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 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.
Claim(s) 1, 5-8, 11, 13, 16-17, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (EP 1 114 618) in view of Brachman et al. (US 10,888,710).
Regarding claim 1, Bakos discloses
A medical device (25, fig. 1) comprising:
a handle (60, fig. 1);
a shaft (82) extending distally from the handle (60, fig. 1) and including:
a working channel (31, fig. 2); and
a distal end (35, fig. 2) extending distally from the working channel (see fig. 2); and
Bakos is silent about a cartridge including a payload and configured to couple to the distal end to form a chamber with the payload received therein, wherein the chamber is in communication with the working channel, and wherein a shape of the cartridge is complementary to a shape of the distal end.
However, Brachman teaches medical devices which implants discrete treatment payload elements to a patient and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims.
Brachman teaches a cartridge (100) including a payload (see fig. 1) and configured to couple to the distal end to form a chamber with the payload received therein (Examiner notes: the limitation “configured to couple…received therein” is interpreted as functional limitation. See fig. 1 and col. 5 lines 3-22), wherein the chamber is in communication with the working channel, and wherein a shape of the cartridge is complementary to a shape of the distal end (see fig. 1, col. 5 lines 3-22 and col. 7 lines 50-64).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Bakos with a cartridge, as taught by Brachman, for the purpose of aiding in placement of the payload in the shaft (Brachman col. 5 lines 3-4).
Regarding claim 5, Bakos in view of Brachman discloses the medical device of claim 1,
Brachman further teaches wherein the cartridge/loader has a shape (see fig. 1 and see also col. 4 lines 30-31 for carriers having various sizes, shapes, configurations) and the lid (120) has dimensions that match the cartridge/loader (see fig. 2 and see col. 8 lines 37-39), and wherein, when the cartridge/loader is coupled to the lid, the cartridge/loader and the lid form a tubular shape (see figs. 1-2 and col. 4 lines 30-31 for carriers having various sizes, shapes, and configurations).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Bakos with a cartridge, as taught by Brachman’s loader and modify the distal end of Bakos’ shaft with a matching shape/configuration, as taught by Brachman’s lid, for the purpose of aiding in placement of the payload in the shaft (Brachman col. 5 lines 3-4).
Bakos in view of Brachman only discloses/teaches various sizes, shapes, and configurations for the cartridge and the distal end of the shaft, but is silent about the arc shape as required by the claim.
There is no evidence of record that establishes that changing the shape of the components would result in a difference in function of the Bakos or Brachman device. Further, a person having ordinary skill in the art, being faced with modifying the shape of the device, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed shape. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the shape to be arc shapes as an obvious matter of design choice within the skill of the art.
Regarding claim 6, Bakos in view of Brachman discloses the medical device of claim 1,
Bakos further discloses wherein the distal end (35) defines a cavity (cavity of 35, see fig. 2) configured to receive the payload (Examiner notes: the limitation “configured to receive the payload” is interpreted as functional limitation. See fig. 2 for the cavity of 35 being able to perform the claimed function).
Regarding claim 7, Bakos in view of Brachman discloses the medical device of claim 1,
Bakos further discloses a plurality of capsules (40, fig. 2).
Brachman further teaches wherein the payload includes a plurality of capsules (see fig. 1 and col. 4 lines 22-35).
Regarding claim 8, Bakos in view of Brachman discloses the medical device of claim 1,
Bakos further discloses a deployment mechanism (55) positioned in the working channel (31, fig. 5) and operable to deploy the payload (40) out of the chamber (figs. 5-7 and pars. 0042-0043), wherein the handle (60) includes an actuation member (66) configured to operate the deployment mechanism (pars. 0042-0043).
Regarding claim 11, Bakos discloses
A medical device (25 fig. 1) comprising:
a handle (60, fig. 1);
a shaft (82) extending distally from the handle (60, fig. 1) and including:
a working channel (31, fig. 2); and
a distal end (35, fig. 2) extending distally from the working channel (see fig. 2)
Bakos is silent about a cartridge having a payload; and the distal end configured to slidably receive the cartridge to couple the cartridge to the distal end, wherein the cartridge and the distal end form a chamber with the payload received therein, and wherein the chamber is in communication with the working channel.
However, Brachman teaches medical devices which implants discrete treatment payload elements to a patient and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims.
Brachman teaches a cartridge (100) having a payload (see fig. 1) and configured to couple to the distal end to form a chamber with the payload received therein (Examiner notes: the limitation “configured to slidably receive the cartridge to couple the cartridge to the distal end” is interpreted as functional limitation. See fig. 1 and col. 5 lines 3-22), wherein the chamber is in communication with the working channel.
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Bakos with a cartridge, as taught by Brachman, for the purpose of aiding in placement of the payload in the shaft (Brachman col. 5 lines 3-4).
Regarding claim 13, Bakos in view of Brachman discloses the medical device of claim 11,
Brachman further teaches wherein a shape of the cartridge is complementary to a shape of the distal end (see fig. 1, col. 5 lines 3-22 and col. 7 lines 50-64).
Regarding claim 16, Bakos discloses
A medical device (25, fig. 1) comprising:
a handle (60, fig. 1);
a shaft (82) extending distally from the handle (60, fig. 1) and including:
a working channel (31, fig. 2); and
a distal end (35, fig. 2) extending distally from the working channel (see fig. 2); and
Bakos is silent about a cartridge including a payload, wherein the cartridge is configured to couple to the distal end to form a chamber with the payload received therein.
However, Brachman teaches medical devices which implants discrete treatment payload elements to a patient and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims.
Brachman teaches a cartridge (100) including a payload (see fig. 1) and configured to couple to the distal end to form a chamber with the payload received therein (Examiner notes: the limitation “configured to couple…received therein” is interpreted as functional limitation. See fig. 1 and col. 5 lines 3-22), wherein the chamber is in communication with the working channel (see fig. 1, col. 5 lines 3-22 and col. 7 lines 50-64).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Bakos with a cartridge, as taught by Brachman, for the purpose of aiding in placement of the payload in the shaft (Brachman col. 5 lines 3-4).
Bakos in view of Brachman only discloses/teaches various sizes, shapes, and configurations for the cartridge and the distal end of the shaft, but is silent about the arc shape as required by the claim.
There is no evidence of record that establishes that changing the shape of the components would result in a difference in function of the Bakos or Brachman device. Further, a person having ordinary skill in the art, being faced with modifying the shape of the device, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed shape. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the shape to be arc shapes as an obvious matter of design choice within the skill of the art.
Regarding claim 17, Bakos in view of Brachman discloses the medical device of claim 16,
Brachman further teaches wherein the distal end is configured to slidably receive the cartridge to couple the cartridge to the distal end (Examiner notes: the limitation “configured to slidably receive…the distal end” is interpreted as functional limitation. See fig. 1, col. 5 lines 3-22 and col. 7 lines 50-64 for the distal end of the delivery device capable of performing the claimed function).
Regarding claim 19, Bakos in view of Brachman discloses the medical device of claim 16,
Bakos further discloses the distal end (35) and the working channel (31, fig. 2).
Brachman further teaches wherein, when the cartridge is coupled to the distal end, the chamber is in communication with the working channel (see fig. 1, col. 5 lines 3-22 and col. 7 lines 50-64).
Claim(s) 2-4, 12, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (EP 1 114 618) in view of Brachman et al. (US 10,888,710) in further view of Bob (US 2006/0173473).
Regarding claim 2, Bakos in view of Brachman discloses the medical device of claim 1, as set forth above, except for wherein the cartridge includes two slide structures and the distal end includes two rail structures.
However, Bob teaches two components (see embodiment shown in figs. 5, 7 and pars. 0066-0071 for two components 12 and 2, or see another embodiment shown in figs. 9, 11 and pars. 0072-0077 for two components 15 and 2) wherein one component includes two slide structures and the other component includes two rail structures (see figs. 5 and 7, or see figs. 9 and 11. See also par. 0067 for the embodiment including two grooves and see par. 0069 for the number of slide rails 14 corresponding to the grooves formed. See par. 0074 for the number of slide rails being two).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the cartridge by adding two slide structures and modify the distal end of the shaft by adding two rail structures, as taught by Bob, for the purpose of providing sliding engagement between the cartridge and the distal end of the shaft and preventing them from being pulled out of each other (par. 0071 of Bob).
Regarding claim 3, Bakos in view of Brachman and Bob discloses the medical device of claim 2,
Bob further teaches wherein the two rail structures are configured to slidably receive the two slide structures (see figs. 5, 7 and pars. 0066-0071, or see figs. 9, 11 and pars. 0072-0077).
Regarding claim 4, Bakos in view of Brachman and Bob discloses the medical device of claim 2,
Bob further teaches wherein each of the two slide structures has a T-shape (see figs. 5, 7 and par. 0071, or see figs. 9, 11 and pars. 0074, 0077).
Regarding claim 12, see the rejections of claims 2 and 3 above.
Regarding claim 18, see the rejections of claim 2 above. Examiner notes: claims 2 and claim 18 are identical.
Claim(s) 9-10, 15, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (EP 1 114 618) in view of Brachman et al. (US 10,888,710) in further view of Geraghty et al. (US 2016/0296719).
Regarding claim 9, Bakos in view of Brachman discloses the medical device of claim 1, as set forth above, except for wherein the shaft further includes: a pair of fluid channels configured to pass fluid and negative pressure there-through; and a guide channel configured to pass a guide wire there-through.
However, Geraghty teaches a medical tube apparatus configured to be used in different applications (par. 0148) wherein the medical tube apparatus comprises multiple lumens (42/44/46/48, figs. 1A-1B and par. 0129), which are capable of passing fluid, negative pressure, and/or a guide wire there-through (Examiner notes: the limitations “configured to pass fluid and negative pressure there-through” and “configured to pass a guide wire there-through” are interpreted as functional limitations, and the limitation “a guide wire” is not positively recited in claim 9).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Bakos by adding multiple lumens/channels, as taught by Geraghty, for the purpose of providing passageways for fluid sampling or drug delivery as needed.
Regarding claim 10, Bakos in view of Brachman and Geraghty discloses the medical device of claim 9,
Geraghty further teaches wherein the multiple lumens/channels (42/44/46/48) extend through the distal end (distal end of tube 30, see fig. 1 and 1A-1B).
Regarding claim 15, see the rejections of claims 9 and 10 above.
Regarding claim 20, see the rejections of claims 2 and 3 above.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (EP 1 114 618) in view of Brachman et al. (US 10,888,710) in further view of Govil et al. (US 9,327,061)
Regarding claim 14, Bakos in view of Brachman discloses the medical device of claim 11,
Bakos further discloses a plurality of capsules (40, fig. 2).
Brachman further teaches wherein the payload includes a plurality of capsules (see fig. 1 and col. 4 lines 22-35).
Bakos in view of Brachman is silent about the capsules being bio-absorbable foam.
However, Govil teaches the payload being bio-absorbable foam (example 1, col. 4 line 66).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Bakos’ payload to be bio-absorbable foam, as taught by Govil, for the purpose of allowing the payload itself not have to be surgically retrieved after its effects have ended.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Thursday 7am-5pm.
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/DUNG T ULSH/Primary Examiner, Art Unit 3783
