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 .
Response to Arguments
Applicant's arguments filed 9/22/2025 regarding, the ids, the existing claim objections, and the “polygonal” and “respectively” claim language 112b rejections, have been considered and the objections/rejections of record removed.
Applicant's arguments filed 9/22/2025 regarding support for the amendment to claim 1 has been fully considered is not persuasive. The specification does not discuss the limitation of “a plurality of polyannular portions”
Applicant's arguments filed 9/22/2025 regarding support for the amendment to claim 2 has been fully considered is not persuasive. The specification does not discuss the limitation of “a plurality of polyannular portions”
Applicant's arguments filed 9/22/2025 regarding support for the amendment to claim 7 has been fully considered is not persuasive. The argument isn’t persuasive because our systems are in black and white the color described in figure 7 is not accepted.
Applicant's arguments filed 9/22/2025 regarding the prior art rejections has been fully considered is not persuasive. The applicant argues that the stent cells of Sirhan appear linear and not annular. Examiner disagrees noting annular means ring-like and the stent cells are ring-like.
Applicant's arguments filed 9/22/2025 regarding the prior art rejections has been fully considered is not persuasive. The applicant argues that the through holes do not pass in an axial direction. Examiner disagrees noting the through holes pass at least partially through in an axial direction, further see new rejection below, the new orientation of the embodiment combinations would occur in an axial direction.
Claim Objections
Claims 1 is objected to because of the following informalities:
Claim 1 recites “wherein a joining member is configured to connect two adjacent bent parts by inserting through the through holes of the two adjacent bent parts, and.” The word “and” at the end of this claim needs to be deleted.
Appropriate correction is required.
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:
“joining member” in claims 1-2 and 4-7.
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.
The joining member is described in [0012] as “The joining member is preferably formed in a linear shape or a ring shape,” and is further shown in various figures.
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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The plurality of polyannuar portions. The drawings appear to show a plurality of annular portions not polyannular portions.
The bent-part-joining-part, the drawings appear to show bent parts, however does not show bent-part-joining-part.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
“Polyannular portions” is not described in the specification
“Plurality of joining members” is not described in the specification.
“Bent-part-joining-part” is not described in the specification.
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 1-2 and 4-7 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.
Claims 1, 2, and 7 refer to the stent as having “plurality of polyannular portions.” Polyannular means many ringed, therefore a “plurality of polyannular portions” would mean a plurality of many ringed portions. The invention appears to comprise a plurality of annular portions not a plurality of polyannular portions. The term polyannular is additionally not described in the specifications, there is a lack of antecedent basis. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite.
Claims 2 and 7 recites “one side,” and “the other side” without proper antecedent basis. It is unclear what physical structure has the two sides.
Claim 7 recites “a bent-part-joining-part” without proper antecedent basis. This term is not described in the specifications. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered
Claim 7 recites “a plurality of joining members” without antecedent basis, this plural term is not described in the specification.
Claim 7 recites “the-bent-part-joining-part is disposed at each of a plurality of locations” it is unclear what is meant by this claim language. The specification does not further add clarity.
Dependent claims are likewise rejected. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite.
Claim Rejections - 35 USC § 103
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) 1-2, 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sirhan (US 20170290686 A1).
Regarding claim 1, as best understood based on the 35 U.S.C. 112(b) issues identified above, Sirhan teaches a stent ([0011]) in a cylindrical shape (stents are cylindrical, fig 90b) having a plurality of openings (see figures, for example, annotated fig 90a), the stent being deformable from a reduced diameter state to an expanded diameter state ([0016]), wherein the stent comprises a plurality of polyannular portions (see annotated figure 90/a) each of the plurality of polyannular portions comprises a linear member, the plurality of polyannular portions are arranged sided by side in an axial direction of the stent and connected to each other (see annotated figure 90a, the portions are side by side in any direction and connected) wherein each of the plurality of polyannular portions has an annular shape when viewed in the axial direction of the stent (see figure 90a/b) ,wherein each of the plurality of polyannular portions comprises a plurality of bent parts that are convex toward one side or one other side in the axial direction of the stent (see annotated figure 90a), wherein each bent part of a polyannular portion is disposed adjacent to a bent part of an adjacent polyannular portion (see annotated figure 90a), wherein bent parts have a through hole passing through the stent part (see Annotated fig 90d, there is through holes for the joining member in a partial axial direction, or see alternative embodiment fig 16h), wherein a joining member is configured to connect two parts by inserting through the through holes of the two adjacent parts (see Annotated fig 90d, or alternative embodiment fig 16h).
The embodiment in figure 90a-d of Sirhan does not exactly teach the adjacent bent parts being connected with the joining member, however, various other embodiments of Sirhan teach adjacent bent parts in an axial direction configured to be connected (for example, figure 14B, 23E, 36, 38, etc).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of a location of the axial bent part connection, as taught by various embodiments, to the figure 90 embodiment because it would be obvious to try choosing from a finite number of known connection locations with reasonable expectation of success (MPEP 2143). Further, Sirhan teaches wherein the connection points can be placed in a variety of patterns ([1365]) and that various combinations of embodiments is within the scope of the invention (for example, [1416], [1446]).
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Annotated fig 90a
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Annotated fig 90d
Regarding claim 2, as best understood based on the 35 U.S.C. 112(b) issues identified above, Sirhan teaches a stent ([0011]) in a cylindrical shape (stents are cylindrical, fig 90b) having a plurality of openings (see figures, for example, annotated fig 90a), the stent being deformable from a reduced diameter state to an expanded diameter state ([0016]), wherein the stent comprises a plurality of polyannular portions (see annotated figure 90/a) each of the plurality of polyannular portions comprises a linear member, the plurality of polyannular portions are arranged sided by side in an axial direction of the stent and connected to each other (see annotated figure 90a, the portions are side by side in any direction and connected) wherein each of the plurality of polyannular portions has an annular shape when viewed in the axial direction of the stent (see figure 90a/b) ,wherein each of the plurality of polyannular portions comprises a plurality of bent parts that are convex toward one side or one other side in the axial direction of the stent (see annotated figure 90a), wherein each bent part of a polyannular portion is disposed adjacent to a bent part of an adjacent polyannular portion (see annotated figure 90a), wherein the linear member of each of the plurality of polyannular portions has two end parts (Annotated fig 90d), wherein each of the two end parts has a through hole passing through the axial direction of the stent (Annotated fig 90d, at least partially in the direction axial), and wherein a joining member is configured to connect two end parts by inserting through the through holes of the two end parts (see Annotated fig 90d, or alternative embodiment fig 16h).
The embodiment in figure 90a-d of Sirhan does not exactly teach the adjacent bent parts being connected with the joining member, however, various other embodiments of Sirhan teach adjacent bent parts in an axial direction configured to be connected (for example, figure 14B, 23E, 36, 38, etc).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of a location of a axial bent part connection, as taught by various embodiments, to the figure 90 embodiment because it would be obvious to try choosing from a finite number of known connection locations with reasonable expectation of success (MPEP 2143). Further, Sirhan teaches wherein the connection points can be placed in a variety of patterns ([1365]) and that various combinations of embodiments is within the scope of the invention (for example, [1416], [1446]).
Regarding claim 4, as best understood based on the 35 U.S.C. 112(b) issues identified above, Sirhan teaches wherein at least one of the linear and the joining member is formed of a biodegradable fiber (abstract, stent scaffold can be degradable).
Regarding claim 6, as best understood based on the 35 U.S.C. 112(b) issues identified above, Sirhan teaches wherein the joining member is formed in a linear shape or a ring shape (Annotated fig 90d is a linear shape).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sirhan (US 20170290686 A1) in view of Gerberding (WO 0178628 A1).
Regarding claim 5, as best understood based on the 35 U.S.C. 112(b) issues identified above, Sirhan is silent to how through holes are formed. Gerberding provides evidence of through holes in stents being formed with needles or lasers (pg. 5, lines 19-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of forming through holes, as taught by Gerberding, to the device, as taught by Sirhan, in order to apply a known technique to achieve predictable results of uniform hole shapes (pg. 5, lines 19-22).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sirhan (US 20170290686 A1) in view of Stinson (US 6251135 B1).
Regarding claim 7, as best understood based on the 35 U.S.C. 112(b) issues identified above, Sirhan teaches herein the stent comprises a plurality of joining members each having a linear shape (Annotated fig 90d is a linear shape), wherein the plurality of joining members spaced apart from each other in a circumferential direction of the stent (view figure 90b, [1365]).
Sirhan does not exactly teach the three parts of the joint member. Stinson teaches a filament member that attaches to crossing points at stent joints(col 2, lines 15-21), wherein the joint member includes a bent-part-joining part (figure 14), the bent- part-joining part includes: a first part extending toward the stent joint from one side to one other side of the stent (see first strand end in fig 12-14) a second part passing through the joint of two adjacent bent parts from the other side to the one side of the stent (see middle of strand in fig 12-14) and a third part extending from the through holes of the two adjacent bent parts toward the other side of the stent and intersecting with the first part (see second strand end in fig 12-14),and wherein the bent-part-joining part is disposed at each of a plurality of locations along the axial direction of the stent (see fig 12). Further, when the joint filament shape in Stinson is combined with the join filament device of Sirah the three parts extend in an axial direction through the through holes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of the filament shape, as taught by Stinson, to the device, as taught by Sirhan, in order to complete a simple substitution of one known element for another, such as known joint filament shapes, to obtain predictable results of securing a joining member through a stent joint.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 7:30PM-5:00PM EST M-F (occasionally off Fridays).
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/H.L.P./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774