DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 lines 3-4 “a second conduit” should read “the second conduit” as it appears to be referring to the same second conduit introduced in line 3.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3, 5, 16, 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “wherein the rod is at least twice as rigid as the coaligned conduits when tested using Test 1”. It is unclear what “Test 1” comprises. The instant specification [0075] discloses the following: “A sample of the material to be tested is anchored at one end and extended horizontally for a distance of 25 mm. A vertical force is applied in the downward direction at a point 19 mm from the anchor point. The force (Gf) required to deflect the sample by 12 mm in the vertical direction is recorded. Ratings are provided below in Table 1”. However it is still unclear what specifically is required of the Test 1. For example it is unclear how the material is anchored, how the material is extended (is the material already that long or should the material be stretched to this length) what is the force applied. For purposed of examination, it is interpreted that any of the materials as outlined in claim 3 (which is dependent on claim 2) would meet the rigidity of “test 1” as recited in claim 2.
Claim 3 is rejected due to its dependence on claim 2.
Claim 5 recites “wherein the rod has a rigidity rating of A or B and the coaligned conduits have a rigidity rating of C or D by Test 1.” It is unclear what a rigidity rating of A, B, C or D refers to. It is also unclear what “Test 1” comprises. The instant specification [0075] discloses the following: “A sample of the material to be tested is anchored at one end and extended horizontally for a distance of 25 mm. A vertical force is applied in the downward direction at a point 19 mm from the anchor point. The force (Gf) required to deflect the sample by 12 mm in the vertical direction is recorded. Ratings are provided below in Table 1”. However it is still unclear what specifically is required of the Test 1. For example it is unclear how the material is anchored, how the material is extended (is the material already that long or should the material be stretched to this length) what is the force applied. For purposed of examination, it is interpreted that any of the materials as outlined in claim 3 (which is dependent on claim 2) would meet the rigidity of “test 1” for the rod, and that any conduit that has some rigidity that could be ‘tested’ would meet this limitation.
Claim 16 recites “the first conduit” and “the second conduit” in lines 3 and 4. These recitations lack antecedent basis.
Claim 18 recites “the rod having a rigidity rating of A or B and the two coaligned flexible conduits have a rigidity rating of C or D”. It is unclear what a rigidity rating of A B, C or D is and how to differentiate the ratings.
Claim 19 recites “the first conduit” and “the second conduit” in lines 2 and 3. These recitations lack antecedent basis.
Claim 20 recites “the second conduit in lines 2-3. This recitation lacks antecedent basis.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4, 7, 9-11 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arias et al. (US 5314406 hereinafter “Arias”) in view of Shtul (US 20170087284).
Regarding Claim 1, Arias teaches (Fig 11g) A surgical suction and irrigation apparatus comprising:
a rod (Col 23 line 50 teaches 1529 is meant for a cautery cable, the cautery cable is interpreted to be a rod); and
two flexible and substantially coaligned first (1528, 1530) and second (1529) conduits wherein the second conduit of the two substantially coaligned conduits has an inner diameter configured to receive the rod (Col 23 line 50 teaches 1529 is meant for a cautery cable, the cautery cable is interpreted to be a rod); and
the first conduit (1528, 1530) is in fluid communication with a vacuum source and an irrigation source (Col 23 line 42-43 teaches 1528 and 1530 are suction and irrigation tubes; therefore they must be in communication with a vacuum and irrigation source).
Arias does not specify that the second conduit of the two substantially coaligned conduits is sealed on a distal end.
Shtul teaches (Fig 5a and [0124]) a device with a tube (523a) comprising a rod (523b), wherein the tube (523a) is sealed on a distal end (see Fig 5a, 523a appears to be sealed by 524).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second conduit of Arias such that the second conduit of the two substantially coaligned conduits is sealed on a distal end as taught by Shtul. One of ordinary skill in the art would recognize this as an alternative shape/design of the tube that would provide the same result of a tube structure that allows for the inner diameter to receive the rod.
Regarding Claim 4, the combination of Arias and Shtul teaches all elements of claim 1 as described above. Arias further teaches the surgical suction and irrigation apparatus wherein at least a first portion (1530) of the first conduit (1528, 1530) of the two substantially coaligned conduits is bonded to or coextruded to at least a second portion (outer surface of 1529) of the second conduit (See Fig 11g, a first portion (portion of 1530) is connected to 1529).
Regarding Claim 7, the combination of Arias and Shtul teaches all elements of claim 1 as described above. Arias further teaches the surgical suction and irrigation apparatus wherein the second conduit (1529) is narrower than the first conduit (1528, 1530; see Col 23 lines 48-62 teaching how 1529 is narrower).
Arias does not specify that the second conduit is shorter than the first conduit. However, Arias does teach in Col 23 lines 48-62 that the size and location of the second conduit 1529 could be varied. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Arias device to have the second conduit is shorter than the first conduit, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Arias by making the second conduit is shorter than the first conduit as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 9, Arias and Shtul teaches all elements of claim 1. Arias further teaches the surgical suction and irrigation apparatus wherein the first conduit is configured to perform suction and irrigation during a surgery (Col 23 lines 39-43 teaches 1528 and 1530 are suction and irrigation tubes).
Regarding Claim 10, Arias and Shtul teaches all elements of claim 1 as described above. The combination does not specify the surgical suction and irrigation apparatus wherein the rod includes an air passageway selected from at least one of a lumen through the rod and a negative feature on an external surface of the rod.
Arias does teach in the embodiment of Fig 6a, a rod (610a) that is hollow (Col 13 lines 32-35). This is considered a lumen through a rod.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rod of Arias Figure 11g such that it includes a lumen as taught by Arias embodiment of Figure 6a. One of ordinary skill in the art would have been motivated to do so in order to allow a probe to communicate through the rod (Arias Col 13 lines 32-35).
Regarding Claim 11, Arias and Shtul teaches all elements of claim 1. Arias further teaches the surgical suction and irrigation apparatus wherein the first conduit (1528, 1530) is in fluid communication with a suction/irrigation tip (distal tip of 1528, 1530) and the second conduit (1529) is not in fluid communication with the suction/irrigation tip (see Fig 11g, 1529 is separate from the distal tip of 1528 and 1530).
Regarding Claim 13, Arias and Shtul teaches all elements of claim 1. Arias further teaches the surgical suction and irrigation wherein the first (1528, 1530) and second (1529) conduits do not share a common axis (see Fig 11g, the tubes are all parallel so do not share same axis).
Regarding Claim 14, Arias and Shtul teaches all elements of claim 1 as described above. Arias further teaches the surgical suction and irrigation apparatus wherein the second conduit (1529) includes a grasping tab (1540a, 1540b).
Claim(s) 1, 4, 6, 8, 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahapatra (US 20190274757) in view of Novell (US 20220031296).
Regarding Claim 1, Mahapatra teaches (Figs 1-3) A surgical suction and irrigation apparatus comprising:
a rod (27; Fig 3c, and [0063] and [050] teaching tensioning means includes rods); and
two flexible and substantially coaligned first (2) and second (100) conduits wherein a second conduit (100) of the two substantially coaligned conduits is sealed on a distal end (See 5 is distal end of 100 and is sealed) and has an inner diameter configured to receive the rod (See Fig 3c; 27 is within distal tip 5 of 100);
Mahapatra does not specify the first conduit is in fluid communication with a vacuum source and an irrigation source.
Novell teaches (figs 1-2) a device with a first conduit (102) and a second conduit (101) wherein the first conduit (102) is in fluid communication with a vacuum source and an irrigation source (See [0043] teaching that the distal end 160 of 102 is in fluid communication with the suction/irrigation device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first conduit of Mahapatra such that the first conduit is in fluid communication with a vacuum source and an irrigation source as taught by Novell. One of ordinary skill in the art would have been motivated to do so in order to position a laparoscopic flexible suction/irrigation device within a surgical site and provide the surgeon a better visualization of the surgical field (Novell [0043]).
Regarding Claim 4, the combination of Mahapatra and Novell teaches all elements of claim 1 as described above. Mahapatra further teaches the surgical suction and irrigation apparatus wherein at least a first portion of the first conduit (2) of the two substantially coaligned conduits is bonded to or coextruded to at least a second portion of the second conduit (100; see fig 1 and [0057] showing how 9 connects 2 and 100, therefore at least a portion of 2 and a portion of 100 are connected/bonded through 9).
Regarding Claim 6, the combination of Mahapatra and Novell teaches all elements of claim 1 as described above. Mahapatra further teaches the surgical suction and irrigation apparatus wherein the second conduit is configured to admit the rod while surgically inserted in a patient and without being removed from the patient (see [0057] teaching how distal tip 5 is inside the patient and see [0063] teaching how rod 27 is within distal tip 5).
Regarding Claim 8, the combination of Mahapatra and Novell teaches all elements of claim 1 as described above. Mahapatra further teaches the surgical suction and irrigation apparatus wherein the surgical suction and irrigation apparatus is configured to be used to retract tissue of a patient while the rod is inserted in the second conduit (this is considered functional language; based on [0063] of Mahapatra, it is interpreted that the device is capable of irrigation, suction to ‘retract tissue’ while the rod 27 is inserted in the second conduit 100, 5).
Regarding Claim 12, the combination of Mahapatra and Novell teaches all elements of claim 1 as described above. Mahapatra further teaches the surgical suction and irrigation apparatus wherein a distal portion of the coaligned conduits is reversibly bendable (See Figs 2a-2c, the distal portions are bendable; also see [0081] teaching multiple points of deflection).
Regarding Claim 14, the combination of Mahapatra and Novell teaches all elements of claim 1 as described above. Mahapatra further teaches the surgical suction and irrigation apparatus wherein the second conduit (100, 5) includes a grasping tab (19; see Fig 3a and [0063]).
Claim(s) 2-3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahapatra and Novell as applied to claim 1 above, and further in view of Berg et al. (US 5951495 hereinafter “Berg”).
Regarding Claims 2-3, the combination of Mahapatra and Novell teaches all elements of claim 1 as described above. The combination does not specify the surgical suction and irrigation apparatus wherein the rod is at least twice as rigid as the coaligned conduits when tested using Test 1; wherein the rod comprises metal, a metal alloy, glass, or a polymer.
Berg teaches (Fig 2) a tube (12) with a support member (15) comprised of a metal braid (See Col 5 lines 63-65). The examiner makes note of the 112 rejection above for claim 2 (it is interpreted that a metal material for the rod would meet the limitation of “test 1”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rod of Mahaparta such that it is made of a metal material as taught by Berg. One of ordinary skill in the art would have been motivated to do so as this is a known high tensile material used to provide support to a tube (Berg Col 5 lines 63-65). Furthermore, it has been held that “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp”.
Regarding Claim 5, the combination of Mahapatra and Novell teaches all elements of claim 1 as described above. The combination does not specify the surgical suction and irrigation apparatus the rod has a rigidity rating of A or B and the coaligned conduits have a rigidity rating of C or D by Test 1.
Berg teaches (Fig 2) a tube (12) with a support member (15) comprised of a metal braid (See Col 5 lines 63-65). As such it is interpreted that the tube mist be less rigid than the support member as the support member is adding tensile strength. The examiner also makes note of the 112 rejection above for claim 5 (it is interpreted that a metal material for the rod would meet the limitation of “test 1”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rod of Mahaparta such that it is made of a metal material as taught by Berg. One of ordinary skill in the art would have been motivated to do so as this is a known high tensile material used to provide support to a tube (Berg Col 5 lines 63-65). Furthermore, it has been held that “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp”.
Claim(s) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arias (US 5314406).
Regarding Claim 15, Arias (Figs 1 and 11g) A method of using a surgical suction and irrigation apparatus comprising a rod (Col 23 line 50 teaches 1529 is meant for a cautery cable, the cautery cable is interpreted to be a rod) and a probe (Fig 1; 500) comprising two substantially coaligned flexible conduits (Fig 11g; first conduit 1528, 1530; second conduit 1529), the method comprising:
inserting the probe (500) into a surgical field (Col 7 lines 18-22 teach the intension is to move the probe through device for surgical use), the probe exhibiting a first rigidity (would be necessarily true); inserting the rod into one of the flexible conduits (Col 23 line 50 teaches 1529 is meant for a cautery cable, the cautery cable is interpreted to be a rod).
Arias does not specify the rod is inserted into one of the flexible conduits to increase the rigidity of the probe by at least 50%. The instant disclosure describes the parameter of “increase the rigidity of the probe by at least 50%” as being merely preferable (See instant specification [0077]), and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as “increase the rigidity of the probe by at least 50%” are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of “increase the rigidity of the probe by at least 50%” would be dependent on the actual application of the system and, thus would be a design choice based on the actual application (any “rod” would provide rigidity to a tube, so the specific percentage of rigidity would be a design choice/routine optimization based on the material of the rod).
Regarding Claim 16, Arias teaches the method of using a surgical suction and irrigation apparatus of claim 15, further comprising: performing the suction and/or irrigation using the first conduit (1528, 1530; see Col 23 line 42-43 teaches 1528 and 1530 are suction and irrigation tubes) while the rod is inserted into the second conduit (Col 23 line 50 teaches 1529 is meant for a cautery cable, the cautery cable is interpreted to be a rod); and removing the rod from the second conduit (Col 23 lines 52-54 teaches that the cable could be removed as desired) and performing suction and/or irrigation using the first conduit while the rod is not inserted into the second conduit (Col 23 lines 52-54 teaches the cable could be removed as desired, therefore the suction/irrigation could be performed while rod is not inserted in 1529).
Regarding Claim 17, Arias teaches the method of using a surgical suction and irrigation apparatus of claim 16, wherein the inserting the rod and removing the rod take place while the surgical suction and irrigation apparatus is surgically inserted in the surgical field during surgery (Col 23 lines 52-54 teaches the cable could be removed as desired, therefore the suction/irrigation could be performed while rod is not inserted in 1529 while the apparatus is in the surgical field).
Regarding Claim 18, Arias teaches the method of using a surgical suction and irrigation apparatus of claim 15, the rod having a rigidity rating of A or B and the two coaligned flexible conduits have a rigidity rating of C or D (since the rod has different dimensions than the conduits see Col 23 lines 41-62) it is interpreted that there would be different rigidity rating between the conduits and the rod).
In the instance that this is not true the examiner also rejects this claim in the following. Arias is silent as to the specifics of “the rod having a rigidity rating of A or B and the two coaligned flexible conduits have a rigidity rating of C or D”. The instant disclosure describes the parameter of “the rod having a rigidity rating of A or B and the two coaligned flexible conduits have a rigidity rating of C or D” as being merely preferable (see 112 rejection above), and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as “the rod having a rigidity rating of A or B and the two coaligned flexible conduits have a rigidity rating of C or D” are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of “the rod having a rigidity rating of A or B and the two coaligned flexible conduits have a rigidity rating of C or D” would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 19, Arias teaches the method of using a surgical suction and irrigation apparatus of claim 15, at least a first portion (1530) of the first conduit (1528, 1530) is bonded to or coextruded to at least a second portion (outer surface of 1529) of the second conduit (See Fig 11g, a first portion (portion of 1530) is connected to 1529).
Regarding Claim 20, Arias teaches the method of using a surgical suction and irrigation apparatus of claim 15, wherein inserting the rod into the second conduit renders the second conduit rigid (See Col 23 line 50 teaches 1529 is meant for a cautery cable, the cautery cable is interpreted to be a rod; furthermore, the addition of the cable would necessarily make second conduit 1529 more rigid compared to when second conduit 1529 does not have the rod/cable; therefore inserting the rod into the second conduit would render the second conduit rigid).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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