Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Reissue: Non-Final Office Action
Prosecution History and Claim Status
On 10/30/2018 US Patent 10,111,853 issued to Bilodeau et al. with claims 1-19.
On 10/30/2020 applicants filed reissue application 17/085,662 (now abandoned) for Patent 10,111,853. The instant reissue application is a CON of '662, and presents substantially the same claims presented in '662.
In the instant reissue application claims 1-19 have been cancelled and claims 20-53 are newly presented. This is the first Office Action on the merits of the claims in reissue Application 18/115,342.
Ongoing Duty To Disclose
Applicant(s) is/are reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 10,111,853 is or was involved. These proceedings would include any trial at the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Information Disclosure Statement
No Information Disclosure Statements have been filed with the present application. Applicants are reminded of their duty to disclose patents and publications relevant to the patentability of the instant claims.
None of the references listed on the IDS(s) in the application(s) to which this application claims benefit will appear on the face of a patent issuing from this application unless they are properly listed on an IDS in this application.
Official Gazette Publication
The Official Gazette (O.G.) publication date for this reissue application was 04/18/2023.
Election by Original Presentation
Newly submitted (product) claims 37-53 are directed to inventions that are independent or distinct from the invention originally claimed for the following reasons:
The inventions for which restriction is required under 35 U.S.C. 121 are as follows:
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 20-36, drawn to a method of treating cancer, classified in A61P 35/00.
II. Claims 37-53, drawn to a pharmaceutical composition, classified in A61K 31/282.
The inventions are distinct, each from the other because of the following reasons:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product can be used in a different process, such as a treatment for autoimmune diseases.
Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply (see MPEP § 803(II)):
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112(a).
Serious search burden exists because the inventions are classified in different classes/subclasses (CPC main groups and sub groups).
Since applicants have received an action on the merits for the originally presented invention (i.e., the method claims in application 15/377,857), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, instant product claims 37-53 are withdrawn from consideration as being directed to non-elected inventions. See 37 CFR 1.142(b) and MPEP § 821.03. A divisional reissue application directed to the constructively non-elected invention may be filed.
Defective Declaration/Oath
The reissue oath/declaration filed with this application is defective because it fails to sufficiently identify at least one error which is relied upon to support the reissue application. See 37 CFR 1.175 and MPEP § 1414.
It is unclear why the original patent is wholly or partially inoperative or invalid because the patentee claimed less than they had the right to claim in the patent. See MPEP § 1414 I and II, which state, in relevant part:
A general statement, e.g., that all claims are broadened, is not sufficient to satisfy this requirement. In identifying the error, it is sufficient that the reissue oath/declaration identify a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid.
It is not sufficient for an oath/declaration to merely state "this application is being filed to correct errors in the patent which may be noted from the changes made in the disclosure." Rather, the oath/declaration must specifically identify an error. In addition, it is not sufficient to merely reproduce the claims with brackets and underlining and state that such will identify the error. See In re Constant, 827 F.2d 728, 729, 3 USPQ2d 1479 (Fed. Cir.), cert. denied, 484 U.S. 894 (1987). Any error in the claims must be identified by reference to the specific claim(s) and the specific claim language wherein lies the error.
Although the error statement of the reissue declaration states, "The claims are too narrow" and points to claims 1 and 19 as claims sought to be broadened, this explanation is not sufficiently specific as it does not identify a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid. Applicants have not pointed out what the original claims lacked that the newly added claim(s) has, or vice versa.
A new reissue declaration with a proper error statement is required. Applicants are advised that they must be specific in pointing out the differences, i.e., the new or deleted features, and in explaining how they broaden the claims. The examiner suggests pointing to claims 1 and 19 as a claim(s) intended to be broadened, and then specifically stating how the new claim(s) is/are broader than claims 1 and 19 by specifically detailing what the new claims lacked that the newly added claim(s) has, or vice versa.
Scope of Claims
The instant application, contains claims 20-53 directed to a method of treating cancer and a pharmaceutical composition. Claims 20 and 37 are representative:
20. (New) A method of treating cancer in a subject, the method comprising administering to the subject an effective amount of a pharmaceutical composition comprising a platinum (IV) compound and a pharmaceutically acceptable excipient, the platinum (IV) compound comprising two axial sites and four equatorial sites, wherein each of the two axial sites and each of the four equatorial sites are each occupied by a ligand,
wherein at least a portion of the platinum compound is contained within a particle, and wherein the total percentage of the compound in the particle is greater than about 0.01% by weight.
37. (New) A pharmaceutical composition comprising a platinum (IV) compound and a pharmaceutically acceptable excipient, the platinum (IV) compound comprising two axial sites and four equatorial sites, wherein each of the two axial sites and each of the four equatorial sites are each occupied by a ligand,
wherein at least a portion of the platinum compound is contained within a particle, and wherein the total percentage of the compound in the particle is greater than about 0.01% by weight.
CLAIM REJECTIONS - 35 USC § 251
Claims 20-36 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
Broadening Reissue and Recapture
Claims 20–36 are rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based.
A broadening aspect is present in the reissue application which was not present in the patent under reissue. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicants previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
See In re McDonald, 43 F.4th 1340, 1345, 2022 USPQ2d 745 (Fed. Cir. 2022); Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984).
In accordance with MPEP 1412.02 (and case law cited therein) we apply the recapture rule as a three-step process:
(1) Determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims.
(2) Determine whether the broader aspects of the reissue claims related to subject matter surrendered in the original prosecution; and
(3) Determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.
In the instant case,
(1) Reissue claims 20–36 are broader in scope than the original patent claims.
Particularly, claim 1 of the '853 patent, which recited a method of inhibiting proliferation of a cell, specified that the cell whose proliferation is inhibited was a lung cancer cell or a colorectal cancer cell, and further specified a Markush group of 42 specific platinum compounds for use in the claimed method. Similarly, claim 19 of the of the '853 patent, which recited a method of treating cancer in a subject, also specified the cancer being treated was lung cancer or colorectal cancer, and specified the same Markush group of platinum compounds as the '853 claim 1.
Instant claims 20-36 are broader than the patented claims in that the instant claims are not limited to lung or colorectal cancer, and are not limited to the specific Markush group of 42 platinum compounds required by the patented claims. While instant claims 21 and 22 recite lung cancer and colorectal cancer, respectively, none of the claims are limited to the group of 42 platinum compounds required by the '853 claims, and thus, all of instant claims 20-36 are broader than the patented claims.
(2) The broader aspect of reissue claims 20–36 is related to subject matter surrendered in the original prosecution.
Particularly, during prosecution of application 15/377,857 that issued as US Patent 10,111,853, original claim 1 recited a method of inhibiting proliferation of a cell (i.e., any cell type), and recited a Markush group of 45 specific platinum compounds. Similarly, original claim 21 recited a method of treating cancer (i.e., any type of cancer) in a subject, and recited the same Markush group of 45 specific platinum compounds as original claim 1. The Examiner rejected claims 1-22 for lack of enablement for treating any cell, and for treating any type of cancer cell (see pgs. 2-10 of the OA dated 5/25/2017). In order to overcome the rejection of claims 1-22 under 35 USC 112, first paragraph, for lack of enablement, applicants narrowed claim 1 to require that the cell be a cancer cell selected from lung cancer or colorectal cancer, and cancelled claim 22. In making this amendment, applicants stated:
"Claim 1 is amended to limit the cell to a lung cancer cell or a colorectal cancer cell. Claim 21 is amended to limit the cancer to lung cancer or colorectal cancer. Therefore, the rejections are rendered moot." (p. 16 of the response filed 8/25/2017)
Note that surrendered subject matter can be created by presentation of new/amended claims or an argument/statement to define the invention over the prior art or new/amended claims or an argument/statement to obviate a rejection based on other grounds. See MPEP § 1412.02(I) and 1412.02(II)(B)(1).
The examiner also rejected claims 1-5 and 17 as being anticipated by Wilson (Wilson, J. J., et al. Inorg. Chem. (2011), 50(7); 3103-3115) (see pgs. 12-13 of the OA dated 5/25/2017). All other claims were rejected as being obvious over Wilson, in view of other references (see pgs. 13-24 of the OA dated 5/25/2017). In order to overcome the rejections of claims 1-22 over Wilson (optionally in view of other references), applicants narrowed claim 1 to delete
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from the Markush group of platinum compounds. In making this amendment, applicants stated:
"The last compound in claim 1 is deleted. Wilson does not teach using any of the other compounds in claim 1 to inhibit proliferation of a cancer cell. Therefore, claim 1 is not anticipated by Wilson." (p. 17 of the response filed 8/25/2017)
In a subsequent Final Office Action, the examiner rejected claims 1, 4, 5, and 17 as being anticipated by Ang (Ang, W. H., et al. J. Med. Chem. (2005), 48; 8060-8069) (see pgs. 2-4 of the OA dated 9/28/2017). All other pending claims were rejected as being obvious over Ang, in view of other references (see pgs. 4-14 of the OA dated 9/28/2017). In order to overcome the rejections of claims 1 and 4-21 over Ang (optionally in view of other references), applicants narrowed claim 1 to delete
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from the Markush group of platinum compounds. In making this amendment, applicants stated:
"Claim 1 has been amended to delete
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. Ang does not teach or suggest using any compound in amended claim 1 to inhibit proliferation of a cancer cell. Therefore, claim 1 is not anticipated by Ang." (p. 17 of the response filed 11/28/2017)
The claims presented with the instant reissue application broaden the claims to encompass any type of cancer cell (except for claims 21-22), and broaden the claims to encompass any platinum (IV) compound (except for claims 28-36). These are broader limitations that applicants surrendered in the prosecution of application 15/377,857, which application issued at US Patent 10,111,853, to gain the allowance of claims 1-19.
(3) There is no evidence of record that the reissue claims were materially narrowed in other respects so that the claims may not have been enlarged, and hence avoid the recapture rule.
The reissue claims further require that at least a portion of the platinum compound is contained within a particle, and wherein the total percentage of the compound in the particle is greater than about 0.01% by weight. However, such limitations are unrelated to the surrendered subject matter. As noted in MPEP 1412.02.II.C, “[t]he material narrowing must relate to what was amended or argued by applicant in the original application, for example to define the claim over the art. Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 1271, 103 USPQ2d 1951, 1958 (Fed. Cir. 2012).”
Accordingly, reissue claims 20-36 present a broadening aspect which relates to claimed subject matter that applicants previously surrendered during the prosecution of the ‘853 patent. Therefore, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claimed subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 20-29, 31, 32, 35, and 36 are rejected under 35 U.S.C. 103(a) as being unpatentable over WILSON (Wilson, J. J., et al. Inorg. Chem. (2011), 50(7); 3103-3115) in view of DEWITT (WO 2012/054923; Filed Oct. 24, 2011).
Wilson discloses platinum(IV) carbamate complexes and methods of using them to treat cancers (title; abstract). Wilson teaches the disclosed platinum compounds as therapeutic agents for lung cancer (abstract; p. 5, last par.; p. 6, under Cytotoxicity Assays; p. 10, under Biological Properties). Specifically, Wilson teaches the following platinum compounds:
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Therefore, Wilson teaches platinum(IV) compounds comprising two axial sites and four equatorial sites, each of which are occupied by a ligand for the treatment of lung cancer. Wilson does not teach nanoparticles. However, nanoparticles were well known delivery vehicles for platinum anticancer drugs before the instant invention.
For example, Dewitt discloses therapeutic nanoparticles comprising about 0.1 to about 40 weight percent of a therapeutic agent encapsulated in a polymeric matrix (i.e., a pharmaceutically acceptable excipient) (title; abstract; [0048], [0053]). The therapeutic agent may be platinum chemotherapeutic agents ([0008], [0087]; Example 11; claim 9). Dewitt teaches nanoparticle delivery systems are advantageous for treating cancer while also reducing side effects ([0003]-[0004]).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to utilize a nanoparticulate delivery system for the platinum(IV) anticancer agents of Wilson. One would have been motivated to do so since nanoparticles are taught to be advantageous for treating cancer while also reducing side effects (per Dewitt). Doing so amounts to no more than combining prior art elements (the known platinum(IV) anticancer agents of Wilson) with a known delivery technique (the nanoparticles of Dewitt) according to known methods to yield predictable results.
Regarding claim 22, Dewitt teaches treatment of cancer types including lung, colon, and rectal cancers ([0099]).
Regarding claim 24, Dewitt teaches the nanoparticles are suitable for intravenous administration ([0047], [0092]).
Regarding claim 26, Dewitt teaches the particle size of the nanoparticles can be about 100 nm to about 220 nm ([00115], [00120], [00148]).
Regarding claim 27, Dewitt teaches the use of sucrose, for example as a cryoprotectant ([0098]).
Regarding claims 28, 29, 31, 32, 35, and 36, Wilson teaches:
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.
Claims 20-28, 31, 33, and 34 are rejected under 35 U.S.C. 103(a) as being unpatentable over KIDANI (US 4,845,124; Issued Jul. 4, 1989) in view of DEWITT (US 4,845,124; Issued Jul. 4, 1989).
The teachings of Dewitt are presented supra, and are incorporated herein.
Claims 33 and 34 recite platinum compounds having an equatorial ring, specifically a cyclohexane-1,2-diamine ring, respectively. Such platinum compounds were known in the art prior to the instant application.
For example, Kidani discloses platinum(IV) complexes having antitumor activity against several tumor types (title; abstract; col. 7, lines 27-34). The disclosed platinum(IV) complexes feature an equatorial 1,2-cyclohexanediamine ring as a ligand (title; abstract; col. 1, line 40 to col. 2, line 11; claim 1). The other equatorial ligands (B and B' of Kidani) may be chlorine (a halide) (col. 2, lines 40-41) as required by instant claims 28 and 31. Kidani teaches the platinum(IV) complexes can be formulated as, inter alia, intravenous injections (col. 7, lines 31-34).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to utilize the antitumor compounds of Kidani in a method for treating cancer using a known nanoparticulate deliver system. One would have been motivated to do so since Dewitt teaches nanoparticles are advantageous for treating cancer while also reducing side effects. Doing so amounts to no more than combining prior art elements (the known platinum(IV) anticancer agents of Kidani) with a known delivery technique (the nanoparticles of Dewitt) according to known methods to yield predictable results.
Claims 20-28, 30, 31, and 32 are rejected under 35 U.S.C. 103(a) as being unpatentable over ANG 2005b (Ang, W. H., et al. JACS (2005), 127; 1382-1383) in view of DEWITT (WO 2012/054923; Filed Oct. 24, 2011).
The teachings of Dewitt are presented supra, and are incorporated herein.
Ang 2005b reports the rational design of the platinum(IV) compound ethacraplatin (compound 1 in Ang 2005b) (p. 1382, cols. 1 and 2). Ang 2005b teaches ethacraplatin was synthesized with the expectation that it would inhibit the drug resistance-mediating GST enzyme, while maintaining the anticancer platinum center (p. 1382, col. 1). Ang 2005b teaches that ethacraplatin was a potent GST inhibitor as well as an anticancer drug (p. 1382, col. 2), and was superior to cisplatin against an array of cancer cell types including lung and colon cancer (p. 1383, cols. 1-2; Table 1).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to utilize a nanoparticulate delivery system for the platinum(IV) anticancer agent of Ang 2005b (i.e., ethacraplatin). One would have been motivated to do so since nanoparticles are taught to be advantageous for treating cancer while also reducing side effects (per Dewitt). Doing so amounts to no more than combining prior art elements (the known ethacraplatin of Ang 2005b) with a known delivery technique (the nanoparticles of Dewitt) according to known methods to yield predictable results.
Conclusion
Claims 20-36 are rejected; claims 37-53 are withdrawn. No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin S Orwig whose telephone number is (571)270-5869. The examiner can normally be reached Mon.-Fri. 8AM-5PM.
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Central Reexam Unit
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/Kevin S Orwig/
Patent Reexamination Specialist
Art Unit 3991
Conferees:
/Alan Diamond/
Patent Reexamination Specialist
Central Reexamination Unit 3991
/T.M.S/Supervisory Patent Examiner, Art Unit 3991