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
Non-Final Rejection
The Status of Claims:
Claims 1-4 and 6-9 are pending.
Claims 1-4 and 6-9 are rejected.
DETAILED ACTION
1. Claims 1-4, 6-9 are under consideration in this Office Action.
Priority
2. It is noted that this application is a 371 of PCT/KR2023/006336 05/10/2023 ,which has foreign priority documents ,KOREA, REPUBLIC OF KR10-2022-0057028 05/10/2022 and KOREA, REPUBLIC OF KR10-2023-0057629 05/03/2023.
Drawings
3. The drawings filed on 11/10/24 are accepted by the examiner.
IDS
4. The IDS filed on 11/10/24, 8/28/25 & 6/02/26 are reviewed by the examiner.
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 6-9 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating specific diseases, does not reasonably provide enablement for preventing a 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. Applicants are not enabled for preventing the cancer. The only established prophylactics are vaccines not the composition comprising an ERK inhibitor and aripiprazole such as present here. In addition, it is presumed that “prevention” of the claimed diseases would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted.
“The factors to be considered [in making an enablement rejection] have been summarized as the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art, and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. 1) As discussed above, preventing diseases requires identifying those patients who will acquire the disease before chronic and acute pain occurs. This would require extensive and potentially opened ended clinical research on healthy subjects. 2) The passages from line 1 to line 18 on page 8 list the diseases Applicant intend to treat. 3) There is no working example of such a preventive procedure in man or animal in the specification. 4) The claims rejected are drawn to clinical preventive cancer medicine and are therefore physiological in nature. 5) The state of the art is that no general procedure is art-recognized for determining which patients generally will become prevented from getting a cancer before the fact. 6) The artisan using Applicants invention would be a Board Certified physician in cancer diseases with an MD degree and several years of experience. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a composition to be effective for the prevention of any cancers generally. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent to be able to prevent any cancers generally. That is, the skill is so low that no composition effective generally against any cancers has ever been found let alone one that can prevent such conditions. 7) 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. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed diseases and on the multitude of composition containing various ERK inhibitors.
The Examiner suggests deletion of the word “preventing” from the claims.
Claims 1-4 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for enhancing an anticancer effect of an ERK inhibitor for melanoma, colorectal cancer, does not reasonably provide enablement for enhancing an anticancer effect of an ERK inhibitor for all kinds of cancer diseases. 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.
The specification falls short because data essential for enhancing an anticancer effect of an ERK inhibitor for any types of cancers such as breast cancer, lymphoma, brain tumor, brain cancer, prostate cancer, lung cancer, osteosarcoma, bone cancer, pancreatic cancer, skin cancer, oral cavity cancer, oropharyngeal cancer, uterine cancer, ovarian cancer, rectal cancer, stomach cancer, endometrial cancer, cervical cancer, vaginal cancer, small intestine cancer, thyroid cancer, parathyroid cancer, chronic or acute leukemia, bladder cancer, kidney cancer, or liver cancer by administering a pharmaceutical composition comprising aripiprazole as an active ingredient to a subject is not described in the specification.
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. § 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The Nature of the Invention
The nature of the invention in claims 1 and 3 is as followed:
A method of enhancing an anticancer effect of an ERK inhibitor, comprising administering a pharmaceutical composition comprising aripiprazole as an active ingredient to a subject.
The method of Claim 1 wherein a cancer for the anticancer effect is melanoma, breast cancer, lymphoma, brain tumor, brain cancer, colorectal cancer, prostate cancer, lung cancer, osteosarcoma, bone cancer, pancreatic cancer, skin cancer, oral cavity cancer, oropharyngeal cancer, uterine cancer, ovarian cancer, rectal cancer, stomach cancer, endometrial cancer, cervical cancer, vaginal cancer, small intestine cancer, thyroid cancer, parathyroid cancer, chronic or acute leukemia, bladder cancer, kidney cancer, or liver cancer.
The amount of direction or guidance present
The direction present in the current specification is that the ERK inhibitor composition comprising aripiprazole as an active ingredient can enhance the anticancer effect for all types of cancers.
However, the specification is silent and fails to provide enough guidance as to whether or not all the claimed cancers or bystander tumors require only the use of the claimed ERK inhibitor composition containing aripiprazole for all kinds of malignant tumor for enhancing anticancer effect successfully; i.e. the specification fails to provide enough correlation between various claimed cancers and the claimed composition. Also, there is no direction and guidance for how all the enhancement of the anticancer effect of the ERK inhibitor for the claimed cancers can be directly linked to the use of the claimed composition.
The presence or absence of working examples
In the specification, there are two examples in which FIG. 3 shows effects of treatment of aripiprazole alone or in combination with an ERK inhibitor on PARP cleavage in A375 cells and FIG. 4 shows effect treatment of aripiprazole alone or in combination with an ERK inhibitor on PARP cleavage in COLO 205 cells. 31But there are no other actual working examples for enhancing an anticancer effect of an ERK inhibitor for all other heterogeneities of cancers using the claimed composition in the specification. Also, the specification does not contain any pharmacological data regarding the enhancing an anticancer effect of an ERK inhibitor for all the heterogeneities of cancers while using the claimed composition. Thus, the specification fails to provide sufficient working examples as to how all the heterogeneities of cancers can have an enhanced anticancer effect of ERK inhibitor by the claimed composition without any unexpected negative effects of using the claimed composition.
The breadth of the claims
The breadth of the claims is that the claimed composition can enhance an anticancer effect of an ERK inhibitor for all the heterogeneities of cancers, without regards as to the clinical side effects of the compound composition on various types of the claimed cancers except for melanoma and colorectal cancer being tested with the claimed composition as shown in examples 1-2.
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine whether or not the claimed composition would provide a beneficial enhancement of the anticancer effect of the ERK inhibitor for all the heterogeneities of cancers.
The level of the skill in the art
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine whether or not the claimed composition can be led to exhibit the desired pharmacological activity for enhancing an anticancer effect of the ERK inhibitor for all the heterogeneities of the claimed cancers.
Thus, the specification fails to provide sufficient support for enhancing an anticancer effect of an ERK inhibitor for all the heterogeneities of the claimed cancers. As a result, it necessitates one of the skilled artisans in the art to perform an exhaustive search for selecting claimed cancers suitable for the claimed composition in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001 (3/13/1997), states that “ a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test an enhanced anticancer effect of the ERK inhibitor on all the claimed cancers by using the claimed composition, which is encompassed in the instant claims, with no assurance of success.
The examiner recommends to put the specific cancer to the claims.
Claims 6-8 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating melanoma, colorectal cancer, does not reasonably provide enablement for treating all kinds of cancer diseases. 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.
The specification falls short because data essential for treating any types of cancers such as breast cancer, lymphoma, brain tumor, brain cancer, prostate cancer, lung cancer, osteosarcoma, bone cancer, pancreatic cancer, skin cancer, oral cavity cancer, oropharyngeal cancer, uterine cancer, ovarian cancer, rectal cancer, stomach cancer, endometrial cancer, cervical cancer, vaginal cancer, small intestine cancer, thyroid cancer, parathyroid cancer, chronic or acute leukemia, bladder cancer, kidney cancer, or liver cancer by administering a pharmaceutical composition comprising an ERK inhibitor and aripiprazole as an active ingredient to a subject is not described in the specification.
Moreover, the claim 6 sets forth a method for treating a cancer, comprising: administering a pharmaceutical composition comprising an ERK inhibitor or a pharmaceutically acceptable salt thereof; and aripiprazole or a pharmaceutically acceptable salt thereof as active ingredients to a subject.
However, there are more than 3000 cancers. Applicants have not identified a specific compound capable of treating “cancers” broadly. Thus, the existence of such a “silver bullet” is contrary to our present understanding in oncology. Even the most broadly effective anti-tumor agents are only effective against a small fraction of the vast number of different cancers known. This is true in part because cancers arise from a wide variety of sources, such as viruses (e.g. EBV, HHV-8, and HTLV-1), exposure to chemicals such as tobacco tars, genetic disorders, ionizing radiation, and a wide variety of failures of the body’s cell growth regulatory mechanisms. The specification falls short because data essential for treating all kinds of cancers is not described in the specification. In the absence of specific malignant tumors or otherwise, data showing inhibition of the multiplication of cancer cells, such a broad assertion is not believable in view of the contemporary knowledge of the art. 34 USPQ 2d, 1436 (Fed Cir. 1995) . See also, MPEP 2107.01, 2107.02. 2107.03, 2164.01©, 2164.04, 2164.07.
Different types of cancers affect different organs and have different methods of growth and harm to the body, and different vulnerabilities. Thus, it is beyond the skill of oncologists today to get an agent to be effective against cancers generally, evidence that the level of skill in this art is low relative to the difficulty of such a task. See also, In re Joller, 206 USPQ 885(CCPA 1980).
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. § 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The Nature of the Invention
The nature of the invention in claims 5-6 is as followed:
6. (Currently Amended) A method of preventing or treating a cancer, comprising: administering a pharmaceutical composition comprising an ERK inhibitor or a pharmaceutically acceptable salt thereof; and aripiprazole or a pharmaceutically acceptable salt thereof as active ingredients to a subject.
8. (Currently Amended) The method of claim 6, the cancer is selected form the group consisting of melanoma, breast cancer, lymphoma, brain tumor, brain cancer, colorectal cancer, prostate cancer, lung cancer, osteosarcoma, bone cancer, pancreatic cancer, skin cancer, oral cavity cancer, oropharyngeal cancer, uterine cancer, ovarian cancer, rectal cancer, stomach cancer, endometrial cancer, cervical cancer, vaginal cancer, small intestine cancer, thyroid cancer, parathyroid cancer, chronic or acute leukemia, bladder cancer, kidney cancer, [[or]] and liver cancer.
The amount of direction or guidance present
The direction present in the current specification is that the composition comprising an ERK inhibitor and aripiprazole as an active ingredient can treat all types of cancers.
However, the specification is silent and fails to provide enough guidance as to whether or not all the claimed cancers or bystander tumors require only the use of the claimed composition for all kinds of malignant tumor /or cancer treatment successfully; i.e. the specification fails to provide enough correlation between various claimed cancers and the claimed composition. Also, there is no direction and guidance for how all the treatments of the claimed cancers are directly linked to the claimed composition.
The presence or absence of working examples
In the specification, there are two examples in which FIG. 3 shows effects of treatment of aripiprazole alone or in combination with an ERK inhibitor on PARP cleavage in A375 cells and FIG. 4 shows effect treatment of aripiprazole alone or in combination with an ERK inhibitor on PARP cleavage in COLO 205 cells. 31But there are no other actual working examples for treating all other heterogeneities of cancers using the claimed composition in the specification. Also, the specification does not contain any pharmacological data regarding the treatment of all the heterogeneities of cancers while using the claimed composition. Thus, the specification fails to provide sufficient working examples as to how all the heterogeneities of cancers can be treated by the claimed composition without any unexpected negative effects of using the claimed composition.
The breadth of the claims
The breadth of the claims is that the claimed composition can treat all the heterogeneities of cancers, without regards as to the clinical side effects of the composition on treating various types of the claimed cancers except for melanoma and colorectal cancer being tested with the claimed composition as shown in examples 1-2.
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine whether or not the claimed composition would provide a beneficial treatment of all the heterogeneities of cancers while treating any types of the claimed cancers.
The level of the skill in the art
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine whether or not the claimed composition can be led to exhibit the desired pharmacological activity for treating all the heterogeneities of the claimed cancers.
Thus, the specification fails to provide sufficient support for the treatment of all the heterogeneities of the claimed cancers. As a result, it necessitates one of the skilled artisans in the art to perform an exhaustive search for selecting claimed cancers suitable for the claimed composition in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001 (3/13/1997), states that “ a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test whether or not all the claimed cancers can be treated by the claimed composition, which is encompassed in the instant claims, with no assurance of success.
The examiner recommends to put the specific cancer to the claim.
Claim 9 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for ameliorating melanoma, colorectal cancer, does not reasonably provide enablement for ameliorating all kinds of cancer diseases. 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.
The specification falls short because data essential for ameliorating any types of cancers such as breast cancer, lymphoma, brain tumor, brain cancer, prostate cancer, lung cancer, osteosarcoma, bone cancer, pancreatic cancer, skin cancer, oral cavity cancer, oropharyngeal cancer, uterine cancer, ovarian cancer, rectal cancer, stomach cancer, endometrial cancer, cervical cancer, vaginal cancer, small intestine cancer, thyroid cancer, parathyroid cancer, chronic or acute leukemia, bladder cancer, kidney cancer, or liver cancer by administering a health functional food composition comprising an ERK inhibitor and aripiprazole as an active ingredient to a subject is not described in the specification.
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. § 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The Nature of the Invention
The nature of the invention in claim 9 is as followed:
9. A method of preventing or ameliorating a cancer, comprising: administering a health functional food composition comprising an ERK inhibitor or a pharmaceutically acceptable salt thereof; and aripiprazole or a pharmaceutically acceptable salt thereof as active ingredients to a subject.
The amount of direction or guidance present
The direction present in the current specification is that the composition comprising an ERK inhibitor and aripiprazole as an active ingredient can ameliorate all types of cancers.
However, the specification is silent and fails to provide enough guidance as to whether or not all the claimed cancers or bystander tumors require only the use of the claimed composition for ameliorating all kinds of malignant tumor /or cancer diseases successfully; i.e. the specification fails to provide enough correlation between various claimed cancers and the claimed composition. Also, there is no direction and guidance for how the amelioration of all the claimed cancers is directly linked to the claimed composition.
The presence or absence of working examples
In the specification, there are two examples in which FIG. 3 shows effects of treatment of aripiprazole alone or in combination with an ERK inhibitor on PARP cleavage in A375 cells and FIG. 4 shows effect treatment of aripiprazole alone or in combination with an ERK inhibitor on PARP cleavage in COLO 205 cells. 31But there are no other actual working examples for ameliorating all other heterogeneities of cancers using the claimed composition in the specification. Also, the specification does not contain any pharmacological data regarding ameliorating all the heterogeneities of cancers while using the claimed composition. Thus, the specification fails to provide sufficient working examples as to how all the heterogeneities of cancers can be ameliorated by the claimed composition without any unexpected negative effects of using the claimed composition.
The breadth of the claims
The breadth of the claims is that the claimed composition can ameliorate all the heterogeneities of cancers, without regards as to the clinical side effects of the composition ameliorating various types of the claimed cancers except for melanoma, colorectal cancer being tested with the claimed compositionas shown in examples 1-2.
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine whether or not the claimed composition would provide a beneficial amelioration for all the heterogeneities of cancers.
The level of the skill in the art
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine whether or not the claimed composition can be led to exhibit the desired pharmacological activity for ameliorating all the heterogeneities of the claimed cancers.
Thus, the specification fails to provide sufficient support for the amelioration of all the heterogeneities of the claimed cancers. As a result, it necessitates one of the skilled artisans in the art to perform an exhaustive search for selecting claimed cancers suitable for the claimed composition in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001 (3/13/1997), states that “ a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test whether or not all the claimed cancers can be ameliorated by the claimed composition, which is encompassed in the instant claims, with no assurance of success.
The examiner recommends to put the specific cancer to the claim.
Conclusion
Claims 1-4 and 6-9 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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, Andrew Kosar can be reached at 571-272-0913. 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.
/TAYLOR V OH/Primary Examiner, Art Unit 1625 8/5/2026
Prosecution Insights