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 .
This office action is in response to the reply filed 11/14/2025.
Election/Restrictions
Claims 20-22, 25, 27-28, 31-32, 34-35 and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/21/2023
Request For Interview
Applicant' s request for an interview has been considered. As MPEP 713.01 (IV) recites, interviews should be had only when the nature of the case is such that the interview could serve to develop and clarify specific issues and lead to a mutual understanding between the examiner and the Applicant and thereby advance the prosecution of the application. In the instant case Applicant' s reply was clear and thus an interview would not be beneficial at this time. Once Applicant has time to review the instant action Applicant may contact Examiner to schedule an interview if desired.
Response to Arguments
All of Applicant’s arguments filed 11/14/2025 have been fully considered.
In view of the claim as amended, all rejections presented in the office action mailed 7/16/2025 are withdrawn and Applicant’s arguments against these rejection are moot.
Claim Interpretation
The instant claims are directed to a device having a functionalized surface. Absent a definition of functionalized surface in the filed specification, this surface functionalization can be achieved through the use of a coating attached to the surface. Said surface comprising the attached/bonded coating reads on surface as claimed.
New 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) 1, 4-5, 7, 9, 11, 14, 16-17 and 40-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Myers (US 2007/0244548) and Cahalan (US 2008/0241349). Cahalan is newly cited.
Myers teaches a medical device having a surface with a uniform or non-uniform layer that includes a mono- or disaccharide sugar and at least one therapeutic agent (Abs).
Myers teaches that when the structure is a vascular stent, a preferred therapeutic agent is heparin (structure has double or more charged sulfate ions), steroids such as dexamethasone, and mixtures thereof [0085]. Thus a mixture of these agents is prima facie obvious. Myers teaches that the layer of therapeutic agent should contain a relatively soluble material like heparin and teaches that the solubility of dexamethasone can be adjusted as desired, with or without the inclusion of heparin, by mixing it with one or more of its relatively soluble derivatives, such as dexamethasone sodium phosphate (structure has double or more charged phosphate ions) [0088].
Myers teaches the sugar and therapeutic agent to be provided as a coating adhered to the structure [0017]. The coating can include one or more layers and covers any portion of the device [0024]. Myers teaches therapeutic layer to be positioned directly on top of the material (i.e. surface) and teaches it to be adhered which reads on a functionalized surface wherein the ions are directly bound to the surface.
Regarding claims 1 and 4: Myers teaches the implantable structure to be made from a biocompatible metal such as tantalum, titanium, nitinol, platinum, gold, etc. [0008].
Regarding claim 5: Suitable medical device include stents, such as vascular stents, heart valves, cardiac pacemaker lead, etc. [0028 and 0031]. Preferred structure include a vascular stent [0035].
Regarding claims 7, 9, 11, 41-42 and 45: Myers teaches the use of at least one layer of mono- or disaccharide sugar and at least one therapeutic agent (heparin and/or dexamethasone mixed with dexamethasone sodium phosphate ) as discussed above, thus the use of 2 coating layers each containing a sugar and double or more charged ions is prima facie obvious. Myers teaches preferred sugars to include sucrose, lactose, trehalose, galactose, etc. [0048], reading on surface sealing as claimed.
Regarding claim 40: Claim 40 requires the surface sealing to dissolve within 30 seconds, while this isn’t taught by Myers, the coating of Myers is applied in the same manner as the claimed coating and comprises the claimed double or more charged ions and required carbohydrate, therefore it is reasonably expected to dissolve in the same manner as the claimed coating, absent evidence to the contrary as a composition and its properties are inseparable.
Regarding claim 14: Myers teaches that the present invention allows for uniform deposition of the active agent layer and allows for uniform application, which reads on seamlessly covering a portion of the surface [0043, 0046 and 0097].
Regarding claim 16: The surfaces of the medical devices of Myers do not appear to be altered so as to fail to meet any broadest reasonable interpretation of the phrase “plain surface.”
Regarding claim 17: Myers makes obvious a surface comprising heparin and/or dexamethasone, these therapeutic agents target specific conditions, thus the surface has a predefined target characteristic.
Regarding claims 17 and 44: Myers teaches plasma treating the primer layer which improves adhesion of, increases the amount of, and allows the hydrophilic therapeutic agent to de deposited in a more uniform layer [0097], this reads on the surface having a predefined characteristics which is hydrophilicity.
Regarding claim 43: Meyers teaches the combination of sugar and therapeutic layer results in a smooth and uniform layer when applied to the medical device, this reads on a plain surface lacking a substantial texture and waviness.
Regarding claim 1 and 46: Myers teaches that when the therapeutic layer is positioned directly on top of the surface it is highly advantageous to surface process the material 14 (i.e. the surface made of biocompatible metal) [0095]. Useful surface processing methods include cleaning, etching, plasma treatment, etc. [0096].
However, Myers does not teach performing surface processing to obtain a pure material.
Cahalan teaches methods for preparing substates coated with a biomolecule (Abs). Cahalan teaches that prior to coating the substrate, the substrate can be cleaned to remove any surface contaminants or impurities. This can be done using plasma treatment [0045].
It would have been prima facie obvious to use the surface processing steps of Myers such as cleaning and/or plasma treatment to remove all contaminants and impurities on the surface prior to application of the therapeutic layer as Myers teaches surface processing to be useful for improving adhesion [0097] and Cahalan teaches that its known in the art to clean the surface of the substrate prior to applying a coating.
Regarding the limitation of “such as the ions are exposed…body lumen,” the prior art makes obvious the claimed device comprising the claimed functionalized surface, as such the ions are expected to be exposed to bodily fluid when inserted in the body lumen.
Conclusion
No claims are allowable.
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.
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.
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 Kwon can be reached on (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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/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613