Ex Parte MORALES

Patent Trials and Appeals BoardMay 30, 2019

15103791 - (D) (P.T.A.B. May. 30, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 15/103,791 06/10/2016 77218 7590 06/03/2019 Medtronic Vascular - APV Division c/o IP Legal Department 3576 Unocal Place Santa Rosa, CA 95403 FIRST NAMED INVENTOR Carlos R. MORALES UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. 355847.USN4 2882 EXAMINER GHALI, ISIS AD ART UNIT PAPER NUMBER 1611 NOTIFICATION DATE DELIVERY MODE 06/03/2019 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): rs. docketingapv@medtronic.com rs.patents.five@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CARLOS R. MORALES Appeal2019-000315 Application 15/103,791 Technology Center 1600 Before JEFFREY N. FREDMAN, JOHN G. NEW, and JAMIE T. WISZ, Administrative Patent Judges. WISZ, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. Â§ 134(a), Appellant1 seeks review of claims 1-24. We have jurisdiction under 35 U.S.C. Â§ 6(b). For the reasons set forth below, we affirm. STATEMENT OF THE CASE The specification describes a method for treating a vein comprising the use of a radiopaque medical cyanoacrylate composition comprising a 1 Appellant identifies the Real Party in Interest as Medtronic plc, which is the ultimate parent entity of the assignee of record, Covidien LP. App. Br. 3. Appeal2019-000315 Application 15/103,791 cyanoacrylate monomer and a radiopacifier. Spec. 2. Claim 1, which is illustrative, is set forth below: 1. A radiopaque medical cyanoacrylate composition compnsmg: a cyanoacrylate monomer; and a radiopacifier comprising nanoparticles having a mean size of from about 3 nanometers (nm) to about 15 nm, wherein the nanoparticles do not substantially agglomerate within the composition at about 20 degrees Celsius (Â°C), and wherein the composition has a viscosity of between about 1,000 centipoise (cP) and about 2,000 cP. App. Br. 19 (Claim Appendix). Independent claim 11 recites a method of forming the claimed radiopaque medical cyanoacrylate composition and independent claim 21 recites a method of using the composition in a patient. Id. at 21-22. The Examiner rejected claims 1-24 under 35 U.S.C. Â§ 112(a) for failing to comply with the written description requirement. The Examiner rejected claims 1-24 under 35 U.S.C. Â§ I03(a) as being obvious over Porter2 and Jackson. 3 ISSUES AND ANALYSIS We reverse the Examiner's written description rejection and affirm the Examiner's obviousness rejection. We address the arguments raised by Appellant below. 2 Porter, US 2003/0039696 Al, published Feb. 27, 2003 ("Porter"). 3 P. Jackson et al., Evaluation of the effects of gold nanoparticle shape and size on contrast enhancement in radiological imaging, 34 AUSTRALAS PHYS ENG SCI MED, 2011, at 243 ("Jackson"). 2 Appeal2019-000315 Application 15/103,791 Written Description The Examiner finds that claims 1-24 fail to comply with the written description requirement because the limitation of a mean particle size of "from about 3 nanometers (nm) to about 15 nm," as recited in the claims, is not disclosed with sufficient specificity. 4 Final Act. 3--4. Appellant asserts that this limitation is supported by a number of species within the claimed range because the specification describes examples of mean particle sizes, including a range of "mean particle size ... less than about . . . 15 nm ... , or less," and "a radiopacifier comprising nanoparticles having a mean size of less than about 15 nanometers (nm) .... " App. Br. 6 (citing Spec. ,r,r 70, 76). Appellant also points out that the specification describes specific mean particle sizes, for example, "about 1 nm, 2 nm, 3 nm, 4 nm, 5nm, ... , or 10 nm." Id. (citing Spec. i-f70). Appellant argues that these facts are similar to those in In re Wertheim, 541 F.2d 257,265 (CCPA 1976) because the specification describes a range and specific examples within the range. Id. We find that Appellant has a better position. The specification discloses an upper range of 15 nm and discloses species within the claimed range of about 3 nm to about 15 nm. We agree with Appellant that this tracks the Wertheim fact pattern and reasonably provides support for the range recited in claim 1. Therefore, to the extent that the rejection of claims 1-24 under 35 U.S.C. Â§ 112(a) is maintained, we reverse. 4 It is not clear whether the Examiner maintains this rejection under 35 U.S.C. Â§ 112(a); therefore, we address the rejection here in the event that the rejection is maintained. It does appear that the Examiner withdrew the rejection of claim 24 under 35 U.S.C. Â§ 112(b) based on the statement in the Jan. 17, 2018 Applicant-Initiated Interview Summary that the "rejection will be withdrawn." Therefore, we do not address theÂ§ 112(b) rejection. 3 Appeal2019-000315 Application 15/103,791 Obviousness The Examiner finds that Porter teaches a method for treating vasculature abnormalities, such as an aneurysm, by administering an embolization composition comprising cyanoacrylate and radiopacifier powder. Final Act. 7 ( citing Porter abstract, ,r,r 6-10). The Examiner also finds that Porter teaches that the radiopacifier powder has sub-micron sized particles and high x-ray absorbance and that the composition has a viscosity between 25 cP and 2,000 cP. Id. ( citing Porter ,r,r 6, 14, 15). The Examiner concedes that Porter does not explicitly teach the claimed particle size and relies on Jackson for this disclosure. Id. at 8. Specifically, the Examiner finds that Jackson teaches "gold nanoparticles (AuNPs) as contrast enhancement in radiological imaging" using nanoparticles of a size of 4-30 nm. Id. (citing Jackson 243). The Examiner concludes: Id. Therefore, it would have been obvious to one having ordinary skill in the art at before the effective filing date of the present invention to provide emobilizing composition comprising cyanoacrylate polymer and radiopacifier of gold particles of sub-micron size as taught by Porter, and use AuNPs having diameter of 4-30 nm taught by Jackson in the emobilizing composition. One would have been motivated to do so because Porter desired to include the radiopacifier to visualize the composition during injection by x-ray, and because Jackson teaches that AuNPs are ideal as radiopaque contrast agent because of their biocompatibility, and nanoparticles of size of 4-30 nm have maximum stability without affecting the size on contrast enhancement. One would reasonably expect formulating biocompatible emobilizing composition comprising cyanoacrylate polymer and AuNPs having diameter of 4-30 nm wherein the composition has maximum stability and wherein the particle sizes does not affect the contrast enhancement. 4 Appeal2019-000315 Application 15/103,791 1. Claims 1-5, 9-15, 19, and 20 Appellant argues that there would have been no apparent reason that would have caused one of ordinary skill in the art to modify the applied references to arrive at the claimed subject matter. App. Br. 8. Specifically, Appellant argues that Jackson does not describe that stability results from a particle size of 4--30 nm but, rather, describes nanoparticle-based contrast agents in this size range "'can be synthesized for maximum stability or cell specificity ( directed cellular uptake) without consideration of effect of size on contrast enhancement,' and Jackson specifically describes '[h]ydrophobised gold nanoparticles stabilised by hexadecylamine,' and 'PVA polymer-stabilised gold nanoparticles[.]"' Id. at 9 (citing Jackson 244). Therefore, Appellant argues that "Jackson's stabilization is a consequence of chemical treatment, rather than particle size" and the "mere description that nanoparticles may have a size of 4--30 nm does not provide a legally sufficient motivation for a person having ordinary skill in the art to modify the radiopacifier particles of Porter to have such a size." Id. Appellant further asserts that even if there would be an apparent reason to modify Porter in view of Jackson, "Porter fails to recognize or suggest the criticality of particle sizes recited by claim 1." Id. at 10. Appellant argues that the specification describes an unexpected result illustrating the criticality of the claimed range by describing that particles having a particle size of "15-500 nm ... or greater size ... surprisingly, tend to sink to the bottom and agglomerate as well." Id. (citing Spec. ,r 67). Appellant argues that "the Examiner has failed to articulate a reason with rational underpinning as to why a person having ordinary skill in the art would have modified Porter's particles to have an upper limit of particle size 5 Appeal2019-000315 Application 15/103,791 of 15 nm in particular, without impermissibly relying on Appellant's own disclosure." Id. We are not persuaded by Appellant's arguments. With respect to the nanoparticle size, Jackson discloses that gold nanoparticles in the size range of 4--30 nm can effectively be used as contrast enhancement in radiological imaging. Jackson 243. Therefore, one of skill in the art would have been motivated to use nanoparticles of this size with the embolizing composition disclosed in Porter with a reasonable expectation of success. "A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art." In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). With regard to Appellant's argument that the specification teaches that particles with particle sizes greater than 15 nm surprisingly tend to sink to the bottom and agglomerate, it would have been obvious to one of skill in the art to optimize the particle size to prevent such agglomeration. See In re Aller, 220 F.2d 454, 456 (CCP A 1955) ("[W]here 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 experimentation."). Such optimization is recognized in Porter which states that "[t]he amount and size of the particles can be determined by one with skill in the art in the manner that is suitable for fluoroscopic visualization of the embolic material during injection through a suitable device, such as a microcatheter, and for achieving the desired stability of the suspended particulates." Porter ,r 55. Similarly, Jackson states that "[w]e advise that for design of prospective nanoparticulate contrast media in this measured size range, particle diameter and shape be tailored to achieve optimal safety and retention profiles." 6 Appeal2019-000315 Application 15/103,791 Jackson 248. Furthermore, Appellant does not provide comparative evidence of unexpected results relative to the closest prior art. See In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) ("[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art."). Appellant also asserts that the viscosity of 50-2,000 cP described by Porter is significantly broader than the viscosity of between about 1,000 cP and 2,000 cP as recited in claim 1 and that one of ordinary skill in the art would not have readily envisioned employing the "much narrower" viscosity range of the claims. Id. Similarly, we are not persuaded by Appellant's arguments. The Examiner has established that Porter discloses a radiopaque cyanoacrylate composition with a viscosity range of 50-2,000 cP, which overlaps with the claimed range of about 1,000 to about 2,000 cP. "In cases involving overlapping ranges, we and our predecessor court have consistently held that even a slight overlap in range establishes a prim a facie case of obviousness." Peterson, 315 F.3d at 1329. Furthermore, although Appellant argues that the viscosity range disclosed in Porter is broader than the claimed range, Appellant has not submitted evidence establishing criticality of the claimed range or comparing representative samples of the claimed compositions with representative samples of the compositions disclosed in the prior art to establish unexpected results, nor is there such exemplification in Appellant's specification. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. These cases have consistently held that in such a 7 Appeal2019-000315 Application 15/103,791 situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F. 2d 1575, 1578 (Fed. Cir. 1990). Consequently, we do not find Appellant has established unexpected results or other criticality of the claimed range. For the foregoing reasons, Appellant does not persuade us that the Examiner erred in rejecting claim I for obviousness over Porter and Jackson. Claims 2----5, 9, and 10 are not argued separately and fall with claim 1. See 37 C.F.R. Â§ 4I.37(c)(l)(iv). With respect to independent claim 11, the Examiner finds that "the method requires only the step of mixing the ingredients that [are] implied by Porter." Final Act. 11. Appellant makes the same arguments as those made for claim 1. App. Br. 15-16. Therefore, for the reasons stated above with respect to claim 1, we are also not persuaded that the Examiner erred in rejecting claim 11 for obviousness over Porter and Jackson. Claims 12----15, 19, and 20 are not argued separately and fall with claim 11. See 37 C.F.R. Â§ 4I.37(c)(l)(iv). 2. Claims 6 and 16 Claim 6 recites the composition of claim 1, "wherein the composition has a shelf life without the nanoparticles agglomerating in the composition of greater than about two weeks." App. Br. 20. Claim 16 recites the same shelf-life limitation with respect to a method of using the composition. Id. at 21. The Examiner finds that because the cited references teach the composition of claim 1 ( and method of claim 11 ), "it is expected that the composition would display the same property, such as absence of 8 Appeal2019-000315 Application 15/103,791 agglomeration and shelf-life, since materials and their properties are inseparable." Final Act. 9-10. Appellant argues that the references do not teach the composition of claim 1 and that "the Examiner has not established that a person having ordinary skill in the art, by modifying Porter's composition in view of Jackson, would have arrived at a composition having a shelf life of greater than two weeks." App. Br. 12-13. We are not persuaded by Appellant's argument. As discussed above, one of skill in the art could optimize the particle size of the nanoparticles to reduce agglomeration, thereby optimizing the shelf life of the composition. Furthermore, with regard to viscosity, Appellant has not demonstrated that the claimed viscosity range is more beneficial than the range provided in Porter with respect to shelf-life. For the foregoing reasons, Appellant does not persuade us that the Examiner erred in rejecting claims 6 and 16 for obviousness over Porter and Jackson. 3. Claims 7 and 17 Claim 7 recites the composition of claim 1 "wherein the nanoparticles include a surface treatment configured to prevent surface oxidation." App. Br. 20. Claims 17 recites the same "surface treatment" limitation with respect to the method of using the composition. Id. at 22. The Examiner finds that Porter teaches that the radiopaque particles are surface modified using thiol compounds to improve the stability of the particles within the composition, just as the specification discloses surface treatment using thiol compounds as a capping agent. Final Act. 7, 10 ( citing Porter ,r 57). In response, Appellant argues: Firstly, Porter's use of thiol as a coupling agent is different from a surface treatment by a thiol ( where the thiol would be at 9 Appeal2019-000315 Application 15/103,791 the surface). Instead, the thiol of Porter is not exposed or at a surface, and is instead coupled between C6 polymers and the surface. Secondly, the Examiner has not established that a person having ordinary skill in the art would have understood thiol coupling a C6 polymer to a surface would have resulted in "a surface treatment configured to prevent surface oxidation," as recited by claim 7. To the extent the Examiner relied on Appellant's description of "surface treatment of [] nanoparticles with a capping agent or other method to avoid surface oxidation," and "treating the particles surface with 1- decanethiol for surface capping," such description is of surface capping with a thiol, not coupling a different species to a surface. Such surface capping is different from the coupling described by Porter. App. Br. 13-14 (internal citations omitted). We are not persuaded by Appellant's argument. The specification at paragraph 72 describes a "surface treatment of the nanoparticles with a capping agent or other method to avoid surface oxidation." Spec. ,r 72. The following paragraph of the specification then appears to provide specific examples of such surface treatments by listing agents that "modify the surface chemistry of the particles," including a modification by thiol coupling to Au. Spec. ,r 73. Porter discloses the same list of surface treatments of the radiopaque particles (compare Porter ,r 57 to Spec. ,r 73), including thiol coupling to Au. Porter ,r 57. Therefore, the Examiner reasonably finds that the thiol coupling to Au disclosed in Porter is a surface treatment configured to prevent surface oxidation as required by claim 7. This finding shifted the burden to Appellant to demonstrate, with evidence, that the surface modifications disclosed in Porter do not prevent surface oxidation. Appellant provides no such evidence. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) ("Where, as here, the claimed and prior art products are identical or substantially identical ... the PTO can require an 10 Appeal2019-000315 Application 15/103,791 applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product."). Although Appellant argues that such thiol coupling is different than thiol capping and does not necessarily prevent surface oxidation, they have not provided sufficient information to explain why this is the case nor to explain why the surface modifications disclosed in paragraph 73 of the specification ( and in paragraph 57 of Porter) are different than the surface treatments disclosed in paragraph 72 of the specification. For the foregoing reasons, Appellant does not persuade us that the Examiner erred in rejecting claims 7 and 17 for obviousness over Porter and Jackson. 4. Claims 8 and 18 Claim 8 recites the composition of claim 7, "wherein the surface treatment comprises a capping agent." App. Br. 20. Claim 18 recites the same "capping agent" limitations with respect to the method claim. Id. at 22. As discussed above, the Examiner finds that "Porter teaches thiol treatment of the surface of metal particles, and applicants disclosed surface treatment using thiol compounds as a capping agent." Final Act. 10. Specifically, the specification states that "1-decanethiol is a capping agent used to repeal electric surface charges and to avoid surface particle agglomeration." Spec. ,r 134. Appellant argues that "[t]o the extent the Examiner has taken the position that Porter's C6 polymers coupled to the particles constitutes surface capping, Porter fails to disclose or suggest that the C6 polymers prevent surface oxidation." Ans. 15. 11 Appeal2019-000315 Application 15/103,791 As discussed above, Appellant has not demonstrated, with evidence, that the surface modifications disclosed in Porter do not prevent surface oxidation. Furtherrnore, use of capping agents on nanoparticles is known as shown, for example, in Jackson. ("The effect of nanopmiicle size and capping agent (surfactant) on changes in attenuation coefficient, as relevant to X-ray absorption spectroscopy (XAS), has been well documented." Jackson 244). Porter similarlv discloses the addition of a surfactant as a , ~ possible surface treatment. Porter ,-r 57. For the foregoing reasons, Appellant does not persuade us that the Examiner erred in rejecting claims 8 and 18 for obviousness over Porter and Jackson. 5. Claims 21-24 Claim 21 recites a method of injecting the claimed composition into a body lumen of a patient. App. Br. 22. The Examiner finds that Porter teaches injection of the composition disclosed therein to a vessel that is obviously an artery or vein. Final Act. 10. Appellant argues that the Examiner erred for the same reasons discussed for claim 1. Therefore, for the reasons explained above for claim 1, Appellant does not persuade us that the Examiner eITed in rejecting claim 21 for obviousness over Porter and Jackson. Claims 22----24 are not argued separately and fall with claim 1. See 37 C.F.R. Â§ 4I.37(c)(l)(iv). CONCLUSION We reverse the Examiner's written description rejection of claims 1- 24. We affirm the Examiner's obviousness rejection of claims 1-24. 12 Appeal2019-000315 Application 15/103,791 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 13