DETAILED ACTION
Claims 1-22 are currently pending. Claims 10-11, 16-18 and 21-22 are currently 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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 07/09/2026 is acknowledged.
Claims 1-9 and 12-15 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 07/29/2026.
Applicant’s election without traverse of metal particles and tantalum as the material that forms the particles in the reply filed on 07/29/2026 is acknowledged.
Claims 19-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/29/2026.
Priority
The instant application is a national stage entry of PCT/EP2023/054860, filed 02/27/2023, which claims priority to DE10 2022 105 492.6, filed 03/09/2022.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 11/09/2024 and 06/11/2025 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Claim Rejections - 35 USC § 112
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 and 21 is 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.
Claim 18: The term “predominantly” in claim 18 is a relative term which renders the claim indefinite. The term “predominantly” 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. Claim 18 contains the limitation of “predominantly consists of metals having an atomic number of greater than 21 or compounds thereof” in regards to metal particles. The term “predominantly” has unclear metes and bounds as it is a relative term, wherein it is unclear what amount constitutes “predominantly”.
Claim 21 recites the limitation "the coating" in second line. There is insufficient antecedent basis for this limitation in the claim. Claim 21 is directed to a volume fraction amount in “the coating”, however claim 10 from which it depends contains a polyurethane coating, hollow/metal particles applied to the polyurethane coating, and the final cured top layer. It is unclear what coating layer claim 21 is referring to as the polyurethane coating does not contain the particles, and the final result is directed to a “top layer” and does not recite a coating. Therefore it is unclear what “the coating” is being referred to for the volume fraction amounts.
Claim Rejections - 35 USC § 103
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) 10-11, 16-17 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0065434 in view of US 2006/0201601.
Regarding claim 10, the of a medical device having markings for imagine comprising applying polyurethane coating to the device to be provided with markings, adhering meal particles, laser curing the coating at defined sites that form patterns with the patterns selected that only a portion of the coating material cures is met by the ‘434 publication teaching high radiopacity is achieve in a polymeric marker by combining a polymeric resin, a powdered radiopaque agent having uniformly shaped particles of specific particle size. The marker is taught as slipped into place on the device, wherein the device is a balloon catheter (abstract). The radiopaque material is taught to be provided with a polymer on a medical device ([0009], [0010]). The polymer is taught to b polyurethane [0012]. The melt bonding is taught [0015]. The marker is attached to the substrate using laser to cause the marker to melt [0035]. An outer coating is taught to be applied through different methods and is placed over all of the wire and polymer markers and is a lubricous type coating [0044]. The top coat is taught to be sufficiently thick to fill in the uneven surface profile to generate a smooth surface profile ([0047], [0052]). A liquid polymer is taught wherein the radiopaque coating is taught to be adhered to the substrate, wherein the polymer would be cured by UV light or heat [0049]. The doping particles are taught to include tantalum [0050]. It is noted that the instant claims are product by process claims wherein the ‘434 publication teaches a polyurethane metal particle layer with a top coat layer, wherein the coating are cured and attached to the device. MPEP 2113 - “[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).
Regarding claim 11, the limitation of wherein said device is a catheter is met by the ‘434 publication teaches a catheter (abstract).
Regarding claim 16, the limitation of wherein the metal particles are 1 to 50 um in size is met by the ‘434 publication teaching the particle size is at least 2 microns and 20 microns max [0011].
Regarding claim 17, the limitation of wherein the metal is tantalum is met by the ‘434 publication teaching the metals are tantalum ([0026], [0050], claim 4).
Regarding claim 21, the limitation of wherein the particles have a volume fraction in the coating of 40 to 75% is met by the ‘434 publication teaching 36.4 volume percent [0011]. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Regarding claim 22, the limitation of wherein the markings are symbols, shapes, graphics, scales or patterns is met by the ‘434 publication teaching lines of radiopaque markers (figure 2, claim 11).
The ‘434 publication does not specifically teach a polyurethane layer with a metal particle layer applied to the polyurethane coating (claim 10).
The ‘601 publication teaches flexible marker material that is visible to at least one form of electromagnetic wave. The marker material is used on a medical device and add little or no bulk to the medical device (abstract). Metal powder is taught to be used which include tantalum [0007]. The marker material can include a variety of adhesives. The adhesive material is taught to include polyurethane or polyurethane based adhesives. The adhesive material is taught to at least partially adhere the metal powder to the medical device. Alternatively, at least a portion of the metal powder can be mixed with the adhesive prior to application to the medical device ([0008], [0036]). The application of an adhesive material layer, a radiopaque material layer and a protective material layer wherein the protective layer may be applied over the adhesive material, radiopaque material or a combination thereof (claims 34-35).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention use a polyurethane adhesive layer below the radiopaque particle containing layer as the ‘601 publication teaches that it was known to use polyurethane as an adhesive layer below a radiopaque particle containing layer on a medical device and the ‘434 publication teaches a radiopaque particle containing layer to be applied on a medical device. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘434 publication and the ‘601 publication are both directed to medical device which comprise polyurethane, radiopaque particle layers applied to medical devices. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘601 publication teaches that it was known to include radiopaque particle in the polyurethane adhesive layer or applied above the adhesive layer.
Regarding the method of making steps, the combination of references teaches the use of polyurethane below a radiopaque particle containing layer, wherein the radiopaque particles are applied as markers (reads on shapes), wherein a top coating layer is applied and where the coating is polymerized (polyurethane). Thus the combination of references teaches the structure of the medical device having markers for imaging, absent factual evidence to the contrary. MPEP 2113 - “[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).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0065434 in view of US 2006/0201601 as applied to claims 10-11, 16-17 and 21-22 above, and further in view of US 5,300,048.
As mentioned in the above 103 rejection, all the limitations of claims 10-11, 16-17 and 21-22 are taught by the combination of the ‘434 publication and the ‘601 publication.
Regarding the limitation of wherein the metal particles predominantly consist of metal shaving an atomic number greater than 21 or compounds there of is met by the ‘434 publication teaching tantalum particles (claim 9).
The combination of references does not specifically teach wherein the metal particle shave a density greater than 4 g/cm3 (claim 18).
The ‘048 patent teaches a catheter with radiographic viewing (abstract). The radiopaque agent is taught to be tantalum which is taught to be present in an excess of 10 grams per cubic centimeter (column 4, lines 15-35).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the density of radiopaque particles as taught by the ‘048 patent on the medical device of the ‘434 publication as the ‘434 publication and the ‘048 patent are both directed to medical devices including tantalum particles as radiopaque particles. It would have been prima facie obvious to one of ordinary skill in the art before ethe filing date of the claimed invention to use known amounts of radiopaque particles on medical device taught to contain radiopaque particles.
Conclusion
No claims are allowed.
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.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
