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 .
Status of the Claims
Claims 1-20 are pending in the application.
Allowable Subject Matter
Claims 2, 9, and 16 are considered allowable over the prior art of record, but are objected to as dependent upon a rejected base claim, such that they would be allowed if rewritten in independent form to include all of the limitations of the claims from which they depend, and subject to the Obviousness Type Double Patenting rejection presented below.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record is Bluni (US 2003/0109930 A1).
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As to independent claims 1, 8, 15, Bluni teaches a ureteral stent 5 (stent 5; at least Fig.2; [0042], Fig.1A, [0026]; Abstract, Fig. 2), comprising:
a proximal end (40) Fig.1A-B,comprising a retention feature (45) (pigtail 45) having a coiled portion (spiral planar coil or helical coil [0041],ll.9-18; Figs. 2, 1A, 4A-C);
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a distal end (18) opposite the proximal end 40 (Fig.1A-B; [0026],ll.4-5); and a middle portion 21 between the proximal end 40 and the distal end 18 (Fig.1A-B; [0026],ll.4-6); wherein the retention feature 45 comprises a coiled shape (spiral planar coil or helical coil [0041],ll.9-18; Figs. 2, 1A, 4A-C), [Claim 1: at least a portion of the coiled shape] lying substantially in a plane orthogonal to the middle portion 21 (Fig.1A-B,4A), [claim 8: the coiled shape extending in a radial direction (Fig.1A-B,4A)], and where the proximal end 40 (Fig.1A, comprising retention feature 45 Fig.2) is configured to be located in a kidney 90 of a patient (Fig.2 Annotated; [0032]); where a distal end 40 of the coiled shape Fig.1A,2 has a fluid entrance aperture 50 into the coiled portion (distal drainage end 50; Fig.2; [0026],ll.6-7); and wherein the coiled portion (of 45, as presented above) forms a substantiallv closed tube (closed tube portion of 45 Fig.1A-B) between the fluid entrance aperture 50 and the middle portion 21 (Fig.1A-B).
However, as to claims 2, 9, and 16, Bluni fails to teach or fairly suggest wherein the coiled shape surrounds the distal end in a spiraled fashion.
It would not have been obvious to one of skill before the effective filing date to modify the coiled shape surrounding the distal end in a spiraled fashion, and one of skill would not have been motivated to do so, wherein Bluni fails to teach or fairly suggest providing these limitations and features, and does not provide any motivation to do so.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims1, 3-8, 10-15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Bluni (US 2003/0109930 A1).
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As to independent claims 1, 8, 15, Bluni teaches a ureteral stent 5 (stent 5; at least Fig.2; [0042], Fig.1A, [0026]; Abstract, Fig. 2), comprising:
a proximal end (40) Fig.1A-B,comprising a retention feature (45) (pigtail 45) having a coiled portion (spiral planar coil or helical coil [0041],ll.9-18; Figs. 2, 1A, 4A-C);
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a distal end (18) opposite the proximal end 40 (Fig.1A-B; [0026],ll.4-5); and a middle portion 21 between the proximal end 40 and the distal end 18 (Fig.1A-B; [0026],ll.4-6); wherein the retention feature 45 comprises a coiled shape (spiral planar coil or helical coil [0041],ll.9-18; Figs. 2, 1A, 4A-C), [Claim 1: at least a portion of the coiled shape] lying substantially in a plane orthogonal to the middle portion 21 (Fig.1A-B,4A), [claim 8: the coiled shape extending in a radial direction (Fig.1A-B,4A)], and where the proximal end 40 (Fig.1A, comprising retention feature 45 Fig.2) is configured to be located in a kidney 90 of a patient (Fig.2 Annotated; [0032]); where a distal end 40 of the coiled shape Fig.1A,2 has a fluid entrance aperture 50 into the coiled portion (distal drainage end 50; Fig.2; [0026],ll.6-7); and wherein the coiled portion (of 45, as presented above) forms a substantiallv closed tube (closed tube portion of 45 Fig.1A-B) between the fluid entrance aperture 50 and the middle portion 21 (Fig.1A-B).
As to claims 3, 10, and 17, Bluni teaches wherein the proximal end 40 [is] comprised at: at least one additional fluid entrance aperture 19 into the coiled portion (of retention feature 45 of stent 5 Fig.1A-B; [0028]).
As to claims 4, 11, and 18, Bluni teaches wherein the coiled portion (of retention feature 45 of stent 5 Fig.1A-B, as presented above) comprises a fluid entrance aperture 19 into the coiled portion at a distal end of the coiled portion 40 proximate the middle portion 21 (e.g., 19 between 40 and 21 Fig.1A-B).
As to claims 5, 12, and 19, Bluni teaches wherein the distal end comprises a tail portion 30 (fixation element 30 Fig.1A-B) configured to float (buoyant [0035],ll.4-10; [0034]-[0035]).
As to claims 6, 13, 20, Bluni teaches wherein the tail portion 30 comprises a foam rnaterial (polymers or copolymers that provide buoyancy and containing hollows with, air, or another gas [0035],ll.1-10,14-20).
As to claims 7 and 14, Bluni teaches wherein the tail portion 30 comprises a trapped gas in a side wall of the tail portion (polymers or copolymers that provide buoyancy and containing hollows with, air, or another gas [0035],ll.1-10,14-20).
Double Patenting
Non Statutory Obviousness Type Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to:
www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting over claims 1-4, 10-11, and 13-17 of US Patent No. US 10,881,842 B2 (‘842) (issued from parent application 15/662973).
As to Claims 1-20, claims 1-4, 7, and 9-17 of ‘842 teach or suggest the claimed invention, as follows (with claim dependencies shown in paratheses, e.g., 3(/2/1) as claim 3 incorporating claims 1 and 2):
Clm
1,8,15
2,9,16
3,10,17
4,11,18
5,12,19
6,13,20
7,14
‘842
1, 9, 10, 11,15
2,3, 9,11, 16
1,ll.8-9; 15,ll.8
1,ll.8-18; 9,ll.8-15; 14,ll.4-6
4,12, 17
13,17
7,9,15:
Tail portion floating requires sealed gas space as ballast
Note that in ‘842, claims 2-4 and 6 depend from claim 1; claims 11 and 14 depend from claim 10, and claim 13 depends from claim 12, such that these dependent claims include the limitations of the claims from which they depend and are therefore cited.
The differences between present claims and the claims of ‘842 claims do not identically recite each element of current claims (e.g., using substantially similar but not identical terms; different elements are in different claims; and/or different combinations of elements).
However, the ‘842 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘842 claims to one of ordinary skill in the art at the time of the present invention. A two-way test is not to be applied in the present cases as Applicant could have filed the claims in a single application and there was no administrative delay. In re Berg, 46 USPQ2d 1226 (Fed. Cir. 1998) (“The two-way exception can only apply when the applicant could not avoid separate filings, and even then, only if the PTO controlled the rates of prosecution to cause the later filed species claims to issue before the claims for a genus in an earlier application . . . In Berg’s case, the two applications could have been filed as one, so it is irrelevant to our disposition who actually controlled the respective rates of prosecution.”). In the absence of administrative delay, a one-way test is appropriate. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993). Unless the record clearly shows administrative delay by the Office and that applicant could not have avoided filing separate applications, the examiner may use the one-way obviousness determination and shift the burden to applicant to show why a two-way obviousness determination is required.
One would be motivated to provide each element of the present claims from the ‘842 claims, as they both relate to the same type of device with the same elements for the same purpose and function in the same field of endeavor.
Claims 1-20 are rejected on the ground of nonstatutory double patenting over claims 1, 3, 6-9, and 12-16 of US Patent No. US 11,969,568 B2 (‘568) (issued from parent application 16/969568).
As to Claims 1-20, claims 1, 3-4, 6-9, and 12-17 of ‘568 teach or suggest the claimed invention, as follows (with claim dependencies shown in paratheses, e.g., 3(/2/1) as claim 3 incorporating claims 1 and 2):
Clm
1,8,15
2,9,16
3,10,17
4,11,18
5,12,19
6,13,20
7,14
‘568
1, 9, 10, 16
1,ll.12-14; 12
3,13
1,ll.12-13; 9,ll.4-5; 16,ll.13-15
6,14
7,15
8,15
Note that in ‘568, claims 1-4 and 6 depend from claim 1; claim 4 depends from claim 4; claims 6-8 depend from claim 6; claims 10-11 and 14 depend from claim 9, claim 13 depends from claim 12, such that these dependent claims include the limitations of the claims from which they depend and are therefore cited.
The differences between present claims and the claims of ‘568 claims do not identically recite each element of current claims (e.g., using substantially similar but not identical terms; different elements are in different claims; and/or different combinations of elements).
However, the ‘568 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘568 claims to one of ordinary skill in the art at the time of the present invention.
A two-way test is not to be applied in the present cases as Applicant could have filed the claims in a single application and there was no administrative delay. In re Berg, 46 USPQ2d 1226 (Fed. Cir. 1998) (“The two-way exception can only apply when the applicant could not avoid separate filings, and even then, only if the PTO controlled the rates of prosecution to cause the later filed species claims to issue before the claims for a genus in an earlier application . . . In Berg’s case, the two applications could have been filed as one, so it is irrelevant to our disposition who actually controlled the respective rates of prosecution.”). In the absence of administrative delay, a one-way test is appropriate. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993). Unless the record clearly shows administrative delay by the Office and that applicant could not have avoided filing separate applications, the examiner may use the one-way obviousness determination and shift the burden to applicant to show why a two-way obviousness determination is required.
One would be motivated to provide each element of the present claims from the ‘842 claims, as they both relate to the same type of device with the same elements for the same purpose and function in the same field of endeavor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NICHOLAS WEISS, can be reached on 571-270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781