Ex Parte TienDownload PDFPatent Trial and Appeal BoardJun 26, 201712888245 (P.T.A.B. Jun. 26, 2017) Copy Citation United States Patent and Trademark Office 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 12/888,245 09/22/2010 Robert Tien 3054CIP-2 4070 29141 7590 06/28/2017 Brundidge & Stanger, P.C./SLG 1925 BAT .TENDER AVENUE, STE. 560 Alexandria, VA 22314 EXAMINER COOK, CHRISTOPHER L ART UNIT PAPER NUMBER 3737 NOTIFICATION DATE DELIVERY MODE 06/28/2017 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): mail@brundidge-stanger.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ROBERT TIEN1 Appeal 2016-007640 Application 12/888,245 Technology Center 3700 Before DONALD E. ADAMS, JOHN G. NEW, and JOHN E. SCHNEIDER, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL appellant states the real party-in-interest is the named inventor, Robert Tien. App. Br. 3. Appeal 2016-007640 Application 12/888,245 SUMMARY Appellant files this appeal under 35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claims 1, 5, 7, and 8. Specifically, claims 1, 5, and 7 stand rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over the combination of E.C. Unger et al., Gene Delivery using Ultrasound Contrast Agents, 18(4) Echocardiography, 355—61 (2001) (“Unger”), Urquhart et al. (US 2005/0049486 Al, March 3, 2005) (“Urquhart”), Liang et al. (US. 2003/0208116 Al, November 6, 2003) (“Liang”), Cath Lab Digest, GE Medical Systems Receives FDA Clearance for Software that Fuses 3D X-ray and MR images of the Brain, Clinical and Industry News, March 30, 2015, http://www.cathlabdigest.com/ articles/Clinical-and-lndustry-News-26 (“Cath Lab”), GE Medical Systems: GE Medical Systems Introduces Revolutionary X-ray Technology: GE Advantx LCA + System Helps Treat Blood Vessel Diseases Linked to Heart Attacks and Strokes, Press Release, (“GE Press Release), Wood et al., US 2007/0167806 Al, July 19, 2007) (“Wood”), Nolte et al. (US 2002/0120192 Al, August 29, 2002) (“Nolte”), Takayama (US 5,123,404, June 23, 1992) (“Takayama”), and Zhu (US 6,264,610 Bl, July 24, 2001) (“Zhu”).2 2 The Examiner also rejected claims 1 5, 7, and 8 as unpatentable under 35 U.S.C. § 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter. Final Act. 2. The Examiner has withdrawn the rejection of independent claim 1 and dependent claims 5 and 8 on this ground. Ans. 2. However, the Examiner maintains the rejection of dependent claim 7 because the claim was dependent on canceled claim 6 and has not been amended by Appellant to be dependent on independent claim 1 and because the claim term “the liquid” of claim 7 lacks proper antecedent basis. See Ans. 2; Final Act. 3. Because Appellant does not address these issues, we summarily affirm the rejection of claim 7 upon 2 Appeal 2016-007640 Application 12/888,245 Claim 8 stands rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over the combination of Unger, Urquhart, Liang, Cath Lab, GE Press Release, Wood, Takayama, Zhu, and Unger et al. (US 2001/0031740 Al, October 18, 2001) (“Unger 2”) We have jurisdiction under 35 U.S.C. § 6(b) We AFFIRM. NATURE OF THE CFAIMED INVENTION Appellant’s invention is directed to a method and system for leading macromolecule substances into target cells, which includes an image picking unit, an image merging unit, an injection unit, and an energy conversion module. Abstract. REPRESENTATIVE CLAIM Claim 1 is representative of the claims on appeal and recites: 1. A system for leading macromolecule substances into target cells, comprising: an imaging device configured to pick up three- dimensional (3D) structure images of tissue that includes the target cells, wherein the imaging device is any of a computed tomography (CT) device and a magnetic resonance imaging (MRI) device; a blood vessel photographic device configured to pick up 3D blood vessel photographic images of the tissue, wherein the blood vessel photographic device injects a developer into at least one blood vessel surrounding the tissue and simultaneously captures consecutive snapshots of the at least one blood vessel to this ground. See 37 C.F.R. § 41.37(c)(iv) (Claims not argued are considered waived). 3 Appeal 2016-007640 Application 12/888,245 provide the 3D blood vessel photographic images of the tissue, wherein the 3D structure images are merged into the 3D blood vessel photographic images, wherein the merged images are used to choose a blood vessel passage that fully covers the target cells; an injection unit configured to inject artificial blood along the chosen blood vessel and to inject the macromolecule substances into the tissue; an ultrasonic wave conversion module configured to exert energy on the artificial blood thereby activating tiny bubbles to perform biological effects which form non-permanent holes in cell membranes of the target cells for leading the macromolecule substances into the target cells, wherein the ultrasonic wave conversion module comprises a base portion, an ultrasound dispersion unit, and an imaging guided robotic arm, wherein the ultrasound dispersion unit comprises a circular disk with eight symmetrically positioned low energy transducers located on a peripheral of the circular disk and a B-Mode diagnostic transducer located in a center of the circular disk, wherein the B- Mode diagnostic transducer has a diameter between 3 to 5 centimeters (cm) and a maximal depth of penetration between 20 to 30 cm. App. Br. 14. ISSUES AND ANALYSIS We herein agree with, and adopt, the Examiner’s findings and conclusion that the appealed claims are obvious over the cited prior art references. We address the arguments raised by Appellant on appeal below. 4 Appeal 2016-007640 Application 12/888,245 Issue 1 Appellant argues the Examiner erred in finding that Unger teaches the limitation of claim 1 reciting “inject[ing] artificial blood along the chosen blood vessel.” App. Br. 8. Analysis The Examiner finds, in relevant part, that Figure 5 of Unger teaches a liquid perfluorocarbon gene carrier, which the Examiner, using the broadest reasonable interpretation of the claim term, interprets as corresponding to the claimed “artificial blood.” Final Act. 4. The Examiner reasons the liquid perfluorocarbon gene carrier may be broadly and reasonably interpreted as artificial blood because (1) it performs a therapeutic/immune function (i.e., a function that human blood performs); and (2) because Appellant’s Specification expressly discloses that: “An example of artificial blood is perfluorocarbon (PFC) nanoemulsions.” Id. (citing Spec. 1 53). Appellant argues that the “liquid perfluorocarbon gene carrier” taught by Unger is not equivalent to the “perfluorocarbon nanoemulsions” recited by Appellant’s Specification as an example of artificial blood. App. Br. 8. According to Appellant, although both devices comprise perfluorocarbon, a nanoemulsion is defined as “oil-in-water (o/w) emulsions with mean droplet diameters ranging from 50 to 1000 nm.” Id. (citing AZO Nano website, http://www.azonano.com/article.aspx?Articlel0= 1244). By comparison, Appellant argues, a gene carrier is not limited in size and also does not include an emulsion layer, such as a nanoemulsion. Id. 5 Appeal 2016-007640 Application 12/888,245 The Examiner responds that, even assuming, arguendo, that a liquid perfluorocarbon gene carrier is not equivalent to a perfluorocarbon nanoemulsion, the claim recites only “inject[ing] artificial blood,” and does not require injecting a perfluorocarbon nanoemulsion. Ans. 3. The Examiner again points to Appellant’s Specification’s disclosure that: “What is meant by artificial blood is that it fulfills some functions of biological blood, especially in humans.” Id. (citing Spec. 1 53). The Examiner finds Unger's liquid perfluorocarbon gene carrier reads on the claimed limitation of injecting artificial blood, in its broadest reasonable interpretation, because it performs a therapeutic or immune function (i.e., a function that human blood performs), as defined in Appellant’s Specification. We agree with the Examiner. Appellant’s Specification provides no explicit definition of the claim term “artificial blood,” other than its disclosure that: “What is meant by artificial blood is that it fulfills some functions of biological blood, especially in humans.” Spec. 1 53. The Specification provides an exemplary definition of such blood as: “An example of artificial blood is perfluorocarbon (PFC) nanoemulsion. The artificial blood has a pretty small volume about 150 nanometer, so that capillary vessel would not be jammed, and the artificial blood would not enter into the apertures between the blood vessels.” Id. Appellant’s Specification thus provides a single example of artificial blood, but one that does not further limit the Specification’s disclosure that artificial blood must “fulfill[ ] some functions of biological blood, especially in humans.” Unger teaches a: Liquid perfluorocarbon gene carrier. The outer surface is stabilized by amphipathic lipid. Targeting ligands have been incorporated onto the head groups of the lipids. The genetic 6 Appeal 2016-007640 Application 12/888,245 material is stabilized by cationic lipids. Electron microscopy studies have shown that the DNA is condensed as an electron- dense granule within the center of the nanoparticle. The diameter of these particles is about 100-200 nanometers. Unger Fig. 5 (caption); see also Fig 3 (depicting “The effects of cavitation on microvascular permeability. Nanospheres and drugs can be delivered into the interstitium as the microbubbles cavitate. This process can be used to improve local drug delivery”). We agree with the Examiner’s finding that Unger thus teaches “artificial blood,” as defined by Appellant’s Specification. Unger teaches artificially-constructed gene delivery vehicles that can be delivered via the microvasculature of the cardiovascular system to deliver drugs at target sites. We find that this corresponds, broadly and reasonably, with “fulfill[ing] some functions of biological blood,” as required by Appellant’s Specification, viz., the delivery of compounds and messengers via the circulatory system. We are therefore not persuaded by Appellant’s arguments upon this issue. Issue 2 Appellant argues the Examiner erred in finding the combined cited prior art references teach or suggest the limitation of claim 1 reciting: “wherein the ultrasound dispersion unit comprises a circular disk with eight symmetrically positioned low energy transducers located on a peripheral of the circular disk.” App. Br. 9. 7 Appeal 2016-007640 Application 12/888,245 Analysis The Examiner finds, inter alia, the arrangement/size of transducer arrays used to facilitate gene transfection/ultrasound imaging is an obvious design choice in the absence of showing any criticality of unexpected result. Final Act. 9 (citing e.g., Wood ]Hf 20-21). The Examiner also finds Takayama teaches therapeutic ultrasound transducers in which the transducer array includes at least eight symmetrically positioned transducers. Final Act. 10 (citing Takayama Fig. 7). The Examiner also finds Zhu teaches a multi-measurement probe having a transducer array located in the center wherein transducer elements appear to have about a 3 cm diameter. Id. (citing Zhu Fig. 3). Appellant disagrees with the Examiner’s finding that Takayama teaches that “the ultrasound dispersion unit comprises a circular disk with eight symmetrically positioned low energy transducers located on a peripheral of the circular disk” at Fig. 7. Ans. 9. Appellant argues that, although Takayama teaches a plurality of transducers that are fitted within holes of the supporting member 10, the piezoelectric elements (i.e., transducers) are arranged across the entire supporting member, and not just on the peripheral of the circular disk as required by the claim 1. Id. (citing Takayama Fig. 7). Furthermore, argues Appellant, there is no teaching of the piezoelectric elements being low energy, or a specific number (eight) of such elements being utilized; indeed, Appellant notes Figure 7 of Takayama appears to depict more than eight transducers. Id. The Examiner responds that the arrangement/size of transducer arrays used to facilitate gene transfection/ultrasound imaging may be considered to be an obvious design choice, in the absence of Appellant’s showing any 8 Appeal 2016-007640 Application 12/888,245 criticality of unexpected result. Ans. 5. The Examiner points especially to Wood, which teaches that the same end result of the claimed invention (i.e., gene transfection or sonoporation) can be achieved by other transducer arrays. Id. The Examiner further finds, by way of example, that Nolte teaches a conventional relationship between transducer diameter, operating frequency and target depth. Id. (citing Nolte Tflf 21—22). Nevertheless, the Examiner further finds, Takayama teaches, with respect to therapeutic ultrasound transducers, a transducer array includes at least eight symmetrically-positioned transducers. Ans. 5 (citing Takayama Fig. 7, col. 5,11. 6-26). The Examiner also finds that Zhu depicts a multi-measurement probe having a transducer array located in the center, in which the transducer elements have approximately a 3 cm diameter. Ans. 6 (citing Zhu Fig. 3). The Examiner finds that Zhu teaches that the operating frequency for transducer array 12 is 6 MHz which is considered to result in a 20-30 cm maximal depth of penetration, as disclosed by Appellant’s Specification. Id. (citing Zhu col. 4, LL. 1—20; Spec. 142). The Examiner therefore concludes that a person of ordinary skill in the art would have been motivated to have modified the transducer arrangement described by Wood with any well-established/conventional, predictable transducer arrangement (i.e., size/position) and configuration settings (i.e., frequency) in order to selectively image and treat target areas within the body. Ans. 6. We are not persuaded by Appellant’s arguments. Figure 7 of Takayama is reproduced below: 9 Appeal 2016-007640 Application 12/888,245 Figure 7 of Takavama depicts a top plan view of a plate for supporting ultrasonic transducers used in one embodiment of the disclosed invention Figure 7 depicts holes Ci-Cn for supporting ultrasound transducers arrayed concentrically on the circular disk, “with eight symmetrically positioned low energy transducers located on a peripheral of the circular disk,” as required by claim 1. It is true, as Appellant asserts, that Takayama also discloses additional transducers, both apparently arranged on the periphery and in the inner concentric rings, but the language of claim 1 does not preclude additional transducers located in the periphery, or in inner concentric rings. Moreover, we also agree with the Examiner that the precise number and location of ultrasound transducers would be a design choice well within the competence of a person of ordinary skill in this art. With respect to Appellant’s argument that Takayama fails to teach or suggest that the piezoelectric elements as being low energy, the Examiner relies upon Zhu as teaching that the operating frequency for transducer array 12 is 6 MHz which is considered to result in a 20—30 cm maximal depth of penetration, as disclosed by Appellant’s Specification. Id. (citing Zhu col. 4, 10 Appeal 2016-007640 Application 12/888,245 11. 1—20; Spec. 142). We consequently agree with the Examiner upon this issue. Issue 3 Appellant argues the Examiner erred by failing to support the combination of the nine cited references by providing some teaching, suggestion or motivation, in the prior art that would have led one of ordinary skill to modify the prior art references or to the combine prior art reference teachings to arrive at Appellant’s claimed invention. App. Br. 9—10. Analysis Appellant argues that, instead of identifying a teaching, suggestion or motivation to combine the references, the Examiner has identified only a “shared advantage” (i.e., an advantage that the recited claimed invention shares with the invention “as combined” from the nine prior art references. App. Br. 10. By way of Example, Appellant points to the Examiner’s finding that, when combining Unger, Urquhart, Liang, Cath Lab, and GE Press Release, the Examiner finds that the shared advantage of how the combination of references would “efficiently plan and target cells in need of therapy.” Id. (citing Final Act. 8). Therefore, argues Appellant, the Examiner has failed to provide any evidence that the “shared advantage” actually might have motivated one skilled in the art to combine the nine prior art references to arrive at the recited claimed invention. Id. Appellant argues further that the Examiner’s “shared advantage” test cannot qualify as a “reason to make the combination” under KSR Int 7 Co. v. 11 Appeal 2016-007640 Application 12/888,245 Teleflex Inc., 550 U.S. 398 (2007), because any combination that would arrive at an invention would always and necessarily share the same advantages as the Appellant’s claimed invention. Id. According to Appellant, if all combinations that reach the recited claimed invention always and necessarily share advantages with the recited claimed invention (because the combination is the recited claimed invention), then whenever an invention is a combination of prior art elements, all such inventions must be deemed unpatentable, which is an incorrect application of the obviousness test promulgated under KSR. Id. at 10-11. Appellant argues further that, under KSR, a rejection on obviousness grounds must be explicit in that it “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” App. Br. 11 (quoting KSR, 550 U.S. at 418 (citing In re Kahn, 441 F. 3d 977, 988 (Fed. Cir. 2006)). Appellant contends that, whereas the Examiner’s shared advantage test may loosely quality as “articulated reasoning,” it does not have the requisite rational underpinning since it cannot differentiate between obvious and nonobvious combinations. Id. Appellant accordingly asserts that it is irrational to employ an obviousness analysis that cannot possibly succeed in distinguishing obvious from nonobvious combinations because it is not only legally insufficient to support obviousness rejections by simply identifying a benefit or advantage that the suggested combination would share with the claimed invention, but it is also logically flawed because it fails to meet KSR’s “rational underpinning” requirement. App. Br. 11. 12 Appeal 2016-007640 Application 12/888,245 The Examiner responds that the number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. Ans. 8 (citing In re Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991)). As for the motivation to combine well-established, conventional pre operative imaging and planning steps to Unger’s targeted gene delivery, the Examiner concludes that: [A]t the time of the invention, it would have been obvious to a person of ordinary skill in the art to have modified the system and method for delivering (e.g., leading) macromolecule substances into target cells in vivo as described by Unger with well-known surgical planning steps of acquiring and merging diagnostic imaging data from multiple modalities or techniques (e.g. CT/MRI and X-Ray), as described by Urquhart, Fiang, [Cath Fab], and [t]he GE Press Release in order to efficiently plan and target cells in need of therapy. Ans. 7 (quoting Final Act. 8). The Examiner points out that the limitation reciting “to choose a blood vessel passage that fully covers the target cells” is not tied to a particular component of the system (i.e., a processor or algorithm) and is therefore considered to be a mental step taken by the surgeon to plan the catheterization procedure. App. Br. 7. Therefore, Examiner finds that the “appropriate” procedure planned by the surgeon using the imaging data as described above would include a step of choosing the blood vessel passage that fully covers the target cells, in its broadest reasonable interpretation. Id. The Examiner finds the motivation for enhancing the pre-operative planning and targeting (i.e., “efficiently planning”) cells in need of therapy with known, predictable techniques relates to examples (C) and (D), as set forth in MPEP § 2143. Id. 13 Appeal 2016-007640 Application 12/888,245 We are not persuaded by Appellant’s arguments. The Examiner finds that Unger teaches most of the limitations of claim 1, as well as the limitations that are most critical to Appellant’s claimed invention, viz.: [I]nject[ing] a developer into at least one blood vessel surrounding the tissue and simultaneously captur[ing] consecutive snapshots of the at least one blood vessel to provide the 3D blood vessel photographic images of the tissue [and] an ultrasonic wave conversion module configured to exert energy on the artificial blood thereby activating tiny bubbles to perform biological effects which form non-permanent holes in cell membranes of the target cells for leading the macromolecule substances into the target cells. See Final Act. 4—5 (citing Unger 355—360). As the Examiner states, the remainder of the references are cited to support the imaging and delivery of the sonoporation-inducing ultrasound, all of which are suggested by Unger and which are all well known in the art. See Final Act. 8, Ans. 7. Specifically, the Examiner concludes with respect to these latter references: [I]t would have been obvious to a person of ordinary skill in the art to have modified the system and method for delivering ([i.e.,] leading) macromolecule substances into target cells in vivo as described by Unger with well-known surgical planning steps of acquiring and merging diagnostic imaging data from multiple modalities or techniques (e.g. [,] CT/MRI and X-Ray) as described by Urquhart, Liang, [Cath Lab], and [t]he GE Press Release in order to efficiently plan and target cells in need of therapy. Final Act. 8. Similarly, with respect to the Wood, Takayama, Nolte, and Zhu references, the Examiner concludes: “[0]ne skilled in the art would have been motivated to use any known or conventional transducer 14 Appeal 2016-007640 Application 12/888,245 arrangement (e.g. [,] size/position) and configuration settings (e.g. [,] frequency) in order to selectively image and treat target areas within the body.” Final Act. 11. In summary, we agree with the Examiner that Unger teaches or suggests the principal inventive limitations of Appellant’s invention and that the rest of the references, relating to the limitations concerned with imaging, injection and delivery of ultrasound energy, are cited to include processes that are well known in the art. Moreover, we find that the Examiner has articulated a rational and reasonable underpinning to a motivation to combine the references, i.e., to clinically implement the teachings of Unger in such a fashion so as “to efficiently plan and target cells in need of therapy” and “to selectively image and treat target areas within the body.” Final Act. 8, 11. We therefore affirm the Examiner’s rejection of the claims. DECISION The Examiner’s rejection of claims 1, 5, 7, and 8 as unpatentable under 35 U.S.C. § 103(a) is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 15 Copy with citationCopy as parenthetical citation