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 .
DETAILED ACTION
Applicant’s arguments, filed 2/23/2026, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 8-10, and 12 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US20170367982 to Nandwana. Nandwana teaches a biocompatible oily ferrofluid comprising iron oxide magnetic nanoparticles (paragraphs 2, 4-10, and 67) and+ an oil phase (paragraphs 58 and 95) comprising a triglyceride (at least one fatty acid ester) (paragraph 74), wherein the magnetic nanoparticles are surface functionalized by molecules of one or more phospholipids (paragraph 75). Surfactants are not taught (free of surfactant). As a chemical cannot be separated from its property, and as the same phospholipid molecules are used as in the present invention, the phospholipid molecules presented in Nandwana would ensure the presently claimed coverages (there is no limitation in the present claims that the phospholipid molecules cover the surface of the iron-oxide based magnetic nanoparticles, only that they have the property of being able to ensure said coverage). Physiologic conditions with a temperature of 35-40° C is used (a colloidal dispersion in said oil phase from a temperature belonging to the range from 20 to 80 oC.” (paragraph 36). The phospholipid may be DPPC (a phospholipid that contains at least one fatty chain) (paragraph 5). The nanoparticles may be a spheroid (paragraph 25). The composition may comprise a steroid (a lipophilic active ingredient) (paragraph 32). The artisan in reading Nawanda would immediately envisage that the magnetic nanoparticles are dispersed in the oil phase as Nawanda expressly teaches the use of dispersing agents (paragraph 92) and the carrier is a dispersion media (paragraph 58).”
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that Nandwana does not teach dispersion of the magnetic nanoparticles in the oil phase, the examiners’ response is that the artisan in reading Nawanda would immediately envisage that the magnetic nanoparticles are dispersed in the oil phase as Nawanda expressly teaches the use of dispersing agents (paragraph 92) and the carrier is a dispersion media (paragraph 58).”
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.
Claims 1-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US20170367982 to Nandwana. The relevant portions of Nandwana are given above.
Nandwana fails to teach that the oil phase comprises at least 70% by mass of fatty acid esters relative to the total mass of the oil phase.
It would have been obvious to one of ordinary skill in the art at the time the invention as filed to optimize the amount of fatty acid esters in the oil phase to improve the composition for diagnosis and treatment of early-stage atherosclerotic plaques and reduction of plaques in arteries. In this way, the artisan would find at least 70% by mass through routine experimentation.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that it would be an undue burden to find at least 70% by mass, the examiner’s response is it would not be an undue burden to optimize the amount of fatty acid esters to improve the composition for diagnosis and treatment of early-stage atherosclerotic plaques and reduction of plaques in arteries, but the artisan would understand that in the pharmaceutical arts that it is routine to adjust amounts of the components of a pharmaceutical composition to optimize therapeutic efficacy of that the formulation. “Differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Claims 1-6 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over US20170367982 to Nandwana in view of Kihara (Lysophospholipid receptors in drug discovery, Exp Cell Res. 2014 Dec 8;333(2):171–177). The relevant portions of Nandwana are given above.
Nandwana fails to teach using a phosopholipid containing the moiety -O(O)P(OH)O-.
Kihara teaches that lysophospholipids (which contain -O(O)P(OH)O ) are bioactive lipids that transduce signals through their specific cell-surface G protein-coupled receptors, LPA1–6, S1P1–5, LPI1, and LysoPS1–3, respectively. These LPs and their receptors have been implicated in both physiological and pathophysiological processes such as autoimmune diseases, neurodegenerative diseases, fibrosis, pain, cancer, inflammation, metabolic syndrome, bone formation, fertility, organismal development, and other effects on most organ systems. Advances in the LP receptor field have enabled the development of novel small molecules targeting LP receptors for several diseases (Abstract; Introduction).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use a lysophospholipid as the phospholipid of Nandwana. The motivation for this would be to diagnose disease, as desired by Nandwana (paragraph 56).
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that the references separately do not disclose the present invention, the examiner’s response is that the rejection is not based on references taken separately but on the combination of references and what that combination would convey to the ordinary artisan. The examiner maintains, as staed above, that although Nandwana fails to teach using a phosopholipid containing the moiety -O(O)P(OH)O-, in view of Kihara, it would have been obvious to use a lysophospholipid as the phospholipid of Nandwana. The motivation for this would be to diagnose disease, as desired by Nandwana.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
May 26, 2026
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