DETAILED ACTION
Claims 1-10, submitted 06 December 2023, are pending in the application and subject to examination in the instant Office 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 .
Election/Restrictions
Applicant’s election without traverse of the elected species, 5-fluorouracil (5-FU), in the reply filed on 23 March 2026 is acknowledged.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Examiner is requesting color drawings due to Figures 2 and 4 being indistinguishable. Color drawings are needed to understand the shape of the fibroblasts under various conditions and the migration of the SNU668 cell line. As it stands, the contents in these drawings cannot be distinguished.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities: Currently, there are parenthesis encompassing the wherein clause of both claims. Examiner suggest amending the claims to delete the parenthesis. Appropriate correction is required.
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 1-10 are 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 inhibiting anti-cancer drug resistance comprising the compound ftaxilide when the cancer is gastric cancer, does not reasonably provide enablement for the inhibition of anti-cancer drug resistance for all species within the genus of Chemical Formula 1 nor all of the claimed cancers of instant claims 5 and 9. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Breadth of the Claims
Independent claim 1 recites “A composition for inhibiting anti-cancer drug resistance comprising a compound represented by Chemical Formula 1…”. This instant specification does not provide enablement for all compounds of the genus to inhibit anti-cancer drug resistance.
Dependent claim 5 recites “The composition for inhibiting anti-cancer drug resistance of claim 4, wherein the cancer is selected from….”. Claim 5 is a dependent claim of instant claim 4. Consequently, claim 4 is further dependent of instant claim 1, and as such, claims the whole genus of the instantly claimed formula instead of the individual compound. Claim 9 is rejected for the same reasons, however, claim 9 is dependent of claim 8 which is further dependent of claim 1.
Nature of the Invention
The nature of the invention is within the pharmaceutical arts with regards to the inhibition of anti-cancer drug resistance comprising a compound of Chemical Formula 1.
State of the Prior Art
The state of the prior art is what one skilled in the art would have known, at the
time the application was filed, about the subject matter to which the claimed invention
pertains. The relative skill of those in the art refers to the skill of those in the art at the
time the application was filed. See MPEP 2164.05(b). See Pac. Bioscience of Cal., Inc.
v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir.
2021).
The state of the prior art provides evidence for the degree of predictability in the
art and is related to the amount of direction or guidance needed in the specification as
filed to meet the enablement requirement. The state of the prior art is also related to the
need for working examples in the specification. See MPEP 2165.05(a).
Currently, the prior art teaches that there a different types of cancer drug resistance. For example, Wang et al. ("Drug resistance and combating drug resistance in cancer." Cancer drug resistance 2.2 (2019): 141.) teaches that “Drug resistance can be categorized as intrinsic or acquired resistance based on the time when it is developed. Intrinsic resistance exists before drug treatment while the acquired resistance is induced after therapy, each occurring in about 50% of cancer patients with drug resistance” (pg. 142, Section “Intrinsic and Acquired Drug Resistance”, 1st paragraph). Wang also teaches that there are multiple mechanisms of drug resistance such as increased efflux of drugs, alteration of drug target, enhanced DNA damage repair, senescence escape, epigenetic alterations, tumor heterogeneity, the tumor microenvironment (TME), and epithelial-mesenchymal transition (EMT) (pgs. 144-150, Section “Mechanisms of Drug Resistance”, Whole Section). Further, Wang teaches Figure 1, shown below, which depicts the same mechanisms taught above.
Wang Figure 1
PNG
media_image1.png
410
641
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Greyscale
(pg. 150).
Li et al. (U.S. Patent No. 11,465,987) teaches a definition for “drug-resistant cancer” which is defined as cancer cells that acquire resistance to chemotherapy (Col. 97-98, 4th and 1st paragraphs, respectively).
There is no prior art on the compound of the invention being used in the inhibition of anti-cancer drug resistance. Keiser et al. ("Evaluation of an FDA approved library against laboratory models of human intestinal nematode infections." Parasites & vectors 9.1 (2016): 376.) teaches methods of treatment for intestinal nematode infections and the need for viable alternatives to drug resistance in parasites (pg. 2, Section “Background”, Left Col., 1st paragraph). However, with respect to the use of ftaxilide, Keiser states that ftaxilide was commercially unavailable for in vivo studies, which would lead to unpredictability among the use of the compound in this particular endeavor (pg. 4, Section “Results”, Right Col., 1st paragraph).
The lack of available prior art gives credence to the unpredictable nature of the use of all compounds of the instantly claimed genus in the inhibition of anti-cancer drug resistance. Additionally, the instant specification states “detailed contents on substances, methods, mechanisms of action, etc. for inhibiting anti-cancer drug resistance of cancer cells induced by cancer-associated fibroblasts are lacking to date.”, which further leads to the unpredictable nature of the instantly claimed invention.
Level of Skill in the Art
The person of ordinary skill in the art is a person who is presumed to have known
the relevant art at the relevant time. Factors that may be considered in determining the
level of ordinary skill in the art may include: (A) “type of problems encountered in the
art;” (B) “prior art solutions to those problems;” (C) “rapidity with which innovations are made;” (D) “sophistication of the technology; and” I “educational level of active workers
in the field. In a given case, every factor may not be present, and one or more factors
may predominate.” In re GPAC, 57 F.3d 1573, 1579, 35 USPQ2d 1116, 1121 (Fed. Cir.
1995); Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962, 1
USPQ2d 1196, 1201 (Fed. Cir. 1986); Environmental Designs, Ltd. V. Union Oil Co.,
713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983). See MPEP 2141.03 (I).
The invention described pertains to the medical or pharmaceutical arts. One of
ordinary skill would be trained in pharmacology, biochemistry, medicine, or a related art
with a Ph. D or other advanced degree in these or other related fields.
Level of Predictability in the Art
The amount of guidance or direction needed to enable the invention is inversely
related to the amount of knowledge in the state of the art as well as the predictability of
the art. In re Fisher, 427, F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount
of guidance or direction” refers to that information in the application, as originally filed,
that teaches exactly how to make or use the invention. The more that is known in the
prior art about the nature of the invention, how to make, and how to use the invention,
and the more predictable the art is, the less information needs to be explicitly stated in
the specification. In contrast, if little is known in the prior art about the nature of the
invention and the art in unpredictable, the specification would need more detail as to
how to make and use the invention in order to be enabling. The scope of the required
enablement varies inversely with the degree of predictability involved, but even in
unpredictable art, a disclosure of every operable species is not required. A single
embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ
122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA
1971). However, in applications directed to inventions in arts where the results are
unpredictable, the disclosure of a single species usually does not provide an adequate
basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA
1938). In cases involving unpredictable factors, such as most chemical reactions and
physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166
USPQ 18, 24 (CCPA 1970). See MPEP 2164.03. The applicant would need to provide
more objective evidence to support the enablement of the aforementioned claims to
contrast the unpredictability of the subject matter art.
There is unpredictability in the field of endeavor regarding the inhibition of all types of anti-cancer drug resistance through the administration of all compounds encompassed by the genus of Chemical Formula 1 as there is no prior art or evidence in the specification to suggest that the whole genus can achieve the instantly claimed method.
Amount of Direction Provided by the Inventor
The amount of direction provided by the inventor is correlated by the nature of
the unpredictability of the art. Given the context and scope of the claims mentioned
above, the inventor failed to provide the necessary amount of direction for one skilled in
the art to adequately use the invention across all suggested utility in the broadly stated
disease and disorders disclosed above. (See: Section (A) Breadth of the Claims).
Applicant has provided guidance for certain aspects of the invention such as the use of ftaxilide in the inhibition of senescence of fibroblast by treating several fibroblasts with the anti-cancer drug 5-fluorouracil (5-FU) and ftaxilide (paragraphs 0078-0081). Applicant has also provided evidence with regards to the inhibition of anti-cancer drug resistance within gastric cancer cells using the cell line SNU668 (paragraphs 0082-0087).
Existence of Working Examples
The provided working examples focused on the use of a single compound of the instantly claimed genus to inhibit anti-cancer drug resistance in a single cancer cell line (i.e., gastric cancer cell line SNU668). It does not appear, however, to support the claim language which asserts that the whole genus of compounds of Chemical Formula 1 have the same effects as there is no working example to support this assertation. It also does not appear to support the inhibition of all mechanisms of drug resistance, nor to inhibit the anti-cancer drug resistance in all of the claimed cancers as, again, there is no working example or evidence in the specification to prove otherwise. One skilled in the art would be unable to adequately use the invention without unduly experimentation, which would require the practitioner to discover that which the Applicant has failed to disclose.
(F) Quantity of Experimentation Needed to Make or Use the Invention Based on the Content of the Disclosure
As previously stated, the amount of experimentation depends on the art, the
predictability of the art, and the direction provided by the inventor. For one skilled in the
art to practice the invention as disclosed, the applicant would be required, but not
limited to providing:
Experimentation to show dosage and frequency required to inhibit the anti-cancer drug resistance of all claimed cancers.
Experimentation to show inhibition of anti-cancer drug resistance across the whole genus of compounds claimed in instant claim 1.
Experimentation to show inhibition of anti-cancer drug resistance across all claimed mechanisms.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN CHRISTOPHER SANCHEZ whose telephone number is (703)756-5336. The examiner can normally be reached Monday -Friday (0730-1700).
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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./ Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
Prosecution Insights