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 without traverse of Group I, claims 1-9 in the reply filed on 06/16/2026 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/16/2026.
Drawings
The drawings are objected to because
Figure 6 includes four views in one figure. Each graph should be labeled 6a, 6b, 6c, and 6d.
Figure 15c’s wording is not clear, blurry in some areas and too light.
Figures 25-29, content is missing from top right of table.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 214 in figure 2.
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.
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.
Claims 1-3, 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Demaria et al (US 20190054233 A1) in view of Wang (US 20150209489 A1).
Regarding claim 1, Demaria discloses an infusion device 200 (fig 14) comprising:
a base 224/230;
an adhesive 232 configured to couple the base to a skin of a patient; and
a catheter 234 having a therapeutic coating 290 [0058-0060], the coating comprising a polymer matrix and a therapeutic agent [0058-0060]. However, Demaria does not disclose specifically the coating defining a thickness of at least 40 micrometers and a therapeutic agent loading of at least 30 wt.%.
Wang teaches a catheter including a coating (that can be used on other medical devices such as infusion catheters [0021,0086]) comprising a polymer matrix and a therapeutic agent [0052,0110,0111,0265], the coating defining a thickness of at least 45 micrometers [0017,0080,0258] and a therapeutic agent loading of at least 30 wt.% [0431]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Demaria’s catheter coating by providing it with the Wang’s teachings of a coating thickness and loading as claimed since such modification is taught old and well known in the art to control the release of the therapeutic coating as desired.
Regarding claims 2-3, Demaria discloses the delivery of wherein the therapeutic agent comprises a nonsteroidal anti-inflammatory drug [0056]. Wang teaches nonsteroidal anti-inflammatory drug meloxicam as the therapeutic agent [0240].
Regarding claim 6, Demaria discloses the catheter is configured to remain inserted in the patient for at least 7 days, and wherein the catheter is configured to continuously release the therapeutic agent while inserted [0033,0055], figs 14-15.
Regarding claim 7, Demaria discloses the invention substantially as claimed. However, it fails to disclose the therapeutic agent is comprised of a plurality of discrete particles embedded in the polymer matrix.
Wang teaches in [0052] drug particles that are dispersed in the mixture of the coating forming the polymer matrix helping with the rapid release of the drug from the polymer matrix. Given the teaching, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Demaria’s polymer matrix by including a plurality of particles embedded in the polymer matrix since it would expedite the release of the therapeutic agent from the polymer matrix.
Regarding claim 8, Demaria/Wang discloses the invention substantially as claimed. However, they fail to disclose the therapeutic coating comprises at least 40 wt.% of the therapeutic agent. The material weight selection is deemed matter of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
Regarding claim 9, Demaria discloses the therapeutic coating further comprises a second therapeutic agent [0028].
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Demaria et al (US 20190054233 A1) in view of Wang (US 20150209489 A1), further in view of Hossainy et al (US 20100330147 A1).
Regarding claims 4-5, Demaria discloses the polymer matrix [0058] to improve solubility or elution properties and/or impart time-release effect to the elution of the medicament 290. Wang also discloses the use of polymer matrix [0052,0110]. However, Demaria/Wang fails to disclose the polymer matrix specifically being at least one of ethyl vinyl acetate, thermoplastic polyurethane, or poly(caprolactone); and (claim 5) wherein the polymer matrix is ethyl vinyl acetate and has a melt index of about 33 dg/min. and a vinyl acetate content of about 25%.
Hossainy teaches an infusion delivery device [0034] comprising a drug containing polymer matrix to alter drug release [0005,0077,0079,0148] which can comprise ethyl vinyl acetate copolymer [0148], and poly((caprolactone). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Demaria/Wang’s catheter polymer matrix with the Hossainy’s teaching of the alternative polymer matrix material as a alternative material since also teaches drug release alteration.
However, Demaria/Wang/Hossainy fails to disclose the polymer matrix is ethyl vinyl acetate and has a melt index of about 33 dg/min. and a vinyl acetate content of about 25%. These parameters are deemed matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
Prosecution Insights