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Claims 1-20 are pending in the application with claims 1-15 under consideration and claims 16-20 withdrawn.
Election/Restrictions
Applicants’ election of Group I claims 1-15 in the 8/18/26 Restriction Response is acknowledged. Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/18/2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: retention member in claims 6-7, where “retention” is the recited function and “member” is the generic placeholder.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
In the instant case, the retention members are interpreted as windings of the filaments into pigtails, corkscrews, malecots, barbs, mushrooms and hook ends, conical shapes, and all known equivalents, as described in ¶s 70-71 of Applicant’s specification.
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.
Claims 1, and 3-9 are rejected under 35 U.S.C. 103 as being unpatentable over Aliski et al. (US 2005/0240277 A1) (which is cited in Applicants IDS filed 11/5/2024), in view of St. Pierre (US 2008/0086215 A1).
Regarding claim 1, Aliski discloses a flexible stent (stent 110, Figs. 3-4), thus being in the same field of endeavor, configured to flex with bodily movement of the patient (body 122, Figs. 3-4; Abstract and ¶s 28 and 33 indicate accommodating body movement), the stent comprising at least one filament (body 122, Figs. 3A, 3B, and 4) extending along a length of the stent (as seen in Figs. 3A, 3B, and 4, the body 122 forms a plurality of coils).
Aliski does not explicitly teach the stent having variable-flexibility and having a first section having a first durometer value and a second section having a second durometer value different from the first durometer value.
However, St. Pierre discloses a variable-flexibility stent configured for placement in a patient’s urinary tract (Abstract and Figs. 2-3), thus being in the same field of endeavor, wherein the stent comprises a first section comprising a first durometer value (first section 24) and a second section having a second durometer value different from the first durometer value (second section 20; ¶s 5 and 35 describe the change in durometer).
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 stent and filament of Aliski to comprise a first section having a first durometer value and a second section having a second durometer value different from the first durometer value. Doing so would thus comprise a variable-flexibility stent. Doing so would be advantageous in simultaneously facilitating patient placement and increasing patient comfort (¶ 4 of St. Pierre).
Regarding claim 3, Aliski further teaches the at least one filament is coiled (¶ 17; Figs. 3A-3B).
Regarding claim 4, St. Pierre further teaches the stent first section corresponds to a proximal portion of the stent to be placed relative to a patient’s bladder, and the stent second section corresponds to a distal portion of the stent to be placed relative to a patient’s kidney (Fig. 3 shows coil 12 being positioned adjacent kidney 100 and coil 14 being positioned adjacent bladder 104; Fig. 1 shows coil 12 corresponding to a second section 20 and coil 14 corresponding to a first section 24; ¶ 25).
As stated above, 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 stent and filament of Aliski to comprise a first section having a first durometer value and a second section having a second durometer value different from the first durometer value. Doing so would thus comprise the stent first section corresponding to a proximal portion of the stent to be placed relative to a patient’s bladder, and the stent second section corresponding to a distal portion of the stent to be placed relative to a patient’s kidney. Doing so would be advantageous in simultaneously facilitating patient placement and increasing patient comfort (¶ 4 of St. Pierre).
Regarding claim 5, St. Pierre further teaches second durometer value is greater than the first durometer value (¶s 5 and 25).
As stated above, 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 stent and filament of Aliski to comprise a first section having a first durometer value and a second section having a second durometer value different from the first durometer value. Doing so would thus comprise the second durometer value is greater than the first durometer value. Doing so would be advantageous in simultaneously facilitating patient placement and increasing patient comfort (¶ 4 of St. Pierre).
Regarding claim 6, Aliski further teaches the first stent section further includes a bladder retention member (proximal end portion 140), and the second stent section further includes a renal retention member (distal end portion 130; ¶s 31-33 describe the retaining curls at both ends).
Regarding claim 7, Aliski further teaches the first stent section further includes a bladder retention member (proximal end portion 140), and the second stent section further includes a renal retention member (distal end portion 130; ¶s 31-33 describe the retaining curls at both ends).
Regarding claim 8, St. Pierre further teaches the stent first section is formed of a material having the first durometer value, and the stent second section is formed of a material having the second durometer value (¶s 5-7).
As stated above, 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 stent and filament of Aliski to comprise a first section having a first durometer value and a second section having a second durometer value different from the first durometer value. Doing so the stent first section is formed of a material having the first durometer value, and the stent second section is formed of a material having the second durometer value. Doing so would be advantageous in simultaneously facilitating patient placement and increasing patient comfort (¶ 4 of St. Pierre).
Regarding claim 9, St. Pierre further teaches comprising a transition section comprising a co-extrusion of the first and second materials (¶s 5-7 with ¶s 7 and 26 specifically indicating third section 22 is a co-extrusion of the first and second materials).
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 stent and filament of Aliski to comprise a transition section comprising a co-extrusion of the first and second materials, as taught by St. Pierre. Doing so would be advantageous in simultaneously facilitating patient placement and increasing patient comfort (¶ 4 of St. Pierre).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Aliski and St. Pierre, as applied to claim 1 above, in view of Amis et al. (US 2005/0043783 A1), which is cited in Applicants IDS filed 11/5/2024.
Regarding claim 2, the combination of Aliski and St. Pierre does not explicitly teach the at least one filament comprises two or more filaments.
However, Amis teaches a coiled stent (stent 10, Fig. 1), thus being in the same field of endeavor, comprising a plurality of filaments helically wound in adjacent groups of coils (strands 16a-16c are wound in adjacent groups of coils; ¶ 22).
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 filament of Aliski and St. Pierre to comprise a plurality of filaments, as taught by Amis. Doing so would be advantageous in providing a stronger and/or more flexible stent (¶ 22 of Aliski).
Claims 10-11 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Aliski in view of Lavelle et al. (US 2007/0276466 A1), which is cited in Applicants IDS filed 11/5/2024.
Regarding claim 10, Aliski discloses a flexible stent (stent 110, Figs. 3-4), thus being in the same field of endeavor, configured to allow controlled extension in response to bodily movement when implanted in a body lumen (body 122, Figs. 3-4; Abstract and ¶s 28 and 33 indicate accommodating body movement), the stent comprising a coiled filament (body 122, Figs. 3A, 3B, and 4) extending along a length of the stent (as seen in Figs. 3A, 3B, and 4, the body 122 forms a plurality of coils).
Aliski does not explicitly teach the coiled filament contains a therapeutic agent deliverable to the patient when the stent is within the patient.
However, Lavelle teaches an implantable ureteral stent (Figs. 2 and 5A-5C; Abstract), thus being in the same field of endeavor, in which the stent body comprises a therapeutic agent deliverable to the patient when the stent is within the patient (¶s 47-53).
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 device of Aliski to comprise the therapeutic coating of Lavelle. Doing so would thus comprise the coiled filament contains a therapeutic agent deliverable to the patient when the stent is within the patient. Doing so would be advantageous in providing therapeutic drug effects sustained over an extended period (¶ 53 of Lavelle).
Regarding claim 11, the limitations of the coils are “configured to extend or contract the stent body along with bodily movements of the patient” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Aliski and Lavelle has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the coils would be configured to accommodate bodily movement in the manner claimed; also see ¶s 6, 28, and 33 of Aliski).
Regarding claim 14, Lavelle teaches a therapeutic agent deliverable to the patient when the stent is within the patient as optional additives (¶s 47-53; ¶ 50 in particular describes a number of optional additives),
As previously stated, 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 device of Aliski to comprise the therapeutic coating of Lavelle. Doing so would thus comprise the stent containing one or more optional additives comprising the therapeutic agent. Doing so would be advantageous in providing therapeutic drug effects sustained over an extended period (¶ 53 of Lavelle).
Regarding claim 15, Lavelle teaches the therapeutic agent is contained in a coating applied to the stent (¶s 47-53).
As previously stated, 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 device of Aliski to comprise the therapeutic coating of Lavelle. Doing so would thus comprise therapeutic agent contained as a coating applied to the stent. Doing so would be advantageous in providing therapeutic drug effects sustained over an extended period (¶ 53 of Lavelle).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Aliski and Lavelle, as applied to claim 10 above, and further in view of St. Pierre.
Regarding claim 12, the combination of Aliski and Lavelle does not explicitly teach the stent having variable-flexibility.
However, St. Pierre teaches a variable-flexibility stent configured for placement in a patient’s urinary tract (Abstract and Figs. 2-3), thus being in the same field of endeavor, wherein the stent comprises a first section comprising a first durometer value (first section 24) and a second section having a second durometer value different from the first durometer value (second section 20; ¶s 5 and 35 describe the change in durometer).
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 stent and filament of Aliski and Lavelle to comprise a first section having a first durometer value and a second section having a second durometer value different from the first durometer value. Doing so would thus comprise a variable-flexibility stent. Doing so would be advantageous in simultaneously facilitating patient placement and increasing patient comfort (¶ 4 of St. Pierre).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Aliski, Lavelle, and St. Pierre, as applied to claim 12 above, and further in view of Koichi et al. (JP 2002253681 A; citations to the specification are made to the attached translation), which is cited in Applicants IDS filed 11/5/2024.
Regarding claim 13, the combination of Aliski, Lavelle, and St. Pierre do not explicitly teach wherein selected adjacent coils of the one or more coils are releasably attached together to vary the flexibility of the stent.
However, Koichi teaches a coiled stent (Figs. 1, 4, and 12; Abstract), thus being in the same field of endeavor, comprising a plurality of filaments helically wound in groups of coils (stent body forms coils; ¶ 10); wherein select adjacent coils are releasably attached together (Fig. 14 best show suppressing layer 31 which holds pairs of coils together; ¶’s 16-17; ¶ 23 also describes the suppressing layer may be formed discontinuously; also see Figs. 12-13 and 17).
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 coils of Aliski, Lavelle, and St. Pierre to comprise the suppressing layers as taught by Koichi. Doing so would thus comprise selected adjacent coils of the one or more coils are releasably attached together to vary the flexibility of the stent. Doing so would be obvious to prevent stent expansion before the device is implanted, and in providing easier insertion (¶’s 17 and 23 of Koichi).
The limitations of the filaments being releasably attached to “vary the flexibility of the stent” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Aliski, Lavelle has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the coils would be configured to accommodate modify movement in the manner claimed; also see ¶s 6, 28, and 33 of Aliski).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Li et al. (US 20030224033 A1) discloses a stent having durometer variation and therapeutic delivery. Miller et al. (US 20040249441 A1) discloses a stent having durometer variation and therapeutic delivery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALESSANDRO R DEL PRIORE/ Examiner, Art Unit 3781
/GUY K TOWNSEND/ Primary Examiner, Art Unit 3781
Prosecution Insights