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 6/22/2026 has been entered. Claims 1 and 3-20 are pending in the application. Applicant’s amendments to the Specification and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 3/20/2026.
Claim Objections
Claims 1 and 5 are objected to because of the following informalities:
Regarding claim 1, “wherein the embolization procedure cost” should be corrected to “wherein an embolization procedure cost” for claim language consistency.
Regarding claim 5, “a second catheter” should be corrected to “the second catheter” for claim language consistency.
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.
Claims 4 and 7-8 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.
Regarding claims 4 and 7, the limitation of “a fourth catheter” renders the claims unclear. A third catheter is not introduced in claim 1 which make the description of “fourth” unclear. The description of a fourth catheter, without the inclusion of a third catheter, creates uncertainty as to the number of catheters being used in the method. The Examiner believes the Applicant is intending to simply limit the claim to include limitations directed toward the use of another, different catheter for the second group of patients.
Claim 8 recites the limitation "embolizing the at least one pedicle" in line 2. There is insufficient antecedent basis for this limitation in the claim. The Examiner is interpreting the limitation to be in reference to the at least one blood vessel 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.
Claim(s) 1 and 3-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Velat (Velat GJ et al. Comparison of N-butyl cyanoacrylate and onyx for the embolization of intracranial arteriovenous malformations: analysis of fluoroscopy and procedure times. Neurosurgery. 2008 Jul;63(1 Suppl 1):ONS73-8) [12th NPL provided in IDS filed January 26th 2023], in view of Walzman (US 20200246584 A1), in view of Backeris (WO 2020160469 A1), and further in view of Beheshti (Beheshti, MV et al. Calculation of Operating Expenses for Conventional Transarterial Chemoembolization in an Academic Medical Center: A Step toward Defining the of Value of TACE) [2nd NPL provided in IDS filed January 26th 2023].
Regarding claims 1 and 3-4, Velat discloses a method for treating unruptured brain arteriovenous malformations in human patients with reduced procedure time (see “Objective” and “Results” on page 1), the method comprising: embolizing, by a first catheter, by delivering a first embolic agent comprising N-butyl cyanoacrylate (the "n-BCA") within at least one blood vessel adjacent a vascular tangle in a first group of human patients (a total of 122 embolizations using a first embolic agent, N-butyl cyanoacrylate (nBCA), were performed on a first group of patients, see abstract and “Per-patient Analysis” and “Per-procedure Analysis” and Table 1 and Table 2);
and decreasing embolization procedure time by at least 0.5 hours, by delivering the first embolic agent comprising n-BCA, compared to a second group of human patients treated by delivering a second embolic agent within at least one blood vessel adjacent a vascular tangle (“Mean fluoroscopy and procedure times were significantly increased when using Onyx (57 min; 2.6 h) compared with nBCA (37 min; 2.1 h) on a per-procedure basis”, see “Per-procedure Analysis” and Table 2; a second group of patients were treated by delivering a second embolic agent, Onyx, see “Per-patient Analysis”; Procedure time using nBCA was 2.1 hours (h), which is 0.5 hours less than the procedure time using Onyx, which was 2.6 h);
wherein the second group of human patients is treated by embolizing by delivering the second embolic agent comprising ethylene vinyl alcohol copolymer ("EVOH") within the least one blood vessel adjacent the vascular tangle (a total of 60 embolizations using a second embolic agent, Onyx, were performed on the second group of patients, see abstract and “Per-patient Analysis” and “Per-procedure Analysis” and Table 1 and Table 2; “Onyx is a liquid nonadhesive mixture of ethylene vinyl alcohol and metrizamide dissolved in dimethyl sulfoxide. Upon contact with blood, dimethyl sulfoxide diffuses rapidly, thereby forming an ethylene vinyl alcohol copolymer”, see right column, first paragraph of page 576), and
wherein the embolization procedure time is at least 30%, 57%, or 53% lower for the first group versus the second group (the first group of patients who received treatment with nBCA had a mean procedure time of 2.1 ± 0.9 h and the second group of patients who received treatment with Onyx had a mean procedure time of 2.6 ± 0.8 h, see “Per-procedure Analysis” and Table 2; therefore, the embolization procedure time using nBCA could be interpreted as 1.2 h and the embolization procedure time using Onyx could be interpreted as 3.4 h; therefore, an embolization procedure time could be at least 30%, 57%, or 53% lower for the first group versus the second group).
Velat discuss the use of catheters, microcatheters, and catheter adherence (first paragraph of right column, page 576, third paragraph of right column, page 577, and page 579).
However, Velat fails to explicitly disclose the method comprising embolizing, by a first catheter, by delivering a first embolic agent within at least one blood vessel adjacent a vascular tangle; and a second group of human patients treated by embolizing, by a second/third/fourth catheter, by delivering a second embolic agent within at least one blood vessel adjacent a vascular tangle, and wherein the embolization procedure cost is at least 30%, 57%, or 53% lower for the first group of human patients versus the second group of human patients.
However, Walzman teaches that “’arteriovenous malformation’ (“AVM”)… refers to a tangle of abnormal and poorly formed blood vessels (e.g., arteries and veins)“ ([0114]-[0115] & Fig. 9-10 and 12) and that “Catheter embolization is a minimally invasive treatment that occludes or blocks one or more blood vessels or vascular channels of malformations (abnormalities). In a catheter embolization procedure, medications or synthetic materials (embolic agents) are placed through a catheter into a blood vessel to prevent blood flow to the area. Using image-guidance, a catheter is inserted through the skin to the treatment site... Next, a medication or an embolic agent is injected through the catheter... Uses of catheter include… to eliminate an arteriovenous malformation (AVM) or arteriovenous fistula (AVF) (abnormal connection or connections between arteries and veins)…” ([0269] & Fig. 9-10 and 12).
Therefore, 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 method of Velat with Walzman to include embolizing, by a catheter, by delivering an embolic agent within at least one blood vessel adjacent a vascular tangle, since Walzman teaches such to be an art effective process for delivering an embolic agent to unruptured brain arteriovenous malformations in a human patient for treatment ([0114]-[0115] and [0269] of Walzman). It would be apparent to one of ordinary skill in the art that the second group of patients receiving the second embolic agent would follow the same catheterization process as taught by Walzman. Walzman, as cited above, teaches that treating brain arteriovenous malformations in a human patient requires the use of catheters to deliver embolic agents within at least one blood vessel adjacent a vascular tangle. One of ordinary skill in the art would understand that a second group of patients receiving a second embolic agent would receive the agent with a different, separate, second/third/fourth catheter, not the first catheter used on a first group of patients, to maintain patient safety and sterility.
Further, Backeris teaches a method for treating brain arteriovenous malformations in a human patient by delivering nBCA achieving a reduced embolization procedure cost (“…improved time efficiency intra-procedurally and overall improvement in healthcare cost savings.”, page 16 all of second paragraph). Beheshti further teaches a method comprising calculating an hourly rate to operate an angiography suite and that “angiography suit and personnel costs comprise 26% of the total procedure cost (see page 58 right column).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the embolization procedure cost be at least 30%, 57%, or 53% lower for the first group of human patients versus the second group of human patients as Backeris and Beheshti teach that embolization procedure time is a result effective variable that directly affects healthcare costs, as taught by Backeris, and overall angiography suite cost is a result effective variable that is directly influenced by procedure time, as taught by Beheshti. Reducing either condition to have embolization procedure cost reduced by at least the claimed percentage would have been a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105, USPQ 233, 235 (CCPA 1955).
In the instant case, Velat teaches that the embolization procedure time is at least 30%, 57%, or 53% lower for the first group versus the second group. Therefore, the embolization procedure cost would be lower for the first group versus the second group. One of ordinary skill in the art would be motivated to reduce embolization cost by at least the claimed percentages to improve healthcare cost savings for patients.
Regarding claims 5-7, Velat, as modified, discloses all the limitations of claim 1. Velat further discloses the method further comprising: achieving, by the n-BCA and the first catheter, approximately 64% lower embolization procedure time (the first group of patients who received treatment with nBCA had a mean procedure time of 2.1 ± 0.9 h and the second group of patients who received treatment with Onyx had a mean procedure time of 2.6 ± 0.8 h, see “Per-procedure Analysis” and Table 2; therefore, the embolization procedure time using nBCA could be interpreted as 1.2 h and the embolization procedure time using Onyx could be interpreted as 3.4 h; therefore, the embolization procedure time is about 64% lower) for
treating at least two pedicles adjacent a vascular tangle (“One or two pedicles were accessed during each procedure.”, see “PATIENT AND METHODS” left column, page 574; the number of pedicles embolized per patient when using nBCA was 1.7 ± 0.8 and the number of pedicles embolized per patient when using Onyx was 1.8 ± 0.8, see Table 1) versus the second group of human patients treated by the second embolic agent comprising ethylene vinyl alcohol copolymer ("EVOH") (“Onyx is a liquid nonadhesive mixture of ethylene vinyl alcohol and metrizamide dissolved in dimethyl sulfoxide. Upon contact with blood, dimethyl sulfoxide diffuses rapidly, thereby forming an ethylene vinyl alcohol copolymer”, see right column, first paragraph of page 576).
However, Velat fails to explicitly disclose treating at least four pedicles and a second/third/fourth catheter, and achieving, by the n-BCA and the first catheter, approximately 67%, 81%, or 79% lower embolization procedure cost.
However, as cited above, Walzman teaches that “Catheter embolization is a minimally invasive treatment that occludes or blocks one or more blood vessels or vascular channels of malformations (abnormalities).”, ([0269] & Fig. 9-10 and 12). Additionally, as cited above in claim 1, Walzman teaches that treating brain arteriovenous malformations in a human patient requires the use of catheters to deliver embolic agents within at least one blood vessel adjacent a vascular tangle. One of ordinary skill in the art would understand that a second group of patients receiving a second embolic agent would receive the agent with a different, separate, second/third/fourth catheter, not the first catheter used on a first group of patients, to maintain patient safety and sterility.
Therefore, 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 method of Velat with Walzman to include treating at least four pedicles and a second/third/fourth catheter since such a modification would allow for the complete elimination of arteriovenous malformations of various size and vascular connection. ([0269] of Walzman). Walzman teaches that treating one or more vessels is necessary to eliminate arteriovenous malformations; therefore, depending on the nature of an arteriovenous malformation, treating at least four vessels may be necessary.
Further, Backeris teaches a method for treating brain arteriovenous malformations in a human patient by delivering nBCA achieving a reduced embolization procedure cost (“…improved time efficiency intra-procedurally and overall improvement in healthcare cost savings.”, page 16 all of second paragraph). Beheshti further teaches a method comprising calculating an hourly rate to operate an angiography suite and that “angiography suit and personnel costs comprise 26% of the total procedure cost (see page 58 right column).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to achieve, by the n-BCA and the first catheter, approximately 67%, 81%, or 79% lower embolization procedure cost as Backeris and Beheshti teach that embolization procedure time is a result effective variable that directly affects healthcare costs, as taught by Backeris, and overall angiography suite cost is a result effective variable that is directly influenced by procedure time, as taught by Beheshti. Reducing either condition to have embolization procedure cost reduced by at least the claimed percentage would have been a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105, USPQ 233, 235 (CCPA 1955).
In the instant case, Velat teaches that the embolization procedure time is approximately 64% lower for the first group versus the second group. Therefore, the embolization procedure cost would be lower for the first group versus the second group. One of ordinary skill in the art would be motivated to reduce embolization cost by at least the claimed percentages to improve healthcare cost savings for patients.
Additionally, Velat discloses delivering nBCA to treat brain arteriovenous malformations by delivering nBCA. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process, In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986) and MPEP 2112.02(I). The positively claimed method step of delivering nBCA to treat brain arteriovenous malformations by delivering nBCA, as claimed and disclosed by Velat, would inherently achieve a lower embolization procedure cost. The prior art device and method would necessarily perform the claimed method as decreasing/achieving a lower embolization cost is simply a result of the known step.
Regarding claim 8, Velat, as modified, discloses all the limitations of claim 1. Velat further discloses that the mean total procedure time and mean embolization procedure time are both lower for the group of patients treated with nBCA (see Table 1 and Table 2).
However, Velat fails to explicitly disclose the method, further comprising calculating a cost adjustment ratio for embolizing the at least one pedicle adjacent a vascular tangle in the first group of human patients compared to the second group of human patients, wherein the cost adjusted ratio comprises conditions comprising at least one of: embolization procedure time,
units of first or second embolic agent,
concentration of first or second embolic agent per unit,
type of catheter,
number of catheters, and
angiography suite time; and identifying at least one condition in the cost adjusted ratio to achieve at least 18% reduced embolization cost of the first group compared to the second group, the cost adjustment ratio being determined by a Generalized estimating equations (GEE) model.
However, Backeris teaches a method for treating brain arteriovenous malformations in a human patient by delivering nBCA achieving a reduced embolization cost (“…improved time efficiency intra-procedurally and overall improvement in healthcare cost savings.”, page 16 all of second paragraph).
Further, Beheshti teaches a method comprising calculating an hourly rate to operate an angiography suite (see page 58 right column).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the cost adjustment ratio conditions of embolization procedure time and angiography suite time to reduce embolization cost by at least 18% as claimed as Backeris and Beheshti teach that embolization procedure time is a result effective variable that directly affects healthcare costs, as taught by Backeris, and overall angiography suite cost is a result effective variable that is directly influenced by procedure time, as taught by Beheshti, and reducing either condition to have embolization cost reduced by at least the claimed percentage would have been a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105, USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would be motivated to reduce embolization cost by at least 18% to improve healthcare cost savings for patients.
Response to Arguments
Applicant's arguments filed 6/22/2026 have been fully considered but they are not persuasive. In response to Applicant’s arguments to the 112(b) rejection of claims 4 and 7, the Examiner finds that the description of a fourth catheter, without the inclusion of a third catheter, creates uncertainty as to the number of catheters being used in the method.
Applicant’s arguments with respect to the prior art rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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