Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
DETAILED ACTION
Status of claims
The amendment filed on 02/27/2026 is acknowledged. Claim 3 has been canceled. Claims 1, 2, and 4-11 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 02/27/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. Applicant’s amendments have overcome the 35 U.S.C. 112 (pre-AIA ), second paragraph, rejection of claim 1, 35 U.S.C. 102(e) rejection of claims 1-7 and 10 over Chen et al. (US 2010/0278923 A1), 35 U.S.C. 102(b) rejection of claims 1-10 over Zhu (WO 2007/048326 A1), and 35 U.S.C. 103(a) rejection of claims 1-7, 10, and 11 over Chen et al. (US 2010/0278923 A1) from the previous Office Action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New ground of rejections necessitated by Applicant’s amendment
The amendments necessitate the following new ground of rejections.
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, 2, 4-7 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) as evidenced by Oh et al. (US 2008/0070011 A1).
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.
According to Oh et al. centrifugation results in precipitation (paragraph 58). Since precipitation is known to include precipitation without centrifugation, i.e., resulted from gravitation; centrifugation is a species of the claimed precipitation in the instant claim 1.
The instant claims 5-7 are further limitations of alternative components.
Claims 1, 2, and 4-10 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) as evidenced by Oh et al. (US 2008/0070011 A1).
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).
According to Oh et al. centrifugation results in precipitation (paragraph 58). Since precipitation is known to include precipitation without centrifugation, i.e., resulted from gravitation; centrifugation is a species of the claimed precipitation in the instant claim 1.
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, 2, 4-7, 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) as evidenced by Oh et al. (US 2008/0070011 A1).
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.
Claims 1, 2, 4-7, 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) in view of Anthony et al. (US 2002/0112407 A1).
The reference of Chen et al. as evidenced by Oh et al. (US 2008/0070011 A1) is described in detail above and that discussion is hereby incorporated by reference. It is recognized that the teachings of Chen et al. as evidenced by Oh et al. (US 2008/0070011 A1) were deemed to anticipate the claims 1, 2, 4-7, and 10 in the preceding ground of rejection. The instant ground of rejection applies an alternative interpretation of centrifugation as a species of precipitation, which alternative interpretation is in expectation of an argument that applicant could make regarding whether centrifugation is a species of precipitation, i.e. that the disclosure of Chen et al. as evidenced by Oh et al. (US 2008/0070011 A1) is not explicit enough to support an anticipation determination with regard to the limitation of precipitation. The Examiner does not agree with such a view, but nonetheless, this alternative ground of rejection is set forth to provide an alternative rationale as to Chen et al.’s teaching of centrifugation, even if they do not anticipate the claimed invention, nonetheless provide ample disclosure, suggestion and motivation for one of ordinary skill in the art to have arrived at the claimed invention.
Anthony et al. teach both precipitation and centrifugation being suitable for separating particles from the medium (claims 24-26).
It would have been prima facie obvious at the time of the invention to a person of ordinary skill in the art based on the teachings in Chen et al. and Anthony et al. to replace centrifugation taught by Chen et al. with precipitation. Both precipitation and centrifugation being suitable for separating particles from the medium was well known to a person of ordinary skill in the art at the time of the invention. The motivation for replacing centrifugation taught by Chen et al. with precipitation flows from both having been used in the prior art, and from both being recognized in the prior art as useful for the same purpose. Furthermore, centrifuge was previously claimed (claim 3 dated 10/23/2023) and disclosed in the instant specification as being suitable. Thus, the criticality of the claimed precipitation over centrifugation taught by Chen et al. is not established.
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.
Claims 1, 2, and 4-10 are rejected under 35 U.S.C. 103(a) as being unpatentable over Zhu (WO 2007/048326 A1, US 2011/0177153 A1 as English translation) in view of Anthony et al. (US 2002/0112407 A1).
The reference of Zhu as evidenced by Oh et al. (US 2008/0070011 A1) is described in detail above and that discussion is hereby incorporated by reference. It is recognized that the teachings of Zhu as evidenced by Oh et al. (US 2008/0070011 A1) were deemed to anticipate the claims 1, 2, and 4-10 in the preceding ground of rejection. The instant ground of rejection applies an alternative interpretation of centrifugation as a species of precipitation, which alternative interpretation is in expectation of an argument that applicant could make regarding whether centrifugation is a species of precipitation, i.e. that the disclosure of Zhu as evidenced by Oh et al. (US 2008/0070011 A1) is not explicit enough to support an anticipation determination with regard to the limitation of precipitation. The Examiner does not agree with such a view, but nonetheless, this alternative ground of rejection is set forth to provide an alternative rationale as to Zhu’s teaching of centrifugation, even if they do not anticipate the claimed invention, nonetheless provide ample disclosure, suggestion and motivation for one of ordinary skill in the art to have arrived at the claimed invention.
Anthony et al. teach both precipitation and centrifugation being suitable for separating particles from the medium (claims 24-26).
It would have been prima facie obvious at the time of the invention to a person of ordinary skill in the art based on the teachings in Zhu and Anthony et al. to replace centrifugation taught by Zhu with precipitation. Both precipitation and centrifugation being suitable for separating particles from the medium was well known to a person of ordinary skill in the art at the time of the invention. The motivation for replacing centrifugation taught by Zhu with precipitation flows from both having been used in the prior art, and from both being recognized in the prior art as useful for the same purpose. Furthermore, centrifuge was previously claimed (claim 3 dated 10/23/2023) and disclosed in the instant specification as being suitable. Thus, the criticality of the claimed precipitation over centrifugation taught by Chen et al. is not established.
Response to Applicants’ arguments:
Applicant’s arguments, filed on 02/27/2026, have been fully considered but they are moot in view of new ground of rejections.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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