DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 cited rejections 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.
3. Response to Election/Restriction filed on 7/8/2026 is acknowledged.
4. Claim filed on 7/8/2026 is acknowledged.
5. Claims 3, 6, 8, 9, 12-14, 16, 20-31, 43 and 46-48 have been cancelled.
6. Claims 1, 2, 4, 5, 7, 10, 11, 15, 17-19, 32-42, 44, 45 and 49-54 are pending in this application.
7. Claims 1, 2, 4, 5, 7, 10, 11, 15, 17-19, 37-42, 44 and 45 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Claims 36 and 50 are withdrawn from consideration as being drawn to non-elected species.
8. Claims 32-35, 49 and 51-54 are under examination.
Election/Restrictions
9. Applicant’s election without traverse of Group 2 (claims 32-36 and 49-54) and election without traverse of a peptoid with the structure
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as species of peptoid; lung cancer as species of cancer; and cancer treatment as species of effect of the method in the reply filed on 7/8/2026 is acknowledged. The requirement is made FINAL in this office action.
Group 2 is drawn to a method of treating or preventing a cancer in a subject, said method comprising: administering to the subject a peptoid selected from the group consisting of
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, a multimer thereof, a derivative thereof, and combinations thereof. A search was conducted on the elected species; and a peptoid with the structure
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as the elected species of peptoid appears to be free of prior art. However, prior art was found for lung cancer as the elected species of cancer; and cancer treatment as the elected species of effect of the method. A search was extended to the genus in claim 32; and prior art was found. Claims 36 and 50 are withdrawn from consideration as being drawn to non-elected species. Claims 32-35, 49 and 51-54 are examined on the merits in this office action.
Claim Interpretations
10. With regards to the recited derivative thereof of the peptoid recited in instant claims, the instant specification fails to define it. Therefore, in the broadest reasonable interpretation, the Examiner is interpretating any peptoid and its multimer meets the limitations of derivative thereof of the instant claimed peptoid and its multimer recited in instant claims 32-35, 49 and 51-54. Such interpretation applies to all the rejections set forth below.
Objections
11. The specification is objected to for the following minor informality: The instant specification recites various chemical structures/formulae throughout the specification, for example, the one on page 1, paragraph [0003] of instant specification. However, the quality of many of these various chemical structures/formulae is extremely poor. Applicant is required to provide clear image of these various chemical structures/formulae.
12. The specification is objected to for the following minor informality: The instant specification recites the term “JMSA” on page 4, paragraphs [0014] and [0018] and many others throughout the specification. There appears to be a typo in this recitation, The recitation should be “JM3A”. Applicant is required to correct this error.
13. The specification is objected to for the following minor informality: The instant specification recites “Both JM3A-BP and the control compound displayed activity” on page 44, paragraph [00163] of instant specification. There appears to be a word missing in this recitation. Applicant is required to correct this error.
Please note: The specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification (see MPEP § 608.01).
14. The drawings are objected to for the following minor informality:
Figures 5 and 6 are described with respect to color. Reference to specific colors in the description of the drawings should be removed.
Figure 14A: It appears only residue at position 8 in JM3A-BP is replaced in compound JM3A-8-BP. However, the chemical structure of JM3A-8-BP has both residues at positions 4 and 8 indicated as replaced residue. Applicant is required to correct this error.
Figure 16C: The chemical structures of many of the tested peptoids are unknown.
Figures 21A-21D: Each of these figures requires its individual description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
15. Claim 32 is objected to for the following minor informality: Applicant is suggested to amend claim 32 as “A method of treating or preventing cancer in a subject, wherein the method comprises administering to the subject a peptoid selected from the group consisting of:
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, a multimer thereof, a derivative thereof, and combinations thereof; and wherein R1, R2, R3, R4, R5, R6, R7 and R8 are each independently selected from the group consisting of…”.
Furthermore, the quality of the chemical structures/formulae recited in instant claim 32 is extremely poor. Applicant is required to address this issue.
16. Claim 49 is objected to for the following minor informality: Applicant is suggested to amend claim 49 as “…wherein the peptoid selected from the group consisting of:… derivatives thereof, and combinations thereof; and wherein R5, R6, R7 and R8 are as defined in claim 32”.
Furthermore, the quality of some of the chemical structures/formulae recited in instant claim 49 is extremely poor. Applicant is required to address this issue.
17. Claim 51 is objected to for the following minor informality: Applicant is suggested to amend claim 51 as “…wherein the peptoids in the multimer are connected…”.
18. Claims 53 and 54 are objected to for the following minor informality: The quality of some of the chemical structures/formulae recited in these claims is extremely poor. Applicant is required to address this issue.
Furthermore, Applicant is suggested to amend claim 53 as “…wherein the peptoid selected from the group consisting of:… derivatives thereof, and combinations thereof; and wherein R1, R2, R3, R4, R5, R6, R7 and R8 are as defined in claim 32”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
19. 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.
20. Claims 32-35, 49 and 51-53 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 pre-AIA the applicant regards as the invention.
21. Claim 32 recites “…wherein R1, R2, R3, R4, R5, R6, R7 and R8 (R groups) are each independently selected from the group consisting of…alkanes, alkenes, ethers, alkynes, alkoxyls, aldehydes, carboxyls, hydroxyls, hydrogen, sulfur, phenyls, cyclic rings, aromatic rings, aliphatic rings, heterocyclic rings, linkers, methyl, aliphatic groups, hydrogen groups, amino acid R groups, tracing agents…”. First, with regards to the recited “cyclic rings”, the instant specification fails to define it. Since every ring is cyclic, it is unclear what is encompassed within the recited “cyclic rings”. Second, with regards to the recited “hydrogen groups”, the instant specification fails to define it. Since each of R1, R2, R3, R4, R5, R6, R7 and R8 group recited in instant claim 32 can be hydrogen, it is unclear what is encompassed within the recited “hydrogen groups”. Third, with regards to the recited “amino acid R groups”, the instant specification fails to define it. Therefore, is unclear what is encompassed within the recited “amino acid R groups”. Fourth, with regards to the recited “tracing agents”, the instant specification fails to define it. However, the instant specification provides some examples of tracing agents, which includes drugs such as chemotherapeutics (see page 27, paragraph [0067] of instant specification). According to the Definition of tracer document (from https://www.merriam-webster.com/dictionary/tracer, 2026, enclosed pages 1-8), tracer (synonym of tracing agent) is a substance used to trace the course of a chemical or biological process (see for example, page 1, 4b). And drugs such as chemotherapeutics are not known in the art to be a tracer. Therefore, it is unclear what is encompassed within “tracing agents”. Taken all these together, the metes and bounds of instant claim 32 is vague and indefinite. Because claims 33-35, 49 and 51-53 depend from indefinite claim 32, and none of the dependent claims clarifies the point of confusion, they must also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
22. Claim 51 recites the term “R groups”. Since claim 32 recited both “R1, R2, R3, R4, R5, R6, R7 and R8 (R groups)” and “amino acid R groups”. It is unclear to what the recited “R groups” in claim 51 is referring. Furthermore, claim 51 recites the relative terms “middle regions”, “regions proximal to the N-terminus” and “regions proximal to the C-terminus” of the peptoid. With regards to these regions, the instant specification fails to define them. Therefore, it is unclear which part of the peptoid is considered to be each of such regions. Taken all these together, the metes and bounds of instant claim 51 is vague and indefinite.
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Written Description
23. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
24. Claims 32-35, 49 and 51-54 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient” (MPEP § 2163).
A claimed genus may be satisfied through sufficient description of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with a known or disclosed correlation between function and structure (MPEP § 2163(3)a(II)). The number of species that describe the genus must be adequate to describe the entire genus; if there is substantial variability, a large number of species must be described.
The analysis for adequate written description considers (a) actual reduction to practice, (b) disclosure of drawings or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure, and (d) representative number of samples.
In the instant case, claims 32-35, 49 and 51-54 are drawn to a method of treating or preventing a cancer in a subject, said method comprising: administering to the subject a peptoid selected from the group consisting of
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, a multimer thereof, a derivative thereof, and combinations thereof.
The genus of instant claimed peptoid is extremely broad, including any peptoid and its multimer.
The instant specification discloses that instant claimed peptoid as an anticancer agent via binding to vimentin on the surface of human lung cancer cell.
The issue at question is whether a person of ordinary skilled in the art would be able to determine what structural feature is required for the instant claimed peptoid to have the functional characteristics of being as an anticancer agent via binding to vimentin on the surface of human lung cancer cell or not.
(a) actual reduction to practice and (b) disclosure of drawings or structural chemical formulas:
In the instant case, the instant specification discloses JM3A with the structure
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as an anti-lung cancer agent by binding to vimentin on the surface of human lung cancer cell via screening a library of about 100,000 peptoids. The peptoid JM3A and its derivatives are tested in the working examples in instant specification. By performing a alanine/sarcosine scan analysis, it appears the derivatives JM3A-1-4 and 8 maintain the functionality and/or property of JM3A. The instant specification further discloses JM3A-BP (having benzophenone at the N-terminus of JM3A) significantly improves the binding affinity of JM3A. Furthermore, the derivatives JM3A-8-BP, JM3A-4,8-BP and JM3A-4-iso-8-BP maintain the functionality and/or property of JM3A-BP. In addition, for a homodimer comprising JM3A-BP, the instant specification discloses that the spatial arrangement of each JM3A-BP monomer plays an important role in its binding to vimentin on the surface of human lung cancer cell.
Taken all these together, other than the limited examples, the instant specification fails to describe what structural feature is required for the instant claimed peptoid to have the functional characteristics of being an anticancer agent via binding to vimentin on the surface of human lung cancer cell.
(c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure:
As discussed above, in the instant case, based on the disclosure of instant specification, other than the limited examples, a person of ordinary skilled in the art would not be able to determine what structural feature is required for the instant claimed peptoid to have the functional characteristics of being an anticancer agent via binding to vimentin on the surface of human lung cancer cell.
With regards to the instant claimed peptoid being an anticancer agent via binding to vimentin on the surface of cancer cells, Shukla et al (Bioorg. Med. Chem., 2022, 58, pages 1-9, filed with IDS) teach JM3A (identical to the peptoid of JM3A disclosed in instant specification) as an anticancer peptoid via binding to vimentin on the surface of human lung cancer cells, for example, Abstract; and page 3, Figure 2. However, Shukla et al do not teach which part of JM3A is important for its anticancer activity. And Shukla et al do not teach any derivative of JM3A.
Therefore, based on the state of art, a person of ordinary skilled in the art would not be able to determine what structural feature is required for the instant claimed peptoid to have the functional characteristics of being an anticancer agent via binding to vimentin on the surface of human lung cancer cell.
(d) representative number of samples:
In the instant case, the genus of instant claimed peptoid is extremely broad, including any peptoid and its multimer.
And, as discussed in (a) and (b) above, the instant specification discloses JM3A with the structure
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as an anti-lung cancer agent by binding to vimentin on the surface of human lung cancer cell via screening a library of about 100,000 peptoids. The peptoid JM3A and its derivatives are tested in the working examples in instant specification. By performing a alanine/sarcosine scan analysis, it appears the derivatives JM3A-1-4 and 8 maintain the functionality and/or property of JM3A. The instant specification further discloses JM3A-BP (having benzophenone at the N-terminus of JM3A) significantly improves the binding affinity of JM3A. Furthermore, the derivatives JM3A-8-BP, JM3A-4,8-BP and JM3A-4-iso-8-BP maintain the functionality and/or property of JM3A-BP. In addition, for a homodimer comprising JM3A-BP, the instant specification discloses that the spatial arrangement of each JM3A-BP monomer plays an important role in its binding to vimentin on the surface of human lung cancer cell.
Furthermore, as stated above, the genus of instant claimed peptoid is extremely broad, including any peptoid and its multimer, such as the about 100,000 peptoids in the library screened by Applicant. However, out of the about 100,000 peptoids, JM3A is the only peptoid that is identified as an anticancer agent via binding to vimentin on the surface of human lung cancer cell.
Considering the broadness of the genus of instant claimed peptoid, the instant specification fails to provide sufficient examples to describe the entire genus of instant claimed peptoid to have the functional characteristics of being an anticancer agent via binding to vimentin on the surface of human lung cancer cell.
Taken all these together, considering the state of the art and the disclosure in instant specification, it is deemed that the instant specification fails to provide adequate written description for the claimed genus of peptoid to have the functional characteristics of being an anticancer agent via binding to vimentin on the surface of cancer cell, including human lung cancer cell; and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Scope of Enablement
25. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
26. Claims 32-35, 49 and 51-54 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 for treating cancer in a subject in need thereof, wherein the method comprises administering to the subject a peptoid selected from the group consisting of JM3A and its derivatives and/or multimers that exhibit anticancer activity via binding to vimentin, and wherein the cancer is selected from the group consisting of breast cancer, lung cancer, renal cell carcinoma, head and neck squamous cell carcinomas, ovarian cancer and pancreatic cancer as disclosed in Tabatabaee et al (Cancer and Metastasis Reviews, 2024, 43, pages 363-377); and a method of treating lung cancer in a subject in need thereof, wherein the method comprises administering to the subject PPS1D1 (a peptoid in dimeric version) as disclosed in Desai et al (Oncotarget, 2016, 7, pages 30678-30690, filed with IDS), does not reasonably provide enablement for a method for treating ALL type of cancer in a subject in need thereof, and/or preventing ANY type of cancer in a subject, wherein the method comprises administering to the subject a peptoid selected from the group consisting of
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, a multimer thereof, a derivative thereof, and combinations thereof.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or 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. When the above factors are weighed, it is the Examiner’s position that one skilled in the art could not practice the invention without undue experimentation.
(1) The nature of the invention and (5) The breadth of the claims:
The instant claims 32-35, 49 and 51-54 are drawn to a method of treating or preventing a cancer in a subject, said method comprising: administering to the subject a peptoid selected from the group consisting of
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, a multimer thereof, a derivative thereof, and combinations thereof.
The instant claims 32, 34, 35, 49 and 51-54 broadly include all types of cancer; and claim 33 limits the cancer to one selected from the group consisting of lung cancer, non-small cell lung cancer, colon cancer, esophageal cancer, breast cancer, melanoma, prostate cancer, cervical cancer, and combinations thereof.
With regards to “preventing a cancer”, other than a diagram of administering the instant claimed peptoid to a subject (instant Figure 1B), the instant specification discloses fails to define it.
The term “preventing” implies a perfect blocker from getting cancer.
Please note: The rejection to instant claimed peptoid being an anticancer peptide via binding to vimentin on the surface of cancer cell, including human lung cancer cell, under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement has been set forth in Section 24 above.
(2) The state of the prior art and (4) The predictability or unpredictability of the art:
With regarding to treating ALL type of cancer and/or preventing ANY type of cancer with the instant claimed peptoid, the art is unpredictable.
With regards to treating cancer via targeting vimentin, Tabatabaee et al (Cancer and Metastasis Reviews, 2024, 43, pages 363-377) teach agents with vimentin inhibitor properties can be used to treat breast cancer, renal cell carcinoma, head and neck squamous cell carcinomas, ovarian cancer and pancreatic cancer, for example, page 370, Table 1.
With regards to the instant claimed peptoid being an anticancer agent, Desai et al (Oncotarget, 2016, 7, pages 30678-30690, filed with IDS) teach a method of treating lung cancer in a subject in need thereof, wherein the method comprises administering to the subject PPS1D1 (a peptoid in dimeric form), for example, Abstract; and pages 30685-30686, Section “Inhibition of growth of H460 lung cancer xenograft by PPS1D1”.
With regards to preventing ANY type of cancer with the instant claimed peptoid, it is unknown in the art.
With regards to treating ALL type of cancer and/or preventing ANY type of cancer in a subject, cancer is not a single disease, or cluster of closely related disorders. There are hundreds of cancers, which have in common only some loss of controlled cell growth. Cancers are highly heterogeneous at both the molecular and clinical level, something seen especially in, for example, the cancers of the breast, brain and salivary glands. Different cancers have different properties. The Cellular and Molecular Basis of Cancer document (from Merck Manual Professional, 2008, enclosed pages 1-5) states that there are many cellular and molecular factors, for example more than 100 oncogenes, associated with cancer. They can occur in pretty much every part of the body. Here are some assorted categories of cancer: CNS cancers, leukemia, carcinomas of the liver, lung and pleural cancers, thyroid cancers, cancers of the skin cells, colorectal cancers, renal carcinoma, prostate cancer, penile carcinoma, the carcinomas of the extrahepatic bile ducts, breast cancers, ovarian cancers, testicular cancers, paratesticular cancers (cancers of the spermatic cord, epididymis, vestigial remnants, and tunica vaginalis), cancers of the vulva, vaginal cancers, endometrial carcinomas, stomach cancers, cancer of the esophagus, cancers of the spleen, salivary gland carcinomas, cancers of the heart (including pericardium, valves, etc.), odontogenic tumors, cancers of the oral cavity and oropharynx, cancers of the lymph glands, cancers of the adrenal glands, cancer of the eye, cervical cancers, gestational trophoblastic neoplasia, cancer of the throat, cancer of the thymus, fallopian tube cancer, bladder cancers, cancers of the gallbladder and many others. Furthermore, each category of cancer includes many diverse subcategories. For example, CNS cancers cover a very diverse range of cancers in many categories and subcategories. There are an immense range of neuroepithelial tumors. Gliomas, the most common subtype of primary brain tumors, most of which are aggressive, highly invasive, and neurologically destructive tumors are considered to be among the deadliest of human cancers. These are any cancers which show evidence (histological, immunohistochemical, ultrastructural) of glial differentiation. These fall mostly into five categories. There are the astrocytic tumors (astrocytomas): pilocytic astrocytoma (including juvenile pilocytic astrocytoma, JPA, and pediatric optic nerve glioma) diffuse astrocytomas (including fibrillary astrocytomas, protoplasmic astrocytomas and gemistocytic astrocytomas), anaplastic astrocytomas (including adult optic nerve glioma), Glioblastoma multiforme (GBM), gliosarcoma and giant cell glioblastoma, and pleomorphic xanthoastrocytoma. GBM exists in two forms, primary and secondary, which have very different clinical histories and different genetics, but GBM is considered to be one clinical entity. Second, there are the oligodendroglial tumors (oligodendrogliomas): low grade oligodendroglioma and anaplastic oligodendroglioma. Third, there is oligoastrocytomas ("mixed glioma"), a type of tumor with both astrocytoma & oligodendroglioma features. The fourth type is the ependymomas, which are intracranial gliomas, including papillary ependymoma, myxopapillary ependymoma, tanycytic ependymoma, anaplastic ependymoma and subependymal giant-cell astrocytomas. A fifth type is the gangliogliomas (glioneuronal tumors or glioneurocytic tumors), which have both glial and neuronal components, and are extremely varied, based in part on what types of glial and what types of neuronal components are present. These include Papillary Glioneuronal Tumor (PGNT), a range of supratentorial gangliogliomas, assorted intramedullary spinal cord gangliogliomas, pineal ganglioglioma, hypothalamic ganglioglioma, cerebellar ganglioglioma, ganglioglioma of the right optic tract, rosetted glioneuronal tumor ("glioneurocytic tumor with neuropil rosettes"), composite pleomorphic xanthoastrocytoma (PXA)- ganglioglioma, desmoplastic ganglioglioma (both infantile (DIG) and non-infantile), angioganglioglioma, and others. There are also some glial tumors which do not comfortably fit into these five categories, notably astroblastoma, gliomatosis cerebri, and chordoid glioma, which are found solely in the hypothalamus and anterior third ventricle. Other neuroepithelial tumors include astrocytic tumors (e.g. astrocytomas) oligodendroglial tumors, ependymal cell tumors (e.g. myxopapillary ependymoma), mixed gliomas (e.g. mixed oligoastrocytoma and ependymo-astrocytomas) tumors of the choroid plexus(choroid plexus papilloma, choroid plexus carcinoma), assorted neuronal and neuroblastic tumors (e.g. gangliocytoma, central neurocytoma, dysembryoplastic neuroepithelial tumor, esthesioneuroblastoma, olfactory neuroblastoma, olfactory neuroepithelioma, and neuroblastomas of the adrenal gland), pineal parenchyma tumors (e.g. pineocytoma, pineoblastoma, and pineal parenchymal tumor of intermediate differentiation), embryonal tumors (e.g. medulloepithelioma, neuroblastoma, ependymoblastoma, atypical teratoid/rhabdoid tumor, desmoplastic medulloblastoma, large cell medulloblastoma, medullomyoblastoma, and melanotic medulloblastoma) and others such as polar spongioblastoma and gliomatosis cerebri. A second Division is tumors of the meninges, this includes tumors of the meningothelial cells, including meningiomas (meningothelial, fibrous (fibroblastic), transitional (mixed), psammomatous, angiomatous, microcystic, secretory, lymphoplasmacyte-rich, metaplastic, clear cell, chordoid, atypical, papillary, rhabdoid, anaplastic meningioma) and the non-meningioma tumors of the meningothelial cells (malignant fibrous histiocytoma, leiomyoma, leiomyosarcoma, rhabdomyoma, rhabdomyosarcoma, chondroma, chondrosarcoma, osteoma, osteosarcoma, osteochondroma, haemangioma, epithelioid haemangioendothelioma, haemangiopericytoma, angiosarcoma, kaposi sarcoma). There are also mesenchymal, non-meningothelial tumors (liposarcoma, (intracranial) solitary fibrous tumor, and fibrosarcoma) as well as primary melanocytic lesions (diffuse melanocytosis, melanocytoma, malignant melanoma, and meningeal melanomatosis). A third division is the tumors of cranial and spinal nerves. This includes cellular schwannomas, plexiform schwannomas and the melanotic schwannomas (e.g. psammomatous melanotic schwannoma, neuro-axial melanotic schwannoma, dorsal dumb-bell melanotic schwannoma). There is also Perineurioma (Intraneural and Soft tissue) and malignant peripheral nerve sheath tumor (MPNST), including Epithelioid, MPNST with divergent mesenchymal differentiation, and MPNST with epithelial differentiation. A fourth division are germ cell tumors, including germinoma, embryonal carcinoma, yolk sac tumor, choriocarcinoma, and teratoma (mature teratoma, immature teratoma, and teratoma with malignant transformation). A fifth division are the tumors of the sellar Region, viz. pituitary adenoma, pituitary carcinoma, granular cell myoblastoma and craniopharyngiomas (adamantinomatous and papillary). Yet another division are local extensions from regional tumors, including paraganglioma, chodroma, chordoma, and chondrosarcoma. There are also Primitive Neuroectodermal Tumors (PNETs) including medulloblastomas, medulloepitheliomas, ependymoblastomas and polar spongioblastomas. There are Vascular Brain Tumors e.g. the hemangioblastomas, there is CNS Lymphoma (which can be primary or secondary) and Meningeal Carcinomatosis. There are lymphoma and haemopoietic neoplasms including malignant lymphomas (which can be primary or secondary), plasmacytoma, and granulocytic sarcoma. And there are many, many others. This also applies to other categories of cancer listed above.
(3) The relative skill of those in the art:
The relative skill of those in the art is high.
(6) The amount of direction or guidance presented and (7) The presence or absence of working examples:
With regarding to treating ALL types of cancer with the instant claimed peptoid, the instant specification discloses JM3A with the structure
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as an anti-lung cancer agent by binding to vimentin on the surface of human lung cancer cell via screening a library of about 100,000 peptoids. The peptoid JM3A and its derivatives are tested in the working examples in instant specification. By performing a alanine/sarcosine scan analysis, it appears the derivatives JM3A-1-4 and 8 maintain the functionality and/or property of JM3A. The instant specification further discloses JM3A-BP (having benzophenone at the N-terminus of JM3A) significantly improves the binding affinity of JM3A. Furthermore, the derivatives JM3A-8-BP, JM3A-4,8-BP and JM3A-4-iso-8-BP maintain the functionality and/or property of JM3A-BP. In addition, for a homodimer comprising JM3A-BP, the instant specification discloses that the spatial arrangement of each JM3A-BP monomer plays an important role in its binding to vimentin on the surface of human lung cancer cell.
The specification does not enable any person skilled in the art to which it pertains to make and/or use the invention commensurate in scope with the claims. The lack of adequate guidance from the specification or prior art with regard to the actual method of treating ALL type of cancer and/or preventing ANY type of cancer with the instant claimed peptoid. Applicants fail to provide the guidance and information required to ascertain which particular type of cancer and which particular peptoid will be effective against without resorting to undue experimentation. Applicant's limited disclosure is noted but is not sufficient to justify claiming a method of treating ALL type of cancer and/or preventing ANY type of cancer in a subject with instant claimed peptoid.
(8) The quantity of experimentation necessary:
Considering the state of prior arts and the disclosure in instant specification, one of ordinary skill in the art would be burdened with undue experimentation to treat ALL type of cancer and/or prevent ANY type of cancer with the instant claimed peptoid.
Claim Rejections - 35 U.S.C. § 102(a)(1)
27. 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.
28. Claims 32-35, 49 and 51-54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Desai et al (Oncotarget, 2016, 7, pages 30678-30690, filed with IDS).
The instant claims 32-35, 49 and 51-54 are drawn to a method of treating or preventing a cancer in a subject, said method comprising: administering to the subject a peptoid selected from the group consisting of
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, a multimer thereof, a derivative thereof, and combinations thereof.
Desai et al, throughout the literature, teach a method of treating lung cancer in a mouse having lung cancer, wherein the method comprises administering to the mouse PPS1D1 (a peptoid in dimeric form), for example, Abstract; and pages 30685-30686, Section “Inhibition of growth of H460 lung cancer xenograft by PPS1D1”. The peptoid PPS1D1 in Desai et al meets the limitations of the peptoid recited in instant claims 32, 49 and 51-54. And the method in Desai et al reads on lung cancer as the elected species of cancer; and cancer treatment as the elected species of effect of the method. And it meets the limitations of instant claims 32, 33, 35, 49 and 51-54. Desai et al further teach the mouse having lung cancer is human lung cancer xenograft, for example, page 30685, the 1st paragraph in Section “Inhibition of growth of H460 lung cancer xenograft by PPS1D1”. Therefore, in view of the teachings of Desai et al as a whole, one of ordinary skilled in the art would at once envision a method of treating lung cancer in a human subject having lung cancer, wherein the method comprises administering to the human subject PPS1D1 (a peptoid in dimeric form). It meets the limitations of instant claim 34.
Since the reference teaches all the limitations of instant claims 32-35, 49 and 51-54; the reference anticipates instant claims 32-35, 49 and 51-54.
Claim Rejections - 35 U.S.C. § 103
29. 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.
30. 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.
31. In the event that Applicant disagrees with how the Examiner interpretates Desai et al (Oncotarget, 2016, 7, pages 30678-30690, filed with IDS), claims 32-35, 49 and 51-54 are rejected under 35 U.S.C. 103 as being unpatentable over Desai et al (Oncotarget, 2016, 7, pages 30678-30690, filed with IDS).
The instant claims 32-35, 49 and 51-54 are drawn to a method of treating or preventing a cancer in a subject, said method comprising: administering to the subject a peptoid selected from the group consisting of
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, a multimer thereof, a derivative thereof, and combinations thereof.
Desai et al, throughout the literature, teach a method of treating lung cancer in a mouse having lung cancer, wherein the method comprises administering to the mouse PPS1D1 (a peptoid in dimeric form), for example, Abstract; and pages 30685-30686, Section “Inhibition of growth of H460 lung cancer xenograft by PPS1D1”. The peptoid PPS1D1 in Desai et al meets the limitations of the peptoid recited in instant claims 32, 49 and 51-54. And the method in Desai et al reads on lung cancer as the elected species of cancer; and cancer treatment as the elected species of effect of the method. And it meets the limitations of instant claims 32, 33, 35, 49 and 51-54.
The difference between the reference and instant claims 32-35, 49 and 51-54 is that the reference does not explicitly teach the limitations of instant claim 34.
However, Desai et al teach the mouse having lung cancer is human lung cancer xenograft, for example, page 30685, the 1st paragraph in Section “Inhibition of growth of H460 lung cancer xenograft by PPS1D1”.
Therefore, in view of the teachings of Desai et al as a whole, it would have been obvious to one of ordinary skilled in the art to develop a method of treating lung cancer in a human subject having lung cancer, wherein the method comprises administering to the human subject PPS1D1 (a peptoid in dimeric form).
In view of the teachings of Desai et al as a whole, one of ordinary skilled in the art would have been motivated to develop a method of treating lung cancer in a human subject having lung cancer, wherein the method comprises administering to the human subject PPS1D1 (a peptoid in dimeric form), because Desai et al teach the mouse having lung cancer is human lung cancer xenograft.
In view of the teachings of Desai et al as a whole, a person of ordinary skilled in the art would have reasonable expectation of success in developing a method of treating lung cancer in a human subject having lung cancer, wherein the method comprises administering to the human subject PPS1D1 (a peptoid in dimeric form).
Obviousness Double Patenting
32. 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 double patenting rejection is appropriate where the claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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.
33. Claims 32, 33, 35, 49 and 51-54 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 4-9 of US patent 10849875 B2.
34. Instant claims 32, 33, 35, 49 and 51-54 are drawn to a method of treating or preventing a cancer in a subject, said method comprising: administering to the subject a peptoid selected from the group consisting of
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, a multimer thereof, a derivative thereof, and combinations thereof.
35. Claims 4-9 of US patent 10849875 B2 are drawn to a method of treating a cancer in a patient, said method comprising: administering to a patient a composition of matter comprising a phosphatidylserine-targeting peptoid selected from the croup consisting of 2P3H-PPS1 and 2-4-PPS1.
36. For the same/similar reasoning/rational as the rejection set forth in Sections 33-35 above, instant claims 32, 33, 35 and 49 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 3-5 of US patent 11660325 B2, and claims 3-6 of US patent 11865157 B2.
37. For the same/similar reasoning/rational as the rejection set forth in Sections 33-35 above, instant claims 32, 33, 49 and 51-54 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable claims 1-9 of US patent 12479886 B2.
In the instant case, the method recited in claims 1-9 of US patent 12479886 B2 comprises administering the same peptoid to the same subject as the method recited in instant claims 32, 33, 49 and 51-54. Therefore, the method recited in claims 1-9 of US patent 12479886 B2 would result in the same effect as what recited in instant claims 32, 33, 49 and 51-54.
38. For the same/similar reasoning/rational as the rejection set forth in Sections 33-35 above, instant claims 32, 33 and 49 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable claims 1 and 2 of US patent 12668610 B2.
In the instant case, the method recited in claims 1 and 2 of US patent 12668610 B2 comprises administering the same peptoid to the same subject as the method recited in instant claims 32, 33 and 49. Therefore, the method recited 1 and 2 of US patent 12668610 B2 would result in the same effect as what recited in instant claims 32, 33 and 49.
39. For the same/similar reasoning/rational as the rejection set forth in Sections 33-35 above, instant claims 32, 33, 49 and 51-54 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 24, 27-29, 32, 35, 37, 38, 47 and 48 of co-pending Application No. 18/015927 (Notice of Allowance mailed on 6/26/2026).
In the instant case, the method recited in claims 24, 27-29, 32, 35, 37, 38, 47 and 48 of co-pending Application No. 18/015927 comprises administering the same peptoid to the same subject as the method recited in instant claims 32, 33, 49 and 51-54. Therefore, the method recited in claims 24, 27-29, 32, 35, 37, 38, 47 and 48 of co-pending Application No. 18/015927 would result in the same effect as what recited in instant claims 32, 33, 49 and 51-54.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
40. For the same/similar reasoning/rational as the rejection set forth in Sections 33-35 above, instant claims 32, 33, 35, 49 and 51-54 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 4-15 of co-pending Application No. 19/479530.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
41 For the same/similar reasoning/rational as the rejection set forth in Sections 33-35 above, instant claims 32, 33 and 49 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3 and 6 of co-pending Application No. 19/678838.
In the instant case, in view of the combined teachings of claims 1-3 and 6 of co-pending Application No. 19/678838, it would have been obvious to one of ordinary skilled in the art to develop a method of administering the peptoid compound recited in claims 1-3 and 6 of co-pending Application No. 19/678838 to a subject. And since the method developed above comprises administering the same peptoid to the same subject as the method recited in instant claims 32, 33 and 49, the method developed above would result in the same effect as what recited in instant claims 32, 33 and 49.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Non-compliant Amendments
42. The claim filed on 7/8/2026 is a non-compliant amendment. In the claim field on 7/8/2026, claim 54 has the status identifier “(Previously Presented)”. However, it seems there are changes indicated as underlined in instant claim 54 (see § MPEP 714).
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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