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 .
Election/Restrictions
Applicant's election with traverse of the species of claim 23 in the reply filed on August 1, 2025 is acknowledged. The traversal is on the ground that Varughese & Joseph is not prior art. This is not found persuasive because the technical feature of administering at least one chemotherapeutic agent to a subject and introducing the jackfruit flour as a dietary intervention for 15-20 days, wherein the jackfruit flour is introduced within 22-25 hours from the start of administering the chemotherapeutic agent, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Joseph, Hershey, and Agiang. As discussed fully below (with citations) in the rejection under 35 U.S.C. 103(a), Joseph teaches using jackfruit flour to reduce the glycemic load of food, Hershey teaches that chemotherapy induces hyperglycemia as well as leukopenia, and Agiang reports that jackfruit flour or powder significantly increase counts of total white blood cell, lymphocyte, and eosinophil. The skilled person would thus have recognized the advantage of including jackfruit flour in a subject’s diet after chemotherapy to treat chemotherapy-induced leukopenia and hyperglycemia.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2-4, 6, 7, 9, 11-15, and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 1, 2025.
Claim Objections
Claim 23 is objected to because of the following informalities: lack of antecedent basis for “the at least one chemotherapeutic agent” and “the jackfruit flour”.
Claim 24 is objected to because of the following informalities: “platinums” should be platinum-based chemotherapy or a similarly descriptive term.
Claim 25 is objected to because of the following informalities: “neo adjuvant”.
Claim 32 is objected to because of the following informalities: “hole vegetable”.
Claim 34 and 36 are objected to because of the following informalities: these claims do not recite “further” before “comprises”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
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 23-36 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.
Claim 23 recites “introducing [ ] jackfruit flour as a dietary intervention…, wherein the jackfruit flour is introduced within 22-25 hours from the start of administering the chemotherapeutic agent”. It is unclear how “introducing …as a dietary intervention” is performed. Presumably “dietary intervention” is incorporating jackfruit flour into the subject’s food. However it is different than “administering” which also appears in the claim. Also the plain meaning of “introduce” is to bring into use or operation for the first time. How something is brought into use for the first time “for 15-20 days” is unclear and unexplained. Furthermore the claim presumes that the subject had not eaten any jackfruit flour prior to the chemotherapeutic agent.
Also a chemotherapeutic cycle could involve daily, weekly, or monthly administration of a chemotherapeutic agent. According to the claim the first or introductory “dietary intervention” would occur 22-25 hours after the first infusion. In a cycle involving daily infusion for one week, for example, the “dietary intervention” would occur around the time of the second infusion but it would not be introductory.
The disclosure does not define the terms in the phrase or the phrase itself. None of the dependent claims resolves this issue and therefore are also rejected as vague and indefinite.
For the purposes of examination now the claim phrase is construed as “introducing jackfruit flour for preventing or reducing chemotherapy-induced leukopenia in the subject, wherein the jackfruit flour is eaten for the first time within 22-25 hours from the start of administering the chemotherapeutic agent”.
Claim 25 recites “method of claim 23, wherein the chemotherapeutic agent is administered with at least one excipient selected from the group consisting of a neo adjuvant, an adjuvant, and a palliative”. Here the phrase “a neoadjuvant[sic], an adjuvant, and a palliative” refers to a substance, i.e., something that is administered to a subject with the chemotherapeutic agent, as recited. Based on the claim language and the entirety of the disclosure, claim 25 is vague and indefinite as failing to set forth what is being administered and when.
First it is noted that none of a neoadjuvant, an adjuvant, and a palliative agent is an excipient. An excipient is an inactive substance that serves as a vehicle or a medium for a drug or another active agent, e.g., a filler. By referring to “a neoadjuvant, an adjuvant, and a palliative” as an “excipient”, Applicant appears to imply a neoadjuvant, an adjuvant, and a palliative agent as something that is administered in conjunction with or simultaneously as the chemotherapeutic agent in claim 23.
Furthermore, according to plain meaning (see ChemoCare, Chemotherapy Terms, available at https://chemocare.com/what-is-chemotherapy/chemotherapy-terms, accessed on September 3, 2025, published online April 12, 2004) an “adjuvant” chemotherapy is chemotherapy “given to destroy left-over (microscopic) cells that may be present after the known tumor is removed by surgery” or another main or primary therapy. Neoadjuvant chemotherapy is a chemotherapy “given prior to the surgical procedure” (or another main or primary therapy) to ideally shrink a tumor and thereby reduce the extent of the main therapy. “Palliative [chemotherapy] is a type of chemotherapy that is given specifically to address symptom management without expecting to significantly reduce the cancer.” Therefore palliative therapy would not be administered in conjunction with a chemotherapeutic agent that is intended for reducing a cancer.
Claim 25 recites “wherein the chemotherapeutic agent is administered with at least one excipient selected from the group consisting of a neo adjuvant, an adjuvant, and a palliative”. In other words “a neoadjuvant[sic], an adjuvant, and a palliative” is administered to a subject with, i.e., simultaneously as, the chemotherapeutic agent. That is inconsistent with the plain meaning of these terms.
The disclosure does not clarify this issue. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). Here, the disclosure defines none of the neoadjuvant, adjuvant, and palliative. The disclosure states chemotherapy agent was given “with” those: “chemotherapeutic agents such as capecitabine in combination with standard neoadjuvant and adjuvant chemotherapy regimens” (para. 00120 (emphasis added); see also paras.0041, 0098). The disclosure does not mention surgery in combination with a neoadjuvant, an adjuvant, and a palliative agent; rather, “[t]he patients received chemotherapy for solid tumors that included cancers of the breasts, lungs,…. [t]he chemotherapeutic drugs used for the treatment included, but not limited to taxanes, anthracyclines, holoxan, capecitabine, platinums,…” (para.0098). “Chemotherapy was given in cycles with the neo adjuvant, adjuvant or palliative indications depending on the health of the patients.” (Id.)
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 23-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claims 23-36 encompass a “method of preventing chemotherapy induced leukopenia…” which is not enabled.
In re Wands, 858 F.2d 731, 736-40, 8 USPQ2d 1400, 1403-07 (Fed. Cir. 1988), set forth eight factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." (MPEP § 2164.01)
a. The breadth of the claim: The rejected claims are drawn to methods of preventing chemotherapy-induced leukopenia in a subject by adding jackfruit flour to the subject’s food. The claim term "preventing" implies that leukopenia is completely absent in patients treated according to the methods claimed.
b. Nature of the invention: The nature of the invention is methods of preventing or inhibiting leukopenia or low white blood cell levels in chemotherapy patients by incorporating jackfruit flour into the patient’s food.
c. The state of the prior art: Jackfruit and chemotherapy-induced leukopenia were known in prior art. Joseph teaches reduction in glycemic index of food by including jackfruit flour. Agiang reported increased levels of white blood cells from including jackfruit powder. Prevention or inhibition of leukopenia as it would be generally understood as absence of leukopenia, however, was not reported in these studies.
d. Level of one of ordinary skill in the art: the level of ordinary skill is high as trained physicians would practice chemotherapy-induced leukopenia management.
e. Level of predictability in the art: the level of predictability in preventing chemotherapy-induced leukopenia is low as the occurrence of leukopenia and its severity would depend on the type and stage of the cancer in a patient, the chemotherapeutic agent and its dose, and individual response of a patient to the chemotherapeutic agent.
f. Amount of direction provided by the inventor: The disclosure repeats the language of claim 23 throughout, at paragraphs [0038] through [0069]. There is no guidance on how to specifically prevent or inhibit chemotherapy-induced leukopenia apart from the clinical examples (discussed below). For instance there is no disclosure regarding how the jackfruit flour is “introduced” for 15-20 days, and whether or how critical it is to introduce the jackfruit flour within 22-25 hours after the start of administering a chemotherapeutic agent.
g. Existence of working examples: Applicant draws on the results of two clinical studies to support prevention of chemotherapy-induced leukopenia. In Example 1, patients having solid tumors were instructed to take 30 grams of jackfruit flour per day with food “from the first day of chemotherapy through the last day of each cycle of 21 days” (para.[00100]). Thus the data in Example 1 is limited to 21 day-cycle of chemotherapy. Also it is unclear whether another agent or “excipient” was administered, because the disclosure states, “Chemotherapy was given in cycles with the neo adjuvant, adjuvant or palliative indications depending on the health of the patients” (para.0098]). Also in paragraph [00102], about 62% and 50% of the participants “received neoadjuvant chemotherapy”. It is not disclosed whether the other participants were receiving adjuvant therapy, i.e., after the primary treatment, or palliative chemotherapy. According to Table 3, no patient experienced leukopenia when “excluding those cycles from study group where jackfruit flour was not taken” (para.[00107]; see also table 5). Thus the data in Tables 3 and 5 support prevention of chemotherapy-induced leukopenia in limited circumstance of that particular clinical study.
Example 2 involved patients undergoing albumin bound paclitaxel chemotherapy for breast cancer. However the patients in both the study and control groups “received 6 mg of pegfilgrastim treatment for prophylaxis after 24 hours of the beginning of the administration of the albumin bound paclitaxel (chemotherapeutic agent)” (para.00112] (emphasis added)). Although Applicant concludes, “the inclusion of jackfruit flour as a dietary intervention prevents chemotherapy-induced leukopenia effectively in patients undergoing chemotherapy with Albumin Bound Paclitaxel” (para.[00117]), the prophylactic pegfilgrastim would have contributed to the result. Also Table 6 shows results “excluding those cycles from the study group patients where jackfruit flour was not taken”, with 2 patients who experienced leukopenia in 2 cycles.
h. Quantity or experimentation needed to make or use the invention based on the content of the disclosure: considering the state of the art as discussed by the references above, particularly regarding the unpredictability of preventing chemotherapy-induced leukopenia, wide variability among individual patients, and the lack of guidance provided in the specification, the person of ordinary skill would have to engage in significant amount experimentation and ingenuity to practice the invention commensurate in the scope of the claims.
In conclusion, 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 claims 23-36.
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 (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 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, 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.
The factual inquiries 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.
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.
Claims 23, 24, and 26-36 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph (US 2018/0303138) in view of Hershey (Hershey, D.S., et al., Hyperglycemic-Inducing Neoadjuvant Agents Used in Treatment of Solid Tumors: A Review of the Literature, Oncology Nursing Forum • Vol. 41, No. 6, E343-54 November 2014) and Agiang (Agiang, M.A., et al., Assessment of the haematological indices of albino rats fed diets supplemented with jackfruit bulb, seed or a blend of bulb and seed, Int. J. Biol. Chem. Sci. 11(1): 397-407, February 2017) as evidenced by Neumann (Neumann, T.A., Foote, M., The Safety Profile of Filgrastim and Pegfilgrastim, The Safety Profile of Filgrastim and Pegfilgrastim. Twenty Years of G-CSF. 2011 Jul 11:395–408).
Regarding claims 23, 26, 29-33, and 35, Joseph teaches a “jackfruit flour prepared from various parts of the jackfruit, which can be used as an additive or a substitute for human consumption, offering reducing in glycemic load, reduced calorie intake, and increased fiber content” (abstract; see title; paras. 0001, 0010, 0019, 0034, 0156-58, 0193-96, 0200; Fig.1; claim 22). The jackfruit flour is prepared by separating jackfruit’s fruit, seed, and strands, drying them, and then grinding them into a flour (claim 8), and comprises the nutrient profile in instant claim 35 (para.0094). Joseph teaches fortified jackfruit flour and a flour comprising a non-jackfruit flour and jackfruit flour in a ratio of 9:1, i.e., 10% jackfruit flour and 90% other flour (paras.0007, 0111, 0113, 0115). The jackfruit flour is reconstituted with water to a moisture content in the range of about 65-80% (para.0066).
Joseph does not specifically teach a method of treating chemotherapy-induced leukopenia as in claim 23.
Hershey reviews hyperglycemia associated with neoadjuvant agents used in the treatment of solid tumor cancers (title; abstract). Pre-existing type-2 diabetes increases the risk for hyperglycemia (E343 left col.) and chemotherapeutic agents such as docetaxel and capecitabine alone or in combination with other agents can promote hyperglycemia (abstract; Table 1; E350-51). Hershey discusses “management of hyperglycemia to improve outcomes for patients with or without diabetes” (E352 box, rt. col.). Hershey further discusses both hyperglycemia and leukopenia (including neutropenia) resulting from chemotherapy (E348 Fury et al., Lee et al.).
Agiang studied “[h]aematological indices of albino rats fed diets supplemented with jackfruit seed (S), bulb (B) or seedbulb blend (SB)” (abstract; see Tables 1, 5, 6 and accompanying text). Much like the process in Joseph, jackfruit seeds and bulbs were blended, dried, and ground into a powder (p.398 rt. col.). After 28 days, the “[t]otal WBC, lymphocyte and eosinophil counts were significantly (p<0.05) increased in the experimental groups” (id.). Agiang concludes, “diet supplementation with 10% jackfruit bulb or the seed-bulb blend is likely to provide some antianaemic benefits and enhance the immune system” (id.).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Joseph, Hershey, and Agiang and administer Joseph’s jackfruit flour to patients to treat chemotherapy-induced leukopenia as recited in the instant claims. The skilled person would have been motivated to do so because Joseph teaches using jackfruit flour to reduce the glycemic load of food, Hershey teaches that chemotherapy induces hyperglycemia as well as leukopenia, and Agiang reports that jackfruit flour or powder significantly increase counts of total white blood cell, lymphocyte, and eosinophil. The skilled person would thus have recognized the advantage of including jackfruit flour in a subject’s diet after chemotherapy to treat chemotherapy-induced leukopenia and hyperglycemia.
Regarding the “dietary intervention” within 22-25 hours from the start of administering the chemotherapy, without more it is not seen that intervention specifically within 22-25 versus some other window when the subject is able to eat after chemotherapy (e.g., 5 hours), would lead to a materially different result.
Regarding claims 24 and 36, Neumann evidences prior art knowledge on administering pegfilgrastim and filgrastim in the doses recited to treat neutropenia and myelosuppression (title; abstract; introduction). “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” MPEP §2144.06 (I) (citations omitted).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614