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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/02/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendments filed on 04/08/2026 has been entered. Claims 1 and 4 have been amended; claims 3 and 19-54 have been cancelled. Accordingly, claims 1-2 and 4-18 are pending and under consideration.
Applicant’s amendments to the claims does not appear to overcome the Double Patenting rejection. See rejections below.
Response to Arguments
Applicant’s thorough arguments with respect to claim(s) 1 regarding Kaye and Beyersdorf have been considered but are moot because the new ground of rejection does not rely on Kaye and Beyersdorf in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed on 04/08/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “…this is a positive perfusion pressure at the delivery catheters, not suction or negative pressure at the collection catheter. To the extent Naghavi discloses any vacuum or negative pressure, it is found only in paragraph 0066, which describes using vacuum to "facilitate the attachment and fixation of perfusion catheter 220 in the coronary ostium. This vacuum is applied at the perfusion catheter for attachment purposes, not at the collection catheter to generate negative pressure for fluid collection", Examiner acknowledged the remarks, but respectfully disagrees in part. While Examiner agrees that Naghavi’s discussion of “vacuum” is only applied to the perfusion catheters, attention is directed to the fact that the device/method of Naghavi forms a completely isolated circulation (Par. 43 of Naghavi). Thus, one of ordinary skill in the art would have had the technological capability to recognize and interpret that the positive pressure at the perfusion catheters would be substantially the same as the negative pressure experienced at the collection catheter, otherwise there would be a buildup or leakage of fluid which would no longer be considered a closed system. Furthermore, since the fluid circuit operates in a closed loop, a positive perfusion (fluid delivery) pressure applied at perfusion catheters would correlate to a negative (fluid removal) pressure applied at the collection catheter. Evidentiary reference Altounian et al. US 2023/0405209 A1 also discusses that positive pressure relates to injection/delivery and negative pressure relates to suction and vacuum (Par. 96 of Altounian). Thus, a system with combined fluid delivery and removal such as Naghavi’s must satisfy these pressure requirements, including negative pressures, to properly perform its function. Thus, Naghavi does read on the limitation of “negative pressure at the drug recovery catheter”. See rejection of claims below.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/638,081 (Holzmeister reference application, claim set dated 07/07/2025) in view of Beyersdorf US 6,306,113 B1 and Murata US 2020/0197588 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of co-opening application discloses the invention of as claimed in claims 1 and 4 of the instant application.
However, the copending application does not disclose “wherein at least about 50% of the perfused drug remains in the closed circuit for at least 45 minutes; and applying suction to minimize leakage of the drug through the Thebesiasn venous system”.
Beyersdorf, in the same field of endeavor of perfusion device (Abstract), teaches and wherein the perfused drug remains in the closed circuit for over 30 minutes (Col. 1, line 33-37 – “This reperfusion solution is introduced, for example by using a reperfusion device, into the vessel over a longer period of time, e.g. over 30 minutes…”).
Murata, in the same field of endeavor of isolated perfusion device/method (Abstract), teaches applying suction (Fig. 1 – arrow to pump 14 indicating withdrawal, and Par. 105 – “a suction rate of around 355 ml/min with the pump 14 for drainage”) to the drug recovery catheter 19 (Fig. 1, and Par. 105 – catheter 19 to the vein) to minimize leakage of the drug though venous system (Par. 7 – “suppressing the leakage of an anticancer agent into the systemic circulation by setting the suction rate to be higher than the injection rate, the leakage of the anticancer agent into the systemic circulation can be reduced”).
According to the discussion of Beyersdorf in Col. 1, line 10-37, reciting “…reperfusion damage, i.e., a tissue lesion which occurs upon the vessel obstruction being eliminated, if the blood starts to flow through the artery again at the full arterial pressure generated by the heart. This disadvantage is avoided or is substantially reduced by using the reperfusion solution…”, the perfusion solution introduced into the circulation over a period of time would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention, because said longer period of time and efficacy of the perfusion solution directly affects vessel health (Col. 1, line 24-36). Therefore, a sufficient perfused solution efficacy and duration is desired to avoid perfusion damage (Col. 1, line 24-36). As such, without showing unexpected results, the claimed at least about 50% of the perfused drug and at least 45 minutes cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the efficacy of the perfused drug and its duration within the closed circuit in the method of Holzmeister reference application to obtain the desired vessel integrity, as taught by Beyersdorf (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223) (see MPEP § 2144 .05, II.). Accordingly, the limitation “wherein at least about 50% of the perfused drug remains in the closed circuit for at least 45 minutes” is reasonably suggested by the prior art.
As Naghavi and Murata both discusses perfusion in a closed circuit, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to further apply the method of applying a suction to the drug recovery catheter as taught by Murata, in order to suppress the leakage of the drug into the systemic circulation (Par. 7 of Murata). The known method disclosed by Naghavi modified by said known technique of Murata will see the same and predictable benefits of reducing drug leakage into the circulation system. MPEP 2143.I.D. In other words, since the method of Naghavi is recovering drug at the coronary sinus via suction/negative pressure, which is the heart’s primary vein, this suction will be capable of affecting the nearby veins, including the Thebesian veins, thereby suppressing drug leakage out of the completely isolated circulation of Naghavi. Thus, the limitation is read.
Claims 5, 6, 7, 8, 9, 10, 11, 15, 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4, 5, 6, 7, 8, 9, 10, 14, 16 of copending Application No. 17/638,081 (Holzmeister reference application, claim set dated 07/07/2025).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Naghavi et al. US 2004/0102732 A1 (previously cited, hereinafter Naghavi), as cited in the IDS, in view of Kaye et al. US 2007/0203445 A1 (previously cited, hereinafter Kaye), as cited in the IDS, Beyersdorf US 6,306,113 B1 (previously cited, hereinafter Beyersdorf), and Murata US 2020/0197588 A1 (newly cited, hereinafter Murata).
Regarding claim 1, Naghavi discloses a method of perfusing a drug in an unarrested beating heart of a patient (Abstract – “methods for local delivery of drugs directly to the coronary circulation which may be isolated from systemic circulation”) comprising:
positioning a first drug delivery catheter 220 (Fig. 5a-5b – perfusing catheter 220) in the right coronary artery of the heart (Fig. 5a-5b – the perfusing catheter 220 branching to the right);
positioning a second drug delivery catheter 220 (Fig. 5a-5b – perfusing catheter 220) in the left main coronary artery of the heart (Fig. 5a-5b – perfusing catheter 220 branching to the left);
positioning a drug recovery catheter 210 (Fig. 5a-5b – collecting catheter 210) in the coronary sinus of the heart (Fig. 5c, and Par. 62 – “collecting catheter 210 may be introduced into coronary sinus”),
wherein the first drug delivery catheter 220 (Fig. 5a-5b – right catheter 220), the second drug delivery catheter 220 (Fig. 5a-5b – left catheter 220), and the drug recovery catheter 210 (Fig. 5a) together with the coronary arteries of the heart (Fig. 5a, and Par. 109 – “Two perfusion catheters 220, one for each of two coronary arteries (FIG. 5b), may be introduced through vehicle catheter 230”), the coronary venous system of the heart (Par. 62 – “…into coronary sinus”), and an oxygenation device 120 (Fig. 1-1a – oxygenator 120) form a closed circuit (Par. 86 – “Referring now to FIG. 5a, in several preferred embodiments, coronary dialysis system 1 is configured as a substantially closed fluid circuit in which the cardiac circulatory system of patient 10 may be completely isolated from systemic circulation”);
perfusing the drug through the closed circuit (Par. 96 – “Blood may be passed to Enricher 130 (FIG. 1a) in which dosages, including high dosages, of drugs and/or other therapeutic agents may be added to the passing blood to be delivered to the systemic circulation as well as coronary circulation”), wherein the closed circuit isolates the coronary circulation of the patient from the systemic circulation of the patient (Par. 86 – “coronary dialysis system 1 is configured as a substantially closed fluid circuit in which the cardiac circulatory system of patient 10 may be completely isolated from systemic circulation”); and
provide a negative pressure at the drug recovery catheter 210 (Fig. 5a-5b of Naghavi, and Par. 71 of Naghavi – “perfusing catheters 220 should be able to maintain a safe coronary perfusion pressure of about 100-150 mmHg in case of complete isolation of coronary artery”, which indicates that the recover catheter 210 has to operate at -100 mmHg to -150 mmHg in a closed circuit).
While Naghavi discloses oxygenation as part of the circuit, Naghavi does not disclose a membrane oxygenation device, wherein at least about 50% of the perfused drug remains in the closed circuit for at least 45 minutes; applying suction to the drug recovery catheter to minimize leakage of the drug thought Thebesian venous system.
Kaye, in the same field of endeavor of isolating cardiac circulation (Title), teaches a membrane oxygenation device (Par. 66 – “Therefore, it is desirable to include in the artificial flow path an oxygenation system, preferably of the kind normally incorporated into a cardiopulmonary bypass system or extracorporeal membrane oxygenation (ECMO) or equivalent”).
Naghavi and Kaye substantially teach the method claimed by Applicant, with the exception of perfusion duration. Beyersdorf, in the same field of endeavor of perfusion device (Abstract), teaches and wherein the perfused drug remains in the closed circuit for over 30 minutes (Col. 1, line 33-37 – “This reperfusion solution is introduced, for example by using a reperfusion device, into the vessel over a longer period of time, e.g. over 30 minutes…”).
Murata, in the same field of endeavor of isolated perfusion device/method (Abstract), teaches applying suction (Fig. 1 – arrow to pump 14 indicating withdrawal, and Par. 105 – “a suction rate of around 355 ml/min with the pump 14 for drainage”) to the drug recovery catheter 19 (Fig. 1, and Par. 105 – catheter 19 to the vein) to minimize leakage of the drug though venous system (Par. 7 – “suppressing the leakage of an anticancer agent into the systemic circulation by setting the suction rate to be higher than the injection rate, the leakage of the anticancer agent into the systemic circulation can be reduced”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the oxygenation mechanism of Naghavi that allows blood to be extracorporeally oxygenated, for the membrane oxygenation mechanism of Kaye since these mechanisms perform the same function of performing blood oxygenation. Simply substituting one oxygenation means for another would yield the predictable result of allowing extracorporeal blood to be treated with oxygen. See MPEP 2143.
According to the discussion of Beyersdorf in Col. 1, line 10-37, reciting “…reperfusion damage, i.e., a tissue lesion which occurs upon the vessel obstruction being eliminated, if the blood starts to flow through the artery again at the full arterial pressure generated by the heart. This disadvantage is avoided or is substantially reduced by using the reperfusion solution…”, the perfusion solution introduced into the circulation over a period of time would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention, because said longer period of time and efficacy of the perfusion solution directly affects vessel health (Col. 1, line 24-36). Therefore, a sufficient perfused solution efficacy and duration is desired to avoid perfusion damage (Col. 1, line 24-36). As such, without showing unexpected results, the claimed at least about 50% of the perfused drug and at least 45 minutes cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the efficacy of the perfused drug and its duration within the closed circuit in the method of Naghavi in view of Kaye to obtain the desired vessel integrity, as taught by Beyersdorf (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). ) (see MPEP § 2144 .05, II.). Accordingly, the limitation “wherein at least about 50% of the perfused drug remains in the closed circuit for at least 45 minutes” is reasonably suggested by the prior art.
As Naghavi and Murata both discusses perfusion in a closed circuit, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to further apply the method of applying a suction to the drug recovery catheter as taught by Murata, in order to suppress the leakage of the drug into the systemic circulation (Par. 7 of Murata). The known method disclosed by Naghavi modified by said known technique of Murata will see the same and predictable benefits of reducing drug leakage into the circulation system. MPEP 2143.I.D. In other words, since the method of Naghavi is recovering drug at the coronary sinus via suction/negative pressure, which is the heart’s primary vein, this suction will be capable of affecting the nearby veins, including the Thebesian veins, thereby suppressing drug leakage out of the completely isolated circulation of Naghavi. Thus, the limitation is read.
Regarding claim 4, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 1. Naghavi further discloses wherein the negative pressure ranges from about -100 mmHg to less than 0 mmHg (Par. 71 of Naghavi – “perfusing catheters 220 should be able to maintain a safe coronary perfusion pressure of about 100-150 mmHg in case of complete isolation of coronary artery”, which indicates that the recover catheter 210 has to operate at -100 mmHg in a closed circuit).
Regarding claim 5, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 1. Naghavi further discloses wherein one or more of the first drug delivery catheter 220 (Fig. 5a-5b of Naghavi), the second drug delivery catheter 220 (Fig. 5a-5b of Naghavi) are introduced percutaneously (Par. 57 of Naghavi – “perfusion catheter 220 introduced percutaneously from out of the body”).
Regarding claim 6, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 1. Naghavi further discloses wherein the first drug delivery catheter 220 (Fig. 5a-5b of Naghavi) and/or the second drug delivery catheter 220 (Fig. 5a-5b of Naghavi) are positioned via antegrade intubation (Par. 57 of Naghavi – “by means of ante grade perfusion catheter 220”).
Regarding claim 7, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 1. Naghavi further discloses wherein the first drug delivery catheter 220 (Fig. 5a-5b of Naghavi) and/or the second drug delivery catheter 220 (Fig. 5a-5b of Naghavi) are positioned via the aorta of the patient by accessing the aorta femoralis (Par. 30 of Naghavi – “two perfusion catheters disposed through the aorta”, and Par. 63 of Naghavi – “through the femoral artery and comprises two or more ports through which one or more perfusion catheters 220…”).
Regarding claim 8, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 1. Naghavi further discloses wherein the drug recovery catheter 210 (Fig. 5a of Naghavi) is positioned in the coronary sinus (Fig. 5c of Naghavi, and Par. 62 of Naghavi “collecting catheter 210 may be introduced into coronary sinus”) via the vena cava of the patient (Par. 87 of Naghavi).
Regarding claim 9, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 1. Naghavi further discloses wherein the drug recovery catheter 210 (Fig. 5a of Naghavi is positioned via the vena jugularis of the patient (Par. 87 of Naghavi – “Collecting catheter 210 may be introduced at a left subclavian vein, right subclavian vein, right jugular vein…”).
Regarding claim 10, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 1. Naghavi further discloses wherein the membrane oxygenation device 120 (Fig. 1-1a of Naghavi modified by Kaye) is positioned between the recovery catheter 210 (Fig. 5a of Naghavi) and one or more of the first drug delivery catheter 220 (Fig. 5a of Naghavi) and the second drug delivery catheter 220 (Fig. 5a of Naghavi; oxygenation device 120 of machine 100 is between the perfusing catheters 220 and collecting catheter 210).
Regarding claim 11, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 1. Naghavi further discloses further comprising circulating blood through the closed circuit (Par. 96 of Naghavi – “Blood may be passed to Enricher 130 (FIG. 1a) in which dosages, including high dosages, of drugs and/or other therapeutic agents may be added to the passing blood to be delivered to the systemic circulation as well as coronary circulation”).
Regarding claim 12, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 11. Naghavi further discloses wherein the blood comprises autologous blood (Par. 46 of Naghavi – “blood is collected such as through collecting catheter 210, drained through fluid inlet 102 (FIG. 1a) of multi-chambered dialysis machine 100, and passed through several chambers 110-150 in which the blood may be filtered, precipitated, enriched, and pumped back through fluid outlet 104 (FIG. 1b) of multi-chambered dialysis machine 100 to the coronary circulation of patient 10”).
Regarding claim 13, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 11. Naghavi further discloses wherein blood components such as serum or plasma are chosen (Par. 47-48 of Naghavi) according to one or more parameter, wherein the one or more parameters comprise presence or absence of selected antibodies (Par. 12 of Naghavi).
Regarding claim 14, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 11. Naghavi further discloses wherein about 50 mL to about 1000 mL of blood is circulated through the closed circuit (Par. 71 of Naghavi).
Regarding claim 17, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 1. Naghavi further discloses wherein the perfusing occurs at a flow rate of about 75 mL/min to about 750 mL/min (Par. 71 of Naghavi).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Naghavi in view of Kaye in view of Beyersdorf in view of Murata as applied to claim 2 above, and further in view of Shapland et al. US 8,292,871 B2 (previously cited, hereinafter Shapland), as cited in the IDS.
Regarding claim 2, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 1. However, the references do not disclose wherein the drug is delivered to at least 30% of the heart tissue during the perfusion.
Shapland, in the same field of endeavor of regional cardiac tissue treatment (Title), teaches wherein the drug is delivered to at least the heart tissue during the perfusion, in order to treat an occlusion in a coronary artery of a patient (Col. 2, line 58-60 of Shapland). (Col. 5, line 38-41 – “a higher dose of the perfusate than could otherwise be administered safely through systemic delivery or delivery to the entire heart of the patient is administered directly and only to the target tissue region CT”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to further deliver the drug to at least the entire heart tissue during the perfusion as disclosed by Shapland, in order to treat an occlusion in a coronary artery of a patient, as taught by Shapland (Col. 2, line 58-60 of Shapland).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Naghavi in view of Kaye in view of Beyersdorf as applied to claim 1 above, and further in view of Thomas et al. US 2010/0076095 A1 (previously cited, hereinafter Thomas).
Regarding claim 15, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 1. However, the references do not disclose wherein the perfusing occurs over a duration of about 5 minutes to about 5 hours.
Thomas, in the same field of endeavor of percutaneous coronary interventions (Par. 2), teaches wherein the perfusing occurs over a duration of about 5 minutes to about 1 hour, which is a standard perfusion duration which is safe for cardiac perfusion (Par. 70).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination such that the perusing occurs over a duration of about 5 minutes to about 1 hour, as disclosed by Thomas, since Thomas teaches that this is a standard perfusion duration which is safe for cardiac perfusion (Par. 70 of Thomas).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Naghavi in view of Kaye in view of Beyersdorf in view of Murata as applied to claim 1 above, and further in view of Lane et al. US 2011/0257577 A1 (previously cited, hereinafter Lane).
Regarding claim 16, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 1. However, the references do not disclose wherein the perfusing occurs for at least 60 minutes.
Lane, in the same field of endeavor of methods and devices for circulatory access (Title), teaches wherein the perfusing occurs for at least 60 minutes, in order to allow treatment to be done over selected time period and be repeated as treatment dictates (Par. 145 – “For example, the treatment or hyperperfusion may be carried out on a patient for 4 to 12 hours”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to have the perfusing occur for at least 60 minutes as disclosed by Lane, in order to allow treatment to be done over selected time period and be repeated as treatment dictates, as taught by Lane (Par. 145 of Lane).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Naghavi in view of Kaye in view of Beyersdorf in view of Murata as applied to claim 1 above, and further in view of Bridges et al. US 6,673,039 B1 (previously cited, hereinafter Bridges).
Regarding claim 18, Naghavi in view of Kaye in view of Beyersdorf in view of Murata suggests the invention of claim 1. Naghavi further discloses wherein the drug is suitable for treatment of a heart condition (Par. 41 of Naghavi “…to deliver drugs, including continuous delivery of a high dose of drugs such as cholesterol removing drugs, locally into the coronary system of patient”), wherein the condition is heart failure (Par. 2-3 of Naghavi).
However, the combination does not suggest wherein the drug comprises a therapeutic polynucleotide sequence is present in one or more viral vectors.
Bridges, in the same field of endeavor of method for transvascular delivery of a composition (Title), teaches wherein the drug comprises a therapeutic polynucleotide sequence (Col. 16, line 36-51 – “Such compositions include gene vectors which comprise one or more polynucleotides…. Exemplary gene products include, by way of example and not limitation, an antisense oligonucleotide …”) is present in one or more viral vectors (Col. 6, line 31-33 – “the macromolecular assembly is a gene vector, preferably an adenoviral gene vector”), since viral vectors in conjunction with therapeutic agent is efficient and well tolerated by mammals (Col. 36, line 38-45).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to further have a drug comprising a therapeutic polynucleotide sequence present in a viral vector as disclosed by Bridges, since Bridges teaches that viral vector in conjunction with therapeutic agent is efficient and well tolerated by mammals (Col. 36, line 38-45 of Bridges). This delivery method achieves an efficiency and volume of vector distribution which is essential for gene therapy in numerous genetic diseases (Col. 36, line 38-45 of Bridges).
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 QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781
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