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 .
Drawings
The drawings are objected to because at least one drawing submitted in file is in color without granted petition to accept color drawings.
Appropriate correction is required.
FIG. 3 is objected to because the “Brief Description of the Figures” in the specification refers to parts “A” and “B”, whereas the drawing is labeled simply as FIG. 3 without the corresponding letters to distinguish the individual sub-figures.
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 abstract of the disclosure is objected to because it is too short in length (34 words). Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, “…a fluorophore and; an agent detectable…” should read “…a fluorophore, and an agent detectable….”
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.
Claim 6 is 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 6 recites “the agent.” It is unclear whether “the agent” in claim 6 refers to “an agent detectable by ultrasound” in claim 1 or to ”a targeting agent” in claim 5. If “the agent” is intended to refer to “a targeting agent” in claim 5, it is suggested that claim 6 be amended to “the targeting agent” to obviate this rejection.
Clarification and/or amendment is required.
For the purposes of applying art, “the agent” is being interpreted as a targeting agent.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Assouline et al. (US 2015 0125398; cited on PTO-892).
Regarding claims 1 and 16, Assouline discloses a method for sequential imaging in a mammal comprising: a) introducing to a mammal a composition comprising mesoporous silica nanoparticles (MSNs) comprising a lanthanide, a fluorophore and an agent detectable by ultrasound; b) applying ultrasound and a magnetic field to the mammal and recording ultrasound and magnetic resonance images that include the MSNs; and c) detecting the presence, location or amount of the MSNs in the mammal (claim 1).
Regarding claims 2 and 3, Assouline discloses that the MSNs can be about 1 nm to about 50 nm in diameter (claim 3).
Regarding claim 4, Assouline discloses that the MSNs can comprise pores about 1 nm to about 10 nm in diameter (claim 5).
Regarding claims 5 and 6, Assouline discloses that the MSNs can further comprise a targeting agent and the agent can be an antibody (claims 6 and 7).
Regarding claim 7, Assouline discloses that the images can be of bladder (claim 8).
Regarding claims 8 and 9, Assouline discloses that the composition can be subcutaneously injected into the mammal (claim 10).
Regarding claim 10, Assouline discloses that the mammal can be a human (claim 11).
Regarding claim 11, Assouline discloses a method to image diagnostic or therapeutic cells such as embryonic stem cells (claims 2 and 14).
Regarding claims 12, 13, and 17, Assouline discloses that the lanthanide can be gadolinium and the gadolinium can be a nanoparticle (claims 16 and 17).
Regarding claims 14 and 19, Assouline discloses that the agent can comprise trifluoropropyl (TFP) groups (claim 19).
Regarding claim 15, since Assouline discloses the same composition comprising MSNs, a fluorophore, and an agent detectable by ultrasound as discussed above, the composition of Assouline inherently possesses the capability to be used for bladder tumor monitoring and controlled delivery of bioactive materials. A statement of intended use in a claim does not limit the claim’s scope if the prior art structure or composition is inherently capable of performing that recited function. See MPEP § 2111.02. Further, Assouline discloses the images can be of bladder (claim 8). Assouline also discloses a multimodal MSN contrast agent can be used for in vivo biomedical imaging and drug delivery of bioactive materials (¶ 7). Assouline discloses that the internalization of MSN can be controlled and a reagent of interest leaded in the MSN can be released in a controlled fashion (¶ 88; ¶120).
Regarding claim 18, Assouline discloses that the composition can comprise gadolinium oxide nanoparticles (claim 20).
Regarding claim 20, Assouline discloses that the surface of MSN can be covalently functionalized with gold (¶ 7).
Claims 1, 4, 8, 9, and 12-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sweeney et al. (PLoS One, 2018; cited on PTO-892).
Regarding claims 1, 12-14, and 16-19, Sweeney disclose a method for imaging using multifunctional nanoparticle comprising MSN for magnetic resonance imaging (MRI), ultrasound, and fluorescent microscopy (sequential imaging) (abstract). Sweeney disclose that the MSNs can comprise Gd2O3 (gadolinium oxide) (lanthanide), FITC (fluorescein isothiocyanate) (fluorophore), and TFP moieties (agent detectable by ultrasound) (page5, Fig 1). Sweeney disclose that the composition can be administered into mice (mammal) and can be tracked following the injections (abstract). Sweeney disclose that the Gd2O3-MSN core had a mean hydrodynamic diameter of 187 nm, indicating the Gd2O3 is nanoparticle (page 5, Fig 1; page 5, ¶ 2).
Regarding claim 4, Sweeney disclose that the average pore diameter of the MSNs can be 24 Å (2.3 nm) (page 5, ¶ 2).
Regarding claims 8 and 9, Sweeney disclose that the composition can be administered into mice via intravenous (intravascular) injection (abstract).
Regarding claim 15, since Sweeney discloses the same composition comprising MSNs, a fluorophore, and an agent detectable by ultrasound as discussed above, the composition of Assouline inherently possesses the capability to be used for bladder tumor monitoring and controlled delivery of bioactive materials. A statement of intended use in a claim does not limit the claim’s scope if the prior art structure or composition is inherently capable of performing that recited function. See MPEP § 2111.02.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney et al. (PLoS One, 2018; cited on PTO-892) in view of Assouline et al. (US 2015 0125398; cited on PTO-892).
As discussed above, regarding claims 1, 12-14, and 16-19, Sweeney disclose a method for imaging using multifunctional nanoparticle comprising MSN for magnetic resonance imaging (MRI), ultrasound, and fluorescent microscopy (sequential imaging) (abstract). Sweeney disclose that the MSNs can comprise Gd2O3 (gadolinium oxide) (lanthanide), FITC (fluorescein isothiocyanate) (fluorophore), and TFP moieties (agent detectable by ultrasound) (page5, Fig 1). Sweeney disclose that the composition can be administered into mice (mammal) and can be tracked following the injections (abstract). Sweeney disclose that the Gd2O3-MSN core had a mean hydrodynamic diameter of 187 nm, indicating the Gd2O3 is nanoparticle (page 5, Fig 1; page 5, ¶ 2). Regarding claim 4, Sweeney disclose that the average pore diameter of the MSNs can be 24 Å (2.3 nm) (page 5, ¶ 2). Regarding claims 8 and 9, Sweeney disclose that the composition can be administered into mice via intravenous (intravascular) injection (abstract). Regarding claim 15, since Sweeney discloses the same composition comprising MSNs, a fluorophore, and an agent detectable by ultrasound as discussed above, the composition of Assouline inherently possesses the capability to be used for bladder tumor monitoring and controlled delivery of bioactive materials. A statement of intended use in a claim does not limit the claim’s scope if the prior art structure or composition is inherently capable of performing that recited function. See MPEP § 2111.02.
Regarding claims 2 and 3, Sweeney discloses that the particle diameter can range from 50 nm to 187 nm, depending on its composition (page 2, ¶ 4). Sweeney discloses that the Gd2O3-MSN core had a mean hydrodynamic diameter of 187 nm, while the complete TFP-FITC-Gd2O3-MSN had a mean hydrodynamic diameter of 227.8 nm. Sweeney does not disclose that the MSNs comprising a lanthanide, a fluorophore, and an agent are about 1 nm to about 50 nm or less than about 200 nm in diameter.
As discussed above, Assouline discloses that the MSNs can be about 1 nm to about 50 nm in diameter (claim 3).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the MSN of Sweeney to have a diameter of about 1 nm to 50 nm. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that the diameter of the MSNs can be about 1 nm to about 50 nm. Further, a person of ordinary skill in the art would have been motivated to optimize the diameter according to the specific requirements of the applications. The diameter of the MSNs is a clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of a parameter is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal diameter of MSNs in order to best achieve the desired compound characteristics, as the diameter critically determines stability and drug delivery efficacy. “[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.” See MPEP § 2144.
Regarding claims 5 and 6, Sweeney does not disclose the MSNs further comprise a targeting agent such as an antibody or an antigen binding portion.
As discussed above, Assouline discloses that the MSNs can further comprise a targeting agent and that the agent can be an antibody (claims 6 and 7).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the MSN of Sweeney to include the targeting agent of Assouline to prepare a more specific agent. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that targeting agent such as antibody can be used in the composition. Further, a person of ordinary skill in the art would have been motivated to utilize a targeting group on the imaging agent in order to achieve more precise disease detection and treatment planning.
Regarding claim 7, Sweeney does not disclose that the composition is detected in an organ such as bladder.
As discussed above, Assouline discloses that the images can be of the bladder (claim 8).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the composition of Sweeney for bladder imaging. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that the compound can be used for bladder imaging. Further, a person of ordinary skill in the art would have been motivated to utilize the composition for bladder imaging and diagnostics in order to expand the applications of the composition.
Regarding claim 10, Sweeney does not disclose the mammal is a human.
As discussed above, Assouline discloses that the mammal can be a human (claim 11).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the composition of Sweeney for humans. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that the composition can be used for humans. Further, a person of ordinary skill in the art would have been motivated to apply the composition to human subjects in order to expand the applications of the composition.
Regarding claim 11, Sweeney does not disclose diagnostic or therapeutic cells such as embryonic stem cells.
As discussed above, Assouline discloses that a method of imaging diagnostic or therapeutic cells such as embryonic stem cells (claims 2 and 11).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize a method of Sweeney for imaging diagnostic or therapeutic cells such as embryonic stem cells. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches a method of imaging diagnostic or therapeutic cells such as embryonic stem cells. Further, a person of ordinary skill in the art would have been motivated to utilize the method for imaging diagnostic or therapeutic cells in order to expand the applications of the method.
Regarding claim 20, Sweeney does not discloses that the MSNs comprise further substance such as gold.
As discussed above, Assouline discloses that the surface of MSNs can be covalently functionalized with materials such as gold (¶ 7).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize gold for the composition of Sweeney to prepare more effective composition for in vivo imaging analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that gold can be used for the composition. Further, a person of ordinary skill in the art would have been motivated to utilize gold in order to achieve enhanced multimodal imaging, targeted drug delivery, and improved efficacy in disease treatment.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. US 11,969,483 (cited on PTO-892; U.S. Patent Application No 17/069,531 cited on IDS filed March 28, 2024) in view of Assouline et al. (US 2015 0125398; cited on PTO-892).
Regarding claim 1, claim 10 of the ‘483 recites a method for sequential imaging and/or imaging diagnostic or therapeutic cells in a mammal, comprising: a) introducing to a mammal a composition comprising MSNs, said MSNs being covalently functionalized with at least one material selected from the group consisting of a lanthanide, a fluorophore and, an agent detectable by ultrasound; and b) detecting the composition in the mammal.
Regarding claims 2 and 3, claim 11 of the ‘483 recites that the MSNs can be less than about 200 nm in diameter . Less than 200 nm of the ‘483 encompasses 1 –50 nm of instant claim 2 and less than 200 nm of instant claim 3. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
Regarding claim 4, the claims of the ‘483 do not recite that the MSNs comprise pores about 1 m, to about 10 nm in diameter. As discussed above, Assouline discloses that the MSNs can comprise pores about 1 nm to about 10 nm in diameter (claim 5). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the MSN of the ‘483 to comprise pores about 1 nm to about 10 nm in diameter in order to utilize for loading with various reagents. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that the pore size of the MSNs can be about 1 nm to about 10 nm in diameter. Further, a person of ordinary skill in the art would have been motivated to optimize the pore size according to the specific requirements of the applications.
Regarding claims 5-7, claim 10 of the ‘483 recites that the MSN cab be covalently linked with a bladder cancer cell specific Cyc6 peptide (Cyc6).
Regarding claims 8-9, claim 12 of the ‘483 recites that the composition can be injected into the mammal by a route selected from the group consisting of subcutaneously, intradermally and intravascularly.
Regarding claim 10, the claims of the ‘483 do not recite that the mammal is a human. As discussed above, Assouline discloses that the mammal can be a human (claim 11). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the method of the ‘483 for human as a mammal. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that the method using MSNs can be used for mammals such as human. Further, a person of ordinary skill in the art would have been motivated to apply the method for human in order to expand the applications of the method.
Regarding claim 11, the claims of the ‘483 do not recite that diagnostic or therapeutic cells such as embryonic stem cells. As discussed above, Assouline discloses a method to image diagnostic or therapeutic cells such as embryonic stem cells (claims 2 and 14). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the method of the ‘483 for imaging diagnostic or therapeutic cells such as embryonic stem cells. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches a method of imaging diagnostic or therapeutic cells such as embryonic stem cells. Further, a person of ordinary skill in the art would have been motivated to utilize the method of the ‘483 for imaging diagnostic or therapeutic cells in order to expand the applications of the method.
Regarding claims 12, 13, and 16-18, claim 4 of the ‘483 recites that the lanthanide can be Gd2O3. The claims of the ‘483 do not recite that the gadolinium (oxide) is a nanoparticle. As discussed above, Assouline discloses that the gadolinium (oxide) can be a nanoparticle (claims 17 and 20). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the gadolinium (oxide) of the ‘483 as a nanoparticle. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that gadolinium (oxide) can be a nanoparticle for the method using MSNs. Further, a person of ordinary skill in the art would have been motivated to use gadolinium (oxide) nanoparticle in order to achieve better imaging and better tumor targeting.
Regarding claims 14 and 19, claim 2 of the ‘483 recites that the agent can comprise TFP groups.
Regarding claim 15, , since claims of the ‘483 recites the same composition comprising MSNs, a fluorophore, and an agent detectable by ultrasound as discussed above, the composition of the ‘483 inherently possesses the capability to be used for bladder tumor monitoring and controlled delivery of bioactive materials. A statement of intended use in a claim does not limit the claim’s scope if the prior art structure or composition is inherently capable of performing that recited function. See MPEP § 2111.02. Further, claim 13 of the ‘483 recites a method for delivering a therapeutic composition comprising a bioactive agent to bladder cancer cells in a mammal.
Regarding claim 20, claim 3 of the ‘483 recites that the MSNs can further comprise a substance selected from the group consisting of gold, bismuth, and iron oxide.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. US 12,102,693 (cited on PTO-892) in view of Assouline et al. (US 2015 0125398; cited on PTO-892).
Regarding claims 1 and 16, claims 1 and 2 of the '693 recites a pharmaceutical composition comprising MSN and contrast agent comprising at least one of a lanthanide, a fluorophore, and a surface modification agent detectable with ultrasound. The claims of the ‘693 do not recite a method for sequential imaging and/or imaging diagnostic or therapeutic cells in a mammal. As discussed above, Assouline discloses method for sequential imaging in a mammal comprising: a) introducing to a mammal a composition; b) applying ultrasound and a magnetic field to the mammal and recording ultrasound and magnetic resonance images that include the MSNs; and c) detecting the presence, location or amount of the MSNs in the mammal. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the composition of the ‘693 for the imaging method of Assouline. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches the method for imaging using the composition. Further, a person of ordinary skill in the art would have been motivated to utilize the composition for imaging analysis in order to expand the applications of the composition.
Regarding claims 2-4, claim 4 of the ‘693 recites that the MSNs can be less than or equal to 200 nm in diameter with a mean pore diameter of about 2-3.8 nm. Less than or equal to 200 nm of the ‘693 encompasses 1 –50 nm of instant claim 2 and less than 200 nm of instant claim 3. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
Regarding claims 5-6, claim 7 of the ‘693 recites the composition can comprise a targeting peptide or amino acid.
Regarding claim 7, claim 8 of the ‘693 recites the composition can comprise a bladder cancer cell specific cyclic peptide (Cyc6), indicating that the composition can be used for detecting bladder cancer cells.
Regarding claims 8 and 9, the claims of the ‘693 do not recite that the composition is injected such as subcutaneously into a mammal such as a human. As discussed above, Assouline discloses that the composition can be subcutaneously injected into a mammal (claim 10). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the composition of the ‘693 to be injected into a mammal subcutaneously for in vivo imaging analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that the composition can be injective subcutaneously into a mammal. Further, a person of ordinary skill in the art would have been motivated to utilize the composition by various administration methods for in vivo imaging analysis in mammals in order to expand the applications of the composition.
Regarding claim 10, the claims of the ‘693 do not recite that the mammal is a human. As discussed above, Assouline discloses that the mammal can be a human (claim 11). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the composition of the ‘693 for humans. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that the composition can be used for human. Further, a person of ordinary skill in the art would have been motivated to apply the composition for human in order to expand the applications of the method.
Regarding claim 11, the claims of the ‘693 do not recite that diagnostic or therapeutic cells such as embryonic stem cells. As discussed above, Assouline discloses a method to image diagnostic or therapeutic cells such as embryonic stem cells (claims 2 and 14). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the method of the ‘693 for imaging diagnostic or therapeutic cells such as embryonic stem cells. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches a method of imaging diagnostic or therapeutic cells such as embryonic stem cells. Further, a person of ordinary skill in the art would have been motivated to utilize the method the ‘693 for imaging diagnostic or therapeutic cells in order to expand the applications of the method.
Regarding claims 12 and 17, claim 2 of the ‘693 recites that the composition can comprise gadolinium.
Regarding claims 13 and 18, the claims of the ‘693 do not recite gadolinium (oxide) nanoparticles. As discussed above, Assouline discloses that the gadolinium can be a nanoparticle and the MSN can comprise gadolinium oxide nanoparticles (claims 17 and 20). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize gadolinium (oxide) nanoparticle of Assouline in the composition of the ‘693 to prepare a more effective composition for in vivo imaging analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that gadolinium (oxide) nanoparticles can be used in the composition. Further, a person of ordinary skill in the art would have been motivated to utilize gadolinium (oxide) nanoparticle in order to achieve the predictable benefits of improved imaging and reduced safety concerns.
Regarding claims 14 and 19, the claims of the ‘693 do not recite that the agent comprises TFP groups. As discussed above, Assouline discloses that the agent comprises TFP groups (claim 19). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize TFP groups for the composition of the ‘693 to prepare more effective composition for in vivo imaging analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that TFP groups can be used for the composition. Further, a person of ordinary skill in the art would have been motivated to utilize TFP groups in order to enhance rapid imaging contrast.
Regarding claim 15, , since claims of the ‘693 recites the same composition comprising MSNs, a fluorophore, and an agent detectable by ultrasound as discussed above, the composition of the ‘693 inherently possesses the capability to be used for bladder tumor monitoring and controlled delivery of bioactive materials. A statement of intended use in a claim does not limit the claim’s scope if the prior art structure or composition is inherently capable of performing that recited function. See MPEP § 2111.02.
Regarding claim 20, claim 2 of the ‘693 recites the contrast agent can comprise a heavy metal. The claims of the ‘693 do not recite the MSNs comprise further substance such as gold. As discussed above, Assouline discloses that the surface of MSN can be covalently functionalized with materials such as gold (¶ 7). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize gold for the composition of the ‘693 to prepare more effective composition for in vivo imaging analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that gold can be used for the composition. Further, a person of ordinary skill in the art would have been motivated to utilize gold in order to achieve advanced multimodal imaging, targeted drug delivery, and disease treatment.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. US 12,285,498 (cited on PTO-892) in view of Assouline et al. (US 2015 0125398; cited on PTO-892).
Regarding claims 1, 7, and 16, claim 7 of the '498 recites a method of treatment bladder cancer comprising administering intravesically to a bladder of a patient a first pharmaceutical composition comprising MSN and contrast agent. Claims 9 of the '498 recites that contrast agent comprises at least one of a lanthanide, a fluorophore, and a surface modification agent detectable with ultrasound. Claims of the ‘498 do not recite a method for sequential imaging and/or imaging diagnostic or therapeutic cells in a mammal. As discussed above, Assouline discloses method for sequential imaging in a mammal comprising: a) introducing to a mammal a composition; b) applying ultrasound and a magnetic field to the mammal and recording ultrasound and magnetic resonance images that include the MSNs; and c) detecting the presence, location or amount of the MSNs in the mammal. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the composition of the ‘498 for the imaging method of Assouline. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches the method for imaging utilizing the composition. Further, a person of ordinary skill in the art would have been motivated to utilize the composition for imaging analysis in order to expand the applications of the composition.
Regarding claims 2-4, claim 11 of the ‘498 recites that the MSNs can be less than or equal to 200 nm in diameter with a mean pore diameter of about 2-3.8 nm. Less than or equal to 200 nm of the ‘498 encompasses 1 –50 nm of instant claim 2 and less than 200 nm of instant claim 3. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
Regarding claims 5 and 6, claim 7 of the ‘498 recites the composition can comprise a targeting peptide or amino acid.
Regarding claims 8 and 9, claim 7 of the ‘498 recites that the composition can be administered intravesically to a bladder of a patient. Claims of the ‘498 do not recite that the composition in injected such as subcutaneously into mammal such as human. As discussed above, Assouline discloses that the composition can be subcutaneously injected into the mammal (claim 10). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the composition of the ‘498 to be injected into the mammal subcutaneously for in vivo imaging analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that the composition can be injective subcutaneously into the mammal. Further, a person of ordinary skill in the art would have been motivated to utilize the composition by various administration methods for in vivo imaging analysis for mammals in order to expand the applications of the composition.
Regarding claim 10, the claims of the ‘498 do not recite that the mammal is a human. As discussed above, Assouline discloses that the mammal can be a human (claim 11). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the composition of the ‘498 for human. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that the composition can be used for human. Further, a person of ordinary skill in the art would have been motivated to apply the composition for human in order to expand the applications of the method.
Regarding claim 11, the claims of the ‘498 do not recite diagnostic or therapeutic cells such as embryonic stem cells. As discussed above, Assouline discloses a method to image diagnostic or therapeutic cells such as embryonic stem cells (claims 2 and 14). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the method of the ‘498 for imaging diagnostic or therapeutic cells such as embryonic stem cells. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches a method of imaging diagnostic or therapeutic cells such as embryonic stem cells. Further, a person of ordinary skill in the art would have been motivated to utilize the method the ‘498 for imaging diagnostic or therapeutic cells in order to expand the applications of the method.
Regarding claims 12 and 17, claim 9 of the ‘498 recites that the composition can comprise gadolinium.
Regarding claims 13 and 18, the claims of the ‘498 do not recite gadolinium (oxide) nanoparticles. As discussed above, Assouline discloses that the gadolinium can be a nanoparticle and the MSN can comprise gadolinium oxide nanoparticles (claims 17 and 20). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize gadolinium (oxide) nanoparticle of Assouline for the composition of the ‘498 to prepare more effective composition for in vivo imaging analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that gadolinium (oxide) nanoparticle can be used for the composition. Further, a person of ordinary skill in the art would have been motivated to utilize gadolinium (oxide) nanoparticle in order to achieve improved imaging and reduced safety concerns.
Regarding claims 14 and 19, the claims of the ‘498 do not recite that the agent comprises TFP groups. As discussed above, Assouline discloses that the agent comprises TFP groups (claim 19). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize TFP groups for the composition of the ‘498 to prepare more effective composition for in vivo imaging analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that trifluoropropyl groups can be used for the composition. Further, a person of ordinary skill in the art would have been motivated to utilize TFP groups in order to enhance rapid imaging contrast.
Regarding claim 15, , since claims of the ‘498 recites the same composition comprising MSNs, a fluorophore, and an agent detectable by ultrasound as discussed above, the composition of the ‘693 inherently possesses the capability to be used for bladder tumor monitoring and controlled delivery of bioactive materials. A statement of intended use in a claim does not limit the claim’s scope if the prior art structure or composition is inherently capable of performing that recited function. See MPEP § 2111.02.
Regarding claim 20, claim 9 of the ‘498 recites the contrast agent can comprise a heavy metal. Claims of the ‘498 do not recite the MSNs comprise further substance such as gold. As discussed above, Assouline discloses that the surface of MSN can be covalently functionalized with materials such as gold (¶ 7). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize gold for the composition of the ‘693 to prepare more effective composition for in vivo imaging analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Assouline teaches that gold can be used for the composition. Further, a person of ordinary skill in the art would have been motivated to utilize gold in order to achieve advanced multimodal imaging, targeted drug delivery, and disease treatment.
Conclusion
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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