DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 71-74 are withdrawn.
Claims 55-56, 58-60 and 62-70 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 10/16/2025 has been entered.
Claims 55-56, 58, 60, 63, 66, and 68-70 were amended. Claim 61 was canceled. No new material was added.
The objections to the specification were not addressed and are maintained.
The new “Drawings” filed 10/21/2025 is a copy of the Remarks file, rather than replacement Drawings. Therefore, the file was not entered and the objections to the Drawings are maintained.
The objection and rejections of claim 61 are moot, because the claim was canceled.
Claim 63 is newly rejected under 35 U.S.C. 112(b) due to the amendment.
The rejection of claims 55-56, 58-60, and 62-70 under 35 U.S.C. 103 is maintained.
Response to Arguments
Applicant's arguments filed 10/21/2025 have been fully considered but they are not persuasive.
Applicant argues that the lipid material making up the core is selected to solubilize the active material and as such the active materials incorporated are lipid-soluble or lipid-dispersible active agents. Applicant further states that Thomas attempts to stably incorporate hydrophilic active agents into wax particles or to contain substances which are difficult to dissolve in wax particles, and therefore the active agents cannot be lipid-soluble or lipid-dispersible as the claims require (Remarks, page 4; page 6, item 1). This argument is not persuasive, because the claims are not limited to an active material solubilized in the lipid core, and rather states only “the solid lipid core comprising at least one lipid-soluble or lipid-dispersible active agent”. Therefore, Thomas’s teaching of active substances distributed in solid lipids (i.e., a solid lipid core; Thomas, page 2, paragraph 0004), wherein the active ingredient can be ibuprofen (i.e., a suitable lipid-soluble or lipid-dispersible active material as defined by the instant specification, page 12, 1st paragraph; Thomas, claim 7) reads on the claim.
Applicant argues that it is clear from Thomas that the metal oxides are incorporated in the preparation and not on a surface of the wax particles and that these particles are coated with a polymeric material (Remarks, page 5; page 6, items 3-4). This argument is not persuasive, because Thomas teaches it is advantageous for the formulation to include inorganic pigments (Thomas, page 14, paragraph 0048), which can be titanium dioxide (i.e., a suitable stabilizing material as defined by the instant specification, page 7, 6th paragraph; Thomas, page 15, paragraph 0049). Thomas teaches inorganic surface coatings which are metal oxides (Thomas, page 15, paragraph 0049), suggesting it would be reasonable to use titanium dioxide as an inorganic surface coating. Further, the specification (page 13, 6th paragraph) states “the decorated nanoparticles are prepared by melt or solvent mixing of the core material and the decorating particles with or without a surfactant so that upon addition to an aqueous solution and vigorously mixing, a uniform dispersion is obtained. In some cases the mixture may be heated to a temperature that is about 5 °C above the lipid melting point.” The method of preparing the instant invention suggests the placement of the “decorating particles” on the outside of the solid lipid core happens inherently. Therefore, the preparation of the particles of Thomas in which the metal oxides are incorporated in the preparation would be expected to yield the same result.
Applicant further states that there is nothing in Thomas that suggests the pigments are provided in nanometric forms (Remarks, pages 5-6). This argument is not persuasive, because as stated previously, Thomas teaches inorganic pigments such as titanium dioxide (i.e., a suitable nanoparticle as defined by the instant specification, page 7, 6th paragraph; Thomas, page 15, paragraph 0049). As evidenced by the FAO, the reported particle size of food grade titanium dioxide particles is in the range of 20-400 nm (FAO, page 1, 4th paragraph), which is in the nanometer regime as claimed.
Applicant argues that Thomas does not teach lipid-based particles that are free of nanoparticles (Remarks, page 6, item 2). This argument is not persuasive, because the current invention defines a particle comprising a solid lipid core with a size ranging from 0.3 to 200 microns as being free of nanoparticles (claims 55-56; specification, pages 5-6). Thomas teaches “nanoparticles” are solid particles with diameters or up to 1000 nm (Thomas, page 2, paragraph 0004). Therefore, one of ordinary skill in the art would reasonably equate the “nanoparticle” of Thomas to the “particle” of the instant invention.
Maintained Objections to the Specification
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
The disclosure is objected to because of the following informalities: The illustration corresponding to “Scheme 1” should instead be a part of the Drawings and presented as “Figure 1”. See MPEP § 608.01(VI). Appropriate correction is required.
The use of the terms Witepsol, Evonik, Sigma Aldrich, POLYTRON, Olympus, Tween, Span, LipoPEG, Cremophor, Zetasizer, Nikon, Yokogawa, Aerosil, DYNASAN, IMWITOR, SOFTISAN, COMPRITOL, and PRECIROL, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Maintained Objections to the Drawings
The drawings are objected to because in Figures 6A and 6B “Witepsol” should read “Witepsol®” and in Figure 7, "Flourescamine" should read "Fluorescamine". 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.
New 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 63 is 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.
Regarding claim 63, the phrase “a size or a diameter” is indefinite, because it is not clear if there is meant to be a difference between these two terms. In the instant specification (page 7), the terms “size” and “diameter” appear to be used interchangeably to refer to the same measurement.
Modified/Maintained Claim Rejections - 35 USC § 103
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.
Claims 55-56, 58-60, and 62-70 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (EP 1477152 B1), and as evidenced by Drugs.com (Stearic Acid, 2025) and the Food and Agriculture Organization (Titanium Dioxide, 2024). The references were cited previously by the Examiner.
Regarding claim 55, Thomas teaches wax nanoparticles (Thomas, claim 1) which are solid lipid nanoparticles in which active substances are distributed in solid lipids (i.e., a solid lipid core; Thomas, page 2, paragraph 0004) and teaches the active ingredient can be ibuprofen (i.e., a suitable lipid-soluble or lipid-dispersible active material as defined by the instant specification, page 12, 1st paragraph; Thomas, claim 7). Thomas teaches surface-treatment with inorganic pigments such as titanium dioxide (i.e., a suitable stabilizing material as defined by the instant specification, page 7, 6th paragraph; Thomas, page 15, paragraph 0049) which can be in combination with organic coating materials such as stearic acid (i.e., a suitable active or non-active material as defined by the instant specification, page 6, 4th paragraph; Thomas, page 15, paragraph 0049). Thomas defines the “nanoparticle” is a solid particle of wax (i.e., the “lipid core” does not comprise nanoparticles; Thomas, page 2, paragraph 0004).
Regarding claim 56, Thomas teaches all the elements of the current invention as applied to claim 55. Thomas teaches the particle has a diameter of up to 1000 nm (Thomas, page 2, paragraph 0004), which overlaps the claimed range of 300 nm to 200 microns. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Regarding claim 58, Thomas teaches all the elements of the current invention as applied to claim 55. Thomas teaches the particles can be surface-treated with solubilizers (Thomas, page 15, paragraph 0049) and teaches solubilizers are used in a proportion (i.e., density) of up to 15% by weight (Thomas, page 5, paragraph 0017), which matches the claimed density.
Regarding claim 59, Thomas teaches all the elements of the current invention as applied to claim 55. As above, Thomas teaches wax nanoparticles (Thomas, claim 1) which are solid lipid nanoparticles comprising a matrix of solid lipids (Thomas, page 2, paragraph 0004). Thomas further teaches the particles are cooled to room temperature (i.e., 25 °C) to yield the wax particle (Thomas, page 19, paragraph 0060).
Regarding claim 60, Thomas teaches all the elements of the current invention as applied to claim 55. Thomas teaches the solid lipid nanoparticle (Thomas, page 2, paragraph 0004) can be composed of triglycerides (Thomas, page 6, paragraph 0022).
Regarding claim 62, Thomas teaches all the elements of the current invention as applied to claim 55. Thomas teaches the solid lipid nanoparticle (Thomas, page 2, paragraph 0004) can be composed of paraffin wax (Thomas, page 6, paragraph 0022).
Regarding claim 63, Thomas teaches all the elements of the current invention as applied to claim 55. Thomas teaches surface-treatment with inorganic pigments such as titanium dioxide (i.e., a suitable nanoparticle as defined by the instant specification, page 7, 6th paragraph; Thomas, page 15, paragraph 0049). As evidenced by the FAO, the reported particle size of food grade titanium dioxide particles is in the range of 20-400 nm (FAO, page 1, 4th paragraph), which is in the nanometer regime as claimed.
Regarding claim 64, Thomas teaches all the elements of the current invention as applied to claim 55. Thomas teaches the active ingredient dispersed in the wax particle can be ibuprofen (i.e., a suitable pharmaceutical agent as defined by the instant specification, page 12, 1st paragraph; Thomas, claim 7) and teaches the coating can comprise stearic acid (i.e., an ingredient common in pharmaceuticals as evidenced by Drugs.com; Thomas, page 15, paragraph 0049).
Regarding claim 65, Thomas teaches all the elements of the current invention as applied to claim 64. Thomas teaches the active ingredient dispersed in the wax particle can be ibuprofen (i.e., a suitable pharmaceutical agent as defined by the instant specification, page 12, 1st paragraph; Thomas, claim 7) and teaches the coating can comprise stearic acid (i.e., an ingredient common in pharmaceuticals as evidenced by Drugs.com; Thomas, page 15, paragraph 0049).
Regarding claim 66, Thomas teaches all the elements of the current invention as applied to claim 65. Thomas teaches the active ingredient dispersed in the wax particle can be ibuprofen (i.e., a suitable pharmaceutical agent as defined by the instant specification, page 12, 1st paragraph; Thomas, claim 7) and teaches the coating can comprise stearic acid (i.e., an ingredient common in pharmaceuticals as evidenced by Drugs.com; Thomas, page 15, paragraph 0049).
Regarding claim 67, Thomas teaches all the elements of the current invention as applied to claim 66. Thomas teaches the active ingredient dispersed in the wax particle can be ibuprofen (i.e., a suitable pharmaceutical agent as defined by the instant specification, page 12, 1st paragraph; Thomas, claim 7). Thomas further teaches active ingredients are known to either be enclosed in or adsorbed to solid lipid particles (Thomas, page 2, paragraph 0004). Therefore, it would be prima facie obvious to one of ordinary skill in the art that the ibuprofen could be either dispersed in the wax particle or part of the coating (i.e., nanoparticle) as claimed.
Regarding claim 68, Thomas teaches all the elements of the current invention as applied to claim 55. Thomas teaches the coating can comprise a water-soluble UV filter (i.e., active agent; Thomas, page 16, paragraph 0051).
Regarding claim 69, Thomas teaches wax nanoparticles (Thomas, claim 1) which in which active substances are distributed in solid lipids (i.e., a lipid core; Thomas, page 2, paragraph 0004) and teaches the active ingredient can be ibuprofen (i.e., a suitable lipid-soluble or lipid-dispersible active material as defined by the instant specification, page 12, 1st paragraph; Thomas, claim 7). Thomas teaches the particles can be surface-treated with inorganic pigments such as titanium dioxide (i.e., a suitable stabilizing material as defined by the instant specification, page 7, 6th paragraph; Thomas, page 15, paragraph 0049) which can be in combination with organic coating materials such as stearic acid (i.e., a suitable active material as defined by the instant specification, page 6, 4th paragraph; Thomas, page 15, paragraph 0049). Thomas defines the “nanoparticle” is a solid particle of wax (i.e., the “lipid core” does not comprise nanoparticles; Thomas, page 2, paragraph 0004).
Regarding claim 70, Thomas teaches wax nanoparticles (Thomas, claim 1) which are solid lipid nanoparticles in which active substances are distributed in solid lipids (i.e., a lipid core; Thomas, page 2, paragraph 0004) and teaches the active ingredient can be ibuprofen (i.e., a suitable lipid-soluble or lipid-dispersible active material as defined by the instant specification, page 12, 1st paragraph; Thomas, claim 7). Thomas teaches the particles can be surface-treated with inorganic pigments such as titanium dioxide (i.e., a suitable stabilizing material as defined by the instant specification, page 7, 6th paragraph; Thomas, page 15, paragraph 0049) which can be in combination with organic coating materials such as stearic acid (i.e., a suitable active material as defined by the instant specification, page 6, 4th paragraph; Thomas, page 15, paragraph 0049). Thomas defines the “nanoparticle” is a solid particle of wax (i.e., the “lipid core” does not comprise nanoparticles; Thomas, page 2, paragraph 0004).
Conclusion
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.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613