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 .
Election/Restrictions
Upon further review, Examiner is withdrawing the restriction/election requirement. Claims 1-15 have been fully considered and examined, details below.
Drawings
The drawings are objected to because Figures 1-5 are of poor quality and contain gray
and black shading. The weight of all lines and letters must be heavy enough to permit adequate reproduction (see MPEP 608.02(V).
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 Off ice
action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1, 2, 6, 8, and 9-15 is/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.
Claims 1 and 15 recite the limitation "is performed for each of the vascular ports (7) of the bionic organ (8)." There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 2, the phrase "preferably from 1 to 20 mm” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examiner notes, the claim is being examined using the range that is positively recited.
Regarding claim 6, the phrase “preferably two fixing loops, one at each end of the stent.” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examiner notes, the claim is being examined using positively recited limitation.
Regarding claim 8, the phrase "preferably from 1 to 20 mm” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examiner notes, the claim is being examined using the range that is positively recited.
Regarding claim 9, the phrase " preferably at the circumferentially notched point” and “preferably by means of a loop“ renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 10, the phrase “preferably a saphenous vein, or - a vessel harvested from a deceased donor and preserved, or - a vessel harvested from a deceased donor and non-preserved, or - a vascular prosthesis, preferably made of EPTFE (expanded polytetrafluoroethylene)” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examiner notes, the claim is being examined using the range that is positively recited.
Regarding claim 14, the phrase "most preferably to a depth of 20 mm” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examiner notes, the claim is being examined using the range that is positively recited.
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.
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.
Claim(s) 1-5, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Lyons et al. US 20120271400 A1 in view of Leeson WO 2017112710 A1, herein referred to as Leeson.
Regarding claim 1, Lyons discloses a system for connecting a bionic organ ([0007] Fully capable of performing graft to bionic organ (an artificial organ) adhesion as claimed) to a vascular graft (Fig 10F, graft 200a, portion of 200 not fully shown in figure), characterized in that it comprises a self-expanding stent (Fig 1, prosthesis 12; [0042]), a casing (Fig 1, retaining body 22) and a mandrel (Fig 10D, elongate body 24) with a breakable tip (Fig 10D tip of 24, [0036]). Lyons teaches wherein in an assembled state of the system the stent in a compressed state is placed in the casing (See Fig 1, 20, which casing holds the stent in a compressed state until the stent is removed from the casing; Fig 11a-b show the stent being removed from 20), and a mandrel is placed inside the stent (Fig 10d-e) for removing the stent from the casing (intended use), the length of the stent is in a range of 10 to 40 mm ([0043] and [0008]; retaining member holding prosthesis is in size range; retaining member explicitly recited to be of corresponding size to prosthesis, the claimed ranges are with the ranges taught by Lyons), and a diameter of the stent is selected such that, in the compressed state, the diameter of the stent is less than diameter of the vascular graft (Fig 10f) and, when expanded, the diameter of the stent is greater than or equal to diameter of the vascular port (Fig 10F, 200a) in the bionic organ (Fig 11a shows sizes to be equal).
Lyons does not explicitly disclose wherein, in the assembled state, the length of the casing and the mandrel is in a range of 20 to 40 cm.
However, in the same field of invention, Leeson teaches a system (Fig 1, 10) for connecting a bionic organ ([0101]) to a vascular graft (Fig 1, 100) comprising a casing (Fig 1, 400, 401) and a mandrel (250 not shown in figure, see [0075]); and wherein the assembled state, the length of the mandrel is in a range of 20 to 40 cm ([0079]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify mandrel length disclosed by Lyons to incorporate wherein the length of the mandrel is in a range of 20 to 40 cm, as taught and suggested by Leeson in order for the device to match geometric needs as needed (Leeson [0079]). Lyons and Leeson both teach that the casing would have some length similar to the stent and/or mandrel length, but are silent as to the length of the casing being within the range of 20 to 40 cm. Since Lyons and Leeson inherently have some length to the casing, 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 casing of Lyons to also be within the range of 20 to 40 cm in order to adjust the applicator as needed.
Regarding claim 2, Lyons further discloses that in the expanded state, the diameter of the stent ranges from 0.2 mm to 50 mm (Lyons [0043]), preferably from 1 to 20 mm.
Regarding claim 3, Lyons discloses [wherein] orientation of casing of Lyons as shown in Fig 1), and the stent has a length of 20 mm ([0043]). Lyons does not disclose wherein the assembled state, the casing and the mandrel have a length of 30 cm.
However, Lesson also teaches the assembled state, the casing and the mandrel have a length of 30 cm (Lesson [0079)].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the mandrel size of as disclosed by Lyons to incorporate wherein the assembled state, the mandrel has a length of 30 cm, as taught and suggested by Lesson in order to in order for the device to match geometric needs as needed (Leeson [0079]). Lyons and Leeson both teach that the casing would have some length similar to the stent and/or mandrel length, but are silent as to the length of the casing being within the range of 20 to 40 cm. Since Lyons and Leeson inherently have some length to the casing, 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 casing of Lyons to also be within the range of 20 to 40 cm in order to adjust the applicator as needed (Leeson [0079]).
Regarding claim 4, Lyons teaches a circumferential notch which allows the breakable tip of the mandrel to be broken off (Lyons Fig 10d shows perforations; [0036]).
Regarding claim 5, Lyons teaches a breakable tip of the mandrel has a conical shape with a rounded end (Lyons Fig 10D tip of 24).
Regarding claim 7, Lyons teaches wherein the casing (3) comprises a depth indicator (Lyons Fig 10d).
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lyons in view of Leesons, and further in view of McGrane et al. US 20200246127 A1, herein referred to as McGrane.
Regarding claim 9, Lyons as modified by Lesson discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches a method for connecting a bionic organ to a vascular graft ([0026]), characterized in that the connection is achieved by means of a system as defined in claim 1, wherein said method comprises the following steps:
a) Inserting the system in the assembled state into the vascular graft (Lyons Figs 10a-c)
b) Partially removing the stent (2) from the casing (3) and attaching the stent (2) to the vascular graft ([0048] Lyons teaching removing the introducer system as the stent is placed; Lyons Figs 10f-h and 11a shows intermediary configuration to reach removal),
c) Breaking off the tip of the mandrel (1) (Lyons Fig 10D and [0036]; tip of 24, has perforation allowing breaking),
d) Inserting the vascular graft (4) with the attached stent (2) in the casing (3) into the vascular port (7) of the bionic organ (8) (Lyons Fig 10d-e),
e) Removing the stent (2) from the casing (3) using the mandrel (Lyons Figs 11a-b)
f) Removing the casing (3) and the mandrel (1*) from the vascular port (7) of the bionic organ (Lyons [0043]).
Lyons and Leesons do not explicitly disclose wherein the method is under ex vivo conditions.
However, in the same field of invention, McGrane discloses a similar method for connecting an organ ([0019] and [0052], teaches grafting to an organ, corresponding to a vein) to a vascular graft [0006], teaches ex vivo preparation to impart better graft-ability) and teaches implanting under ex vivo conditions ([0006]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the method of Lyons and Leesons to incorporate where the implantation is done under ex vivo conditions, as taught and suggested by McGrane in order to prepare the nitric oxide production of the graft in vivo (McGrane [0006]).
Claim(s) 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lyons in view of Lesson and McGrane, and further in view of Cook et al. US 6206931 B1, herein referred to as Cook.
Regarding claim 10, Lyons as modified by Lesson and McGrane discloses the invention substantially as claimed and as discussed above with respect to claim 9, but does not disclose wherein the following are used as the vascular graft:- a decellularized or recellularized vessel of animal origin, or - a preserved vessel of animal origin, or - an autogenous vessel.
Cook discloses a vascular graft (Summary of invention). Cook teaches wherein the following are used as the vascular graft:- a decellularized or recellularized vessel of animal origin, or - a preserved vessel of animal origin, or - an autogenous vessel Col 13, lines 42-67; teaches autologous tissue for grafting).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the vascular graft of Lyons as modified by Lesson and McGrane to incorporate wherein the following are used as the vascular graft (4):- a decellularized or recellularized vessel of animal origin, or - a preserved vessel of animal origin, or - an autogenous vessel, as taught and suggested by Cook in order to the graft to be suitable for burn treatment (Col 13, lines 42-67).
Regarding claim 11, Lyons as modified by Lesson, McGrane, and Cook discloses the invention substantially as claimed and as discussed above with respect to claim 10. Lyons teaches wherein implementing step a), the vascular graft (4) is decellularized ([0030]). Lyons does not disclose then populating with endothelial cells.
Cook teaches then populated with endothelial cells (Cook:; teaches proliferative process for endothelial cells in ECM).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the method of Lyons to incorporate populating the decellularized vascular graft with endothelial cells, as taught and suggested by Cook in order to allow endothelial cells to support the proliferation and/or differentiation of other neighboring cell types (Cook Col 13, lines 16-28)
Regarding claim 12, Lyons does not disclose use of 3D printing, however Lesson further discloses that the bionic organ (8) is prepared using 3D bioprinting technology (Leeson [0070]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the method of Lyons to incorporate that the bionic organ (8) is prepared using 3D bioprinting technology, as taught and suggested by Leeson in order to be compatible with an electrospun manufacturing process (Leeson [0070] and [0071]).
Regarding claim 13, Lyons as modified by Lesson, McGrane and Cook discloses the invention substantially as claimed and as discussed above with respect to claim 9. Lyons teaches wherein: d) is controlled by the depth indicator (5) and it corresponds to the length of the stent (2) used (Fig 10h indicates when entire stent is placed; [0049]).
Regarding claim 14, Lyons as modified by Lesson, McGrane, and Cook discloses the invention substantially as claimed and as discussed above with respect to claim 9. Lyons teaches wherein step d) the stent (2) is inserted to a depth of 10 to 40 mm ([0043] the claimed ranges are with the ranges taught by Lyons).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lyons in view of Leeson, and further in view of Elachchabi et al. EP 2143389 A1, herein referred to as Elachchabi.
Regarding claim 6, Lyons as modified by Lesson discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not explicitly disclose that the stent comprises at least one fixing loop.
However, in the same field of invention, Elachchabi teaches a stent (50), wherein the stent comprises at least one fixing loop (Fig 5a).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the stent disclosed by Lyons in view of Leeson to incorporate at least one fixing loop, as taught and suggested by Elachchabi in order to allow grasping of the stent (Elachchabi [0074]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lyons in view of Leeson, and further in view of Palermo et al. US 20200253711 A1, herein referred to as Palermo.
Regarding claim 8, Lyons as modified by Lesson discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose the system characterized in that it comprises a set of at least two samplers that allows for selecting the diameter of the stent (2) to match the diameter of the vascular port (7), wherein the samplers have diameters of different sizes ranging from 0.2 mm to 50 mm, preferably from 1 mm to 20 mm.
However, in the same field of invention, Palermo teaches a stent, wherein a set of at least two samplers (Fig 14, 40 and 50) that allows for selecting the diameter of the stent (Fig 14, 80) to match the diameter of the vascular port (70), wherein the samplers have diameters of different sizes ranging from 0.2 mm to 50 mm [0100], preferably from 1 mm to 20 mm.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the vascular port of Lyons as modified by Leeson to incorporate wherein a set of at least two samplers that allows for selecting the diameter of the stent to match the diameter of the vascular port, wherein the samplers have diameters of different sizes ranging from 0.2 mm to 50 mm, preferably from 1 mm to 20 mm, as taught and suggested by Palermo in to allow sizing of stent components (Palermo [0100]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./Patent Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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