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 6/16/2026 is acknowledged.
4. Claim filed on 12/27/2023 is acknowledged.
5. Claims 5-9 have been cancelled.
6. New claims 10 and 11 have been added.
7. Claims 1-4, 10 and 11 are pending in this application.
8. Claim 10 is withdrawn from consideration as being drawn to non-elected species.
Please note: In the instant case, Applicant elected breast cancer recited in instant claim 11 as species of type of cancer from claims 10 and 11 in the reply filed on 6/16/2026.
9. Claims 1-4 and 11 are under examination.
Election/Restrictions
10. Applicant’s election of a peptide consisting of the amino acid sequence of SEQ ID NO: 2 as species of peptide and breast cancer recited in claim 11 as species of type of cancer from claims 10 and 11 in the reply filed on 6/16/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The requirement is made FINAL in this office action.
The instant claims 1-4, 10 and 11 are drawn to a method for treating cancer, the method comprising administering a pharmaceutical composition comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 3 to 5 as an active ingredient to a subject in need thereof. A search was conducted on the elected species; and a peptide consisting of the amino acid sequence of SEQ ID NO: 2 as the elected species of peptide appears to be free of prior art. However, prior art was found for breast cancer recited in claim 11 as the elected species of type of cancer from claims 10 and 11. A search was extended to the genus in claim 1; and prior art was found. Claim 10 is withdrawn from consideration as being drawn to non-elected species. Claims 1-4 and 11 are examined on the merits in this office action.
Specification
11. 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).
Objections
12. The drawings are objected to for the following minor informality:
Figure 2: It is impossible to tell which bar is corresponding to Adipocyte, Cardiomyocyte or Neuroblastoma.
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.
13. Claim 1 is objected to for the following minor informality: Applicant is suggested to amend claim 1 as “A method for treating cancer in a subject in need thereof, wherein the method comprises administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a peptide comprising the amino acid sequence selected from the group consisting of SEQ ID NOs: 3 to 5”.
The Examiner would like to point out the term “an amino acid sequence” broadly includes a peptide comprising both full-length and any fragment of any one of instant SEQ ID NOs: 3-5. As an example, a peptide comprising FR is a peptide comprising an amino acid sequence of instant SEQ ID NO: 3.
14. Claim 2 is objected to for the following minor informality: Applicant is suggested to amend claim 2 as “…wherein the peptide consists of the amino acid sequence of SEQ ID NO: 1, 2 or 3”.
15. Claim 3 is objected to for the following minor informality: Applicant is suggested to amend claim 3 as “…wherein the peptide inhibits metastasis of cancer cells”.
16. Claim 4 is objected to for the following minor informality: Applicant is suggested to amend claim 4 as “…wherein the peptide induces apoptosis of cancer cells”.
17. Claim 11 is objected to for the following minor informality: Applicant is suggested to amend the recited “brain tumors” as “brain tumor”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Written Description
18. 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.
19. Claims 1-4 and 11 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 1-4 and 11 are drawn to a method for treating cancer, the method comprising administering a pharmaceutical composition comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 3 to 5 as an active ingredient to a subject in need thereof.
The genus of instant claimed peptide/amino acid sequence is extremely broad, including any peptide/protein comprising the amino acid sequence selected from the group consisting of SEQ ID NOs: 3 to 5. The peptide of instant SEQ ID NO: 3 consists of the amino acid sequence YFR; the peptide of instant SEQ ID NO: 4 is a fragment of either human or bovine IF1 protein; and the peptide of instant SEQ ID NO: 5 is a fragment of human IF1.
The instant specification discloses that peptides of instant SEQ ID NO: 1-5 function as anticancer peptide.
The issue at question is whether a person of ordinary skilled in the art would be able to determine what structural feature/amino acid sequence is required for the instant claimed peptide/amino acid sequence to have the functional characteristics of being an anticancer peptide of or not.
(a) actual reduction to practice and (b) disclosure of drawings or structural chemical formulas:
In the instant case, the instant specification discloses peptides of SEQ ID NOs: 1-5 as examples of the instant claimed amino acid sequence/peptide.
Furthermore, peptides of instant SEQ ID NOs: 1-5 are tested in the working examples in instant specification. Peptides of instant SEQ ID NOs: 1-5 appear to exhibit anticancer activity against the triple-negative breast cancer cell line (MDA-MB-231) in vitro. Peptides of instant SEQ ID NOs: 1 and 2 are further tested to identify their mechanism of action via in vitro experiment. Peptide of instant SEQ ID NO: 1 is tested in a xenograft tumor animal model with transplanted MDA-MB-231 cell.
Taken all these together, other than the limited examples, the instant specification fails to describe what structural feature/amino acid sequence is required for the instant claimed peptide/amino acid sequence to have the functional characteristics of being an anticancer peptide.
(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/amino acid sequence is required for the instant claimed peptide/amino acid sequence to have the functional characteristics of being an anticancer peptide.
With regards to the instant claimed peptide/amino acid sequence being an anticancer peptide, Chung et al (KR 20200038412 A, filed with IDS) teach IF1 (ATPase inhibitory factor 1) as an anticancer peptide, wherein IF1 exhibits its anticancer activity against liver cancer cell line HepG2, breast cancer cell lines MDA-MB-231 and T47D; and cervical cancer cell line HeLa in vitro, wherein IF1 consists of the amino acid sequence of SEQ ID NO: 1 (comprising the amino acid sequence of instant SEQ ID NO: 1 or 3), and wherein IF1 inhibits cancer cell migration and/or induces apoptosis, for example, paragraphs [0001], [0008] and [0022]; Figures 2-4; and SEQ ID NO: 1 on page 16 of the original document. However, Chung et al do not teach any fragment of IF1 being anticancer peptide, and/or the core sequence of IF1 that is important for its anticancer activity.
Therefore, based on the state of art, a person of ordinary skilled in the art would not be able to determine what structural feature/amino acid sequence is required for the instant claimed peptide/amino acid sequence to have the functional characteristics of being an anticancer peptide.
(d) representative number of samples:
In the instant case, the genus of instant claimed peptide/amino acid sequence is extremely broad, including any peptide/protein comprising the amino acid sequence selected from the group consisting of SEQ ID NOs: 3 to 5. The peptide of instant SEQ ID NO: 3 consists of the amino acid sequence YFR; the peptide of instant SEQ ID NO: 4 is a fragment of either human or bovine IF1 protein; and the peptide of instant SEQ ID NO: 5 is a fragment of human IF1.
And, as discussed in (a) and (b) above, the instant specification discloses peptides of SEQ ID NOs: 1-5 as examples of the instant claimed amino acid sequence/peptide.
Furthermore, peptides of instant SEQ ID NOs: 1-5 are tested in the working examples in instant specification. Peptides of instant SEQ ID NOs: 1-5 appear to exhibit anticancer activity against the triple-negative breast cancer cell line (MDA-MB-231) in vitro. Peptides of instant SEQ ID NOs: 1 and 2 are further tested to identify their mechanism of action via in vitro experiment. Peptide of instant SEQ ID NO: 1 is tested in a xenograft tumor animal model with transplanted MDA-MB-231 cell.
However, the SEQ ID NO: 3 STIC search results document (2026, pages 1-10) teaches that other than IF1, there are many different proteins comprising the amino acid sequence of instant SEQ ID NO: 3; and there is no evidence to indicate these different proteins exhibit any anticancer activity.
Considering the broadness of the genus of instant claimed peptide/amino acid sequence, the instant specification fails to provide sufficient examples to describe the entire genus of instant claimed peptide/amino acid sequence to have the functional characteristics of being an anticancer peptide.
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 peptide/amino acid sequence to have the functional characteristics of being an anticancer peptide; 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
20. 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.
21. Claims 1-4 and 11 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 pharmaceutical composition comprising a therapeutically effective amount of IF1 comprising the amino acid sequence selected from the group consisting of instant SEQ ID NOs: 1-5 or a peptide consisting of instant SEQ ID NO: 1 or 2, and wherein the cancer is selected from the group consisting of breast cancer, liver cancer and cervical cancer, does not reasonably provide enablement for a method for treating ALL type of cancer in a subject in need thereof, wherein the method comprises administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of ALL peptide comprising the amino acid sequence selected from the group consisting of instant SEQ ID NOs: 3 to 5. The specification does not enable any person skilled in the art to which it pertains (i.e. treatment of cancer) to make and/or use the invention commensurate in scope with the claims.
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 1-4 and 11 are drawn to a method for treating cancer, the method comprising administering a pharmaceutical composition comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 3 to 5 as an active ingredient to a subject in need thereof.
The instant claims 1-4 broadly include all types of cancer; and claim 11 limits the cancer to one selected from the group consisting of lung cancer, ovarian cancer, colorectal cancer, colon cancer, pancreatic cancer, liver cancer, cervical cancer, kidney cancer, stomach cancer, prostate cancer, breast cancer, brain tumors, uterine cancer, and bladder cancer.
Please note: The rejection to instant claimed peptide/amino acid sequence being an anticancer peptide 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 19 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 with the instant claimed peptide/amino acid sequence, the art is unpredictable.
With regards to the instant claimed peptide/amino acid sequence being an anticancer peptide, Chung et al (KR 20200038412 A, filed with IDS) teach IF1 (ATPase inhibitory factor 1) as an anticancer peptide, wherein IF1 exhibits its anticancer activity against liver cancer cell line HepG2, breast cancer cell lines MDA-MB-231 and T47D; and cervical cancer cell line HeLa in vitro, wherein IF1 consists of the amino acid sequence of SEQ ID NO: 1 (comprising the amino acid sequence of instant SEQ ID NO: 1 or 3), and wherein IF1 inhibits cancer cell migration and/or induces apoptosis, for example, paragraphs [0001], [0008] and [0022]; Figures 2-4; and SEQ ID NO: 1 on page 16 of the original document. However, Chung et al do not teach any fragment of IF1 being anticancer peptide, and/or the core sequence of IF1 that is important for its anticancer activity.
With regards to treating ALL type of cancer in a subject in need thereof, 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.
Furthermore, Domínguez-Zorita et al (Cancers, 2023, 15, pages 1-26) teach the complexity of the mitochondrial ATP synthase/IF1 axis in cancer progression; and depends on the cancer type, IF1 can be either a tumor promoter or a tumor suppressor, for example, page 12, Figure 5.
(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 peptide/amino acid sequence, the instant specification discloses peptides of SEQ ID NOs: 1-5 as examples of the instant claimed amino acid sequence/peptide. The peptides of instant SEQ ID NO: 1-5 are fragments of IF1.
Furthermore, peptides of instant SEQ ID NOs: 1-5 are tested in the working examples in instant specification. Peptides of instant SEQ ID NOs: 1-5 appear to exhibit anticancer activity against the triple-negative breast cancer cell line (MDA-MB-231) in vitro. Peptides of instant SEQ ID NOs: 1 and 2 are further tested to identify their mechanism of action via in vitro experiment. Peptide of instant SEQ ID NO: 1 is tested in a xenograft tumor animal model with transplanted MDA-MB-231 cell.
The specification does not enable any person skilled in the art to which it pertains (i.e. cancer treatment) 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 in a subject in need thereof with the instant claimed peptide/amino acid sequence. Applicants fail to provide the guidance and information required to ascertain which particular type of cancer and which particular peptide/amino acid sequence 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 in a subject in need of with instant claimed peptide/amino acid sequence.
(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 in a subject in need thereof with instant claims peptide/amino acid sequence.
Claim Rejections - 35 U.S.C. § 102(a)(1)
22. 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.
23. Claims 1, 3, 4 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chung et al (KR 20200038412 A, filed with IDS).
The instant claims 1, 3, 4 and 11 are drawn to a method for treating cancer, the method comprising administering a pharmaceutical composition comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 3 to 5 as an active ingredient to a subject in need thereof.
Chung et al teach IF1 (ATPase inhibitory factor 1) as an anticancer peptide, wherein IF1 exhibits its anticancer activity against liver cancer cell line HepG2, breast cancer cell lines MDA-MB-231 and T47D; and cervical cancer cell line HeLa in vitro, wherein IF1 consists of the amino acid sequence of SEQ ID NO: 1 (comprising the amino acid sequence of instant SEQ ID NO: 1 or 3), and wherein IF1 inhibits cancer cell migration and/or induces apoptosis of cancer cell, for example, paragraphs [0001], [0008] and [0022]; Figures 2-4; and SEQ ID NO: 1 on page 16 of the original document. Chung et al further teach IF1 has a beneficial effect on cancer treatment; and a method of treating cancer in a subject in need thereof, wherein the method comprises administering to the subject a pharmaceutical composition comprising IF1, and wherein IF1 inhibits metastasis of cancer, for example, paragraphs [0021], [0029], [0043] and [0044]. Therefore, in view of the teachings of Chung et al as a whole, one of ordinary skilled in the art would immediately envision a method of treating cancer in a subject in need thereof, wherein the method comprises administering to the subject a pharmaceutical composition comprising IF1, wherein IF1 consists of the amino acid sequence of SEQ ID NO: 1 (comprising the amino acid sequence of instant SEQ ID NO: 1 or 3), wherein IF1 inhibits metastasis of cancer cells and/or induces apoptosis of cancer cells, and wherein the cancer is selected from the group consisting of liver cancer, breast cancer and cervical cancer. It reads on breast cancer recited in claim 11 as the elected species of type of cancer from claims 10 and 11; and meets the limitations of instant claims 1, 3, 4 and 11.
Since the reference teaches all the limitations of instant claims 1, 3, 4 and 11; the reference anticipates instant claims 1, 3, 4 and 11.
Obviousness Double Patenting
24. 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.
25. Claims 1, 3, 4 and 11 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 2 of US patent 12059450 B2 and in view of Chung et al (KR 20200038412 A, filed with IDS).
26. Instant claims 1, 3, 4 and 11 are drawn to a method for treating cancer, the method comprising administering a pharmaceutical composition comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 3 to 5 as an active ingredient to a subject in need thereof.
27. Claims 1 and 2 of US patent 12059450 B2 are drawn to a method for preventing, or treating cancer or inhibiting cancer metastasis comprising administering IF1 (ATPase
inhibitory factor 1) as an active ingredient to a subject in need thereof; wherein the cancer is liver cancer or cervical cancer.
28. The difference between the method recited in claims 1 and 2 of US patent 12059450 B2 and the method recited in instant claims 1, 3, 4 and 11 is that claims 1 and 2 of US patent 12059450 B2 do not explicitly teach the amino acid sequence recited in instant claim 1; and the limitations of instant claim 4.
However, in view of the teachings of Chung et al as set forth in Section 23 above, it would have been obvious to one of ordinary skilled in the art to modify the method recited in claims 1 and 2 of US patent 12059450 B2 and develop the method recited in instant claims 1, 3, 4 and 11.
29. For the same/similar reasoning/rational as the rejection set forth in Sections 25-28 above, instant claims 1, 3, 4 and 11 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5 of co-pending Application No. 18/776191; and in view of the teachings of Chung et al (KR 20200038412 A, filed with IDS) as set forth in Section 23 above.
This is a provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
30. Claims 1, 3, 4 and 11 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 5-9 of US patent 12263206 B2 and in view of Williams et al (2019, enclosed pages 1-8, from https://dailynews.ascopubs.org/do/relationship-between-sarcopenia-and-cancer) and Chung et al (KR 20200038412 A, filed with IDS).
31. Instant claims 1, 3, 4 and 11 are drawn to a method for treating cancer, the method comprising administering a pharmaceutical composition comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 3 to 5 as an active ingredient to a subject in need thereof.
32. Claims 5-9 of US patent 12263206 B2 are drawn to a method for treating sarcopenia comprising administering recombinant exogenous ATPase inhibitory factor 1 (IF1) as an active ingredient to a subject in need thereof, wherein the recombinant exogenous IF1 consists of the amino acid sequence of SEQ ID NO: 1.
The recombinant exogenous IF1 consisting of the amino acid sequence of SEQ ID NO: 1 comprises the amino acid sequence of instant SEQ ID NO: 1 or 3.
33. The difference between the method recited in claims 5-9 of US patent 12263206 B2 and the method recited in instant claims 1, 3, 4 and 11 is that claims 5-9 of US patent 12263206 B2 do not explicitly teach the subject recited in instant claim 1; and the limitations of instant claims 3, 4 and 11.
However, Williams et al, throughout the literature, teach cancer patient suffers from sarcopenia, including patient with breast cancer, for example, Sections “Article Highlights”, “Relevance of Sarcopenia in Oncology” and “Recent Studies on Sarcopenia”.
Furthermore, Chung et al teach IF1 inhibits cancer cell migration and/or induces apoptosis of cancer cells, for example, paragraphs [0001], [0008] and [0022]; and Figures 2-4.
Therefore, in view of the combined teachings of Williams et al and Chung et al, it would have been obvious to one of ordinary skilled in the art to modify the method recited in claims 5-9 of US patent 12263206 B2 and develop the method recited in instant claims 1, 3, 4 and 11.
34. For the same/similar reasoning/rational as the rejection set forth in Sections 30-33 above, instant claims 1-4 and 11 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 19 and 20 of co-pending Application No. 18/574665; and in view of the combined teachings of Williams et al (from https://dailynews.ascopubs.org/do/relationship-between-sarcopenia-and-cancer, 2019, enclosed pages 1-8) and Chung et al (KR 20200038412 A, filed with IDS) as set forth in Section 33 above.
This is a provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
35. Claims 1, 3 and 4 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of co-pending Application No. 18/258578 and in view of Papathanassiu (US 2002/0091081 A1, filed with IDS).
36. Instant claims 1, 3 and 4 are drawn to a method for treating cancer, the method comprising administering a pharmaceutical composition comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 3 to 5 as an active ingredient to a subject in need thereof.
37. Claim 1 of co-pending Application No. 18/258578 is drawn to a peptide consisting of an amino acid sequence represented by SEQ ID NO: 1 or 2.
The peptide of SEQ ID NO: 1 or 2 recited in claim 1 of co-pending Application No. 18/258578 comprises the amino acid sequence of any one of instant SEQ ID NOs: 1-4.
38. The difference between claim 1 of co-pending Application No. 18/258578 and instant claims 1, 3 and 4 is that claim 1 of co-pending Application No. 18/258578 does not apply the peptide in the method recited in instant claims.
However, Papathanassiu teaches peptide of SEQ ID NO: 1 or 2 (comprising the amino acid sequence of any one of instant SEQ ID NOs: 1-4), and a method of treating cancer in a subject in need thereof with such peptide, for example, claims 1, 2, 4 and 13.
Therefore, in view of the teachings of Papathanassiu, it would have been obvious to one of ordinary skilled in the art to apply the peptide recited in claim 1 of co-pending Application No. 18/258578 in a method of treating cancer in a subject in need thereof.
With regards to the limitations recited in instant claims 3 and 4, the peptide in the method developed above meets all the structural limitations of the amino acid sequence/peptide recite din instant claim 1, therefore, the peptide in the method developed above would necessarily have the same properties and functionality of the amino acid sequence/peptide recite din instant claim 1. Thus, the peptide in the method developed above inhibits metastasis of cancer cells and/or induces apoptosis of cancer cells. Furthermore, the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP § 2112.01 I). In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
This is a provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
39. For the same/similar reasoning/rational as the rejection set forth in Sections 35-38 above, instant claims 1, 3 and 4 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6, 9 and 10 of co-pending Application No. 18/861693, and claims 1-13 of co-pending Application No. 19/471420; and in view of the teachings of Papathanassiu (US 2002/0091081 A1, filed with IDS) as set forth in Section 38 above.
These are provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached on 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LI N KOMATSU/Primary Examiner, Art Unit 1658
Prosecution Insights