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 I, silica nanoparticles and the intended outcome being oral delivery in the reply filed on July 10, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
While the required presence of targeting, diagnostic and/or therapeutic was not elected, upon further search, the presence of such materials was found to be obvious and therefore claims 5 and 6 are under examination.
Drawings
The drawings are objected to because there are various issues with discerning the different data in the figures and reading some text. In Figures 2A and 2B, the symbols and shading for TMOS, Dye-silane, TEOS and L-arginine are highly similar to each other and which one is being represented over the reaction arrow cannot be readily discerned. While arrows have been added in Figures 3A and 3B to aid in identifying which lines in the graph correspond to the legend, this information does carry over for all the data giving how the lines intersect at various points in the graph. At least in Figures 4A – 4F and 9A, the legend indicates multiple lines but different lines are not visible in the graph. There is explanatory text in Figure 5B that cannot be clearly read. 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.
Specification
The disclosure is objected to because of the following informalities: particularly in ¶ [0049] of the PGPub of the instant application, various trade names or marks used in commerce are not properly formatted are materials that are not are formatted as trade names or marks used in commerce.
Trade names or marks used in commerce, have been noted in this application. Each term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
ALEXA® and BODIPY® are trade names or marks used in commerce that are not accompanied by the either appropriate symbol or generic terminology. Others such as DYLIGHT® 633 and IRDYE® 800CW have the appropriate mark but are not accompanied by generic terminology. While materials such as CY3 DIRECT and CY5 DIRECT are trademarked based on a search of the trademark database, compounds such as Cy5 and Cy3 do not appear to be trademarked and are presented with the registered trademark symbol.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1 – 6 are rejected under 35 U.S.C. 103 as being unpatentable over Wiesner et al. (US 2015/0366995).
Wiesner et al. discloses mesoporous oxide nanoparticles with an average size of less than 15 nm and a narrow size distribution that can be used in imaging applications and delivery of molecular cargo such as a drug to an individual (whole document, e.g., abstract). Silica is exemplified as a suitable material for the mesoporous nanoparticle (e.g., ¶ [0012]) and is used in the examples. The mesoporous nanoparticles comprise polyethylene-glycol (PEG) with at least a portion of the non-pore surface at least partially functionalized with such groups (¶ [0006]). The outer surface can also be functionalized with targeting groups with exemplified attachment chemistry being a thiol-maleimide reaction at one end and N-hydroxysuccinimide (NHS) ester amine to the surface of the particle such as through a thiol (¶ [0060]). Size control of the particles in the range of from about 5 to 15 nm can be achieved by varying the conditions for particle synthesis (e.g., ¶ [0130]). At least 90% of the nanoparticles are within 3 nm of the average size (e.g., ¶ [0006] and claim 1). The compositions can be administered to an individual for delivery of a molecular cargo (¶ [0012]). Amongst the disclosed routes suitable for administration is oral (¶ [0076]). Exemplified molecular cargos include diagnostic agents such as fluorescent dyes and therapeutic agents (¶ [0053]).
Oral administration of the silica nanoparticles to a subject is not disclosed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to orally administer the PEG-functionalized mesoporous silica nanoparticles of Wiesner et al. to a subject for delivery of the orally administered particles to the subject. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because silica nanoparticles as required by the claims are disclosed by Wiesner et al. that can be administered by various routes, including oral administration. In addition to the PEG functionalization, targeting agents or molecular cargo can also be present in the particles that are administered and will impart additional functionality to the administered materials. The particle size range disclosed is completely encompassed by the range for the longest linear dimension being about 20 nm or less recited in claim 1 and substantially overlaps with the narrower range of about 7 nm or less recited in claim 2 and such ranges result in the instant claims not being patentably distinguished over the prior art absent evidence of criticality (see MPEP 2144.05).
The in vivo behavior, diffusion coefficients and that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual are not explicitly disclosed by the prior art. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The behavior of the particles will be determined by the nature of the particles administered and the administration route. Here the prior art discloses oral administration of silica particles with sizes falling within the scope of the claims that are at least partially functionalized with PEG as required by the instant claims. Properties such as the diffusions coefficient in various material and the in vivo fate of such particles, such as that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual, are determined by the particles themselves and the administration route. There is no evidence of record that these limitations are not met as they are determined by the particles and nanoparticles as claimed are rendered obvious by Wiesner et al. It is also noted that the same attachment chemistries are disclosed in ¶ [0060] of Wiesner et al. and for the instant constructs (e.g., ¶ [0057] of the PGPub of the instant application) also these are not required by the claims and the Examiner was unable to locate any experimental results as to the post-stomach delivery generally or more specifically, the retention of at least a portion of the targeting, diagnostic or therapeutic activities of the particles, in the disclosure as originally filed.
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 - 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 13 of U.S. Patent No. 9,623,456 in view of Wiesner et al. (US 2015/0366995). The claims of US’456 recite a fluorescent silica based nanoparticles, 1 – 8 nm in diameter, as measured by dynamic light scattering, with a fluorescent compound in the core and an organic polymer for attachment of the targeting peptide RGD (single letter amino acid abbreviations; claim 1). The organic polymer can be PEG (claim 2) attached via thiol and maleimido chemistry (claim 7).
Oral administration of such particles is not claimed.
Wiesner et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to orally administer the fluorescent silica nanoparticles of US’456 to a subject as taught by Wiesner et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because highly similar particles are disclosed by Wiesner et al. and to be used, they must be administered to a subject and oral administration is one suitable route. The size range for the particle at least overlap and such ranges result in the instant claims not being patentably distinguished over the prior art absent evidence of criticality (see MPEP 2144.05).
The in vivo behavior, diffusion coefficients and that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual are not explicitly disclosed by the prior art. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The behavior of the particles will be determined by the nature of the particles administered and the administration route. Here the prior art discloses oral administration of silica particles with sizes falling within the scope of the claims that are at least partially functionalized with PEG as required by the instant claims. Properties such as the diffusions coefficient in various material and the in vivo fate of such particles, such as that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual, are determined by the particles themselves and the administration route. There is no evidence of record that these limitations are not met as they are determined by the particles and nanoparticles as claimed are rendered obvious by Wiesner et al. It is also noted that the same attachment chemistries are disclosed in ¶ [0060] of Wiesner et al. and for the instant constructs (e.g., ¶ [0057] of the PGPub of the instant application) also these are not required by the claims and the Examiner was unable to locate any experimental results as to the post-stomach delivery generally or more specifically, the retention of at least a portion of the targeting, diagnostic or therapeutic activities of the particles, in the disclosure as originally filed.
Claims 1 – 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 10 of U.S. Patent No. 11,291,737 in view of Wiesner et al. (US 2015/0366995). The claims of US’737 recite a method that results in the production of silica core or core-shell nanoparticles comprising a fluorescent dye functionalized with PEG (claim 1). The resultant nanoparticles can have an average size of 2 – 15 nm (claim 9).
Oral administration of the formed particles is not claimed.
Wiesner et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to orally administer the fluorescent silica nanoparticles of US’737 to a subject as taught by Wiesner et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because highly similar particles are disclosed by Wiesner et al. and to be used, they must be administered to a subject and oral administration is one suitable route. The size range for the particle at least overlap and such ranges result in the instant claims not being patentably distinguished over the prior art absent evidence of criticality (see MPEP 2144.05).
The in vivo behavior, diffusion coefficients and that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual are not explicitly disclosed by the prior art. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The behavior of the particles will be determined by the nature of the particles administered and the administration route. Here the prior art discloses oral administration of silica particles with sizes falling within the scope of the claims that are at least partially functionalized with PEG as required by the instant claims. Properties such as the diffusions coefficient in various material and the in vivo fate of such particles, such as that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual, are determined by the particles themselves and the administration route. There is no evidence of record that these limitations are not met as they are determined by the particles and nanoparticles as claimed are rendered obvious by Wiesner et al. It is also noted that the same attachment chemistries are disclosed in ¶ [0060] of Wiesner et al. and for the instant constructs (e.g., ¶ [0057] of the PGPub of the instant application) also these are not required by the claims and the Examiner was unable to locate any experimental results as to the post-stomach delivery generally or more specifically, the retention of at least a portion of the targeting, diagnostic or therapeutic activities of the particles, in the disclosure as originally filed.
Claims 1 – 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 17 of U.S. Patent No. 12,115,231 in view of Wiesner et al. (US 2015/0366995). The claims of US’231 recited a method that results in the production of silica nanoparticles with a PEG coating that comprises a fluorescent dye (claim 1) that can be 2 – 15 nm in diameter (claim 15). Additional materials such as therapeutic agents (claims 9 – 11) or a ligand with specific binding affinity for a tumor, reading on a targeting agent, can be attached (claim13).
Oral administration of such particles is not claimed.
Wiesner et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to orally administer the fluorescent silica nanoparticles of US’231 to a subject as taught by Wiesner et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because highly similar particles are disclosed by Wiesner et al. and to be used, they must be administered to a subject and oral administration is one suitable route. The size range for the particle at least overlap and such ranges result in the instant claims not being patentably distinguished over the prior art absent evidence of criticality (see MPEP 2144.05).
The in vivo behavior, diffusion coefficients and that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual are not explicitly disclosed by the prior art. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The behavior of the particles will be determined by the nature of the particles administered and the administration route. Here the prior art discloses oral administration of silica particles with sizes falling within the scope of the claims that are at least partially functionalized with PEG as required by the instant claims. Properties such as the diffusions coefficient in various material and the in vivo fate of such particles, such as that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual, are determined by the particles themselves and the administration route. There is no evidence of record that these limitations are not met as they are determined by the particles and nanoparticles as claimed are rendered obvious by Wiesner et al. It is also noted that the same attachment chemistries are disclosed in ¶ [0060] of Wiesner et al. and for the instant constructs (e.g., ¶ [0057] of the PGPub of the instant application) also these are not required by the claims and the Examiner was unable to locate any experimental results as to the post-stomach delivery generally or more specifically, the retention of at least a portion of the targeting, diagnostic or therapeutic activities of the particles, in the disclosure as originally filed.
Claims 1 – 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 22 of U.S. Patent No. 12,485,189 in view of Wiesner et al. (US 2015/0366995). The claims of US’189 recite a process that results in the production of silica nanoparticles functionalized with PEG (e.g., claim 1) that can further contain a drug (claims 5 – 6) or a targeting group (claim 9). The nanoparticles can have a diameter of 10 nm or less (claim 12).
Oral administration of such nanoparticles is not claimed.
Wiesner et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to orally administer the fluorescent silica nanoparticles of US’189 to a subject as taught by Wiesner et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because highly similar particles are disclosed by Wiesner et al. and to be used, they must be administered to a subject and oral administration is one suitable route. The size range for the particle at least overlap and such ranges result in the instant claims not being patentably distinguished over the prior art absent evidence of criticality (see MPEP 2144.05).
The in vivo behavior, diffusion coefficients and that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual are not explicitly disclosed by the prior art. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The behavior of the particles will be determined by the nature of the particles administered and the administration route. Here the prior art discloses oral administration of silica particles with sizes falling within the scope of the claims that are at least partially functionalized with PEG as required by the instant claims. Properties such as the diffusions coefficient in various material and the in vivo fate of such particles, such as that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual, are determined by the particles themselves and the administration route. There is no evidence of record that these limitations are not met as they are determined by the particles and nanoparticles as claimed are rendered obvious by Wiesner et al. It is also noted that the same attachment chemistries are disclosed in ¶ [0060] of Wiesner et al. and for the instant constructs (e.g., ¶ [0057] of the PGPub of the instant application) also these are not required by the claims and the Examiner was unable to locate any experimental results as to the post-stomach delivery generally or more specifically, the retention of at least a portion of the targeting, diagnostic or therapeutic activities of the particles, in the disclosure as originally filed.
Claims 1 – 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8, 10, 11, 17, 18, 20 – 22 and 51 - 63 of copending Application No. 17/459,562 in view of Wiesner et al. (US 2015/0366995). The claims of US’562 recite silica nanorings, which read on silica nanoparticles, functionalized with PEG having an outer diameter or [sic] 5 nm – 20 nm (claim 1). Display groups such as dye groups or drugs can also be present on the outer and/or inner surface of the nanoring (claim 4).
Oral administration of such nanoparticles is not claimed.
Wiesner et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to orally administer the fluorescent silica nanoparticles of US’562 to a subject as taught by Wiesner et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because highly similar particles are disclosed by Wiesner et al. and to be used, they must be administered to a subject and oral administration is one suitable route. The size range for the particle at least overlap and such ranges result in the instant claims not being patentably distinguished over the prior art absent evidence of criticality (see MPEP 2144.05).
The in vivo behavior, diffusion coefficients and that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual are not explicitly disclosed by the prior art. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The behavior of the particles will be determined by the nature of the particles administered and the administration route. Here the prior art discloses oral administration of silica particles with sizes falling within the scope of the claims that are at least partially functionalized with PEG as required by the instant claims. Properties such as the diffusions coefficient in various material and the in vivo fate of such particles, such as that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual, are determined by the particles themselves and the administration route. There is no evidence of record that these limitations are not met as they are determined by the particles and nanoparticles as claimed are rendered obvious by Wiesner et al. It is also noted that the same attachment chemistries are disclosed in ¶ [0060] of Wiesner et al. and for the instant constructs (e.g., ¶ [0057] of the PGPub of the instant application) also these are not required by the claims and the Examiner was unable to locate any experimental results as to the post-stomach delivery generally or more specifically, the retention of at least a portion of the targeting, diagnostic or therapeutic activities of the particles, in the disclosure as originally filed.
This is a provisional nonstatutory double patenting rejection although it is noted that a Notice of Allowance has been prepared but the Application has not issued as of the preparation of this Office Action.
Claims 1 – 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3, 5, 6, 8 – 16 and 18 - 21 of copending Application No. 17/773,267 in view of Wiesner et al. (US 2015/0366995). The claims of US’267 recite a method that results in the production of silica nanoparticles comprising one or more dyes and a surface functionalized with PEG 2 – 15 nm in average size (claim 1).
Oral administration of such nanoparticles is not claimed.
Wiesner et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to orally administer the fluorescent silica nanoparticles of US’267 to a subject as taught by Wiesner et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because highly similar particles are disclosed by Wiesner et al. and to be used, they must be administered to a subject and oral administration is one suitable route. The size range for the particle at least overlap and such ranges result in the instant claims not being patentably distinguished over the prior art absent evidence of criticality (see MPEP 2144.05).
The in vivo behavior, diffusion coefficients and that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual are not explicitly disclosed by the prior art. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The behavior of the particles will be determined by the nature of the particles administered and the administration route. Here the prior art discloses oral administration of silica particles with sizes falling within the scope of the claims that are at least partially functionalized with PEG as required by the instant claims. Properties such as the diffusions coefficient in various material and the in vivo fate of such particles, such as that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual, are determined by the particles themselves and the administration route. There is no evidence of record that these limitations are not met as they are determined by the particles and nanoparticles as claimed are rendered obvious by Wiesner et al. It is also noted that the same attachment chemistries are disclosed in ¶ [0060] of Wiesner et al. and for the instant constructs (e.g., ¶ [0057] of the PGPub of the instant application) also these are not required by the claims and the Examiner was unable to locate any experimental results as to the post-stomach delivery generally or more specifically, the retention of at least a portion of the targeting, diagnostic or therapeutic activities of the particles, in the disclosure as originally filed.
This is a provisional nonstatutory double patenting rejection.
Claims 1 - 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 6, 8, 10 – 14, 16, 20, 22, 24, 32, 34, 42 and 44 of copending Application No. 18/616,147 in view of Wiesner et al. (US 2015/0366995). The claims of US’147 recite silica nanorings functionalized with PEG (claim 1) that can have an outer diameter of 5 – 20 nm (claim 2). Display groups such as dye groups or drugs can also be present on the outer and/or inner surface of the nanoring (claim 4). In claims 42 and 44, the silica nanorings are administered to a subject for either imaging (claim 42) or to treat cancer (claim 44).
Oral administration of such nanoparticles is not claimed.
Wiesner et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to orally administer the fluorescent silica nanoparticles of US’147 to a subject as taught by Wiesner et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because highly similar particles are disclosed by Wiesner et al. and to be used, they must be administered to a subject and oral administration is one suitable route. The size range for the particle at least overlap and such ranges result in the instant claims not being patentably distinguished over the prior art absent evidence of criticality (see MPEP 2144.05).
The in vivo behavior, diffusion coefficients and that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual are not explicitly disclosed by the prior art. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The behavior of the particles will be determined by the nature of the particles administered and the administration route. Here the prior art discloses oral administration of silica particles with sizes falling within the scope of the claims that are at least partially functionalized with PEG as required by the instant claims. Properties such as the diffusions coefficient in various material and the in vivo fate of such particles, such as that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual, are determined by the particles themselves and the administration route. There is no evidence of record that these limitations are not met as they are determined by the particles and nanoparticles as claimed are rendered obvious by Wiesner et al. It is also noted that the same attachment chemistries are disclosed in ¶ [0060] of Wiesner et al. and for the instant constructs (e.g., ¶ [0057] of the PGPub of the instant application) also these are not required by the claims and the Examiner was unable to locate any experimental results as to the post-stomach delivery generally or more specifically, the retention of at least a portion of the targeting, diagnostic or therapeutic activities of the particles, in the disclosure as originally filed.
This is a provisional nonstatutory double patenting rejection.
Claims 1 - 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 18 of copending Application No. 18/908,740 in view of Wiesner et al. (US 2015/0366995). The claims of US’740 include a method that results in the production of silica nanoparticles functionalized with surface PEG groups that results in nanoparticles 2 – 15 nm in average size (claim 1). Dye precursors can also be included that result in dye, a diagnostic agent, being present in the resultant particles (claim 3). Claim 18 is drawn to a method of imaging using dye containing silica nanoparticles that are administered to an individual.
Oral administration of such nanoparticles is not claimed.
Wiesner et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to orally administer the fluorescent silica nanoparticles of US’740 to a subject as taught by Wiesner et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because highly similar particles are disclosed by Wiesner et al. and to be used, they must be administered to a subject and oral administration is one suitable route. The size range for the particle at least overlap and such ranges result in the instant claims not being patentably distinguished over the prior art absent evidence of criticality (see MPEP 2144.05).
The in vivo behavior, diffusion coefficients and that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual are not explicitly disclosed by the prior art. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The behavior of the particles will be determined by the nature of the particles administered and the administration route. Here the prior art discloses oral administration of silica particles with sizes falling within the scope of the claims that are at least partially functionalized with PEG as required by the instant claims. Properties such as the diffusions coefficient in various material and the in vivo fate of such particles, such as that at least a portion of the silica nanoparticles are delivered to a post-stomach portion of the gastrointestinal tract of the individual, are determined by the particles themselves and the administration route. There is no evidence of record that these limitations are not met as they are determined by the particles and nanoparticles as claimed are rendered obvious by Wiesner et al. It is also noted that the same attachment chemistries are disclosed in ¶ [0060] of Wiesner et al. and for the instant constructs (e.g., ¶ [0057] of the PGPub of the instant application) also these are not required by the claims and the Examiner was unable to locate any experimental results as to the post-stomach delivery generally or more specifically, the retention of at least a portion of the targeting, diagnostic or therapeutic activities of the particles, in the disclosure as originally filed.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Nissa M Westerberg/Primary Examiner, Art Unit 1618
Prosecution Insights