Ex Parte OgisoDownload PDFPatent Trial and Appeal BoardMar 25, 201610569556 (P.T.A.B. Mar. 25, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 10/569,556 0212712006 7055 7590 03/29/2016 GREENBLUM & BERNSTEIN, PLC 1950 ROLAND CLARKE PLACE RESTON, VA 20191 FIRST NAMED INVENTOR Makoto Ogiso 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. P29315 7641 EXAMINER LOPEZ, LESLIE ANN ART UNIT PAPER NUMBER 3774 NOTIFICATION DATE DELIVERY MODE 03/29/2016 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): gbpatent@gbpatent.com greenblum.bernsteinplc@gmail.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MAKOTO OGIS0 1 Appeal2013-008481 Application 10/569,556 Technology Center 3700 Before EDWARD A. BROWN, BRANDON J. WARNER, and FREDERICK C. LANEY, Administrative Patent Judges. LANEY, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Makoto Ogiso (Appellant) appeals under 35 U.S.C. § 134(a) from the Examiner's decision to reject claims 1, 2, 5, 6, 9, 10, 14, 17-19, 22, and 25- 28. Br. 6. Claims 7, 8, 20, and 11 have been canceled. Id. Claims 3, 4, 11- 13, 15, 16, 23, and 24 have been withdrawn. Id. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 According to Appellant, the Real Party in Interest is Pentax Corporation. Br. 4. Appeal2013-008481 Application 10/569,556 CLAIMED SUBJECT MATTER The subject matter of Appellant's application generally relates to "a porous or surface roughened structure suitable for artificial bones and dental roots and its production method, particularly to a porous or surface roughened structure of a biocompatible material impregnated with fine bone powder and its production method." Spec. 1:6-10.2 Claims 1 and 17 are independent. Claim 1 is illustrative of the claimed subject matter, and recites: 1. A bone-powder-impregnated, porous structure comprising a porous matrix made of a biocompatible material impregnated with fine living bone powder obtained by pulverizing living bones and/or teeth, wherein the fine living bone powder comprises sub-micron particles. EVIDENCE The Examiner relies upon the following evidence: Takagi Kagechi Boyce Levine Smith us 4;654;314 us 5, 134,031 us 5,899,939 US 2003/0220696 Al US 2004/0253279 Al REJECTIONS Mar. 31; 1987 July 28, 1992 May 4, 1999 Nov. 27, 2003 Dec. 16, 2004 The Examiner rejects claims 1, 2, 5, 6, 9, 10, 14, 17-19, 22, and 25- 28 as follows: 2 Our citations to the Specification herein are in reference to the "Substitute Specification" received February 27, 2006. 2 Appeal2013-008481 Application 10/569,556 l. claims 1, 2, 5, 6, 9, 10, 14, 17-19, 22, and 25-28 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement; II. claims 1, 2, 5, 6, 9, 10, 14, 17-19, 22, and 25-28 under 35 U.S.C. § 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter Appellant regards as the invention; III. claims 1, 9, 10, 14, 17, 22, and 25 under 35 U.S.C. § 103(a) as being unpatentable over Boyce and Kagechi; IV. claims 1, 2, 5, 6, and 17-19 under 35 U.S.C. § 103(a) as being unpatentable over Smith, Boyce and Kagechi; V. claim 26 under 35 U.S.C. § 103(a) as being unpatentable over Boyce, Kagechi, and Takagi; and VI. claims 27 and 28 under 35 U.S.C. § 103(a) as being unpatentable over Boyce, Kagechi, and Levine. ANALYSIS Rejection I The Examiner finds the Specification fails to provide evidence Appellant incorporated "living bone powder" into the disclosed invention because the Specification repeatedly uses the phrases "bone powder" and "fine bone powder" without demonstrating the references to those phrases apply to "living bone powder." Final Act. 3; Ans. 3-5. According to the Examiner, the Specification only uses "living bone powder" in one instance to describe the storage conditions of "living bone powder", but does not tie "living bone powder" to the discussions of "bone powder" or "fine bone 3 Appeal2013-008481 Application 10/569,556 powder" associated with the disclosed invention. Final Act. 3. As such, the Examiner concludes the claimed "living bone powder" constitutes new matter. Id. Appellant contends the Specification supports the phrase "living bone powder" and demonstrates Appellant's possession of the presently claimed invention. Br. 10-13. We agree. In the "Disclosure of the Invention" section of the Specification, Appellant describes the "bone-powder- impregnated, porous structure" as "impregnated with fine bone powder obtained by pulverizing living bones and/or teeth." Spec. 5:5-8, 6:5---6. In addition, in "The Best Mode for Carrying out the Invention" section, Appellant identifies various examples of bones, teeth, and how the bone powder is prepared. Id. at 12:25-13:27. In the claims, "living bone powder" is likewise described as being "obtained by pulverizing living bones and/or teeth." Br. 59 (Claims App.). Although the Specification uses the phrase "fine bone powder" instead of "living bone powder", this can demonstrate to a skilled artisan that Appellant had invented what is now claimed. Simply because the same words are not used in both the Specification and the claims does not, in and of itself, demonstrate a failure to satisfy the "written description" requirement. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995) ("In order to determine whether a prior application meets the 'written description' requirement with respect to later-filed claims, the prior application need not describe the claimed subject matter in exactly the same terms as used in the claims; it must simply indicate to persons skilled in the art that as of the earlier date the applicant had invented what is now claimed."). 4 Appeal2013-008481 Application 10/569,556 In the Answer, the Examiner "notes any tissue once removed from the body of the donor immediately starts dying" and "[t]he only point at which all bone implants can be considered living, under the ordinary meaning of the word living, is while they remain in a living donor." Ans. 4 (emphasis added). Furthermore, according to the Examiner, "the process of freezing kills cellular tissue." Id. As a result, the Examiner concludes "any bone powder used after a freezing process would be considered without living tissue to an artisan of ordinary skill in the art." Id. There are several issues with the above analysis. First, with respect to core factual findings in a determination of patentability, an Examiner cannot establish a prima facie case based on conclusions simply deemed to be basic knowledge or common sense. In re Zurko, 258 F.3d 1379, 1385-86 (Fed. Cir. 2001). Rather, the Examiner "must point to some concrete evidence in the record in support of those findings." Id. The above findings by the Examiner are not based on any evidence in the record and, therefore, lack evidentiary support and have little, if any, probative value. Second, the Examiner's analysis appears directed to enablement rather than written description. Written description and enablement are separate requirements under 35 U.S.C. § 112, first paragraph. Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). As such, they require different evaluations. See id. at 1352. Written description requires an evaluation of whether the Specification "clearly allows persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed." Id. at 1351. Enablement requires an evaluation of whether the Specification allows a skilled artisan to make and use the claimed invention 5 Appeal2013-008481 Application 10/569,556 without undue experimentation. See id. at 1352; see also United States v. Telectronics, Inc., 857 F.2d 778, 785 (Fed. Cir. 1988) (The enablement test evaluates "whether one reasonably skilled in the art could make or use the invention from the disclosures in the patent [application] coupled with information known in the art without undue experimentation."). The Examiner's rejection is limited to "written description." See Final Act. 3. The Examiner's analysis, however, is directed to whether a skilled artisan can make or use "living bone powder" from bone that has been removed from its host and/or frozen, which is an enablement analysis. Setting aside whether, after being excised and frozen, "living bone" can remain "living" to make "living bone powder," because enablement is not before us, the Examiner notably does not explain why the Specification's description of "fine bone powder" as being "obtained by pulverizing living bones and/or teeth" is not sufficiently clear to evidence the inventor invented what is claimed- i.e., "living bone powder," which is bone powder obtained by pulverizing living bones and/or teeth. Therefore, because a preponderance of the evidence does not support the Examiner's written description rejection, we do not sustain that rejection of claims 1, 2, 5, 6, 9, 10, 14, 17-19, 22, and25-28. Rejection II The Examiner finds "living bone powder" is indefinite because "[i]t is unclear what constitutes living bone powder." Final Act. 4. As support, the Examiner offers the following analysis: All bone powder must be from some type of bone via a donor. As it is unclear what is meant by "living" in this case, it is also unclear at what point during processing bone powder is no longer 6 Appeal2013-008481 Application 10/569,556 considered "living". Lacking any evidence or reference that states a distinction and/ or differences between what is considered "living bone powder" and demineralized bone powder, it is the Examiner's position that "living bone powder" limitation is met [by] demineralized bone powder. Id. Further, regarding the claim language "obtained by pulverizing living bones and/or teeth," the Examiner notes that clause "does not provide a definition of what is meant by 'living bone powder', but rather provides a process by which 'living bone powder' is made." Ans. 6. Appellant asserts "living bone powder" is a structure defined by the process for making it. Br. 14. Regarding demineralized bone powder, Appellant maintains that the Specification never suggests "living bone powder" and "demineralized bone powder" are equivalent or interchangeable. Id. at 15. Appellant further points to the fact that the claims, as originally filed, made a clear distinction between the two by separately identifying "living bone powder" and "demineralized bone powder" in completely separate claims - e.g., original claims 7, 8, 20 and 21. Id. As such, Appellant asserts "bone powder obtained by pulverizing living bones and/or teeth was specifically contemplated and disclosed as a distinct embodiment from demineralized bone powder." Id. A claim satisfies the definiteness requirement of 35 U.S.C. § 112, second paragraph, when one skilled in the art understands the claim parameters as read in light of the specification. BJ Servs. Co. v. Halliburton Energy Servs., 338 F.3d 1368, 1372 (Fed. Cir. 2003) (quoting Union Pac. Res. Co. v. Chesapeake Energy Corp., 236 F.2d 684, 692 (Fed. Cir. 2001) ("The definiteness inquiry focuses on whether those skilled in the art would understand the scope of the claim when the claim is read in light of the rest of the specification.")). Defining a product in terms of the process used to 7 Appeal2013-008481 Application 10/569,556 make it does not necessarily make the identified product indefinite. Jn re Hughes, 496 F.2d 1216, 1218 (CCPA 1974). "[I]t is well established that product claims may include process steps to wholly or partially define the claimed product." In re Luck, 476 F.2d 650, 653 (CCPA 1973). Consistent with the Specification and plain meaning of the term, we are persuaded that a skilled artisan, in this case, would readily recognize the meaning of "living bone powder" as the resulting product derived from "pulverizing living bone and/or teeth." The Specification describes the "Preparation of bone powder" as taking bone pieces and/or teeth and breaking them down into a powder using a mortar and pulverizer. Spec. 13: 19-14: 15. In addition, the Specification provides an example in which, "Bone pieces were taken from the tibia of an adult dog by a trepan bar mounted to an electric dental engine, and pulverized in a physiological saline solution in an alumina mortar in a sterile environment." Id. at 23: 11- 13. The solution with the fine bone powder was then put into a centrifugal separator to separate the powder from the saline solution. Id. at 23: 13-20. Neither the Specification nor the claim language demonstrates ambiguity in the understanding of "living bone powder." The Examiner suggests there is some ambiguity about whether "living bone powder" excludes "demineralized bone powder." Ans. 6. The Examiner, however, does not offer any evidence, nor provide an explanation with a rational underpinning, demonstrating a skilled artisan would consider "living bone" and "demineralized bone" as equivalents or interchangeable. We note the Reddi et al., Proceeding of the National Academy of Sciences of the United States of America 69, pp. 1601-1605 (1972), paper does evidence, however, that a skilled artisan would recognize demineralized 8 Appeal2013-008481 Application 10/569,556 bone powder results from employing an acid solution to the bone to remove the mineralized organic matrix within a bone. See Br. 61 (Evidence App.) (hereinafter "the Reddi paper"). As such, the described process of "demineralizing" bone supports Appellant's contention that a skilled artisan understands living bone and demineralized bone are distinctly different because the mineralized organic matrix is obviously necessary for "living bone" and completely removing it would effectively remove (or kill) the living cells embedded in the mineralized organic matrix. Br. 21-22. The Examiner has also not established "living bone powder" is unclear simply because bone "starts dying" immediately after it has been removed from the donor. We note the Examiner has not asserted the term "living bone" used in the claims is indefinite. We note further the Reddi paper evidences the term "living bone" is a term used and understood by those skilled in the art. See Br. 64---65 (Evidence App.). Because the Examiner does not assert "living bone" is unclear and because the Reddi paper indicates "living bone" is an art-recognized term, the evidence shows a skilled artisan would know what is or is not "living bone." Opining that bone starts dying after being removed from the donor does not evidence ambiguity as to the meaning of "living bone powder." Ans. 6. To the contrary, it suggests the skilled artisan recognizes the bone is still "living" because it is not yet "dead." Also, to state the skilled artisan recognizes when bone is dying, presupposes the skilled artisan is also capable of determining the extremes at both ends of the process- i.e., living bone at one end and dead bone at the other. To the extent the Examiner is suggesting that it is basic knowledge or common sense to a skilled artisan that "living bone" cannot exist for any period of time outside its donor or 9 Appeal2013-008481 Application 10/569,556 after being frozen, the Examiner has not identified any evidence in the record to support such a finding and, therefore, it has little, if any, probative value. In re Zurko, 258 F.3d at 1385-86. Because "living bone powder" is the product of pulverized living bone and/ or teeth and because the Examiner has not demonstrated by evidence, or by articulating a reason with rational underpinnings, that a skilled artisan cannot identify living bone, the evidence in this record supports a determination that a skilled artisan understands the claim parameters. Therefore, we do not sustain the Examiner's indefiniteness rejection of claims 1, 2, 5, 6, 9, 10, 14, 17-19, 22, and 25-28. Rejection III Appellant raises two dispositive issues regarding the Examiner's obviousness rejection of independent claim 1. First, Appellant asserts the Examiner erred by relying on Boyce's disclosure of "demineralized bone powder" to satisfy the claimed "living bone powder" element. Br. 17-22. Second, Appellant asserts the Examiner erred by relying on Kagechi because it is non-analogous art. Br. 23-25. We agree with Appellant in both instances. Relying on Boyce to disclose "living bone powder," the Examiner "notes that demineralized bone powder is considered to meet the claim limitation because, lacking any definition of 'living' ... , the bone was living at the time it was still within the living source of the bone (the only known point at which all bone implants can be considered living under the ordinary meaning of the word living)." Ans. 8. Other than the demineralized bone powder, the Examiner does not identify any other bone composition from 10 Appeal2013-008481 Application 10/569,556 Boyce to purportedly satisfy the "living bone powder" limitation. As discussed above (see supra, Rejection II), "living bone powder" is the product of "living bone" pulverized into a powder and the evidence demonstrates a recognized difference between "living bone" and "demineralized bone." Consistent with this fact, Boyce also recognizes there are distinctions between fully mineralized bone and demineralized bone (partially and fully). See Boyce 3:41-57. As a result, simply pointing out that Boyce discloses demineralized bone powder, without something more, does not establish by a preponderance of the evidence that it was known to impregnate a porous structure with living bone powder. In addition, the Examiner's reliance on Kagechi was error. The Examiner finds Kagechi is "concerned with the same field of endeavor, namely pulverizing bone into powder." Final Act. 6; Ans. 11. According to the Examiner, "one skilled in bone powders would consider sources using bone powders and processes for making them." Although the Examiner references the test for determining whether a reference is outside the field of endeavor, no such analysis is performed. Ans. 11. Instead, the Examiner simply concludes Kagechi is analogous because it is in the "field of bone powders." Id. Determining whether prior art is analogous requires consideration of "(1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor's endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved." In re Clay, 966 F.2d 656, 658-59 (Fed. Cir. 1992). As the above criteria instructs, if the reference is within the same field of endeavor, then the problem being 11 Appeal2013-008481 Application 10/569,556 addressed by the inventor is irrelevant; however, if the reference is not within the same field of endeavor, then the reference must be "reasonably pertinent" to a problem facing the inventor. Precedent provides guidance as to when a reference is reasonably pertinent to the problem: A reference is reasonably pertinent if ... it is one which, because of the matter with which it deals, logically would have commended itself to an inventor's attention in considering his problem. If a reference disclosure has the same purpose as the claimed invention, the reference relates to the same problem, and that fact supports use of that reference in an obviousness rejection. Innovention Toys, LLC v. MGA Entm 't, Inc., 637 F.3d 1314, 1321 (Fed. Cir. 2011) (quoting Clay, 966 F .2d at 659). "The pertinence of the reference as a source of solution to the inventor's problem must be recognizable with the foresight of a person of ordinary skill, not with the hindsight of the inventor's successful achievement." Scientific Plastic Products, Inc. v. Biotage AB, 766 F.3d 1355, 1359 (Fed. Cir. 2014). Broadly stated, the field of endeavor for Appellant's invention is medical devices and, more specifically, medical devices related to inducing bone growth. Spec. 1:7-11, 4:26-5:2. Broadly stated, Kagechi's field of endeavor is textiles, and, more specifically, animal protein fiber composites. Kagechi 1:5-10. No explanation is provided about how or why the Examiner finds Kagechi' s "field of endeavor" is "bone powders" or "pulverizing bone into powder." Nor does the Examiner provide a reference to any supporting evidence within Kagechi to support such a finding. Although Kagechi discusses using animal protein powders, only one example of which includes pulverizing bones into very fine powder, it does so in the context of using 12 Appeal2013-008481 Application 10/569,556 the powder as an additive to further develop a fiber composite. Kagechi 1 :48-3:35. As such, rather than defining the field of endeavor, the pulverized bone is simply one example of an additive used within the field of textile materials. Textiles and medical devices are different fields of endeavor. Because Kagechi is in a different field of endeavor than the claimed invention, we next focus on the problems facing the inventor to determine whether a problem was of a nature that the attention of a skilled artisan facing such a problem would have been logically directed to Kagechi. Appellant describes the problems addressed as follows: [T]he technique of medically repairing large bone defects has not been established yet. In the case of using artificial dental roots in patients with advanced absorption and shrinkage of jawbone, too, a bone regeneration technique needing no living bone in a large amount is desired. Further, in the implantation of artificial bones and dental roots such as outer heads, etc. in the bone, they are required to be strongly integrated with the surrounding bone as soon as possible after the implantation. Spec. 4: 17-23. Put more succinctly, the problem facing the inventor was how to minimize the amount of living bone needed and still enable an implanted medical device to strongly integrate with the surrounding bone as soon as possible after the implantation. Kagechi describes the problems it addresses as follows: [M]ixing and kneading of natural leather powder with synthetic fiber material led to the poor spinning performance due to the adverse influence exerted on the spinning machine such as occurrence of clogging because the synthetic fiber becomes lacking in flexibility, poorer in elongation characteristics and thus liable to break. Moreover, the natural leather powder to be mixed and kneaded with the synthetic fiber material has a particle size only enough to pass through the 50 to 250 mesh sieve, the 13 Appeal2013-008481 Application 10/569,556 fiber must be designed to be considerably thick as compared with general fibers, thus resulting in "thick, hard and fragile" one. Furthermore, such composite fiber material was not applicable to actual textile products and was thus of little practical use because it is slow in moisture absorbing and desorbing speed, though its water-holding performance is improved. Kagechi 1 :29--45. Put another way, the problem facing Kagechi was how to create animal protein fiber composites with improved moisture absorptivity and permeability characteristics, capable of being freely knitted or woven, and good touch and feel qualities. Id. at 1:5-10, 48---64. What is noticeably absent from both Kagechi and Appellant's Specification is any discussion about a need or problem specific to bone powder or creating bone powder. In addition, the purposes for using the bone powder are completely different. Appellant uses bone powder to facilitate bone growth; whereas, Kagechi uses bone powder to improve the mechanical and physical characteristics of composite fibers. There is not enough evidence to support a finding that Kagechi is reasonably pertinent to the problems facing Appellant leading to the claimed invention. Therefore, the Examiner erred by relying on Kagechi as analogous art. Because we find identifying "demineralized bone powder" alone, without more, is insufficient to establish a prima facie case Boyce discloses "living bone powder," and because we find Kagechi is not analogous art, we do not sustain the Examiner's obviousness rejection of claim 1. Independent claim 1 7 has similar limitations as claim 1 and the Examiner relies on the same analysis to determine obviousness. As a result, and for the same reasons, we also do not sustain the Examiner's rejection of claims 9, 10, 14, 17, 22, and 25. 14 Appeal2013-008481 Application 10/569,556 Rejection IV The Examiner's rejection of claims 1, 2, 5, 6, and 17-19 as unpatentable over Smith, Boyce, and Kagechi also relies on the erroneous determination that Boyce and Kagechi disclose a porous structure "impregnated with fine living bone powder obtained by pulverizing living bones and/or teeth, wherein the fine living bone powder comprises sub- micron particles," which is a limitation in both independent claims 1 and 17. Final Act. 7-9. The Examiner's application of Smith in this rejection does not cure the deficiencies of the rejection discussed above (see supra Rejection III) for claim 1. Thus, we do not sustain the rejection of claims 1, 2, 5, 6, and 17-19 as unpatentable over Smith, Boyce, and Kagechi. Rejection V Claim 26 depends from claim 1. Br. 60 (Claims App.). The Examiner's rejection of claim 26 as unpatentable over Boyce, Kagechi, and Takagi is based on the erroneous determination that Boyce and Kagechi disclose a porous structure "impregnated with fine living bone powder obtained by pulverizing living bones and/or teeth, wherein the fine living bone powder comprises sub-micron particles," which is a limitation in independent claim 1. Final Act. 9. The Examiner's application of Takagi in this rejection does not cure the deficiencies of the rejection discussed above (see supra Rejection III) for claim 1. Thus, we do not sustain the rejection of claim 26 as unpatentable over Smith, Boyce, and Takagi. Rejection VI Claim 27 depends from claim 1 and claim 28 depends from claim 17. 15 Appeal2013-008481 Application 10/569,556 Br. 60 (Claims App.). The Examiner's rejection of claims 27 and 28 as unpatentable over Boyce, Kagechi, and Levine is based on the erroneous determination that Boyce and Kagechi disclose a porous structure "impregnated with fine living bone powder obtained by pulverizing living bones and/or teeth, wherein the fine living bone powder comprises sub- micron particles," which is a limitation in both independent claims 1 and 17. Final Act. 10. The Examiner's application of Levine in this rejection does not cure the deficiencies of the rejection discussed above (see supra Rejection III) for claim 1. Thus, we do not sustain the rejection of claim 26 as unpatentable over Smith, Boyce, and Levine. DECISION We reverse the decision of the Examiner to reject claims 1, 2, 5, 6, 9, 10, 14, 17-19, 22, and 25-28. REVERSED 16 Copy with citationCopy as parenthetical citation