Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-17 are currently pending.
Claim Objections
Claim 15 objected to because of the following informalities: "Wilms' tumor. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Improper Dependency
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 depends on claim 8. However, based on claim 1's language of the peptide comprising one of SEQ ID NOs:1-5, claim 12 should depend on claim 9. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Indefinite Language
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation SEQ ID NO:1, which contains X instead of a specific amino acids.
SEQ ID NO:2-5 are specific amino acid sequences.
Amending claim 1 drawn to SEQ ID NO: 1 only and list the specific amino acids in a dependent claim would obviate this rejection.
Claim 10 recites the limitation "the pharmaceutical agent" in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the peptide of SEQ ID NO:5" in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim. Amending claim dependence to claim 8 would obviate this rejection.
Priority
This application claims benefit to US Provisional Application US 63/399,010 effectively filed on 8/18/2022.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fan, M. et al (02/07/2017, "Fan", see references cited).
Claim 1 recites:
A peptide-drug conjugate, wherein the peptide comprises one of SEQ ID NOs:1- 5.
Regarding claim 1, Fan teaches a peptide-drug conjugate wherein the peptide comprises SEQ ID NOs: 1-2 (Fan; Abstract; Figure 2A).
Regarding claim 2, Fan teaches the peptide-drug conjugate of claim 1 wherein the drug is a chemotherapeutic agent or a radioactive agent (Fan; Abstract; Figure 2A).
Regarding claim 3, Fan teaches the peptide drug conjugate of claim 2 wherein the chemotherapeutic is doxorubicin (Fan; Abstract; Figure 2A).
Regarding claim 4, Fan teaches the peptide-drug conjugate of claim 3, wherein the chemotherapeutic agent comprises doxorubicin (Fan; Abstract; Figure 2A).
Regarding claim 5, Fan teaches the peptide-drug conjugate of claim 1, wherein the peptide comprises SEQ ID NO:1 (Fan; Abstract; Figure 2A; referred to as GE11 peptide).
Regarding claim 6, Fan teaches the peptide-drug conjugate of claim 1, wherein the peptide comprises SEQ ID NO:2 (Fan; Abstract; Figure 2A; referred to as GE11 peptide). Fan’s GE11 peptide is the same as SEQ ID NO:2 of the instant application. Claims 1-6, as currently written, do not exclude additional sequence at the end of the claimed GE11 peptide to link the peptide to a therapeutic where Fan has introduced a disulfide linker to the C-terminus of GE11 (see Figure 2A). In fact, claim 10, which depends on claim 1, claims a linker sequence (see below).
Regarding claim 10, Fan teaches the peptide-drug conjugate of claim 1, further comprising a linker linking the peptide to the pharmaceutical agent (Fan; Figure 2A; Section 3.1; Discussion; disulfide bond linker). Since claims 1-6, as currently written, do not exclude additional sequence at the end of the claimed GE11 or GE11 derivative peptides, the linker taught by Fan teaches the linker of instant claim 10.
Regarding claim 13, Fan teaches a pharmaceutical composition comprising the peptide-drug conjugate of claim 1 (Fan; Figure 2A).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 7-9, 12, 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fan, M. et al (02/07/2017, "Fan", see references cited) in view of Hossein-Nejad-Ariani, H. et al (02/25/2019, “Hossein”, see references cited).
Regarding claim 7, Fan teaches the peptide drug conjugate of claim 1. Fan does not teach wherein the peptide comprises SEQ ID NO:3. Hossein does teach the peptide comprising SEQ ID NO:3 (Hossein; Table 1 [Peptide 22]).
Regarding claim 8, Fan teaches the peptide drug conjugate of claim 1. Fan does not teach wherein the peptide comprises SEQ ID NO:4. Hossein does teach the peptide comprising SEQ ID NO:4 (Hossein; Table 1 [Peptide 27]).
Regarding claim 9, Fan teaches the peptide drug conjugate of claim 1. Fan does not teach wherein the peptide comprises SEQ ID NO:5. Hossein does teach the peptide comprising SEQ ID NO:5 (Hossein; Figure 4B; page 3, section: In vitro Cell Uptake of Soluble (Free) Peptides, “It is anticipated that these peptide binds to the same site on EGFR as the native ligand EGF, and comparison of the amino acid sequence of these peptides and EGF shows that E and R may be preferred residues at positions 9 and 10 (vide infra)").
Regarding claim 12, Fan teaches the peptide drug conjugate of claim 8 and the peptide conjugated to doxorubicin. Fan does not teach wherein the peptide-drug conjugate comprises the peptide of SEQ ID NO:5. Hossein does teach SEQ ID NO:5 (Hossein; Figure 4B; page 3, section: In vitro Cell Uptake of Soluble (Free) Peptides, “It is anticipated that these peptide binds to the same site on EGFR as the native ligand EGF, and comparison of the amino acid sequence of these peptides and EGF shows that E and R may be preferred residues at positions 9 and 10 (vide infra)").
Regarding claim 14, Fan teaches the peptide-drug conjugate of claim 1. Fan does not teach a method of treating cancer comprising administering to a cancer patient in need thereof the peptide drug conjugate. Hossein does teach a method of treating cancer comprising administering to a cancer patient in need thereof the peptide drug conjugate (Hossein; Abstract; page 2, paragraph 2, lines 17-18).
Regarding claim 15, Fan teaches the peptide-drug conjugate of claim 1. Fan does not teach a method of treating cancer comprising administering to a cancer patient in need thereof the peptide drug conjugate wherein the cancer is selected from acute lymphoblastic leukemia, acute myeloid leukemia, adrenocortical carcinoma, anal cancer, astrocytoma, bile duct cancer, bladder cancer, bone cancer, brain tumor, breast cancer, carcinoid tumor, carcinoma, cervical cancer, chronic lymphocytic leukemia, chronic myelogenous leukemia, myeloproliferative disorders, colorectal cancer, cutaneous T-cell lymphoma, endometrial cancer, ependymoma, esophageal cancer, Ewing's family of tumors, germ cell tumor, retinoblastoma; gallbladder cancer, gastric cancer, glioma, hairy cell leukemia, head and neck cancer; hepatocellular cancer, Hodgkin's lymphoma, islet cell carcinoma, Kaposi's sarcoma, kidney cancer, laryngeal cancer, lip and oral cavity cancer, liver cancer, lung cancer, non-small cell lung cancer, small cell lung cancer, lymphoblastic leukemia, lymphocytic leukemia, lymphoma, non-Hodgkin's lymphoma, Waldenstrom's macroglobulinemia, mesothelioma, malignant thymoma, medulloblastoma, melanoma, multiple endocrine neoplasia syndrome, multiple myeloma/plasma cell neoplasm, mycosis fungoides, myelodysplastic syndromes, myelogenous leukemia, myeloid leukemia, nasopharyngeal cancer, neuroblastoma, oral cancer, oropharyngeal cancer, osteosarcoma/malignant fibrous histiocytoma of bone, ovarian cancer, pancreatic cancer, parathyroid cancer, penile cancer, pheochromocytoma, pituitary tumor, prostate cancer, rectal cancer, renal cell cancer, retinoblastoma, rhabdomyosarcoma, salivary gland cancer, sarcoma, Sezary syndrome, skin cancer, soft tissue sarcoma, squamous neck cancer, testicular cancer, thymoma, thyroid cancer, trophoblastic tumor, urethral cancer, uterine sarcoma, vaginal cancer, vulvar cancer, and Wilms' tumor:. Hossein does teach a method of treating breast cancer (Hossein; Abstract; page 2, paragraph 2, lines 17-18).
Regarding claim 16, Fan teaches the peptide-drug conjugate of claim 1. Fan does not teach a method of treating cancer comprising administering to a cancer patient in need thereof the peptide drug conjugate wherein the cancer is breast cancer. Hossein does teach a method of treating breast cancer (Hossein; Abstract; page 2, paragraph 2, lines 17-18).
Regarding claim 17, Fan teaches the peptide-drug conjugate of claim 1. Fan does not teach a method of treating cancer comprising administering to a cancer patient in need thereof the peptide drug conjugate wherein the cancer is triple negative breast cancer. Hossein does teach a method of treating triple negative breast cancer (Hossein; Abstract; page 2, paragraph 2, lines 17-18).
Therefore, it would have been prima facie obvious to one of ordinary skill, in the art as of the effective filing date, to have modified the peptide-drug conjugate of Fan with the peptide sequences of Hossein with reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification to improve targeted therapies for triple negative breast cancer by increasing both peptide-receptor affinity and doxorubicin accumulation in tumor cells; thus, leading to improved therapeutic outcomes for patients receiving the peptide drug conjugate.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fan and Hossein as applied to claims 7-9, 12, and 14-17 above, and further in view of Alas et al (12/31/2020, "Alas", see references cited).
Regarding claim 11, Fan and Hossein teach the peptide drug conjugate of claim 1 wherein the peptide comprises SEQ ID NO:5 with a disulfide bond linker (see above). Fan and Hossein do not teach wherein the linker comprises a thioester, an amide, a carbamate, an ester, or a carbonate. Alas does teach a peptide drug conjugate with thioester, an amide, a carbamate, an ester, or a carbonate (Alas; Abstract; Figure 1).
Therefore, it would have been prima facie obvious to one of ordinary skill, in the art as of the effective filing date, to have modified the peptide-drug conjugate with a disulfide bond linker of Fan with the peptide sequences of Hossein with the linkers of Alas with reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification as the linker constitutes a feature of the peptide-drug conjugate that can be substituted with another type of linker to perform the same function as the original one. This substitution represents a known and predictable design choice yielding predictable results.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8, 10-11, and 13-15 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 7-10 of copending Application No. 18/330,748 [Yang et al. (748)] in view of (Alas et al (12/31/2020, "Alas", see references cited).
This is a provisional nonstatutory double patenting rejection.
The teachings of Yang et al. (748) have been set forth above as applied to claims 1-8 and 13-15 of the instant application. Yang et al (748) teaches a pharmaceutical composition comprising a chemotherapeutic agent comprising doxorubicin and a tumor-targeting peptide comprising one of: YHWYGTPQNVI, YHWYGYTPENVI, and YHWYGYTPQKVI (see claims 4 and 5) which embody SEQ ID NOs:2-4 of the instant application. They also teach that the composition can be used to treat melanoma (see claims 7-9).
The teachings of Alas have been discussed above. Regarding claims 10-11, Alas teaches various linkers linking the peptide to the pharmaceutical agent (see Graphical Abstract and Figure 1). They also teach peptide-drug conjugates can be used as cancer therapeutics (see Abstract and Introduction). It would have been obvious for person of ordinary skill in the art to combine the peptide-doxorubicin composition of Yang et al. (748) and the linker alternatives of Alas with reasonable expectation of success. A person of ordinary skill in the art would have been motivated to make this modification to improve circulation time of the conjugate and release of the drug for full activity at the target site to reduce side effects and/or complications.
Therefore, the claims in the copending application are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Conclusion
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/MISOOK YU/ Supervisory Patent Examiner, Art Unit 1641