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
Claims 48, 55, 62, 64, 70, and 73 are withdrawn by the Examiner from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/28/2025.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. See pages 48-50 of the Specification.
Specification
The disclosure is objected to because of the following informalities:
The Specification is missing a “Cross-Reference to Related Applications” section which states the serial numbers and filing dates of the applications to which the instant application claims priority.
Appropriate correction is required.
Claim Objections
Claims 1, 3-4, 7, 14, 17, and 30 are objected to because of the following informalities:
-Claim 1, line 2: please correct “the side holes” to “the plurality of side holes”
-Claim 1, line 3: please correct “the length” to “a length”
-Claim 1, line 5: please correct “the catheter lumen” to “the lumen”
-Claim 3, line 1: please correct “the bioscaffold” to “the biocompatible bioscaffold”
-Claim 4, line 2: please correct “the bioscaffold” to “the biocompatible bioscaffold”
-Claim 7, line 2: please correct “the side holes” to “the plurality of side holes”
-Claim 7, line 3: please correct “each side hole” to “each of the plurality of side holes”
-Claim 14, line 2: please correct “the macropores” to “the plurality of macropores”
-Claim 14, line 2: please correct “the micropores” to “the plurality of micropores”
-Claim 14, line 3: please correct “the bioscaffold” to “the biocompatible bioscaffold”
-Claim 17, line 2: please correct “the bioscaffold” to “the biocompatible bioscaffold”
-Claim 30, line 3: please correct “therapeutic cells” to “the therapeutic cells”
Appropriate correction is required.
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 3 is 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.
Claim 3 recites “The intravascular catheter of claim 12” in line 1, however claim 12 is cancelled. See the amendment filed on 1/25/2023, in which “The intravascular catheter of claim 1 or 2” appears to be amended improperly to “The intravascular catheter of claim 1
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, 24, 27-28, 30-31, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Stankus et al. (US 8,038,991 B1) in view of Schon et al. (US 2003/0153898 A1) and further in view of Desai et al. (US 2019/0119462 A1).
Regarding claim 1, Stankus discloses an intravascular catheter comprising:
a catheter tube comprising a lumen (see col. 16 lines 11-22, col. 41 lines 9-29); and
a biocompatible bioscaffold, wherein the biocompatible bioscaffold is contained within the catheter lumen (see col. 16 lines 11-22).
However, Stankus fails to state the catheter tube comprising a plurality of side holes, wherein the side holes are distributed along the length of the catheter tube in a spiraling corkscrew pattern; and the biocompatible bioscaffold comprising a plurality of macropores and micropores.
Schon teaches an intravascular catheter (see Fig. 1, par. [0047]) comprising a catheter tube (either of distal end tubes 14 or 16) comprising a plurality of side holes (side holes 50), wherein the side holes (side holes 50) are distributed along the length of the catheter tube (either of distal end tubes 14 or 16) in a spiraling corkscrew pattern (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 intravascular catheter of Stankus to include the catheter tube comprising a plurality of side holes, wherein the side holes are distributed along the length of the catheter tube in a spiraling corkscrew pattern, as taught by Schon, in order to provide additional flow paths and optimal flow properties (see Schon par. [0100]).
However, modified Stankus 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 Stankus 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 2, modified Stankus teaches the intravascular catheter of claim 1 substantially as claimed. However, modified Stankus 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 Stankus 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 3, modified Stankus teaches the intravascular catheter of claim 1 substantially as claimed. However, modified Stankus fails to state wherein the 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 Stankus to include collagen, as taught by Desai, in order to promote encapsulation of therapeutic cells (see Desai par. [0114]).
Regarding claim 14, modified Stankus teaches the intravascular catheter of claim 1 substantially as claimed. However, modified Stankus fails to state wherein the macropores have an average diameter ranging from about 150 micrometers to about 800 micrometers, the micropores have an average diameter of 30 micrometers or less, and the bioscaffold has a porosity ranging from 30 percent to 95 percent.
Desai teaches a biocompatible bioscaffold wherein the macropores have an average diameter ranging from about 150 micrometers to about 800 micrometers (see par. [0084]), the micropores have an average diameter of 30 micrometers or less (see par. [0085]), and the 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 Stankus to include wherein the macropores have an average diameter ranging from about 150 micrometers to about 800 micrometers, the micropores have an average diameter of 30 micrometers or less, and the bioscaffold has a porosity ranging from 30 percent to 95 percent, as taught by Desai, because these characteristics provide a 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 Stankus teaches the intravascular catheter of claim 1 substantially as claimed. However, modified Stankus fails to state wherein the 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 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 Stankus 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 Stankus teaches the intravascular catheter of claim 17 substantially as claimed. However, modified Stankus 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 Stankus 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 Stankus teaches the intravascular catheter of claim 17 substantially as claimed. However, modified Stankus 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 Stankus 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 Stankus teaches the intravascular catheter of claim 17 substantially as claimed. However, modified Stankus 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 Stankus 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]).
Regarding claim 27, modified Stankus 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 Stankus includes a biocompatible bioscaffold that was previously modified in view of Desai to comprise therapeutic cells for treating a disease; the catheter of modified Stankus is placed within the subject to deliver the scaffold as taught by Stankus col. 16 lines 11-22).
However, modified Stankus 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 Stankus 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 Stankus teaches the method of claim 27 substantially as claimed. Modified Stankus 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 Stankus teaches the method of claim 27 substantially as claimed. However, modified Stankus 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 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 Stankus to include retrieving the intravascular catheter from the subject and exchanging the intravascular catheter for another intravascular catheter comprising therapeutic cells, as taught by Desai, in order to provide additional therapies (see Desai par. [0144]).
Regarding claim 31, modified Stankus 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 Stankus 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 Stankus is placed within the subject to deliver the scaffold as taught by Stankus col. 16 lines 11-22).
However, modified Stankus 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 Stankus 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 Stankus teaches the method of claim 31 substantially as claimed. Modified Stankus 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 Stankus teaches the method of claim 31 substantially as claimed. However, modified Stankus 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 Stankus 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 Stankus et al. (US 8,038,991 B1) in view of Schon et al. (US 2003/0153898 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 Stankus teaches the intravascular catheter of claim 1 substantially as claimed. However, modified Stankus fails to state wherein the 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 Stankus 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 Stankus et al. (US 8,038,991 B1) in view of Schon et al. (US 2003/0153898 A1) and further in view of Desai et al. (US 2019/0119462 A1), as applied to claim 1 above, and 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 Stankus teaches the intravascular catheter of claim 1 substantially as claimed. However, modified Stankus fails to state wherein the side holes are about 0.1 to about 5.0 mm wide, about 3 mm to about 10 mm apart, and rotated about 30 degrees to about 60 degrees between each side hole.
Schon teaches an intravascular catheter (see Fig. 1, par. [0047]) wherein the side holes (side holes 50) are rotated 60 degrees between each side hole (side holes 50) (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 Stankus to include wherein the side holes are rotated about 60 degrees between each side hole, as taught by Schon, in order to provide additional flow paths and optimal flow properties (see Schon par. [0100]-[0101]).
However, modified Stankus still fails to state wherein the side holes are about 0.1 to about 5.0 mm wide, and about 3 mm to about 10 mm apart.
Fang teaches an intravascular catheter (see Figs. 1-2, par. [0003], [0033]), wherein the 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 Stankus to include wherein the side holes are about 0.6 mm wide, as taught by Fang, in order to properly space the side holes to avoid the side holes being blocked (see Fang par. [0038], [0054]).
However, modified Stankus still fails to state wherein the side holes are about 3 mm to about 10 mm apart.
Sverdlik teaches an intravascular catheter (see Fig. 4A, par. [0195]), wherein the 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 Stankus to include wherein the 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]).
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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