Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
DETAILED ACTION
Claims 1-11 are pending in this application. This application is a continuation of 15/267,656, filed on 09/16/2016, now U.S. Patent 11/826,087, which is a continuation of 14/471,319, filed on 08/28/2014, now U.S. Patent 9/44,6126, which is a continuation of 14/020,423, filed on 09/06/2013, now U.S. Patent 8,834,933, which is a continuation of 13/219,514, filed 08/26/2011, now U.S. Patent 9,061,056, which claims priority from provisional application 61/516/308, filed on 04/01/2011, from provisional application 61/422,612, filed on 12/13/2010, and from provisional application 61/402,305, filed on 08/27/2010.
Claim Rejections - 35 USC 112/Second paragraph
The following is a quotation of the second paragraph 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.
Claim 1 is rejected under 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 applicant regards as the invention.
Claim 1 recites the limitation “the first solvent” in line 4. There is insufficient antecedent basis for this limitation in the claim.
To expedite the prosecution "the first solvent " is given its broadest reasonable interpretations by the examiner in light of the specification paragraph 142 in the 102 and 103 rejections as being in the first mixture.
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
Claims 1-7 and 10 are rejected under 35 U.S.C. 102(e) as being anticipated by Chen et al. (US 2010/0278923 A1, filed on 09/15/2008).
Chen et al. meet all of the limitations of claims 1-4 and 10. Chen et al. disclose photothermal metal (the claimed thermoablative plasmonic in the instant claim 1) functional nanoparticle-based antibiotics (abstract and claims 7-9) and a pharmaceutical composition comprising the antibiotics and a pharmaceutically acceptable carrier (the claimed combining with a pharmaceutically acceptable carrier to form a nanoparticle composition in the instant claim 1) (claims 14 and 15) and
exemplified in embodiment 2 in paragraph 45:
vancomycin-modified gold nanoparticle solution (Au@van) being separated by the centrifuge, rinsed with deionized (DI) water, and then the solution (Au@van in DI water, the claimed 1st solvent in the instant claims 1 and 2) being isolated by the centrifuge (the instant claim 3) followed by resuspended in DI water (the claimed 2nd solvent in the instant claims 1 and 4, the claimed exchange the 1st solvent with the 2nd solvent in the instant claim 1, and the claimed aqueous solution in the instant claim 10) to complete the preparation of vancomycin-modified gold nanoparticles.
The instant claims 5-7 are further limitations of alternative components.
Claims 1-10 are rejected under 35 U.S.C. 102(b) as being anticipated by Zhu (WO 2007/048326 A1, US 2011/0177153 A1 as English translation).
Zhu meets all of the limitations of claims 1-4 and 8-10. Zhu discloses targeted magnetic nanoparticle drug for targeted magnetic thermoablation treatment (the claimed thermoablative plasmonic in the instant claim 1) (abstract); and
exemplified in example 3: Fe magnetic nanoparticles being added to a sodium dodecyl sulfate (the instant claim 9) aqueous solution (the claimed 1st solvent in the instant claims 1 and 2) at weight ratio of 1:0.01 between the magnetic nanoparticle and sodium dodecyl sulfate, followed by centrifugal separation (the instant claim 3), the supernatant being discarded, the resultant precipitate being washed fully with DI water (the claimed 2nd solvent in the instant claims 1 and 4, the claimed exchange the 1st solvent with the 2nd solvent in the instant claim 1);
wherein freeze-drying powder of said magnetic particle in the examples 1-35 can be made with the DI water (the claimed combining with a pharmaceutically acceptable carrier to form a nanoparticle composition in the instant claim 1 and the claimed aqueous solution in the instant claim 10) with weight ratio of the targeted drugs to the DI water being 1:≤0.5 (example 36, paragraph 71).
The weight percentage of Fe magnetic nanoparticles of example 3 in the composition of example 36 is calculated to be 66.7% (1/(1+0.5)=0.667 based on 1:0.5 drug to DI water weigh ratio), thus, the weight percentage of sodium dodecyl sulfate in the composition is calculated to be 0.67% by weight (66.7%x0.01=0.67) (the instant claim 8). Given the density of sodium dodecyl sulfate being 1.01 g/mL, similar to that of water, 0.67% by weight is converted to 0.67% v/v.
The instant claims 5-7 are further limitations of alternative components.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-7, 10, and 11 are rejected under 35 U.S.C. 103(a) as being unpatentable over Chen et al. (US 2010/0278923 A1, filed on 09/15/2008).
The teachings of Chen et al. are discussed above and applied in the same manner. Chen et al. teach, in paragraph 44, 9.7 ml of sodium oxalate in DI water being added into gold chloride trihydrate (HAuCl4) solution (0.01 M, 0.3 ml) to form gold nanoparticle solution. The concentration of gold nanoparticle in the DI water solution is calculated to be 5.91 mg/mL, i.e., 5.91% w/v,: (0.3 mL x 0.01 mol/1000 mL) / (9.7 mL + 0.3 mL) → 3x10-7 mol gold /mL → 3x10-7 mol gold x (197 g/mol) /mL → 5.91 x10-5 g of gold/mL → 5.91 x10-2 mg of gold/mL. According to paragraph 45, 0.06 mg vancomycin being added and washed, thus, there is ≤0.06 mg of vancomycin being attached to gold nanoparticles in 0.2 mL of the vancomycin-modified gold nanoparticles in DI water solution, i.e., 5.91-6.21 mg/mL (5.91x10-2 + 0.06/0.2 = 6.21) → 5.91-35.91% w/v.
Chen et al. do not specify the same weight percentage of nanoparticles in the carrier (5.91-35.91% w/v vs the claimed 1-20% w/v in the instant claim 11).
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition overlaps with the range disclosed in the prior art, such as in the instant rejection.
The claimed range of nanoparticles is 1-20% w/v and the range of nanoparticles taught in the prior art is 5.91-35.91% w/v and therefor, overlaps with the claimed range.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614
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