TECRES S.P.A.

Patent Trials and Appeals BoardMar 31, 2020

15203435 - (D) (P.T.A.B. Mar. 31, 2020)

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. 15/203,435 07/06/2016 Giovanni Faccioli 374-74 (CIP DIV) 3033 24336 7590 03/31/2020 TUTUNJIAN & BITETTO, P.C. 401 Broadhollow Road, Suite 402 Melville, NY 11747 EXAMINER SUMMITT, LYNNSY M ART UNIT PAPER NUMBER 3773 NOTIFICATION DATE DELIVERY MODE 03/31/2020 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): docketing@tb-iplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte GIOVANNI FACCIOLI and RENZO SOFFIATTI __________ Appeal 2019-005435 Application 15/203,435 Technology Center 3700 __________ Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and ANNETTE R. REIMERS, Administrative Patent Judges. HOELTER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–10. Final Act. 1 (Office Action Summary). We have jurisdiction under 35 U.S.C. § 6(b). For the reasons explained below, we AFFIRM the Examiner’s rejections. CLAIMED SUBJECT MATTER 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “Tecres S.p.A.” Appeal Br. 3. Appeal 2019-005435 Application 15/203,435 2 The disclosed subject matter “relates to a disposable device for treatment of infections of human limbs, more specifically limbs having long bones susceptible to stabilization by intramedullary nails.” Spec. 1:10–11. Claim 1 is the sole independent claim on appeal, is representative of the claims on appeal, and is reproduced below. 1. A method for providing a device for treatment of infections of human limbs comprising the steps of: providing a solution comprised of a base material composed of a polymer or bone-cement material with an organic or aqueous solvent in which the concentration of the base material versus the solvent is about 1% (w/w) to about 75% (w/w); adding a drug or other medicament in the solution at a concentration versus the polymer of about 5% (w/w) to about 65% (w/w); homogenizing the solution; applying the solution to an intramedullary nail through immersion of the intramedullary nail in the solution and emersion of the intramedullary nail; waiting about 10–60 minutes; repeating the steps of applying and waiting alternatively at least other two times; and eliminating the solvent to provide a tubular member formed on the intramedullary nail with pores integrated arbitrarily throughout said tubular member, said pores being of a size comprising a dimension of about 1–100 micrometers to avoid bone growth through them. THE REJECTIONS ON APPEAL Claim 7 is rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. Final Act. 2. Claims 1–10 are rejected under 35 U.S.C. § 112, second paragraph, as being indefinite. Final Act. 3. Appeal 2019-005435 Application 15/203,435 3 ANALYSIS The rejection of claim 7 for failing to comply with the written description requirement Claim 7 recites “wherein a thickness of the tubular member is 10 micrometers to 1000 micrometers.” Appeal Br. 32 (Claims App.; emphasis added). The Examiner finds, “the disclosure as originally filed [does not] provide[] support for the thickness being between about 10 micrometers to 1000 micrometers.” See Final Act. 2 (citing Spec. 8:27–28; emphasis added). Appellant replies contending, “the recitation ‘wherein a thickness of the tubular member is 10 micrometers to 1000 micrometers’ is fully supported by and encompassed by the statement ‘the thickness being between about 10 micrometers to 1000 micrometers.’” Appeal Br. 10. In rejecting a claim under 35 U.S.C. § 112, first paragraph, for lack of adequate descriptive support, it is incumbent upon the Examiner to establish that the originally-filed disclosure would not have reasonably conveyed to one having ordinary skill in the art that Appellant had possession of the now claimed subject matter. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Adequate description under 35 U.S.C. § 112, first paragraph, does not require literal support for the claimed invention. Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (“In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.”); See also In re Herschler, 591 F.2d 693, 701 (CCPA 1979); In re Edwards, 568 F.2d 1349, 1351–52 (CCPA 1978); In re Wertheim, 541 F.2d 257, 262 (CCPA 1976). Rather, it is sufficient if the originally-filed disclosure would have conveyed to one having ordinary skill in the art that Appellant had possession of what is Appeal 2019-005435 Application 15/203,435 4 claimed. See In re Anderson, 471 F.2d 1237, 1242 (CCPA 1973). Thus, “written description is about whether the skilled reader of the patent disclosure can recognize that what was claimed corresponds to what was described.” Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d 1180, 1191 (Fed. Cir. 2014). The Examiner does not direct us to any language in the Specification– –and we are unable to find such language––that would lead a skilled reader to understand that Appellant intends to exclude the end points of a recited range when the “about” language is used to describe that range. In other words, a preponderance of the evidence does not support the Examiner’s finding that an Appellant who expressed a “thickness between about 10 micrometers to 1000 micrometers” did not also contemplate a thickness that “is 10 micrometers to 1000 micrometers.” As such, we conclude that Appellant had possession of the subject matter of claim 7. For these reasons, the rejection of claim 7, for failing to comply with the written description requirement, is not sustained. Appeal 2019-005435 Application 15/203,435 5 The rejection of claims 1–10 as being indefinite The Examiner determines that the term “about” before the recited ranges or values in claims 1–5, 8,2 and 93 render these claims indefinite because “[t]he disclosure does not define the term about and to what extent the term about changes the range.” Final Act. 3–6. For example, in regards to the recitation “about 1% to about 75%,” the Examiner questions: “does the range include .5% – 85%, or 10% – 50%?” Final Act. 3. Further, the Examiner finds that the term “substantially eliminate” renders claim 2 indefinite because “it is unclear how much solvent is eliminated.” Final Act. 6. We begin with the term “substantially eliminate” which is recited in claim 2. A claim is properly rejected as being indefinite under 35 U.S.C. § 112, second paragraph if, after applying the broadest reasonable interpretation in light of the specification, the metes and bounds of a claim are not clear because the claim “contains words or phrases whose meaning is unclear.” In re Packard, 751 F.3d 1307, 1310 (Fed Cir. 2014). 2 We understand the recitation of “about about 25%” in claim 8 is a typographical error. See Appeal Br. 32 (Claims App.). Appellant states that the After-Final Amendment filed on September 4, 2018, which attempted to correct this typographical error, was not entered. Id. at 3. However, we note that the Advisory Action dated September 26, 2018 indicates that “[f]or purposes of appeal, the proposed amendment(s) . . . will be entered.” Adv. Act. 1. 3 The Examiner discusses the recitation “about 15%” of claim 8. Final Act. 6. However, “about 15%” is recited in claim 9, rather than in claim 8. See Appeal Br. 32 (Claims App.). Appeal 2019-005435 Application 15/203,435 6 The term “substantially” is defined as “of ample or considerable amount, quantity, size, etc.”4 This term is not recited before a range or a value but rather, is recited in the phrase “substantially eliminate the solvent itself.” See Appeal Br. 31 (Claims App.). A skilled reader would understand the phrase “substantially . . . eliminate the solvent” recited in claim 2 as “amply or considerably eliminate the amount or quantity of solvent.” We thus agree with Appellant that the term “substantially” does not render claim 2 indefinite. See Appeal Br. 18. We next turn to the term “about” which is recited in claims 1–5, 8, and 9. The Examiner identifies where “about” is recited before a range or a value in each of these claims. Final Act. 3–6; see also Appeal Br. 31–32 (Claims App.). As an initial matter, we agree with Appellant that there is no per se rule that the term “about” renders a claim indefinite. See Appeal Br. 13. On this point, our reviewing court has stated that a claim “employing terms of degree has long been found definite where it provided enough certainty to one of skill in the art when read in the context of the invention.” Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370 (Fed. Cir. 2014). In other words, patents with claims involving terms of degree “must provide objective boundaries for those of skill in the art” in the context of the invention. One-E-Way, Inc. v. International Trade commission, 859 F.3d 1059, 1068 (Fed. Cir. 2017) (quoting Interval Licensing LLC v. AOL, Inc., 766 F.3d at 1371). We also note that the courts have held that “[t]he 4 See https://www.dictionary.com/browse/substantially (last accessed March 13, 2020). Appeal 2019-005435 Application 15/203,435 7 meaning of the word ‘about’ is dependent on the facts of the case, the nature of the invention, and the knowledge imparted by the totality of the earlier disclosure to those skilled in the art. . . . We are also mindful that the word ‘about’ may lead to indefiniteness under § 112, ¶ 2.” Eiselstein v. Frank, 52 F.3d 1035, 1040 (Fed. Cir. 1995). Here, the Specification does not define the term “about.” See Spec., passim. Nothing in the Specification informs an ordinary artisan as to the scope of the term “about,” relative to the concentration, time, and pore size, which are relevant to claims 1–5, 8, and 9. Additionally, Appellant has not cited any close prior art, or provided any evidence, which address the extent of the claim term “about” relative to the recited ranges of concentration, time, and pore size. In fact, the Examiner asked a direct question regarding one particular range, to which Appellant does not respond, i.e., “does the range include .5% – 85%, or 10% – 50%?” Final Act. 3. It is clear the Examiner was seeking to ascertain some guidance from Appellant as to the boundaries of this range, but none was forthcoming. Instead, Appellant states: (1) “one familiar of the art would understand that deviating so drastically from the recited ranges would negatively affect the process” (Appeal Br. 15; italics added); (2) the information provided in the Specification concerning preferred embodiments “provides even further guidance for one of skill in the art to determine the suitable concentrations of base material vs. the solvent and antibiotic to be used, as well as a suitable waiting time” (id. at 15; emphasis added); (3) “claim 1 goes on to recite a certain range so as to achieve a certain desired result, and thus clearly provides context” (id. at 16); and (4) “one of ordinary skill working with these materials would also be familiar with Appeal 2019-005435 Application 15/203,435 8 polymerization and evaporation and the average ratios of the concentrations of the respective materials, as well as the average amount of time needed for activities such as polymerization or evaporation to occur” (id.). See also Appeal Br. 17–29. Appellant’s contentions are unpersuasive. Concerning contentions (1) and (2), Appellant does not provide any criteria by which a skilled artisan would understand what a “drastic” deviation would be, or what a “suitable concentration” or a “suitable waiting time” would be. Concerning contention (3), the Examiner correctly responds that one of ordinary skill in the art would not be able to ascertain the metes and bounds of claim 1 because claim 1 contains so many ambiguous ranges that depend on one another to arrive at the end product. For example, a variation in the concentration of base material vs. solvent may impact the waiting time, so there is no way for one of ordinary skill in the art to determine what is actually encompassed by a waiting time of about 10–60 minutes. Ans. 10. Regarding contention (4), the Examiner also correctly points out that the claims do not require any specific material and that there are numerous relevant factors involved, such as temperature, humidity, and light, such that a skilled artisan would not have been able to fully understand or comprehend the average amount of time needed for polymerization and evaporation to occur. Ans. 11–12. As such, we agree with the Examiner that because of Appellant’s usage of the term “about” in the relevant claims, an ordinary artisan would not be able to ascertain the metes and bounds of those claims. See Ans. 10. In summation, and based on the record presented, Appellant does not apprise us of Examiner error. Accordingly, the rejection of claims 1–10 as being indefinite is sustained. Appeal 2019-005435 Application 15/203,435 9 CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/B asis Affirmed Reversed 7 112, first paragraph Written Description 7 1–10 112, second paragraph Indefiniteness 1–10 Overall Outcome5 1–10 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 5 37 C.F.R. § 41.50(a)(1) states: “The affirmance of the rejection of a claim on any of the grounds specified constitutes a general affirmance of the decision of the examiner on that claim.”