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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/US2022/022750 filed 03/31/2022, which claims the benefit of the priority of US Provisional application 63/291,522 filed 12/20/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement submitted on 09/10/2025 has been considered by the examiner.
Claim Status
Claims 1-28, and 30 are being examined on the merits in this office action.
Claim Objections
Claim 6, 8, 15-16, 26-28 are objected to because of the following informalities:
Claim 6 recites “…pharmaceutically-acceptable carrier…”. The claim can be amended to recite “..pharmaceutically acceptable carrier…”.
Regarding claim 8, the claim recites “normal (n.) saline (~0.9% NaCl)”. The claim can be amended to recite “0.9% normal saline”.
Claim 15-16 recites “…therapeutically-effective amount…”. The claim can be amended to recite “…therapeutically effective amount…”.
Claim 28 has a semicolon after “detectable label”. Applicant can delete the semicolon.
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 12-23, and 30 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 a method of treating lung cancer comprising administering the oligopeptide EIDTVLTPTGWVAKRYS (SEQ ID NO:1), does not reasonably provide enablement for a method of treating all cancers comprising administering the oligopeptide. 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. This is a scope of enablement rejection.
To be enabling, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1561 (Fed. Cir., 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558,1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547, the court recited eight factors to consider when assessing whether or not a disclosure would require undue experimentation. These factors are:
1) the quantity of experimentation necessary
2) the amount of direction or guidance provided
3) the presence or absence of working examples
4) the nature of the invention
5) the state of the art
6) the relative skill of those in the art
7) the predictability of the art
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099,1108,427 F.2d 833, 839,166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The breadth of the claims and the nature of the invention
The invention is drawn to a method of treating cancer, said method comprising administering a plurality of immune checkpoint inhibitor oligopeptides. Cancer is a broad term and encompasses cancers occurring in various hard and soft tissues. The main categories include: Carcinoma (cancers that begin in the skin or tissues that line or cover organs), Sarcoma (Cancers in bone, cartilage, muscles or connective tissues), Leukemia (Cancers that form in the blood forming tissues), Lymphoma and myeloma (Cancers that begin in the immune system) and Central nervous system cancer (cancers of the brain or spinal cord). The claims of the instant application do not limit the cancer being treated, prevented or suppressed to any particular type of cancer, for example lung cancer or breast cancer.
The claims are thus broad insofar as to suggest that the claimed oligopeptide can treat all cancers in general.
The state of the prior art and the level of predictability in the art and the relative skill of those in the art
The state of the art is such that there is evidence and established literature on the many types of cancers (National Cancer Institute-https://www.cancer.gov/about-cancer/understanding/what-is-cancer (NCI), page 6, paragraph 1) and each cancer has its own causative factor and different cellular behaviors (National Cancer Institute, https://www.cancer.gov/about-cancer/causes-prevention/patient-prevention-overview-pdq (NCI2) page 2 and 3). Examples of the numerous forms of cancers include Breast cancer, uterine corpus endometrial carcinoma, Bladder Urothelial carcinoma, Lung cancer, cervical cancer, pancreatic cancer, Prostate cancer, ovarian cancer, Blood cancer or Brain and nervous system cancers. These are further subdivided to include carcinomas like Basal cell carcinoma, squamous cell carcinoma, renal cell carcinoma and Adenocarcinoma. There are also other forms of malignant melanoma, cylindroma, germ cell tumors and many more. Treatment of cancer is complex and usually takes into consideration the type of cancer including location, its stage and genetic characteristics. Therefore, treatment for one type of cancer, may not be useful in treating other types of cancers (Merck Manual - Cancer treatment Principles By Robert Gale, page 1, paragraph 1 and 2).
Given that there is no evidence in the art of a compound that has been found to generally treat all cancers, the treatment of cancer generally is not considered enabled. Most cancer drugs are known to be effective against a limited or closely related cancers (Merck Manual - Cancer therapy, By Robert Gale, page 1, and paragraph 1, 2). Therefore a compound that is effective against cancer generally would be an exception and more proof of the claimed invention would be required. Merck teaches the median 5 year survival rates of various types of cancer as shown below (Merck - cancer therapy, page 3).
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581
1009
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Medical News Today (https://www.medicalnewstoday.com/articles/322700 - By Christina Chun) teaches that a 5- year survival rate does not indicate whether or not treatment has removed all signs of cancer, but is useful for comparing relative severity of different types of cancer (Medical News Today, Page 1, paragraph 8).
One of ordinary skill in the art would not be able to use the claimed invention to treat cancer generally and achieve a reasonable level of success in doing so due to the absence in the art of a compound that is able to treat cancer generally. It is well established that a utility rejection is therefore proper when the scope of enablement is not reasonably correlated to the scope of the claim.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)”. The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.”
The instant disclosure is focused on the synthesis of the oligopeptide and the use of the oligopeptide in reducing the tumor numbers as well as tumor volume in subjects with LLC (See Fig. 8-12).
With regards to cancer, Ex parte Kranz, 19 USPQ2d 1216, 1219 notes the “general unpredictability of the field [of] ... anti-cancer treatment.” In re Application of Hozumi et al., 226 USPQ 353 notes the “fact that the art of cancer chemotherapy is highly unpredictable”. 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, 166 USPQ 18, at 24 (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.).
As a result, the specification needs to have more details on how to make and use the invention in order to be enabling.
The relative skill of those in the art is high. However, the art of cancer treatment generally is highly unpredictable.
The examiner cites Kojoh et al. (US12565517B2) as an evidentiary reference to illustrate the state of the art.
Kojoh teaches the use of checkpoint inhibitor oligopeptide to treat a tumor in a subject, wherein the tumor is selected from the group consisting of malignant lymphoma, colorectal cancer, non-small cell lung cancer, ovarian cancer, renal cancer, prostate cancer, and malignant melanoma (claim 16).
Kojoh does not teach that the oligopeptide was effective in treating all cancers. These teachings show how unpredictable the treatment of cancer is especially in the case of a peptide that is used to treat cancer in general. Considering the state of the prior art, it is apparent that the instantly claimed oligopeptide is not capable of use to treat all cancers.
The amount of direction or guidance provided and the presence or absence of working examples
The claims are drawn to a method of treating cancer, said method comprising administering a plurality of immune checkpoint inhibitor oligopeptides.
The instant disclosure is focused on the synthesis of the oligopeptide and the use of the oligopeptide in reducing the tumor numbers as well as tumor volume in subjects with LLC (See Fig. 8-12). The instant specification does not include other examples showing effect of the claimed oligopeptide on any other cancers such as brain cancer.
The quantity of experimentation necessary
Given the well-known unpredictability of the art as well the incomplete experimental evidence commensurate in scope with the claims, the skilled artisan would not be able to agree that the claimed oligopeptide can treat all cancers. To determine if the claimed oligopeptide would treat any particular cancer, suitable dosage as well as clinical trials or assays that can correlate to clinical efficacy of such treatment would be needed. This is undue experimentation given the limited guidance and experimentation provided by the applicant.
In view of the Wands factors discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in unduly burdensome experimentation to assess whether administration of the claimed oligopeptide would be successful in treating cancers in general. Thus, the rejection of these claims under 35 USC 112(a) is proper.
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 6-28 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.
Claims 6, 12, 24, and 28 depend on claim 1 and recite plural of oligopeptides. However, claim 1 is directed to one oligopeptide EIDTVLTPTGWVAKRYS (SEQ ID NO:1). The claims are indefinite because it is unclear which other oligopeptide is being referenced. Claims 7-11, 13-23, 25-27 depend on the rejected claims and are also rejected.
Additionally, claim 7 depends on claim 6 and recites “amount of said oligopeptide”. The claim is indefinite because it is unclear which other oligopeptide is being referenced.
Regarding claim 8, the limitations in parenthesis, “(~0.9% NaCl)” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claim 9, the claim recites “other checkpoint inhibitors”. It is unclear what other checkpoint inhibitors the claim is referring to. Applicant can amend the claim to recite “checkpoint inhibitors”. Claim 11 depends on claim and is also rejected.
Regarding claim 18, the claim recites “other immunotherapies and/or chemotherapies”. It is unclear which immunotherapies the claim is referring to. Applicant can amend the claim to recite “coadministered with immunotherapies and/or chemotherapies”.
Examiners comment and Allowable subject matter
Instant peptide of SEQ ID NO: 1 is free of prior art. Additionally, SEQ ID NO: 1 is not a fragment of any naturally occurring protein, thus there are no subject matter eligibility issues. As a result, claims 1-5 are allowable.
Closest prior art
Closest prior art is Kojoh et al. (US12565517B2).
Kojoh teaches a checkpoint inhibitor cyclic peptide which comprises the amino acid sequence represented by formula (I) X1-His-Pro-X4-Leu-X6-X7-X8-Ser-X10-His-Phe. Kojoh teaches a pharmaceutical composition which comprises the cyclic peptide according to claim 1 and a pharmaceutically acceptable carrier or excipient (Abstract, claims 1-15). Kojoh teaches the use of checkpoint inhibitor oligopeptide to treat a tumor in a subject, wherein the tumor is selected from the group consisting of malignant lymphoma, colorectal cancer, non-small cell lung cancer, ovarian cancer, renal cancer, prostate cancer, and malignant melanoma (claim 16). Kojoh does not teach that the checkpoint inhibitor oligopeptide comprises the instant sequence of SEQ ID NO: 1.
Conclusion
Claims 6-28, and 30 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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