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 .
DETAILED ACTION
This Office Action is responsive to the Response to Election/Restriction filed 12/23/2025. The preliminary amendment filed 05/08/2023, cancelled claims 1-153, and added claims 154-244.
Claims 154-169 and 241-244 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12/01/2025 and 12/23/2025, and election without traverse of S-2-(3-aminopropylamino)ethyl phosphorothioic acid (amifostine, WR-2721) as the target compound and computed tomography (CT) as the diagnostic imaging/interventional radiology procedure, in a telephone call with Christopher Lightner on January 7, 2025, is acknowledged.
Claims 162-169 and 243-244 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
In the course of the search the election of species of the target compound was expanded to additionally include WR-1065.
Since Group I, the product claims were elected, the election of computed tomography as the diagnostic imaging/interventional radiology procedure, is not required for examination of Group I.
Claims 154-161 and 241-242 are pending and examined on the merits herein.
Claim Objections
Claim 161 is objected to because of the following informalities:
-In claim 161, line 2, the term “comprises” should be replaced with - -is- - or - -is in the form of- -.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 155, 158, and 241-242 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.
-In claim 155, lines 3, 5, and 6, the terms “amifostine free thiol form,” and “amifostine disulfide form,” within parenthetic recitations following 2-[(aminopropyl)amino]ethanethiol and [2-[(aminopropyl)amino] ethanethiol] N,N’,-dithiodi-2,1(ethanediyl) bis-1,3-propanediamine, respectively, renders the claim indefinite, because it is not clear how these terms relate to the chemical names preceding them. It is not clear if these terms are generically describing 2-[(aminopropyl)amino]ethanethiol and [2-[(aminopropyl)amino] ethanethiol] N,N’,-dithiodi-2,1(ethanediyl) bis-1,3-propanediamine, or if these terms are further limiting following 2-[(aminopropyl)amino]ethanethiol and [2-[(aminopropyl)amino] ethanethiol] N,N’,-dithiodi-2,1(ethanediyl) bis-1,3-propanediamine, to a specific form
In view of compound prosecution, for the purpose of applying prior art, these terms are interpreted as not further limiting the compounds which precede them.
This rejection can be overcome by deleting these terms.
-Claims 158, and 241-242 recite the limitation "the target composition" in lines 2. There is insufficient antecedent basis for this limitation in the claim.
In view of compact prosecution, for the purpose of applying prior art, the phrase “wherein the composition includes the target composition at a” is interpreted as “wherein a dosage of the target compound is about 10mg/m2 to about 600 mg/m2, about 25mg/m2 to about 225 mg/m2, and about 600mg/m2 to about 2250 mg/m2,” respectively.
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitations are: “configured for” in claims 159-160.
In the instant case, the recitation “for single systemic administration” and “for repeated systemic administration” implies sufficient structure for performing the claimed function. Moreover, the instant specification does not further define “configured for single systemic administration” or “configured for repeated systemic administration.”
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 112(a)-Written Description
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.
Claims 154, 156-161, and 241-242 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See MPEP 2163.
Claim 1 recites a composition, wherein the composition comprises a phosphorothioate compound having one or more disulfide, mixed disulfide, or free thiol groups and a polyamine backbone with positively charged amine groups or an analog, derivative, prodrug, or salt thereof.
However, the instant specification only defines, by example, seven compounds which are “a phosphorothioate one or more disulfide, mixed disulfide, or free thiol groups and a polyamine backbone with positively charged amine groups or an analog, derivative, prodrug, or salt thereof,” wherein these compounds are structurally similar:
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. And the instant specification provides no definition of “a phosphorothioate one or more disulfide, mixed disulfide, or free thiol groups and a polyamine backbone with positively charged amine groups as an analog, a derivative, or a prodrug,” and provides no examples of these compounds. As such, the only forms of a phosphorothioate compound having one or more disulfide, mixed disulfide, or free thiol groups and a polyamine backbone with positively charged amine groups or an analog, derivative, prodrug, or salt thereof, are WR-2721, WR-1065, WR-33278, WR-3689, WR-255591, WR-151327, and WR-151326.
The prior art appears to be silent in reference to analogs, derivatives, and prodrugs of WR-2721, WR-1065, WR-33278, WR-3689, WR-255591, WR-151327, and WR-151326, let alone analogs, derivatives, or prodrugs of compounds of phosphorothioate one or more disulfide, mixed disulfide, or free thiol groups and a polyamine backbone with positively charged amine groups.
US 2003/0139323 to Cassatt (published 2003, PTO-892). teaches a method of protecting against one or more toxicities or the symptoms thereof, associated with ionizing radiation, comprising subcutaneously administering a composition comprising amifostine (WR-2721), WR-1065, or mixtures thereof (pgs. 23-24- claims 1, 13-14, 17, 22-24, 29-32, 37-38, 41, 45-46, 47, 51-52).
NCT00003225 (published 08/03/2020, PTO-892), teaches an intravenous composition comprising 740mg/m2 amifostine, administered over 10 minutes (i.e., Ethyol) (pg. 5). As evidenced by PubChem, Ethyol is amifostine/WR-2721.
Thus, the prior art teaches a single compound of a “phosphorothioate having one or more disulfide, mixed disulfide, or free thiol groups and a polyamine backbone with positively charged amine groups,” for the instantly claimed use.
Regarding pharmaceutical analogues, Fisher (Analogue-based Drug Discovery, published 2006, PTO-892) teaches that the usual objects of analogue design are the identification and development of a possibly improved version of a prototype drug.
Fisher further teaches that there are three classes of drug analogues:
analogues presenting chemical and pharmacological similarities,
analogues presenting only structural similarities, and
chemically different compounds displaying similar pharmacological properties (pg. 20, 1.4).
As such, an analogue encompasses structurally similar and structurally dissimilar compounds that may or may not share the same properties, making it impossible to determine a structure-function relationship between analogues that is critical for their therapeutic effect.
For these reasons, the recitation of “a phosphorothioate compound having one or more disulfide, mixed disulfide, or free thiol groups and a polyamine backbone with positively charged amine groups or an analog, derivative, prodrug, or salt thereof” was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, had possession of a phosphorothioate compound having one or more disulfide, mixed disulfide, or free thiol groups and a polyamine backbone with positively charged amine groups or an analog, derivative, prodrug, or salt thereof, aside from WR-2721, WR-1065, WR-33278, WR-3689, WR-255591, WR-151327, and WR-151326 and salts thereof. Nor is it clear from the specification as filed what other types of phosphorothioate compounds having one or more disulfide, mixed disulfide, or free thiol groups and a polyamine backbone with positively charged amine groups or an analog, derivative, prodrug, or salt thereof would possess the same utility as WR-2721, WR-1065, WR-33278, WR-3689, WR-255591, WR-151327, and WR-151326 and salts thereof.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 154-161 and 241 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 2003/0139323 to Cassatt (published 2003, PTO-892).
Regarding claims 154-157, Cassatt teaches a method of protecting against one or more toxicities or the symptoms thereof, associated with ionizing radiation, comprising subcutaneously administering a composition comprising amifostine, WR-1065, or a combination thereof, and a pharmaceutically acceptable diluent (pgs. 23-24-claims 1, 13-14, 17, 22-24, 29-32, 37-38, 41, 45-46, 47, 51-52).
The compound is administered in one or more divided cutaneous injections (pgs. 23-24- claims 12, 21, 29, 44, 50; [0061]), meeting the limitations of instant claims 159 and 160.
Regarding claims 157-161 and 241, Cassatt exemplifies an intravenous infusion of amifostine (200 mg/m2), an oral formulation (500mg) of amifostine, and a subcutaneous injection (500mg) of amifostine ([0085]-[0086]). Specifically exemplified is amifostine (200mg/m2) as a continuous intravenous infusion (Treatment A), Amifostine (500mg) in a liquid formulation as a single oral dose (Treatment B), and amifostine (500mg) as two simultaneous subcutaneous injections (Treatment C) ([0085]).
For intravenous infusion a 500mg vial of amifostine is reconstituted with sodium chloride injection and a dose of 200mg/m2 amifostine is diluted with sodium chloride injection to produce a volume of 50 mL for administration ([0090]).
For oral administration, a 500mg vial of amifostine is reconstituted with 5mL of normal saline and drawn up in a 10mL syringe for administration ([0092]).
For subcutaneous administration, a 500mg vial of amifostine is reconstituted with 2.5mL saline and divided into two syringes for administration ([0094]).
Claims 154-161 and 241 are product claims and not method of use claims. Thus, regarding the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” in claim 154 and regarding claims 156-157, this phrase and these claims are intended-use recitations. The intended use of a composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. In the instant case, the composition of Cassatt is capable of performing the intended use.
Thus, since the prior art composition, i.e., Cassatt, is capable of performing the intended use, it meets the intended use limitations of claims 154 and 156-157. See MPEP 2112.01.
Further regarding claim 154, the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” is in the preamble; if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. In the instant case, the body of the claim fully and intrinsically sets forth all the limitations of the claimed composition.
Claims 154-157, 159, 161, and 242 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NCT00003225 (published 08/03/2020, PTO-892), as evidenced by PubChem (Amifostine, PTO-892)
NCT ‘225 teaches an intravenous composition comprising 740mg/m2 amifostine, administered over 10 minutes (i.e., Ethyol) (pg. 5). NCT ‘225 teaches amifostine as a protective agent for irinotecan, a chemotherapeutic, in patients with advanced colorectal cancer (pg. 1).
As evidenced by PubChem, Ethyol is amifostine/WR-2721.
Claims 154-157, 159, 161 and 242 are product claims and not method of us claims. Thus, regarding the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” in claim 154 and regarding claims 156-157, this phrase and these claims are intended-use recitations. The intended use of a composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. In the instant case, the composition of NCT ‘225 is capable of performing the intended use. Thus, since the prior art composition, i.e., NCT ‘225, is capable of performing the intended use, it meets the intended use limitations of claims 154 and 156-157. See MPEP 2112.01.
Further regarding claim 154, the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” is in the preamble; if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. In the instant case, the body of the claim fully and intrinsically sets forth all the limitations of the claimed composition.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 154-161 and 241-242 are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0139323 to Cassatt (published 2003, PTO-892).
Cassatt is applied to claims 154-161 and 241 as discussed in the above 35 USC 102 rejection, and incorporated herein.
While Cassatt teaches a composition comprising amifostine, WR-1065 or a combination thereof, it differs from that of instant claims 242, in that it does not teach a dosage from about 600 mg/m2 to about 2250 mg/m2.
Regarding dosage, Cassatt teaches that the actual amount of amifostine and/or WR-1065 delivered, as well as the dosing schedule necessary to achieve an advantageous pharmacokinetic profile will depend on such factors as the bioavailability of amifostine and/or WR-1065, the disorder being treat, the desired therapeutic dose, and other factors that are apparent to those of skill in the art ([0052]; [0067]-[0083]).
Regarding subcutaneous administration, Cassatt teaches that usual doses range from about 22mg/m2 to 1000mg/m2 ([0075]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the subcutaneous administration of amifostine, WR-1065, or mixtures thereof, to 600-1000mg/m2, to arrive at instant claim 242. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Cassatt teaches dosages of 22-1000mg/m2,
-In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05), and
-Cassatt teaches that the actual amount of amifostine and/or WR-1065 delivered, as well as the dosing schedule necessary to achieve an advantageous pharmacokinetic profile will depend on such factors as the bioavailability of amifostine and/or WR-1065, the disorder being treat, the desired therapeutic dose, and other factors that are apparent to those of skill in the art.
An ordinary skilled artisan would have been motivated to make such a modification, to predictably arrived at an optimized dosage of amifostine, WR-1065, and mixtures thereof.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 154-157, and 159-161 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 33, 36, 43, 49 and 51 of copending Application No. 17/302,143 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘143 claims a method of inhibiting genomic instability in a subject caused by CT scan radiation by administering an effective dose of a phosphorothioate compound or derivative thereof, such as amifostine, WR-1065, and others (claims 1, 33, 36, 49, 51).
The compound is administered subcutaneously, intravenously, topically, and by other modes (claim 43).
While ‘143 does not explicitly teach a composition comprising the phosphorothioate compound, since the compound is administered to a subject, the compound is necessarily administered as a composition.
While ‘143 does not teach the limitations of instant claims 159 or 160, an ordinary skilled artisan would have been motivated to modify the composition for single or repeated administration, to predictably arrive at a mode of administration that is optimized for a patient’s dosage needs.
Claims 154-157 and 159-161 are product claims and not method of us claims. Thus, regarding the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” in claim 154 and regarding claims 156-157, this phrase and these claims are intended-use recitations. The intended use of a composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. In the instant case, the composition of ‘143 is capable of performing the intended use.
Thus, since the prior art composition, i.e., ‘143, is capable of performing the intended use, it meets the intended use limitations of claims 154 and 156-157. See MPEP 2112.01.
Further regarding claim 154, the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” is in the preamble; if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. In the instant case, the body of the claim fully and intrinsically sets forth all the limitations of the claimed composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 154-157 and 159-161 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, and 13 of U.S. Patent No. 10,987,366 (published 2021, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘366 claims a method of inhibiting genomic instability by administering an effective dose of a phosphorothioate compound or derivative thereof selected from amifostine, WR-1065 and others (claims 1, 5, 13).
‘366 is administered orally, intravenously and by other modes (claim 6).
While ‘366 does not explicitly teach a composition comprising the phosphorothioate compound, since the compound is administered to a subject, the compound is necessarily administered as a composition.
While ‘366 does not teach the limitations of instant claims 159 or 160, an ordinary skilled artisan would have been motivated to modify the composition for single or repeated administration, to predictably arrive at a mode of administration that is optimized for a patient’s dosage needs.
Claims 154-157 and 159-161 are product claims and not method of us claims. Thus, regarding the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” in claim 154 and regarding claims 156-157, this phrase and these claims are intended-use recitations. The intended use of a composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. In the instant case, the composition of ‘366 is capable of performing the intended use.
Thus, since the prior art composition, i.e., ‘366, is capable of performing the intended use, it meets the intended use limitations of claims 154 and 156-157. See MPEP 2112.01.
Further regarding claim 154, the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” is in the preamble; if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. In the instant case, the body of the claim fully and intrinsically sets forth all the limitations of the claimed composition.
Claims 154-157 and 159-160 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 15, 19-20 of U.S. Patent No. 9,877,976 (published 2018, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘976 claims a method of inhibiting genomic instability by administering an effective dose of a phosphorothioate compound or derivative thereof selected from amifostine or WR-1065 (claims 1, 4, 6, 15, 19-20).
While ‘976 does not explicitly teach a composition comprising the phosphorothioate compound, since the compound is administered to a subject, the compound is necessarily administered as a composition.
While ‘976 does not teach the limitations of instant claims 159 or 160, an ordinary skilled artisan would have been motivated to modify the composition for single or repeated administration, to predictably arrive at a mode of administration that is optimized for a patient’s dosage needs.
Claims 154-157 and 159-160 are product claims and not method of us claims. Thus, regarding the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” in claim 154 and regarding claims 156-157, this phrase and these claims are intended-use recitations. The intended use of a composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. In the instant case, the composition of ‘976 is capable of performing the intended use.
Thus, since the prior art composition, i.e., ‘976, is capable of performing the intended use, it meets the intended use limitations of claims 154 and 156-157. See MPEP 2112.01.
Further regarding claim 154, the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” is in the preamble; if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. In the instant case, the body of the claim fully and intrinsically sets forth all the limitations of the claimed composition.
Claims 154-157, 159-161, and 241-242 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, and 14 of U.S. Patent No. 6,984,619 (published 2006, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘619 claims a method for reducing the number of lung metastases in an animal comprising administering 50mg/kg-100mg/kg of WR-2721 (claims 1, 3-4, 14).
‘619 claims intravenous and other modes of administration, and teaches WR-2721 formulated into tablets, solutions and more (claims 5-6).
While ‘619 does not explicitly teach a composition comprising WR-2721, since the compound is administered to a subject, the compound is necessarily administered as a composition.
Regarding claims 158 and 241-242, ‘619 differs from that of the claims 158 and 241-242 in that it does not teach the mg/mg2 dosages.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the amounts of the WR-2721, to arrive at instant claims 158 and 241-241. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-‘619 claims dosages of 50mg/kg-100mg/kg, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
While ‘619 does not teach the limitations of instant claims 159 or 160, an ordinary skilled artisan would have been motivated to modify the composition for single or repeated administration, to predictably arrive at a mode of administration that is optimized for a patient’s dosage needs.
Claims 154-157, 159-161 and 241-242 are product claims and not method of us claims. Thus, regarding the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” in claim 154 and regarding claims 156-157, this phrase and these claims are intended-use recitations. The intended use of a composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. In the instant case, the composition of ‘619 is capable of performing the intended use.
Thus, since the prior art composition, i.e., ‘619, is capable of performing the intended use, it meets the intended use limitations of claims 154 and 156-157. See MPEP 2112.01.
Further regarding claim 154, the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” is in the preamble; if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. In the instant case, the body of the claim fully and intrinsically sets forth all the limitations of the claimed composition.
Claims 154-160, and 241-242 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 16-20, 24-34, and 39-42 of U.S. Patent No. 5,869,338 (published 1999, IDS of 09/03/2025).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘338 claims a method for altering gene expression in mammalian cells comprising contacting mammalian cells with a compound selected from the group consisting of an aminoalkylphosphorothioate and an associated aminoalkylphosphorothioate metabolite, such as WR-2721 and WR1065, wherein the mammalian cells are located in and administered to a mammal (claims 1-11, 16, 17, 24-34, 39).
While ‘338 does not explicitly teach a composition comprising an aminoalkylphosphorothioate and an associated aminoalkylphosphorothioate metabolite, since the compound is administered to a subject, the compound is necessarily administered as a composition.
Regarding claims 158 and 241-242, ‘338 differs from that of the claims 158 and 241-242 in that it does not teach the mg/mg2 dosages.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the amounts of the WR-2721 or WR-1065, to arrive at instant claims 158 and 241-241. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-‘338 claims dosages of about 25mg/kg about 50mg/kg, about 100mg/kg (claims 18-20, and 40-42 and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
While ‘338 does not teach the limitations of instant claims 159 or 160, an ordinary skilled artisan would have been motivated to modify the composition for single or repeated administration, to predictably arrive at a mode of administration that is optimized for a patient’s dosage needs.
Claims 154-160 and 241-242 are product claims and not method of us claims. Thus, regarding the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” in claim 154 and regarding claims 156-157, this phrase and these claims are intended-use recitations. The intended use of a composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. In the instant case, the composition of ‘338 is capable of performing the intended use.
Thus, since the prior art composition, i.e., ‘338, is capable of performing the intended use, it meets the intended use limitations of claims 154 and 156-157. See MPEP 2112.01.
Further regarding claim 154, the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” is in the preamble; if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. In the instant case, the body of the claim fully and intrinsically sets forth all the limitations of the claimed composition.
Claims 154-160 and 241-242 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 16-20, 24-34, and 39-42 of U.S. Patent No. 5,567,686 (published 1996, IDS of 09/03/2025).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘686 claims a method for reducing mammal cell mutations induced by radiation comprising preparing a dosage of a compound selected from the group consisting of an aminoalkylphosphorothioate and an associated aminoalkylphosphorothioate metabolite, such as WR-3689, WR-33278 and WR-255591, in an amount of 50mg/kg and administering the dosage to a mammal (claims 1-3, 6-9).
While ‘686 does not explicitly teach a composition comprising an aminoalkylphosphorothioate and an associated aminoalkylphosphorothioate metabolite compound, since the compound is administered to a subject, the compound is necessarily administered as a composition.
Regarding claims 158 and 241-242, ‘686 differs from that of the claims 158 and 241-242 in that it does not teach the mg/mg2 dosages.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the amounts of the WR-3689, WR-33278 and WR-255591, to arrive at instant claims 158 and 241-241. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-‘686 claims dosages of about 25mg/kg and about 50mg/kg, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
While ‘686 does not teach the limitations of instant claims 159 or 160, an ordinary skilled artisan would have been motivated to modify the composition for single or repeated administration, to predictably arrive at a mode of administration that is optimized for a patient’s dosage needs.
Claims 154-160 and 241-242 are product claims and not method of us claims. Thus, regarding the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” in claim 154 and regarding claims 156-157, this phrase and these claims are intended-use recitations. The intended use of a composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. In the instant case, the composition of ‘686 is capable of performing the intended use.
Thus, since the prior art composition, i.e., ‘686, is capable of performing the intended use, it meets the intended use limitations of claims 154 and 156-157. See MPEP 2112.01.
Further regarding claim 154, the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” is in the preamble; if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. In the instant case, the body of the claim fully and intrinsically sets forth all the limitations of the claimed composition.
Claims 154-160 and 241-242 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 16-20, 24-34, and 39-42 of U.S. Patent No. 5,488,042 (published 1996, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘042 claims a method for reducing mammal cell mutations induced by prior irradiation comprising the step of preparing a dosage of at least about 25 mg/kg of a compound selected from the group consisting of an aminoalkylphosphorothioate and an associated aminoalkylphosphorothioate metabolite, such as WR3689 and WsR-255591, and administering the dosage to a mammal (claims 1-3).
While ‘042 does not explicitly teach a composition comprising an aminoalkylphosphorothioate and an associated aminoalkylphosphorothioate metabolite compound, since the compound is administered to a subject, the compound is necessarily administered as a composition.
Regarding claims 158 and 241-242, ‘042 differs from that of the claims 158 and 241-242 in that it does not teach the mg/mg2 dosages.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the amounts of the WR3689 and WR-255591, to arrive at instant claims 158 and 241-241. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-‘042 claims dosages of about-400mg/kg (claim 2), and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
While ‘042 does not teach the limitations of instant claims 159 or 160, an ordinary skilled artisan would have been motivated to modify the composition for single or repeated administration, to predictably arrive at a mode of administration that is optimized for a patient’s dosage needs.
Claims 154-160 and 241-242 are product claims and not method of us claims. Thus, regarding the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” in claim 154 and regarding claims 156-157, this phrase and these claims are intended-use recitations. The intended use of a composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. In the instant case, the composition of ‘042 is capable of performing the intended use.
Thus, since the prior art composition, i.e., ‘042, is capable of performing the intended use, it meets the intended use limitations of claims 154 and 156-157. See MPEP 2112.01.
Further regarding claim 154, the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” is in the preamble; if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. In the instant case, the body of the claim fully and intrinsically sets forth all the limitations of the claimed composition.
Claims 154-160 and 241-242 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 16-20, 24-34, and 39-42 of U.S. Patent No. 5,891,856 (published 1999, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘856 claims a method for reducing mammal cell mutations induced by a mutagenic event comprising preparing a dosage of a compound selected from the group consisting of an aminoalkylphosphorothioate and an associated aminoalkylphosphorothioate metabolite, such as WR-3689 and WR-255591, in an amount of about 25mg/kg, about, 50mg/kg, or about 400mg/kg, and administering the dosage to a mammal (claims 1-2, 6-8, 12-24).
While ‘856 does not explicitly teach a composition comprising an aminoalkylphosphorothioate and an associated aminoalkylphosphorothioate metabolite compound, since the compound is administered to a subject, the compound is necessarily administered as a composition.
Regarding claims 158 and 241-242, ‘856 differs from that of the claims 158 and 241-242 in that it does not teach the mg/mg2 dosages.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the amounts of the WR-3689 and WR-255591, to arrive at instant claims 158 and 241-241. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-‘856 claims dosages of about 25mg/kg, about 50mg/kg, and about 400mg/kg, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
While ‘856 does not teach the limitations of instant claims 159 or 160, an ordinary skilled artisan would have been motivated to modify the composition for single or repeated administration, to predictably arrive at a mode of administration that is optimized for a patient’s dosage needs.
Claims 154-160 and 241-242 are product claims and not method of us claims. Thus, regarding the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” in claim 154 and regarding claims 156-157, this phrase and these claims are intended-use recitations. The intended use of a composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. In the instant case, the composition of ‘856 is capable of performing the intended use.
Thus, since the prior art composition, i.e., ‘856, is capable of performing the intended use, it meets the intended use limitations of claims 154 and 156-157. See MPEP 2112.01.
Further regarding claim 154, the phrase “for preventing genomic instability from a diagnostic imaging or interventional radiology procedure” is in the preamble; if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. In the instant case, the body of the claim fully and intrinsically sets forth all the limitations of the claimed composition.
Conclusion
No claims are allowed.
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/LAUREN WELLS/Examiner, Art Unit 1622
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