AMERICAN STERILIZER COMPANY

Patent Trials and Appeals Board

Apr 1, 2022

2021004961 (P.T.A.B. Apr. 1, 2022)

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. 16/664,261 10/25/2019 Nancy-Hope E. KAISER STERIS-AT-CON 1791 28862 7590 04/01/2022 Hudak, Shunk & Farine Co. LPA 30B Northwest Avenue, Suite 210 Tallmadge, OH 44278 EXAMINER CHEYNEY, CHARLES ART UNIT PAPER NUMBER 3754 NOTIFICATION DATE DELIVERY MODE 04/01/2022 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): dhudakjr@hsf-iplaw.com dperkins@hsf-iplaw.com lbelinsky@hsf-iplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte NANCY-HOPE E. KAISER, DANIEL ROCHETTE, and BRADLEY A. BAAN Appeal 2021-004961 Application 16/664,261 Technology Center 3700 Before KEVIN F. TURNER, DANIEL S. SONG, and MICHAEL L. HOELTER, Administrative Patent Judges. SONG, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the Examiner’s decision to reject claims 1-20. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). The Appellant identifies the real party in interest as American Sterilizer Company. Appeal Br. 2. Appeal 2021-004961 Application 16/664,261 2 CLAIMED SUBJECT MATTER The claims are directed to a non-aspirating transport gel dispenser. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. An ergonomic friendly non-aspirating dispenser for ejecting a thixotropic gel, comprising: a dispenser, said dispenser having walls forming a container and a flexible bag therein, a non-bag volume located between said dispenser walls and said flexible bag, said dispenser adapted to eject a thixotropic gel in the form of non- aspirated, reduced drift, non-foam gel, droplets having a mean volume diameter from about 150 to about 500 microns, formed by said thixotropic gel located in said flexible bag and having a viscosity of from about 100 to about 1,500 centipoises, a pressurized gas in said non-bag volume of from about 25 to about 50 psi, and said flexible bag having a volume of from about 65% to about 90% based on the total volume of said dispenser container; said non-bag volume being substantially free of a propellant, a volatilizable liquid, or a foam forming gas, or any combination thereof; and said dispenser having a valve, an actuator operatively connected to said valve, said actuator upon activation thereof being capable of opening said valve so that said pressurized gas exerting pressure on said flexible bag will force said thixotropic gel out of said dispenser container in the form of said non- aspirated droplets. Appeal Br. 27 (Claims App.). REFERENCES The prior art relied upon by the Examiner is: Appeal 2021-004961 Application 16/664,261 3 Name Reference Date Kim US 5,976,573 Nov. 2, 1999 Carlsson US 6,547,770 B2 Apr. 15, 2003 Rayner US 2018/0272367 A1 Sept. 27, 2018 OPINION The Examiner rejects claims 1-20 under 35 U.S.C. § 103 as being unpatentable over Rayner in view of Kim and Carlsson. Final Act. 4. As to independent claim 1, the Examiner finds that Rayner discloses a non- aspirating dispenser for a thixotropic gel substantially as claimed, but fails to explicitly disclose “a thixotropic gel with a viscosity of 100 to 1,500 centipoises.” Final Act. 4-5 (citing Rayner ¶¶ 60, 154, 187, 188, 207, 226; Fig. 4B). The Examiner finds that Kim discloses a thixotropic gel having a viscosity between 100 to 1500 centipoises, and concludes that using a gel having such a viscosity would have been obvious to one of ordinary skill in the art because “such a viscosity has the advantage of suspending agent in an amount effective to maintain said particles dispersed uniformly in the composition and to impart to the composition the . . . specific thixotropic properties as needed by the user.” Final Act. 5-6 (citing Kim, col. 2, ll. 25- 39, col. 3, ll. 45-46, col. 4, ll. 30-31, 39-41). The Examiner also concludes that “a selection of a gel with a certain viscosity would have been within the general skill of a worker in the art as a matter of obvious design choice for intended use.” Final Act. 6. The Examiner further finds that Rayner fails to disclose droplets that are about 150 to 500 microns, but relies on Carlsson to conclude that it would have been obvious to eject the gel to provide: Appeal 2021-004961 Application 16/664,261 4 a droplet mean volume diameter [] from about 80 to about 500 microns as taught by Carlsson, since Carlsson states . . . that choosing such a material with a particular droplet size has the advantage of lowering or increasing the impact pressure as needed such that a small droplet size will efficiently give a large specific rinsing surface of the spray and also the impact pressure will be low as needed by the user. Final Act. 6 (citing Carlsson, col. 3, ll. 15-24). The Examiner also concludes that the “selection of a gel with a certain droplet size would have been within the general skill of a worker in the art as a matter of obvious design choice for intended use.” Final Act. 6-7. The Appellant disagrees with the Examiner’s conclusions. In addition to its Appeal Brief and Reply Brief, the Appellant relies on a Declaration of Kaiser, a Supplemental Declaration of Kaiser, and numerous exhibits, in support of patentability of claim 1. Appellant’s arguments mostly address claim 1, with the exceptions noted below, so we primarily address independent claim 1. See Appeal Br. 9-19; Reply Br. We affirm the rejection of claim 1 for the reasons discussed below. The Appellant argues that Rayner “is silent with regard to any viscosity or any range thereof.” Appeal Br. 11; see also Reply Br. 1. However, the Examiner relied on Kim for teaching viscosity of a thixotropic gel within the range claimed. Final Act. 5-6. The Appellant also argues that Rayner “does not teach or suggest any flexible bag volume.” Appeal Br. 11, 15. However, as the Examiner points out, Rayner discloses “a flexible lumen 51,” which is a “pouch or [a] bag for holding the material to be dispensed.” Ans. 4 (citing Rayner ¶¶ 19, 149; Figs. 2A, 4B). Moreover, the Examiner is correct in finding that Rayner discloses “flexible bag volume is Appeal 2021-004961 Application 16/664,261 5 from about 65% to about 90% based on the total volume of said dispenser container” as claimed. Final Act. 4 (citing Rayner ¶ 154). As to the recited pressure, the Appellant points out that the art2 discloses a “high pressure of . . . 58 to 102 psi, [which] is greater than the claimed about 25 to about 50 psi range of the present application and thus inherently teaches away therefrom.” Appeal Br. 11; see also Appeal Br. 16. According to the Appellant, the claimed pressure is necessary because “higher pressures will lead to the splashing of the droplets on the intended surface as well as uneven coverage thereof, and that too low pressures will result in a discontinuous coating of the surface.” Appeal Br. 15-16. However, as the Examiner points out, 58 psi is only “8 [psi] over the claimed range,” and “prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” Ans. 6 (citing Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783 (Fed. Cir. 1985)). In Titanium Metals, the claim recited an alloy having “0.3% Mo and 0.8% Ni,” whereas the applied prior art disclosed two example alloys having “0.25% Mo-0.75% Ni and 0.31% Mo-0.94% Ni.” Titanium Metals, 778 F.2d at 783. Thus, the percentage difference between the claimed range versus the prior art was 20% for Mo and 6.67% for Ni in the first example alloy, and 3.2% for Mo and 14.89% Ni in the second example alloy. The court determined that “[t]he proportions are so close that prima facie one 2 The Appellant misattributes the disclosure of 58 to 102 psi to Rayner when this pressure is actually disclosed in Carlsson. Appeal Br. 11; see Carlsson, col. 6, ll. 20-22 (disclosing pressure inside the container as being “4-7 bar,” which is 58-102 psi). Appeal 2021-004961 Application 16/664,261 6 skilled in the art would have expected them to have the same properties,” and that no evidence was produced to rebut that prima facie case such that the claim would “therefore be considered to have been obvious from known alloys.” Id. Such is the instance in the present appeal wherein the lower value disclosed in Carlsson of 58 psi is merely 16% greater than 50 psi recited in claim 1. To any extent the Appellant’s unclaimed assertion that “higher pressures will lead to the splashing of the droplets on the intended surface as well as uneven coverage thereof” has any relevance, the Appellant does not provide us with any evidence that 8 psi difference would result in different properties as asserted. In that regard, the Appellant’s Specification does not attribute criticality to the recited pressure of 50 psi, but instead, states that “[s]uitable pressures range from about 25 to about 60 psi, and preferably from about 30 to about 50 psi.” Spec. ¶ 24. Hence, 60 psi is disclosed in the Specification as being suitable. Accordingly, 58 psi would likewise be suitable. We also find the Appellant’s assertion of teaching away to be unpersuasive because mere description of an implementation in the prior art that differs from the Appellants’ claimed invention, without more, does not show that the prior art is “teaching away” from the invention claimed. Appeal Br. 11; In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Moreover, we agree with the Examiner’s assessment that “the pressure exerted on lumen/bag/divider/bladder is capable of adjustment as desired by the user, providing obviousness basis of adjustment to the claimed pressure range.” Ans. 4 (citing Rayner ¶¶ 188, 198, 226; Figs. 2A, 2B, 4B). The Appellant also argues that “Rayner does not teach or suggest any claimed particle size,” and that “[n]owhere within the Rayner reference is Appeal 2021-004961 Application 16/664,261 7 there any teaching, motivation or suggestion that the droplet size of the foamable or flowable material thereof is important, critical, or necessary.” Appeal Br. 11, 16. However, the Examiner is correct that “Rayner contemplates controlling the variables of dispensing to produce a desired spray, flow rate, and droplets,” which is pertinent to claim 1. Ans. 4 (citing Rayner ¶¶ 198, 226). In that regard, Rayner suggests “control[ling] the flow of that material through the nozzle such as in relation to its flow rate, amount of flowable material, and/or in other respects that may be configured to control the flow, such as with respect to its thixotropic and/or viscos [sic, viscous] properties.” Rayner ¶ 198. Rayner further teaches that: In various instances, the nozzle may be configured to distribute a flowable material, e.g., a liquid or gas or suspension or semi- solid, etc., over an increased area, such as to break up the fluid into droplets so as to increase the surface area of the flowable material, and/or create a decreased impact force. Rayner ¶ 223. Thus, Rayner establishes that it was known, and within the skill of those in the art, to control the flow of the material taking into consideration thixotropic and viscous properties of the thixotropic gel, and to break up the fluid into droplets to increase the surface area of the material and/or to decrease impact force. The Appellant also argues that the dispenser of Kim “is totally different than Applicant’s dispenser, and also that of Carlsson” because it does not utilize a gas or a bag, has a different structure than Rayner, and does not disclose any pressure or droplet size, such that it teaches away from the invention of claim 1. Appeal Br. 14; see also Appeal Br. 16. However, as the Examiner notes, Kim was cited for disclosing that viscosity of thixotropic gels used in dispensers that are within the claimed range was known. Ans. 5 (citing Kim, col. 3, ll. 45-46, col. 4, ll. 30-31, 39-41); see Appeal 2021-004961 Application 16/664,261 8 also Kim, col. 2, ll. 36-41 (disclosing that the viscosity of the thixotropic gel is about 400 to about 1000 centipoises). The Appellant is essentially arguing the references individually, whereas the rejection is based on a combination of references. In re Merck, 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references.”); see also In re Keller, 642 F.2d 413, 425 (CCPA 1981). The Appellant further argues that Carlsson merely “relates to an ophthalmic solution that does not teach or suggest any thixotropic gel,” or the viscosity thereof. Appeal Br. 15, 16. However, Carlsson was cited for disclosing, inter alia, the recited droplet size and benefits thereof. Final Act. 6; see also Ans. 6. In that regard, Carlsson specifically discloses that “droplet size of 20-400 μm, preferably 35-90 μm,” which is within the claimed range, “will efficiently give a large specific rinsing surface of the spray and also the impact pressure will be low for each droplet.” Carlsson, col. 3, ll. 18-22. This teaching of Carlsson is entirely consistent with the teachings of Rayner noted above, and demonstrates the knowledge and level of skill of those in the art as to attaining a desired droplet size from a dispenser for a given application. The Appellant asserts that: A proper droplet size of the dispensed thixotropic fluid is very important because if it is too small, it can be carried away in any breeze or draft and invade other rooms of a hospital, clinic, other medical facilities, etc. The antipodal effect of a too large droplet size is that they typically converge and form a stream (no spray) upon being ejected from the dispenser and does not Appeal 2021-004961 Application 16/664,261 9 cover the entire surface of an instrument. Hence, a discontinuous coating is formed. Appeal Br. 16. However, the pertinence of this assertion is unclear because claim 1 is directed to a “non-aspirating dispenser.” There are no recitations pertaining to “hospital, clinic, other medical facilities” or covering “surface of an instrument.” Although the noted considerations may be the reason why the inventors invented the dispenser claimed, such considerations pertain to the intended use of the dispenser, which are not explicitly set forth as meaningful limitations in claim 1. Indeed, claim 1 does not even recite a specific type of thixotropic gel, so as to encompass any and all types of thixotropic gels having a viscosity in the claimed range, which, as demonstrated by Kim, was known. The Appellant also argues that “there is no reasonable expectation of success if the three references were combined would yield Applicant’s claimed reduced drift droplets since the Rayner and Kim references are different than Applicant’s claimed ranges.” Appeal Br. 17. However, the Appellant again appears to argue the references individually, and omits Carlsson, which as discussed above, discloses droplet sizes in the range claimed. The Appellant further argues that the rejection is based on impermissible hindsight, because it “is merely picking and choosing isolated features from the prior art,” using the claim “as an instruction manual or ‘template’ to piece together the teachings of the prior art,” whereas the “claimed invention as a whole has to be considered.” Appeal Br. 15-17; see also Reply Br. 1. However, as the Examiner points out, “there is no structure within the [claimed] device itself that helps to encourage said droplet sizes, thus said droplet size is merely a product of adjusting claimed Appeal 2021-004961 Application 16/664,261 10 ranges.” Ans. 7-8. In addition, claim 1 does not positively recite limitations that would limit the claimed dispenser to a narrow field of use, such as in treatment of medical instruments, by claiming the composition of the thixotropic gel. As to lack of distinguishing structure, the Appellant responds that functional claiming is not improper. Reply Br. 2 (citing MPEP § 2173). The Appellant is correct, and it is settled law that “[a] patent applicant is free to recite features of an apparatus either structurally or functionally.” In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). That said, claim 1 as a whole, is directed to a “non-aspirating dispenser” with a thixotropic gel having a viscosity known in the art, in a bag having a size known in the art, to dispense the thixotropic gel at a suitable pressure, to attain a known droplet size. Thus, the Appellant has chosen to define the invention of claim 1 based on various parameters that are known or otherwise within the skill of those of ordinary skill. As discussed above, the art also provides a reason for dispensing the gel as droplets, and selection of a droplet size within the claimed range. Rayner ¶ 223, Carlsson, col. 3, ll. 19-22. Accordingly, it is not apparent to us, nor does the Appellant persuasively explain, how the Examiner engages in hindsight in concluding that a person of ordinary skill would have the knowledge, skill, and creativity, and find it obvious, to utilize the dispenser of Rayner with a thixotropic gel having a viscosity known in the art, in a bag having a size known in the art, to dispense the thixotropic gel at a suitable pressure, to attain a known droplet size, in view of the applied art. See Ans. 4-5; KSR Int’l v. Teleflex, Inc., 550 U.S. 398, 421 (2007) (“[a] person of ordinary skill is also a person of ordinary creativity, not an automaton.”). Therefore, we Appeal 2021-004961 Application 16/664,261 11 ultimately agree with the Examiner that “the rejection of record demonstrates that the claimed ranges have been implemented into prior art for dispensing gels,” and that the rejection is not based on impermissible hindsight. Ans. 7; see also id. at 4, 5. The Appellant also relies on the evidence of commercial success submitted, which is set forth in the Declaration of Kaiser and the Supplemental Declaration of Kaiser. Appeal Br. 23-24; Decl. of Kaiser, pp. 3-4; Suppl. Decl. of Kaiser, pp. 1-2. Initially, we generally agree with the Examiner that nexus has not been adequately demonstrated. Ans. 8. The Appellant argues that nexus has been established in view of the Declaration of Kaiser with respect to the PRE-KLENZ dispenser product, which is also the subject of the numerous submitted exhibits. See Appeal Br. 23; Decl. of Kaiser, pp. 2-3. We note that the proffered evidence only pertains to the PRE-KLENZ product. However, as discussed above, claim 1 encompasses much more than a product used in a hospital, clinic, other medical facilities, or a product that covers a surface of an instrument. The scope of the “objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support.” In re Tiffin, 448 F.2d 791, 792 (CCPA 1971); see also Asyst Technologies, Inc. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008). The objective evidence is not commensurate in scope with the claimed subject matter if the claims are unreasonably broader in scope than the scope of the objective evidence or if the product included elements or features not recited in the claims which may be responsible for the commercial success or praise. See Joy Tech., Inc. v. Manbeck, 751 F. Supp. 225, 229-30 (D.D.C. 1990) (and cases cited therein), aff’d, Appeal 2021-004961 Application 16/664,261 12 959 F.2d 226 (Fed. Cir. 1992); see also Fox Factory, Inc. v. SRAM, LLC, 813 F. App’x 539, 542 (Fed. Cir. 2020) (“a product is not coextensive with a claimed invention simply because it falls within the scope of the claim.”). As such, because the evidence is not commensurate in scope with the claims, it fails to establish sufficient nexus. Moreover, even if we consider nexus as being established, the provided evidence is of little probative value in establishing commercial success because it lacks supporting details such as actual sales numbers, monetary value of such sales, market share of the product, etc. See Kansas Jack, Inc. v. Kuhn, 719 F.2d 1144, 1150-51 (Fed. Cir. 1983) (“There was no evidence of market share, of growth in market share, of replacing earlier units sold by others or of dollar amounts, and no evidence of a nexus between sales and the merits of the invention. Under such circumstances, consideration of the totality of the evidence, including that relating to commercial success, does not require a holding that the invention would have been nonobvious at the time it was made to one skilled in the art.”). Instead, the commercial success evidence provided is based on comparative proportion to sales of an earlier product. Decl. of Kaiser 3-4; Supp. Decl. of Kaiser 1. Although such increase in the proportion of sales of PRE-KLENZ product does indicate some level of commercial success, especially in view of the fact that it costs 72% more than the earlier product, the size or magnitude of the alleged success cannot be evaluated based on such evidence. Decl. of Kaiser 4. Thus, the evidence of commercial success is of little probative value. The Appellant further relies on the numerous exhibits entitled “Technical Data Monograph” that document the superior results attained by Appeal 2021-004961 Application 16/664,261 13 the PRE-KLENZ product in comparative testing of various evaluative parameters against numerous competing products. See Exhibits “A” (testing overspray and runoff); “B” (testing dispensing pattern and cling); “E” (testing protection); “F” (testing soil breakdown). This evidence does appear to support the Declarant’s contention that the claimed gel dispenser “out performed all other commercially available dispensers” as to the tested parameters, and appears to support the above-discussed limited commercial success evidence. Suppl. Decl. of Kaiser, p. 2. The Declarant then asserts that this evidence establishes non-obviousness through “unexpected results, commercial success, failure by others, and a solution to long-felt need with regard to the various noted properties.” Suppl. Decl. of Kaiser, p. 3; see also id. at p. 2 (“unexpected results and/or superior results that have led to Applicant’s commercial success results.”). However, although unexpected results, failure by others, and long-felt need has been asserted, the Appellant fails to substantiate such assertions. Specifically, as to unexpected results, 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) (internal quotation omitted). There has been no showing that the claimed invention is outside the capabilities of one of ordinary skill in the art, or that the attained results are “different in kind and not merely in degree from the results of the prior art.” Instead, the evidence appears to indicate that results are simply superior, not unexpected. Appeal 2021-004961 Application 16/664,261 14 In addition, establishing long-felt need and failure of others requires objective evidence showing existence of a persistent problem recognized by those of ordinary skill in the art for which a solution was not known. In re Gershon, 372 F.2d 535, 538-39 (CCPA 1967). To show that there was a long-felt need, the Appellant must present affidavits or other factual evidence of “a failure of others to provide a feasible solution to [a] long- standing problem” and evidence “that experts did not foresee” the solution claimed. See In re Piasecki, 745 F.2d 1468, 1475 (Fed. Cir. 1984). In the record before us, we do not find such objective, persuasive evidence directed to establishing long-felt need or failures of others. Thus, upon considering the evidence of obviousness in conjunction with the secondary consideration evidence submitted by the Appellant, we agree with the Examiner that claim 1 is unpatentable, and affirm its rejection. The Appellant essentially relies on the same arguments submitted relative to claim 1 for patentability of claims 2-6, 10-14, and 18-20, which includes independent claims 10 and 18 that recite limitations similar to those of claim 1. Appeal Br. 19-23. Thus, the rejection of these claims are affirmed for substantially the same reasons as claim 1. Claims 7-9 and 15-17 These claims recite that the dispenser is “capable of applying said thixotropic gel to a medical instrument.” Appeal Br. 28 (Claims App.). The Appellant argues that this limitation distinguishes these claims from Rayner because “paragraph [0013] of Rayner is vague and indefinite with regard to application to an external instrument since it does not directly refer to the same but rather to consumer, a user, to the mouth of a user, and the like.” Appeal 2021-004961 Application 16/664,261 15 Appeal Br. 20, 22. However, this argument is unpersuasive because it is entirely unclear why any dispenser, such as that of Rayner, which ejects thixotropic material therefrom, would not be capable of performing the recited function of applying the ejected thixotropic material to a medical instrument. Therefore, we affirm the rejection of these claims as well. CONCLUSION The Examiner’s rejection is affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-20 103 Rayner, Kim, Carlsson 1-20 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED