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 is the initial Office action based on application number 18/241184 filed August 31, 2023. Claims 1-10 are currently pending and have been considered below.
Election/Restrictions
Claims 9-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 April 27, 2026.
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.
Claims 1-5 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Plans et al. (US 2008/0067728).
Regarding claim 1: Plans et al. discloses a stent holder (10) for holding stents (5) of varying sizes while they are being coated, having a mandrel (13) which is a jig shaft portion, with two stent receiving fixtures (15) which are first and second block portions coupled to opposed ends of the mandrel (13), with at least one of the fixtures (16) being slidable along the mandrel (13) such that the holder (10) can accommodate stents of different sizes (pars. 39-48, figure 1), where the fixtures can be rough such that they have a roughness, and the mandrel (13) can be made of metal or plastic which also inherently have predefined roughness, such that any of these surfaces can be considered a surface region having a surface roughness formed thereon (pars. 41, 44).
Regarding claim 2: Plans et al. discloses that the fixtures above can be used in an embodiment in which one of the stent retaining fixtures (146) is fixed while the other stent retaining fixture (144) is slidably movable such that it changes the distance between the two fixtures (pars. 72-77, 89-90, figures 1 and 7).
Regarding claim 3: Plans et al. discloses that the stent holder (10) is used primarily for coating the stents (par. 78) and teaches that the coating material is applied to the length of the stent (5) on the mandrel (13) as well as the fixtures (20) (par. 51), and further discloses a luer fitting (19) which is a stopper disposed in a non-coating region which fixes the position of the movable fixtures (16, 144) (pars. 79-82, figures 1B-1C).
Regarding claim 4: Plans et al. discloses an embodiment in which one of the stent retaining fixtures has an entire mandrel assembly (75a) which is a rotating body that includes a shaft member (71) which has an aperture (148) which defines a penetration hole along the rotational axis such that the mandrel (13) can communicate with both ends of the shaft member (71), where the opening of the aperture (148) can be considered an annular groove in a lower side of the shaft member (71) (pars. 73-77, 87, 90, figure 7).
Regarding claim 5: Plans et al. discloses that arms (72) are provided within the aperture (148) which can be considered a stopper portion that fix a position of the mandrel assembly (75a) (par. 73, figure 7).
Regarding claim 8: Plans et al. does not explicitly disclose how the roughness of the surfaces is made. However, the means by which the surface of an apparatus is roughened is by definition a product-by-process limitation. it is noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) . Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP § 2113. Therefore, absent evidence of criticality regarding the presently claimed (process) and given that Plans et al. meets the requirements of the claimed composition, Plans et al. clearly meet the requirements of present claim 8.
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.
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Plans et al. as applied to claims 1-5 and 8 above.
Regarding claim 7: Plans et al. fails to explicitly disclose the level or depth of the roughness of the fixtures (15) or mandrel (13). However, Plans et al. does state that they can have a surface finish ranging from a rough surface to a polished surface, indicating that the exact roughness amount is a result effective variable which can be tuned specifically to the needs of the particular process (pars. 44). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to experiment and optimize the roughness level to be in a range of tens to hundreds of micrometers because optimization of result effective variables is not considered to be a patentable advance (Discovery of optimum value of result effective variable in known process is ordinarily within skill of art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Plans et al. as applied to claims 1-5 and 7-8 above and further in view of Park et al. (KR 20160142481, attached translation used for citation purposes).
Regarding claim 6: Plans et al. fails to explicitly disclose the exact format of the roughened surface, or that it is formed by irregular depressed grooves. However, Park et al. discloses a similar stent mounting jig (10) which includes a plurality of grooves (11) in the jig (10) surface for minimizing the contact surface with the stent being coated, where the grooves can either have a predetermined interval or an arbitrary (i.e., irregular) interval (page 3, figure 1). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use arbitrary arranged grooves like those of Park et al. in the rough surface of Plans et al. because Park et al. teaches that this helps minimize the contact between the stent and the jig surface which improves the uniformity of the drug coating (page 3).
Claim 7 is alternately rejected under 35 U.S.C. 103 as being unpatentable over Plans et al. as applied to claims 1-5 and 8 above and further in view of Costello (US 2013/0103162).
Regarding claim 7: Plans et al. fails to explicitly disclose the level or depth of the roughness of the fixtures (15) or mandrel (13). However, Costello discloses a similar stent mandrel (710) which has a plurality of wells over its entire surface which present an overall roughness, where the size, shape and depth of the wells are all result effective variables which directly affect the quality of the coating and strain on the stent (par. 37, figures 7-8). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use such wells as taught by Costello for the mandrel of Plans et al. because Costello teaches that they help achieve a desired coating and also balance strain to help avoid wrinkling (par. 37), and further obvious to experiment and optimize the shape, size and depth of the wells to arrive at an overall roughness in a range of tens to hundreds of microns because they are recognized to directly affect the coatings and strain on the stent (par. 37) and because routine optimization of result effective variables is not considered to be a patentable advance (Discovery of optimum value of result effective variable in known process is ordinarily within skill of art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pacetti et al. (US 6,565,659) and Kerrigan (US 2004/0191405) disclose similar but structurally different stent holding mandrels used for coating stents.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN A KITT whose telephone number is (571)270-7681. The examiner can normally be reached M-F 9am-5pm.
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/S.A.K/
Stephen KittExaminer, Art Unit 1717
6/25/2026
/Dah-Wei D. Yuan/Supervisory Patent Examiner, Art Unit 1717
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