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 .
Claim Status
Claims 1-3, 7-9, 11-12, 17-23, 26-35, 37, 40-42, and 45-46 are pending.
Priority
Receipt is acknowledged of certified copies of paper required by 37 CFR 1.55.
Election/Restriction
Applicant’s election without traverse of Group I (claims 1-3, 7-9, and 11-12) in the reply filed 8/3/2026 is acknowledged. Applicant’s species election without traverse of i) gold (metallic core), ii) ATP and ATPαS (nucleotide and analog), iii) human immunodeficiency virus (HIV)-Tat (specific internalization sequence, protein transduction domain, or cell penetrating peptide), iv) Pseudomonas aeruginosa infection (bacterial infection), v) ear infection (infection type), and vi) medical device (article of treatment) in the reply filed 8/3/2026 is acknowledged.
In a conversation with Brian E Davy, Ph.D. on 8/17/2026, the election for the nucleotide or analog was further clarified to be ATP in particular.
Claims 17-23, 26-35, 37, 40-42, and 45-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim 3 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1-2, 7-9, and 11-12 remain under consideration to the extent that the metallic core is gold, the nucleotide is ATP, the cell penetrating peptide is HIV-Tat, the bacterial infection is Pseudomonas aeruginosa, the infection type is ear infection, and the article of treatment is a medical device.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 8-9, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Hainfeld et al. (Gold-ATP, Journal of Structural Biology 127, 120-134 (1999)).
Claims 1-2, 8-9, and 12 recite a nanocluster comprising a metallic core conjugated to a nucleotide, wherein the core has a diameter of less than 10 nm. Further, the instant claims recite adenosine triphosphate (ATP) as the nucleotide, wherein the metallic core comprises a noble metal of gold. The instant claims also recite a composition comprising these gold-ATP nanoclusters and a pharmaceutically acceptable excipient, pharmaceutically acceptable carrier, an antibiotic, or combination thereof.
Hainfeld teaches the synthesis, purification, and chemical analysis of two covalent conjugates between ATP and undecagold, wherein the ATP is covalently bonded to the gold nanocluster via the ribose moiety of ATP or via the N-6 position of the adenine base (abstract) (cf. claim 2, claim 9). Undecagold is a gold cluster with a 0.8-nm diameter core of gold metal (p. 120 col. 2) (cf. claim 1).Gold is a noble metal (cf. claim 8). Hainfeld teaches the method of making these gold nanoclusters covalently bound to ATP (see Materials and Methods), as well as methods of analyzing these nanocluster particles. One such method of preparation of ATP-attached undecagold discloses a reaction mixture to form the covalently-bound gold-ATP nanocluster, wherein the reaction mixture is diluted and mixed with a 0.1 M sodium phosphate buffer at pH 7.4 (p. 124 col. 1) (cf. claim 12). One such method of analysis described is scanning transmission electron microscopy (STEM). Hainfeld teaches the use of STEM to characterize the gold-ATP conjugates, and discloses that the conjugates do, in fact, maintain the nanocluster diameter of 0.8-nm (p. 132 col. 2).
The instant claims are anticipated by the teachings of Hainfeld, as Hainfeld teaches a gold-ATP nanocluster, wherein the gold core and ATP small molecule are covalently bonded, wherein the gold core has a diameter of 0.8-nm, wherein it may be present in a composition along with a 0.1 M sodium phosphate buffer (i.e. a pharmaceutically acceptable excipient, as evidenced by Rao; see article).
Therefore, claims 1-2, 8-9, and 12 are anticipated by Hainfeld.
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 1-2, 7-9, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hainfeld et al. (Gold-ATP, Journal of Structural Biology 127, 120-134 (1999)).
As noted in the anticipation rejection above Hainfeld anticipates claims 1-2, 8-9, and 12, and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over Hainfeld for the reasons set forth above ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
The instant specification defines that “about 1 nm to about 10 nm” includes any diameter within this range such as the diameters of 0.5 nm, 0.75 nm, 1 nm, etc. (instant specification par. [0008], [0043]).
The teachings of Hainfeld have been described supra.
Hainfeld does not teach the nanocluster wherein the diameter “ranges from about 1 nm to about 2 nm as measured using transmission electron microscopy” with sufficient specificity for anticipation, however, as the instant claims recite “about” as a limitation, the diameter of 0.8 nm as taught by Hainfeld is considered to be “about 1 nm,” rendering obvious instant claim 7.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the reference.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hainfeld et al. (Gold-ATP, Journal of Structural Biology 127, 120-134 (1999)) as applied to claims 1-2, 7-9, and 11-12 above, and further in view of Berry (Intracellular delivery of nanoparticles via the HIV-1 tat peptide, Nanomedicine 3(3), 357-365 (2008)).
Hainfeld has been described supra.
However, Hainfeld does not teach linking the nanocluster to the cell penetrating peptide (CPP) HIV-Tat.
This deficiency is made up for by the teachings of Berry.
Berry teaches the functionalization of nanoparticles by attaching the CPP tat peptide to the nanoparticles or nanoclusters (abstract). Berry teaches that these nanoparticles may be gold, and that smaller gold particles functionalized with tat demonstrate nuclear localization, indicating that covalently functionalizing this gold material with tat successfully results in transport of the particles to the nucleus (p. 360 col. 2). Berry also teaches that using this peptide with smaller diameter gold nanoparticles (about 3 nm) is more successful when evaluating localization that larger diameter particles (p. 361 col. 1).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify the teachings of Hainfeld with the teachings of Berry, wherein the resulting nanocluster comprises a metallic core of gold, wherein the diameter of these nanoclusters is about 0.8 nm, wherein it is conjugated to ATP wherein the nanocluster is covalently bound to the HIV-1 tat CPP. One would be motivated to do so, and have a reasonable expectation of success, as it has been shown that the method of nuclear localization via this CPP is successful in transporting the gold nanocluster to the nucleus, as evidenced by Berry. The covalent linking of the CPP to the nanocluster as taught by Hainfeld would result in the nanocluster as claimed in instant claim 11. Therefore, claim 11 is rejected.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
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, 7-9, and 11-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-32 and 34-35 of copending Application No. 19/101,503 (reference application) (hereafter App. No. ‘503 in view of Berry (Intracellular delivery of nanoparticles via the HIV-1 tat peptide, Nanomedicine 3(3), 357-365 (2008)).
Instant claims 1-2, 7-9, and 11-12 recite a nanocluster comprising a metallic core conjugated to a nucleotide, wherein the metallic core has a diameter of less than 10 nm, wherein the nucleotide is ATP, wherein the diameter of the nanocluster ranges from about 1 nm to about 2 nm (i.e. less than 10 nm), wherein the metallic core comprises a noble metal, wherein the noble metal is gold, wherein the nanocluster is covalently linked to the HIV-1 tat cell penetrating peptide, wherein the composition may further comprise a pharmaceutically acceptable excipient, carrier, antibiotic, or combination thereof.
Claims 31-32 and 34-35 of App. No. ‘503 a composition comprising a metallic nanocluster having a size of less than 10 nm, wherein the nanocluster is conjugated to ATP or an analogue thereof, wherein the composition further comprises a pharmaceutically acceptable excipient or carrier, wherein the metallic nanocluster comprises a noble metal, wherein the noble metal is gold.
Claims 31-32 and 34-35 of App. No. ‘503 do not recite the linking of the nanocluster to a cell penetrating peptide of HIV-1 tat peptide.
This deficiency is made up for in the teachings of Berry.
Berry has been described supra.
Instant claims 1-2, 7-9, and 11-12 are an obvious variant of claims 31-32 and 34-35 of the ‘663 application because it would have been prima facie obvious to one of ordinary skill in the art to include the CPP of HIV-1 tat as described by Berry covalently bound to a nanocluster as claimed by App. No. ‘503. The inclusion of the tat peptide would be motivated, and expected to be successful, by the teachings of Berry, wherein the gold nanoclusters are successfully localized to the nucleus. The instant claims are patentably indistinct from the claims as outlined in App. No. ‘503 as the claims recite a metallic nanocluster having a size of less than 10 nm, wherein the nanocluster is conjugated to ATP, wherein the metal is a noble metal, wherein the noble metal is gold, wherein a pharmaceutically acceptable excipient or carrier may be present. The claims of App. No. ‘503 are indistinct from the instant claims, as the instant claims recite a nanocluster comprising a metallic core conjugated to a nucleotide, wherein the core has a diameter of less than 10 nm, wherein the nucleotide is ATP, wherein the diameter is about 1 nm to about 2 nm (i.e. less than 10 nm), wherein the core comprises a noble metal, wherein the core is gold, wherein the nanocluster is linked to the HIV-1 tat CPP, wherein it may be present with a pharmaceutically acceptable excipient, carrier, antibiotic, or combination thereof. The inclusion of the CPP as taught by Berry to the nanocluster as claimed by App. No. ‘503 would result in the instantly claimed composition. Therefore, the instant claims are indistinct from the claims of ‘663.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW RYAN BURKE whose telephone number is (571)272-8949. The examiner can normally be reached Mon-Fri. 8am-5pm.
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/MATTHEW RYAN BURKE/Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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