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 1, 3-5, 9 and 21-24 are pending in the application.
This action is in response to applicants' amendment dated September 19, 2025. Claims 1, 3-5 and 9 have been amended, claims 2, 6-8 and 10 have been canceled and claims 21-24 are newly added.
Response to Amendment
Applicant's arguments filed September 19, 2025 have been fully considered with the following effect:
The applicants’ amendments are sufficient to overcome the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection, labeled paragraph 1) in the last office action, which is hereby withdrawn.
The applicant's amendments are sufficient to overcome the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection, labeled paragraph 2) in the last office action, which is hereby withdrawn.
With regards to the 35 U.S.C. 102(a)(1), anticipation rejection or, in the alternative 35 U.S.C. 103, obviousness rejection, labeled paragraph 3) in the last office action, the applicant’s amendments and remarks have been fully considered but they are not persuasive. The applicants stated that the amended claims require that the cancer is mediated by a genetically altered MET having a protein c-Met point mutation at P9918, T992I, V1092I, H1094Y, G1163R, T11731, L1195V, F12001, D1228H, D1228N, Y1230A, Y1230C, Y1230D, Y1230H, Y1235D, D1246H, D1246N, Y1248C, Y1248D, Y1248H, M1250T, or M1268T and that Cui neither describes nor suggests the specific c-Met point mutations described and exemplified in the present application
The reference shows the compound
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, example 5, but is silent to the specific c-Met point mutations at P9918, T992I, V1092I, H1094Y, G1163R, T11731, L1195V, F12001, D1228H, D1228N, Y1230A, Y1230C, Y1230D, Y1230H, Y1235D, D1246H, D1246N, Y1248C, Y1248D, Y1248H, M1250T, or M1268T. MPEP 2112 states:
“SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY
The claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
In this case, the “unknown property” is the particular c-Met point mutations. This is unknown because the reference is silent on this property. MPEP 2112 goes on to state:
“A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTIC
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection.”
This is not an ordinary inherency situation where it is not explicitly stated what the product actually is. In every reference applied, the reference explicitly teaches exactly what the compound is. In fact, it is the opposite. In a normal inherency situation, the claim is of known structure, and the reference is of unknown structure. Here, the latter is not true, and hence the legal circumstances of inherency in the prior art do not apply. The only difference is the property about which the reference happens to be silent. Recitation of a property, inherently possessed by the prior art thing, does not distinguish a claim drawn to those things from the prior art, In re Swinehart, 169 USPQ 226, 229.
See for example Ex parte Anderson, 21 USPQ 2d 1241 at 1251, discussion of Rejection E. The claims had “numerical or functional values for certain properties which [the authors of the references] did not measure”. The PTO presented no reasoning as to why the prior art material would have been expected to have those properties. Instead, the decision states, “There is ample precedent for shifting the burden to an applicant to reproduce a prior art product whose final structure or properties are, at least, in part determined by the precise process used in its manufacture.” (page 1253).
In another example, certain claims of Ex parte Raychem Corp. 25 USPQ2d 1265 required a linearity ratio of less than 1.2. The decision notes that neither reference discloses any values of the linearity ratio. The PTO presented no reasoning as to what the ratio would be expected to be in the references. The Decision states: “However, this does not end the inquiry since, where the Patent and Trademark Office is not equipped to perform the needed testing, it is reasonable to shift the burden of proof to Raychem to establish that (1) the argued difference exists….”
And indeed, there have been a number of cases in which pointed to silence of the prior art with regard to this or that property: In re Pearson, 181 USPQ 641; In re Zierden 162 USPQ 102; In re Lemin, 140 USPQ 273; Titanium Metals Corporation of America v. Banner, 227 USPQ 773; In re Benner, 82 USPQ 49; In re Wilder, 166 USPQ 545; Ex parte Kucera, 165 USPQ 332; General Electric Co. v. Jewel Incandescent Lamp Co., 67 USPQ 155; In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607; In re Parker, 43 USPQ 457. Such efforts to avoid anticipation on that basis invariably failed. Going further, if silence about properties of prior art compounds could be relied on, then one could not reject over references with no utility (see In re Schoenwald, 22 USPQ2d 1671), since applicants could always insert the utility into the claim as a property.
It is well settled that the PTO can require an applicant to establish that a prior art product does not necessarily possess the characteristics of the claimed product when the prior art and claimed products are identical or substantially identical. An applicant's burden under these circumstances was described in In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-434 (CCPA 1977) as follows:
Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. . . . Whether the rejection is based on ‘inherency' under 35 U.S.C. § 102, or ‘prima facie obviousness’ under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products (footnote omitted).
Overcoming the rejection is very straightforward. One simply replicates the prior art procedure. If the claimed characteristic does not appear at all in the product, or if on repetition, it sometimes does not appear in the product, then the rejection is overcome.
Further support for several of the c-Met point mutations can be found in Ghiso, E.; Giordano, S. Targeting MET: why, where and how? Curr. Opin. Pharmacol. 2013, 13, 511-518 provided herewith which was sited in the applicants disclosure to reference a “diverse set of MET mutations”.
Claim(s) 1, 3-5, 9 and 21-24 is/are rejected under 35 U.S.C. 102(a)({1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Cui et al., WO 2019/023417, for reasons of record and stated above.
With regards to the nonstatutory double patenting rejection as being unpatentable over claims 1-20 of U.S. Patent No. 11,981,684 of the last office action, the applicant’s amendments and remarks have been fully considered but they are not persuasive. The applicants stated that any nonstatutory double patenting rejection made under the obviousness analysis make clear the differences between the claims and the reasons why one of skill in the art would find the claims at issue obvious over the reference claims. The Office has not explained why a skilled artisan would be motivated to modify a method of US ‘684 claim 1 to arrive at the presently claimed method of treating a cancer mediated by a genetically altered MET having a protein c-Met point mutation at P9918, T9921, V1092I, H1094Y, G1163R, T11731, L1195V, F1200I, D1228H, D1228N, Y1230A, Y1230C, Y1230D, Y1230H, Y1235D, D1246H, D1246N, Y1248C, Y1248D, Y1248H, M1250T, or M1268T. However, as stated above in the 102/103 the “unknown property” is the particular c-Met point mutations is an inherit characteristic of compounds that inhibits MET, SRC and CSF1R. Further support for several of the c-Met point mutations can be found in Ghiso, E.; Giordano, S. Targeting MET: why, where and how? Curr. Opin. Pharmacol. 2013, 13, 511-518 provided herewith which was cited in the applicant’s disclosure to reference a “diverse set of MET mutations”.
Claims 1, 3-5, 9 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,981,684, for reasons of record and stated above.
With regards to the nonstatutory double patenting rejection as being unpatentable over claims 1-21 of U.S. Patent No. 11,286,264 of the last office action, the applicant’s amendments and remarks have been fully considered but they are not persuasive. The applicants stated that the Office has not explained why a skilled artisan would be motivated to modify a compound of U.S. ‘264 to arrive at the presently claimed method. The disclosure of ‘264 teaches the method of use of the compound and thus would motivate one of skilled in the art to use the compounds as claimed herein. The applicant’s also stated that the Office has not explained why a skilled artisan would be motivated to modify a method of US ‘684 claim 1 to arrive at the presently claimed method of treating a cancer mediated by a genetically altered MET having a protein c-Met point mutation at P9918, T9921, V1092I, H1094Y, G1163R, T11731, L1195V, F1200I, D1228H, D1228N, Y1230A, Y1230C, Y1230D, Y1230H, Y1235D, D1246H, D1246N, Y1248C, Y1248D, Y1248H, M1250T, or M1268T. However, as stated above in the 102/103 the “unknown property” is the particular c-Met point mutations is an inherit characteristic of compounds that inhibits MET, SRC and CSF1R. Further support for several of the c-Met point mutations can be found in Ghiso, E.; Giordano, S. Targeting MET: why, where and how? Curr. Opin. Pharmacol. 2013, 13, 511-518 provided herewith which was cited in the applicant’s disclosure to reference a “diverse set of MET mutations”.
Claims 1, 3-5, 9 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,286,264, for reasons of record and stated above.
With regards to the nonstatutory double patenting rejection as being unpatentable over claims 1-3 of U.S. Patent No. 11,155,563 of the last office action, the applicant’s amendments and remarks have been fully considered but they are not persuasive. The applicants stated that the Office has not explained why a skilled artisan would be motivated to modify a compound of U.S. ‘563 to arrive at the presently claimed method. The disclosure of ‘264 teaches the method of use of the compound and thus would motivate one of skilled in the art to use the compounds as claimed herein. The applicant’s also stated that the Office has not explained why a skilled artisan would be motivated to modify a method of US ‘684 claim 1 to arrive at the presently claimed method of treating a cancer mediated by a genetically altered MET having a protein c-Met point mutation at P9918, T9921, V1092I, H1094Y, G1163R, T11731, L1195V, F1200I, D1228H, D1228N, Y1230A, Y1230C, Y1230D, Y1230H, Y1235D, D1246H, D1246N, Y1248C, Y1248D, Y1248H, M1250T, or M1268T. However, as stated above in the 102/103 the “unknown property” is the particular c-Met point mutations is an inherit characteristic of compounds that inhibits MET, SRC and CSF1R. Further support for several of the c-Met point mutations can be found in Ghiso, E.; Giordano, S. Targeting MET: why, where and how? Curr. Opin. Pharmacol. 2013, 13, 511-518 provided herewith which was cited in the applicant’s disclosure to reference a “diverse set of MET mutations”.
Claims 1, 3-5, 9 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,155,563, for reasons of record and stated above.
In view of the amendment dated September 19, 2025, the following new grounds of rejection apply:
Claim Rejections - 35 USC § 112
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 24 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 24 is to the compound
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which is the only compound present in claim 1. 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624