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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on August 21, 2026 is acknowledged.
Drawings
The drawings are objected to because at least one drawing submitted in file is in color without granted petition to accept color drawings.
The drawings are objected to because the reference numerals in Fig. 1 do not properly correspond to the description in the specification. In ¶ 36 of the specification, the reference numeral 120 is assigned to PEG-b-PGA and 130 is assigned to FeCl2. However, in Fig. 1, the reference numeral 130 indicates the polymer chain while reference numerals 110 and 120 indicate the spherical components.
Appropriate correction is required.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The specification is objected to because the reference numerals 120 and 130 in ¶ 36 of the specification do not properly correspond to Fig. 1. In ¶ 36 of the specification, the reference numeral 120 is assigned to PEG-b-PGA and 130 is assigned to FeCl2. However, in Fig. 1, the reference numeral 130 indicates the polymer chain while reference numerals 110 and 120 indicate the spherical components.
Abstract is objected to because of a formal typographical error. The final sentence of the Abstract terminates with duplicate periods (“..”).
Appropriate correction is required.
Claim Rejections - 35 USC § 112 Indefiniteness
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 8-16 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.
Claim 1 recites “A use of a metal composite.” Use claims create ambiguity as to whether the scope of protection is directed to a product or to a method/process. Additionally, claim 8 recites both preparation and administration steps within the body of the claim. It is not clear whether the claim is intended to be a method of preparation and/or a method of treatment/use. This hybrid format renders the metes and bounds of the claimed subject matter vague and indefinite.
Similarly, the dependent claims recite “The use” in their preambles, thereby inheriting and compounding the indefiniteness of the independent claim 8.
The dependent claims fall therewith.
Clarification and/or amendment is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 8-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter.
Claims 8-16 recite a “use” of a metal composite, which does not fall within any of the four statutory categories (process, machine, manufacture, or composition of matter). Thus, claims directed merely to a “use” per se are non-statutory under 35 U.S.C. 101. To overcome this rejection, Applicant is advised to amend claims 8-16 into a recognized statutory format such as a method claim.
Claim Rejections - 35 USC § 103
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 8-16 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (EP 2783679, 2014) in view of Yang et al. (US 2008 0107598; cited on PTO-892).
Regarding claim 8, Wang discloses a chelating complex micelle (a metal composite) comprising a metal at the center (metal core, contrast core), which interacts with a polymer possessing chelating ligands (shell ligands) to form coordinate bonds (abstract; ¶ 9). Wang discloses that the polymer having chelating ligands can be a Lewis base and can conjugate to a metal Lewis acid via a coordinate bond (a special kind of covalent bond) (¶ 9). Wang discloses that the covalent bond is very stable and less susceptible to enzyme degradation or hydrolysis (¶ 6). Wang discloses that this composite can be a nano-scaled micelle with a core-shell structure (¶ 6). Wang discloses that this composite can be used for imaging analysis (¶ 11). Regarding claims 9, 11, and 13, Wang discloses that the metal composite can comprise a drug molecule such as WR-1065 (amifostine thiol) (contrast ligand) (¶ 15; ¶ 29; Fig. 1). Wang discloses that the contrast ligand can act as a Lewis base and can interact with the metal in the core through coordinate bonding (a special kind of covalent bonding) (¶ 9; ¶ 15). Wang discloses the structure of WR-1065
PNG
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110
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(Fig. 2B), which reads on the structure of formula (1) of instant claim 12, when R1, R2, and R3 are hydrogen. Regarding claim 9, WR-1065 of Wang comprises a group 16 element (S). Regarding claim 14, Wang discloses that the metal ion can be Fe (¶ 14). Regarding claims 15 and 16, Wang discloses that the polymer can comprise PGA (polyglutamic acid) as a chelating segment and PEG (polyethylene glycol) as a neutral segment used for enhancing dispersity in an aqueous solution (¶ 17).
Wang does not disclose administration to a vasculature of a location in need (instant claim 8) and that the location in need comprises human organ tissue such as heart (instant claim 10).
Yang discloses chelator-targeting ligand conjugates for methods of imaging, treating, and diagnosing disease in a subject (abstract). Yang discloses that a method of imaging can comprise administering to the subject an effective amount of a metal ion labeled chelator-targeting ligand conjugate (¶ 105). Yang discloses that the composition of the conjugates can be administered intraarterially, intravenously, locally, by injection, by localized perfusion, or by other method or any combination of the forgoing as would be known to one of ordinary skill in the art (¶ 381). Yang discloses that the site to be imaged can be any site such as heart in a subject such as human (¶ 114).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer an effective dose of the metal composite of Wang to a vasculature of a location in need such as heart for imaging human organ tissue effectively. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Yang teaches that such a metal composite can be administered to a vasculature of a specific location in need such as heart in human. Further, a person of ordinary skill in the art would have been motivated to utilize the metal composite as an organism imaging composition for imaging various human organ tissues in order to expand the application of the metal composite. A person of ordinary skill in the art would have been motivated to optimize the administration method according to the specific requirements of the intended application. The administration method is a matter of routine optimization for a person in the art, as taught by Yang. Such an optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success.
Claims 8-16 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (US 2014 0212371; cited on PTO-892; hereinafter “Chen 2014”) in view of Wang et al. (EP 2783679, 2014) and Yang et al. (US 2008 0107598; cited on PTO-892).
Regarding claim 8, Chen 2014 discloses a controlled-release method for a pharmaceutical composition comprising metals in a drug carrier, comprising administration of a chelating complex micelles (metal composites) comprising at least a drug molecule (contrast ligand), a polymer ligand (shell ligand), and a metal core (abstract; claim 1). Chen 2014 discloses that the contrast ligand and polymer can donate a lone pair of electrons (Lewis base) to the metal to form the complex micelles via coordinate bonding (FIG. 1; ¶ 47; ¶ 38). Regarding claims 9, 11, 12, and 13, Chen 2014 discloses recites that the drug can be WR-1065 (claim 5), which inherently has a group 16 element (S) and reads on the structure of formula (1) of instant claim 12, when R1, R2, and R3 are hydrogen. Regarding claim 14, Chen 2014 discloses that the metal core can be Fe (claim 2). Regarding claims 15 and 16, Chen 2014 discloses that the polymer ligand of the chelating complex micelles can be PEG and PGA (claim 3). Chen 2014 discloses that the polymer ligand can comprise a dispersion segment (FIG. 1; ¶ 47).
Chen 2014 does not disclose administering an effective dose of the organism imaging composition to a vascular of a location in need such as heart in human (instant claims 8 and 10). Chen 2014 does not disclose that the polymer comprises a chelating group such as PGA and a dispersing group such as PEG (instant claims 15 and 16).
As discussed above, Wang discloses a chelating complex micelle (a metal composite) comprising a metal at the center (metal core, contrast core), which interacts with a polymer possessing chelating ligands (shell ligands) to form coordinate bonds (abstract; ¶ 9). Wang discloses that this composite can be used for imaging analysis (¶ 11). Wang discloses the polymer having chelating ligands can be a Lewis base and can conjugate to metal Lewis acid via a coordinate bond (a special kind of covalent bond) (¶ 9). Wang discloses that the polymer can comprise PGA as a chelating segment and PEG as a neutral segment used for enhancing dispersity in an aqueous solution (¶ 17).
As discussed above, Yang discloses chelator-targeting ligand conjugates for methods of imaging, treating, and diagnosing disease in a subject (abstract). Yang discloses that the composition of the conjugates can be administered intraarterially, intravenously, locally, by injection, by localized perfusion, or by other method or any combination of the forgoing as would be known to one of ordinary skill in the art (¶ 381). Yang discloses that the site to be imaged can be any site such as heart in a subject such as human (¶ 114).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer an effective dose of the composition of Chen 2014 to a vasculature of a location in need such as heart to image human organ tissue effectively. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Wang teaches that such a composition can be used for imaging and Yang teaches that such a metal composite can be administered to a vasculature of a specific location in need such as heart in human. Additionally, it would have been expected that the PEG of the Chen 2014 can act as a dispersing group and the PGA of the Chen 2014 can act as a chelating group which is a Lewis base and forms a coordinate covalent bond with the metal ion, as taught by Wang. A person of ordinary skill in the art would have been motivated to utilize a copolymer comprising PGA and PEG to achieve simultaneous chelating and dispersing functions tailored to specific clinical imaging applications. Further, a person of ordinary skill in the art would have been motivated to utilize the metal composite as an organism imaging composition for imaging various human organ tissues in order to expand the application of the metal composite. A person of ordinary skill in the art would have been motivated to optimize the administration method according to the specific requirements of the intended application. The administration method is a matter of routine optimization for a person in the art, as taught by Yang. Such an optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success.
Claims 8-16 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (CN105997878, 2016; cited on IDS filed February 7, 2024; all citations from the machine translation accompanying this Office Action; hereinafter “Chen 2016”) in view of Wang et al. (EP 2783679, 2014) and Yang et al. (US 2008 0107598; cited on PTO-892).
Regarding claim 8, Chen 2016 discloses the use of a composite microcellular carrier pharmaceutical composition comprising a metal ion, a drug (contrast ligand), and a drug carrier, wherein the drug can be coordinately bonded to the metal ion and the drug carrier can be coordinately bonded to the metal ion (claim 1). Regarding claims 9, 11, 12, and 13, Chen 2016 discloses that the drug can be WR-1065 (claim 5), which inherently has a group 16 element (S) and reads on the structure of formula (1) of instant claim 12, when R1, R2, and R3 are hydrogen. Regarding claim 14, Chen 2016 discloses that the metal ion core can be Fe (claim 2). Regarding claims 15 and 16, Chen 2016 discloses that the polymer ligand of chelating complex micelles can be PEG and PGA (claim 3).
Chen 2016 does not disclose administering an effective dose of the organism imaging composition to a vasculature of a location in need such as heart in human (instant claims 8 and 10). Chen 2016 does not disclose that the polymer comprises a chelating group such as PGA and a dispersing group such as PEG (instant claims 15 and 16).
As discussed above, Wang discloses a chelating complex micelle (a metal composite) comprising a metal at the center (metal core, contrast core), which interacts with a polymer possessing chelating ligands (shell ligands) to form coordinate bonds (abstract; ¶ 9). Wang discloses that this composite can be used for imaging analysis (¶ 11). Wang discloses that the polymer having chelating ligands can be a Lewis base and can conjugate to metal Lewis acid via coordinate bond (a special kind of covalent bond) (¶ 9). Wang discloses that the polymer can comprise PGA as a chelating segment and PEG as a neutral segment used for enhancing dispersity in an aqueous solution (¶ 17).
As discussed above, Yang discloses chelator-targeting ligand conjugates for methods of imaging, treating, and diagnosing disease in a subject (abstract). Yang discloses that the composition of the conjugates can be administered intraarterially, intravenously, locally, by injection, by localized perfusion, or by other method or any combination of the forgoing as would be known to one of ordinary skill in the art (¶ 381). Yang discloses that the site to be imaged can be any site such as heart in a subject such as human (¶ 114).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer an effective dose of the composition of Chen 2016 to a vasculature of a location in need such as heart to image human organ tissue effectively. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Wang teaches that such a composition can be used for imaging and Yang teaches that such a metal composite can be administered to a vasculature of a specific location in need such as heart in human. Additionally, it would have been expected that the PEG of the Chen 2016 can act as a dispersing group and the PGA of the Chen 2016 can act as a chelating group which is a Lewis base and forms a coordinate covalent bond with the metal ion, as taught by Wang. A person of ordinary skill in the art would have been motivated to utilize copolymer comprising PGA and PEG to achieve simultaneous chelating and dispersing functions tailored to specific clinical imaging applications. Further, a person of ordinary skill in the art would have been motivated to utilize the metal composite as an organism imaging composition for imaging various human organ tissues in order to expand the application of the metal composite. A person of ordinary skill in the art would have been motivated to optimize the administration method according to the specific requirements of the intended application. The administration method is a matter of routine optimization for a person in the art, as taught by Yang. Such an optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 8-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. US 9,597,406 in view of Wang et al. (EP 2783679, 2014) and Yang et al. (US 2008 0107598; cited on PTO-892).
Regarding claims 8, 9, and 14, claim 1 of the ‘406 recites a controlled-release method for manipulating drug release, comprising administration of: chelating complex micelles (metal composites) formed via coordinate bonding comprising at least a drug molecule (contrast ligand) that donates lone pairs of electrons (Lewis base), a polymer ligand (shell ligand) that donates an electron pair to a metal core which is Fe. Regarding claims 9, 11, 12, and 13, claim 3 of the ‘406 recites that the contrast ligand can be WR-1065, which inherently has a group of 16 element (S) and reads on the structure of formula (1) of instant claim 12, when R1, R2, and R3 are hydrogen. Regarding claims 15 and 16, claim 2 of the ‘046 recites that the polymer ligand can be PEG and PGA.
Claims of the ‘406 do not recite a polymer having a chelating group (instant claims 8 and 15) and administration to a vasculature of a location in need such as heart in human (instant claims 8 and 10). Claims of the ‘406 do not recite that the polymer further comprises a dispersing group (instant claim 16).
As discussed above, Wang discloses a chelating complex micelle (a metal composite) comprising a metal at the center (metal core, contrast core), which interacts with a polymer possessing chelating ligands (shell ligands) to form coordinate bonds (abstract; ¶ 9). Wang discloses that the polymer having chelating ligands can be a Lewis base and can conjugate to a metal Lewis acid via a coordinate bond (a special kind of covalent bond) (¶ 9). Wang discloses that the polymer can comprise PGA as a chelating segment and PEG as a neutral segment used for enhancing dispersity in an aqueous solution (¶ 17).
As discussed above, Yang discloses chelator-targeting ligand conjugates for methods of imaging, treating, and diagnosing disease in a subject (abstract). Yang discloses that the composition of the conjugates can be administered intraarterially, intravenously, locally, by injection, by localized perfusion, or by other method or any combination of the forgoing as would be known to one of ordinary skill in the art (¶ 381). Yang discloses that the site to be imaged can be any site such as heart in a subject such as human (¶ 114).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer an effective dose of the metal composite of the ‘406 to a vasculature of a location in need such as heart to image human organ tissue effectively. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Yang teaches that such a metal composite can be administered to a vasculature of a specific location in need such as heart in human. Additionally, it would have been expected that the PEG of the ‘406 can act as a dispersing group and the PGA of the ‘406 can act as a chelating group which is a Lewis base and forms a coordinate covalent bond with the metal ion, as taught by Wang. A person of ordinary skill in the art would have been motivated to utilize a copolymer comprising PGA and PEG to achieve simultaneous chelating and dispersing functions tailored to specific clinical imaging applications. Further, a person of ordinary skill in the art would have been motivated to utilize the metal composite as an organism imaging composition for imaging various human organ tissues in order to expand the application of the metal composite. A person of ordinary skill in the art would have been motivated to optimize the administration method according to the specific requirements of the intended application. The administration method is a matter of routine optimization for a person in the art, as taught by Yang. Such an optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
Prosecution Insights