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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 02, 2026 has been entered.
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 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.
Claims 1-2, 3, 5, 7-9, 11, 13-14, 16, 29, 31-35, 37-42 are rejected under 35 U.S.C. 102 as being anticipated by Hayakawa et. al. (WO2020/225603A1—previously of record and cited in an IDS dated 05/12/2022).
Regarding claim 1, Hayakawa discloses: a device for lymphovenous bypass surgery (Abstract, para. [0002]) comprising: a first coupling element 1b (Fig. 8) having a first tissue grasping element 2 configured to attach to tissue (Fig. 7; tissue grasping element 2 is shown as attaching to a tubular tissue element 10) and a second coupling element 1a (Fig. 8) couplable to the first coupling element along a common axis A (Fig. 7), the second coupling element having a cone-shaped surface (Figure 12 shows a conical surface that is unlabeled but which corresponds to the same conical surface indicated by element 7 in Fig. 7) and a plurality of second tissue grasping elements 2 that protrude around a smaller diameter ring (Para. [0053] discloses that the lager diameter ring has spikes that are positioned radially farther than the spikes of the smaller diameter ring; see also Fig. 8 reproduced below) along the common axis (para. [0053] i.e., since tissue grasping elements surround each corresponding channel of 1a and 1b, they are also positioned along the common axis A), the second tissue grasping elements protruding in an opposite direction from the first tissue grasping element on the first coupling element (Fig. 8 shows the elements 2 of one side being in the opposite direction of the others on the opposing side) that has a larger diameter ring (Fig. 8 reproduced below) than the smaller diameter ring and configured to grasp an open end of a vein or artery to the cone shaped surface of the second coupling element (Fig. 8), wherein the first coupling element and the second coupling element are configured to position the plurality of lymphatic channels into an open end of the vein of a patient to deliver lymph fluid from the lymphatic channel into the vein (Fig. 8).
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Hayakawa does not expressly disclose that the tissue is adipose tissue, that the second tissue grasping element protrudes from the cone shaped surface, or the second tissue grasping elements grasp an open end of a vein or artery.
The limitation “configured to attach to adipose tissue…extend from within adipose tissue…grasp an open end of a vein or artery” is being interpreted as an intended use limitation. As seen in MPEP section 2114 section 2, a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647. Thus, it’s seen if the prior art has the claimed structure of the invention, it is able to perform the function. As seen here all of the structure limitations for the claim including a coupling element attaching to tissue is met, thus the function is met.
Hayakawa does disclose in para. [0046] that the aperture 6 is constructed to be optimized such that it is large enough to pass and house an intended end of a tubular structure to be anastomosed as well as attach the intended structure thereto. Additionally, the curvature of the bevel 7 is optimized such that abrasion and potential damage is reduced to the attached tubular structure (para. [0046]) since the bevel allows the artery wall to make a more gradual transition when widened and reduces stain on the arterial wall (para. [0048]). The amount of beveling on surface 7 extending to surface 9 of Fig. 1 is disclosed to be a result effective variable in that the amount of bevel along surface 9 would affect the strain on the arterial wall resulting in abrasion and damage. As such, the strain can be adjusted as needed for the given type of tubular structure inserted therein by modifying the beveled surface. Additionally, since the tissue grasping elements are a predetermined distance from the passageways (approximately 0.5 mm away from the edge according to para. [0053]), changing the bevel surface would not impact the placement of the spikes. See also paras. [0058]-[0061] which disclose angling the spikes along a beveled surface.
Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Hayakawa device to have a bevel that extends into surface 9 such that the spikes would protrude from the cone shaped surface, 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 at the time of the invention to modify the device of Hayakawa by making the second tissue grasping element protrudes from the cone shaped surface 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).
Additionally, according to para. [0053], it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of the second tissue grasping element protrudes from the cone shaped surface since according to para. [0053], the spikes can be moved in any position and para. [0046] discloses that both the bevel size and angle may be changed and as such there is a finite amount of space for a bevel that would limit its size and angle and a finite amount of space for the spikes that limit the radial locations with respect to the passageways 6a/6b such that the positioning of the spikes would still meet the requirements of remaining attached to the annular body 1a, 1b without damaging and/or preventing or reducing detachment after attachment. As such, there are few options apparent to one of ordinary skill in the art, with there being no undue experimentation and there being a reasonable expectation of success at arriving at the second tissue grasping element protrudes from the cone shaped surface such that a person of ordinary skill would be reasonably motivated to try any position and work towards reducing or preventing detachment. The first tissue grasping element 2 is fully capable of attaching to tissue including a plurality of lymphatic channels, if one desired to do so - note that the limitations of claim 1 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
The second tissue grasping element 2 is fully capable of grasping an open end of a vein or artery to the second coupling element, if one desired to do so - note that the limitations of claim 1 are merely functional limitations and do not affect the structure of the claimed invention as discussed above.
The first coupling element and the second coupling element are fully capable of positioning a plurality of lymphatic channels relative to the vein of a patient to deliver lymph fluid from the lymphatic channel into the vein, if one desired to do so - note that the limitations of claim 1 are merely functional limitations and do not affect the structure of the claimed invention as discussed above.
Regarding claim 3, Hayakawa discloses the device of claim 1. Hayakawa fails to directly disclose: wherein the cone shaped surface has a first diameter in a range of 1-3 mm and a second diameter in a range from 7-12 mm. Instead, Hayakawa discloses a first diameter D1 being smaller than a second diameter D2 (Fig. 12).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Hayakawa to have a first diameter in a range of 1-3 mm and a second diameter in a range from 7-12 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hayakawa would not operate differently with the claimed diameters. Further, applicant places no criticality on the range claimed, because the specification doesn’t state any benefit for the claimed range (page 32 line 20-23).
Regarding claim 5, Hayakawa discloses the device of claim 1. Hayakawa further discloses: wherein the first tissue grasping element and the plurality of second tissue grasping elements each include one or more pins 2 (Fig. 8).
Regarding claim 7, Hayakawa discloses the device of claim 1. Hawakaya further discloses: wherein the first coupling element comprises a ring aperture 6b that is configured to receive the tissue including the plurality of lymphatic channels wherein the tissue is inserted through the ring aperture for connection to the first tissue grasping element (Fig. 8).
The device of Hayakawa is fully capable of having tissue inserted through the ring aperture for connection to the first tissue grasping element, if one desired to do so - note that the limitations of claim 7 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Regarding claim 8, Hayakawa discloses the device of claim 1. Hayakawa also discloses: wherein the first coupling element and the second coupling element couple together along a common longitudinal axis (Fig. 12) and pins that are configured to attach to the tissue extend parallel to the longitudinal axis (Fig. 12), and wherein at least one of the first coupling element and the second coupling element comprises a biocompatible polymer material (para. [0042]).
Regarding claim 9, Hayakawa discloses the device of claim 1. Hayakawa further discloses: wherein the first coupling element comprises a plurality of connecting elements 4 that each engage with a respective recess (para. [0045]) of the second coupling element to fasten the first coupling element and the second coupling element together (Fig. 8).
Regarding claim 11, Hayakawa discloses the device of claim 1. Hayakawa further discloses wherein the first coupling element and the second coupling element each have a circular shape with a diameter in a range of 1 mm to 15 mm (para. [0046]).
Regarding claim 13, Hayakawa discloses the device of claim 1. Hayakawa further discloses: wherein the cone-shaped surface has a wider diameter at the upper surface D2 relative to a narrower diameter D1 at which the cone-shaped surface is coupled to a tube (Fig. 8) configured to receive the vein that extends through the tube.
Regarding claim 14, Hayakawa discloses the device of claim 1. Hayakawa further discloses: wherein the cone-shaped surface has a plurality of at least six openings 5 in which pins can be inserted (para. [0053] five or more holes are provided which reasonably encompasses at least six openings. See MPEP 2131.03).
Regarding claim 16, Hayakawa discloses: the device of claim 1. Hayakawa further discloses: wherein the first tissue grasping element comprises at least six pins 2 (para. [0043] discloses that more or less than eight spikes 2 may be provided) that are spaced apart around a periphery of the first coupling element (Fig. 8) and the pins on the first coupling element are positioned in a single plane that extends through pins on the second coupling element (Fig. 8).
Regarding claim 29, Hayakawa discloses the device of claim 1. Hayakawa further discloses: wherein the second coupling element includes an aperture D2 that is configured to receive the vein that is inserted through the aperture to connect to the plurality of second tissue grasping element (Fig. 8).
The first coupling element and the second coupling element are fully capable of positioning the lymphatic channels (i.e., lymphatic channels can include tubular tissue element 10) through the ring aperture and into the vein of the patient, if one desired to do so - note that the limitations of claim 1 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Regarding claim 31, Hayakawa discloses the device of claim 7. Hayakawa further discloses wherein an aperture D1 of the second coupling element is configured to receive the vein, wherein the aperture is smaller than the ring aperture of the first coupling element D2 (Fig. 8).
Regarding claim 32, Hayakawa discloses the device of claim 1. Hayakawa further discloses wherein the cone-shaped surface 7 is elevated above a surface 6 of the second coupling element to increase a depth of insertion of the plurality of lymphatic channels into the vein.
Regarding claim 33, Hayakawa discloses the device of claim 1. Hayakawa further discloses: comprising an interior volume that is created within the device when the first coupling element and the second coupling element are connected (Fig. 12 shows an interior volume created when the first and second coupling element are connected).
Regarding claim 34, Hayakawa discloses the device of claim 14. Hayakawa further discloses wherein the six openings are recessed into the cone-shaped surface (Fig. 8).
Regarding claim 35, Hayakawa discloses: a device for lymphovenous bypass surgery (Abstract, para. [0002]) comprising: a coupling device (Fig 8) that is configured to couple a plurality of lymphatic channels into a vein or artery, the coupling device having a first coupling element 1b (Fig. 8) and a second coupling element 1a (Fig. 8) wherein the coupling device includes first tissue grasping elements 2 configured to attach to adipose tissue including the plurality of lymphatic channels (Fig. 8), and second tissue grasping elements 2 protruding from a surface within a smaller ring diameter (Fig. 8 reproduced above) and configured to attach to an open end of the vein or artery, the first tissue grasping elements extending from a larger ring diameter (para. [0053] Fig. 8 reproduced above) with an opening that is separated from the smaller ring diameter (Fig. 8 reproduced above), the first tissue grasping elements extending in an opposite direction from the second tissue grasping elements that extend parallel to a common axis of the coupling device (Fig. 8); wherein the second coupling element is configured to connect to the first coupling element (Fig. 8) with a peripheral latch (Fig. 7), the second coupling element having an opening configured to receive the vein or artery; and wherein the first coupling element and the second coupling element are configured to position the plurality of lymphatic channels into an open end of the vein or artery of a patient to deliver lymph fluid from the plurality of lymphatic channels into the vein or artery.
Hayakawa does not expressly disclose the second tissue grasping element protrudes from the cone shaped surface.
Hayakawa does disclose in para. [0046] that the aperture 6 is constructed to be optimized such that it is large enough to pass and house an intended end of a tubular structure to be anastomosed as well as attach the intended structure thereto. Additionally, the curvature of the bevel 7 is optimized such that abrasion and potential damage is reduced to the attached tubular structure (para. [0046]) since the bevel allows the artery wall to make a more gradual transition when widened and reduces stain on the arterial wall (para. [0048]). The amount of beveling on surface 7 extending to surface 9 of Fig. 1 is disclosed to be a result effective variable in that the amount of bevel along surface 9 would affect the strain on the arterial wall resulting in abrasion and damage. As such, the strain can be adjusted as needed for the given type of tubular structure inserted therein by modifying the beveled surface. Additionally, since the tissue grasping elements are a predetermined distance from the passageways (approximately 0.5 mm away from the edge according to para. [0053]), changing the bevel surface would not impact the placement of the spikes. See also paras. [0058]-[0061] which disclose angling the spikes along a beveled surface.
Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Hayakawa device to have a bevel that extends into surface 9 such that the spikes would protrude from the cone shaped surface, 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 at the time of the invention to modify the device of Hayakawa by making the second tissue grasping element protrudes from the cone shaped surface 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).
The first tissue grasping elements 2 are fully capable of attaching to adipose tissue including a plurality of lymphatic channels, if one desired to do so - note that the limitations of claim 35 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
The second tissue grasping element 2 is fully capable of receiving the vein or artery, if one desired to do so - note that the limitations of claim 35 are merely functional limitations and do not affect the structure of the claimed invention as discussed above.
The first coupling element and the second coupling element are fully capable of positioning the plurality of lymphatic channels into an open end of the vein or artery of a patient to deliver lymph fluid from the plurality of lymphatic channels into the vein or artery, if one desired to do so - note that the limitations of claim 35 are merely functional limitations and do not affect the structure of the claimed invention as discussed above.
Further, Hayakawa doesn’t specifically disclose: wherein the larger ring diameter has a first opening in a range of 5-12mm and the second coupling element has a second opening have a diameter in a range of 1-3mm. Instead, Hayakawa discloses a first diameter D1 being smaller than a second diameter D2 (Fig. 12).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Hayakawa to have a first diameter in a range of 1-3 mm and a second diameter in a range from 5-12 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hayakawa would not operate differently with the claimed diameters. Further, applicant places no criticality on the range claimed, because the specification doesn’t state any benefit for the claimed range (page 32 line 20-23).
Regarding claim 36, Hayakawa discloses the device of claim 35. Hayakawa further discloses: wherein the second tissue grasping elements protrude from the cone-shaped surface (Fig. 8) in concentric positions around the smaller ring diameter (Fig. 8).
Regarding claim 37, Hayakawa discloses the device of claim 36. Hayakawa fails to directly disclose: wherein the cone shaped surface has a first diameter in a range of 1-3 mm and a second diameter in a range from 7-12 mm. Instead, Hayakawa discloses a first diameter D1 being smaller than a second diameter D2 (Fig. 12).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Hayakawa to have a first diameter in a range of 1-3 mm and a second diameter in a range from 7-12 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hayakawa would not operate differently with the claimed diameters. Further, applicant places no criticality on the range claimed, because the specification doesn’t state any benefit for the claimed range (page 32 line 20-23).
Regarding claim 38, Hayakawa discloses the device of claim 36. Hayakawa also discloses: where the second diameter D2 of the cone-shaped surface aligns with a ring aperture 6b of the first coupling element along a common axis (Fig. 9).
Regarding claim 39, Hayakawa discloses the device of claim 35. Hayakawa further discloses: wherein the first tissue grasping element and the second tissue grasping elements each include one or more pins 2 (Fig. 8).
Regarding claim 40, Hayakawa discloses the device of claim 35. Hayakawa further discloses: wherein the first coupling element comprises a ring aperture 6b that is configured to receive the tissue including the plurality of lymphatic channels that are inserted through the ring aperture for connection to the first tissue grasping elements (Fig. 8).
Regarding claim 41, Hayakawa discloses the device of claim 40. Hayakawa further discloses wherein the ring aperture is larger than the opening of the second coupling element (Fig. 12).
Regarding claim 42, Hayakawa discloses the device of claim 35 wherein the first tissue grasping elements extend around a ring portion (Fig. 9) of the coupling device having a larger diameter D2 than an inner ring D1 wherein the second tissue grasping elements extend from the inner ring of the coupling device (Fig. 9).
Claims 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hayakawa in view of Agarwal et al. (US2016/0324522A1—previously of record).
Regarding claim 10, Hawakaya discloses the device of claim 9. Hawakaya fails to directly disclose: wherein each connecting element comprises a hook or latch element.
In the same field of endeavor, namely vascular coupling devices, Agarwal discloses wherein each connecting element 100, 200 comprises a hook 122 or latch element 116.
It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to modify the device of Hawakaya to have each connecting element comprises a hook or latch element as taught by Agarwal for the purpose of securing the coupling elements together (para. [0028]).
Regarding claim 19, Hawayaka discloses the device of claim 1. Hawayaka fails to directly disclose: wherein connector elements extending from the first coupling element are spaced apart around a peripheral ring of the first coupling element, each connector element having a latch that couples to a portion of the second coupling element such that the device comprises a cylindrical body having slots to enable the cylindrical body to be grasped by a user.
In the same field of endeavor namely vascular coupling devices, Agarwal discloses: wherein connector elements 116 extending from the first coupling element 100 are spaced apart around a peripheral ring of the first coupling element (Fig. 1A), each connector element having a latch 126 that couples to a portion of the second coupling element 200 (Fig. 3E) such that the device comprises a cylindrical body having slots 118 to enable the cylindrical body to be grasped by a user.
It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to modify the device of Hawakaya to have connector elements extending from the first coupling element are spaced apart around a peripheral ring of the first coupling element, each connector element having a latch that couples to a portion of the second coupling element such that the device comprises a cylindrical body having slots to enable the cylindrical body to be grasped by a user as taught by Agarwal for the purpose of securing the coupling elements together (para. [0029]).
Response to Arguments
Applicant's arguments filed March 02, 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that Hayakawa does not illustrate or contemplate the use of spikes protruding from a cone, Examiner disagrees and points to the arguments in the Final Rejection dated December 01, 2025.
Examiner also notes that the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding Applicant’s argument that Regarding Applicant’s first argument that Hayakawa does not teach a device that can join ends of two veins or tubular structures by eversion of both tubular bodies that flare away from the flow path, Examiner disagrees. Examiner points to MPEP 2114(II) which states “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).”
In response to applicant's argument that Hayakawa does not recognize the same problem as the invention, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Additionally, as described above, because the spikes may be moved anywhere including on the beveled region in accordance with para. [0053] (see above rejection with regard to claim 1), and as such there are variations where the spikes go through the cone-shaped bevel portion, a position on the bevel may be selected such that the spikes would not protrude into the blood flow path at least since there is room to move the spikes without interfering with the blood flow path. Further, the test for obviousness is not whether the features (i.e., placement of the spikes) of the reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Conclusion
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771