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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/27/2026 has been entered.
Response to Amendment
The amendment filed on 8/27/2026 has been entered. Claims 1-4, 7, 14, 17, 19, 21, 24, 27-28, 30-31, 33, 35, 48, 55, 62, 64, 70, and 73 are pending in the application. Claims 48, 55, 62, 64, 70, and 73 are withdrawn. Claims 5-6, 8-13, 15-16, 18, 20, 22-23, 25-26, 29, 32, 34, 36-47, 49-54, 56-61, 63, 65-69, and 71-72 are cancelled. The amendments to the claims overcome each and every drawing objection, 112(a) rejection, and 112(b) rejection previously set forth in the Final Office Action mailed on 5/27/2026.
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.
Claims 1, 3, 14, 17, 19, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2010/0093066 A1) in view of O'Connell et al. (US 2017/0080178 A1) and further in view of Desai et al. (US 2019/0119462 A1).
Regarding claim 1, Taylor discloses an intravascular catheter (see Figs. 3-4) comprising:
a catheter tube (catheter 301) comprising a lumen (see Figs. 3-4, par. [0107], [0111]); and
a biocompatible bioscaffold (see Figs. 3-4. par. [0036], [0107]),
wherein:
the biocompatible bioscaffold is contained within the lumen (see Figs. 3-4. par. [0036], [0107], [0111]) and configured to remain within the lumen when the catheter (catheter 301) is placed into and withdrawn from a vein (see Figs. 3-4, par. [0107], [0111]), the catheter (catheter 301) is arranged to allow blood to flow through the bioscaffold and waste products produced by the bioscaffold to be removed from the catheter (catheter 301) when the catheter (catheter 301) is placed into a vein (see par. [0025], [0030]-[0031], [0036]-[0037], [0079]).
However, Taylor fails to state the catheter tube comprising a plurality of side holes, wherein the plurality of side holes are distributed along a length of the catheter tube in a spiraling corkscrew pattern; the biocompatible bioscaffold comprising a plurality of macropores and micropores; the plurality of side holes are arranged to allow the blood to flow through the catheter.
O'Connell teaches an intravascular catheter (guide extension catheter 100, see Figs. 1-5 and 14, par. [0047], [0060]) comprising a catheter tube (distal shaft 104) comprising a plurality of side holes (perfusion openings 106), wherein the plurality of side holes (perfusion openings 106) are distributed along an entire length of the catheter tube (distal shaft 104) in a spiraling corkscrew pattern (see Figs. 1-5 and 14, par. [0060]), the plurality of side holes (perfusion openings 106) are arranged to allow the blood to flow through the catheter (guide extension catheter 100) (see par. [0047]-[0048], the perfusion openings 106 allow fluid communication between the interior and exterior of the distal shaft 104 such that this functional limitation can be achieved).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular catheter of Taylor to include the catheter tube comprising a plurality of side holes, wherein the plurality of side holes are distributed along an entire length of the catheter tube in a spiraling corkscrew pattern; the plurality of side holes are arranged to allow the blood to flow through the catheter, as taught by O'Connell, in order to allow the inserted catheter to allow material to be transferred between the interior and the exterior of the catheter in a manner that provides increased flexibility for the vasculature (see O'Connell par. [0047]-[0048], [0060]).
However, modified Taylor still fails to state the biocompatible bioscaffold comprising a plurality of macropores and micropores.
Desai teaches a biocompatible bioscaffold comprising a plurality of macropores and micropores (see par. [0003], [0076], [0080], [0139]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the biocompatible bioscaffold of the intravascular catheter of modified Taylor to include a plurality of macropores and micropores, as taught by Desai, in order to implant the pores with therapeutic cells to treat a disease (see Desai par. [0139]) and to provide desirable nutrient transport and vascular integration to grow and maintain cells (see Desai par. [0080]).
Regarding claim 3, modified Taylor teaches the intravascular catheter of claim 1 substantially as claimed. However, modified Taylor fails to state wherein the biocompatible bioscaffold comprises polydimethylsiloxane (PDMS), collagen, or graphene.
Desai teaches a biocompatible bioscaffold comprising collagen (see par. [0003], and [0114]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the biocompatible bioscaffold of the intravascular catheter of modified Taylor to include collagen, as taught by Desai, in order to promote encapsulation of therapeutic cells (see Desai par. [0114]).
Regarding claim 14, modified Taylor teaches the intravascular catheter of claim 1 substantially as claimed. However, modified Taylor fails to state wherein the plurality of macropores have an average diameter ranging from about 150 micrometers to about 800 micrometers, the plurality of micropores have an average diameter of 30 micrometers or less, and the biocompatible bioscaffold has a porosity ranging from 30 percent to 95 percent.
Desai teaches a biocompatible bioscaffold wherein the plurality of macropores have an average diameter ranging from about 150 micrometers to about 800 micrometers (see par. [0084]), the plurality of micropores have an average diameter of 30 micrometers or less (see par. [0085]), and the biocompatible bioscaffold has a porosity ranging from 30 percent to 95 percent (see par. [0087]-[0088]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the biocompatible bioscaffold of the intravascular catheter of modified Taylor to include wherein the plurality of macropores have an average diameter ranging from about 150 micrometers to about 800 micrometers, the plurality of micropores have an average diameter of 30 micrometers or less, and the biocompatible bioscaffold has a porosity ranging from 30 percent to 95 percent, as taught by Desai, because these characteristics provide a biocompatible bioscaffold which can implant the pores with therapeutic cells to treat a disease (see Desai par. [0139]) and to provide desirable nutrient transport and vascular integration to grow and maintain cells (see Desai par. [0080]).
Regarding claim 17, modified Taylor teaches the intravascular catheter of claim 1 substantially as claimed. However, modified Taylor fails to state wherein the biocompatible bioscaffold further comprises one or more drugs, growth factors, angiogenic agents, cytokines, therapeutic cells, or extracellular matrix components, or a combination thereof.
Desai teaches a biocompatible bioscaffold wherein the biocompatible bioscaffold further comprises one or more drugs (see par. [0115]-[0118], growth factors (see par. [0100] and [0115]-[0118]), cytokines (see par. [0101]), therapeutic cells (see par. [0100]- [0101] and [0139]), or extracellular matrix components (see par. [0114]), or a combination thereof.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the biocompatible bioscaffold of the intravascular catheter of modified Taylor to include one or more drugs, growth factors, cytokines, therapeutic cells, or extracellular matrix components, or a combination thereof, as taught by Desai, because these characteristics provide a bioscaffold which can treat a disease (see Desai par. [0139]).
Regarding claim 19, modified Taylor teaches the intravascular catheter of claim 17 substantially as claimed. However, modified Taylor fails to state wherein the therapeutic cells are stem cells, progenitor cells, mature cells, or genetically modified cells.
Desai teaches a biocompatible bioscaffold wherein the therapeutic cells are stem cells (see par. [0137]), progenitor cells (see par. [0137], partially differentiated cells), mature cells (see par. [0137], fully differentiated cells), or genetically modified cells (see par. [0100]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the biocompatible bioscaffold of the intravascular catheter of modified Taylor to include wherein the therapeutic cells are stem cells, progenitor cells, mature cells, or genetically modified cells, as taught by Desai, because these characteristics provide a bioscaffold which can treat a disease (see Desai par. [0139]).
Regarding claim 21, modified Taylor teaches the intravascular catheter of claim 17 substantially as claimed. However, modified Taylor fails to state wherein the therapeutic cells secrete a cytokine, a chemokine, a growth factor, or a hormone.
Desai teaches a biocompatible bioscaffold wherein the therapeutic cells secrete a cytokine (see par. [0101]), a growth factor (see par. [0100]), or a hormone (see par. [0100]-[0101]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the biocompatible bioscaffold of the intravascular catheter of modified Taylor to include wherein the therapeutic cells secrete a cytokine, a growth factor, or a hormone, as taught by Desai, because these characteristics provide a bioscaffold which can treat a disease (see Desai par. [0139]).
Regarding claim 24, modified Taylor teaches the intravascular catheter of claim 17 substantially as claimed. However, modified Taylor fails to state wherein the therapeutic cells are insulin-secreting cells.
Desai teaches a biocompatible bioscaffold wherein the therapeutic cells are insulin-secreting cells (see par. [0111]-[0113]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the biocompatible bioscaffold of the intravascular catheter of modified Taylor to include wherein the therapeutic cells are insulin-secreting cells, as taught by Desai, because these characteristics provide a bioscaffold which can treat type 1 or type 2 diabetes, pre-diabetes, or hyperglycemia (see Desai par. [0139]).
Claims 2, 27-28, 30-31, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2010/0093066 A1) in view of O'Connell et al. (US 2017/0080178 A1) and further in view of Desai et al. (US 2019/0119462 A1), as applied to claims 1, 17, and 24 above, and further in view of Schon et al. (US 2003/0153898 A1).
Regarding claim 2, modified Taylor teaches the intravascular catheter of claim 1 substantially as claimed. However, modified Taylor fails to state wherein the catheter tube comprises polyurethane or silicone.
Schon teaches an intravascular catheter (see Fig. 1, par. [0047]) wherein the catheter tube (either of distal end tubes 14 or 16) comprises polyurethane (see par. [0104]-[0105]) or silicone (see par. [0107]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular catheter of modified Taylor to include wherein the catheter tube comprises polyurethane or silicone, as taught by Schon, in order to provide a soft durometer (see Schon par. [0105]) and/or a flexible, durable, soft, and biocompatible catheter that reduces risk of harming vessel walls (see Schon par. [0107]).
Regarding claim 27, modified Taylor teaches a method of implanting therapeutic cells in a subject, the method comprising placing the intravascular catheter of claim 17 (see claim 17 rejection above) within the subject (see rejections of claims 1 and 17 above wherein the intravascular catheter of Taylor includes a biocompatible bioscaffold that was previously modified in view of Desai to comprise therapeutic cells for treating a disease; the catheter of modified Taylor is placed within the subject to deliver the scaffold as taught by Taylor par. [0107], [0111]).
However, modified Taylor fails to expressly state placing the intravascular catheter within a major vein of the subject.
Schon further teaches a method comprising placing the intravascular catheter (see Fig. 1, par. [0047]) within a major vein of the subject (see par. [0047]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Taylor to include placing the intravascular catheter within a major vein of the subject, as taught by Schon, in order to deliver the bioscaffold into a suitable major vein of the subject depending upon the desired procedure (see Schon par. [0047]).
Regarding claim 28, modified Taylor teaches the method of claim 27 substantially as claimed. Modified Taylor further teaches wherein the major vein is selected from the group consisting of an internal jugular vein, a subclavian vein, and a femoral vein (see Schon par. [0047], see previous modifications in rejection of claim 27 above).
Regarding claim 30, modified Taylor teaches the method of claim 27 substantially as claimed. However, modified Taylor fails to state retrieving the intravascular catheter from the subject and exchanging the intravascular catheter for another intravascular catheter comprising the therapeutic cells.
Desai teaches a method comprising retrieving the intravascular catheter from the subject and exchanging the intravascular catheter for another intravascular catheter comprising the therapeutic cells (see par. [0144], after the bioscaffold is implanted, another catheter can administer another therapeutic drug).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Taylor to include retrieving the intravascular catheter from the subject and exchanging the intravascular catheter for another intravascular catheter comprising the therapeutic cells, as taught by Desai, in order to provide additional therapies (see Desai par. [0144]).
Regarding claim 31, modified Taylor teaches a method of treating a subject for type 1 diabetes, the method comprising placing the intravascular catheter of claim 24 (see claim 24 rejection above) within the subject (see rejections of claims 1, 17, and 24 above wherein the intravascular catheter of Taylor includes a biocompatible bioscaffold that was previously modified in view of Desai to comprise therapeutic insulin-secreting cells for treating type 1 diabetes, see Desai par. [0139]; the catheter of modified Taylor is placed within the subject to deliver the scaffold as taught by Taylor par. [0107], [0111]).
However, modified Taylor fails to expressly state placing the intravascular catheter within a major vein of the subject.
Schon further teaches a method comprising placing the intravascular catheter (see Fig. 1, par. [0047]) within a major vein of the subject (see par. [0047]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Taylor to include placing the intravascular catheter within a major vein of the subject, as taught by Schon, in order to deliver the bioscaffold into a suitable major vein of the subject depending upon the desired procedure (see Schon par. [0047]).
Regarding claim 33, modified Taylor teaches the method of claim 31 substantially as claimed. Modified Taylor further teaches wherein the insulin-secreting cells are autologous, allogeneic, or xenogeneic pancreatic beta cells or islets, or insulin-secreting cells derived from stem cells or pancreatic progenitor cells (see Desai par. [0016], [0102], [0111]-[0113], see previous modifications in rejection of claim 24 above).
Regarding claim 35, modified Taylor teaches the method of claim 31 substantially as claimed. However, modified Taylor fails to state retrieving the intravascular catheter from the subject and exchanging the intravascular catheter for another intravascular catheter comprising therapeutic cells.
Desai teaches a method comprising retrieving the intravascular catheter from the subject and exchanging the intravascular catheter for another intravascular catheter comprising insulin-secreting cells (see par. [0111]-[0113] and [0144], after the bioscaffold is implanted, another catheter can administer another therapeutic insulin-secreting cell).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Taylor to include retrieving the intravascular catheter from the subject and exchanging the intravascular catheter for another intravascular catheter comprising insulin-secreting cells, as taught by Desai, in order to provide additional therapies (see Desai par. [0144]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2010/0093066 A1) in view of O'Connell et al. (US 2017/0080178 A1) and further in view of Desai et al. (US 2019/0119462 A1), as applied to claim 1 above, and further in view of Chian et al. (WO 2008/069760 A1).
Regarding claim 4, modified Taylor teaches the intravascular catheter of claim 1 substantially as claimed. However, modified Taylor fails to state wherein the biocompatible bioscaffold further comprises a coating comprising an anticoagulant.
Chian teaches a biocompatible bioscaffold comprising a coating comprising an anticoagulant (see par. [021]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the biocompatible bioscaffold of the intravascular catheter of modified Taylor to include a coating comprising an anticoagulant, as taught by Chian, in order to reduce the thrombogenic reaction at the site where the bioscaffold is implanted (see Chian par. [021]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2010/0093066 A1) in view of O'Connell et al. (US 2017/0080178 A1) and further in view of Desai et al. (US 2019/0119462 A1), as applied to claim 1 above, and further in view of Schon et al. (US 2003/0153898 A1), further in view of Fang (US 2017/0251977 A1), and further in view of Sverdlik et al. (US 2013/0218068 A1).
Regarding claim 7, modified Taylor teaches the intravascular catheter of claim 1 substantially as claimed. However, modified Taylor fails to state wherein each of the plurality of side holes are about 0.2 to about 5.0 mm wide, and adjacent ones of the plurality of side holes are about 3 mm to about 10 mm apart, and rotated about 30 degrees to about 60 degrees.
Schon teaches an intravascular catheter (see Fig. 1, par. [0047]) wherein adjacent ones of the plurality of side holes (side holes 50) are rotated 60 degrees (see par. [0101]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular catheter of modified Taylor to include wherein adjacent ones of the plurality of side holes are rotated 60 degrees, as taught by Schon, in order to provide additional flow paths and optimal flow properties (see Schon par. [0100]-[0101]).
However, modified Taylor still fails to state wherein each of the plurality of side holes are about 0.2 to about 5.0 mm wide, and adjacent ones of the plurality of side holes are about 3 mm to about 10 mm apart.
Fang teaches an intravascular catheter (see Figs. 1-2, par. [0003], [0033]), wherein each of the plurality of side holes (side holes 131) are about 0.6 mm wide (see par. [0038], [0054]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular catheter of modified Taylor to include wherein each of the plurality of side holes are about 0.6 mm wide, as taught by Fang, in order to prevent the side holes from being blocked (see Fang par. [0038], [0054]).
However, modified Taylor still fails to state wherein adjacent ones of the plurality of side holes are about 3 mm to about 10 mm apart.
Sverdlik teaches an intravascular catheter (see Fig. 4A, par. [0195]), wherein adjacent ones of the plurality of side holes (ports 1250) are about 3 mm to about 10 mm apart (see par. [0196] and [0200]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravascular catheter of modified Taylor to include wherein adjacent ones of the plurality of side holes are about 3 mm to about 10 mm apart, as taught by Sverdlik, in order to properly space the side holes apart for customizable injection of substances into the blood vessel (see Sverdlik par. [0196] and [0200]-[0202]).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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