DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 2 and 13, as well as claims 14-15 based on their dependency to claim 13, are 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.
5. The term “thread-like” in Claim 2 is a relative term which renders the claim indefinite. The term “thread-like” 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. It is unclear whether the term “thread-like” is meant to mean that the “core” is a thread or another structure. Therefore, this renders the claim indefinite.
6. It is noted that Claim 2 also recites the term “hose-like” in reference to the structure of the sheath. The specification does define this term as “a tubular structure” (see present specification, pg. 5, lines 21-23). Therefore, this term is not rendered indefinite. However, the term “thread-like” is rendered indefinite, as explained above.
7. Claim 13 recites the limitation "a magnetically heatable filler" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. The remainder of Claim 13 recites that the implant, first recited in line 2, is to be configured according to claim 1 (see lines 3-4 of Claim 13). In Claim 1, there is also a recitation of “a magnetically heatable filler” in lines 3-4. Therefore, it is unclear whether the recitation of the “magnetically heatable filler” in Claim 13 is the same as the “magnetically heatable filler” recited in Claim 1, or if these are two separate “fillers”. Proper correction is required.
Claim Rejections - 35 USC § 102
8. 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.
9. Claims 1-8 and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jackson U.S. 2003/0004563 (herein referred to as “Jackson”).
10. Regarding Claim 1, Jackson teaches an implant for implanting in a body, in particular in a hollow organ or a vessel of a body (Fig. 1, ref num 10; para 0036, “a stent 10… shown inside a lumen 22 of an arterial vessel 24”), the implant being composed of a filament which comprises at least one polymeric matrix material (Fig. 7 shows the filament; Fig. 7, ref num 62 = polymeric matrix material; para 0050 “polymeric structure of a stent”; para 0042, “a stent incorporating the present invention can embody a polymeric shape memory polymer”; para 0049) in which a magnetically heatable filler is arranged (para 0049, “a layer of filler-radiopaque material”), the filament having a cross section with a core-sheath structure (see Fig. 7) characterized in that the core (Fig. 7, ref num 60) forms a polymeric reinforcing structure (para 0049, “inner polymer core 60”; para 0014), and in the sheath comprises the polymeric matrix material (Fig. 6, ref num 62 makes up the sheath) in which the magnetically heatable filler is disposed (para 0049, “a layer of filler-radiopaque material and MR material 62 is configured”; para 0030), the loading of the filler being greater in the sheath than in the core (see Fig. 7, the filler, ‘radiopaque material’ is greater in ref num 62 than 60; para 0049).
11. Regarding Claim 2, Jackson teaches that the core is thread-like and the sheath has a hose-like structure and at least partially envelopes the core (see Fig. 7, ref num 62 envelopes ref num 60).
12. Regarding Claim 3, Jackson teaches the magnetically heatable filler is a superparamagnetic filler (para 0030, “a polymer in combination with a material that generates a magnetic susceptibility artifact such as… superparamagnetic substance”).
13. Regarding Claim 4, Jackson teaches the filler has a crystallite size in a range from greater than or equal to 3 nm to less than or equal to 100 nm (para 0035, “The additives described may be distributed uniformly throughout the stent or confined to selected regions to serve as markers. The size of the particles are preferred to be on the order of 0.1 to 10 microns. If colloidal particles were used, and properly sealed inside the stent, the particles can be arbitrarily small (ten nanometers is possible)…”).
14. Regarding Claim 5, Jackson teaches the filament has a crossed structure or an entangled structure or that the filament has a braided structure (para 0041, “polymer based stents embodying structure defined by a wire or ribbon coil or helix or a knitted mesh configuration”).
15. Regarding Claim 6, Jackson teaches the implant forms a tubular structure (see Figs. 4 and 5, ref num 10 is tubular; para 0040, “the stent 10 is formed from an elongated tubular member”).
16. Regarding Claim 7, Jackson teaches the magnetically heatable filler is present in the sheath (Fig. 7, ref num 62 contains the filler; para 0049) in a proportion of greater than or equal to 0.1% by weight to less than or equal to 90% by weight (para 0034, 0046 describe the volume loading of the filler by a proportionate weight).
17. Regarding Claim 8, Jackson teaches the polymeric matrix material is selected from the group consisting of polypropylene, polyethylene terephthalate, polyvinylidene fluoride, polyethylene, polyamide and thermoplastic polyurethane (para 0014, “an engineering polymer such as… polypropylene”).
18. Regarding Claim 10, Jackson teaches the core is free of the magnetically heatable filler (par 0049).
19. Regarding Claim 11, Jackson teaches in that the core-sheath structure is produced by a coextrusion process (para 0029, “filaments of the compounded polymer may be extruded”).
20. Regarding Claim 12, Jackson teaches that the core-sheath structure forms a two-layer structure (see Fig. 7, there are two layers).
21. Regarding Claim 13, Jackson teaches arrangement of a radiation source for emitting electromagnetic radiation and an implant (Fig. 1, ref num 10; para 0027, “a stent embodying a polymer into which one or more materials have been compounded to improve visibility under MRI and x-ray based fluoroscopy”; para 0037, “the stent of the present invention can be made visible under MRI”; para 0048) wherein the implant comprises a magnetically heatable filler (para 0049, “a layer of filler-radiopaque material”) characterized in that the implant is configured according to claim 1 (see claim 1 rejection above).
Claim Rejections - 35 USC § 103
22. 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.
23. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson.
24. Regarding Claim 9, Jackson fails to explicitly teach the core forms a polymeric reinforcing structure comprising the same polymeric matrix material as the sheath. However, Jackson does teach that the core may be formed of a combination of the polymer blended with the other materials (para 0049, “Another approach that can be used is to combine a polymer core blended with radiopaque filler material, with an MR material”). There are various combinations of materials that may be used in the core and sheath (para 0050); therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified one embodiment of Jackson with another in order to have the core form a polymeric reinforcing structure that is the same polymeric matrix material as the sheath, as these materials produce the same expected result of improving visibility of the implant under an imaging modality.
25. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson and in view of Schwagten U.S. 9,572,618 (herein referred to as “Schwagten”).
26. Regarding Claim 14, Jackson fails to teach the implant and the radiation source are matched to each other in such a way that the implant is heatable by electromagnetic radiation emitted by the radiation source, at least in the sheath, to a temperature which lies in a range from 40oC to 100 oC.
Schwagten teaches an implant of analogous art (Figs. 1a-2b) and a radiation source (Col. 17, lines 55-65, “The body of the implant device may comprise portions which are externally triggerable by means of an energy field or a combination of energy fields chosen from electromagnetic radiation… Energy can be provided to the implant device by external means through electromagnetic radiation”), such that the radiation source and implant are matched to each other in such a way that the implant is heatable by electromagnetic radiation emitted by the radiation source (Col. 17, lines 55-65). The implant is heatable to a temperature that lies in a range from 40oC to 100 oC (Col. 17, lines 55-65, “The body of the implant device may comprise portions which are externally triggerable by means of an energy field or a combination of energy fields chosen from electromagnetic radiation… Energy can be provided to the implant device by external means through electromagnetic radiation”; Col. 18, lines 40-43, “The implant device may be provided of a thermoactive coating which is only activated upon temperatures above 45° C. so that an external application of an energy field would trigger activation”). This temperature allows for the implant to apply the desired treatment to the vessel that the implant is applied without further damaging tissue (Col. 20, lines 33-40, “one can engineer the temperature profile through the implant device. It should be clear that the parts of the implant which are meant to contact the vessel wall and the form lesions by ablation, should be heated mostly while other parts of the implant, which are in contact with the vessel or the blood and are not meant to form lesions, should receive as little heat as possible for the wellbeing of a patient”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jackson to have the radiation source heat the implant by electromagnetic radiation to a temperature between 40oC to 100 oC as this treats the tissue as desired.
27. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson and in view of Parsai U.S. 2017/0216623 (herein referred to as “Parsai”).
28. Regarding Claim 15, Jackson fails to teach the radiation source is arranged to emit radiation of a frequency in a range from 10 kHz to 1 MHz at a field amplitude range from 1 kA/m to 100 kA/m.
Parsai teaches an implant and radiation source of analogous art (para 0025, “a method of treating a subject in need thereof, the method comprising inserting at least one brachytherapy seed of claim 1 into the subject, and inducing a magnetic field applied to the brachytherapy seed to deliver a therapeutic dose of heat to tissue of the subject in proximity to the brachytherapy seed, wherein the brachytherapy seed also delivers a therapeutic dose of radiation to the tissue”; also see Claim 1), wherein the radiation source emits a radiation of a frequency in a range from 10 kHz to 1 MHz (para 0025, “the magnetic field strength can be on the order of… a frequency in the range of ~50-200 kHz is used”) at a field amplitude range from 1 kA/m to 100 kA/m (para 0025, “the magnetic field strength can be on the order of about 2.5-10 kA/m”). This delivers a thermotherapeutic treatment to the patient in order to treat the desired tissue via the implant (para 0142, 0144; also see Claim 24). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jackson to have the radiation source emit a radiation to the implant of a frequency in a range from 10 kHz to 1 MHz at a field amplitude range from 1 kA/m to 100 kA/m in order to apply the desired energy treatment to the tissue surrounding the implant.
Conclusion
29. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794