch, 315 F.2d 381 [137 USPQ 43] (C.C.P.A. 1963)}.
Moreover, the inventor or joint inventor should further note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Furthermore, the inventor or joint inventor should also note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Also, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Comparably, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Analogously, the inventor or joint inventor should further note that [W]here general conditions of a claim are disclosed
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the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation. {See In re Aller, Lacey and Hall, 220 F.2d 454, 105 USPQ 233 (CCPA 1955)}.
Additionally, the inventor or joint inventor should also note that [M]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. {See In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979); and MPEP § 2145}.
Correspondingly, the inventor or joint inventor should further note that [G]ranting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. {See In re Wiseman, 596 F.2d 1022, 201 USPQ 661 (CCPA 1979); In re Baxter Travenol Labs, 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991); and MPEP § 2145}.
Consequently, since: a) Fourtounis teaches a method for treating… cancer of a cancer patient, wherein the method comprises administering a combination of a chemotherapeutic agent and an MYT1 inhibitor which is identical to the MYT1 inhibitor administered within the instantly recited method for treating… cancer of a cancer patient, wherein the method comprises administering a combination of a chemotherapeutic agent and an MYT1 inhibitor; b) Fourtounis teaches a method for treating… cancer of a cancer patient, wherein the method comprises a cancer patient overexpressing cyclin E1 (CCNE1); c) Guarducci teaches that modulation of cyclin E1 (CCNE1) and retinoblastoma 1 (RB1) activity, including overexpression of cyclin E1 (CCNE1) and down-regulation of retinoblastoma 1 (RB1), are alternative and/or concomitant events in the treatment of cancer patients; d) the courts have recognized that [S]tructural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions or compounds, creates a prima facie case of obviousness; e) the courts have further recognized that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer; f) the courts have further recognized that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable; g) the courts have further recognized that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated; h) the courts have further recognized that [I]f the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present; i) the courts have further recognized that [W]here general conditions of a claim are disclosed
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the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation; j) the courts have further recognized that [M]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention; and k) the courts have further recognized that [G]ranting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art, one having ordinary skill in the art, before the effective filing date of the recited invention, would have been motivated to utilize the teachings of Fourtounis and Guarducci and perform Guarducci’s method for treating… cancer of a cancer patient, wherein the method comprises administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient, in an alternatively treatable patient characterized as requiring modulation of retinoblastoma 1 (RB1) activity, including having a retinoblastoma 1 (RB1) gene mutation positivity, a decrease in expression of a retinoblastoma 1 (RB1) gene, or positive expression of a hyperphosphorylated retinoblastoma 1 (RB1) protein, with a reasonable expectation of methodical success and/or similar therapeutic activity, rendering claims 10, 16-18 and 20-23 obvious.
Here, the inventor or joint inventor should further note that, although not explicitly discussed herein, the Fourtounis reference contains additional MYT1 inhibitor species that may be administered to the cancer patient in combination with a chemotherapeutic agent to obviate the instantly recited method for treating… cancer of a cancer patient. Consequently, any amendments to the claims and/or arguments formulated to overcome rejections rendered under 35 U.S.C. § 103(a) should address this reference as a whole and should not be limited to the species discussed or disclosed explicitly herein.
Now, the inventor or joint inventor should also note that this invention currently names joint inventors. In considering patentability of the claims under 35 U.S.C. § 103(a), the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention, absent any evidence to the contrary. The inventor or joint inventor is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Finally, the inventor or joint inventor should further note that in the event the determination of the status of the invention as subject to AIA 35 U.S.C. § 103 (or as subject to pre-AIA 35 U.S.C. § 103) is incorrect, any correction of the statutory basis for the instant 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.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624