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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-2, 10-15, 28 in the reply filed on 4/27/2025 remains acknowledged.
Applicant's election with traverse of:
BiOCl recited in claim 1;
A single coating comprising polyethylene glycol (PEG) and a derivative of the PEG recited in claim 14 (the examiner choses PEG for prosecution);
A single use of the nanocomposite in a preparation of a material for integrated tumor diagnosis and treatment recited in claim 28;
in the reply filed on 4/27/2025 remains acknowledged.
Claims 16-22, 24-27 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/27/2025.
Claim 13 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/27/2025.
Response to Arguments
Applicants' arguments, filed 10/29/2025, have been fully considered. Arguments are persuasive regarding the rejections under 25 USC 112(b), 112(d), & 101, in view of the claim amendments, but they are not deemed to be persuasive regarding the rejection under 35 USC 103. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claim(s) 1-2, 10, 12, 14-15, 28, 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (CN 110193372 (A); 2019 Mar 9; IDS reference); in view of CN105770893 (A) (2016; IDS reference).
English Machine translations of Wu and CN105770893 were obtained from WIPO. Citations reference these English language MTs.
Wu teaches a photocatalyst. The photocatalyst comprises citric acid and bismuth oxyhalide, the citric acid is modified on the surface of the bismuth oxyhalide. The chemical formula of the bismuth oxyhalide is BiOX; X is selected from at least one of inter alia, Cl (i.e., corresponding to Applicant elected BiOCl). The color of the photocatalyst is black. The energy band structure of the photocatalyst has stable oxygen vacancy energy levels between a conduction band and a valence band. High efficiency visible photocatalytic performance is taught (abstract). Solvents used to prepare the photocatalyst include Applicant elected polyethylene glycol (claim 4).
The size of the photocatalyst is preferably 20 nm to 100 nm, within the size range of claim 10. The photocatalyst is lamellar and is a sheet material (5th page of specification, 3rd paragraph; construed to read on the claim 12 2D layered crystals).
Near-infrared irradiation at 808 nm is taught, and the material results in killing effect on tumor cells (the preparation of this material reads on the elected preparation of a material for integrated tumor diagnosis and treatment recited in claim 28 (4th page of specification, near bottom).
Regarding the elected coating material PEG, while PEG is utilized as a solvent for preparation, coating with PEG is not unambiguously taught by Wu (however the citrate coating is taught).
CN105770893 teaches a use of a bismuth-based nanomaterial, which includes tumor therapy, and preparation of a diagnosis and treatment combined pharmaceutical composition (claim 1). The bismuth-based nanomaterial includes a core material A and a stabilizer B compounded with the core material A; the core material includes Applicant elected BiOCl (claims 1, 5, 13, 17). The stabilizer B is Applicant elected PEG (claim 3, 15). Oxygen defects (vacancy) are taught (claim 7). Black BiOCl nanosheets are among those taught (claim 34).
Photothermal conversion efficiency of the bismuth-based nanomaterial includes greater than 10% and greater than 20% (2nd page of specification, near bottom). Black BiOX mainly uses near-infrared light to excite the black BiOX nanomaterial to achieve a photothermal therapy effect (specification, 6th page, near bottom).
Particle size in the 50 nm to 300 nm range is taught (specification, 10th page, near top).
Thus, it would have been obvious to utilize elected BiOCl nanoparticle, such as a 2D layered crystals, in the nm size range, and to coat with PEG as clearly taught by the second CN document; utility of the black version leads to conversion efficiency of at least 10% and at least 20%, and efficacy in tumor treatment with NIR irradiation at 808 nm: These results show that the black BiOCl-Fe3O4-PEG composite nanomaterial is a good nanomaterial that can be applied to tumor photothermal therapy (near bottom of last page of specification).
Absent a showing to the contrary, the properties recited in claims 1-2, 12 would have been characteristic (examiner notes the instant disclosed BiOCl particle material is black).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). In the instant case the burden is shifted to Applicant to show that the properties recited in lines 1 & 3-6 of claim 1, claim 2 and claim 12 are not present in the nanocomposite obvious over the two references, i.e., BiOCl (an oxygen vacancy-containing BiOX particle, where X is Cl and the material is black), coated with Applicant elected PEG.
Regarding the coating ratio of claim 15, a ratio within the claimed range would have been obvious as a result of routine optimization, starting with the procedures and amounts of the second reference (e.g., Embodiment 4) and then optimization of relative amounts of components A and B, absent a showing to the contrary.
Regarding new claim 39, the instant specification discloses (p. 58; 5th page of specification, 3rd paragraph) that “BiOX particle with an oxygen vacancy proportion of 40% of higher is black”. Since black BiOCl are among those taught, absent to the contrary, the black version is construed to have 40% or higher oxygen vacancy, per the disclosed characteristic of black BiOX particles.
Oath/Declaration
The Declaration under 37 CFR 1.130(a) filed 10/29/2025 is insufficient to overcome the rejection of claims 1-2, 10, 12, 14-15, 28 based, in part, upon Wu et al. (CN110193372 (A)) as set forth in the last Office action because Wu states that :
The CN was published 9/3/2019; the instant claimed invention has an effective filing date of 12/31/2019, i.e., the CN reference was published less than one year before the effective filing date of the claimed invention.
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country (priority document CN201911411094.0).
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Since there is no English translation of CN201911411094.0 present in the record, priority has not been established back to this document. Current priority has been established for the international stage application, PCT/CN2020/140788, filed 12/29/2020, but the Examiner is unable to determine support under 35 USC 112(a) in the Chinese language document CN201911411094.0 for the current claims.
Accordingly, the prior art CN110193372 (A) reference Wu et al. does not qualify as a “grace period” disclosure.
Furthermore, in view of compact prosecution, the 2nd inventor of Wu et al is Xu Yu; In the declaration of Aiguo Wu, Wu makes a bare assertion that Xu Yu (called “the other inventor of the reference Wu et al (CN110193372 (A))” by the declaration, was allegedly “merely working under the direction of inventor Aiguo Wu”.
MPEP 2109 discusses inventorship. This section indicates, inter alia, that an inventor must contribute to the conception of the invention (II).
Because Xu Yu is named as an inventor in the CN110193372 (A) Chinese patent document, this is prima facie evidence that Yu is one of the inventors in this document. The Declaration of Wu is in conflict with this, alleging that Yu was merely working under the direction of Wu, in conflict with the fact that Yu is named as an inventor. The allegation of the Declaration is in clear conflict with inventorship facts in this case. The allegation of mere “working under direction of” Wu is not sufficient to remove this inventor from this Chinese patent, effectively converting this Chinese patent document to be only by Wu. In contrast, the Examiner takes the position that Yu is still a named inventor of CN110193372 (A) Chinese patent document, and is not removed by the mere assertion of Wu. Accordingly, even if a translation of the CN priority document establishes the dates argued, the Declaration is insufficient to establish fats that render the CN document to be only by an instant inventor.
Conclusion
No claim is 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (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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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614