BN INTELLECTUAL PROPERTIES, LLC (Assignee) et al.Download PDFPatent Trials and Appeals BoardJan 28, 20222022001188 (P.T.A.B. Jan. 28, 2022) 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. 90/019,004 11/11/2020 8225795 190403.00002 5980 22429 7590 01/28/2022 HAUPTMAN HAM, LLP 2318 Mill Road Suite 1400 Alexandria, VA 22314 EXAMINER DAWSON, GLENN K ART UNIT PAPER NUMBER 3993 MAIL DATE DELIVERY MODE 01/28/2022 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BN INTELLECTUAL PROPERTIES, INC. Patent Owner and Appellant Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B21 Technology Center 3900 Before DANIEL S. SONG, JEREMY M. PLENZLER, and CYNTHIA L. MURPHY, Administrative Patent Judges. SONG, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. §§ 134(b) and 306, the Appellant2 appeals from the final rejection of claims 1-10, 12, and 13. The Appellant informs us that the ’795 Patent is also the subject of BioNebicine Corp. et al v. Smiths 1 Issued to Donald M. Pell on July 24, 2012 (“the ’795 Patent”). 2 The Appellant identifies the real party in interest as BN Intellectual Properties, Inc., which is identified as being a wholly-owned subsidiary of BioNebicine Corp. Appeal Br. 2. Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 2 Medical ASD, Inc., Case No. 0:20-cv-00595, filed: February 25, 2020 (D. Minn.). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. CLAIMED SUBJECT MATTER The claims are directed to a kink resistant endotrachael tube. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A kink resistant endotracheal tube with an inflatable cuff for positioning said endotracheal tube in a patient’s bronchia, said endotracheal tube comprising: a flexible elongated tubular member having distal and proximal open ends, a beveled tip at said distal end and a curved portion between said distal and proximal ends, and said tubular member defining a central major passageway for ventilation of a patient; a first minor passageway and an inflatable cuff for centering said tubular member in a patient’s trachea and for accumulating secretions above said cuff and wherein said inflatable cuff is of a gas impervious material secured to an exterior surface of said tubular member at the distal end adjacent said beveled tip and at an upper portion a short distance above said distal end; and wherein said inflatable cuff is folded over upon itself at said upper portion to form a concave area for pooling secretions above said cuff; wherein said inflatable cuff is folded over upon itself for a distance of about ¼ inch at said upper portion to form a concave area for pooling secretions above said cuff. Appeal Br. 32 (Claims App.). Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Goldin US 4,327,721 May 4, 1982 Turnbull US 5,201,310 Apr. 13, 1993 Pell US 5,697,365 Dec. 16, 1997 Watton US 2002/0195110 A1 Dec. 26, 2002 Blom US 2007/0144526 A1 June 28, 2007 Clayton US 2008/0078403 A1 Apr. 3, 2008 REJECTIONS 1. Claims 1-10 are rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Pell in view of Blom, Goldin, Clayton, or Turnbull. Final Act. 4. 2. Claims 12 and 13 are rejected under pre-AIA 35 U.S.C. §103(a) as being unpatentable over Pell in view of Blom, Goldin, Clayton, or Turnbull as applied to claim 1, and further in view of Watton. Final Act. 12. OPINION Rejection 1: Claims 1-10 Independent Claim 1 The Examiner finds that Pell discloses a kink resistant endotracheal tube with an inflatable cuff substantially as claimed, but fails to disclose that the inflatable cuff “is folded over upon itself . . . for a distance of about 1/4 inch.” Final Act. 4-5. The Examiner finds that Blom, Goldin, Clayton, and Turnbull, each disclose “[a] concave area above the cuff where secretions collect and pool, along with a suction catheter or tube to remove the secretions,” wherein “the inflatable cuff is folded over upon itself at the Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 4 upper portion forming the concave area.” Final Act. 5. Accordingly, the Examiner concludes that it would have been obvious to one of ordinary skill in the art to provide the device of Pell “with a cuff having a folded-over upper end which when inflated forms a concave area,” to thereby allow “secretions to collect and pool,” and be removed by suction. Final Act. 5-6. As to the recited fold distance of about ¼ inch, the Examiner notes that “the present invention provides absolutely no disclosure as to the criticality of this degree of fold on the cuff,” and concludes that a person of ordinary skill in the art would have found such a degree of fold (about ¼ inch) to have been a mere obvious design choice and obvious to try; many different fold-over distances would have been tried to determine what was most efficient and what did not work to form the necessary concave area. It would have been an obvious choice of one of a finite number of possible ranges given the size of cuffs and the body lumen in which the endotracheal tube is placed. Final Act. 6. The Appellant argues that the Examiner has not set forth a proper prima facie case of obviousness based on design choice reasoning or obvious to try reasoning, and that the Examiner did not properly consider the declaration evidence. Appeal Br. 9, 11, 21. We disagree with the Appellant, and address its arguments infra. Design Choice The Appellant points out that “none of the applied secondary references teach or suggest the recited fold distance of about ¼ inch at the upper portion.” Appeal Br. 9. Accordingly, the Appellant argues that “the Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 5 Examiner must present a ‘convincing line of reasoning’ as to why one of ordinary skill in the art would have found the claimed invention to have been obvious.” Appeal Br. 10 (quoting Ex parte Clapp, 227 USPQ 972, 973 (BPAI 1985), 1985 WL 71951). The Appellant proceeds to argue that “[s]uch ‘convincing line of reasoning’ requires two steps identified in Ex parte Clapp,” the second step being that “the Examiner also should explain the reasoning used to determine that the prior art would have performed equally as well as the claimed invention.” Appeal Br. 10 (citing Ex parte Clapp, 227 USPQ at 973). The Appellant argues that the rejection fails to set forth a prima facie case of obviousness because “Step 2 above is clearly missing from the Examiner’s ‘obvious design choice’ rationale.” Appeal Br. 11; see also Appeal Br. 14. The Appellant’s arguments are unpersuasive. First, we note that Ex parte Clapp is a Board decision that is not precedential so as to be binding in this appeal. Nonetheless, we note that the general premise that the Examiner must present reasoning to support the conclusion of obviousness is correct. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“[t]o facilitate review, this [obviousness] analysis should be made explicit” (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds 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”)). Second, the alleged two step tests set forth by the Appellant as being required by Ex parte Clapp, does not appear in Clapp. Nor does it appear in MPEP § 706.02(j) also referenced by the Appellant. Appeal Br. 10. It is not Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 6 apparent where the Appellant’s quoted test comes from, nor does the Appellant establish that such test is binding in the present appeal. Third, the recited second step appears to merely be suggestive, stating that “[t]he Examiner should explain the reasoning used to determine that the prior art would have performed equally as well as the claimed invention,” in contrast to the first step mandating that “the Examiner must review the Specification.” Appeal Br. 10. Design choice may serve as a basis for obviousness where alternative elements or configurations in the prior art perform the same function as the claimed aspects with no novel or unexpected results. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). The relevant issue in the context of design choice is whether the alleged differences between the claimed invention and the prior art “result in a difference in function or give unexpected results.” In re Rice, 341 F.2d 309, 314 (CCPA 1965). Moreover, pertinent to the present appeal, size is not ordinarily a patentable feature. In re Rose, 220 F.2d 459, 463 (CCPA 1955) (“size of the article under consideration [] is not ordinarily a matter of invention”); see also Gardner v. TEC Systems, Inc., 725 F.2d 1338, 1349 (Fed. Cir. 1984) (holding that, where the only difference between the prior art and claims was recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from prior art device). Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 7 As noted by the Examiner, the Specification provides “absolutely no disclosure as to the criticality” of the recited fold distance “of about ¼ inch.” Final Act. 12. No novel or unexpected results are disclosed. Therefore, in view of the above, the Appellant’s assertion that the Examiner failed to establish a prima facie case of obviousness based on obvious design choice reasoning is unpersuasive. Declarations The Appellant argues that it “submitted the First Declaration[3] showing, among other things, criticality” of the limitation at issue, and further argues that the Examiner failed to give proper weight to the declaration evidence, or define the level of ordinary skill. Appeal Br. 22. Preliminarily, we note that the cited prior art can be considered as representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown.’”). Substantively, we agree with the Examiner that “[t]he supposed criticality mentioned in the 1st declaration of the sufficient size and robustness of the basin and the comfortability of the patient . . . [is] lacking sufficient weight” to, on balance, establish non-obviousness of the claimed invention in view of the applied art of record. Ans. 39. As the Examiner 3 The Declaration of Dr. Donald M. Pell dated May 13, 2021, and entered on May 17, 2021. See Appeal Br. 7. Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 8 points out, the evidence is based solely on “statements made by the interested party of the inventor of the claimed subject matter,” and thus, is of diminished probative value. Ans. 39; see also Ans. 43 (“A declaration by an interested party does not receive the same weight given to one by a disinterested party.”). The Appellant responds that “[d]eclarations would have at least some weight, although reduced, but not zero.” Reply Br. 5. However, the Examiner did not give the evidence “zero weight.” Rather, the Examiner explained that such evidence by an interested inventor is given “reduced weight.” Ans. 43. In addition, the Appellant argues that “such ‘reduced weight’ would be sufficient to show that the prior art is not capable of performing equally as well as the claimed invention.” Reply Br. 6. However, the Appellant again unpersuasively relies on Ex parte Clapp and on a passage that does not exist therein. More importantly, we agree with the Examiner that the declarative statements in the submitted Declarations are “not backed up with actual objective evidence,” and are essentially “argument and opinion evidence,” which is not of substantial probative value. Ans. 39; see, e.g., 1st Decl. ¶¶ 6- 9, 12; see also Ans. 41 (“All of this ‘evidence’ is mere opinion evidence unsupported by any actual probative objective evidence and data.”). For example, the declarant asserts that “the fold distance of about ¼ inch is critical to achieve a basin or concave area for accumulating secretions, while ensuring robustness of the basin or concave area as well as comfort to the patient during intubation.” 1st Decl. ¶ 6. But the only substantiating evidence in support of that assertion are other assertions of the inventor that fold distance of about ¼ inch provides a basin with sufficient size for Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 9 secretion while also being sufficiently strong to not collapse, while fold distances less than about ¼ inch would not be sufficient to collect most of the secretions and collapse, and fold distances more than about ¼ inch would result in too strong of pressure thereby causing patient discomfort. 1st Decl. ¶¶ 6-9, 12. Nothing in the record provides objective evidence that establishes what constitutes sufficient size and strength, sizes/distances that collapse and/or cause discomfort, and how all of these different considerations are resolved by the “critical” distance of “about ¼ inch.” As the Examiner points out, “[n]o test results were submitted comparing the effectiveness of the basin formed by a ‘about 1/4 inch’ fold-over cuff with respect to sufficiency of amount of secretions pooled, robustness of the cuff or patient comfort with results from other fold-over lengths both above and below the claimed ‘about 1/4 inch’.” Ans. 32. The Second Declaration4 of the inventor is also not helpful. This declaration again makes clear that the alleged criticality and benefits associated with the recited distance of “about ¼ inch” are based on the declarant’s observation and opinion. 2nd Decl. ¶¶ 8.1, 8.3. Although the declarant states that an endotracheal tube was made in accordance with the claimed invention, it is not apparent how much objective information as to criticality can be gathered from a single data point. 2nd Decl. ¶ 8.2. The declarant further disputes the Examiner’s contentions as to smaller fold distance, but again, actual objective evidence is not provided as to sufficient 4 The Declaration of Dr. Donald M. Pell dated August 9, 2021, and entered on August 26, 2021. See Appeal Br. 7. Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 10 basin size for collection of sufficient amount of secretions, whatever that may be. 2nd Decl. ¶¶ 9.1-9.3. Thus, when the submitted evidence is considered and weighed in totality together with the prior art evidence of record applied in the rejection, we find no error in the Examiner’s assessment that the invention as claimed would have been obvious to one of ordinary skill in the art. Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (“It is within the discretion of the trier of fact to give each item of evidence such weight as it feels appropriate . . . In giving more weight to prior publications than to subsequent conclusory statements by experts, the Board acted well within that discretion”); see also Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value in a validity determination.”).5 5 Although reliance of the following is unnecessary, we agree with the Examiner’s observation that “[t]he claimed about ¼ inch fold-over is really a range in that it would cover lengths slightly above and slightly below ¼ inch.” Ans. 37. As to claiming specific ranges, 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 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). However, the Appellant and the declarations evidence does not even argue, much less establish, “unexpected results.” See also In re DeBlauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (“It is well settled that unexpected results must be established by factual evidence. Mere argument or conclusory statements in the specification does not suffice.”). To establish unexpected Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 11 Obvious to Try The Appellant also argues that the Examiner failed to establish a prima facie case of obviousness based on obvious to try reasoning because “the Examiner failed to provide a finding that there had been a finite number of identified, predictable potential solutions to any need or problem in the prior art” as required. Appeal Br. 11-12 (citing MPEP 2143.E (requiring findings of a recognized problem or need in the art, and finite number of identified predictable potential solutions); see also Appeal Br. 14; Reply Br. 6 (“for the ‘obvious to try’ rationale to be applicable, the solutions must be identified in the prior art.”). results, “it is not enough to show that results are obtained which differ from those obtained in the prior art: that difference must be shown to be an unexpected difference.” In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). In that regard, even though applicant’s modification results in great improvement and utility over the prior art, it may still not be patentable if the modification was within the capabilities of one skilled in the art, unless the claimed ranges “produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art.” In re Huang, 100 F.3d 135, 139 (Fed. Cir. 1996)). Moreover, “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). The Appellant does not argue, much less set forth objective evidence in support of, unexpected results, including attainment of results of a different kind or comparing results with the closest prior art. At best, even if we take the declarant’s assertions as being true, they merely establish improvement that is merely of degree from the prior art, rather than results that are different in kind. Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 12 However, the Examiner is correct that the record indicates that “prior art was aware of the problem of tracheal secretions pooling above the migration to the lungs which can cause serious complications; and each of these used cuffs with folded over tops which allow for better removal of the pooling secretions above the cuff.” Ans. 37; see Blom ¶ 2, Fig. 2; Goldin, col. 3, ll. 3-6; Fig. 3; Clayton ¶ 5, Fig. 8; Turnbull col. 1, ll. 13-18, Figs. 2 and 4; and texts discussing figures in these references. As such, we also agree with the Examiner’s assessment that “[t]he claimed length of fold- back would have been one choice of a finite number of choices of ranges given the small size of endotracheal tube cuffs and the trachea body lumen where these are placed in the body.” Ans. 35; see also Ans. 37 (“Given the size of tracheas and the general size of tracheal tubes and cuffs thereon the claimed degree of fold-over would have been one that a POSITA would have obviously tried.”). The Appellant argues that the rejection is conclusory “because the prior art did not recognize any problem or need associated with the fold-over distance, the prior art could not possibly identify any solutions or fold-over distances.” Appeal Br. 14, 21; see also Reply Br. 6-7. However, the Appellant does not appear to fully appreciate the Examiner’s logical position in which the issue is the selection of an appropriate fold-over distance. Specifically, as the Examiner explains, In attempting to manufacture the prior art devices a POSITA would, absent a specific teaching of what the cuff parameters are, be required to try different specifications for the various tracheal tube components, including the cuff and the degree of fold-over of the cuff, in order to arrive at a working tracheal tube with Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 13 folded-over cuff capable of facilitating the suction removal of secretions pooling above the cuff. Ans. 38; see also Ans. 33-34 (“When first constructing the cuff and attaching it to the endotracheal tube with folded-over ends some length of fold-over inevitably must originally be selected. How else could it be made? A POSITA would clearly test the device to make sure it operated as desired when actually used in a patient . . . to seal the passageway without causing undue discomfort.”). We agree with the Examiner that While the “about 1/4 inch” length of the fold-over was not disclosed[,] a POSITA would have, in the normal course of designing the cuff structure for the combination, experimented with different cuff parameters, including that of degree of fold- over, in order to facilitate the ability to suction off the secretions pooled above the cuff. Final Act. 27-28. Thus, in our view, the Examiner has properly established a prima facie case of obviousness based on obvious to try reasoning. The Appellant again argues that criticality of “about ¼ inch fold-over” was established by the submitted declarations to overcome any prima facie case of obviousness. Appeal Br. 12. However, as already discussed above, the declarations do not provide persuasive, objective evidence. See also Ans. 38 (“the evidence of criticality presented in the declarations was insufficient to establish non-obviousness.”). The Appellant also asserts that the secondary references are only concerned with sealing and facilitating suction removal of secretions pooling such that “any basin for collecting secretions would be sufficient,” and whereas “[t]he main point is that the inventor was concerned with patient comfort or discomfort, the secondary references do not teach or suggest any concern about patient comfort or discomfort” such that “[t]here is no Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 14 suggestion or desirability in the secondary references to try different basin configurations.” Reply Br. 8, 10. Thus, the Appellant asserts that the Examiner’s reasoning based on comfort or discomfort is improperly based on hindsight using the inventor’s declaration. Reply Br. 8. The Appellant’s assertions are not credible. It is reasonable that, without the benefit of Appellant’s disclosure, a person of ordinary skill in the art would consider patient comfort in designing an endotracheal tube, which is placed in the patient’s mouth and down the patient’s throat. Moreover, as the Examiner finds, “Clayton discloses a balloon cuff with inner and outer layers, the cuff is described in [0028] that the multiple layer cuff may reduce over-inflation and resulting patient discomfort.” Ans. 42- 43; Clayton ¶ 28 (“Also, such a barrier may prevent the inflow of anesthesia gases into a fully inflated cuff and may reduce cuff overinflation as well as any resulting patient discomfort.”); see also Clayton ¶ 29 (“The multi-layer inflatable balloon cuffs as provided herein combine the advantages of the comfort and structural stability of a low pressure cuff with the relatively smooth seal of a high pressure cuff.”). Taking into consideration the patient’s comfort/discomfort would be common sense, especially to those of ordinary skill in the art of medical devices such as endotracheal tubes, and is further explicitly disclosed in the art of record, and is not based on hindsight. Ans. 42. The Appellant argues that “there is no evidence of record that POSITA would have experimented with any balloon cuff parameters” because the prior art fails to teach or suggest that “any balloon cuff parameter that could be varied, optimized or experimented with.” Appeal Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 15 Br. 17. In that regard, the Appellant asserts that “[t]here is no evidence of record[] or rationale that, to ensure the sealing function of the cuff, POSITA would have experimented, if at all, with the fold-over distance.” Appeal Br. 21; see also 2nd Decl. ¶ 13 (“no POSITA would be ‘confronted with how to size and configure the cuff’ because none of the applied references expressed any concern about the size of the upper cuff and/or the fold distance.”). In addition, the Appellant points out that “[t]he legal authority related to ‘experimentation’ is completely different,[] and requires a showing of a result-effective variable which is clearly absent from the applied secondary references.” Appeal Br. 18. Again, the Appellant appears to mischaracterize or misunderstand the rejection being applied. As already explained above, it cannot be reasonably disputed that a person of ordinary skill in the art “would have been motivated to try one possible fold-over distance and check for evidence that it performed as necessary, and if not would try a somewhat different (shorter or longer) fold-over, especially given the fact the prior art taught the general fold-over but gave no specific parameters.” Ans. 37. Designing of the inflatable cuff in view of the art of record would include determining the fold over distance, and as the Examiner explains, designing an endotracheal tube “would involve some degree of experimentation.” Ans. 40. The Appellant argues that “the Examiner failed to explain why POSITA would have selected the fold-over distance, and not any other parameter, to be experimented with.” Appeal Br. 17. However, the Examiner did, in fact, state that other parameters would also have to be determined and selected. See Ans. 38 (“In attempting to manufacture the Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 16 prior art devices a POSITA would, absent a specific teaching of what the cuff parameters are, be required to try different specifications for the various tracheal tube components, including the cuff and the degree of fold-over of the cuff.”). Pell and Blom The Appellant argues that teachings of Blom would not be applied to the endotracheal tube of Pell because Blom “is directed to a tracheostomy tube (paragraph 0028) which is to be inserted through a cut in a patient’s neck,” allows the patient to “expel mucus or secretions by coughing,” and has a removable balloon. Appeal Br. 24 (quoting Amendment filed May 17, 2021, page 7). The declarant also states that “[t]racheotomy tubes are much shorter, they do not need a balloon because the chords are not being propped open by a tube, and there are no issues with kinking in these tracheotomy tubes.” 3rd Decl. ¶ 7.6 According to the Appellant, because of such differences, “a person of ordinary skill in the art would not have reasonably considered modifying the endotracheal tube of Pell with a different type of tube, i.e., the tracheostomy tube of Blom.” Appeal Br. 23; see also 3rd Decl. ¶ 7. These arguments are unpersuasive because Blom clearly discloses a device for removal of mucus and secretions. Blom ¶¶ 2, 28, 30; Fig. 2. In that regard, contrary to the declarant’s assertion that such tracheotomy tubes do not need a balloon, “Blom specifically teaches that it was known to 6 The Declaration of Dr. Donald M. Pell dated August 9, 2021, and entered on August 26, 2021. See Appeal Br. 7. Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 17 employ the use of an inflatable cuff and nearby suction lumen on a tracheal tube to minimize the downward migration of secretions from the pharynx into the lungs, and that secretions which pooled above the top of the cuff could be removed by a vacuum or suction tube 70.” Ans. 13. In that regard, to the extent that the Appellant is alleging Blom is nonanalogous, we agree with the Examiner that “[e]ven if Blom were not in the [inventor’s] field of endeavor, which the examiner does not agree, Blom clearly is reasonably pertinent to the problem facing the inventor; that of removing secretions pooling above a cuff on a tube in a body lumen,” which Appellant does not dispute. Ans. 13; In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992) (“A reference is reasonably pertinent if, even though it may be in a different field from that of the inventor’s endeavor, 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.”). Summary Therefore, in view of the above considerations, we are not persuaded of Examiner error in concluding that the invention of independent claim 1 would have been obvious to one of ordinary skill in view of the prior art of record, and affirm the rejection of claim 1. The Appellant unpersuasively relies on dependency on claim 1 for the patentability of claims 2-5 and 10, but also submits separate arguments for dependent claims 4 and 10. Appeal Br. 24; Reply Br. 12. Thus, claims 2, 3, and 5 fall with claim 1, and we address the Appellant’s arguments directed to claims 4 and 10 below. Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 18 Claim 4 Claim 4 ultimately depends from claim 1 and recites “said curved portion defines an inner pathway wherein said tubular member is under compression and an outer pathway wherein said tubular member is under tension and wherein said first and said second minor passages are disposed in the portion of said tubular member that are under tension.” Appeal Br. 33 (Claims App.). The Examiner concludes that claim 4 would have been obvious because Pell teaches that “placing a minor lumen in the portion under compression-inside of the curved tubular portion- can cause a kink or collapse of this lumen.” Final Act. 7-8 (col. 5, l. 48-col. 6, l. 8, col. 9, ll. 5- 11). Indeed, Pell specifically teaches that “it has been found with conventional tubes, that a kink or collapse is initiated with a small or minor lumen in the tube wall when that wall is subjected to compression.” Pell, col. 5, ll. 52-55. Pell further claims “said cuff inflation lumen is within that portion of said wall which is under tension.” Pell, col. 9, ll. 5-11. The Examiner concludes that “[t]herefore, it would have been obvious to have placed both the inflation lumen and suction lumen on the tension side-the larger diameter side of the curved tube which is under tension so the tube was not susceptible to kinking or collapse of the lumens.” Final Act. 8. The Appellant disagrees and argues that “Pell states that placing a minor lumen in the portion of the tube which is subjected to the maximum amount of compression causes the tube to kink or collapse. The cited portions of Pell do not explicitly support the Examiner’s overbroad allegation that simply ‘placing a minor lumen in the portion under compression-inside of the curved tubular portion- can cause a kink or Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 19 collapse of this lumen.’” Appeal Br. 26. The Appellant is referring to another portion of Pell which states “in conventional tubes, the minor lumen is located in that portion of the tube which is subjected to the maximum amount of compression.” Pell, col. 5, ll. 60-62. Based thereon, the Appellant argues that a person of ordinary skill “would understand that placing a minor lumen outside the portion subjected to the maximum amount of compression would be sufficient to avoid tube kinking or collapse,” and “would not have found it obvious to move the suction lumen all the way to the other side of the tube where Pell’s inflating lumen is already formed.” Appeal Br. 26-27. However, the additional teaching in Pell referenced by the Appellant does not detract from its earlier teaching as to kinks being initiated in minor lumens when the wall is subjected to compression, and teaching to place such lumens on the wall that is under tension by claiming such positioning. Pell, col. 5, ll. 52-55, col. 9, ll. 5-11. Thus, the Examiner’s entirely correct that the general teaching of Pell is that the compression causes the minor lumen to kink or collapse, and that Pell provides a solution in providing the minor lumen on the portion that is under tension. Pell, col. 9, ll. 5-11; see also Ans. 46. Accordingly, the Examiner is also correct that “when the combinations are made and Pell is modified to have a 2nd minor passageway to apply suction to remove the secretions[,] it too should not be placed along the inner pathway due to its possible collapse and occlusion when the tube is bent.” Ans. 15. As such, we agree with the Examiner that positioning the minor passages “in the portion of said tubular member that are under Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 20 tension” as recited by claim 4 would have been obvious to one of ordinary skill in the art. Therefore, the Examiner’s rejection of claim 4 is also affirmed. Claim 10 Claim 10 depends from claim 1, and similar to claim 4, recites that “both the first minor passageway and second minor passageway are positioned within a wall of the tubular member along the outer pathway of the curved portion,” which has a greater radius and is under tension. Appeal Br. 35 (Claims App.). The Examiner finds that “Turnbull discloses both passageways are positioned within a wall of the tubular member,” and concludes that, in view of the teachings of Pell, positioning of such minor passageways along the outer pathway would have been an obvious design choice in order to prevent collapse of the passageways. Final Act. 10-11. The Appellant argues that “claim 10 is patentable for at least analogous reasons to those offered above with respect to claim 4.” Appeal Br. 28. However, reliance on claim 4 is unpersuasive considering the Appellant’s arguments directed to claim 4 are not persuasive. The Appellant also argues that the “obvious design choice” analysis “fails to follow both steps required by Ex parte Clapp.” Appeal Br. 26. However, as discussed above, the Appellant’s reliance on Clapp is unfounded. The Appellant further asserts that the Examiner rejected claim 10 for the same reasons as claim 4, but claim 4 was not rejected based on obvious design choice, and that this inconsistency merits reversal. Reply Br. 14. The Appellant’s argument is unpersuasive. The Examiner’s rejection of claim 10 from which Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 21 this appeal is taken does not mention claim 4. Final Act. 10-11. Nor does claim 10 depend from claim 4. We are also not aware of any precedent that requires the Examiner to rely on exactly the same obviousness reasoning in rejecting different claims. Moreover, “obvious design choice” is merely a sub-category of “obviousness” generally. Thus, the Appellant’s arguments are unpersuasive, and the rejection of claim 10 is also affirmed. Independent Claim 6 The Examiner’s rejection of claim 6 is substantively the same as those of claims 1-4. Indeed, the Appellant notes that “[i]ndependent claim 6 recites features similar to those discussed above with respect to claims 1 and 4,” and as such, argues that “claim 6 is patentable over the applied art of record for at least analogous reasons to those offered above with respect to claims 1 and 4.” Appeal Br. 28. The Appellant’s arguments submitted relative to claims 1 and 4, and thus, claim 6, are unpersuasive for reasons already discussed. Thus, we affirm the Examiner’s rejection of independent claim 6. The Appellant does not separately argue claims 7 and 9 that depend from claim 6, and thus, these claims fall with claim 6. We address the Appellant’s separate arguments directed to dependent claim 8 below. Claim 8 Claim 8 depends from claim 6 and recites “a thickened wall in an area of said curved portion that is under compression.” Appeal Br. 34 (Claims Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 22 App.). The Examiner finds that “Pell as seen in fig. 6a shows a thickened portion 26 of the tube where the minor passageway is located. As seen in fig. 1 both sides of the tube are going to be under some form of compression due to the anatomical structures exerting pressure on both sides of the tube.” Final Act. 10. Based thereon, the Examiner concludes that it would have been obvious to provide a thickened wall on the inner curved portion as well. Final Act. 10. The Appellant argues that Pell does not explicitly or implicitly disclose any anatomical structures exerting pressure on the tube, and that the Examiner “failed to provide a clear articulation of the reason(s) why it would have been obvious[] from cited FIG. 1 of Pell that part A is under some form of compression due to the anatomical structures exerting pressure thereon.” Appeal Br. 29 (referring to annotated Figure 1 of Pell). The Examiner’s findings are sufficiently supported by Pell in that a person of ordinary skill in the art of endotracheal tubes would know, and as apparent from Figure 1 of Pell, that such tubes are positioned adjacent to the base of the patient’s tongue, i.e., an anatomical structure. Thus, by virtue of the tube’s positioning, we are not persuaded that the Examiner erred in finding that “both sides of the tube would be under some compression due to the anatomical structures exerting pressure on them.” Ans. 46. Therefore, we affirm the Examiner’s rejection of claim 8 as well. Rejection 2: Claims 12 and 13 The Appellant relies on ultimate dependency on claim 1 for patentability of claims 12 and 13, arguing that the Examiner’s application of Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 23 Watton does not remedy the deficiency with respect to the modification of Pell in view of the secondary references. Appeal Br. 30; see also Reply Br. 14. Thus, having found no deficiency in the Examiner’s rejection of claim 1, this rejection of claims 12 and 13 is affirmed. CONCLUSION The Examiner’s rejections are affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-10 103(a) Pell, Blom, Goldin, Clayton, Turnbull 1-10 12, 13 103(a) Pell, Blom, Goldin, Clayton, Turnbull, Watton 12, 13 Overall Outcome 1-10, 12, 13 REQUESTS FOR EXTENSIONS OF TIME Requests for extensions of time in this ex parte reexamination proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. § 41.50(f). AFFIRMED Appeal 2022-001188 Reexamination Control 90/019,004 Patent US 8,225,795 B2 24 For Third Party Requester: FOX ROTHSCHILD LLP 222 SOUTH NINTH STREET, SUITE 2000 MINNEAPOLIS, MN 55402 Copy with citationCopy as parenthetical citation