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 Claims
This office action is responsive to the amendment filed on 08/31/2026. As directed by the amendment: claims 1, 5, 7, 18 and 20 have been amended, claim 8 has been cancelled and new claim 21 has been added. Thus, claims 1-7 and 9-21 are presently pending in this application, and currently examined in the Office Action.
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 medical device comprising a tubular scaffold having a folded-over portion extending axially over, and spaced radially outward from, a portion of a medial region of the scaffold, wherein a membrane is disposed along at least a portion of the medial region, the portion of the medial region spaced apart from the radially from the fold-over portion being devoid of the membrane, and the membrane extending along an inner surface of the medial region from the distal end region to the proximal end region (claim 6) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
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.
Claims 6 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 6, which depends from claim 1, which sets forth the parameters of “the folded-over portion extends from the distal end region to the proximal end region” and that “the portion of the medial region spaced apart radially from the fold-over portion is devoid of a membrane”; and claim 6 further sets forth the parameter of “the membrane extends along an inner surface of the medial region of the tubular scaffold from the distal end region to the proximal end region” (emphasis added); however, this parameter was never mentioned, or suggested in the originally filed disclosure. Specifically, the originally filed disclosure does not mention or suggest a medical device having a folded-over portion extends from the distal end region to the proximal end region, wherein a portion of the medial region spaced apart radially from the fold-over portion is devoid of a membrane, and the membrane extending along an inner surface of the medial region of the tubular scaffold from the distal end region to the proximal end region.
Regarding claim 20, which sets forth the parameters of the folded-over portion extends axially over and circumferentially surrounds a portion of the medial region such it is spaced radially apart from the portion of the medial region defining a gap between the outer surface of the medial region and an inner surface of the folded-over portion, the second portion of the medial region being devoid of the membrane, and that “the second portion of the medial region of the tubular scaffold which is devoid of the membrane extends into the gap”; however, this parameter was never mentioned, or suggested in the originally filed disclosure. Specifically, the originally filed disclosure does not mention or suggest a medical device having a folded-over portion extending axially over and circumferentially surrounding a portion of the medial region such it is spaced radially apart from the portion of the medial region defining a gap between the outer surface of the medial region and an inner surface of the folded-over portion, and wherein the second portion of the medial region, which is devoid of the membrane, extending into the gap.
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 6 and 20 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 6, which depends from claim 1, which sets forth the parameters of “the folded-over portion extends from the distal end region to the proximal end region” and that “the portion of the medial region spaced apart radially from the fold-over portion is devoid of a membrane”; and claim 6 further sets forth the parameter of “the membrane extends along an inner surface of the medial region of the tubular scaffold from the distal end region to the proximal end region” (emphasis added); however, this parameter is found to be confusing since it is not clear how the membrane can extend from the distal end region to the proximal end region, when the fold-over portion extends from the distal end region and the portion of the medial region spaced apart radially from the fold-over portion is devoid of the membrane. Specifically, how can the portion of the medial region spaced apart radially from the fold-over portion be devoid of the membrane and also have the membrane extend from the distal end to the proximal end. The originally filed specification does not aid in clarifying the parameter, since it is completely silent regarding such a parameter; thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 20, which sets forth the parameters of the folded-over portion extends axially over and circumferentially surrounds a portion of the medial region such it is spaced radially apart from the portion of the medial region defining a gap between the outer surface of the medial region and an inner surface of the folded-over portion, the second portion of the medial region being devoid of the membrane, and that “the second portion of the medial region of the tubular scaffold which is devoid of the membrane extends into the gap”; however, this parameter is found to be confusing since it is not clear how the second portion of the medial region, which is devoid of the membrane, can extend into “the gap”, which is defined, in the claim, as a space between the outer surface of the medial region and the inner surface of the fold-over portion. The originally filed specification does not aid in clarifying the parameter, since it is completely silent regarding such a parameter; thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 102
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 18 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Binmoeller et al. (US PG Pub. 2016/0135941), as previously disclosed, hereinafter Binmoeller.
Regarding claim 18, Binmoeller discloses an expandable medical device (142), illustrated in Figure 7B, comprising a tubular scaffold including an inner surface, an outer surface, a proximal end region, a distal end region, and a medial region (110/146) extending between the proximal end region and the distal end region, wherein the tubular scaffold defines an everted portion (146) extending from the distal end region back toward the proximal end region, wherein the everted portion (146) circumferentially surrounds and is spaced apart radially outward from the outer surface of the medial region (110/146); a membrane disposed along a first portion (110) of the medial region of the tubular scaffold, wherein a second portion (148) of the medial region (110) is devoid of the membrane, and positioned radially interior to the everted portion (146), illustrated in Figure 7B ([0024]; [0041]; [0042] & [0066]).
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.
Claims 1-5, 7, 9-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Binmoeller in view of Amplatz et al. (US PG Pub. 2009/0210048), as disclosed in the IDS dated 04/23/2024, hereinafter Amplatz.
Regarding claims 1, 9 and 10, Binmoeller discloses an expandable medical device (142), illustrated in Figure 7B, comprising a tubular scaffold including an inner surface, an outer surface, a proximal end region, a distal end region, and a medial region (110/148) extending between the proximal end region and the distal end region, wherein the tubular scaffold defines a folded-over portion (146) extending from the distal end region toward the proximal end region, wherein an inner-facing surface of the folded-over portion (146) is spaced radially outward from a portion of the medial region (148) to define a gap therebetween; and a membrane disposed along at least a portion (110) of the medial region of the tubular scaffold, wherein the portion (148) of the medial region spaced apart radially from the folded-over portion (146) is devoid of the membrane, and the membrane is configured to maintain a passageway for fluid to flow therethrough and is formed from an elastic material, illustrated in Figure 7B ([0024]; [0041]; [0042] & [0066]); but does not specifically disclose the folded-over portion extends axially over a portion of the medial region.
However, Amplatz teaches a medical device, in the same filed of endeavor, comprising a tubular scaffold (10) including a proximal end region (32) and a distal end region (34), wherein the tubular scaffold defines a folded-over portion (28) extending from the distal end region (34) toward the proximal end region (32), illustrated in Figure 1; wherein the folded-over portion (28) aids in fixing the tubular scaffold in a body lumen and resisting radial forces/pressure from blood flow of the body lumen by providing additional hoop strength. Furthermore, Amplatz discloses the length of the folded-over portion (28)/the distance the folded-over portion (28) extends towards the proximal end can vary depending on the amount to additional hoop strength needed
([0027]; [0042], Last 5 Lines & [0052]).
In view of the teachings of Amplatz, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the folded-over portion, of the medical device Binmoeller, to extend a length such that it extends axially over a portion of the medial region, based on intended use/patient need, in order to provide additionally hoop strength to aid in fixing the medical device in the body lumen, as taught by Amplatz.
Regarding claim 2, Binmoeller in view of Amplatz disclose the medical device of claim 1, wherein Binmoeller teaches the folded-over portion (146) extends away from the outer surface of the medial region (110) toward the proximal end region, illustrated in Figure 7B; and though it is not specifically disclosed that the folded-over portion extends away from the outer surface at an acute angle, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form for the folded-over portion, of the medical device of Binmoeller in view of Amplatz, including extending away from the outer surface at an acute angle, since doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04). Additionally, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the folded-over/everted portion extending at an acute angle, as opposed to any other angle/having any other shape/form.
Regarding claim 3, Binmoeller in view of Amplatz disclose the medical device of claim 2, wherein Binmoeller teaches the folded-over portion (146) includes interstices extending from an outer surface of the folded-over portion to an inner surface of the folded-over portion, illustrated in Figure 7B; and though the embodiment of medical device (142), illustrated in Figure 7B, shows that the interstices of the folded-over portion (146) have a membrane to inhibit tissue growth, Binmoeller state that it is possible for the membrane to only be formed around the central saddle/medial region (Binmoeller: [0042], Last 4 Lines). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the medical device of Binmoeller in view of Amplatz to only have the member at the central saddle/medial region, as taught by Binmoeller, such that the interstices of the folded-over portion permit tissue to grow therein, based on intended use and/or patient need.
Regarding claim 4, Binmoeller in view of Amplatz disclose the medical device of claim 3, wherein Binmoeller teaches the folded-over portion (146) extends circumferentially around a longitudinal axis of the tubular scaffold, illustrated in Figures 7A and 7B.
Regarding claim 5, Binmoeller in view of Amplatz disclose the medical device of claim 1, and though it is not specifically disclosed that the folded-over portion is positioned substantially parallel to a central longitudinal axis of the tubular scaffold, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form for the folded-over portion, of the medical device of Binmoeller in view of Amplatz, including being substantially parallel to a central longitudinal axis of the stent, since doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04). Additionally, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the folded-over portion being positioned substantially parallel to a central longitudinal axis of the stent, as opposed to having other angle/shape/form.
Regarding claim 7, Binmoeller in view of Amplatz disclose the medical device of claim 1, wherein Binmoeller teaches the membrane extends along a portion of an inner surface of the medial region (110) of the tubular scaffold, illustrated in Figure 7B (Binmoeller: [0042] & [0066]).
Regarding claim 11, Binmoeller in view of Amplatz disclose the medical device of claim 1, wherein Binmoeller teaches the medical device further comprises a retention member (144) extending radially away from the outer surface at the proximal end region, wherein the retention member (144) has a distally facing surface positioned substantially parallel to a proximally facing surface, illustrated in Figure 7B (Binmoeller: [0066]).
Regarding claims 12 and 13, Binmoeller in view of Amplatz disclose the medical device of claim 11, wherein Binmoeller teaches the tubular scaffold includes interstices extending from the outer surface of the tubular scaffold to the inner surface of the tubular scaffold, and wherein the membrane spans the interstices of, and is in direct contact with the inner surface of, the portion of the tubular scaffold which defines the retention member (144), illustrated in Figure 7B (Binmoeller: [0042] & [0066]).
Regarding claims 14-16, Binmoeller in view of Amplatz disclose the medical device of claim 13, wherein Binmoeller teaches the distal end region (at 148) of the tubular scaffold includes interstices extending from the outer surface to the inner surface, and is devoid of the membrane such that tissue is permitted to grow through the interstices; and the folded-over portion (146) is spaced apart from and extends away from the outer surface of distal end region (148), illustrated in Figure 7B (Binmoeller: [0066]); and though it is not specifically disclose that the distal end region includes a flared portion and that the folded-over portion extends at an acute angle, these parameters are deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form for the distal end region devoid of the membrane and the folded-over portion, including the distal end region having a flared portion and that the folded-over portion extending away from the outer surface at an acute angle, since doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04). Additionally, it is to be noted that neither the claims, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameters of the distal end region having a flared portion and/or the folded-over/everted portion extending at an acute angle, as opposed to any other shapes/forms.
Regarding claim 17, Binmoeller in view of Amplatz disclose the medical device of claim 16, wherein Binmoeller teaches the retention member (144) has an outermost diameter (D1), the folded-over portion (146) has an outermost diameter (D2), the flared portion (148) has an outermost diameter; and wherein the outmost diameter (D1) of the retention member (144) is greater than the outmost diameter (D2) of the folded-over portion (146), illustrated in Figure 7B and modified figure 7B, below.
PNG
media_image1.png
711
322
media_image1.png
Greyscale
Regarding claim 20, Binmoeller discloses an expandable medical device (142), illustrated in Figure 7B, comprising a tubular scaffold including an inner surface, an outer surface, a proximal end region, a distal end region, and a medial region (110/148) extending between the proximal end region and the distal end region, wherein the tubular scaffold defines a folded-over portion (146) extending from the distal end region toward the proximal end region, wherein the folded-over portion (146) circumferentially surrounds a portion (148) of the medial region such that the folded-over portion (146) is spaced radially outward from the portion (148) of the medial region defining a gap between the outer surface of the medial region and an inner surface of the folded-over portion; and a membrane disposed along a first portion (110) of the medial region of the tubular scaffold, wherein a second portion (148) of the medial region (110) is devoid of the membrane, and extends into the gap and is positioned radially interior to and spaced apart from the folded-over portion (146); and wherein the tubular scaffold further comprises a retention member (144) extending radially away from the medial region (110), wherein the retention member (144) is a double-walled flange having a distal wall positioned substantially parallel to and spaced apart from a proximal wall of the double-walled flange, illustrated in Figure 7B ([0024]; [0041]; [0042] & [0066])l but does not specifically disclose the folded-over portion extends axially over a portion of the medial region.
However, Amplatz teaches a medical device, in the same filed of endeavor, comprising a tubular scaffold (10) including a proximal end region (32) and a distal end region (34), wherein the tubular scaffold defines a folded-over portion (28) extending from the distal end region (34) toward the proximal end region (32), illustrated in Figure 1; wherein the folded-over portion (28) aids in fixing the tubular scaffold in a body lumen and resisting radial forces/pressure from blood flow of the body lumen by providing additional hoop strength. Furthermore, Amplatz discloses the length of the folded-over portion (28)/the distance the folded-over portion (28) extends towards the proximal end can vary depending on the amount to additional hoop strength needed
([0027]; [0042], Last 5 Lines & [0052]).
In view of the teachings of Amplatz, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the folded-over portion, of the medical device Binmoeller, to extend a length such that it extends axially over a portion of the medial region, based on intended use/patient need, in order to provide additionally hoop strength to aid in fixing the medical device in the body lumen, as taught by Amplatz.
Regarding claim 21, Binmoeller in view of Amplatz disclose the medical device of claim 1, wherein Binmoeller teaches the folded-over portion (146) surrounds the portion (148) of the medial region devoid of the membrane, illustrated in Figure 7B; and though it is not specifically disclosed that the folded-over portion extends along substantially an entire axial length of the portion of the medial region devoid of the membrane, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate length for the folded-over portion, of the medical device Binmoeller in view of Amplatz, including extending along substantially an entire axial length of the portion of the medial region devoid of the membrane, based on intended use/patient need, in order to provide additionally hoop strength to aid in fixing the medical device in the body lumen, as taught by Amplatz. Additionally, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the folded-over portion extending along substantially an entire axial length of the portion of the medial region devoid of the membrane, as opposed to extending any other distance/having any other length.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Binmoeller.
Regarding claim 19, Binmoeller discloses the medical device of claim 18, wherein the everted portion (146) extends away from the outer surface of the medial region (110) toward the proximal end region, illustrated in Figure 7B; and though it is not specifically disclosed that the everted portion extends away from the outer surface at an acute angle, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form for the everted portion, including extending away from the outer surface at an acute angle, since doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04). Additionally, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the folded-over/everted portion extending at an acute angle, as opposed to any other angle/having any other shape/form.
Response to Arguments
Applicant’s arguments with respect to independent claim 1 have been considered but are moot because the arguments do not apply to the current rejections presently used in the Office Action. Specifically, in response to Applicant’s amendment, Examiner now cites the prior art of Amplatz, in addition to the prior art of Binmoeller; rejecting independent claim 1, and those claims that depend from it, as being unpatentable over Binmoeller in view of Amplatz.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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, Jerrah Edwards can be reached at 408-918-7557. 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.
/DINAH BARIA/Primary Examiner, Art Unit 3774 09/28/2026
