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 .
DETAILED ACTION
Response to Amendment
The Information Disclosure Statement (IDS) filed 28 January 2026 has been entered. Applicant’s submission of the replacement drawings filed 28 January 2026 is acknowledged. Applicant’s submission of a substitute specification in both marked-up and clean formats in compliance with 37 C.F.R. 1.52, 1.121(b)(3), and 1.125, filed 28 January 2026, is acknowledged. Applicant’s amendment of the claims filed 28 January 2026 has been entered. Applicant’s remarks filed 28 January 2026 are acknowledged.
Claims 1-12 and 14 are cancelled. Claims 13 and 15-17 are pending and under examination.
Drawings
The objection to the drawings (Figures 1A, 1B, 1D, 2A, 2F, 3C, 6A and 6C) under 37 CFR 1.83(a), because they fail to show details as described in the specification, is withdrawn in response to Applicant’s submission of the replacement drawings.
Specification
The objection to the specification for errors (e.g., paragraphs [9], [103], [105], [111], [115], [122], [126], [132], [134], [140], [144] and [146] are blank, and paragraphs [64] and [119] should be started from a new line) is withdrawn in response to Applicant’s submission of the substitute specification.
Claim Objections/Rejections Withdrawn
The objections to claims 13-14 and 16 for informalities are withdrawn in response to Applicant’s amendment of claims 13 and 16 and cancellation of claim 14.
The rejection of claim 17 under 35 U.S.C. 112(b), as being indefinite for referring to the 512th tyrosine without specifying the amino acid sequence of ICAM-1, is withdrawn in response to Applicant’s amendment of the claim to recite “512th tyrosine of ICAM-1 of SEQ ID NO: 1”.
Claim Objections/Rejections Maintained
Claim Objections
Claim 15 remains objected to because of the following informalities:
In claim 15, the phrase “by a reducing the expression of …” should be “by reducing the expression …”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Amended claims 13 and 15-17 remain 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.
Applicant argues that the rejection is based on the theoretical assumption that “antibodies cannot penetrate the cell membrane”, however, “inhibiting a binding of ICAM-1 to SRC” can be an indirect downstream effect, e.g., via a conformational change or signaling pathways. Applicant argues that the specification demonstrates an “ICAM-1 monoclonal antibody” that significantly reduced the number of metastatic nodules and induced a reduction in the expression of EMT markers (Snail, Zeb1, etc.) in colorectal cancer mouse models (Example 6), thus, Applicant has reduced to practice the claimed method with an anti-ICAM-1 antibody. Applicant argues that the specification provides specific screening methods, and a person of ordinary skill in the art could obtain antibodies with the desired function (SRC signal blocking) using known libraries or hybridoma technology. Applicant further argues that the present claims are directed to a method of treatment rather than to a genus of antibodies like in the Amgen case cited by the Examiner, and the “functional limitation” rule in Amgen is unwarranted in this case. Applicant also refers to the claims of U.S. Patent No. 11,234,996 and argues that the USPTO has previously allowed patents under similar circumstances.
Applicant’s arguments have been fully considered but have not been found to be persuasive.
The instant claims are drawn to a method of treatment by using a genus of antibodies that are defined by antigen and one or more functional characteristics. Applicant argues that Applicant has reduced to practice the claimed method with an “anti-ICAM-1 monoclonal antibody”, however, the specification does not adequately describe the structures of the “anti-ICAM-1 monoclonal antibody” as presently claimed. It is well known in the art that the properties of antibodies directed to a protein may be dramatically different (see, for example, Wolf et al. and Mölgg et al., cited in the previous Office Action). Not all anti-ICAM-1 monoclonal antibodies would exhibit the activities required by the present claims, e.g., being capable of inhibiting epithelial to mesenchymal transition (EMT) by reducing the expression of one or more markers of CDH1, Vimentin, Snail, and Zeb1; being capable of inhibiting angiogenesis by reducing the expression of one or more markers of PDFGB, VEGFA, and CD31 in colorectal cancer; and being capable of, directly or indirectly, inhibiting the binding of ICAM-1 to SRC. Further, not all anti-ICAM-1 monoclonal antibodies would exhibit the effect of inhibiting metastasis of colorectal cancer in a subject. The specification does not provide adequate written description for the genus of anti-ICAM-1 antibodies that exhibit these properties/activities and are capable of inhibiting metastasis of colorectal cancer in a subject. Applicant has not shown possession of the genus as claimed.
With respect to Applicant’s argument that a person of ordinary skill in the art could obtain the antibodies by using the specific screening methods provided in the specification, however, adequate written description requires more than a mere statement that is part of the invention and reference to a method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. With respect to Applicant’s argument that the "functional limitation" rule in Amgen is unwarranted in this case because the present claims are directed to a method of treatment rather than to a genus of antibodies, however, adequate written description is required regardless whether the claimed invention is drawn to a product or a process of using a product. The requirement under 35 U.S.C. 112(a) sets forth that the specification should 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. One skilled in the art cannot predict the structural or functional features of plethora of antibodies as presently claimed, and therefore, would not recognize that Applicant was in possession of the genus at the time the application was filed. Further, the instant case is not analogous to U.S. Patent No. 11,234,996. The claims of the ‘996 patent are drawn to the use of a monoclonal antibody that specifically binds to SMOC2, whereas the instant claims require the use of an anti-ICAM-1 antibody exhibiting specific properties/activities; further, SMOC2 and ICAM-1 are different proteins, and antibodies directed these divergent proteins have different status in the art.
For reasons set forth above, the disclosure does not meet the written description requirement for the full scope of the anti-ICAM-1 antibodies with the properties and functional activities as claimed, and therefore, the rejection is maintained.
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 13 remains rejected under 35 U.S.C. 102(a)(1), as being anticipated by Hansson et al. (WO 2012/007516 A1, Int'l. Pub. Date; 19 January 2012).
Applicant argues that claim 13 has been amended to incorporate limitations of claim 14 which is not rejected over Hansson, therefore, the present claims are patentable over Hansson.
Applicant’s arguments have been fully considered but have not been found to be persuasive.
While the limitation from previous claim 14 (which was not included in the rejection) is incorporated into independent claim 13, the incorporated limitation, however, is only one of the two alternatives. Claim 13 recites: “wherein the anti-ICAM-1 antibody is capable of inhibiting the metastasis of colorectal cancer in the subject by at least one selected from followings: an inhibition of an epithelial to mesenchymal transition of the colorectal cancer; and an inhibition of an angiogenesis induced by the colorectal cancer, wherein the inhibition of the epithelial to mesenchymal transition of the colorectal cancer is induced by reducing the expression of one or more markers selected from CDH1, Vimentin, Snail, and Zebi.” Hansson teaches a method for treating cancer in a patient who has previously been treated for the cancer and either not responded or subsequently relapsed, the method comprising administering to the patient an effective amount of an antibody or an antigen-binding fragment thereof with binding specificity for ICAM-1 (p. 9, lines 28-33). Hansson teaches that the antibodies of the invention may be effective in the treatment of colorectal cancer (p. 10, lines 8-24). Hansson teaches that the antibody or antigen-binding fragment is capable of inhibit angiogenesis (p. 34, lines 19-29). Therefore, Hansson teaches using an anti-ICAM-1 antibody which is capable of inhibiting the metastasis of colorectal cancer in the subject by an inhibition of an angiogenesis induced by the colorectal cancer.
Hansson therefore anticipates the claimed invention.
Conclusion
NO CLAIM IS ALLOWED.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Xiaozhen Xie, whose telephone number is 571-272-5569. The examiner can normally be reached on M-F, 8:30-5.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa L. Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/XIAOZHEN XIE/Primary Examiner, Art Unit 1674
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