Ex Parte RavikumarDownload PDFBoard of Patent Appeals and InterferencesNov 12, 200911420927 (B.P.A.I. Nov. 12, 2009) 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. 11/420,927 05/30/2006 Sundaram Ravikumar RAV-024 1834 36822 7590 11/13/2009 GORDON & JACOBSON, P.C. 60 LONG RIDGE ROAD SUITE 407 STAMFORD, CT 06902 EXAMINER LANG, AMY T ART UNIT PAPER NUMBER 3731 MAIL DATE DELIVERY MODE 11/13/2009 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 BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte SUNDARAM RAVIKUMAR __________ Appeal 2009-009819 Application 11/420,927 Technology Center 3700 __________ Decided: November 12, 2009 __________ Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a surgical assembly. The Patent Examiner rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in- part. Appeal 2009-009819 Application 11/420,927 2 STATEMENT OF THE CASE The invention “relates [to] minimally invasive surgical instruments incorporating a needle and a working device which extends through and beyond the needle and which can be retracted into the needle.” (Id.) The invention is said to have particular application to laparoscopic-type surgery, although not limited thereto. (Id.) Claims 1-8, 10-17, 26 and 27, which are all the pending claims, are on appeal. The representative and separately argued claims read as follows: 1. A surgical assembly consisting essentially of: a) a hollow needle having an outer diameter of substantially 2mm or smaller and a sharp distal end for creating a puncture incision in the human body; and b) a surgical instrument consisting essentially of a shaft, end effectors connected to said shaft at a first end of said shaft, said end effectors having opposed distal tips, and a proximal handle or knob coupled to a second end of said shaft, said surgical instrument having no wires extending through said shaft or about said shaft for manipulating said end effectors, said shaft extending through said hollow needle, said surgical instrument being movable relative to said hollow needle, and said end effectors are biased to a first position such that when said end effectors extend out of said needle said end effectors automatically open relative to each other with said opposed distal tips substantially separated from one another in a first position, and when said hollow needle extends over said end effectors, said needle operates on said end effectors to automatically force said end effectors into a second position with said opposed distal tips disposed in proximate contact to one another in said second position, and wherein said end effectors are moveable relative to said outer hollow needle to a retracted position wherein said distal tips of said end effectors are positioned proximal relative to said sharp distal end of said outer hollow needle to thereby expose said sharp distal end of said hollow needle. 3. A surgical assembly consisting essentially of: Appeal 2009-009819 Application 11/420,927 3 a) a hollow needle having an outer diameter of substantially 2mm or smaller and a sharp distal end for creating a puncture incision in the human body; b) a surgical instrument consisting essentially of a shaft, end effectors connected to said shaft at a first end of said shaft, said end effectors having opposed distal tips, and a handle or knob coupled to a second end of said shaft, said surgical instrument having no wires extending through said shaft or about said shaft for manipulating said end effectors, said shaft extending through said hollow needle, said surgical instrument being movable relative to said hollow needle, wherein said end effectors are biased to a first position such that when said end effectors extend out of said needle said end effectors automatically open relative to each other with said opposed distal tips substantially separated from one another in a first position, and when said hollow needle extends over said end effectors, said needle operates on said end effectors to automatically force said end effectors into a second position with said opposed distal tips, disposed in proximate contact to one another in said second position, and wherein said end effectors are moveable relative to said outer hollow needle to a retracted position wherein said distal tips of said end effectors are positioned proximal relative to said sharp distal end of said outer hollow needle to thereby expose said sharp distal end of said hollow needle; and c) at least one of (i) a first fixing means coupled to said surgical instrument and said needle for fixing a relative location of said surgical instrument and said needle, and (ii) second fixing means coupled to and movable relative to said needle for fixing a relative location of said needle to a patient. 15. A surgical assembly according to claim 1, wherein: the needle has a central axis, and the sharp distal end of said needle has an end wall angled at substantially 35° relative to the central axis. 26. A surgical assembly according to claim 1, wherein: the end effectors are moveable relative to the outer hollow needle to a partially-extended position wherein the distal tips of the end effectors are Appeal 2009-009819 Application 11/420,927 4 positioned outside but close to the sharp distal end of the outer hollow needle such that the end effectors act as an obturator for protecting against accidental trauma caused by the sharp distal end of the outer hollow needle. 27. A surgical assembly consisting of: a) a hollow needle consisting essentially of a sharp distal end for creating a puncture incision in the human body and a proximal handle or knob; b) a surgical instrument consisting essentially of a shaft, end effectors connected to said shaft at a first end of said shaft, said end effectors having opposed distal tips, and a handle or knob coupled to a second end of said shaft, said surgical instrument having no wires extending through said shaft or about said shaft for manipulating said end effectors, said shaft extending through said hollow needle, said surgical instrument being movable relative to said hollow needle, wherein said end effectors are biased to a first position such that when said end effectors extend out of said needle said end effectors automatically open relative to each other with said opposed distal tips substantially separated from one another in a first position, and when said hollow needle extends over said end effectors, said needle operates on said end effectors to automatically force said end effectors into a second position with said opposed distal tips, disposed in proximate contact to one another in said second position, and wherein the end effectors are moveable relative to the outer hollow needle to a retracted position wherein said distal tips of said end effectors are positioned proximal relative to said sharp distal end of said outer hollow needle to thereby expose said sharp distal end of said hollow needle; and c) at least one of (i) a first fixing means coupled to said surgical instrument and said needle for fixing a relative location of said surgical instrument and said needle, and (ii) second fixing means coupled to and movable relative to said needle for fixing a relative location of said needle to a patient. Appeal 2009-009819 Application 11/420,927 5 The Examiner rejected the claims as follows: • claims 1, 2, 11-17 and 26 under 35 U.S.C. § 103(a) as unpatentable over the combined teachings of Levin1 and Hasson;2 • claims 3-8 and 27 under 35 U.S.C. § 103(a) as unpatentable over the combined teachings of Levin, Hasson, and Hamel3 or Sterman;4 and • claim 10 under 35 U.S.C. § 103(a) as unpatentable over the combined teachings of Levin, Hasson, Hamel or Sterman, and Bark.5 Claims 2, 11-14, 16 and 17 have not been argued separately and therefore stand or fall with claim 1; claims 4-8 have not been argued separately and therefore stand or fall with claim 3. 37 C.F.R. § 41.37(c)(1)(vii). OBVIOUSNESS Principles of Law Relating to Claim Interpretation “In simple terms, a drafter uses the phrase ‘consisting of’ to mean ‘I claim what follows and nothing else.’ A drafter uses the term ‘comprising’ to mean ‘I claim at least what follows and potentially more.’” Vehicular Technologies Corp. v. Titan Wheel Int’l, Inc., 212 F.3d 1377, 1383 (Fed. Cir. 2000). The phrase “consisting essentially of” in a patent claim “has long been understood to permit inclusion of components not listed in a 1 Pub. No. US 2003/0130693 A1, by John M. Levin et al., published Jul. 10, 2003. 2 U.S. Patent No. 4,174,715, issued to Harrith M. Hasson, Nov. 20, 1979. 3 U.S. Patent No. 7,001,333 B2, issued to Ross J. Hamel et al., Feb. 21, 2006. 4 Pub. No. US 2003/0145865 A1, by Wesley D. Sterman et al., published Aug. 7, 2003. 5 U.S. Patent No. 5,354,283, issued to Jeffrey E. Bark et al., Oct. 11, 1994. Appeal 2009-009819 Application 11/420,927 6 claim, provided that they do not ‘materially affect the basic and novel properties of the invention.’” AK Steel Corp. v. Sollac, 344 F.3d 1234, 1239 (Fed. Cir. 2003) (citations omitted). Principles of Law Relating to Obviousness A prior art reference is said to teach away from an Applicant’s invention “when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). “The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Findings of Fact 1. Levin described a surgical assembly for laparascopic procedures that comprised a hollow needle 104 and a surgical instrument 20. (Fig. 7.) 2. Levin’s needle had “a width, for example, about 14 gauge.” (Levin, ¶ 31.) 3. Levin taught that the instrument could be retracted in the hollow needle, as shown by the position of the forceps in Fig. 9. (Id., ¶ 35.) 4. Hasson’s patent is entitled “MULTI-PRONGED LAPAROSCOPY FORCEPS.” 5. Hasson disclosed that “the preferred instrument includes an internal elongated shaft coupled to the prongs, and an outer elongated tubular Appeal 2009-009819 Application 11/420,927 7 sleeve for slidably receiving the internal shaft and portions of the flexible prongs.” (Col. 1, ll. 48-51.) 6. Hasson’s “forceps arms 18 are so mounted or formed on stem 12 as to be normally resiliently biased outwardly, away from each other” (col. 3, ll. 5-7), and “[t]he elongated stem is slidable within the tubular guide means such that the forceps arms 18 may be cammed by the tubular sleeve 26 to draw their distal ends toward a clustered relationship when the stem is moved rearwardly” (col. 3, ll. 18-23). 7. When operating Hasson’s instrument, “[m]ovement of the thumb- operated actuator towards the finger grip means causes the stem to move forward so that the prongs project to an open or expanded position forwardly of the tubular guide tube.” (Col. 5, ll. 1-5.) 8. Hasson taught advantages of the spring loaded forceps were that “[s]uch an instrument holds tissue securely with even tension and only a minimal effort is necessary to maintain the held tissue in a stable position.” (Col. 6, ll. 5-9.) A. Rejection of claims 1, 15 and 26 over Levin and Hasson The Issues The Examiner’s position is that Levin described a surgical assembly for laparoscopic procedures that comprised the elements claimed but for forceps (“end effectors” as recited in claim 1) biased “automatically open” when distally extended from the needle. (Ans. 3-4.) However, the Examiner found that Hasson evidenced that forceps biased open were “well known in the art,” and “advantageously require only minimal effort to hold and maintain tissue in a stable position.” (Id. at 4.) The Examiner Appeal 2009-009819 Application 11/420,927 8 concluded it would have been obvious to use Hasson’s forceps as an instrument inserted through Levin’s needle. (Id. at 4-5.) Appellant contends that each of Levin and Hasson teaches away from the invention (App. Br. 16-17), and that the Examiner failed to address claim limitations that (i) the instrument “consists essentially of” shaft, end effectors, and a proximal handle; (ii) the instrument has no wires; and (iii) the needle forces the end effectors into a second position (id. at 19-20). Appellant argues that the combination of Levin’s needle with Hasson’s forceps would have many more components than claimed. (Id. at 22.) Further, “the distal tips of Hasson are not disposed in proximate contact to one another as required by claim 1, and Hasson actually teaches away from such proximate contact.” (Id. at 21.) Appellant contends that “the Examiner’s stated incentive for combination is not supported by any evidence,” and “the opposite may be true.” (Id. at 23.) Appellant contends that claim 15’s “end wall angled at substantially 35° relative to the central axis” is not met by Levin’s needle (104), which Appellant says “makes a 45 degree angle.” (Id. at 24.) Appellant contends that claim 26 could not be obvious in the absence of a “disclosure in Levin or Hasson to locate a forceps in an extended position where the end effectors ‘act as an obturator.’” (Id. at 24-25.)6 The issues with respect to this rejection are did Levin or Hasson teach away from the invention; 6 MERRIAM-WEBSTER’S MEDICAL DICTIONARY defines obturator as “a device that blocks the opening of an instrument (as a sigmoidoscope) that is being introduced into the body.” See , accessed Oct. 19, 2009. Appeal 2009-009819 Application 11/420,927 9 did Hasson disclose distal forcep tips in proximate contact; would the combination of Levin’s needle with Hasson’s forceps necessarily require many more parts than claimed; was the Examiner’s stated incentive for combination supported by evidence; did Levin’s needle have an end wall “angled at substantially 35°” as recited in claim 15; did Hasson disclose forceps in a position where the end effectors act as an obturator? Analysis First, Appellant has not shown that the fact that the example instrument Levin deployed through the needle had wires, clevis, pin, etc., would have discouraged a person of ordinary skill in the art deploying a different instrument, such as Hasson’s, through the needle. Appellant did not provide evidence that a person of ordinary skill would have understood that Levin’s disclosure meant these elements (wires, clevis, etc.) were necessary. To the contrary, Levin’s disclosure of instruments to deploy through the needle was broad, and included clamps, dissectors, and other surgical devices. See Levin Abstract. Nor has Appellant provided evidence that the substitution of Hasson’s spring biased forceps for Levin’s illustrated forceps would have been anything more than the substitution of one known instrument for another, with results that would have been predictable. We also do not agree with Appellant’s argument that replacing Levin’s forceps with Hasson’s forceps would have produced an instrument having at least four coaxial elements, in contrast to the claimed instrument Appeal 2009-009819 Application 11/420,927 10 “consisting essentially of” a shaft, end effectors and a proximal handle. (App. Br. 22.) The Examiner concluded that it would have been obvious to use Hasson’s forceps with shaft 12 and end effectors 18, as the instrument in Levin’s needle (Ans. 4-5), not that it would have been obvious to use additional coaxial elements (24, 26, 29) from Hasson. We find Appellant’s argument misdirected, and conclude that the Examiner did not ignore the limiting “consisting essentially of” language. We find the evidence supports the Examiner’s finding that Hasson taught specific advantages of using the spring biased forceps (FF8), and we therefore reject Appellant’s contention that the Examiner relied improperly on hindsight. We also agree with the Examiner that Hasson’s opposed end effectors tips may be in proximate contact, and would continue to so operate if used in Levin’s needle. (See, e.g., Hasson at Fig. 13.) In the Final Rejection, the Examiner found that Levin’s needle had an end wall angled at “substantially” 35 degrees, and that Appellant’s claim 15 reciting this numerical value would have been obvious. (Fin. Rej. 6.) Appellant argues that a measurement of the angle shown in Levin’s Fig. 7 shows a 45 degree angle, not a 35 degree angle, and that the Specification’s definition of “substantially” means that 45 degrees cannot meet claim 15’s “substantially 35 degrees” limitation. (App. Br. 24, citing Spec. ¶ 14.) Spec. ¶ 14 states: “the term ‘substantially’, for purposes of this application meaning ± 10%.” Applying the meaning given in the Specification, we interpret the claim limitation “substantially 35 degrees” to mean the range 31.5 - 38.5 degrees. Appellant’s undisputed 45 degree measurement is not within the claimed range. Although the Examiner’s Answer repeats the finding from the Final Rejection, the Answer now inconsistently argues that Appeal 2009-009819 Application 11/420,927 11 angle measurements taken from Levin’s figures “should not be representative of [Levin’s] entire disclosed invention” (Ans. 13). We take this as a concession by the Examiner that, contrary to the finding in the Final Rejection, Levin did not disclose an angle of “substantially 35 degrees.” The Examiner proposes no further explanation that 35 degrees would have been obvious. We find that Appellant rebutted the original rejection, and that the Examiner has not made a new case. Accordingly, we will reverse the rejection of claim 15. With respect to claim 26, we agree with the Examiner that Hasson’s forceps are end effectors that act as the claimed “obturator.” (Ans. 8.) Hasson’s Figures show forceps extending beyond the end of the shaft from which they are deployed. (See e.g., Fig. 2, 5, 6, et al.) When deployed in the manner shown by Hasson, the forceps impede the sharp end of the trocar or needle from accidentally damaging tissue at least to some extent. Appellant provides no reason to think Hasson’s forceps would not function the same way if deployed through Levin’s needle. Appellant’s argument about claim 26 merely observes that the term “obturator” does not appear in either of Levin or Hasson. (App. Br. 24-25.) While neither Levin nor Hasson used the term “obturator,” the evidence supports the Examiner’s finding that Hasson’s forceps perform that function. B. Rejection of claims 3 and 27 over Levin, Hasson, and Hamel or Sterman The Issues The Examiner applied the same obviousness analysis to claim 3 as applied to claim 1, but found that Levin and Hasson did not specifically Appeal 2009-009819 Application 11/420,927 12 disclose a “fixing means” for fixing a relative location of the forceps and needle. (Ans. 8.) However, Hamel and Sterman disclosed trocars with various instrument fixing means to enhance manipulation. (Id.) The Examiner concluded it would have been obvious to use a fixing means to lock the forceps in place within Levin’s needle “to securely fasten the forceps to the needle for easier manipulation.” (Id. at 9.) Appellant restates the arguments relative to Levin and Hasson that were presented against the rejection of claim 1, and argues that the Examiner has not accounted for the “consisting essentially of” phrase in claim 3. (App. Br. 25-31.) Appellant also argues that “Hamel and Sterman teach fixing a surgical instrument relative to a blunt trocar tube, but not relative to a needle,” and “there is no teaching to provide a fixing means which is coupled to a needle.” (Id. at 31.) For claim 27, Appellant reiterates arguments related to Levin, Hasson, Hamel and Sterman, and argues further that the rejection did not account for claim 27’s phrase “consisting of.” (Id. at 32-38.) The issues with respect to this rejection are: did the rejection properly account for the transitional phrase “consisting essentially of”; if the Hamel or Sterman teaching concerned a trocar, did the Examiner err in applying it to the needle Levin taught in place of a trocar; did the rejection properly account for claim 27’s transitional phrase “consisting of”? Analysis For reasons already explained, we find Appellant’s “consisting essentially of” argument unpersuasive because it is directed to a rejection the Appeal 2009-009819 Application 11/420,927 13 Examiner did not make. The same reasoning applies to Appellant’s “consisting of” argument. Appellant’s other arguments apparently rely on the absence of an anticipating reference to dispute the obviousness of using known fixing means on the needle/instrument combination suggested by Levin and Hasson. The Examiner stated a reason why a person skilled in the art would have seen an advantage to using known trocar/instrument fixing means in the suggested needle/instrument combination. Appellant’s arguments seem to mean only that because the invention is novel (on this record) it would not have been obvious. We are unpersuaded of error. The obviousness rejection of claims 3 and 27 is affirmed. C. Rejection of claim 10 over Levin, Hasson, Hamel or Sterman, and Bark The Issues The Examiner found that Bark taught a trocar fixed to a relative location on a patient by a stabilizing member (suction cups). (Ans. 10.) The trocar was thus “advantageously stable during the medical procedure, but can also be rotated to improve the surgeon’s view.” (Id.) The Examiner concluded it would have been obvious to use Bark’s suction cup fixing means on the device suggested by the references that rendered claim 3 obvious. (Id.) In addition to the arguments presented against the rejection of claim 3, Appellant contends that “Bark does not provide a teaching to provide a fixing means which is coupled to a needle.” (App. Br. at 31-32.) Appeal 2009-009819 Application 11/420,927 14 The issue with respect to this rejection is whether Bark’s alleged failure to teach a fixing means coupled to a needle supports a conclusion of nonobviousness. Analysis Appellant’s arguments are basically that because the invention is not anticipated, it would not have been obvious. We find this argument unpersuasive against the Examiner’s prima facie case. As explained above, the Examiner explained why it would have been obvious to have used a fixing means attached to the instrument and needle as claimed. The rejection of claim 10 is affirmed. CONCLUSIONS OF LAW Rejection A. Neither Levin nor Hasson taught away from the invention. Hasson disclosed distal forcep tips in proximate contact. The combination of Levin’s needle with Hasson’s forceps would not have required many more parts than claimed. The Examiner’s stated incentive for combining the Levin and Hasson teachings was supported by evidence. The Examiner did not establish with evidence that Levin’s needle had an end wall “angled at substantially 35°” as recited in claim 15; The evidence shows that Hasson’s forceps had end effectors that acted as an obturator? Rejection B. Appeal 2009-009819 Application 11/420,927 15 We find that the Examiner’s rejection of claim 3 properly accounted for the transitional phrase “consisting essentially of.” Appellant has not shown the Examiner erred in combining the Hamel or Sterman trocar/instrument fixing means teachings with Levin’s teachings. We find that the Examiner’s rejection properly accounted for claim 27’s transitional phrase “consisting of.” Rejection C. Appellant has not shown that Bark’s failure to teach a fixing means coupled to a needle rebutted the Examiner’s prima facie reason for using a known trocar fixing means on Levin’s needle. SUMMARY We affirm the rejection of claims 1, 2, 11-14, 16, 17 and 26 under 35 U.S.C. § 103(a) as unpatentable over the combined teachings of Levin and Hasson; we reverse the rejection of claim 15 under 35 U.S.C. § 103(a) as unpatentable over the combined teachings of Levin and Hasson; we affirm the rejection of claims 3-8 and 27 under 35 U.S.C. § 103(a) as unpatentable over the combined teachings of Levin, Hasson, and Hamel or Sterman; and we affirm the rejection of claim 10 under 35 U.S.C. § 103(a) as unpatentable over the combined teachings of Levin, Hasson, Hamel or Sterman, and Bark. Appeal 2009-009819 Application 11/420,927 16 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-IN-PART lp GORDON & JACOBSON, P.C. 60 LONG RIDGE ROAD SUITE 407 STAMFORD CT 06902 Copy with citationCopy as parenthetical citation