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 .
Response to Amendment
The amendment filed 08/21/2025 has been entered. Claims 1-20 are pending in the application. Claims 9-10 are Withdrawn. Applicant’s amendments to the claims have not overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 03/24/2025.
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 4 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 4 recites the limitation “maintaining a pressure within an interior volume of the second balloon greater than a diastolic blood pressure of the patient and less than a systolic blood pressure of the patient”. It is unclear what pressure values are being claimed as diastolic and systolic blood pressures vary from individual to individual especially if there are diseases or disorders affecting the blood pressure. For the sake of examination, the pressure will be interpreted to be in the range of 60-100mmHg based on paragraph 0390 of the instant specification.
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.
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.
Claims 1-3, 11, 15, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Letort (US 2003/0204236) in view of Ogle (US 2011/0218517) as evidenced by Vyavahare (US 8,100,961).
Regarding claim 1, Letort discloses a method for treating a leaking endovascular graft of a patient (Para 0011), comprising: positioning a first balloon (142A, Fig 1A) in an artery in a region (106, Fig 1A) of the leaking endovascular graft (Para 0036); expanding the first balloon such that it presses against surfaces of the artery or the leaking endovascular graft in contact with a surface of the first balloon (Para 0046-0047).
Letort is silent regarding delivering a therapeutic agent to tissue in the region of the leaking endovascular graft through pores in the first balloon.
Ogle teaches a method of treating an artery comprising delivering a therapeutic agent (PGG) to tissue in a region of the artery through pores (196, Fig 3) in the first balloon (Para 0054; Para 0072).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and balloon disclosed by Letort to further include delivering a therapeutic agent to tissue in the region of the leaking endovascular graft through pores in the first balloon as taught by Ogle in order to stabilize a degrading blood vessel (Para 0006). Vyavahare further supports that pentagalloyl glucose (PGG) can be used in the treatment of aneurisms and with a leaky balloon (Col 3, line 64 – Col 4, line 15; Col 6, lines 34-45; also see Claim 1).
Regarding claim 2, the modified invention of Letort and Ogle discloses expanding the first balloon comprises introducing an inflation fluid into an interior volume of the first balloon (Para 0046-0047 -Letort; Para 0072 -Ogle).
Regarding claim 3, the modified invention of Letort and Ogle discloses delivering the therapeutic agent comprises introducing a solution comprising the therapeutic agent into an interior volume of the first balloon, the introduction of the solution being configured to expand and/or maintain an expanded state of the first balloon (Para 0072 -Ogle).
Regarding claim 11, the modified invention of Letort and Ogle discloses the therapeutic agent comprises pentagalloyl glucose (PGG) (Para 0054 -Ogle).
Regarding claim 15, Letort discloses a method for treating a leaking endovascular graft of a patient (Para 0011), comprising delivering a repair agent to tissue in a region of the leaking endovascular graft (Para 0040).
Letort is silent regarding delivering a therapeutic agent to tissue in a region of the leaking endovascular graft, wherein the therapeutic agent comprises at least one of pentagalloyl glucose (PGG) and a biocompatible poloxamer gel having reverse thermosensitive properties.
Ogle teaches a method of treating an artery comprising delivering a therapeutic agent to a region of an artery through pores in a balloon (0072), the therapeutic agent comprises pentagalloyl glucose (PGG) (Para 0054).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and balloon disclosed by Letort to further include delivering a therapeutic agent to tissue in the region of the leaking endovascular graft through pores in the first balloon as taught by Ogle in order to stabilize a degrading blood vessel (Para 0006). Vyavahare further supports that pentagalloyl glucose (PGG) can be used in the treatment of aneurisms and with a leaky balloon (Col 3, line 64 – Col 4, line 15; Col 6, lines 34-45; also see Claim 1).
Regarding claim 19, the modified invention of Letort and Ogle discloses the region is situated behind the leaking endovascular graft (Para 0036 -Letort).
Regarding claim 20, the modified invention of Letort and Ogle discloses the therapeutic agent is delivered by a weeping balloon (Para 0072 -Ogle).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Letort (US 2003/0204236) in view of Ogle (US 2011/0218517) and further in view of Parekh (US 2019/092164).
Regarding claim 4, the modified invention of Letort and Ogle discloses all of the elements of the invention as discussed above, however, is silent regarding expanding the first balloon comprises maintaining a pressure within an interior volume of the first balloon greater than a diastolic blood pressure of the patient and less than a systolic blood pressure of the patient.
Parekh teaches that a blood vessel is occluded when the balloon reaches a pressure of 100mmHg (Para 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to maintain a pressure of 100mmHg as taught by Parekh in order to ensure occlusion of the blood vessel (Para 0063).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Letort (US 2003/0204236) in view of Ogle (US 2011/0218517) and further in view of Bacino (US 2016/0339212).
Regarding claim 5, the modified invention of Letort and Ogle discloses expanding the first balloon and delivering the therapeutic agent through the pores comprises introducing a solution into an interior volume of the first balloon (Para 0072 -Ogle), however is silent regarding wherein the solution is introduced at a first volumetric flow rate to expand the first balloon and the solution is introduced at a second volumetric flow rate to deliver the therapeutic agent through the pores, the first volumetric flow rate being greater than or equal to the second volumetric flow rate.
Bacino teaches an analogous balloon with pores wherein the solution is introduced at a first volumetric flow rate to expand the first balloon and the solution is introduced at a second volumetric flow rate to deliver the therapeutic agent through the pores, the first volumetric flow rate being greater than or equal to the second volumetric flow rate (Para 0055-0056; the pressure and flow rate have an inverse relationship as described and thus a higher second pressure would mean a lower flow rate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and balloon to have the solution introduced at a first volumetric flow rate to expand the first balloon and the solution introduced at a second volumetric flow rate to deliver the therapeutic agent through the pores, the first volumetric flow rate being greater than the second volumetric flow rate as taught by Bacino in order to have a balloon wherein the expansion and perfusion are independently controllable (Para 0055).
Regarding claim 6, the modified invention of Letort, Ogle, and Bacino discloses the first volumetric flow rate is greater than the second volumetric flow rate (Para 0055-0056 -Bacino; the pressure and flow rate have an inverse relationship as described and thus a higher second pressure would mean a lower flow rate).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Letort (US 2003/0204236) in view of Ogle (US 2011/0218517) and further in view of Klein (US 5,810,767).
Regarding claim 7, the modified invention of Letort and Ogle discloses all of the elements of the invention as discussed above, however, is silent regarding blood flow is occluded by the first balloon no longer than approximately 3 minutes.
Klein teaches blood flow is occluded by the first balloon no longer than approximately 3 minutes (Col 12, lines 6-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to occlude the blood flow for no longer than 3 minutes as taught by Klein in order to prevent causing ischemia (Col 12, lines 6-10).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Letort (US 2003/0204236) in view of Ogle (US 2011/0218517) and further in view of Wolinsky (US 5,087,244).
Regarding claim 8, the modified invention of Letort and Ogle discloses all of the elements of the invention as discussed above, however, is silent regarding at least 1 mL of solution comprising the therapeutic agent is delivered while downstream blood flow and retrograde blood flow is occluded.
Wolinsky teaches an analogous balloon with pores that can deliver a solution at a flow rate of 2-5mL/min (See Table in Col 5) for one to two minutes (Col 5, lines 31-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and device to deliver a solution at a flow rate of 2-5mL/min for one to two minutes as taught by Wolinsky in order to deliver high concentrations of medication to a localized area of a vessel without delivering large doses to the patient’s overall system (Col 1, line 66- Col 2, line 4).
Claims 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Letort (US 2003/0204236) in view of Ogle (US 2011/0218517) and further in view of Cho (“Isolation and identification of pentagalloylglucose with broad-spectrum antibacterial activity from Rhus trichocarpa Miquel”) and further in view of Vyavahare (US 8,100,961).
Regarding claim 12, the modified invention of Letort and Ogle discloses all of the elements of the invention as discussed above, however, is silent regarding the PGG is at least 99.9% pure.
Cho teaches that pentagalloyl glucose can be purified to over 99.9% (See section 2.4 Extraction and isolation).
Vyavahare teaches that pentagalloyl glucose can be toxic if it is not of high purity (Col 6, lines 15-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the PGG to be at least 99.9% pure in order to minimize or prevent toxicity to the patient (Col 6, lines 15-45 -Vyavahare).
Regarding claim 16, the modified invention of Letort and Ogle discloses the therapeutic agent is PGG (Para 0054 -Ogle), however is silent regarding the PGG is at least 99.9% pure.
Cho teaches that pentagalloyl glucose can be purified to over 99.9% (See section 2.4 Extraction and isolation).
Vyavahare teaches that pentagalloyl glucose can be toxic if it is not of high purity (Col 6, lines 15-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the PGG to be at least 99.9% pure in order to minimize or prevent toxicity to the patient (Col 6, lines 15-45 -Vyavahare).
Claims 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Letort (US 2003/0204236) in view of Ogle (US 2011/0218517) and further in view of Vyavahare (US 8,100,961).
Regarding claim 13, the modified invention of Letort and Ogle discloses all of the elements of the invention as discussed above, however, is silent regarding the therapeutic agent is substantially free of gallic acid or methyl gallate.
Vyavahare teaches that pentagalloyl glucose can be of high purity with little or no gallic acid (Col 6, lines 15-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the PGG to be substantially free of gallic acid in order to minimize or prevent toxicity to the patient (Col 6, lines 15-45 -Vyavahare).
Regarding claim 17, the modified invention of Letort and Ogle discloses all of the elements of the invention as discussed above, however, is silent regarding the therapeutic agent is substantially free of gallic acid or methyl gallate.
Vyavahare teaches that pentagalloyl glucose can be of high purity with little or no gallic acid (Col 6, lines 15-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the PGG to be substantially free of gallic acid in order to minimize or prevent toxicity to the patient (Col 6, lines 15-45 -Vyavahare).
Claims 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Letort (US 2003/0204236) in view of Ogle (US 2011/0218517) and further in view of Isenburg (US 2009/0214654).
Regarding claim 14, the modified invention of Letort and Ogle discloses all of the elements of the invention as discussed above, however, is silent regarding the therapeutic agent is in admixture with a biocompatible poloxamer gel having reverse thermosensitive properties.
Isenburg teaches delivering a therapeutic agent to tissue for the treatment of aneurisms wherein the therapeutic agent is admixture with a biocompatible poloxamer gel having reverse thermosensitive properties (Para 0059; Para 0104).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the therapeutic agent to be a mixture of PGG and a biocompatible poloxamer gel having reverse thermosensitive properties (i.e., Poloxamer 407) as taught by Isenburg in order to control the release kinetics of the therapeutic agent to locally deliver dosage of PGG to be effective against expansion of AAAs (Para 0104).
Regarding claim 18, the modified invention of Letort and Ogle discloses all of the elements of the invention as discussed above, however, is silent regarding the therapeutic agent is in admixture of PGG and the biocompatible poloxamer gel.
Isenburg teaches delivering a therapeutic agent to tissue for the treatment of aneurisms wherein the therapeutic agent is admixture of PGG and a biocompatible poloxamer gel having reverse thermosensitive properties (Para 0059; Para 0104).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the therapeutic agent to be a mixture of PGG and a biocompatible poloxamer gel having reverse thermosensitive properties (i.e., Poloxamer 407) as taught by Isenburg in order to control the release kinetics of the therapeutic agent to locally deliver dosage of PGG to be effective against expansion of AAAs (Para 0104).
Response to Arguments
Applicant’s arguments regarding Letort and Ogle not being combinable have been fully considered but are not persuasive. Applicant argues that Ogle refers to stabilization of a location with vulnerable plaque while Letort is directed to repair of endoluminal leaks. Both references are concerned with stabilizing a blood vessel. As detailed by Vyavahare, pentagalloyl glucose (PGG) is advantageous in the treatment of aneurisms and can be delivered with a leaky balloon (Col 3, line 64 – Col 4, line 15; Col 6, lines 34-45; also see Claim 1). Thus, while Ogle is primarily concerned with the treatment of vulnerable plaque, it is well documented in the art that a leaky balloon such as that taught in Ogle can be used to stabilize a blood vessel in the treatment of aneurisms.
Applicant’s arguments regarding the modification of Letort in view of Ogle would render the balloon of Letort inoperable for its intended purpose have been fully considered but are not persuasive. As detailed in Para 0072 of Ogle, a leaky balloon comprises material over the pores that allow for gradual leaking and allows for pressure to be maintained within the balloon. Therefore, the modified balloon would still be able to perform its intended purpose.
Applicant’s arguments regarding the Office Action not establishing the prior art teaches “a biocompatible poloxamer gel having reverse thermosensitive properties” have been fully considered but is not persuasive. Claim 15 recites the therapeutic agent comprises “at least one of pentagalloyl glucose and a biocompatible poloxamer gel having reverse thermosensitive properties”. Therefore, a teaching that the therapeutic agent comprises pentagalloyl glucose reads on the claim.
Conclusion
THIS ACTION IS MADE FINAL. 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 ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783