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 of Group III, claims 5-7, in the reply filed on 6/3/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/3/2026.
Drawings
The drawings are objected to because there is only one figure and the drawing refers to it as "Fig. 1". However, 37 CFR 1.84(u)(I) indicates when there is only one drawing, it must not be numbered and the abbreviation FIG must not appear. Therefore, the figure must be referred to as The Figure. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: Page 6 of the specification refers to “Fig. 1” but should state “The Figure” as there is only one figure.
Appropriate correction is required.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5, step 2, recites “prepare barium sulfate slurry” it should read “prepare a barium sulfate slurry”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 5-7 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.
Claim 5 recites “Group I or Group 2 element” and “purity test…described in the standard…2021.” This renders the claim indefinite as claims are to be complete in themselves. Incorporation by reference to a specific figure or table or specific steps "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
Claim 5, step 1, recites “washing…with an aqueous solution… or with sulfuric acid,” it is unclear from the claim is the washing step can be performed with sulfuric acid alone, or if it must be an aqueous solution of sulfuric acid.
Claim 5, step 3 line 3, recites “the fired product” there is insufficient antecedent basis for this limitation in the claim as its unclear if it’s referring back to the mixture that was fired, or some other fired product.
Claim 5, step 3 line 5, line 6 and line 9, recite “a mixture” or “the mixture” there is insufficient antecedent basis for this limitation in the claim as its unclear what mixture it is referring back to as the claim recites multiple mixtures (i.e. mixture of barium sulfate/silica; dried mixture, etc.).
Claim 5, step 4, recites “the mixture” there is insufficient antecedent basis for this limitation in the claim as its unclear what mixture it is referring back too as the claim recites multiple mixtures (i.e. mixture of barium sulfate/silica; dried mixture, etc.).
Claim 5, step 5, recites “the mixture” there is insufficient antecedent basis for this limitation in the claim as its unclear what mixture it is referring back too as the claim recites multiple mixtures (i.e. mixture of barium sulfate/silica; dried mixture, etc.).
Claim 5, step 4, recites “the raw material” there is insufficient antecedent basis for this limitation in the claim as the claim never previously references a raw material.
Claim 5, step 6, recites “the dried product” there is insufficient antecedent basis for this limitation in the claim as its unclear what dried product the claim is referring back to as the claim recites multiple dried products (i.e. dried product in step 3 and dried product in step 5, etc.).
Claims 6-7 are rejected in view of their dependency on claim 5. They do not resolve the deficiencies of claim 5 and are deficient for the same reasons.
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) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP2016199454, Stone (CA1050235), Kamada (US 2019/0375652), as evidenced by Nissan Chemical Corporation (2019) and Pinto (2021). JP’454 was previously cited by the examiner and Kamada was cited on the 9/16/2024 IDS.
JP’454 teaches a method of providing spherical barium sulfate made by a) providing a slurry of barium sulfate particles and 2) calcining the dried product of step 1. JP’454 teaches the calcining to be a firing step performed at a temperature ranging from 750-1100°C (pg. 4).
Regarding claim 5, Step 1
JP’454 teaches that the barium sulfate particles can be obtained by reacting barium sulfide with sulfuric acid (pg.3), however, JP’454 does not teach washing the barium sulfate with sulfuric acid.
Stone teaches the production of pharmaceutical barium sulfate and teaches leaching barium sulfate with sulfuric acid to remove acid soluble impurities (Abs), these impurities must be removed to meet USP standards (pg. 5), this reads on washing barium sulfate with sulfuric acid. It would have been prima facie obvious to modify the teachings of JP’454 with those of Stone and use sulfuric acid to wash the barium sulfate particles of JP’454, prior to inclusion in the slurry, to remove any acid soluble impurities. One of skill in the art would have a reasonable expectation of success as Stone teaches that this step is known to be used to formulate barium sulfate for pharmaceutical compositions and it would have obvious to apply this step to the barium sulfate of JP’454 which is to be used on the skin.
Regarding claim 5, Step 2 and Step 3 (obtaining a mixture of barium sulfate with silica…firing the dried mixture)
JP’454 teaches the preparation of a slurry of barium sulfate, but does not teach repulping the washed barium sulfate to obtain a slurry and mixing this slurry with silica.
Kamada teaches the preparation of composite barium sulfate spherical particles with silica. The composite particles are made by preparing a slurry containing barium sulfate and silica sol, spray drying the slurry and firing the slurry (abs). Kamada teaches that the inclusion of silica to form composite particles followed by firing has significantly higher particle strength and better texted than conventional spherical barium sulfate. This composite particle exhibits a very high soft focus effect when used in cosmetics [0008]. Kamada teaches that the barium sulfate can be obtained by reacting barium sulfide with sulfuric acid [0034]. The silica can be added to a powder or a slurry of particulate barium sulfate, when a slurry of particulate barium sulfate is used, it may be made by repulping the particulate with water [0037]. Kamada teaches the mass ratio between the barium sulfate and the silica in the slurry to be between 95/5 to 70/30 [0038]. Kamada exemplified using Snowtex ST-O as the silica [0103].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teaching of the above reference with those of Kamada. One of skill in the art would have been motivated to modify the barium sulfate particles of JP’454 with Kamada and add silica to form a composition particle comprising both barium sulfate and silica as taught by Kamada as Kamada teaches that this combination has benefits not found in particles having just barium sulfate. One of ordinary skill in the art would have also been motivated to use the washed barium sulfate particles made obvious above and repulp these with water to create a barium sulfate slurry and mix this slurry with silica and subject the slurry mixture to a spray drying and firing steps taught by JP’454. One of skill in the art would have a reasonable expectation of success as JP’454 teaches making a barium sulfate slurry prior to the spray drying and firing step and Kamada teaches that the silica can be added to a barium sulfate slurry that was repulped with water and its prima facie obvious to pursue the known options within the technical grasp of a skilled artisan.
Regarding claim 5, Step 3 (subjecting the fired product to a purity test…)
JP’454 teaches that the spherical barium sulfate obtained satisfies the purity items of hydrochloric acid-soluble matter as described in the quasi-drug raw material standard 2006. It has a residue of hydrochloric acid soluble matter in an amount of 15mg or less, the liquid obtained in the purity test should not be cloudy as cloudiness indicated soluble barium salt was detected and the lead acetate paper obtained shall not turn black indicating that sulfide was not detected (pg. 6-7 and 10). JP’454 teaches that examples 1-6 of barium sulfate satisfy the above conditions, this reads on subjecting the fired product to a purity test as the test would have necessarily been performed in order to determine the that the barium sulfate meets the requirements desired.
While JP’454 does not teach the test liquid to have an absorbance of less than 0.03, the working examples in the specification indicate that absorbance levels of less than 0.03 resulted in no soluble barium salt being detected, as JP’454 teaches no soluble barium salt was detected, it’s reasonable to expect the absorbance level of JP’454 is less than 0.03.
However, JP’454 does not teach using the 2021 standards.
Pinto teaches that that the Japanese standards of quasi-drug ingredients (JSQI 2021) was introduced laying down new quasi-drug application ruled and new permitted quais-drug additive lists, amending the JSQI 2006.
As such, it would have been prima facie obvious for a skilled artisan before the effective filing date of the claimed invention to modify the teachings of JP’454 and follow the JSQI 2021 instead of the JSQI 2006 as the 2021 version replaced the 2006 version and it would have been prima facie obvious to use the newest version required.
Regarding claim 5, Step 4
As the barium sulfate of JP’454, made obvious above, satisfied the claimed feature (a), step 4 is not required to be performed.
Regarding claim 5, Step 5-6
In view of the 112b rejections above, it is unclear what mixture is being referred to. As discussed above, the prior art makes obvious the steps of spray drying a slurry of barium sulfate and silica, firing this mixture and subjecting it to the required purity test, as such the limitations of the claimed have been met.
Regarding claim 6: Kamada teaches the mass ratio between the barium sulfate and the silica in the slurry to be between 95/5 to 70/30 [0038], this overlaps with the silica being present in an amount of at least 1% or more based in the total weight of the barium sulfate and silica.
Regarding claim 7: Kamada teaches using Snowtex ST-O, as evidenced by Nissan Chemical Corporation, Snowtex ST-O has a particle size of 12nm. While Kamada doesn’t specify this to be an average particle size, The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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