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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant has amended the claims to overcome the previous rejection and a new grounds of rejection is made below in view of Lydecker and Kliger (US 3935863).
Applicant’s arguments, with respect to the rejection(s) of claim(s) 16-18 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lydecker in view of Bicakci (US 2006/0100605).
Applicant's arguments regarding claims 19-20 have been fully considered and are persuasive. Specifically, Applicant argues the pore sizes are functional as opposed to mere dimensions. Accordingly, this action is second Non-Final Rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-7, 9, 12, 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Lydecker (US 2021/0268241) in view of Kliger (US 3935863).
Regarding claim 1, Lydecker discloses a medical device comprising:
a distal body (110, figure 3, sponge, [0039]) coupled to a distal end of a vacuum tube (142), wherein the distal body is in fluid communication with a lumen of the vacuum tube ([0039]), the distal body comprising:
a core (116 and 140, figure 3, [0039]) including a plurality of openings (144); and
one or more layers (112, 114, figure 3, [0039]) surrounding the core.
Lydecker does not disclose wherein an outer layer of the one or more layers is formed of a mesh or cloth and wherein the mesh or cloth comprises one or more protrusions extending radially outward.
Kliger discloses a surgical sponge and teaches an outer layer (10, figure 1) is formed of a mesh or cloth (col 2, lines 30-35) and wherein the mesh or cloth comprises one or more protrusions (26 protrudes outward, figure 3) extending radially outward.
Kliger provides alternate materials for the sponge and secures the sponge on the vacuum tube (col 2, lines 1-10, col 2, lines 30-35). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lydecker with the sponge and material of Kliger in order to provide alternate materials that achieves the same function of wicking fluid while also securing the sponge to the device.
Regarding claim 4, Lydecker discloses wherein the one or more layers completely surround the core (figure 3).
Regarding claim 5, Lydecker wherein the one or more layers surround only a portion of the core (figure 3, 118 only surrounds the core and not the vacuum tube).
Regarding claim 6, Lydecker discloses wherein the one or more layers are coated with an antimicrobial material (118 is antibacterial layer).
Regarding claim 7, Lydecker does not disclose wherein at least one of the one or more layers is coupled to the distal end of the vacuum tube via a clip, drawstring, or suture.
Kliger discloses sponges in the same field of endeavor as the Applicant and teaches at least one of the one or more layers (10) is coupled to the distal end of the vacuum tube via a clip, drawstring, or suture (26, figure 4, col 1, lines 50-60).
Kliger provides an alternative method to secure the sponge to the tube (col 1, lines 50- 60). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lydecker with the cord securement portion of Kliger in order to secure the layers of sponge onto the tube and prevent movement away from the tubing.
Regarding claim 9, Lydecker discloses wherein the one or more layers include one or more intermediate layers (116, 114) surrounding the core and an outer layer(112) surrounding the intermediate layer.
Regarding claim 12, Lydecker discloses wherein a proximal portion of an outer surface of the outer layer includes an adhesive ([0044]).
Regarding claim 21, Lydecker discloses the device made from layers of foam (116, [0049]) which would be different from the layer of mesh or cloth disclosed in Kliger.
Regarding claim 22, Lydecker does not disclose the material of the one or more protrusions different from a material of the mesh or cloth.
Kliger discloses a surgical sponge and teaches an outer layer (10, figure 1) is formed of a mesh or cloth (col 2, lines 30-35) and wherein the mesh or cloth comprises one or more protrusions (26 protrudes outward, figure 3) extending radially outward, the cord is not a cloth material.
Kliger provides alternate materials for the sponge and secures the sponge on the vacuum tube (col 2, lines 1-10, col 2, lines 30-35). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lydecker with the sponge and material of Kliger in order to provide alternate materials that achieves the same function of wicking fluid while also securing the sponge to the device.
Claims 3 are rejected under 35 U.S.C. 103 as being unpatentable over Lydecker (US 2021/0268241) in view of Kliger (US 3935863) in view of McRae (US 3978855).
Regarding claim 3, Lydecker while showing the openings on the core which appear to be larger than any depicted opening on the sponge (figure 3), does not specifically disclose wherein the plurality of openings, and wherein the plurality of openings of the one or more layers has a smaller average size than the plurality of openings of the core.
McRae discloses a surgical dressing and teaches wherein the plurality of openings, and wherein the plurality of openings of the one or more layers has a smaller average size than the plurality of openings of the core (col 4, lines 35-57).
McRae provides the difference in pore sizes in order to allow proper wicking while preventing tissue ingrowth (col 3, lines 35-45, col 4, lines 35-57). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lydecker with the surgical pore distribution of McRae to allow wicking but preventing ingrowth.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lydecker in view of Kliger further in view of Dilnik (US 2005/0031833).
Regarding claim 10, Lydecker and Kliger do not disclose wherein an absorbency of the one or more intermediate layers is greater than an absorbency of the outer layer and wherein an absorbency of the core is greater than absorbency of the core of the intermediate layers.
Dilnik discloses a sponge head relatively pertinent to problem posed by Applicant of absorbing bodily fluids and teaches wherein an absorbency of the one or more intermediate layers is greater than an absorbency of the outer layer and wherein an absorbency of the core is greater than absorbency of the core of the intermediate layers ([0047], [0056], Dilnik is able to vary the absorbency of layers in the flexible material 12 which includes 2 or more areas that correspond to layers ,figure 1c). When combined with Kliger which teaches the wicking of material away from the outer surface of the sponge, the absorbency of the material would naturally wick away from the outer surface, i.e., absorbency increasing towards the core of the sponge).
Dilnik provides an absorbent with multiple regions that are customizable according to characteristics such as absorbency, mesh size, stiffness. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lydecker with the layout of Dilnik in order to customize the sponge as desired for absorbing fluid.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lydecker in view of Slater (US 2005/0107738).
Regarding claim 11, Lydecker discloses the layers being made of a hydrophilic material ([0030]) but does not disclose the core includes a hydrophobic material.
Slater discloses a catheter device relatively pertinent to problem posed by Applicant of moving fluid and teaches the catheter core can use hydrophobic material ([0280]).
Slater provides hydrophobic material for desirable material properties of the catheter [0280]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lydecker with the hydrophobic material in order to obtain a desirable core material property.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Lydecker in view of Kubek (US 2018/0296395).
Regarding claim 13, Lydecker does not disclose wherein the one or more layers are coated with a material comprising alginate.
Kubek discloses a porous material relatively pertinent to problem posed by Applicant of absorbing material and teaches wherein the one or more layers are coated with a material comprising alginate ([0007]).
Kubek provides alginate in order to raise absorptive capacity of foam ([0007]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lydecker with the alginate of Kubek in order to raise the absorptive capacity of foam.
Claims 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Lydecker in view of Kliger further in view of Bicakci (US 2006/0100605).
Regarding claims 14-15, Lydecker does not disclose wherein the core includes a first channel and a second channel, wherein the first channel and the second channel extend from a proximal end of the core to a distal end of the core, and wherein a distal end of each of the first channel and the second channel terminate proximal of a distalmost end of the core (claim 14) and wherein the first channel and the second channel converge at the proximal end of the core to form a third channel (claim 15).
Bicakci discloses a suction tube tip in the same field of endeavor as the Applicant and teaches the core includes a first channel (path from opening 40 to the interior tube 22) and a second channel (path from another opening 40 to interior tube 22), wherein the first channel and the second channel extend from a proximal end of the core to a distal end of the core (both paths interior to 24 but exterior to 22), and wherein a distal end of each of the first channel and the second channel terminate proximal of a distalmost end of the core (terminates at opening adjacent 30 near distal end) and wherein the first channel and the second channel converge at the proximal end of the core to form a third channel (the paths combine to form a singular path interior to inner tube 22 that extends to the proximal end, figure 5, [0028-0030]).
Bicakci provides a dual tube arrangement to allow the suction tip to smoothly be maneuvered within the operating field without snagging by the apertures, and further preclude the apertures from being occluded by contact with the tissue of the patient or surgical debris ([0029]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lydecker with the dual tube core of Bicakci in order to further preclude the apertures from being occluded by contact with the tissue of the patient or surgical debris.
Regarding claim 16, Lydecker discloses a medical device comprising:
a distal body (110, figure 3, sponge, [0039]) coupled to a distal end of a vacuum tube (142), wherein the distal body is in fluid communication with a lumen of the vacuum tube ([0039]), the distal body comprising:
a core (140, figure 3, [0039]) including a plurality of openings (144) disposed on the outer surface of the core (figure 3); and
one or more layers (114, 116, 112, figure 3, [0039]) surrounding the core.
Lydecker does not disclose a first channel; and a second channel, wherein the first channel and the second channel converge at a proximal end of the core to form a third channel; and wherein an entirety of each of the first channel and second channel is distal to a distal end of the third channel.
Bicakci discloses a suction tube tip in the same field of endeavor as the Applicant and teaches the core includes a first channel (path from opening 38 to the interior tube 22) and a second channel (path from distal most opening 40 to interior tube 22 as seen in figure 5), wherein the first channel and the second channel converge at the proximal end of the core to form a third channel (the paths combine to form a singular path interior to inner tube 22 that extends to the proximal end, figure 5, [0028-0030]), wherein an entirety of each of the first channel and second channel is distal to a distal end of the third channel (the path from 38 to 40 are distal to the distal end of the third channel, figure 5).
Bicakci provides a dual tube arrangement to allow the suction tip to smoothly be maneuvered within the operating field without snagging by the apertures, and further preclude the apertures from being occluded by contact with the tissue of the patient or surgical debris ([0029]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lydecker with the dual tube core of Bicakci in order to further preclude the apertures from being occluded by contact with the tissue of the patient or surgical debris.
Regarding claim 17, the combined device of Lydecker and Bicakci would have a distal end that is closed since Lydecker shows the distal end of the core is closed (figure 3).
Bicakci provides a dual tube arrangement to allow the suction tip to smoothly be maneuvered within the operating field without snagging by the apertures, and further preclude the apertures from being occluded by contact with the tissue of the patient or surgical debris ([0029]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lydecker with the dual tube core of Bicakci in order to further preclude the apertures from being occluded by contact with the tissue of the patient or surgical debris.
Regarding claim 18, Bicakci has a third lumen (18-20 at the proximal end of the inner tube) wherein the third channel is adjacent to the lumen of the vacuum tube (12, figure 3, [0024]).
Bicakci provides a dual tube arrangement to allow the suction tip to smoothly be maneuvered within the operating field without snagging by the apertures, and further preclude the apertures from being occluded by contact with the tissue of the patient or surgical debris ([0029]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lydecker with the dual tube core of Bicakci in order to further preclude the apertures from being occluded by contact with the tissue of the patient or surgical debris.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lydecker (US 2021/0268241) in view of McRae (US 3978855).
Regarding claim 19, Lydecker discloses a medical device comprising:
a distal body (110, figure 3, sponge, [0039]) coupled to a distal end of a vacuum tube (142), the distal body comprising:
a core (140, figure 3, [0039]) including a plurality of openings (144) in fluid communication with a lumen of the vacuum tube ([0039]); and
a first layer surrounding the core (116, figure 3, [0039]) surrounding the core;
a second layer (114, figure 3) surrounding the first layer, wherein each of the first layer and the second layer include a plurality of openings ([0049], foam has openings).
Lydecker while showing the openings on the core which appear to be larger than any depicted opening on the sponge (figure 3), does not specifically disclose wherein the plurality of openings, and wherein the plurality of openings of the one or more layers has a smaller average size than the plurality of openings of the core.
McRae discloses a surgical dressing and teaches wherein the plurality of openings, and wherein the plurality of openings of the one or more layers has a smaller average size than the plurality of openings of the core (col 4, lines 35-57).
McRae provides the difference in pore sizes in order to allow proper wicking while preventing tissue ingrowth (col 3, lines 35-45, col 4, lines 35-57). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lydecker with the surgical pore distribution of McRae to allow wicking but preventing ingrowth.
Regarding claim 20, Lydecker discloses wherein at least one of the one more layers includes one or more protrusions extending radially outward from an outer surface of the at least one of the one or more layers (figure 3 shows various ridges and protrusions on the surface of the layers that extend radially outward, further these sponge layers can be designed and shaped [0043]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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