Prosecution Insights
Last updated: April 19, 2026
Application No. 18/021,368

POROUS MULTILAYER TUBULAR STRUCTURE HAVING PHYSIOLOGICALLY ACTIVE SUBSTANCES CONTAINED IN PORES

Final Rejection §103§112
Filed
Feb 14, 2023
Examiner
BARIA, DINAH N
Art Unit
3774
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Dae Joong Kim
OA Round
2 (Final)
73%
Grant Probability
Favorable
3-4
OA Rounds
2y 9m
To Grant
99%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allow Rate
456 granted / 622 resolved
+3.3% vs TC avg
Strong +29% interview lift
Without
With
+29.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
50 currently pending
Career history
672
Total Applications
across all art units

Statute-Specific Performance

§101
1.7%
-38.3% vs TC avg
§103
34.9%
-5.1% vs TC avg
§102
21.3%
-18.7% vs TC avg
§112
30.8%
-9.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 622 resolved cases

Office Action

§103 §112
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 10/30/2025. As directed by the amendment: claims 1, 2, 4-12, 14 and 16 have been amended, claims 3, 13, 15 and 17-19 have been cancelled and no new claims have been added. Thus, claims 1, 2, 4-12, 14 and 16 are presently pending in this application. Information Disclosure Statement The information disclosure statement filed 10/30/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Non-patent literature/Other reference No. AD, which has been lined through, has been placed in the application file, but the information referred to therein has not been considered, because the copy provided was illegible. 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 vascular conduit comprising three or more layers, wherein a porosity of a layer positioned next to an outermost layer on an abluminal side is smaller than porosities of other layers, and the outermost layer on the abluminal side having a smaller porosity than that of the other layers (claim 11) 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 6-12, 14 and 16 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 independent claim 1, which sets forth that “the tubular structure is formed of three or more layers, and a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers”, and claim 6 further sets forth the parameter of “an amount of the physiologically active substance in each of the layers decreases in a direction from an innermost layer on a luminal side of the tubular structure to the outermost layer on the abluminal side of the tubular structure”; however, this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, or suggests, a vascular conduit comprising a tubular structure, wherein the tubular structure is formed of three or more layers, a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers, and also has an amount of the physiologically active substance in each of the layers decreasing in a direction from an innermost layer on a luminal side of the tubular structure to the outermost layer on the abluminal side of the tubular structure. Regarding claim 8, which depends from independent claim 1, which sets forth that “the tubular structure is formed of three or more layers, and a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers”, and claim 8 further sets forth the parameter of “an amount of the physiologically active substance per area of an innermost layer on a luminal side of the tubular structure is 0.25 to 1.5mg/mm2”; however, this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, or suggests, a vascular conduit comprising a tubular structure, wherein the tubular structure is formed of three or more layers, a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers, and also has an amount of the physiologically active substance per area of an innermost layer on a luminal side of the tubular structure is 0.25 to 1.5mg/mm2. Regarding claim 9, which depends from independent claim 1, which sets forth that “the tubular structure is formed of three or more layers, and a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers”, and claim 9 further sets forth the parameter of “an amount of the physiologically active substance per area of a layer positioned next to an innermost layer on a luminal side of the tubular structure is 0.25 to 0.75mg/mm2”; however, this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, or suggests, a vascular conduit comprising a tubular structure, wherein the tubular structure is formed of three or more layers, a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers, and also has an amount of the physiologically active substance per area of a layer positioned next to an innermost layer on a luminal side of the tubular structure is 0.25 to 0.75mg/mm2. Regarding claim 10, which depends from independent claim 1, which sets forth that “the tubular structure is formed of three or more layers, and a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers”, and claim 10 further sets forth the parameter of “the outermost layer on an abluminal side of the tubular structure does not contain the physiologically active substance, or when the physiologically active substance is paclitaxel, an amount of the physiologically active substance per area of the outermost layer is 0.25mg/mm2 or less”; however, this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, or suggests, a vascular conduit comprising a tubular structure, wherein the tubular structure is formed of three or more layers, a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers, and also has the outermost layer on an abluminal side of the tubular structure not containing the physiologically active substance, or when the physiologically active substance is paclitaxel, an amount of the physiologically active substance per area of the outermost layer is 0.25mg/mm2 or less. Regarding claim 11, which depends from independent claim 1, which sets forth that “the tubular structure is formed of three or more layers, and a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers”, and claim 11 further sets forth the parameter of “the outermost layer on an abluminal side of the tubular structure has a smaller porosity than that of other layers”; however, this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, or suggests, a vascular conduit comprising a tubular structure, wherein the tubular structure is formed of three or more layers, a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers, and also has the outermost layer on an abluminal side of the tubular structure having a smaller porosity than that of other layers. Regarding claim 12, depends from independent claim 1, which sets forth that “the tubular structure is formed of three or more layers, and a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers”, and claim 12 further sets forth the parameter of “the outermost layer on an abluminal side of the tubular structure has a porosity of less than 25mm”; however, this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, or suggests, a vascular conduit comprising a tubular structure, wherein the tubular structure is formed of three or more layers, a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers, and also has the outermost layer on an abluminal side of the tubular structure having a porosity of less than 25mm. Regarding claim 14, which depends from independent claim 1, which sets forth that “the tubular structure is formed of three or more layers, and a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers”, and claim 14 further sets forth the parameter of “an amount of the physiologically active substance in each of the layers decreases in a direction from the outermost layer on an abluminal side of the tubular structure to the innermost layer on a luminal side of the tubular structure”; however, this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, or suggests, a vascular conduit comprising a tubular structure, wherein the tubular structure is formed of three or more layers, a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers, and also has an amount of the physiologically active substance in each of the layers decreasing in a direction from the outermost layer on an abluminal side of the tubular structure to the innermost layer on a luminal side of the tubular structure. Regarding claim 16, depends from independent claim 1, which sets forth that “the tubular structure is formed of three or more layers, and a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers”, and claim 16 further sets forth the parameter of “the porosity of the layer positioned next to the outermost layer on the abluminal side of the tubular structure is less than 25mm”; however, this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, or suggests, a vascular conduit comprising a tubular structure, wherein the tubular structure is formed of three or more layers, a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers, and also having the porosity of the layer positioned next to the outermost layer on the abluminal side of the tubular structure is less than 25mm. 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, 4-12, 14 and 16 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 1, which recites the limitation “the physiologically active substance”, on lines 4-5; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this issue, it is suggested the above mentioned limitation be amended by deleting the word “the” and replacing it with the word “a”. Regarding claims 1 and 11, the last two lines of claim 1, and the last 3 lines of claim 11, set forth the parameter of “the porosity being defined according to International Standardization Organization (ISO) standard 7198:1998”; however, this parameter is found to be confusing for a few reasons. Firstly, it is to be noted that ISO 7198:1998 is no longer valid and has been withdrawn; it has been replaced by new version ISO 7198:2016. Secondly, even if ISO 7198:1998 is used/referenced, it is unclear what exactly is meant by the term “porosity”; specifically, ISO 7198:1998 states “Porosity may be expressed as the percentage void to the total area of volume, mean distance between nodes, or mean pore diameter”. Therefore, it is not clear if the term “porosity” is meant to reference a “percentage void to the total area of volume”, or a “mean distance between nodes”, or a “mean pore diameter”. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claims indefinite. Regarding claim 11, which depends from independent claim 1, which sets forth that “the tubular structure is formed of three or more layers, and a porosity of a layer positioned next to the outermost layer of an abluminal side of the tubular structure is smaller than the porosities of other layers” (emphasis added), and claim 11 further sets forth the parameter of “the outermost layer on an abluminal side of the tubular structure has a smaller porosity than that of other layers” (emphasis added); however, this parameter is found to be confusing since it is not clear how exactly the tubular structure can have a porosity of the layer next to the outermost layer being smaller than the porosities of the other layers (as set forth in claim 1) and also having the porosity of the outermost layer being smaller than the porosities of the other layers (as set forth in claim 11). Specifically, the parameter of claim 11 seems to be contradicting the parameter set forth in claim 1, i.e. claim 1 essentially states the layer next to the outermost layer has the smallest porosity, while claim 11 essentially states the outermost layer has the smallest porosity; hence, it isn’t clear how the outermost layer and the layer next to the outermost layer can both have a porosity smaller than the porosities of the other layers. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claims 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; intended use/functional language and/or method of manufacturing is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2113 & 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 § 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, 2, 6, 7, 10, 12, 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Dubson et al. (US PG Pub. 2005/0137675), hereinafter Dubson. Regarding claim 1, Dubson discloses a vascular conduit, illustrated in Figures 1B and 8, comprising a tubular structure in which a plurality of layers (12-14) are stacked, wherein a plurality of pores are formed in each of the layers, and a physiologically active substance is contained in the pores of at least one of the layers, wherein the plurality of layers are all made of polyurethane, wherein the tubular structure is formed of three layers (12-14), illustrated in Figure 1b ([0067]; [0069]; [0097]; [0098]; [0100] & [0101], Lines 1-7); and though it is not specifically disclosed that the porosity of the layer (13) positioned next to an outermost layer (14) on an abluminal side of the tubular structure is smaller than porosities of other layers, Dubson does state that “any predetermined porosity distributions may be employed” ([0100], Lines 9-11). Thus, 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 porosity distribution for the plurality of layers, including having the porosity of the layer next to the outermost layer, on the abluminal side of the tubular structure, be smaller than porosities of the other layers, based on specific patient need and/or type of surgical procedure to be performed. It is also to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the porosity of the layer positioned next to an outermost layer being smaller than porosities of other layers, as opposed to having any other type of porosity distribution; in fact, the originally filed disclosure of the current application at hand recites multiple different types of porosity distributions, including the porosity decreasing, and also increasing, as a function of the distance of the layer form the center/lumen of the conduit. Regarding claim 2, Dubson discloses the vascular conduit according to claim 1, and though it is not specifically disclosed that an amount of the physiologically active substance in at least one of the layers is different from an amount of the physiologically active substance in the other layer, Dubson does state “the drug incorporated, as well as the concentration and method of incorporation into-the prosthesis is in accordance with the type of vessel being replaced, and with the particular pathology of the patient” ([0101], Last 4 Lines). 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 appropriate amounts of the physiologically active substance for each of the layers, including one layer having a different amount than the other layers, based on the intended use/type of vessel being replaced and/or specific patient need/pathology of the patient, as taught by Dubson ([0101], Last 4 Lines). It is also to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of an amount of the physiologically active substance in at least one layer being different from an amount in the other layers, as opposed to having any other distribution profile of the physiologically active substance in the layers. Regarding claims 6, 7 and 10, Dubson discloses the vascular conduit according to claim 1, and though it is not specifically disclosed that an amount of the physiologically active substance in each of the layers decreases in a direction from an innermost layer on a luminal side of the tubular structure to the outermost layer on the abluminal side of the tubular structure, such that the outermost layer does not contain the physiologically active substance, Dubson does state “the drug incorporated, as well as the concentration and method of incorporation into-the prosthesis is in accordance with the type of vessel being replaced, and with the particular pathology of the patient” ([0101], Last 4 Lines). 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 appropriate amounts of the physiologically active substance for each of the layers, including the physiologically active substance decreasing in a direction from an innermost layer on a luminal side of the tubular structure to the outermost layer on the abluminal side of the tubular structure, such that the outermost layer does not contain the physiologically active substance, based on the intended use/type of vessel being replaced and/or specific patient need/pathology of the patient, as taught by Dubson ([0101], Last 4 Lines). It is also to be noted that neither the claims, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the amount of the physiologically active substance decreasing in a direction from an innermost layer to the outermost layer, such that the outermost layer does not contain the physiologically active substance, as opposed to having any other distribution profile of the physiologically active substance in the layers; in fact, the originally filed disclosure of the current application at hand recites multiple different distribution profiles of the physiologically active substance in the layers, including decreasing in a direction from an outermost layer to the innermost layer. Regarding claims 12 and 16, Dubson discloses the porous vascular conduit according to claim 1, and though it is not specifically disclosed that the outermost layer on an abluminal side of the tubular structure and/or the layer positioned next to the outermost layer on the abluminal side of the tubular structure have/has a porosity of less than 25mm, 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 pore size for the plurality of pores, including the outermost layer on an abluminal side of the tubular structure and/or the layer positioned next to the outermost layer on the abluminal side of the tubular structure having a pore size less than 25mm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (see MPEP 2144.05). Regarding claim 14, Dubson discloses the vascular conduit according to claim 1, and though it is not specifically disclosed that an amount of the physiologically active substance in each of the layers decreases in a direction from the outermost layer on an abluminal side of the tubular structure to an innermost layer on a luminal side of the tubular structure, Dubson does state “the drug incorporated, as well as the concentration and method of incorporation into-the prosthesis is in accordance with the type of vessel being replaced, and with the particular pathology of the patient” ([0101], Last 4 Lines). 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 appropriate amounts of the physiologically active substance for each of the layers, including the physiologically active substance decreasing in a direction from the outermost layer on an abluminal side of the tubular structure to an innermost layer on a luminal side of the tubular structure, based on the intended use/type of vessel being replaced and/or specific patient need/pathology of the patient, as taught by Dubson ([0101], Last 4 Lines). It is also to be noted that neither the claims, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the amount of the physiologically active substance decreasing in a direction from the outermost layer on an abluminal side of the tubular structure to an innermost layer on a luminal side of the tubular structure, as opposed to having any other distribution profile of the physiologically active substance in the layers; in fact, the originally filed disclosure of the current application at hand recites multiple different distribution profiles of the physiologically active substance in the layers, including decreasing in a direction from an innermost layer to the outermost layer. Claims 4, 5, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Dubson as applied to claim 1 above, and in view of Radspinner (US PG Pub. 2014/0142682), as previously disclosed. Regarding claims 4 and 5, Dubson discloses the vascular conduit according to claim 1, but does not specifically disclose the physiologically active substance is a substance that inhibits cell proliferation/cell migration and is paclitaxel, rapamycin, or everolimus; however, Dubson does state “the drug incorporated, as well as the concentration and method of incorporation into-the prosthesis is in accordance with the type of vessel being replaced, and with the particular pathology of the patient” (Dubson: [0101], Last 4 Lines). Nevertheless, Radspinner teaches a vascular conduit, in the same field of endeavor, which comprises an anti-proliferative drug/drug to inhibit cell proliferation, such as paclitaxel, and/or comprises an immunosuppressive drug, such as rapamycin/sirolimus ([0052]). In view of the teachings of Radspinner, 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 physiologically active substance, for the vascular conduit of Dubson, including being an anti-proliferative/drug to inhibit cell proliferation, such as paclitaxel, and/or an immunosuppressive drug, such as rapamycin/sirolimus, based on the intended use/type of vessel being replaced and/or specific patient need/pathology of the patient, as taught by Dubson (Dubson: [0101], Last 4 Lines). Regarding claims 8 and 9, Dubson discloses the vascular conduit according to claim 1, but does not specifically disclose the physiologically active substance is paclitaxel, and that an amount of the physiologically active substance per area of an innermost layer on a luminal side of the tubular structure is 0.25 to 1.5mg/mm2, and of a layer positioned next to an innermost layer is 0.25 to 0.75 g/mm2. However, Radspinner teaches a vascular conduit, in the same field of endeavor, comprising paclitaxel, which is known as an anti-proliferative drug/drug to inhibit cell proliferation ([0052]). In view of the teachings of Radspinner, 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 physiologically active substance, for the vascular conduit of Dubson, including paclitaxel, in order to aid in inhibit cell proliferation, as taught by Radspinner. Furthermore, though it is not specifically disclosed that an amount of the physiologically active substance/paclitaxel per area of an innermost layer on a luminal side of the tubular structure is 0.25 to 1.5mg/mm2, and of a layer positioned next to an innermost layer is 0.25 to 0.75 g/mm2, Dubson does state “the drug incorporated, as well as the concentration and method of incorporation into-the prosthesis is in accordance with the type of vessel being replaced, and with the particular pathology of the patient” (Dubson: [0101], Last 4 Lines). Thus, it would further 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 appropriate amounts of the physiologically active substance/paclitaxel for the layers, including having 0.25 to 1.5mg/mm2 per area of an innermost layer on a luminal side of the tubular structure is, and 0.25 to 0.75mg/mm2 per area of the layer positioned next to an innermost layer, based on the intended use/type of vessel being replaced and/or specific patient need/pathology of the patient, as taught by Dubson (Dubson: [0101], Last 4 Lines). It is also to be noted that neither the claims, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the amount of the physiologically active substance/paclitaxel per area of an innermost layer on a luminal side of the tubular structure being 0.25 to 1.5mg/mm2, and of a layer positioned next to an innermost layer being 0.25 to 0.75 g/mm2, as opposed to having any other distribution profile of the physiologically active substance in the layers. Response to Arguments Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. 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
Read full office action

Prosecution Timeline

Feb 14, 2023
Application Filed
Sep 30, 2025
Non-Final Rejection — §103, §112
Oct 30, 2025
Response Filed
Jan 20, 2026
Final Rejection — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
73%
Grant Probability
99%
With Interview (+29.1%)
2y 9m
Median Time to Grant
Moderate
PTA Risk
Based on 622 resolved cases by this examiner. Grant probability derived from career allow rate.

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