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
In view of the amendments to the claims made by the applicant in the response filed 21 August 2026, the restriction requirement set forth in the Office action mailed 24 June 2026 is withdrawn.
In view of the withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 20 is objected to because the term "methacrylate)" on line 3 contains a closed parenthesis without a corresponding open parenthesis. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-3, 5, 6, 9-11, and 16-21 rejected under 35 U.S.C. 112(a) because the specification, while being enabling for coated products (and processes of forming such products) wherein the coating is chemically bound to the surface of the product, does not reasonably provide enablement for coated products wherein the coating is not chemically bound to the surface. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Case law holds that applicant’s specification must be "commensurately enabling [regarding the scope of the claims]" Ex Parte Kung, 17 USPQ2d 1545, 1547 (Bd. Pat. App. Inter. 1990). Otherwise, undue experimentation would be involved in determining how to practice and use applicant’s invention. The test for undue experimentation as to whether or not all compounds within the scope of claims 1-3, 5, 6, 9-11, and 16-21 can be used as claimed and whether claims 1-3, 5, 6, 9-11, and 16-21 meet the test is stated in Ex parte Forman, 230 USPQ 546, 547 (Bd. Pat. App. Inter. 1986) and In re Wands, 8 USPQ2d 1400, 1404 (Fed.Cir. 1988). Upon applying this test to claims 1-3, 5, 6, 9-11, and 16-21, it is believed that undue experimentation would be required because:
(a) The quantity of experimentation necessary is great since claims 1-3, 5, 6, 9-11, and 16-21 read on 1-3, 5, 6, 9-11, and 16-21 while the specification discloses the "coating is chemically bound to the surface of the vascular medical product or at least one part thereof" (see page 5, lines 3-10). This disclosure is not presented as a preferred or alternative embodiment, but rather as an essential feature that prevents release of the particles from the surface. The release of a very low number of particles is described as a feature of the coating (see page 2, lines 24-28)
(b) There is no direction or guidance presented for coatings that are not chemically bound to the surface. On the contrary, the perfluorophenyl azide moiety is taught as employed for the purpose of inserting the coating into a chemical C-H bond on the surface of the vascular medical product or at least a part thereof.
(c) There is an absence of working examples concerning coatings that are not chemically bound to the surface. On the contrary, all the illustrated embodiments show the coating chemically bound to the coated surface (see Figure 6 as well as the pictorial representations on pages 3-7 and 16).
In light of the above factors, it is seen that undue experimentation would be necessary to make and use the invention of claims 1-3, 5, 6, 9-11, and 16-21.
Claims 12-17, 20, and 21 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a vascular medical product or part thereof coated with a composition comprising an alcohol and water component, does not reasonably provide enablement for a vascular medical product or part thereof coated with a composition that does not contain an alcohol and water component. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Applying the test for undue experimentation - as outlined in paragraph 6 above - to claims 12-17, 20, and 21, it is believed that undue experimentation would be required because:
(a) The quantity of experimentation necessary is great since claims 12-17, 20, and 21 read on coatings applied as a solid or vapor while the specification discloses that "components a) to d) are dissolved in aqueous alcohol" (see page 25, lines 10-21).
(b) There is no direction or guidance presented for applying coatings without the use of an alcohol and water component. Rather, all the means for applying the coating recited in the specification (e.g., page 2, lines 4-7) require the coating composition to be a liquid.
(c) There is an absence of working examples concerning coating compositions that are not liquid based.
In light of the above factors, it is seen that undue experimentation would be necessary to make and use the invention of claims 12-17, 20, and 21.
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.
Claims 1-3, 5, 6, and 9-21 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1 (as well as claims 2, 3, 5, 6, 9-11, 18, and 19 due to their dependency from claim 1) and claim 16 (as well as claims 12-15, 17, 20, and 21 due to their dependency from claim 16) are rendered indefinite because it is unclear what type of molecular weight (e.g., number average, weight average, viscosity average, etc.) is recited in sections a) and b) of claims 1 and 16.
The term "lower-molecular" in claims 1 and 16 is a relative term which renders the claims (as well as claims 2, 3, 5, 6, 9-15, and 17-21 due to their dependency from either claim 1 or claim 16) indefinite. The term "lower-molecular" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The phrase "comprises at least one of the following copolymer or consists of one of the following copolymers" on lines 4-5 of claim 12 renders the claim indefinite because only one structure is shown following the phrase.
Cited Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bennis (US 2019/0343987) is directed to a lubricating coating for a medical device (paragraph 0002). The coating comprises a high molecular weight polyvinylpyrrolidone and a low molecular weight polyvinylpyrrolidone (paragraph 0004), wherein the high molecular weight polyvinylpyrrolidone has a weight average molecular weight of as high as 1,300,000 g/mol and the low molecular weight polyvinylpyrrolidone has weight average molecular weight of no more than about 95,000 g/mol (paragraphs 0054-0055).
While the high and low molecular weight polyvinylpyrrolidones read on components a) and b) of claims 1 and 16, Bennis does not teach or fairly suggest the inclusion of components corresponding copolymer c) or phenyl azide compound d).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAMSEY E ZACHARIA whose telephone number is (571)272-1518. The best time to reach the examiner is weekday mornings, Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Callie Shosho, can be reached on 571 272-1123. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RAMSEY ZACHARIA/Primary Examiner, Art Unit 1787
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