DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Status
Claim(s) 1-7 is/are currently pending and presented for examination on the merits.
Foreign Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Specification
The use of trade name(s) or mark(s) used in commerce (e.g., Herceptin, Genentech, Roche), has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 2-7 is/are rejected under 35 U.S.C. 101 because the claimed recitation of a use of a monoclonal anti-CK8 antibody, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). See MPEP 2173.05(q).
Claim Rejections - 35 USC § 112(b)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 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.
Claim(s) 1-7 is/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.
Claims 1-7, recite “monoclonal antibody CK8-1R5 of CK8” and/or “monoclonal antibody CK8-1R5”, rendering the meets and bounds of the claims are indefinite (see MPEP 2173.05). Specifically, it is unclear if phrase is intended to mean (1) the antibody is the Applicant designated “CK8-1R5” antibody and the “of CK8” portion of the phrase is merely descriptive and not part of the instant invention, (2) the antibody designated “CK8-1R5” is derived from another “CK8” antibody, or (3) Applicant designated antibody CK8-1R5 binds to CK8 antigen. For the purposes of compact prosecution, for claim 1 the phrase “monoclonal antibody CK8-1R5 of CK8” will be considered to read “monoclonal antibody that binds CK8 antigen, wherein the antibody is CK8-1R5”. For claims 2-7 the phrase(s) “monoclonal antibody CK8-1R5 of CK8” and/or “monoclonal antibody CK8-1R5” is/are considered to read “monoclonal antibody” (because the specifics of the antibody are recited in base claim 1). This rejection may be overcome by amending claim 1 to recite “A monoclonal antibody that binds CK8 antigen, wherein the antibody is CK8-1R5 which comprises (i) a heavy chain variable region of SEQ ID NO: 1 and (ii) a light chain variable region of SEQ ID NO: 2.”. Dependent claims 2-7 can overcome this rejection by amending claim 1 as recited above and amending claims 2-7 to remove “CK8-1R5” or “CK8-1R5 of CK8”, as appropriate (e.g., in dependent claims simply refer to “the monoclonal antibody”).
Claim 2-7 provide for the use of a monoclonal anti-CK8 antibody (CK8-1R5), but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. MPEP 2173.05(q) states attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness. Recitation of a use without any active, positive steps delimiting how this use is actually practiced is indefinite.
Regarding claims 3-5, claim 3 recites the limitation "the exosome" in line 1. There is insufficient antecedent basis for this limitation in the claim. This rejection may be overcome by amending claim 3 to provide antecedent basis (e.g., replacing “the” with “a” or “an”). Dependent claims 4-5 may overcome this rejection by amending claim 3 as described above.
Claims 4-5, recites the limitation "the loading" in line 2. There is insufficient antecedent basis for this limitation in the claim. This rejection may be overcome by amending claim 4 to provide antecedent basis. Dependent claim 5 may overcome this rejection by amending claim 4 as described above.
Claims 4-5, claim 4 recites “a chemical anticancer drug loaded exosome is prepared by mixing an equal amount of exosome with chemical anticancer drugs through electroconversion”, rendering the meets and bounds of the claims are indefinite (see MPEP 2173.05). Specifically, it is unclear (1) if one chemical drug or more than one chemical drug is loaded into the exosome as singular and plural forms are both used in the claim language, and (2) if ‘equal amount’ means equal (a) concentration, (b) volume, (c) weight, (d) activity, or (e) some other measurement. This rejection may be overcome by amending claim 4 to clarify (1) if a single drug or more than one drug is loaded into the exosome, and (2) what ‘equal amount’ means. Dependent claim 5 may overcome this rejection by amending claim 4 as described above.
Claim Rejections - 35 USC § 112(a)
Claim(s) 1-7 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that the hybridoma cells of CK8 antibody producing clone(s) 1R5 are required to practice the claimed invention. As required elements, they must be known and readily available to the public or obtainable by a repeatable method set forth in the specification. If they are not so obtainable or available, the enablement requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the hybridomas See 37 CFR 1.801-1.809.
In addition to the conditions under the Budapest Treaty, applicant is required to satisfy that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent in U.S. patent applications.
Amendment of the specification to recite the date of deposit and the complete name and address of the depository is required. Further, a statement is required that the deposit was made under conditions that are consistent with those specified in the rules of the Budapest Treaty, including the provision that requires, with one possible exception (37 CFR 1.808(b)), and that all restrictions on the accessibility be irrevocably removed by the applicant upon the granting of the patent. As an additional means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the original deposit is made after the effective filing date of an application for patent, the applicant should promptly submit a verified statement from a person in a position to corroborate the fact, and should state, that the biological material which is deposited is a biological material specifically identified in the application as filed, except if the person is an attorney or agent registered to practice before the Office, in which the case the statement need not be verified. See MPEP 1.804(b).
Affidavits and declarations, such as those under 37 C.F.R. § 1.131 and 37 C.F.R. § 1.132, filed during prosecution of the parent application do not automatically become a part of this application. Where it is desired to rely on an earlier filed affidavit, the applicant should make the remarks of record in the later application and include a copy of the original affidavit filed in the parent application.
Alternatively, applicant is invited to make the record clear whether satisfaction of the requirements under 35 USC 112, first paragraph, enablement for biological materials has been satisfied in a current U.S. Patent for CK8 antibody producing clone(s) 1R5 in order to make the record of the instant application complete.
Allowable Subject Matter
During the course of examination, the CK8-1R5 anti-CK8 antibody comprising a VH of SEQ ID NO: 1 and a VL of SEQ ID NO: 2 was found to be free from the prior art. Specifically, a sequence search of the prior art returned no 100% sequence identity matches to the instant claimed VH and VL sequences (see alignments below).
Alignment of instant VH SEQ ID NO: 1 with EP2020419-A1 (Human anti-EphB4 receptor antibody MOR03639 VH CDR-H, SEQ ID:21):
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351
681
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Alignment of instant VL SEQ ID NO: 2 with WO2019164929-A1 (Anti-CD33 antibody ADI-11839 Ab28 VL region, SEQ 301):
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263
684
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In summary, the closest prior art (1) is not a 100% sequence identity match to either the VH or the VL sequences claimed and (2) does not retain CK8 antigen binding. Additionally, no rationale was found in the prior art to make substitutions, particularly in the CDR regions, to arrive at the instant invention.
For the reasons provided above, the CK8-1R5 anti-CK8 antibody comprising a VH of SEQ ID NO: 1 and a VL of SEQ ID NO: 2 is considered free from the prior art.
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M CHATTIN whose telephone number is (571)270-0646. The examiner can normally be reached T-F 0600-1600 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY M. CHATTIN/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643