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 of Group I and species of polydopamine in the reply filed on July 28, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Drawings
The drawings are objected to because they contain features that are not described in the specification. Specifically, Figures 3D-H, 5A, and 14A-F appear on the drawing sheets but there is no corresponding explanation within the specification. It also appears that the Figures 5A-C are described as Figures 5B-D in the specification. Every feature shown in the drawings must be explicitly described in the specification.
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.
Specification
The disclosure is objected to because the specification fails to provide a description corresponding to all figures presented in the drawings. Specifically, while the drawings include sub-figures 3D-H, 5A, and 14A-F, the specification omits any description for these figures. The description referring to Figure 14 lacks sufficient detail regarding Figures 14A-F. It also appears that the Figures 5A-C in the drawings are described as Figures 5B-D in the specification. The specification must be amended to include a full corresponding description for all figures in the specification.
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 1-5 and 13 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.
Regarding claim 1, the phrase "a hydrodynamic diameter comprised between 200 and 2000 nm” renders the claim indefinite. The open-ended term “comprised” is improper and ambiguous when used to define a numerical range. The specification defines that the expression “comprised between … and … ” should be understood to include the boundaries of the recited range (PGPub of the instant application, ¶ 18). However, it is unclear whether the boundaries are limited to the recited range or whether values outside the range are also encompassed by the claim. Accordingly, it creates uncertainty as to the metes and bounds of the claimed hydrodynamic diameter range. It is suggested that claim 1 be amended to delete “comprised” to obviate this rejection.
Similarly, regarding claim 4, the phrase "the iron concentration is comprised between 50% and 95%” renders the claim indefinite. The open-ended term “comprised” is improper and ambiguous when used to define a numerical range. The specification defines that the expression “comprised between … and … ” should be understood to include the boundaries of the recited range (PGPub of the instant application, ¶ 18). However, it is unclear whether the boundaries are limited to the recited range or whether values outside the range are also encompassed by the claim. Accordingly, it creates uncertainty as to the metes and bounds of the claimed iron concentration range. It is suggested that claim 4 be amended to delete “comprised” to obviate this rejection.
The dependent claims fall therewith.
Clarification and/or amendment is required.
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 1-5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (Nanomaterials, 2019; cited on PTO-892) in view of Oh et al. (Progress in polymer Science, 2011; cited on PTO-892).
Regarding claims 1 and 3, Singh discloses polydopamine (PDA) coated iron oxide nanoparticles (IONPs) (page 3, Scheme 1). Singh discloses that the hydrodynamic diameter of the PDA-IONPs can be about 200 nm, and that the diameter of IONPs can be about 8 nm (ultrasmall particles) (page 7, Figure 1). The instant specification defines that the term “ultrasmall particle” refers to a material having a particle size of less than 50 nm, in particular ranging from 1 to 50 nm, more particularly from 1 to 30 nm (PGPub of the instant application, ¶ 24). Regarding claim 2, Singh discloses that the IONPs can be Fe3O4 (page 4, ¶ 9). Regarding claim 4, Singh discloses that the weight % of PDA-IONPs remaining after heating (thermogravimetric analysis) can be 78% (page 14, Figure 8), indicating that the wt% of IONPs (Fe3O4) can be 78%. Thus, the wt% of iron can be about 56% (78 X 0.7236). Regarding claim 5, Singh discloses that the PDA-IONPs can be dispersed in water or PBS (phosphate buffered saline) (page 5, ¶¶ 2-3), which reads on a suspension of particles. Regarding claim 13, Singh discloses a composition comprising an aqueous dispersion of PDA-IONPs and an anticancer drug (page 5, ¶ 6).
Singh does not disclose that the iron oxide particles are embedded within a polymer matrix.
Oh discloses the biological applications of polymeric nanomaterials embedded with IONPs (abstract). Oh discloses that IONPs can be embedded within a polymer matrix in order to prevent aggregation and improve solubility, stability, and biocompatibility (page 169; ¶¶ 2-3).
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 particles of Singh by embedding the IONPs within a polymer matrix such as PDA in order to improve particle solubility, stability, and biocompatibility. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Oh teaches that the IONPs can be embedded within a polymer matrix for improved biological applications. Further, a person of ordinary skill in the art would have been motivated to utilize an embedded and coated nanoparticle system (a multi-layered system) in order to protect active nanoparticle cores such as IONPs, prevent clumping, and substantially improve overall safety, efficacy, and durability.
Claims 1-3, 5, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Masri et al. (WO 2016 007629) in view of Oh et al. (Progress in polymer Science, 2011; cited on PTO-892)
Regarding claims 1 and 3, Masri discloses a composition comprising biocompatible magnetic, magnetizable, or magnetically responsive agents (abstract). Masri discloses that the agent can be a nanoparticle having a 20 nm (ultrasmall particle) iron oxide core (page 24, ¶ 4) and a biocompatible polymer coating comprising PDA (page 31 ¶ 3-page 32, ¶ 1). The instant specification defines that the term “ultrasmall particle” refers to a material having a particle size of less than 50 nm, in particular ranging from 1 to 50 nm, more particularly from 1 to 30 nm (PGPub of the instant application, ¶ 24). Masri discloses that the size of the agent including core and coating can vary such as from about 250 nm to about 500 nm (page 23, ¶ 2), and FIG. 2 shows the utilization of nanoparticles having a 300 nm hydrodynamic diameter (page 6, ¶ 5). Regarding claim 2, Masri discloses that the core material can be Fe3O4 (page 22, ¶ 3). Regarding claim 5, Masri discloses that a particle suspension can be created by suspending nanoparticles in a sodium carbonate buffer (page 32, ¶ 3). Regarding claim 13, Masri discloses that a composition comprising the particle suspension, pharmaceutically acceptable carriers, and a therapeutic agent can be used for treating a condition affecting a tooth or periodontium in a subject (claims 1 and 3; page 30, ¶ 4; page 32, ¶ 3; page 35, ¶ 1).
Masri does not disclose that the iron oxide is embedded within the polymer matrix.
As discussed above, Oh discloses the biological applications of polymeric nanomaterials embedded with IONPs (abstract). Oh discloses that IONPs can be embedded within a polymer matrix in order to prevent aggregation and improve solubility, stability, and biocompatibility (page 169; ¶¶ 2-3).
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 particles of Masri by embedding the IONPs within a polymer matrix such as PDA in order to improve particle solubility, stability, and biocompatibility. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Oh teaches that the IONPs can be embedded within a polymer matrix for improved biological applications. Further, a person of ordinary skill in the art would have been motivated to utilize an embedded and coated nanoparticle system (a multi-layered system) in order to protect active nanoparticle cores such as IONPs, prevent clumping, and substantially improve overall safety, efficacy, and durability.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Masri and Oh as applied to claims 1-3, 5, and 13 above, and further in view of Singh et al. (Nanomaterials, 2019; cited on PTO-892).
In addition to the teachings of Masri discussed above, Masri discloses that the fill fraction of iron can be 20-30% or the ratio of iron mass to particle mass can be about 2:5 (page 36, ¶ 1), indicating that the iron concentration can be about 40 wt% with respect to the total weight of the particle.
Oh is discussed above.
Neither Masri nor Oh discloses that the iron concentration is between 50% and 95% in weight with respect to the total weight of the particle.
As discussed above, Singh discloses that the weight % of PDA-IONPs remaining after heating (thermogravimetric analysis) can be 78% (page 14, Figure 8), indicating that the wt% of IONPs (Fe3O4) can be 78%. Thus, the wt% of iron can be about 56% (78 X 0.7236).
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 particles of Masri and Oh by increasing the iron weight concentration to about 56 wt % in order to improve magnetic response and imaging contrast. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Singh teaches that the iron weight concentration can be about 56% in the nanoparticle. Further, a person of ordinary skill in the art would have been motivated to optimize the concentration of iron according to the specific requirements of the target applications. The concentration of iron is a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters 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 concentration of iron and optimal core-shell ratio to achieve desired characteristics as imaging agents.
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 1-5 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17, 19, and 27 of copending Application No. 18/291,666 in view of Singh et al. (Nanomaterials, 2019; cited on PTO-892).
Regarding claim 1, claim 15 of the ‘666 recites a particle having a hydrodynamic diameter between 200 nm and 2000 nm, and that the particle comprising nanoparticles of iron oxide embedded within a matrix of polycathecolamine or polyserotonine. Claims of the ‘666 do not recite that ultrasmall particles of iron oxide having a diameter between 1 and 50 nm. As discussed above, Singh discloses PDA coated IONPs (page 3, Scheme 1). Singh discloses that the diameter of IONPs can be about 8 nm (ultrasmall particles) (page 7, Figure 1). The instant specification defines that the term “ultrasmall particle” refers to a material having a particle size of less than 50 nm, in particular ranging from 1 to 50 nm, more particularly from 1 to 30 nm (PGPub of the instant application, ¶ 24). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the IONPs having a diameter of about 8 nm as IONPs of the ‘666. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Singh teaches that IONPs can have a diameter about 8 nm. Further, a person of ordinary skill in the art would have been motivated to optimize the diameter of IONPs according to the specific requirements of the target applications. The diameter of IONPs is a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters 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 IONPs to achieve desired characteristics as imaging agents.
Regarding claim 2, claim 16 of the ‘666 recites that the iron oxide can be Fe304.
Regarding claim 3, claim 17 of the ‘666 recites that the polycathecolamine can be PDA.
Regarding claim 4, claims of the ‘666 do not recite that the iron concentration is comprised between 50% and 95% in weight with respect to the total weight of the particle. As discussed above, Singh discloses PDA coated IONPs (page 3, Scheme 1). Singh discloses that the weight % of PDA-IONPs remaining after heating (thermogravimetric analysis) can be 78% (page 14, Figure 8), indicating that the wt% of IONPs (Fe3O4) can be 78%. Thus, the wt% of iron can be about 56% (78 X 0.7236). 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 particles of the ‘666 by having the iron weight concentration to about 56 wt % in order to improve magnetic response and imaging contrast. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Singh teaches that the iron weight concentration can be about 56% in the nanoparticle. Further, a person of ordinary skill in the art would have been motivated to optimize the concentration of iron according to the specific requirements of the target applications. The concentration of iron is a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters 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 concentration of iron and optimal core-shell ratio to achieve desired characteristics as imaging agents.
Regarding claim 5, claim 19 of the ‘666 recites a suspension comprising a plurality of particles.
Regarding claim 13, claim 27 of the ‘666 recites a composition comprising a suspension comprising the particles.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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 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.
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.
/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
Prosecution Insights