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 .
DETAILED ACTION
Pursuant to the preliminary amendment dated 10/16/2023, claims 3, 4, 6, 7, 9-14 are amended. No claims are newly added or canceled.
Claims 1-16 are pending in the instant application and are examined on the merits herein.
Priority
The application is a National Stage entry of PCT/US2022/025225 filed on 4/18/2022, which claims priority to provisional application 63/175762 filed on 4/16/2021.
Information Disclosure Statement
The information disclosure statement (IDS) dated 10/16/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS has been placed in the application file and the information therein has been considered as to the merits.
Claim Objection
Claims 1-14 are objected to as follows: 1) Claims 1-14 all recite the phrase “…treating a treating…”, which appears to be a typographical error. Claim 10 ends with, “…species. In one aspect the bacteria is not Bacillus anthracis.”, which is improper form due to the presence of two periods in the same claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) - Enablement
The following is a quotation 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.
Claims 1-14 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for inhibiting, decreasing, reducing or ameliorating an infectious disease or highly immunosuppressive cancer, does not reasonably provide enablement for treating, inhibiting, decreasing, reducing, ameliorating and/or preventing an infectious disease or highly immunosuppressive 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. With respect to the claimed method, attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. All of the Wands factors have been considered and those most relevant to the cited claims are discussed below. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below. Nature of the invention: The rejected invention is drawn to a method for treating, inhibiting, decreasing, reducing, ameliorating and/or preventing an infectious disease or highly immunosuppressive cancer by administering an agent that increases fucosylation of myeloid derived suppressor cells (MDSC).
Relative skill of those in the art: The relative skill of those in the art is high. Breadth of claims: The claims are broad with respect to the concepts of treatment and prevention, as well as the nature of the infectious disease or cancer. The full scope of the claims encompasses the entire definition of treating or preventing. The specification at pp. 14-15 provides definitions as follows: “By "prevent" or other forms of the word, such as "preventing" or "prevention," is meant to stop a particular event or characteristic, to stabilize or delay the development or progression of a particular event or characteristic, or to minimize the chances that a particular event or characteristic will occur…The term "treatment" refers to the medical management of a patient with the intent to cure, ameliorate, stabilize, or prevent a disease, pathological condition, or disorder.” (emphasis added)
Amount of guidance/Existence of working examples:
The working examples at pp. 34-73 of the specification provide detailed experiments and data showing the effectiveness of the claimed method for inhibiting, decreasing, reducing, or ameliorating melanoma. There are no working examples showing evidence supporting the full scope of treating melanoma (to include stopping) or the full scope of preventing (to include curing) melanoma. Moreover, there are no working examples showing the effectiveness of the claimed method at treating, inhibiting, decreasing, reducing, ameliorating or preventing any condition related to an infectious disease.
Quantity of experimentation: One of skill in the art would have to conduct a myriad number of experiments comprising trial and error administration of the claimed fucosylation agent to both healthy individuals and individuals having a representative number of infectious diseases or highly immunosuppressive cancers, to determine if the claimed compositions can be used in the fully claimed scope to treat and prevent such conditions. Genetech, 108 F.3d at 1366, 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 as discussed above, e.g., the breadth of the claims, the amount of guidance provided, and the lack of working examples, one of skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims, with no assurance of success.
Claim Rejections - 35 USC § 112—Second Paragraph
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.
Claims 1-14 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 recites “highly immunosuppressive cancer”, which renders the claim, and its’ dependents, indefinite due to the lack of clarity on which cancers are within the scope of this phrase. The term “highly” is a relative term. One of ordinary skill in the art is aware that there are numerous immunosuppressive cancers including pancreatic cancer, brain cancer, prostate cancer, breast cancer, ovarian cancer, liver cancer, lung cancer (e.g. NSCLC), melanoma, renal cell carcinoma, Hodgkin lymphoma and head and heck squamous cell carcinomas. However, what subset of the known immunosuppressive cancers would be considered “highly” immunosuppressive is unclear. The phrase " highly immunosuppressive cancer " is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 5 is further indefinite because the claim recites numerous trademarked compounds rendering the claim indefinite. If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b). Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. In fact, the value of a trademark would be lost to the extent that it became descriptive of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to identify or describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8, 13 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lau (WO 2019/075449, PTO-892).
Lau discloses a method for treating cancers, preferably melanoma, by the oral administration of a fucosylation agent (L-fucose, D-fucose, fucose-1-phosphate, or GDP-L-fucose), wherein the method is effective to: 1) increase the number of tumor infiltrating lymphocytes (TIL) (such as, for example NK cells, dendritic cells, and T cells) at least 10-25 fold in a subject with a tumor; and 2) at least a 20% reduction in myeloid-derived suppressor cells (MDSC), further wherein the method may further comprise: A) co-administering an anti-tumor agent (such as a chemotherapeutic agent,
antibody, or checkpoint inhibitor (such as lambrolizumab)), either before or during administration of the fucosylation agent; and/or B) combining administration of fucosylation agent with a second anti-cancer therapy, such as TIL therapy.(¶2-6, 52, 54, 102, 103, 106; Claims 1-11)
Accordingly, the instant claims are anticipated by the prior art.
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 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Lau (WO 2019/075449, PTO-892), in view of Kuchroo et al. (WO 2009/097394A2, PTO-892).
The disclosure of Lau is referenced as discussed above. Lau does not teach treating an infectious disease.
Kuchroo et al. discloses that methods effective to decrease MDSC may be employed to treat infectious diseases caused by bacteria (e.g. Shigella species), viruses (e.g. Human Immunodeficiency Virus (HIV)), fungi (e.g. Candida species) and parasites (e.g. Trypanosoma cruzi). (¶0076; Claims 7 and 11)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to expand upon the method of Lau, to treat infectious disease, thereby arriving at the instant invention. One would be motivated to expand Lau in this manner due to the teaching of Kuchroo which discloses that it is known that methods decreasing MDSCs are effective for treating infectious disease. Since Lau discloses that administration of a fucosylation agent is effective at decreasing MDSC, to treat melanoma, one would reasonably expect that the method of Lau would also be effective at treating infectious disease by decreasing MDSCs.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lau (WO 2019/075449, PTO-892), in view of Hakasson et al. (US 2016/0311854A1, PTO-892).
The disclosure of Lau is referenced as discussed above. Lau does not teach detection of an immunosuppressive cancer, such as melanoma, prior to administration of a therapeutic agent.
Hakasson et al. discloses a method for detecting the presence of cancerous cells in a subject having cancer by contacting the cancer cells with a labeled peptide, wherein the cancer cells may include colorectal cancer cells, renal cancer cells, breast cancer cells, skin cancer cells, ovarian cancer cells, prostate cancer cells, pancreatic cancer cells, lung cancer cells, renal cancer cells, malignant melanoma cells, or hematopoietic cancer cells. (¶0097) Hakasson also teaches that the methods can include identifying a patient having a condition associated with immunosuppression such as cancer or a bacterial or viral infection or an enduring or chronic bacterial or viral infection. The methods can include administering to the identified patient one or more of the peptide inhibitors ( e.g., an inhibitor of one or more albumin-derived immunoregulatory peptides or structures), as described herein and, optionally, detecting activation or stimulation of an immune cell, as evidenced by an increase in CD69 or CD71 expression, induction of the secretion of a signal substance, as evidenced by interferon gamma or IL-12 production, stimulation of the release of a cytolytic substance, as evidenced by the release of granzyme B or perforin, enhanced cytotoxicity, cytokine production, cell migration, and/or cell proliferation. (¶0144)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lau, to detect the presence of an immunosuppressive cancer, such as melanoma, prior to administering a therapeutic agent, thereby arriving at the instant invention. One would be motivated to modify Lau in this manner based on the teaching of Hakasson, which teaches that it is known in the art to detect the presence of immunosuppressive cancerous cells, including melanoma, prior to administering a therapeutic agent.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-8 and 13 of the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-9 of US 11,911,404. Although the conflicting claims are not identical, they are not patentably distinct from each other because the method of ‘404 is directed to enhancing an immune response in a subject with a tumor, or treating cancer, by orally administering a fucosylation agent (e.g. fucose), where the method results in increased tumor infiltrating lymphocytes (TIL) and decreased myeloid derived suppressor cells (MDSC), which is of overlapping scope with the instant claims directed to a method of treating cancer by orally administering a fucosylation agent (e.g. fucose), which is effective to decrease myeloid derived suppressor cells (MDSC).
Conclusion
No claims are allowed.
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/DALE R MILLER/Primary Examiner, Art Unit 1693