DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species D (figure 11) in the reply filed on 10/28/2025 is acknowledged.
However, the examiner notes that applicant’s representative has incorrectly indicated all pending claims are directed to the elected species. As claims 78-86 are directed to Species E (figure 12) (singular catheter system; “an integrated catheter 1202 for performing both occlusion and SSO2 delivery”; paragraph [00197]), said claims do not read on elected Species D (two catheter system; paragraph [00191]).
As such, claims 78-86 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/28/2025.
Claims 68-77 remain pending for examination.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 06/07/2022, 07/19/2022, and 02/05/2025, have been considered by the examiner.
Claim Objections
Claim 75 is objected to because of the following informalities: The claim appears to be missing the word “a” between the words “comprises” and “gas-enrichment” in the 2nd line of the claim. 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 68-77 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.
[Claim 68] The claim recites the limitation of “an occlusion structure configured to partially obstruct a flow of blood within the vasculature of the patient” in the 11th and 12th lines of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if “a flow of blood” is the same or different recitation of “a flow of blood” recited in the 2nd line of the claim. For purposes of examination, it is interpreted that the limitation should recite “an occlusion structure configured to partially obstruct the flow of blood within the vasculature of the patient.”
[Claim 68] The claim recites the limitation of “the second catheter comprising one or more lumens and an occlusion structure configured to partially obstruct a flow of blood within the vasculature of the patient while allowing the first catheter to deliver the gas-enriched liquid to the region of the vasculature, and to divert the blood flow to the region where the gas-enriched liquid is delivered” in the 11th-14th lines of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if the limitation intends to assign the functionality of “to divert the blood flow to the region where the gas-enriched liquid is delivered” to the first catheter or the second catheter. For purposes of examination, it is interpreted that either scenario meets the limitations of the claim.
[Claim 72] The claim recites the limitation of “an occlusion structure” in the 4th line of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to the same or different “occlusion structure” recited in independent claim 68. For purposes of examination, it is interpreted that the same “occlusion structure” is being recited.
[Claim 72] The claim recites the limitation of “the catheter” in the 4th line of the claim. There is a lack of antecedent basis for this limitation in the claims. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation intends to refer to the “first catheter,” the “second catheter,” or if a new structure is being introduced into the claim language. For purposes of examination, it is interpreted that “the catheter” refers to the previously recited “second catheter.”
[Claim 73] The claim recites the limitation of “from one or more sensors” in the 2nd line of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to the previously recited “one or more sensors” recited in claim 71, or if additional structures are being introduced into the claim limitations. For purposes of examination, it is interpreted that “from one or more sensors” refers to the previously introduced “one or more sensors” of claim 71.
[Claim 74] The claim recites the limitation of “the concentration” in the 2nd line of the claim. There is a lack of antecedent basis for this limitation in the claims. For purposes of examination, it is interpreted that the limitation should recite “a concentration.”
[Claims 69-77] The claims are rejected based upon their dependency from independent claim 68.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 68, 71, and 72, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kassab (PGPub 2011/0196282).
[Claim 68] Kassab teaches a system (figure 5, item 300) for delivering gas-enriched liquid within a vasculature of a patient while partially obstructing a flow of blood within the vasculature of the patient (figures 4 and 5; paragraph [0030]), the system comprising:
a source of a gas-enriched liquid (paragraph [0057]) (the examiner notes arterial oxygenated blood is a “source of gas-enriched liquid”);
a first catheter (figure 5, item 10) coupled to the source of the gas-enriched liquid (paragraph [0060]), the first catheter (figure 5, item 10) configured to be inserted into a vasculature of a patient and deliver the gas-enriched liquid to a region of the vasculature of the patient (figure 5), the first catheter (figure 5, item 10) comprising one or more lumens (figure 1, items 15/18) configured to receive the gas-enriched liquid from the source of the gas-enriched liquid (paragraphs [0060], [0061]); and
a second catheter (figure 5, item 150) configured to be inserted into the vasculature of the patient (figure 5),
the second catheter (figure 5, item 150) comprising one or more lumens (figure 4a, items 156/160) and an occlusion structure (figure 4a, item 158) configured to partially obstruct a flow of blood within the vasculature of the patient while allowing the first catheter (figure 5, item 10) to deliver the gas-enriched liquid to the region of the vasculature (figure 5), and to divert the blood flow to the region where the gas-enriched liquid is delivered (figures 4a and 5) (paragraphs [0069], [0072], [0075]).
[Claim 71] Kassab teaches the limitations of claim 68, upon which claim 71 depends. In addition, Kassab discloses a controller (figure 5, items 170/180; paragraph [0076], [0079], [0080]) and one or more sensors (figure 5, item 166), wherein the one or more sensors are configured to measure one or more parameters of blood of the patient (figure 4a; paragraph [0074]), wherein operation of the first catheter (figure 5, item 10), the second catheter (figure 5, item 150), or both the first catheter (figure 5, item 10) and the second catheter (figure 5, item 150) are controlled based on the measured one or more parameters (paragraphs [0074], [0085]).
[Claim 72] Kassab teaches the limitations of claim 71, upon which claim 72 depends. Kassab also teaches the controller (figure 5, items 170/180) is configured for receiving, from one or more sensors (figure 5, item 166), a signal representing a measured blood pressure in the vasculature of the patient (paragraph [0074]) and based on the measured blood pressure, adjusting an occlusion percentage in the vasculature of the patient caused by an occlusion structure (figure 4a, item 158) of the catheter (figure 5, item 150) (paragraphs [0080], [0085], [0117], [0119], [0121]).
Claims 68 and 76 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (PGPub 2012/0172781).
[Claim 68] Wang teaches a system (figure 2) for delivering gas-enriched liquid within a vasculature of a patient while partially obstructing a flow of blood within the vasculature of the patient (figure 2; paragraph [0019]), the system comprising:
a source of a gas-enriched liquid (figure 2, items 207/208; paragraph [0066]);
a first catheter (figure 2, item 202) coupled to the source of the gas-enriched liquid (figure 2, items 207/208) (figure 2), the first catheter (figure 2, item 202) configured to be inserted into a vasculature of a patient (figure 2) and deliver the gas-enriched liquid to a region of the vasculature of the patient (paragraph [0062]), the first catheter (figure 2, item 202) comprising one or more lumens configured to receive the gas-enriched liquid from the source of the gas-enriched liquid (figure 2; paragraph [0063], [0064]); and
a second catheter (figure 2, item 204) configured to be inserted into the vasculature of the patient (figure 2),
the second catheter (figure 2, item 204) comprising one or more lumens and an occlusion structure (“balloon”) configured to partially obstruct a flow of blood within the vasculature of the patient (figure 2) while allowing the first catheter (figure 2, item 202) to deliver the gas-enriched liquid to the region of the vasculature (figure 2; paragraph [0062]), and to divert the blood flow to the region where the gas-enriched liquid is delivered (figure 2; paragraph [0062]).
[Claim 76] Wang teaches the limitations of claim 68, upon which claim 76 depends. Wang further discloses the gas-enriched liquid (figure 2, items 207/208) comprises a supersaturated oxygen liquid (paragraph [0066]).
Claims 68, 76, and 77, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spears (USPN 5,599,296).
[Claim 68] Spears teaches a system (figures 1a/2) for delivering gas-enriched liquid within a vasculature of a patient while partially obstructing a flow of blood within the vasculature of the patient (abstract; column 4, lines 19-22), the system comprising:
a source of a gas-enriched liquid (“OSPS”) (figure 2, item 34; column 8, lines 21-28);
a first catheter (figures 1e and 3b, item 16) coupled to the source of the gas-enriched liquid (figure 2, item 34), the first catheter (figures 1e and 3b, item 16) configured to be inserted into a vasculature of a patient and deliver the gas-enriched liquid to a region of the vasculature of the patient (abstract), the first catheter (figures 1e and 3b, item 16) comprising one or more lumens (figure 3a, item 18) (column 4, lines 26-28) configured to receive the gas-enriched liquid from the source of the gas-enriched liquid (column 4, lines 33-38); and
a second catheter (figure 1a, item 12) configured to be inserted into the vasculature of the patient (abstract),
the second catheter (figure 1a, item 12) comprising one or more lumens (figure 1e) and an occlusion structure (figure 1a, item 60) configured to partially obstruct a flow of blood within the vasculature of the patient (column 5, lines 1-9) while allowing the first catheter (figures 1e and 3b, item 16) to deliver the gas-enriched liquid to the region of the vasculature (column 4, lines 23-32; column 6, lines 63-67), and to divert the blood flow to the region where the gas-enriched liquid is delivered (figure 1a; column 5, lines 1-9).
[Claims 76 and 77] Spears teaches the limitations of claim 68, upon which claims 76 and 77 depend. In addition, Spears discloses the gas-enriched liquid (figure 2, item 34) comprises a supersaturated oxygen liquid which has an O2 concentration of 0.1-6 ml O2 / ml liquid (STP) (column 3, lines 35-39).
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 69 and 70 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (PGPub 2012/0172781), in view of Myrick et al. (USPN 9,919,276).
[Claims 69 and 70] Wang teaches the limitations of claim 68, upon which claims 69 and 70 depend. Wang does not specifically teach the catheter configured to deliver gas-enriched liquid comprises two or more capillaries extending from a tip.
However, Myrick teaches a system for delivering gas-enriched liquid comprising a catheter (figure 2, item 500) having two or more capillaries (figure 2, items 10/11) extending from a tip of the first catheter (figure 4a; column 5, lines 38-53), the two or more capillaries (figure 2, items 10/11) configured to simultaneously dispense respective streams (figure 1, items 5/6) of the gas enriched liquid directly into the vasculature of the patient (figure 1), wherein the catheter (figure 2, item 500) is configured to position the two or more capillaries (figure 2, items 10/11) at one or more predetermined angles relative to one another (column 8, lines 64-67; column 9, lines 1-5), such that the streams of the gas enriched liquid intersect and mix with blood of the patient (column 5, lines 38-53).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the first catheter (gas-enriched liquid delivery) taught by Wang, to have utilized two or more capillaries extending from the tip, as taught by Myrick, in order to provide increased functionality and control, by allowing for a means for localized convective mixing prior to interaction with tissues (Myrick; column 5, lines 38-53).
Claims 73 and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Kassab (PGPub 2011/0196282), in view of Eggers (USPN 5,788,647).
[Claim 73] Kassab teaches the limitations of claim 71, upon which claim 73 depends. Although teaching a controller configured for adjusting an occlusion percentage in the vasculature of a patient (paragraphs [0080], [0085], [0117], [0119], [0121]), Kassab does not specifically disclose the controller is also configured to adjust a concentration of gas in the gas-enriched liquid.
However, Eggers teaches a system (figure 12) for delivering gas-enriched liquid within a vasculature (figure 1; via oxygenator 60) comprising a controller (figure 12, item 200) configured for receiving (figure 12, items 222/234), from one or more sensors (figure 12, items 220/252), a signal representing a measured pO2 in the vasculature of the patient (figure 12; column 14, lines 16-30; column 15, lines 2-23); based on the measured pO2, adjusting a concentration of oxygen in the gas-enriched liquid (figure 12, via item 250; column 14, lines 46-67; column 15, lines 1-8); and delivering the gas-enriched liquid having the adjusted concentration of oxygen to the region of the vasculature of the patient (figure 1; via oxygenator 60; column 8, lines 64-67; column 9, lines 1-5).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified system taught by Kassab to have a controller configured to adjust both gas concentration and an occlusion percentage, as taught by Eggers, in order to provide increased functionality and control, by allowing for additional active feedback parameters to be utilized to maximize localized perfusion treatment.
[Claim 74] Kassab teaches the limitations of claim 71, upon which claim 74 depends. Although teaching a controller configured for adjusting an occlusion percentage in the vasculature of a patient (paragraphs [0080], [0085], [0117], [0119], [0121]), Kassab does not specifically disclose the controller is also configured to adjust a concentration of gas in the gas-enriched liquid.
However, Eggers teaches a system (figure 12) for delivering gas-enriched liquid within a vasculature (figure 1; via oxygenator 60) comprising a controller (figure 12, item 200) configured for adjusting both the concentration of gas in a gas-enriched liquid (figure 12, via item 250; column 14, lines 46-67; column 15, lines 1-8) and an occlusion percentage in the vasculature of the patient (column 8, lines 47-57).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified system taught by Kassab to have a controller configured to adjust both gas concentration and an occlusion percentage, as taught by Eggers, in order to provide increased functionality and control, by allowing for additional active feedback parameters to be utilized to maximize localized perfusion treatment.
Claim 75 is rejected under 35 U.S.C. 103 as being unpatentable over Kassab (PGPub 2011/0196282), in view of Wang (PGPub 2012/0172781).
[Claim 75] Kassab teaches the limitations of claim 71, upon which claim 75 depends. Kassab does not specifically disclose the source of the gas-enriched liquid comprises a gas-enrichment chamber configured to form the gas-enriched liquid by mixing gas with atomized liquid.
However, Wang teaches a system for delivering gas-enriched liquid within a vasculature of a patient (figure 2; paragraph [0061]), comprising a gas-enrichment chamber (figure 2, items 207/208) configured to form gas-enriched liquid by mixing gas with atomized liquid (figure 2; paragraph [0066]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the system taught by Kassab, to have utilized a gas-enrichment chamber, as taught by Wang, in order to provide increased control and functionality, by allowing for a means by which the level of delivered oxygenation might be precisely controlled.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JASON E FLICK/Primary Examiner, Art Unit 3783 01/30/2026