Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-17 are pending in the application. Claims 1, 2, 7, 11, 12, 13, 15 and 16 are rejected. Claim 1 is objected to. Claims 3-6, 8-10, 14 and 17 are withdrawn.
Restriction/Election of Species
Applicant's election with traverse of Group I, claims 1-16, and further elected species of “Example 25” having the following nomenclature/chemical structure in the reply filed on February 17, 2026 is acknowledged:
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The traversal is on the ground(s) that the prior art reference, cited in the Election of Species Requirement mailed on December 17, 2025, teaches a genus which “describes options for the variables, and the compound itself the Office cites by selecting each of the variables from the disclosure is not specifically described in the reference.” See page 13 of Applicant’s Remarks filed on February 17, 2026. It appears Applicant is asserting that the cited reference is NOT prior art because an example compound(s) which anticipates the instantly claimed compound of Formula 1 “is not specifically disclosed” in the prior art reference. This is not found persuasive as the instant claims have been found obvious over the prior art. See 35 U.S.C. § 103 rejection below.
The requirement is still deemed proper and is therefore made FINAL.
Pursuant to MPEP § 803.02, the Markush claims that read on the elected species were examined fully with respect to the elected species. Upon examination, the elected species was found to be rendered obvious by prior art; therefore, the Markush claim and claims to the elected species will be rejected. The claim(s) and subject matter that do not read on the elected species have NOT been examined and searched and are withdrawn from further consideration by the examiner.
Claims 3-6, 8-10, 14 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the election of species requirement in the reply filed on February 17, 2026.
Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/KR2022/003945, filed on March 22, 2022, which claims priority to Korean Application No. KR10-2021-0037824, filed on March 24, 2021.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. § 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on September 22, 2023 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 should be amended to include the word -and- after
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for sake of proper Markush language.
Appropriate correction is required.
Claim Rejections - 35 USC § 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.
Claim 16 is rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating viral infection, rheumatoid arthritis, melanoma, pancreatic cancer, prostate cancer, brain cancer, and depression related to the inhibition of indoleamine 2,3-dioxygenase (IDO) with a compound of Formula 1, does not reasonably provide enablement for i) the treatment of any and all types of the recited diseases (e.g., viral infection) and ii) the prevention of the recited diseases, wherein the recited diseases are not related to IDO activity. 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 use the invention commensurate in scope with this claim.
As a general rule, enablement must be commensurate in scope with the claim language. The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). See MPEP § 2164.08. That some experimentation may be required is not fatal; the issue is whether the amount of experimentation required is “undue.” In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991).
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; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. 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 present invention, are summarized as follows:
Breadth of the Claim – The breadth of the claim is drawn to the intended use of a pharmaceutical composition comprising a compound of Formula 1 for preventing or treating viral infection, rheumatoid arthritis, melanoma, pancreatic cancer, prostate cancer, brain cancer, and depression. For instance, since “viral infection” implies any and all viral infections, the claim is drawn to an enormously broad scope of preventing (i.e., keeping from happening) or treating viral infections, etc.
Nature of the Invention – The nature of the invention pertains to the compound of Formula 1- which, according to the instant disclosure, has inhibitory activity against IDO- and its intended use for preventing or treating viral infection, rheumatoid arthritis, melanoma, pancreatic cancer, prostate cancer, brain cancer, and depression.
State of the Prior Art and Predictability in the Art – Even in view of the seemingly high level of skill in the art, there is no absolute predictability when determining the physiological effects of a compound of Formula 1, for instance, against any and all viral infections. It is well established that “the scope of enablement [] varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Therefore, a skilled artisan would reasonably expect the efficacy of treatment methods to vary when considering the diverse causes and symptoms associated with, for instance, any and all viral infections.
Relative Skill of Those in the Art – The artisan making and using applicant’s pharmaceutical compound would be a synthetic chemist and/or a health practitioner, possessing a commensurate degree level and/or skill in the art, as well as several years of professional experience. The level of skill in the art is high; however, due to the unpredictability in the pharmaceutical art and the wide scope of viral infections, it is difficult to assess the potential pharmacological activity of a compound of Formula 1 against any and all viral infections.
Amount of Direction/Guidance Provided and Existence/Absence of Working Examples – The specification provides in vitro data regarding the instantly claimed compound of Formula 1 and IDO1 inhibition in Hela and HEK293 cells. See e.g., pages 46-50. The specification also provides in vivo data regarding the IDO inhibitory activity of the instantly claimed compound of Formula 1 in rat models. See e.g., page 50. The specification also provides general support for treating the recited diseases “associated with IDO” in paragraph [161]. However, the disclosure does not provide support for treating any and all viral infections. Accordingly, there is no actual evidence of the effectiveness of the claimed composition in treating the full scope of viral infections that are being claimed.Quantity of Experimentation Necessary – The quantity of experimentation needed to use the invention based on the content of the disclosure is undue. One of skill in the art would need to determine which specific viral infection not embraced by the instant disclosure would benefit from the pharmacological activities of a compound of Formula 1 by administering said compound to a patient. Using the full scope of the instant claim would require a person having ordinary skill to invest an indefinite amount of experimentation clearly beyond what can be considered as routine.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application 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. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976). In view of the Wands factors and In re Fisher (CCPA 1970) discussed above, a person of skill in the art would have to engage in undue experimentation to test which viral infection can be treated by a compound of Formula 1, with no assurance of success. It is suggested Applicant amend the claim to limit the treatment of the recited diseases to the inhibition of 2,3-dioxygenase activity to overcome this issue of lack of enablement.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 7, 11-13, 15 and 16 are rejected under 35 U.S.C. § 103 as being unpatentable over PCT Publication No. WO 2018/039512 A1 (March 1, 2018) by Cherney et al.
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Regarding instant claims 1, 2, 7, 11 and 12, the prior art teaches compounds of formula I having the following generic chemical structure (see e.g., page 3):
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With respect to the above prior art genus, the prior art teaches, for instance, the following variable definitions: “X” is N; “T” is CH; “R1” is H; “R1A” is halo; “V” is a bond; “Y” is CH; “W” is -CH-; “n” is 2; “L” is C1-C6alkylene substituted with C1-C6 alkyl; “Z” is -NH-; and “B” is benzoxazolyl. See e.g., page 3. The prior art also teaches Example No. 11, having the structure below, as a species of the above prior art genus.
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Example No. 11 of the prior art is encompassed by variable definitions of the prior art compound of formula I, wherein “X” is N; “T” is CH; “R1” is H; “R1A” is fluoro; “V” is a bond; “Y” is CH; “W” is -CH-; “n” is 2; “L” is C1alkylene substituted with C1alkyl; “Z” is -NH-; and “B” is benzoxazolyl substituted with halo (i.e., chloro). See e.g., page 3.
Regarding instant claim 13, the prior art teaches that the compound (i.e., “Preparation 8A”) below was utilized (i.e., reacted) with a heteroaryl halide,
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, to prepare Example No. 11 (see e.g., paragraph [00174]):
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The prior art “Preparation 8A” is encompassed by variable definitions of the instantly claimed compound of Formula 2, wherein R is a C1 alkyl group. The prior art heteroaryl halide is encompassed by the instantly claimed compound of compound of Formula 3, wherein X is benzoxazolyl and X is halogen (i.e., chloro).
Regarding instant claims 15 and 16, the prior art teaches “compounds that modulate or inhibit the enzymatic activity of indoleamine 2,3-dioxygenase (IDO, [and] pharmaceutical compositions containing said compounds.” See e.g., paragraph [0002]. Note that the expressions “for inhibiting indoleamine 2,3-dioxygenase,” as recited in instant claim 15, and “for preventing or treating...or depression,” as recited in instant claim 16, are both drawn towards characteristics that would necessarily be present in the instantly claimed pharmaceutical composition and are, therefore, non-limiting. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. MPEP § 2112.01(II)
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claims 1, 2, 7, 11 and 12, the prior art Example No. 11 is encompassed by variable definitions of the instantly claimed compound of Formula 1, wherein R is a C1 alkyl group and A is benzoxazolyl. The prior art Example No. 11, however, does not teach the instantly required methylene group where indicated below in the instantly claimed compound of Formula 1.
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However, as discussed above, the prior art defines variable “L” of the prior art genus as “C1-C6alkylene.” The term “alkylene” is defined in paragraph [00130] of the prior art as follows:
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Therefore, the prior art provides support for the position corresponding to variable “L” (indicated below) of Example No. 11 to be either a methylene or an ethylene group.
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For example, the prior art teaches compounds, such as Example No. 15 (see e.g., page 59) shown below, wherein the prior art variable “L” is defined as an ethylene (i.e., substituted with C1alkyl) instead of a methylene:
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Note that the prior art does not require variable “Z” to be substituted on the terminal position of variable “L.” Accordingly, when the methylene group corresponding to the prior art variable “L” of Example No. 11 is replaced with an ethylene group, the resulting structure (shown below) is an obvious homolog/positional isomer of Example No. 11.
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The resulting homolog structure also corresponds to Applicant’s elected species, the 25th compound as recited in instant claim 11 and the 3rd compound as recited in instant claim 12. MPEP § 2144.09 states that homology and isomerism are facts that must be considered with all other relevant facts in determining obviousness. Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.)
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Therefore, considering that Applicant’s elected species is a homolog/positional isomer of the prior art Example No. 11, it would have been obvious to arrive at Applicant’s elected species based on the teachings of the prior art. Compounds that differ only by the presence or absence of an extra methyl group are considered to be homologues. Homologues are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. As stated in In re Grose, 201 USPQ 57, 63, “The known structural relationship between adjacent homologues, for example, supplies a chemical theory upon which a prima facie case of obviousness of a compound may rest.” The homologue is expected to be preparable by the same method and to possess the same general properties. Therefore, at least in the interest of preparing additional indoleamine 2,3-dioxygenase inhibitor compounds for further experimental analysis, a person of ordinary skill would have been motivated to prepare a homolog/positional isomer of the prior art Example No. 11. “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210, 1214. See MPEP § 2144.09.
Conclusion
No claims are allowed.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626