DETAILED ACTION
Claims 16, 18-19, 21-36 are currently pending. Claims 16, 18-19, 21-26 and 31-36 are under examination.
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 .
Withdrawn Rejections
The rejection of claim(s) 16-19, 21-22, 26 and 31-36 under 35 U.S.C. 103 as being unpatentable over US 2009/0076591 in view of CN111976813 and US 2019/0046693 is withdrawn based on Applicant’s claim amendments to specify the core-shell layer consists of core shell particle and the nanoparticle layer consists of a drug nanoparticles and unexpected results, wherein the ‘693 publication teaches the particles to be in the same layer as the hydrophobic matrix.
Examiner’s Note
Applicant's amendments and arguments filed 06/11/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. In the Applicant’s response, filed 06/11/2026, it is noted that claims 16, 21 and 23-25 are amended.
Modified/New Rejections:
The following rejections are modified and newly applied based on Applicant’s claim amendments.
Specification
The amendment filed 06/11/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The derivatives comprise common derivatives such as everolimus and zotarolimus.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Interpretation
Claims 32-35 are dependent on claim 21. Claim 21 is directed to at least one feature selected from the group A-F, therefore only requiring a single component of A-F. Newly added claims 32-35 further define A (claim 32), B (claim 33), C (claim 34) and D (claim 34). As each of A-F is not required by claim 21, dependent claims 32-35 additionally only require at least one of A-F. Claims 32-35 simply further define A, B, C and D if their category of ingredient is included.
Claim Objections
Claims 16, 18-19, 21-26 and 31-36 are objected to because of the following informalities:
Claim 16 recites “A drug coating, wherein the drug coating consisting of…” is grammatically awkward and would be remedial to recite “A drug coating consists of…”.
Claim 16 recites “consisting of” in multiple locations wherein the use of “consists of” is grammatically correct.
Claims 18-19, 21-26 and 31-36 are additionally object due to dependency and not curing the deficiencies of claim 16.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) New Matter
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.
Claim 21 and 32-36 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.
Claim 21 contains the newly added limitation ‘the rapamycin derivative is selected from everolimus and zotarolimus'. Applicant has provided an amendment to the instant specification to support everolimus and zotarolimus, however the specification amendment is not entered as new matter. As such the instant claim amendment is also not support and results in new matter. The instant specification recited “rapamycin derivatives” however provides not examples of specific rapamycin derivatives.
Alternatively, if Applicant believes that support for claim 21, drawn to the rapamycin derivative is selected from everolimus and zotarolimus, is present and clearly envisaged in the instant application or earlier filed priority documents, applicant must, in responding to this Office Action, point out with particularity, where such support may be found.
Applicant does not indicate where these limitations are supported by the original specification, or how, as is Applicant's burden. See MPEP §714.02, last sentence of the third paragraph from the end and MPEP §2163.06 (I) last sentence.
Claim Rejections - 35 USC § 112 (b)
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 18-19, 21, 23-25 and 31-36 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 18-19, 21, 23-25 and 31-36 are either directly or indirectly dependent on canceled claim 17. Claims dependent on a canceled do not have clear metes and bounds as the scope cannot be determined.
Claim 21 A contains the limitation of “the core shell structure layer comprises a binder. Amended claim 16 contains the limitation “the core-shell structure layer consisting of a core shell structure particle. Instant claim 21 has unclear metes and bounds as it is unclear if the additional binder is contained in the core shell structure particles or an additional ingredient in the layer, thus leading to unclear metes and bounds.
Claim 21 B contains the limitation of “the nanoparticle layer comprises a binder. Amended claim 16 contains the limitation “the drug nanoparticle layer consisting of a drug nanoparticle”. Instant claim 21 has unclear metes and bounds as it is unclear if the additional binder is contained in the drug nanoparticle or an additional ingredient in the layer, thus leading to unclear metes and bounds.
Claim 21E: Claim 21E recites the limitation “the drug". There is insufficient antecedent basis for this limitation in the claim. Instant claim 16 contains limitations to a drug particle in the core shell structure and drug nanoparticles. It is unclear if “the drug” is the drug in the core shell particles, the drug nanoparticles or both.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 and 32-36 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 21 A contains the limitation of “the core shell structure layer comprises a binder”. Amended claim 16 contains the limitation “the core-shell structure layer consisting of a core shell structure particle. Instant claim 21 fails to further limit as it is unclear if the additional binder is contained in the core shell structure particles or an additional ingredient in the layer, which is broader than claim 16 consisting of the core shell particles, thus leading to failure to further limit. Claim 32 additionally recited a ratio of the binder to the core-shell structure which demonstrates binder separate from the core shell particle, wherein additional ingredients are excluded by the consisting of language in claim 16.
Claim 21 B contains the limitation of “the drug nanoparticle layer comprises a binder”. Amended claim 16 contains the limitation “the drug nanoparticle layer consisting of a drug nanoparticle. Instant claim 21 fails to further limit as it is unclear if the additional binder is contained in the drug nanoparticle or an additional ingredient in the layer, which is broader than claim 16 consisting of the drug nanoparticle, thus leading to unclear metes and bounds. Claim 34 additionally recited a ratio of the binder to the drug nanoparticle which demonstrates binder separate from the drug nanoparticle, wherein additional ingredients are excluded by the consisting of language in claim 16.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 16, 18-19, 21-26 and 31-36 are found to be free of the prior art. See above withdrawn Rejections section.
The instant specification compares Examples 1-3 containing DC cholesterol and stearic acid to Examples 4-6 contains DOPE and phytanic acid. Based on the ‘693 publication contains stearic acid and phytanic acid in a group of fatty acids to be used in the hydrophobic phase and DC-cholesterol and DOPE as the hydrophobic cationic matrix ([0028], [0030]), the coatings would be expected to be functional equivalents. The instant specification demonstrates the amount of coating transferred to the vessel for examples 4-6 is greater than examples 1-3, thus demonstrating the combination of DOPE and phytanic acid have greater than expected results over equivalent DC-cholesterol and stearic acid.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
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