DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
CONTINUING DATA
This application is a 371 of PCT/JP2022/037001 10/03/2022
FOREIGN APPLICATIONS
JAPAN 2021-165100 10/06/2021
Claims 1-5 are pending.
Specification
Chem. 7 on page 16 of the specification is pixelated and unclear. Chem. 13 on page 22 of the specification is pixelated and unclear. Chem. 16 on page 25 of the specification is pixelated and unclear. Chem. 22 on page 31 of the specification is pixelated and unclear.
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 1-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-5 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.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en
banc), the Federal Circuit noted the importance of an application's disclosure and stated, "the
hallmark of written description is disclosure." A disclosure 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).
What is required to meet the written description requirement "varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The Federal Circuit
explained what is required to meet the written description requirement in Ariad Pharm., Inc. V.
Eli Lilly & Co.: This inquiry, as we have long held, is a question of fact. Ralston Purina, 772
F.2d at 575. Thus, we have recognized that determining whether a patent complies with the
written description requirement will necessarily vary depending on the context. Capon v.
Eshhar, 418 F.3d 1349, 1357-58 (Fed. Cir. 2005). Specifically, the level of detail required to
satisfy the written description requirement varies depending on the nature and scope of the
claims and on the complexity and predictability of the relevant technology. Id. For generic
claims, we have set forth a number of factors for evaluating the adequacy of the disclosure,
including "the existing knowledge in the particular field, the extent and content of the prior art,
the maturity of the science or technology, [and] the predictability of the aspect at issue." Id. at
1359.
A written description of a chemical genus "requires a precise definition, such as by
structure, formula, [or] chemical name" of the claimed subject matter sufficient to distinguish it
from other materials. Regents of the Univ. of Cal. V. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed.
Cir. 1997). The Federal Circuit reflected on Eli Lilly in Ariad while explaining how to
sufficiently describe of a genus of compounds: We held that a sufficient description of a genus
instead requires the disclosure of either a representative number of species falling within the
scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus. Id. at 1568-69. We explained that 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. at 1568 (quoting Fiers V. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But 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.
A "representative number of species" must typify the entire claimed genus and account
for variation between the species of the genus.
[A] patentee of a biotechnological invention cannot necessarily claim a genus after only
describing a limited number of species because there may be unpredictability in the results
obtained from species other than those specifically enumerated. Noelle V. Lederman, 355 F.3d
1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004).
The current claims are drawn to a compound of formula 1 wherein RL2 is a "ligand" and RL1 is optionally an "organic group". The scope of these groups are incredibly large and encompass both known and potentially unknown groups of compounds.
By contrast, the specification provides very limited examples; with the ligand being phosphine ligands, and specifically trialkylphosphine ligands; and acetyl groups as representative "organic groups". One example does not serve to typify the entirety of the genus, because one example cannot, by default, account for any variation amongst the claimed genus of compounds. There is no disclosure of structure/function relationship for other ligands or organic groups.
Chemistry is generally considered to be unpredictable and/or have unpredictable factors. See, e.g.,In re Carleton, 599 F.2d 1021, 202 USPQ 165, 170 (CCPA 1979) ("Although there is a vast amount of knowledge about general relationships in the chemical arts, chemistry is still largely empirical, and there is often great difficulty in predicting precisely how a given
compound will behave."). The pharmaceutical arts, that is the use of a chemical compound to
affect a desired physiological activity, is generally considered to be unpredictable and/or have
unpredictable factors. See, e.g., In re Fisher, 427 F.2d 833, 839 (CCPA 1970) ("In cases
involving unpredictable factors, such as most chemical reactions and physiological activity, the
scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved (emphasis added); In re Bowden, 183 F.2d 115, 86 USPQ 419, 423 ("chemical
reactions frequently are unpredictable").
Considering the unpredictability found in chemistry, altering the identity of the groups
and retaining functionality cannot be considered a foregone conclusion. Accordingly, when a
claim presents a genus with substantial variation as that currently presented by claims 1-5, the
disclosure must adequately reflect such variation with a representative number of species. The
lack of any disclosure of examples may be considered in determining whether a claimed
invention was adequately described. Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d
1353 (Fed. Cir. 2011).
One example does not provide a "representative number of species" for an unpredictable art such as a chemistry. Sec, c.g., Ariad, 598 F.3d at 1354-55 (claiming that the inventor has an obligation to disclose examples when the art is unpredictable). The specification, then, is considered devoid of sufficiently detailed, relevant, identifying characteristics demonstrating that Applicant was in possession of the entirety of the genus now 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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fudickar (cited on IDS).
Fudickar teaches the following compound on page 8691 and further on page 8686:
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This is a compound of Formula (2) wherein XD1 is OMe and each of XD3, XD4, and XD5 are all OH. RD2 is gold.
The specification does not define “ligand,” so the broadest reasonable interpretation in light of the specification is the plain meaning of “ligand.” The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. An examiner must construe claim terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. MPEP 2111. The NIH, MeSH defines ligand as follows:
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Thus, the plain meaning of the claimed ligand is a group, ion, or molecule which binds to gold. In this instance, other gold molecules bind to gold and so those gold molecules are ligands.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant 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.
Claim(s) 1-3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Priebe (WO 2012/142615 A2) in view of Fudickar.
Priebe teaches the following compound on page 6:
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The compound is an auranofin analog used to treat cancer (see abstract). Auranofin is a glucose-based molecule [0028]. An exemplary method of synthesis is shown in paragraph [0063]:
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Priebe’s page 6 compound substituted at the 2-position, as shown above, differs from the claimed compound because it is drawn without stereochemistry so it is not necessarily a glucose derivative.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare a glucose analog of Priebe’s compound taught on page 6. Priebe contemplates glucose analogs, as seen in the examples in paragraph [0073]. Furthermore, the compounds are Auranofin analogs, and Auranofin is a glucose derivative. The skilled artisan would have chosen a glucose derivative because Auranofin is a glucose derivative and glucose is one of the carbohydrates used by Priebe. The skilled artisan would have had a reasonable expectation of success of preparing the compound on page 6 using a process analogous to Priebe’s process. Alternatively, Fudickar (cited above) teaches a method to prepare beta-gluco-SH, which could be used as a starting material having SH at the 2-position.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Priebe in view of Fudickar as applied to claims 1-3 and 5 above, and further in view of Ono (Cancers 2020, 12, 850).
Priebe teaches as set forth above, but does not teach an L-glucose derivative.
Ono teaches that a D-glucose tracer enters both non-malignant and malignant cells, while the corresponding L-glucose tracer enters malignant cells only. See Figure 6.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare the L-glucose analog of the compound suggested by Priebe. Priebe’s compounds are used for treating cancer, and L-glucose compounds enter malignant cells preferentially, so the skilled artisan would have chosen an L-glucose compound for treating cancer.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693
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