Ex Parte Gentle et alDownload PDFPatent Trial and Appeal BoardAug 2, 201812382979 (P.T.A.B. Aug. 2, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/382,979 03/27/2009 147462 7590 Botos Churchill IP Law LLP 430 Mountain A venue Suite 401 New Providence, NJ 07974 08/06/2018 FIRST NAMED INVENTOR thomas Gentle 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. BECTON 3.0-151 DIV 8543 EXAMINER GAKH, YELENA G ART UNIT PAPER NUMBER 1797 NOTIFICATION DATE DELIVERY MODE 08/06/2018 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): rbotos@bciplaw.com ip.docket@bd.com pto@bciplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte THOMAS GENTLE, RICHARD MOORE, THOMAS WINEGAR, SONG SHI, and ZHE JIN Appeal2017-010280 Application 12/382,979 1 Technology Center 1700 Before KAREN M. HASTINGS, JAMES C. HOUSEL, and JEFFREY R. SNAY, Administrative Patent Judges. HOUSEL, Administrative Patent Judge. DECISION ON APPEAL A. STATEMENT OF THE CASE Appellants filed an appeal under 35 U.S.C. § 134(a) from the Examiner's final decision rejecting claims 36, 38, 42--47, and 54. 2 1 Appellants identify the real party in interest as Becton, Dickinson and Company. Appeal Brief (Appeal Br.) 1, filed March 6, 2017. 2 Claims 39--41, 48, 49, 51, 53, and 55-58 have been withdrawn from consideration. Final Office Action (Final Act.) 2, notice emailed October 6, 2016. Appeal2017-010280 Application 12/382,979 We have jurisdiction under 35 U.S.C. § 6(b). 3 We AFFIRM. The subject matter on appeal relates to specimen collection containers (see, e.g., claim 36). The Inventors disclose that great clinical interest has grown for proteins as drugs, drug targets, and biomarkers for a variety of diseases. Spec. ,r 3. According to the Inventors, tools have emerged for the analysis of proteins, but tedious and complicated front-end sample preparation is required, which limits the tools to research applications. Id. ,r,r 4--5. In view of this, the Inventors disclose a specimen collection container that includes a dendrimer internal standard. Id. ,r,r 15. The Inventors state this arrangement allows an investigator to correct for instrument variations and reduces the number of handling or processing steps required to analyze a sample, which reduces the chances for a sample to be lost and/or contaminated. Id. ,r,r 43, 60. Independent claim 36 is illustrative and is reproduced below from the Claims Appendix of the Appeal Brief. Limitations at issue are italicized. 36. A specimen collection container comprising: (a) an evacuated reservoir with an interior wall wherein the collection container is adapted to receive specimen into the evacuated reservoir; and (b) a known quantity of a dendrimer that serves as an internal standard for mass spectrometry located within the evacuated reservoir, wherein the evacuated reservoir of the container is evacuated prior to receiving the specimen by removal of at least a portion of the air from the reservoir. 3 Our Decision additionally refers to the Specification (Spec.) filed March 27, 2009, the Examiner's Answer (Ans.) dated May 31, 2017, and the Reply Brief (Reply Br.) dated July 29, 2017. 2 Appeal2017-010280 Application 12/382,979 REJECTIONS ON APPEAL 4 I. Claim 54 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement; II. Claims 36, 38, and 45--47 under 35 U.S.C. § I02(b) as being anticipated by Tomalia '524; 5 III. Claims 36, 38, and 45--47 under 35 U.S.C. § I02(b) as being anticipated by Dvomic; 6 IV. Claims 36 and 45--47 under 35 U.S.C. § I02(b) as being anticipated by Kim; 7 V. Claims 36, 38, 42--47, and 54 as being unpatentable under 35 U.S.C. § I03(a) over Stevens8 in view of Domanski; 9 and VI. Claims 36, 38, 42--47, and 54 as being unpatentable 4 The rejection of claims 36 and 47 under 35 U.S.C. § I02(b) as being anticipated by Mikael Trollsas et al., Conformational and Structural Properties of High Functionality Dendrimer-Like Star Polymers Synthesized from Living Polymerization Techniques, 153 MACROMOLECULAR SYMPOSIA 1-17 (2000) (http://www.slac.stanford.edu/cgi-wrap/getdoc/slac-pub- 8422.pdf) (last visited July 25, 2018), has been withdrawn by the Examiner. Ans. 2. 5 Tomalia et al., US 5,527,524, issued June 18, 1996 ("Tomalia '524"). 6 Dvomic et al., US 5,739,218, issued Apr. 14, 1998 ("Dvomic"). 7 Kim et al., US 2002/0020669 Al, published Feb. 21, 2002 ("Kim"). 8 Stevens et al., US 7,309,468 B2, issued Dec. 18, 2007 ("Stevens"). 9 D.M. Domanski et al., Influence of PAMAM Dendrimers on Human Red Blood Cells, 63 BIOELECTROCHEMISTRY 189-91 (2004) ("Domanski"). 3 Appeal2017-010280 Application 12/382,979 under 35 U.S.C. § 103(a) over Wilkinson10 in view of T omalia NPL 11 and Stevens. B. DISCUSSION Rejection I Claim 54 is rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. Claim 54 depends from claim 3 6 and further recites "wherein the dendrimer that serves as an internal standard is located in a capsule." The test for sufficiency of a written description is whether the disclosure "'clearly allow[s] persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.'" Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane) (quoting Vas- Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562---63 (Fed. Cir. 1991)). The disclosure must "reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Id. at 13 51. Possession means "possession as shown in the disclosure" and "requires an objective inquiry into the four comers of the specification from the perspective of a person of ordinary skill in the art." Id. The Examiner finds Appellants' disclosure does not provide support for claim 54 because the Specification discloses either an evacuated 10 William R. Wilkinson et al., Selection of Internal Standards for Quantitative Analysis by Matrix-Assisted Laser Desorption-Ionization (MALDI) Time-of-Flight Mass Spectrometry, 357 FRESENIUS' J. OF ANALYTICAL CHEMISTRY 241--48 (1997) ("Wilkinson"). 11D. A. Tomalia et al., Structure Control Within Poly(amidoamine) Dendrimers: Size, Shape and Regio-chemical Mimicry of Globular Proteins, 59 Tetrahedron 3799-3813 (2003) ("Tomalia NPL"). 4 Appeal2017-010280 Application 12/382,979 container into which a dendrimer is directly placed or, as an alternative, dendrimer placed into a capsule but does not disclose that a capsule containing dendrimer is placed in an evacuated container. Ans. 3, 10. The Examiner's rejection appears to be based upon a lack of explicit support for the limitations of claim 54. Satisfying the written description requirement, however, does not necessitate describing the exact subject matter claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563; Martin v. Johnson, 454 F.2d 746, 751 (CCP A 1972) (stating "the description need not be in ipsis verb is[, i.e., 'in the same words,'] to be sufficient"). Appellants contend paragraphs 15 and 53 (among others) of the Specification, as originally filed, provide support for claim 54. Appeal Br. 17-18. Appellants' arguments are persuasive. Paragraph 15 discloses a composition (i.e., a dendrimer as an internal standard) in a specimen collection container, which is partially evacuated. Paragraph 53 discloses that a container may be an opaque tube to protect the internal standard from light or, alternatively, the internal standard may be placed into a capsule, which is then placed into the tube. Thus, the latter disclosure of a capsule is not an alternative to a container, but is a disclosure of a capsule placed within the tube (i.e., container), which may be evacuated in view of the disclosure in paragraph 15. As a result, Appellants' disclosure reasonably conveys to one of ordinary skill in the art that the Inventors had possession of the subject matter for claim 54. In further support of the Examiner's written description rejection of claim 54, the Examiner determines that Figure 3 is new matter because Figure 3 depicts an insert ( e.g., capsule) within a container. Ans. 2 and 4. In particular, the Examiner finds Figure 3 does not correspond to Figure 1 of 5 Appeal2017-010280 Application 12/382,979 Stevens, which was incorporated by reference. Spec. ,r 56. However, as discussed above, the Specification, as originally filed, provides support for dendrimer in a capsule, which is located in a specimen collection container that may be evacuated, as depicted in Figure 3. 12 The Examiner has not shown that Figure 3 includes any other structures not clearly depicted in Stevens' Figure 1. See Stevens Fig. 1; Appeal Br. 6-9. Therefore, we are persuaded that the Examiner's determination that Figure 3 is new matter is erroneous. For these reasons, we do not sustain the Examiner's objection to Figure 3 as introducing new matter into the originally filed disclosure nor the Examiner's rejection of claim 54 under 35 U.S.C. § 112, first paragraph, for failing to comply with the written description requirement. Rejections II-IV Claims 36, 38, and 45--47 are rejected under 35 U.S.C. § 102(b) as being anticipated by Tomalia '524. Claims 36, 38, and 45--47 are rejected under 35 U.S.C. § 102(b) as being anticipated by Dvomic. 12 While drawing and specification objections are normally non-appealable matters properly raised via petition under 3 7 C.F .R. § 1.181 when they are not directly connected with the merits of issues involving rejections of claims (see 37 C.F.R. § 1.144 (2016); In re Berger, 279 F.3d 975, 984--985 (Fed. Cir. 2002) (citing In re Hengehold, 440 F.2d 1395, 1403 (CCPA 1971)); see also MPEP § 1201), here the Examiner raises the new matter objection to Figure 3 within the written description rejection of claim 54. As such, it is apparent that the new matter objection to Figure 3 is directly connected with the merits of the written description rejection of claim 54 thereby compelling decision on both. 6 Appeal2017-010280 Application 12/382,979 Claims 36 and 45--47 are rejected under 35 U.S.C. § 102(b) as being anticipated by Kim. These rejections are separately presented in the Final Office Action and separately argued by Appellants. We address the rejections together for purposes of efficiency. The Examiner's findings for these three rejections are similar in nature because the Examiner cites an intermediate product disclosed by each of the applied references. Specifically, the Examiner finds Tomalia '524 discloses drying a methanolic solution of generation 8.0 PAMAM dendrimer via rotary evaporation13 in Example 29. Ans. 5; Tomalia '524, 55:25-31. For Dvomic, the Examiner cites an example in which dendrimer is lyophilized under high vacuum overnight in a flask. Ans. 6; Dvomic 6:6-7. The Examiner finds Kim's Example 1 includes freeze drying of generation 3.0 PAMAM dendrimer in a flask and subsequent evacuation of the flask under vacuum. Ans. 6; Kim ,r 4 7. Thus, the Examiner finds each of the applied references discloses a process in which an intermediate product (i.e., an evacuated container containing dendrimer) is prepared and this is encompassed by claim 3 6. An argument raised by Appellants against the three § 102(b) rejections may be best summarized at page 6 of the Reply Brief: 13 Although Tomalia '524 does not explicitly disclose a container, such as a flask, used for the rotary evaporator in Example 29, one of ordinary skill in the art would be able to "at once envisage" such a container in order to provide a space in which to draw the vacuum disclosed by Tomalia '524. To anticipate, one skilled in the art must be able to "at once envisage" the claimed subject matter in the prior art disclosure. In re Petering, 301 F.2d 676, 681 (CCPA 1962). Moreover, Tomalia '524 describes the use of flasks for rotary evaporation. See Tomalia '524, 28:45-51. 7 Appeal2017-010280 Application 12/382,979 To anticipate claim 36, the reference must also disclose that the container is "adapted to receive specimen into [an] evacuated reservoir." The Examiner has failed to demonstrate that the containers disclosed in Tomalia, Dvorni[c], and Kim satisfy this limitation. To address this argument, we first construe the limitation "wherein the collection container is adapted to receive specimen into the evacuated reservoir" of claim 36. Although it is not clear in the record before us, it appears the Examiner considers this language to encompass a container that is evacuated and contains a dendrimer that functions as an internal standard for mass spectrometry, but the container need not maintain the vacuum when a specimen is placed into the reservoir of the container. However, because claim 36 recites the container is adapted so the specimen is received "into the evacuated reservoir," the broadest reasonable interpretation of "wherein the collection container is adapted to receive specimen into the evacuated reservoir" requires that the container is adapted to receive a specimen into the reservoir that is still evacuated, i.e., the vacuum is maintained when the specimen is received in the reservoir of the container. This interpretation is consistent with the Specification which discloses a collection container that includes closure 22 14 that may be pierced by needle 26 to introduce specimen into reservoir 12. Spec. ,r 57; Fig. 3. The Examiner has not made findings to address whether the containers used in the examples of Tomalia '524, Dvomic, and Kim would be capable of receiving a specimen so that the specimen is received within a reservoir of the containers that remains evacuated. As a result, Appellants' 14 Throughout this Decision, for clarity, we present labels to elements in figures in bold font, regardless of their presentation in the original document. 8 Appeal2017-010280 Application 12/382,979 argument is persuasive that the Examiner has not demonstrated that Tomalia '524, Dvomic, and Kim each anticipate a collection container adapted to receive a specimen into an evacuated reservoir, as recited in claim 36. For these reasons, we do not sustain the respective§ I02(b) rejections over Tomalia '524, Dvomic, and Kim. Rejection V Claims 36, 38, 42--47, and 54 are rejected as being unpatentable under 35 U.S.C. § I03(a) over Stevens in view of Domanski. The Examiner finds Stevens discloses a container having an evacuated reservoir that would be evacuated prior to receiving a specimen. Ans. 7. The Examiner finds Stevens discloses that the evacuated reservoir can include a stabilizing agent as well as any other reagent or combination of reagents used to treat biological samples for analysis. Id. The Examiner finds Stevens does not disclose a dendrimer. Id. The Examiner finds Domanski discloses the influence of P AMAM dendrimers on human blood cells and concludes it would have been obvious to modify the container of Stevens in view of Domanski and place dendrimer, as a reagent to treat blood samples, in Stevens' specimen collection container. Id. Appellants contend Stevens does not describe collecting a sample into a container containing a dendrimer and Domanski does not suggest placing a dendrimer in a sample collection device. Appeal Br. 22; Reply Br. 7. Thus, Appellants argue that the combination of references does not suggest the placement of dendrimers in a sample collection container. Appeal Br. 22; Reply Br. 7. Appellants further argue there would not have been a reason 9 Appeal2017-010280 Application 12/382,979 for one of ordinary skill in the art to add dendrimer to the claimed sample collection device and the Examiner has relied upon impermissible hindsight. Appeal Br. 22. Stevens discloses a blood collection device 10 that includes a container 12 defining an internal chamber 14. Stevens 9:48-52, Fig. 1. Stevens discloses the device includes a stabilizing agent to prevent the degradation and/or fragmentation of proteins in blood and that other additives and reagents used to treat biological samples for analysis may be included. Id. at Abstract, 3:18-27, 6:38--44, 9:1-15. Stevens further discloses the container can be evacuated. Id. at 4:4---6. As discussed above with regard to the§ 102(b) rejections, claim 36 requires a specimen collection container to be able to receive a specimen into a reservoir that is still evacuated when the specimen is received within the reservoir. The Examiner finds Stevens' container is adapted to receive a specimen into an evacuated reservoir. Ans. 7. Stevens' s container has such a capability because Stevens discloses container 12 may be a hollow collection tube including closure 22 to maintain an internal pressure differential and needle 26 or other cannula that pierces the closure 22. Stevens 5:63---67, 10:30-37, Fig. 1. Thus, Stevens's disclosure supports the Examiner's findings. Domanski discloses the effect of P AMAM dendrimers upon human red blood cell morphology and membrane integrity. Domanski Abstract, 190-191:3 (Results and discussion). PAMAM dendrimers are a type of dendrimer contemplated by Appellants for use as an internal standard for mass spectrometry. Spec. ,r,r 42--46. Thus, the dendrimer disclosed by Domanski is identical or substantially identical to Appellants' and would 10 Appeal2017-010280 Application 12/382,979 therefore necessarily function as an internal standard for mass spectrometry, as recited in claim 3 6. Appellants do not cite to any evidence or persuasive technical reasoning that demonstrates otherwise. Furthermore, Domanski demonstrates that P AMAM dendrimers are reagents that affect or treat blood, which Stevens permits, as explained at page 15 of the Examiner's Answer. Therefore, the combination of Stevens and Domanski is merely a combination of familiar elements according to known methods that does no more than yield predictable results. KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Moreover, we note that whether the Examiner listed Stevens as the primary reference or Domanski as the primary reference is irrelevant. See In re Bush, 296 F .2d 491, 496 (CCP A 1961) ("In a case of this type where a rejection is predicated on two references each containing pertinent disclosure which has been pointed out to the applicant, we deem it to be of no significance, but merely a matter of exposition, that the rejection is stated to be on A in view of B instead of on B in view of A, or to term one reference primary and the other secondary"). We, therefore, conclude that the combination of Domanski in view of Stevens also demonstrates the nonobviousness of claim 36. As discussed above, Domanski discloses the effect of dendrimers upon blood and its functionality as a reagent for red blood cells. It would have been obvious to one of ordinary skill in the art to modify Domanski in view of Stevens so the dendrimer is included within Stevens' s container as a reagent, which is permitted by Stevens. Such a modification would have permitted Domanski's dendrimer to be readily combined with a sample of blood via Steven's container and would have benefitted from the prevention of blood protein degradation and/or 11 Appeal2017-010280 Application 12/382,979 fragmentation due to Stevens' stabilizing agent, as disclosed by Stevens. Stevens 3:21-27. As such, the disclosures of Stevens and Domanski support the Examiner's findings and one of ordinary skill in the art would have had a reason to combine Stevens and Domanski. Accordingly, Appellants' arguments do not identify a reversible error in the rejection of claim 36. With regard to claims 42--44, Appellants assert that Domanski does not suggest that the effect of dendrimers upon red blood cells is observable or, otherwise, affected by the presence of other additives, that Stevens is silent about the addition of dendrimers to its collection device, and that neither Stevens nor Domanski suggest the inclusion of dendrimer in a specimen collection container as an internal standard for mass spectrometry. Appeal Br. 23-24. These arguments are also unpersuasive because they argue the applied references individually. The test for obviousness is not that the claimed invention be expressly suggested in any one or all of the references, but what the combined teachings of the references would have suggested to one of ordinary skill in the art. In re Keller, 642 F.2d 413, 425 (CCP A 1981 ). As discussed above, the combination of Stevens and Domanski would have suggested a specimen collection container including a stabilizing agent and a dendrimer as a reagent in its evacuated reservoir, which is adapted to receive a specimen, e.g., blood, into the evacuated reserv01r. Appellants further argue that Stevens does not disclose or suggest a capsule containing dendrimer, as recited in claim 54. Appeal Br. 23. This argument is unpersuasive because the Examiner correctly finds that Stevens discloses the use of a capsule. Ans. 7; Stevens 7:39-52. Although Stevens discloses placing stabilizing agent in the capsule, Stevens also discloses the 12 Appeal2017-010280 Application 12/382,979 use of reagents in addition to the stabilizing agent. Stevens 9: 1-12. Therefore, the combination of Stevens and Domanski, which discloses dendrimers as a reagent for blood, would have suggested the limitations of claim 54. For the reasons discussed above and those set forth in the Examiner's Answer, we sustain the Examiner's§ 103(a) rejection of claims 36, 38, 42--47, and 54 over Stevens and Domanski. Re} ection VI Claims 36, 38, 42--47, and 54 are rejected as being unpatentable under 35 U.S.C. § 103(a) over Wilkinson in view of Tomalia NPL and Stevens. The Examiner finds Wilkinson describes desirable qualities of an ideal internal standard for matrix-assisted laser desorption-ionization (MALDI) time-of-flight mass spectrometry, such as chemical similarity and similar extraction efficiency. Ans. 8. The Examiner finds Wilkinson does not disclose using dendrimers as an internal standard, but finds Tomalia NPL discloses P AMAM dendrimers may be designed to mimic the sizes, shapes, and regio-specific chemo-domains observed for globular proteins. Id. at 8-9. The Examiner concludes it would have been obvious to modify Wilkinson in view of Tomalia NPL to use P AMAM dendrimers as an internal standard for MALDI mass spectrometry because Tomalia NPL demonstrates that such dendrimers meet the requirements for an ideal internal standard disclosed by Wilkinson. Id. at 9. The Examiner finds Wilkinson, as modified by T omalia NPL, does not disclose that dendrimer is placed in an evacuated container. Id. The Examiner finds Stevens discloses such a container and a stabilizer and it 13 Appeal2017-010280 Application 12/382,979 would have been obvious to modify Wilkinson, as modified by Tomalia NPL, in view of Stevens in order to provide a convenient container that further includes a stabilizer. Id. Appellants argue that Wilkinson does not disclose the use of dendrimers as an internal standard for MALDI, that Tomalia NPL does not expressly suggest its dendrimers are useful in Wilkinson's context or in an evacuated specimen collection container, and that Stevens does not disclose collecting a sample into a container containing a dendrimer. Appeal Br. 24; Reply Br. 7-8. In view of this, Appellants argue the applied references do not disclose or suggest adding dendrimer to a sample collection device as an internal standard for mass spectrometry and the Examiner relies upon impermissible hindsight. Appeal Br. 24. Appellants' arguments are unpersuasive because they focus again upon the references individually and not what the combination of the applied references would have suggested to one of ordinary skill in the art. Keller, 642 F.2d at 425. Wilkinson discloses an ideal internal standard for MALDI mass spectrometry would have chemical similarity with an analyte and similar extraction efficiency. Wilkinson 241. Tomalia NPL discloses that P AMAM dendrimers may be designed to mimic the sizes, shapes, and region specific chemo-domains observed for globular proteins. Tomalia NPL abstract. Therefore, the disclosures of Wilkinson and T omalia NPL support the Examiner's findings and obviousness conclusion because Tomalia NPL discloses P AMAM dendrimers can be designed to be similar in size, shape, and region specific chemo-domains for globular proteins, which correspond to the similarities described by Wilkinson for an ideal internal standard for 14 Appeal2017-010280 Application 12/382,979 MALDI mass spectrometry. See Ans. 16. Further, Stevens describes a specimen collection container adapted to receive a specimen into an evacuated reservoir and further includes a stabilizing agent that prevents the degradation and/or fragmentation of proteins in a sample, as discussed above with regard to the§ 103(a) rejection over Stevens and Domanski. Thus, it would have been obvious to modify Wilkinson, as modified by Tomalia NPL, in view of Stevens to use a sample container so a sample may be readily collected and handled and so proteins are prevented from degrading and/or fragmenting due to the stabilizing agent disclosed by Stevens. Appellants further argue that Stevens does not disclose or suggest a capsule containing dendrimer, as recited in claim 54. Appeal Br. 24. As explained above with regard to the§ 103(a) rejection over Stevens and Domanski, this argument is unpersuasive because Stevens discloses placing its stabilizing agent in a capsule and the use of reagents in addition to the stabilizing agent. Thus, the combination of Wilkinson, Tomalia NPL, and Stevens would have suggested the limitations of claim 54. For the reasons discussed above and those set forth in the Examiner's Answer, we sustain the Examiner's§ 103(a) rejection of claims 36, 38, 42--47, and 54 over Wilkinson, Tomalia NPL, and Stevens. C. DECISION The decision of the Examiner 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). 15 Appeal2017-010280 Application 12/382,979 AFFIRMED 16 Copy with citationCopy as parenthetical citation