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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 6/15/2023, 1/26/2025 and 5/28/2025 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4 and 6-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3 (and thereby dependent claim 4), the phrase "the corrugated ring farthest from a distal end of the inner core tube in the intravascular stent is a distal corrugated ring" renders the claim(s) indefinite because it appears that either “the corrugated ring closest to a distal end of the inner core tube in the intravascular stent is a distal corrugated ring” or “the corrugated ring farthest from the proximal end of the inner core tube in the intravascular stent is a distal corrugated ring”, thereby rendering the scope of the claim(s) unascertainable. It appears that a typographical error may be the cause of this claimed ambiguity. Appropriate correction is required.
Claim 6 recites the limitation "the maximum axial length" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 7 recites the limitation "the central angle" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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 (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 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 person shall be entitled to a patent unless –
(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.
Claim(s) 1-4, 6 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Slazas et al. (US 2014/0277332).
Slazas discloses (see Figs. 6-7) a stent and delivery system comprising the following claim limitations:
(claim 1) A delivery device, used for delivering an intravascular stent (10), the intravascular stent (10) comprising a plurality of corrugated rings (20a/20b); the delivery device comprising an inner core tube (54), the inner core tube (54) having a loading region (i.e., between 56 and 58) for loading the intravascular stent (10) (as shown in Figs. 6-7), wherein the delivery device further comprises at least one positioning member (62/68) arranged on the inner core tube (54); the positioning member (62/68) is located in the loading region (between 56 and 58); and during delivery or release of the intravascular stent (10) by the delivery device, the positioning member (62/68) axially interferes with at least one of the plurality of corrugated rings (20a/20b) (as shown in Fig. 7);
(claim 2) wherein the positioning member (62/68) is a rigid member (as shown in Figs. 6-7; [0031]);
(claim 3) wherein the corrugated ring (20b) that is closest to a proximal end of the inner core tube (54) in the intravascular stent (10) is a proximal corrugated ring (20b) (as shown in Figs. 6-7); the corrugated ring (20a) farthest from a distal end of the inner core tube (54) in the intravascular stent (10) is a distal corrugated ring (20a) (as shown in Figs. 6-7); a plurality of positioning members (62/68) are provided (as shown in Figs. 6-7); at least one of the plurality of positioning members (62) axially interferes with the distal corrugated ring (20a) (as shown between Figs. 6-7); and at least one of the plurality of positioning members (20b) axially interferes with the proximal corrugated ring (20b) (as shown in Fig. 7; see Abstract; [0025]; [0035]; allowing for retraction and recapturing of stent 10 for repositioning if so desired);
(claim 4) wherein at least one of the plurality of positioning members (62) is located on a proximal side of the distal corrugated ring (20a) and axially interferes with the distal corrugated ring (20a) (as shown between Figs. 6-7); and at least one of the plurality of positioning members (68) is located on a distal side of the proximal corrugated ring (20b) and axially interferes with the proximal corrugated ring (20b) (as shown in Fig. 7; see Abstract; [0025]; [0035]; allowing for retraction and recapturing of stent 10 for repositioning if so desired);
(claim 6) wherein a clearance is reserved between two adjacent corrugated rings (20a/20b) of the intravascular stent (10) (as shown in Figs. 6-7); the positioning member (62/68) is located between two adjacent corrugated rings (20a/20b) (as shown in Figs. 6-7); and the maximum axial length of the positioning member is equal to the clearance between the two adjacent corrugated rings, or the maximum axial length of the positioning member (62/68) is less than the clearance between the two adjacent corrugated rings (20a/20b) (as shown in Figs. 6-7); and
(claim 12) An intravascular stent system, comprising an intravascular stent (10) and the delivery device according to claim 1 (see claim 1 above), wherein the delivery device delivers the intravascular stent (10) (as shown in Figs. 6-7, i.e., disposed within vasculature 52; [0030]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Slazas as applied to claim 1 above, and further in view of Nageswaran et al. (US 2019/0336312).
Slazas, as applied above, discloses a stent and delivery system comprising all the limitations of the claim except for the positioning member being a ring component having a plurality of concave structures disposed circumferentially around the outer surface and having a wall thickness between 0.05 mm to 0.8 mm.
However, Nageswaran teaches (see Figs. 5A-7) a similar stent delivery system (500) comprising a positioning member (523) comprising a ring component having a plurality of concave structures (at recesses 559) disposed circumferentially around the outer surface (555) and having a wall thickness between 0.05 mm to 0.8 mm ([0122]). Accordingly, Nageswaran teaches that it is well-known that cylindrical positioning members and plate positioning members having circumferential recesses are elements that are functional equivalents for providing a mechanical interface with a stent allowing for effective pushing for deployment or pulling for recapture of the stent, as desired ([0122]-[0123]; [0127]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the plate positioning members taught by Nageswaran for the cylindrical positioning members of Slazas because both elements were known equivalents for providing a mechanical interface with a stent allowing for effective pushing for deployment or pulling for recapture of the stent, as desired, within the stent delivery art. The substitution would have resulted in the predictable results of providing a mechanical interface with a stent allowing for effective pushing for deployment or pulling for recapture of the stent, as desired, to the device of Slazas.
Regarding claim 5, Nageswaran expressly teaches the wall thickness (i.e., the radius that is equal to half of the diameter “D” shown in Fig. 6A) being between approximately 12.5 microns to 50 microns (equal to 0.125 mm to 0.05 mm) ([0122]). However, Nageswaran does not explicitly disclose the wall thickness being between 0.05 mm to 0.8 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the wall thickness from being between 0.125 mm to 0.05 mm to between 0.05 mm to 0.8 mm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed ranges.
Claim(s) 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Slazas as applied to claim 1 above, and further in view of Tatalovich et al. (US 2013/0204344).
Slazas, as applied above, discloses a stent and delivery system comprising all the limitations of the claim except for the positioning member being a ring component; and in a projection plane perpendicular to the central axis of the inner core tube, the central angle corresponding to a projection of a proximal end portion and/or a distal end portion of the positioning member is a, 180°<a<360°.
However, Tatalovich teaches (see Fig. 11A) a similar stent delivery system comprising a positioning member (327) being a ring component (as shown in Fig. 11A); and in a projection plane perpendicular to the central axis of the inner core tube (i.e., in a cross-section view), the central angle corresponding to a projection of a proximal end portion and/or a distal end portion of the positioning member is a, 180°<a<360° (as shown in Fig. 11A, the central angle is shown to be C-shaped approximately forming 270°). Accordingly, Tatalovich teaches that it is known that a solid cylindrical positioning member and a C-shaped positioning member are elements that are functional equivalents for providing attachment of a stent positioning member to the inner core tube. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the C-shaped positioning member taught by Tatalovich for the solid cylindrical positioning member of Slazas because both elements were known equivalents for providing attachment of a stent positioning member to the inner core tube within the stent delivery art. The substitution would have resulted in the predictable results of providing attachment of a stent positioning member to the inner core tube of the device of Slazas.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Slazas as applied to claim 1 above, and further in view of Vo et al. (US 2012/0226343).
Slazas, as applied above, discloses a stent and delivery system comprising all the limitations of the claim except for the positioning member being spiral along an axial direction of the inner core tube; and the spiral width of the positioning member is H, and the clearance between two adjacent corrugated rings of the intravascular stent is A, H≤A.
However, Vo teaches (see Figs. 1-4A) a similar stent and delivery system (10) comprising a positioning member being spiral (38) along an axial direction of the inner core tube (30); and the spiral (38) width of the positioning member is H, and the clearance between two adjacent corrugated rings of the intravascular stent (of Slazas) is A, H≤A (i.e., the width/thickness of the coiling wire 38 of Vo is much smaller than the clearance of the stent of Slazas) in order to beneficially provide a positioning member structure that allows for perfusion channels permitting fluid to flow from an interior region of the sheath proximal of the frictional interfacing member to an interior region of the sheath distal of the frictional interfacing member (see Abstract; [0006]; [0008]; [0033]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the delivery device of Slazas to have a positioning member being spiral along an axial direction of the inner core tube, and the spiral width of the positioning member is H, and the clearance between two adjacent corrugated rings of the intravascular stent is A, H≤A in order to beneficially provide a positioning member structure that allows for perfusion channels permitting fluid to flow from an interior region of the sheath proximal of the frictional interfacing member to an interior region of the sheath distal of the frictional interfacing member, as taught by Vo.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see Nishigishi (US 2016/0113793).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771