DETAILED ACTION
Claims 1-10, submitted 06 July 2022, are pending in the application. Claims 4 and 7-10 have been withdrawn. Claims 1-3 and 5-6 are under 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 Group I, claims 1-6, and the single disclosed elected species of compound,
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, the elected species of solid tumor of instant claims 6 and 10, the elected species of lung cancer of instant claims 6 and 10 in the reply filed on 05 November 2025 is acknowledged.
Claims 4 and 7-10 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05 November 2025.
The Examiner did not find prior art on the elected species of claim 5. In the search of the claimed species, prior art which reads on the genus and subsequent species of claim 5 of the instant application was found. Thus, the species election was expanded to include the specific species identified below in the prior art rejection. As detailed in the following art rejection, the generic claim encompassing the elected species was not found patentable.
Claims 1-3 and 5-6 are under examination in the instant application.
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.
Claim 6 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 human squamous cell carcinoma, pancreatic cancer, melanoma, glioma multiforme, colon cancer, and rectal cancer and in view of the prior art disclosing camptothecin derivatives in the treatment of kidney cancer, ovarian cancer, breast cancer, gastric cancer, esophageal cancer, and lung cancer, does not reasonably provide enablement for urethral cancer, liver cancer, bladder cancer, or prostate cancer. 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
Claim 6 recites “wherein the solid tumor or blood tumor comprises lung cancer, kidney cancer, urethral cancer, colon cancer, rectal cancer, prostate cancer, glioma multiforme, ovarian cancer, pancreatic cancer, breast cancer, melanoma, liver cancer, bladder cancer, gastric cancer, lung cancer or esophageal cancers”. The instant specification provides support for some of the listed tumors but does not provide adequate support for all of the above listed tumors.
Nature of the Invention
The nature of the invention is within the pharmaceutical arts with regards to treating a solid tumor or a blood tumor with a camptothecin compound.
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).
Okamoto et al. ("Pharmacokinetics of trastuzumab deruxtecan (T-DXd), a novel anti-HER2 antibody-drug conjugate, in HER2-positive tumour-bearing mice." Xenobiotica 50.10 (2020): 1242-1250.) discloses the use of a camptothecin compound in the treatment of HER2-positive human breast cancer cells, KPL-4, in mice (pg. 1244, Section “KPL-4 tumor-bearing mice”, Left Col., 1st paragraph). Additionally, Okamoto teaches wherein the Phase I trials of the camptothecin compound, T-DXd, demonstrated anti-tumor effects in patients with breast, gastric, gastro-oesophageal, colorectal, and non-small cell lung cancer (pg. 1243, Section “Introduction”, Left Col., 2nd paragraph).
Han et al. ("The potential of topoisomerase inhibitor-based antibody–drug conjugates." Pharmaceutics 14.8 (2022): 1707.) discloses that the use of camptothecin-derived TOP1 inhibitors such as topotecan, irinotecan, belotecan, and deruxtecan have been approved for the treatment of non-small cell lung cancer, ovarian cancer, and colorectal cancer (pg. 2, Section “TOP1 Inhibitors in Cancer Therapy”, 2nd paragraph).
Perez-Ortega et al. ("Camptothecin in Cancer Therapy: Current Challenges and Emerging Strategies with Nanoemulsions." Pharmaceutics 17.11 (2025): 1414.) teaches wherein camptothecin is an inhibitor of the enzyme topoisomerase I and wherein the compound has shown antiproliferative activity in colorectal, ovarian, breast, lung, and renal cancers (pg. 2, Section “Introduction”, 2nd paragraph).
What the prior art does not teach is the use of a camptothecin derived compound in the treatment of the urethral cancer, liver cancer, bladder cancer, or prostate cancer. The Applicant also fails to provide data with regards to the above mentioned cancers which would lead to the unpredictability of urethral cancer, liver cancer, bladder cancer, or prostate cancer with the camptothecin derived compound of the instant 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 currently claimed method of treating all of the listed cancers of instant claim 6 with the camptothecin compound of independent claim 1 as there is no prior art to suggest that a camptothecin-derived compound can treat all of the listed cancers, such as urethral cancer, liver cancer, bladder cancer, or prostate cancer. As detailed by Perez-Ortega, the camptothecin-derived compound, rubitecan, showed limited benefits against solid tumors, with the exception of pancreatic cancer (pg. 14, Section “Rubitecan”, 1st paragraph).
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 provided guidance for certain aspects of the invention, such as the in-vitro anti-proliferative effects of the camptothecin compounds, Compounds 2, 12, 13, 25, 28, 29, 30, and 31, in comparison to the compound SN38 in the cancer cell lines Fadu, BXPC-3, A431, U87-MG, and SW620, as found in Example 26 of the instant specification in paragraphs 102-108. Additionally, guidance is provided for the general coupling of compounds 11, 20, 21, 23, and 24 to the antibody molecule C and the in vivo drug efficacy in A431 tumor-bearing mice with the antibody-drug conjugates, C-11, found in Examples 27 and 28 in paragraphs 109-114 of the instant specification.
Existence of Working Examples
The provided working examples focused on the in vitro treatment of squamous cell carcinoma, pancreatic cancer, melanoma, glioma multiforme, colon cancer, and rectal cancer. Applicant also provided the working example of in vivo treatment of melanoma cell line tumor-bearing mice. It does not appear, however, applicable in the treatment of urethral cancer, prostate cancer, liver cancer or bladder cancer as there is no prior art or Applicant provided data to suggest otherwise.
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 artisan trying to practice Applicant’s
claimed invention would be required to undertake unduly burdensome activities
including:
Experimentation to demonstrate application of the camptothecin compounds of the instant application in the treatment of the aforementioned tumors of instant claim 6.
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.
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ying et al. (CA 3114474 A1).
Ying discloses a genus, shown below, similar to that of the Applicant. Ying also exemplifies 2 camptothecin compounds, shown below, which reads on the genus claimed by the Applicant, also shown below, in the instant application when R1 = hydrogen and R2 = -CF3.
Genus taught by Ying
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(pg. 3, Line 24)
Compound 3-A taught by Ying
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(pg. 36, Line 28)
Compound 3-B taught by Ying
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(pg. 36, Line 28)
Genus taught by Applicant
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With respect to claim 2, Ying teaches wherein the camptothecin compound has a formula identical to that of formulae (a) and (c). Ying teaches the above compounds of 3-A and 3-B which read on the limitation of formula (a) when R2 = -CF3. Ying also teaches the limitation wherein R1 and R2, together with the carbon atoms to which they are connected form cyclobutene or cyclopentane which reads on formula (c) when Y of the above genus is
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or
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(pg. 6, Lines 14-19).
Regarding claim 3, Ying teaches the camptothecin compound of formulae (a-1) or (a-2), as mentioned above in the rejection of independent claim 1. The compounds 3-A and 3-B, shown below, read on the limitations of the instant claim when R1 = hydrogen and R2 = -CF3 and further teaches wherein R2 is attached in both the R and S configuration.
Compound 3-A taught by Ying
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(pg. 36, Line 28)
Compound 3-B taught by Ying
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(pg. 36, Line 28)
With respect to claim 6, Ying teaches wherein the camptothecin compound is used in the in vitro treatment of human brain astroblastoma cells, lung cancer cells, pharyngeal carcinoma cells, and kidney cancer cells (pg. 58, Lines 20-27) which reads on the limitations wherein the camptothecin compound is used to treat solid tumors.
Claim 5 is rejected as it is a dependent claim stemming from the rejected independent claim 1, and Ying’s compounds 3A and 3B are depicted/recited in rejected dependent claim 5.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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