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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 11/18/2024 wherein claims 3-9, 11, and 13 were amended. In addition, the Examiner acknowledges the substitute specification filed on 1/18/2024.
Note(s): Claims 1-13 are pending.
Priority and Priority Document
This application is a 371 of PCT/JP2022/031237 filed 8/18/2022 and claims benefit to JAPAN JP2021-149210 filed 9/14/2021.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 USC 119 (a) – (d). The certified copy was filed with the pending application on1/18/2024.
While a certified copy of the prior document was submitted, an English language translation is not of record. Should Applicant desire to obtain the benefit of foreign priority under 35 USC 119 (a) – (d) prior to declaration of an interference, a certified English language translation of the foreign application should be submitted. 37 CFR 41.154(b) and 41.202(e). Failure to provide the certified translation may result in no benefit being accorded for the non-English document.
Note(s): The earliest effective filing date is 8/18/2022 because the pending invention is fully supported in the PCT application.
Claim Interpretation
Independent claim 1 is directed to an x-ray opaque filler which is blended in a curable composition including a polymerizable monomer to impart x-ray opacity to the curable composition and a cured body thereof, the x-ray opaque filler comprising any powder selected from the group consisting of a first powder including crystalline rare earth metal fluoride particles as a main component and having a full width at half maximum of a maximum intensity peak derived from the crystalline rare earth metal fluoride particles of 0.3 degrees or more in an x-ray diffraction pattern and a second powder obtained by subjecting the first powder to surface treatment.
Independent claim 8 is directed to a dental x-ray opaque filler which is blended in a curable composition including a polymerizable monomer to impart x-ray opacity to the curable composition and a cured body thereof, the x-ray opaque filler comprising any powder selected from the group consisting of a first powder including crystalline rare earth metal fluoride particles as a main component and having a full width at half maximum of a maximum intensity peak derived from the crystalline rare earth metal fluoride particles of 0.3 degrees or more in an x-ray diffraction pattern and a second powder obtained by subjecting the first powder to surface treatment.
Independent claim 9 is directed to a method of producing an x-ray opaque filler comprising a step of subjecting raw material powder including crystalline rare earth metal fluoride particles as a main component and having a full width at half maximum of a maximum peak derived from the crystalline rare earth metal fluoride particles of less than 0.3 degrees in an x-ray diffraction pattern to mechanochemical treatment so that the full width at half maximum becomes 0.3 degrees or more.
Independent claim 11 is directed to a dental curable composition, comprising a polymerizable monomer and an x-ray opaque filler wherein the x-ray opaque filler comprises any powder selected from the group consisting of a first powder including crystalline rare earth metal fluoride particles as a main component and having a full width at half maximum of a maximum intensity peak derived from the crystalline rare earth metal fluoride particles of 0.3 degrees or more in an x-ray diffraction pattern and second powder obtained by subjecting the first powder to surface treatment, and wherein the x-ray opaque filler imparts x-ray opacity to the dental curable composition and a cured body thereof.
Applicant’s Election
Applicant's election without traverse of Group II (pending claims 9 and 10) filed 8/6/2026 is acknowledged. The restriction requirement is still deemed proper and is therefore made FINAL.
Applicant elected the following species for initial examination: and x-ray opaque filler comprising crystalline ytterbium fluoride particles as the main component in combination with a methacrylate base monomer.
Initially, Applicant’s elected species was searched. Since prior art was found which could be used to reject the claims, the search was not further extended.
Withdrawn Claims
Claims 1-8 and 11-13 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statements
The information disclosure statements filed 1/18/2024, 7/3/2025, 3/16/2026, 8/3/2026, and 9/2/2026 were considered.
Written Description Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what was before. The inventor must be able to describe the item to be patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection. The pending application does not sufficiently describe the invention as it relates to raw material powders comprising crystallin rare ear metal fluoride particles other than ytterbium fluoride, cerium fluoride, gadolinium fluoride, and lanthanum fluoride. Thus, what the reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
112 Second Paragraph Rejections
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation 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.
Claims 9 and 10 are rejected under 35 U.S.C. 112(b) or 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 the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 9 and 10: The claims are ambiguous for the following reasons. According to MPEP 2173.05(h), while a Markush grouping may include a large number of alternatives, and not necessarily be indefinite under 35 USC 112(b), in certain circumstances, a Markush group may be so expansive that a skilled artisan cannot determine the metes and bounds of the claimed invention.
In pending claims 9 and 10, the invention is directed to any x-ray opaque filler having a raw material powder that includes a rare earth metal fluoride particle as the main component. In addition, claim 9 encompasses any mechanochemical treatment.
The claims encompasses multiple Markush groups and subgroups thereof. As a result, pending claim 9 and 10 encompass a massive number of distinct alternative members such that one skilled in the art cannot determine the metes and bounds of the claims. Thus, one cannot readily envision all of the compounds defined by the Markush groups that result in species having a full width at half maximum of a maximum peak derived from the crystalline rare earth metal fluoride particle of less than 0.3 degrees an x-ray diffraction pattern. Hence, the claims are vague and indefinite.
102/103 Rejection
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 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.
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 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Fusejima et al (US 2010/0093886) as supported by the following evidentiary references: Hockmeyer (June 17, 2021, 5 pages, https://hockmeyer.com/blog/articles/wet-milling-vs-dry-milling-the-differences-advantages-and-challenges/); Niwa et al (International Journal of Pharmaceutics, 2011, Vol. 405, pages 218-227); and Platzer et al (Multiscale Science and Engineering, 2021, Vol. 3, pages 119-128.
Independent claim 9 is directed to a method of producing an x-ray opaque filler comprising a step of subjecting raw material powder including crystalline rare earth metal fluoride particles as a main component and having a full width at half maximum of a maximum peak derived from the crystalline rare earth metal fluoride particles of less than 0.3 degrees in an x-ray diffraction pattern to mechanochemical treatment so that the full width at half maximum becomes 0.3 degrees or more.
Claim 10 is directed to a method of producing the x-ray opaque filler of claim 9 wherein the mechanochemical treatment is wet bead mill treatment.
Fusejima et al is directed to organic and inorganic composite fillers which have high x-ray imaging properties and high mechanical strength as dental restoration material. The composite fillers are produced by curing and pulverizing a methacrylate compound (see entire document, especially, abstract; pages 1-2, paragraph [0010]).
The methacrylate compound used in the composite filler may be a monomer or commoner of methacrylate or acrylate and its oligomer or prepolymer. The methacrylate compounds include those listed on page 2, paragraph [0013]. Fillers that are preferably used with the methacrylate compound include compounds of lanthanoids such as lanthanum fluoride and ytterbium fluoride. The lanthanoids may be used alone or by mixing two or more (page 2, paragraph [0018].
The pending invention discloses that mechanochemical treatment is treatment in which mechanical energy is applied to the raw material powder and includes at least one of mechanical frictional crushing, pulverization, or dispersion (specification, page 22, paragraph [0034]). The method of Fusejima et al comprises mixing the filler (e.g., ytterbium fluoride) with the methacrylate compound with a mixer, the methacrylate compound is cured and the obtained product is pulverized so as to product the organic and inorganic composite filler. As for a curing agent for curing the methacrylate compound, an organic peroxide, an azo compound or the like is used in a case of thermal curing. A photopolymerization initiator or the like is used in a case of optical curing. In addition, chemical polymerization in ordinary temperature polymerization or the like is used (page 3, paragraph [0022]).
In an example of Fusejima et al, it is disclosed that the materials are mixed and pulverizing occurs for 10 hours by a ball mill (a process used to reduce the size of a material into a fine powder) (page 3, paragraph [0033]). In Examples 1-4, ytterbium fluoride powder in various percentages was mixed with a methacrylate compound and azoisobutyronitrile was added as a curing agent for curing the methacrylate compound, thermally curing the mixture, and pulverizing the cured mixture (page 4, paragraphs [0034] and [0035]; page 4, Table 3). A pasty dental restoration material was generated (page 4, paragraph [0036]).
While Fusejima et al does not use the specific terminology ’mechanochemical treatment’, it would have been obvious to the skilled artisan prior to the effective date of the pending invention that the technique of ball milling to go from the initial raw material to a powder is encompassed within Applicant’s definition of ‘mechanochemical treatment’ found on page 22, paragraph [0034] of the specification.
In addition, it should be noted that in generating the x-ray filler composite of Fusejima et al, it is disclosed that one adds components to the mixture that include an organic peroxide, and azo compound, and methacrylate to result in a pasty dental restoration material (page 4, paragraphs [0034] – [0036]). Thus, Platzer et al (Multiscale Science and Engineering, 2021, Vol. 3, pages 119-128) is made of record as an evidentiary reference to illustrate that in chemistry and materials science, a pasty material is a semi-solid material (mixture of a fine grained dry solid and a liquid) that flows like a fluid and is classified as a Bingham plastic fluid because it flows with constant shear stress (see entire document, especially, abstract). Thus, the mechanochemical process that occurred in Fusejima et al to generate the pasty dental restoration material underwent a wet bead (ball) mill treatment.
Niwa et al is made of record as an evidentiary reference to illustrate that it is well known n the art that wet milling is used for general oral products. Thus, the skilled artisan would recognize that wet bead (ball) mill treatment is common in generating products that are used orally (see entire document, especially, abstract).
Hockmeyer is made of record as an evidentiary reference to illustrate that it is well known in the art that wet milling (also known as ‘wet grinding’) is process through which particles that are suspended in a liquid slurry are dispersed in that liquid b shearing or crushing. Since wet milling incorporates a liquid, the process has the powder to reduce a product into finer particles which allows for the production of a greater variety of byproducts and improved physical properties in the final product (see entire document, especially, page 2, left column, first complete paragraph).
While Fusejima et al do not specifically disclose that full width at half maximum of a maximum peak derived from the rare earth fluoride particles, both Applicant’s elected species and the composition of Fusejima et al disclose overlapping components (ytterbium fluoride and a methacrylate-based monomer) and both involve wet milling to yield an x-ray filler material. According to MPEP 2112.01, products of identical chemical composition cannot have mutually exclusive properties. As a result, a chemical composition and its properties are inseparable. Thus, the properties associated with Applicant product would also be properties associated with the product of the prior art.
For the reasons set forth supra, the pending invention is anticipated by Fusejima et al. Alternatively, if the invention is not anticipated, it would have been obvious to one of ordinary skill in the art to optimize the product of Fusejima et al because according to MPEP 2144.05, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable range (properties) by routine experimentation.
Evidentiary References
Hockmeyer (June 17, 2021, 5 pages, https://hockmeyer.com/blog/articles/wet-milling-vs-dry-milling-the-differences-advantages-and-challenges/) was made of record for its teachings of the advantages of using wet milling versus dry milling.
Niwa et al (International Journal of Pharmaceutics, 2011, Vol. 405, pages 218-227) was made of record for its teachings which confirm that the wet milling technique is well known in the pharmaceutical arts to be useful in preparing oral products .
Platzer et al (Multiscale Science and Engineering, 2021, Vol. 3, pages 119-128) was made of record for its teachings that pasty material are mixtures of a fine grained dry solid and a liquid and that such materials flow like a viscous fluid under certain stress levels.
Comments/Notes
It should be noted that the full scope of Group II was not searched.
Conclusion
Claims 9 and 10 are rejected and claims 1-8 and 11-13 are withdrawn.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. Hartley can be reached at (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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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
September 5, 2026
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