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 in the reply filed on 7/14/2025 is acknowledged.
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 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 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160243254 to Artzi (IDS filed 12/10/2021). Artzi discloses theranostic nanoprobes comprising gold nanoparticles functionalized with a monolayer of thio-PEG-OH, corresponding to applicant’s formula (1) (a nanoparticle comprising a metal surface pre-functionalized using a self-assembled protective monolayer formed by a matrix of molecules); HS-C2H4-CONH-PEG-O-C3H6-COOH (3500 Da), corresponding to applicant’s formula (7) SHCH2CH2(CH2CH2O)qOqO--F, where F is C3H6-COOH and q is 41; and a thiol-DNA-hairpin (a biomolecule comprising a thiol function), corresponding to the thiolated molecule of instant claim 3 (abstract; paragraphs 9-13; 44-71, and 112). The PEG spacer imparts stability to the theranostic nanoprobes, ensures facile functionalization of the gold nanoparticle with the DNA-hairpins, anchors, including DNA-oligonucleotides, and ensures a desirable distribution of DNA-hairpins on the surfaces of the gold nanoparticles (paragraph 446) The gold nanoparticles are functionalized with an amount of spacer molecules sufficient to cover from about 5% to about 50% of the surface area of the gold nanoparticles (paragraph 65). In another embodiment, the gold nanoparticles are functionalized with an amount of spacer molecules sufficient to cover from about 10% to about 50% of the surface area of the gold nanoparticles (a covareage rate of between 1.5% and 99%; a coverage rate of at least 1%; a coverage rate which is at least 10%). In a further embodiment, the gold nanoparticles are functionalized with an amount of spacer molecules sufficient to cover from about 20% to about 40% of the surface area of the gold nanoparticles (a coverage rate of between 1.5% and 99%; a coverage rate of at least 1%; a coverage rate which is at least 10%). (paragraph 64). In a particular embodiment, the gold nanoparticles are functionalized with an amount of spacer molecules sufficient to cover about 30% of the surface area of the gold nanoparticles (a coverage rate of between 1.5% and 99%; a coverage rate of at least 1%; a coverage rate which is at least 10%). (paragraph 64). The gold nanoparticles of the theranostic nanoprobes provided herein may be selected from those that are commercially available, or made by techniques known in the art, such as the citrate reduction method (paragraph 44). It is well-known, for example, that a thiol functional group can undergo an exchange with a citrate group on the surface of a gold nanoparticle (paragraph 44). The gold nanoparticles, in some embodiments, include citrate groups on their surfaces, and these citrate groups may be contacted with a thiol-DNA-hairpin to bond a thio-DNA-hairpin to the surface of a gold nanoparticle. In one embodiment, DNA-hairpin includes a thio-DNA hairpin (paragraph 53). The spacer (linker), in embodiments, comprises polyethylene glycol (PEG) and a functional group capable of covalently bonding the linker to a gold nanoparticle. Such a spacer is referred to herein as a "PEG spacer." (paragraph 64). A PEG linker may include a thiol group that reacts with a citrate group on the surface of a gold nanoparticle in order to bond a thio-PEG spacer to the surface of the gold nanoparticle (paragraph 64). A variety of functional group anchors are envisioned, which correspond to applicant’s F (paragraphs 66-70). The anchor may be a thiol-DNA-oligonucleotide (a biomolecule comprising a thiol function).
Artzi fails to teach instant n is equal to or greater than 3 and equal to or less than 11, and further fails to teach that instant m is equal to or greater than 1 and equal to or less than 12.
It would have been obvious to one of ordinary skill in the art at the time the instant invention was filed to optimize the number of PEG units in the linker of Artzi to improve the nanoparticle for theranostic nanoproble applications in cancer multidrug resistance. In this way, one would find n is i is equal to or greater than 3 and equal to or less than 11, and further fails to teach that instant m is equal to or greater than 1 and equal to or less than 12 through routine experimentation. “‘[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.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” MPEP § 2144.05, II. A prima facie case of obviousness is proper when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In rePayne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In rePapesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963). MPEP 2144.09, I. As in the present invention, Artzi discloses theranostic nanoprobes comprising gold nanoparticles functionalized with a monolayer of thio-PEG-OH, corresponding to applicant’s formula (1) (a nanoparticle comprising a metal surface pre-functionalized using a self-assembled protective monolayer formed by a matrix of molecules); HS-C2H4-CONH-PEG-O-C3H6-COOH (3500 Da), corresponding to applicant’s formula (7) SHCH2CH2(CH2CH2O)qOqO--F, where F is C3H6-COOH and q is 41; and a thiol-DNA-hairpin (a biomolecule comprising a thiol function), corresponding to the thiolated molecule of instant claim 3 (abstract; paragraphs 9-13; 44-71, and 112). The PEG spacer imparts stability to the theranostic nanoprobes, ensures facile functionalization of the gold nanoparticle with the DNA-hairpins, anchors, including DNA-oligonucleotides, and ensures a desirable distribution of DNA-hairpins on the surfaces of the gold nanoparticles (paragraph 446). It would have been obvious to optimize the number of PEG units in the linker of Artzi to improve the nanoparticle for theranostic nanoprobe applications in cancer multidrug resistance. In this way, one would find n is equal to or greater than 3 and equal to or less than 11, and further fails to teach that instant m is equal to or greater than 1 and equal to or less than 12 through routine experimentation. Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In reWilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In reMay, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.). MPEP 2144.09, II.
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 11-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11925692. Although the claims at issue are not identical, they are not patentably distinct from each other because patent claim 1 is directed to a nanoparticle comprising a metal surface pre-functionalized with a self-assembled protective monolayer formed by a matrix of molecules M of formula (1): HS(CH2)n (OCH2CH2)m OH, in which: n represents the number of CH2, where 3≤n≤11; and m represents the number of ethylene glycol, where 1≤m≤12; the molecules bearing a thiol function at one end thereof, the other end thereof being inert; wherein a coverage rate of the monolayer is between 1.5% and 99%, and the nanoparticle is further functionalized with at least one L-PEG molecule of formula (7): SH—CH2CH2(CH2CH2O)qO—F, in which: q represents the number of ethylene glycol, where 20≤q≤500; and F represents a functional group selected from among CH3, OH, COOH or NH2, a coverage rate of the L-PEG molecule being at least 1%, and patent claim 2 is directed to wherein the nanoparticle is further functionalized with at least one thiolated molecule, the thiolated molecule being either: a PEG-F linker molecule of formula (8): HS(CH2)r (OCH2CH2)p O—F, in which: r represents the number of CH2 and is a whole number greater than or equal to 3; p represents the number of ethylene glycol, where 2≤p≤12; and F represents a functional group selected from among CH3, COOH or NH2, the linker molecule bearing a thiol function at one end thereof and bearing an active or reactive group that is capable of interacting with a biomolecule at the other end thereof; or a biomolecule comprising a thiol function, and further patent claim 3 is directed to wherein the thiolated molecule is a the PEG-F linker molecule, and wherein F is COOH, and a coverage rate of which is at least 1%, and further patent claim 4 is directed to wherein the nanoparticle is further functionalized with at least one biomolecule bound to the linker molecule, and further claim 5 is directed to wherein the thiolated biomolecule is a thiolated DNA, a coverage rate of which is at least 10%, which anticipates present claims 11-21.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
October 16, 2025