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 .
Status of the claims
The response filed 06/26/26 is acknowledged and has been entered. Currently, claims 1-6 are pending and under examination.
NOTE: The Examiner has now rejected claims 1-6 under 35 U.S.C. and 35 U.S.C. 103 (see rejections below) and therefore the following rejection has been made non-final. The Examiner apologizes for any inconvenience.
Claim Rejections - 35 USC § 102/103
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.
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 1-6 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wong et al., (Nano Lett. 2017, 17, 1685-1695).
Wong et al. discloses “a monolayer of RGD-grafted magnetic nanoparticles (Fe3O4, MNPs coated with silica) via a poly(ethylene glycol) linker (PEG, average molecular weight: 2000)” (e.g. Page 1686, col. 1). The RGD peptides are grafted onto MNPs via thiol-ene reaction:
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(e.g. Page 1686, col. 2). Wong et al. does not expressly teach that the integrin-specific ligand is negatively charged. However, because thiolate groups are known to be negatively-charged, the thiolation of the RGD peptide would teach or suggest that it is negatively-charged (current claim 5). It is axiomatic that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (“Products of identical chemical composition cannot have mutually exclusive properties.”). Wong et al. teaches “MNPs of ∼20 nm in diameter and amino-functionalized silica coated MNPs (MNP@SiO2) and amino-functionalized silica nanoparticles (SiO2) NPs 40 nm in diameter.” (e.g. Page 1686).
That said, where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. Further, “the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product.”
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being obvious over the Kang et al article (ACS Nano, Vol. 11, pages 9636-9649) (submitted in the IDS filed 06/21/13) in view of the Cao et al article (ACS Applied Materials & Interfaces, Vol. 7, pages 6698-6705) (submitted in the IDS filed 06/21/23).
Kang et al discloses nanoligands comprising silica-coated iron oxide nanoparticles conjugated to RGD ligand through a poly(ethylene glycol) linker. The size of nanoligands is 40 ± 4 nm, and the size of the iron oxide nanoparticles is 15 ± 3 nm. The nanoligands can be further coupled to a substrate which has been immersed in an HCl solution and then thiolized. Kang et al uses the nanoligands to regulate the adhesion and differentiation of human mesenchymal stem cells (hMSCs). The substrate comprising the coupled RGD peptide can be used, either in vitro or in vivo, to control adhesion and differentiation of hMSCs, under the influence of an oscillating magnetic field for 4, 12, or 48 hours ( e.g., the Abstract; Scheme 1; page 9638, column 2, lines 6-8; page 9647, column 2, third full paragraph; page 9647, column 1, third paragraph, and column 2, third full paragraph).
Kang et al differs from the instant invention in failing to teach the RGD ligand is negatively charged.
Cao et al teaches that negatively charged RGD peptides, i.e. c(RGD-D) and c(RGD-G), enhance osteogenic differentiation of mesenchymal stem cells. The negatively charged RGD peptides comprise a Cys residue for tethering the peptides to a substrate (e.g., the Abstract; Scheme 1(A); Figure 1(A); page 9646, column 2, first full paragraph).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to substitute the negatively charged RGD peptides, i.e. c(RGD-D) and c(RGD-G), taught by the Cao et al for the RGD ligand of Kang et al because the substitution of one known RGD ligand for another is routine and conventional in the RGD peptide arts; because the negatively charged RGD peptides taught by the Cao et al can be tethered to a substrate just like the RGD ligand taught by Kang et al and because Cao et al teaches that its negatively charged RGD peptides are effective for the same purpose that Kang et al uses its RGD ligand, i.e. to enhance differentiation of mesenchymal stem cells.
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 1-2, 5-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11828719. Although the claims at issue are not identical, they are not patentably distinct from each other because the 719’ patent, albeit directs to a method, nevertheless still uses essentially same nano-ligand comprising a core including magnetic nano-particle, a coating layer provided to surround the core and including an integrin-binding ligand peptide (RGD), a linker provided between the core and the coating layer, and the integrin-binding ligand is negatively charged. As to the method of making the nano-ligand in claim 6, it would have been prima facie obvious to one ordinary skilled person to couple the magnetic nanoparticle core having a linker thereon with the RGD ligand peptide to form the features of the current nano-ligand product.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11828719 in view of Santamaria (US 20150125536). As to the specific linker PEG in current claim 3, although 719’ patent does not explicitly specify the linker, it would have been prima facie obvious to one ordinary skilled person in the art to use the PEG linker taught by Santamaria where Santamaria teaches a variety of PEG linkers to the core of a nanoparticle (see Table 1 and 2; page 24 to 26). Therefore it would have been prima facie to one ordinary skilled person in the field to choose one of the PEG linker from Table 1 or 2 as taught by Santamaria for linking core and coating layer of a nanoparticle with reasonable expectation of success because PEG linkers have been shown to be suitable for linking the core of a nanoparticle.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11828719 in view of Hirari (US 20080156736).
As to claim 4, 719’ patent does not specify the size of the magnetic nanoparticle. Hirari teaches having a smaller size of magnetic nanoparticle, i.e. <50 nm, would enable the nanoparticle penetrate into interior of cells to trap the target molecule (section 0021). The current nano-ligand is for study of cell adhesion and differentiation of stem cells. Therefore it would have been prima facie obvious to one ordinary skilled person to use 50nm or smaller magnetic nanoparticles as taught by Hirari for suitable cell penetration to study stem cell adhesion and differentiation.
Response to Arguments
Applicant's arguments filed 06/26/26 have been fully considered but they are not persuasive.
Double Patenting Rejections:
Applicant argues that a terminal disclaimer with respect to U.S. Patent No. 11,828,719 was submitted and therefore the rejection should be withdrawn
This argument is not found persuasive because the terminal disclaimer submitted 06/26/26 has been disapproved because the person who signed the terminal disclaimer does not have power of attorney, and thus, is not of record. See the terminal disclaimer review filed 07/06/26.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678
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