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
This office action is in response to applicant’s reply filed on June 22, 2026.
Restrictions/Elections.
Applicant’s election without traverse of Group I (Claims 1-16) in the reply filed on June 22, 2026, is acknowledged.
Applicant election of the following species:
2-amino-N-(12-(piperazin-1-yl)-dodecyl)-nicotinamide (Formula 14, GO88):
PNG
media_image1.png
108
330
media_image1.png
Greyscale
Is also acknowledged.
Since the above species is free of prior art, the examination was expanded to the following species:
6-chloro-N-[8-(1H-imidazol-1-yl)-octyl]-3-pyridinecarboxamide (CAS# 101457-35-6):
PNG
media_image2.png
126
430
media_image2.png
Greyscale
Status of Claims
Claims 1- 30 are currently pending and are the subject of this office action.
Claims 17-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 22, 2026.
The elected species reads on claims 1-5, 14 and 16.
The expanded species reads on claims: 1-2 and 16.
The combined set of claims that encompass one or both species and therefore are under examination are: 1-5, 14 and 16.
So, claims 6-13 and 15 are further withdrawn since they do not encompass any of the above species.
Priority
PNG
media_image3.png
106
390
media_image3.png
Greyscale
Claim Rejections - 35 USC § 112
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 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
1- Claim 1 and claims dependent thereon are vague and indefinite in that it is not
known what is meant by "Derivative" which implies more then what is positively recited.
2- Claim 1 and claims dependent thereon are vague and indefinite in that it is not
known what is meant by the second occurrence of the moiety -SH in the definition of Z¹.
3- Claim 1 and claims dependent thereon are vague and indefinite in that it is not
known what is meant by -NO₂- in the definition of Z¹.
4- Claim 1 and claims dependent thereon are vague and indefinite in that it is not
known what is meant by the variable "n" within the definition of Z¹ which is not defined
within the claim.
5- Claim 1 and claims dependent thereon are vague and indefinite in that it is not
known what is meant by "analogs" which implies more then what is positively recited.
6- Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the moiety Pi43 in the definition of the substituents on R¹⁰ which is a duplicate of the moiety Pi35.
7- Claim 1 and claims dependent thereon are vague and indefinite in that it is not
known what is meant by the moiety Py25 in the definition of the substituents on R¹⁰
which is a duplicate of the moiety Py16.
8- Claim 1 and claims dependent thereon are vague and indefinite in that it is not
known what is meant by the moiety O10 in the definition of the substituents on R¹⁰ which is a duplicate of the moiety O9.
9- Claim 1 and claims dependent thereon are vague and indefinite in that it is not
known what is meant by the moiety O17 in the definition of the substituents on R¹⁰ which contains a positive charge forming an ion without the presence of a counter ion creating the charged balanced compound.
10- Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the moieties that appear in the last two lines of the claim outside Table 1 which are also in the Table as follows:
PNG
media_image4.png
170
462
media_image4.png
Greyscale
10b- Claim 3 recites the limitation "the carbon number is 7 or less, making it difficult to exhibit an immunosuppressive effect, and when the carbon number is 15 or more, it becomes difficult to form other stereochemical bonds or to be absorbed in the body" in the claim. There is insufficient antecedent basis for this limitation in the claim, because claim 3 depends on claim 1 that limits the R10 chain from 8 to 14 carbons.
11- Claim 4 recites the limitation "2-amino-N-dodecyI nicotinamide” in the 4th line of the claim. There is insufficient antecedent basis for this limitation in the claim since claim 3 depends on claim 1 that requires that at least one of the terminal hydrogens of the R10 chain be substituted.
12- Claim 5 recites the limitation:
PNG
media_image5.png
64
64
media_image5.png
Greyscale
in chemical formula 11. There is insufficient antecedent basis for this limitation in the claim since claim 5 depends on claim 1 and the above structure is not encompassed by claim 1.
13- Claim 5 recites the limitation:
PNG
media_image6.png
64
104
media_image6.png
Greyscale
in chemical formula 12. There is insufficient antecedent basis for this limitation in the claim. since claim 5 depends on claim 1 and the above structure is not encompassed by claim 1.
14- Claim 5 is vague and indefinite in that it is not known what is meant by the
second occurrence of the compound labeled chemical formula 17 which is a duplicate of the chemical formula 3.
15- Claim 5 is vague and indefinite in that it is not known what is meant by the
second occurrence of the compound labeled chemical formula 20 which is a duplicate of the chemical formula 15.
16- Claim 14 recites the limitations:
PNG
media_image7.png
64
102
media_image7.png
Greyscale
in chemical formula 182,
PNG
media_image8.png
64
98
media_image8.png
Greyscale
in chemical formula 183,
PNG
media_image9.png
64
82
media_image9.png
Greyscale
in chemical formula 184,
PNG
media_image10.png
66
68
media_image10.png
Greyscale
in chemical formula 185,
PNG
media_image11.png
64
88
media_image11.png
Greyscale
in chemical formula 186,
PNG
media_image12.png
64
84
media_image12.png
Greyscale
in chemical formula 187,
PNG
media_image13.png
76
74
media_image13.png
Greyscale
in chemical formula 189, and
PNG
media_image14.png
64
64
media_image14.png
Greyscale
in chemical formula 190,
There is insufficient antecedent basis for these limitations in the claim. since claim 14 depends on claim 1 and the above structures are not encompassed by claim 1.
17- Claim 14 is vague and indefinite in that it is not known what is meant by the
second occurrence of the compound labeled chemical formula 188 which is a duplicate of the chemical formula 14.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 16 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. This is a written description rejection.
Claims 1-3 and 16 encompass compounds of general Formula I
Z1-Prd-CONH-R10
M.P.E.P. #2163 states: “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….one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process”.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the Federal Circuit stated that “the hallmark of written description is disclosure.” A specification adequately describes an invention when it “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. at 1351. “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbott Labs, 636 F.3d 1341, 1348 (Fed. Cir. 2011).
The description requirement of the patent statute requires a description of an actual invention, not merely an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984) (holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate’). This matter is of particular importance in the evaluation of claims drawn to a chemical genus which identifies a core compound bearing variable substituents. It has been held that “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification...demonstrates that the applicant has invented species sufficient to support a claim to a genus” with such breadth. Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2D 1161, 1171 (Fed. Cir. 2010). An adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties of species falling within the genus sufficient to distinguish the genus from other materials. Id., quoting Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997).
However, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. Ariad, 94 USPQ2D at 1171. 35 U.S. C. 112, first paragraph, requires a description of the invention that “clearly allow[s] persons of ordinary skill in the art to recognize that the inventor invented what is claimed.” Ariad at 1172, quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (1562-63) (Fed. Cir. 1991) (emphasis added). A sufficient disclosure is one which reasonably conveys to one having ordinary skill in the art that the inventor had possession of the claimed subject matter as of the filing date of the application in question. Vas-Cath, 935 F.2d at 1563. The description must reasonably describe the invention, not simply indicate a result which one might achieve if one actually made the invention. Eli Lilly, 119 F.3d at 1568. To properly evaluate whether an applicant has complied with the written description requirement therefore requires an analysis of whether the skilled artisan would recognize, from the description provided, the applicants were in possession of sufficient compounds representing the full breadth of diversity of the genus claimed.
A description of a chemical genus will usually comprise a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the members of the genus, which features constitute substantial portion of the genus. See Univ. of California vs. Eli Lilly, 43 USPQ 2d 1398, 1406 (Fed. Cir. 1997). This is analogous to enablement of a genus under section 112 first, by showing enablement of a representative number of species within the genus. A chemical genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus.
Here, applicants have claimed an extraordinarily large genus of chemical compounds encompassed by general Formula I which encompasses millions of possible combinations. The specification discloses only 225 compounds that are encompassed by the general Formula I (see pages 59-88 of the instant specification):
The number of different Z1-Prd-CONH- groups disclosed is very limited compared to what is claimed since most of the time the Z1-Prd-CONH- group is:
PNG
media_image15.png
78
78
media_image15.png
Greyscale
Furthermore, each R10 is always unsubstituted C8-C14 alky, despite claiming a large variety of groups (see claim 1).
The size of the genus thus described is phenomenal, against which the applicants have offered evidence of being in possession of about 225 compounds (see pages 59-88 of the instant specification). This small set of compounds cannot be viewed as being reasonably representative of the genus of compounds of Formula I in its claimed scope because no readily apparent combination of identifying characteristics is provided, other than the disclosure of those specific species as examples of the claimed genus, and in no way either represent the breadth of variable moieties which applicants have claimed, nor permit the skilled artisan to recognize that such claim breadth was actually in the applicants possession as of the time of filing the instant application.
Given the broad scope of the claimed subject matter, Applicant has not provided sufficient written description that would allow the skilled in the art to recognize that Applicant was in possession of most the compounds of the above general Formula I claimed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2 and 16 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Wright et. al. (US 4,555,519).
For claims 1-2 and 16, Wright teaches the following compound:
6-chloro-N-[8-(1H-imidazol-1-yl)-octyl]-3-pyridinecarboxamide (CAS# 101457-35-6):
PNG
media_image2.png
126
430
media_image2.png
Greyscale
(see claim 18),
wherein:
Z1 Chlorine (halogen),
Prd is pyridine,
R10 is C8-alkyl, and
One of the terminal hydrogens of R10 is substituted with O41:
PNG
media_image16.png
64
64
media_image16.png
Greyscale
The prior art is silent regarding: “Characterized in that exhibits a non-competitive inhibitory effect on the phosphorylation of PDK1” as in claim 2.
Apparently, Applicant has discovered a new property or advantage (the compound "exhibits a non-competitive inhibitory effect on the phosphorylation of PDK1”) of the compound anticipated by the prior art
MPEP 2112 I states: “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”.
MPEP 2112.01 further states: "When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions (in the instant case: "exhibits a non-competitive inhibitory effect on the phosphorylation of PDK1”) are presumed to be inherent”. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the compound anticipated by the prior art does not possess the same material, structural and functional characteristics claimed in the instant application ("exhibits a non-competitive inhibitory effect on the phosphorylation of PDK1”). In the absence of evidence to the contrary, the burden is on the applicant to prove that the instant compounds are different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
The statement in claim 16: “characterized by being used for inhibiting, antagonizing, or regulating PDK1”, is considered an intended use of a compound anticipated by the prior art and does not add any new limitation to the claim.
Catalina Mktg. Int’l, Inc. V. Coolsavings.com, Inc., 289 F.3d 801, 808, 62 USPQ2d 1781, 1785 (fed. Cir. 2002). “The recitation of a new intended use for an old product does not make a claim to that old product patentable.” In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
1) Claims 1-5, 14 and 16 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-5, 14 and 16 of copending Application No. 19/548,820 (reference application).
Claims 1-5, 14 and 16 of the copending application recite the exact same compounds as claims 1-5, 14 and 16 of the instant application. The only difference is that the copending application recites that the claimed compounds are “anticancer compounds”, while the instant claims recite that the compounds are: “immunosuppressive compounds”. However, these are considered intended uses of the exact same compounds and are not given any patentability weight.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
2) Claims 1-5, 14 and 16 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-5, 14 and 16 of copending Application No. 19/548,838 (reference application).
Claims 1-5, 14 and 16 of the copending application recite the exact same compounds as claims 1-5, 14 and 16 of the instant application. The only difference is that the copending application recites that the claimed compounds are “anti-aging compounds”, while the instant claims recite that the compounds are: “immunosuppressive compounds”. However, these are considered intended uses of the exact same compounds and are not given any patentability weight.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
3) Claims 1-5, 14 and 16 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-5, 14 and 16 of copending Application No. 19/548,853 (reference application).
Claims 1-5, 14 and 16 of the copending application recite the exact same compounds as claims 1-5, 14 and 16 of the instant application. The only difference is that the copending application recites that the claimed compounds are “antifibrotic compounds”, while the instant claims recite that the compounds are: “immunosuppressive compounds”. However, these are considered intended uses of the exact same compounds and are not given any patentability weight.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 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 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
July 10, 2026.
Prosecution Insights