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 .
Response to Amendment
This Office action is in response to the applicant’s communication filed 06/04/2025.
Status of the claims:
Claims 1, 3 – 20 are pending in the application.
Claims 1 and 8, are amended.
Claims 14 – 20 are withdrawn.
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:
the generic placeholder is “one or more tension members” in claim 12, which is coupled to the functional language “configured to maintain the stented prosthesis in the radially compressed configuration”. Furthermore, there are no structural modifiers either preceding or following the generic placeholders. For the purpose of examination, the “one or more tension members” in claim 12 will be read as a suture, a chord, a wire, or a filament (which is the disclosed corresponding structure, as described in paragraph [0043] of the Instant Specification) or an equivalent structure, which is any structure that performs the identical function of the generic placeholder(s) specified in the claim in substantially the same way.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejections of claims 1 and 3 – 13 under U.S.C 35 112(a) for failing to comply with the written description requirement, recited in the previous action dated 03/12/2025 have been withdrawn in light of the Applicant’s amendments filed 06/05/2025. Specifically, the rejection of claims 1 and 8 which recited “a decreasing inner diameter from a midpoint of the bumper to the proximal end”, wherein Applicant’s disclosure did not provide adequate support for wherein the inner surface (i.e., the decreasing inner diameter) tapers from the midpoint of the bumper to the proximal end of the bumper has been withdrawn, as the claims have been amended to no longer require the taper to start at a midpoint, and the rejection of claims 3 – 7 and 9 – 13 for being dependent on claims 1 and 8 have been withdrawn as claims 1 and 8 are no longer rejected under 112(a).
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.
The rejection of claims 1 and 3 – 7 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 03/12/2025 have been withdrawn in light of the Applicant’s amendments filed 06/05/2025. Specifically, the rejection of claim 1, regarding the phrases "a tapered inner surface" and “a decreasing inner diameter”, has been withdrawn as the appropriate corrections have been made, additionally, the rejection of claims 3 – 7 for being dependent on an indefinite claim have been withdrawn as the claims are no longer dependent on an indefinite claim.
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.
Claims 1, 3 – 10 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lenker et al (US 6,350,278 B1).
Regarding claim 1, Lenker discloses a delivery device (delivery catheter 250) for delivering a stented prosthesis (prosthesis ‘P’) to a target site (abstract, col. 10 line 60 – col. 11 line 22, and Figs. 19A-D), the delivery device comprising:
an inner shaft assembly (flexible shaft 252) comprising a distal portion configured to receive the stented prosthesis (col. 10 line 60 – col. 11 line 22, and Figs. 19A-D);
a middle tube (sliding tube 260) defining a recess within which the inner shaft assembly (flexible shaft 252) is received such that the middle tube is configured to be slidable relative to the inner shaft assembly (Examiner’s note: as stated in col. 11 lines 1 – 22, the prosthesis P may be fully released by moving the anchors 256 and 258 axially apart in order to free the compressed ends of the prosthesis, and the anchors 256 and 258 can only be moved axially apart by the sliding tube 260 (i.e., the middle tube) moving relative to the flexible shaft 252 (i.e., the inner shaft assembly)); and
a bumper (anchor 258; designated in annotated Fig. 19A) attached to an end of the middle tube (Fig. 19A) and defining a cavity within which the inner shaft assembly is received (see annotated Fig. 19A) such that the bumper is configured to be slidable relative to the inner shaft assembly (Examiner’s note: as stated in col. 11 lines 1 – 22, the prosthesis P may be fully released by moving the anchors 256 and 258 axially apart in order to free the compressed ends of the prosthesis, and the anchors 256 and 258 can only be moved axially apart by the flexible shaft 252 (i.e., the inner shaft assembly) moving relative to the anchor 258 (i.e., the bumper)),
the bumper (anchor 258; designated in annotated Fig. 19A) extending between a distal end and a proximal end (see annotated Fig. 19A), the bumper comprising a tapered inner surface with an inner diameter that increases from the proximal end of the bumper toward the distal end of the bumper (see annotated Fig. 19A), the distal end of the bumper configured to receive a proximal end of the stented prosthesis within the cavity such that the stented prosthesis is maintained in a radially-compressed configuration (see annotated Fig. 19A), wherein the tapered inner surface surrounds a proximal portion of the cavity and faces the proximal end of the stented prosthesis (see annotated Fig. 19A), with the proximal end of the stented prosthesis received within the cavity and the tapered inner surface (see annotated Fig. 19A), the inner diameter of the tapered inner surface decreasing continuously from a midportion of the bumper to a face of the proximal end of the bumper (see annotated Fig. 19A), and wherein a distal end of the stented prosthesis is unsheathed and maintained in the radially-compressed configuration (Examiner’s note: as shown in Fig. 19B, the distal end of the prosthesis ‘P’ is unsheathed from sheath 254 but still compressed via anchor 256).
Annotated Figure 19A of Lenker
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Regarding claim 3, Lenker discloses wherein a first segment of the stented prosthesis is received within the cavity such that the bumper circumferentially surrounds the first segment (see annotated Fig. 19A), and wherein a second segment of the stented prosthesis is located outside of the bumper such that the second segment is not circumferentially surrounded by the bumper (see annotated Fig. 19A).
Regarding claim 4, Lenker discloses wherein a midpoint (location just after the beginning of the taper – see Examiner’s note below) outer diameter of the bumper at the midpoint is less than a distal outer diameter at the distal end of the bumper and greater than a proximal outer diameter at the proximal end of the bumper (see annotated Fig. 19A), the midpoint located halfway between the distal end of the bumper and the proximal end of the bumper (see annotated Fig. 19A) (Examiner’s note: as shown in the annotated Fig. 19A, the bumper is 13 dots long (see the center dotted line) and the mid-point is at dot number 7 (such that there are 6 dots on each side); furthermore, as shown in the annotated Fig. 19A the mid-point is just after the beginning of the taper, and therefore, the midpoint will have an outer diameter less than the outer diameter of the distal end of the bumper).
Regarding claim 5, Lenker discloses wherein the proximal outer diameter of the bumper is greater than a compressed diameter of the stented prosthesis when the proximal end of the stented prosthesis is within the cavity such that the stented prosthesis is maintained in the radially-compressed configuration (Figs. 19A/B and annotated Fig. 19A).
Regarding claim 6, Lenker discloses the bumper comprising a distal outer diameter (diameter at the distal end) that is greater than a compressed diameter of the stented prosthesis in the radially- compressed configuration (Figs. 19A/B and annotated Fig. 19A).
Regarding claim 7, Lenker discloses further comprising a capsule (sheath 254) comprising an elongated channel within which the bumper and the stented prosthesis are received (col. 10 line 60 – col. 11 line 22, and Figs. 19A-D), and wherein a radial axis intersects the distal end of the stented prosthesis (prothesis ‘P) and the capsule (sheath 254) without intersecting any structures between the distal end of the stented prosthesis and the capsule, the radial axis extending perpendicular to the inner shaft assembly (Examiner’s note: as shown in annotated Fig. 19A the radial axis intersects a portion of the capsule and a portion of the distal end of the prothesis without intersecting another structure).
Regarding claim 8, Lenker discloses a delivery device (delivery catheter 250) for delivering a stented prosthesis (prosthesis ‘P’) to a target site (abstract, col. 10 line 60 – col. 11 line 22, and Figs. 19A-D), the delivery device comprising:
an inner shaft assembly (flexible shaft 252) comprising a distal portion configured to receive the stented prosthesis (col. 10 line 60 – col. 11 line 22, and Figs. 19A-D);
a middle tube (sliding tube 260) defining a recess within which the inner shaft assembly (flexible shaft 252) is received such that the middle tube is configured to be slidable relative to the inner shaft assembly (Examiner’s note: as stated in col. 11 lines 1 – 22, the prosthesis P may be fully released by moving the anchors 256 and 258 axially apart in order to free the compressed ends of the prosthesis, and the anchors 256 and 258 can only be moved axially apart by the sliding tube 260 moving relative to the flexible shaft 252); and
a bumper (anchor 258; designated in annotated Fig. 19A) attached to an end of the middle tube (Fig. 19A) and defining a cavity within which the inner shaft assembly is received (see annotated Fig. 19A) such that the bumper is configured to be slidable relative to the inner shaft assembly (Examiner’s note: as stated in col. 11 lines 1 – 22, the prosthesis P may be fully released by moving the anchors 256 and 258 axially apart in order to free the compressed ends of the prosthesis, and the anchors 256 and 258 can only be moved axially apart by the flexible shaft 252 (i.e., the inner shaft assembly) moving relative to the anchor 258 (i.e., the bumper)),
the bumper (anchor 258; designated in annotated Fig. 19A) extending between a distal end and a proximal end, the bumper comprising a tapered inner surface with an inner diameter that increases from the proximal end of the bumper toward the distal end of the bumper (see annotated Fig. 19A), the distal end of the bumper configured to receive a proximal end of the stented prosthesis within the cavity such that the stented prosthesis is maintained in a radially-compressed configuration (see annotated Fig. 19A), wherein the tapered inner surface surrounds a proximal portion of the cavity and faces the proximal end of the stented prosthesis, with the proximal end of the stented prosthesis received within the cavity and the tapered inner surface (see annotated Fig. 19A), the inner diameter of the tapered inner surface decreasing continuously from a midportion of the bumper to a face of the proximal end of the bumper (see annotated Fig. 19A), and wherein a distal end of the stented prosthesis is unsheathed and maintained in the radially-compressed configuration (Examiner’s note: as shown in Fig. 19B, the distal end of the prosthesis ‘P’ is unsheathed from sheath 254 but still compressed via anchor 256); and
a capsule (sheath 254) comprising an elongated channel within which the middle tube (sliding tube 260) received such that the capsule is configured to be slidable relative to the middle tube, the inner shaft assembly, and the bumper (col. 10 line 60 – col. 11 line 22, and Figs. 19A-D), the elongated channel comprising an inner diameter that is greater than the distal outer diameter of the bumper (anchor 258; designated in annotated Fig. 19A) such that the capsule receives the bumper and the stented prosthesis when the capsule moves in a distal direction (Figs. 19A-D and annotated Fig. 19A).
Annotated Figure 19A of Lenker
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Regarding claim 9, Lenker discloses wherein a first segment of the stented prosthesis is received within the cavity such that the bumper circumferentially surrounds the first segment (see annotated Fig. 19A), and wherein a second segment of the stented prosthesis is located outside of the bumper such that the second segment is not circumferentially surrounded by the bumper (see annotated Fig. 19A).
Regarding claim 10, Lenker discloses wherein the distal outer diameter of the bumper is greater than a compressed diameter of the stented prosthesis in the radially-compressed configuration (Figs. 19A/B/C and annotated Fig. 19A).
Regarding claim 13, Lenker discloses wherein the capsule is configured to move between a first position (position shown in Fig. 19A), in which the bumper and the stented prosthesis are received within the elongated channel (Fig. 19A), and a second position, in which the bumper and the stented prosthesis are outside of the elongated channel (Fig. 19D) (Examiner’s note: as shown in Fig. 19D the distal tip of the anchor 258 (i.e., the bumper) is outside of the sheath 254 (i.e., the capsule)).
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.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lenker et al (US 6,350,278 B1), as applied to claims 8 above, and further in view of Goetz et al (US 2012/0277734 A1) (cited in IDS).
Regarding claims 11 and 12, as discussed above, Lenker discloses the delivery device of claim 8.
However, Lenker is silent regarding (i) [claim 11] wherein the inner shaft assembly comprises a plurality of apertures extending radially through the inner shaft assembly, and (ii) [claim 12] further comprising one or more tension members extending through the plurality of apertures, the one or more tension members circumferentially surrounding the stented prosthesis and configured to maintain the stented prosthesis in the radially-compressed configuration.
As to the above, Goetz teaches, in the same field of endeavor, a delivery device (apparatus 100) for delivering a stented prosthesis (implant 300) (abstract, paragraphs [0081], [0124 – 0132], and Figs. 2 – 11), comprising an inner shaft assembly (shaft 1; which equates to the slidable shaft 260 of Lenker as it also holds the prosthesis) comprising a plurality of apertures (apertures 9) extending radially through the inner shaft assembly (paragraphs [0124], [0132], and Fig. 7) and one or more tension members (tensioning threads 11 and 11’) (Examiner’s note: as discussed above, the one or more tension member(s) are being interpreted under 112(f) as a suture, chord, wire, or filament configured to restrain the stented prosthesis (as disclosed by Applicant). Goetz discloses, in paragraph [0130], the tensioning members are threads (i.e., filaments) configured to restrain the implant, thus the tensioning threads are considered equivalent structure to the claimed tension members), the one or more tension members (tensioning threads 11 and 11’) extending through the plurality of apertures (apertures 9) (paragraphs [0124], [0132], and Fig. 2), the one or more tension members (tensioning threads 11 and 11’) circumferentially surrounding the stented prosthesis (paragraphs [0124], [0130], and Figs. 3 – 4) and are configured to maintain the stented prosthesis in the radially-compressed state (paragraph [0130]) for the purpose of being able to have parts or sections of the implant that can be folded or unfolded while other parts or sections of the implant have already been completely folded or unfolded. This can be reasonable when an unfolded implant and the implantation site do not completely match in their dimensions, or if the implant does, e.g., not have a uniform shape over its entire length (paragraph [0088]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the inner shaft assembly of Lenker to incorporate apertures and tensioning threads, as taught by Goetz, for the purpose of being able to have parts or sections of the implant that can be folded or unfolded while other parts or sections of the implant have already been completely folded or unfolded; this can be reasonable when an unfolded implant and the implantation site do not completely match in their dimensions, or if the implant does, e.g., not have a uniform shape over its entire length (paragraph [0088] – Lenker).
Response to Arguments
Applicant’s arguments, filed 06/04/2025, with respect to the rejection of claims 1 and 8 have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments. Specifically, the rejections were withdrawn because Applicant’s amendments have overcome the 112(a) written description requirement rejection. It is noted that a new rejection has been made in view of Lenker.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew Restaino/Examiner, Art Unit 3771