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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/18/2026 has been entered.
Response to Amendment
The amendment filed 05/18/2026 has been entered. Claims 1-20 are pending in the application. Claims 9-10 are Withdrawn. Applicant’s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Final Office Action mailed 11/26/2025.
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 15 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 15 recites the limitation “delivering a therapeutic agent to tissue in a region of the leaking endovascular graft behind an existing stent graft”. It is unclear the “existing stent graft” is the same or different than the “leaking endovascular graft” previously recited in the claim. For the sake of examination, the limitation will be interpreted as “delivering a therapeutic agent to tissue in a region of the leaking endovascular graft behind the endovascular leaking graft” as detailed in claim 19. However, Examiner wants to bring attention to the fact that this change would introduce a 112d issue with claim 19, so should be addressed if this is the interpretation that Applicant chooses.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 18 details the same mixture of PGG and biocompatible poloxamer gel as required by amended claim 15. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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) and further in view of Roorda (US 2014/0276608).
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).
The modified invention of Letort and Ogle discloses all of the elements of the invention as discussed above, however, is silent regarding wherein the plurality of pores comprises between 5 and 1000 pores and wherein a diameter of each of the plurality of pores is between 0.01 mm and 1 mm so as to deliver a fluid from the plurality of pores at a volumetric flow rate between 0.05 mL/min and 20 mL/min, and wherein the volumetric flow rate is constant or substantially constant.
Roorda teaches an analogous balloon catheter comprising a plurality of pores wherein the plurality of pores comprises between 5 and 1000 pores and wherein a diameter of each of the plurality of pores is between 0.01 mm and 1 mm so as to deliver a fluid from the plurality of pores at a volumetric flow rate between 0.05 mL/min and 20 mL/min, and wherein the volumetric flow rate is constant or substantially constant (Para 0155, 0158).
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 balloon to have the number and size of pores as taught by Roorda in order to tune the flow rate for a particular agent and treatment site (Para 0090, 0102)
Regarding claim 2, the modified invention of Letort, Ogle, and Roorda 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, Ogle, and Roorda 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, Ogle, and Roorda discloses the therapeutic agent comprises pentagalloyl glucose (PGG) (Para 0054 -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 Roorda (US 2014/0276608)and further in view of Parekh (US 2019/092164).
Regarding claim 4, the modified invention of Letort, Ogle, and Roorda 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 Roorda (US 2014/0276608) and further in view of Bacino (US 2016/0339212).
Regarding claim 5, the modified invention of Letort, Ogle, and Roorda 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 Roorda (US 2014/0276608) and further in view of Klein (US 5,810,767).
Regarding claim 7, the modified invention of Letort, Ogle, and Roorda 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 Roorda (US 2014/0276608) and further in view of Wolinsky (US 5,087,244).
Regarding claim 8, the modified invention of Letort, Ogle, and Roorda 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).
Claim 12 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 Roorda (US 2014/0276608) 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, Ogle, and Roorda 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).
Claim 13 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 Roorda (US 2014/0276608) and further in view of Vyavahare (US 8,100,961).
Regarding claim 13, the modified invention of Letort, Ogle, and Roorda 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).
Claim 14 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 Roorda (US 2014/0276608) and further in view of Isenburg (US 2009/0214654).
Regarding claim 14, the modified invention of Letort, Ogle, and Roorda 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).
Claims 15 and 18-20 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 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 behind an existing stent graft (Para 0035, 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).
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 having reverse thermosensitive properties.
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).
Regarding Claim 18, the modified invention of Letort, Ogle, and Isenburg discloses the therapeutic agent is an admixture of the PGG and the biocompatible poloxamer gel
Regarding claim 19, the modified invention of Letort, Ogle, and Isenburg discloses the region is situated behind the leaking endovascular graft (Para 0036 -Letort).
Regarding claim 20, the modified invention of Letort, Ogle, and Isenburg discloses the therapeutic agent is delivered by a weeping balloon (Para 0072 -Ogle).
Claim 16 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 Isenburg (US 2009/0214654) 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 16, the modified invention of Letort, Ogle, and Isenburg 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).
Claim 17 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 Isenburg (US 2009/0214654) and further in view of Vyavahare (US 8,100,961).
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).
Response to Arguments
Applicant’s arguments filed 05/18/2026, on pages 6-7, regarding Letort and Ogle failing to teach the pore count, pore diameter, and volumetric flow rates have been fully considered but are moot in view of the current rejection that relies on Roorda to teach the amended limitations.
Applicant’s arguments filed 05/18/2026, on page 7, regarding Letort, Ogle, and Vyavahare failing to teach delivering behind a stent graft an admixture of PGG and a reverse-thermosensitive poloxamer gel have been fully considered but are not persuasive. As detailed in the rejection of claim 15 above, Letort teaches that the treatment region is behind an existing stent graft (See target site 106 begin graft 102 in Fig 1B; detailed in Para 0035). Further, Isenburg teaches admixture of PGG and a biocompatible poloxamer gel having reverse thermosensitive properties to control the release kinetics of the therapeutic agent (Para 0059; Para 0104). Therefore, all of the elements of claim 15 are taught by the current art of record.
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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