DETAILED ACTION
Receipt is acknowledged of applicant’s Response to Restriction Requirement filed 5/26/2026.
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 .
Status of the Claims
Claims 1-20 are pending.
Election/Restriction
Applicant's election with traverse of Group II (claims 11-20) in the reply filed on 5/26/2026 is acknowledged.
After further consideration, the Restriction Requirement dated 3/25/2026 is withdrawn.
Accordingly, claims 1-20 are currently under examination.
Information Disclosure Statements
The IDS’s filed 5/27/2025 and 11/14/2025 have been considered. Signed copies are enclosed herewith.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chirila et al. (“Photocrosslinking of Adventitial Collagen in the Porcine Abdominal Aorta: A Preliminary Approach to a Strategy for Prevention of Aneurysmal Rupture”, Designs 2022, 6(1), 5, pp. 1-14; hereafter as “Chirila”).
Instant claims 1-10 are drawn to a method of inhibiting rupture of an artery in a subject, comprising applying to at least part of the arterial wall a photosensitizer that initiates crosslinking in response to photo-activating radiation, and irradiating the arterial wall with photo-activating radiation to initiate crosslinking in the arterial wall.
Instant claims 11-20 are drawn to a method of treating or inhibiting the progression of an arterial aneurysm in a subject, comprising applying to at least part of an arterial wall comprising an aneurysm a photosensitizer that initiates crosslinking in response to photo-activating radiation, and irradiating the arterial wall with photo-activating radiation to initiate crosslinking in the arterial wall.
Regarding claims 1-11 and 13-20, Chirila teaches a method to prevent the rupture of the abdominal aortic aneurysm (AAA) by crosslinking of adventitial collagen of the vessel’s walls through a photochemical process promoted by UV-A radiation (abstract). Chirila teaches that riboflavin (riboflavin 5’-phosphate monosodium salt) is utilized as a photosensitizer and the UV radiation has a wavelength of 365 nm (abstract; page 2, 5th paragraph). Chirila teaches that such a method can be applied to an aneurysmal dilated wall region and the stabilization of tunica adventitia may delay or prevent the rupture of the aneurysm and potentially arrest the progression of AAA (abstract).
Regarding instant claim 12, Chirila teaches the elements above. Chirila also teaches that an aortic aneurysm is commonly described as the localized degenerative weakening of the aortic wall, leading to the formation of an irreversibly progressing dilatation (bulge) that exceeds the diameter of the normal aorta by at least 1.5 times, i.e., to ≥3 cm in diameter (page 1, section 1., 1st paragraph). Chirila further teaches that, currently, repair surgery is the only treatment for AAAs, applicable preventively for aneurysms larger than 5 to 5.5 cm in diameter, and to ruptured aneurysms in emergency settings (page 1, section 1., 2nd paragraph). Chirila also teaches that there is no therapeutic option available now for the patients having small aneurysms (<5 cm in women, <5.5 cm in men) and for those deemed unfit for surgical intervention (page 2, 1st full paragraph). Chirila’s teachings imply that the method is contemplated for patients having small aneurysms (≥3 cm and <5 cm in women, <5.5 cm in men) and for those deemed unfit for surgical intervention which require aneurysms larger than 5 to 5.5 cm which encompasses the claimed diameter of greater than about 4 cm.
Thus, the teachings of Chirila render the instant claims anticipated.
Claim Rejections - 35 USC § 103
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 and 3-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schreck et al. (US 2004/0230156 A1, Nov. 18, 2004, hereafter as “Schreck”) in view of Cleveland Clinic (“Aneurysm”, Apr. 16, 2002, hereafter as “Cleveland Clinic”) and Aggarwal et al. (“Abdominal aortic aneurysm: A comprehensive review”, Exp Clin Cardiol. 2011 Spring;16(1):11–15; hereafter as “Aggarwal”) as evidenced by Cleveland Clinic (“Atherosclerosis”, Feb. 15, 2024, hereafter as “Cleveland Clinic 2”).
The instant invention is described above.
Regarding instant claims 1 and 3-8, Schreck teaches a method for treating vulnerable plaque by crosslinking the fibrous cap, or collagenous extracellular matrix layer, on the inner wall or vascular intima of the vessel, the method comprising delivering a crosslinking agent to the extracellular matrix layer and irradiating the extra cellular matrix layer and the crosslinking agent with light energy (abstract). Schreck teaches the particular crosslinking agents, riboflavin and riboflavin-5-phosphate (abstract). Schreck teaches that vulnerable plaque is a rupture-prone plaque in the walls of coronary arteries, aorta, carotid arteries as well as the whole arterial system ([0005]).
Schreck is silent to inhibiting rupture of an artery, in particular an abdominal aorta.
Cleveland Clinic teaches that atherosclerosis, a gradual buildup of plaque in the wall of arteries as evidenced by Cleveland Clinic 2, is a known cause of aneurysms (Cleveland Clinic at page 3).
Aggarwal teaches that aneurysms are defined as a focal dilation of a blood vessel with respect to the original artery and are common in patients with atherosclerosis (abstract; page 11, right col. 1st full paragraph). Aggarwal teaches that aneurysm size is one of the strongest predictors of the risk of rupture with risk increasing markedly at aneurysm diameters of greater than 5.5 cm (page 11, right col., 3rd full paragraph). Aggarwal further teaches that a statement from the Joint Council of the American Association for Vascular Surgery and Society for Vascular Surgery (20) estimated the annual rupture risk according to abdominal aortic aneurysm (AAA) diameter to be the following:
• Less than 4.0 cm in diameter – 0%
• 4.0 cm to 4.9 cm in diameter – 0.5% to 5%
• 5.0 cm to 5.9 cm in diameter – 3% to 15%
• 6.0 cm to 6.9 cm in diameter – 10% to 20%
• 7.0 cm to 7.9 cm in diameter – 20% to 40%
• 8.0 cm in diameter or greater – 30% to 50% (paragraph bridging pages 11-2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to inhibit rupture of an artery such as a carotid artery, aorta, or abdominal aorta utilizing the method of Schreck with a reasonable expectation of success because Schreck teaches that the method treats vulnerable plaque by treating the tissue of the arterial wall including in the coronary artery and aorta, Cleveland Clinic teaches that that atherosclerosis, a gradual buildup of plaque in the wall of arteries, is a known cause of aneurysms and Aggarwal teaches that aneurysms including abdominal aortic aneurysms, as they grow, increase the risk of rupture. One of ordinary skill in the art would have reasonably expected that treating an arterial wall having plaque, which is known to cause aneurysms that can eventually rupture, would thereby inhibit the rupture of an artery such as the abdominal aorta.
Regarding instant claims 9 and 10, Schreck, Cleveland Clinic and Aggarwal teach the elements discussed above. Schreck further teaches that the wavelength of the irradiation energy is desirably between about 200 and 500 nm, and more preferably 220-225 nm, 266 nm, 371 nm, 444 nm, or 475 nm ([0020]). MPEP states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Because the claimed range of about 300 to about 400 nm lies inside the range of about 200 to about 500 disclosed by the prior art, a prima facie case of obviousness exists. Further, the wavelength of 371 nm disclosed by the prior art falls within the claimed range as well as reads on the claimed wavelength of about 365 nm. It is noted that the instant specification defines the term “about” to mean up to a 15% variation of the recited value. Thus, the claimed “about 365 nm” is being given its broadest most reasonable interpretation to mean 310.25 nm to 419.7 nm.
Regarding instant claims 11 and 13-18, Schreck teaches a method for treating vulnerable plaque by crosslinking the fibrous cap, or collagenous extracellular matrix layer, on the inner wall or vascular intima of the vessel, the method comprising delivering a crosslinking agent to the extracellular matrix layer and irradiating the extra cellular matrix layer and the crosslinking agent with light energy (abstract). Schreck teaches the particular crosslinking agents, riboflavin and riboflavin-5-phosphate (abstract). Schreck teaches that vulnerable plaque is a rupture-prone plaque in the walls of coronary arteries, aorta, carotid arteries as well as the whole arterial system ([0005]).
Schreck is silent to inhibiting the progression of an arterial aneurysm.
Cleveland Clinic teaches that atherosclerosis, a gradual buildup of plaque in the wall of arteries as evidenced by Cleveland Clinic 2, is a known cause of aneurysms (Cleveland Clinic at page 3).
Aggarwal teaches that aneurysms are defined as a focal dilation of a blood vessel with respect to the original artery and are common in patients with atherosclerosis (abstract; page 11, right col. 1st full paragraph). Aggarwal teaches that aneurysm size is one of the strongest predictors of the risk of rupture with risk increasing markedly at aneurysm diameters of greater than 5.5 cm (page 11, right col., 3rd full paragraph). Aggarwal further teaches that a statement from the Joint Council of the American Association for Vascular Surgery and Society for Vascular Surgery (20) estimated the annual rupture risk according to abdominal aortic aneurysm (AAA) diameter to be the following:
• Less than 4.0 cm in diameter – 0%
• 4.0 cm to 4.9 cm in diameter – 0.5% to 5%
• 5.0 cm to 5.9 cm in diameter – 3% to 15%
• 6.0 cm to 6.9 cm in diameter – 10% to 20%
• 7.0 cm to 7.9 cm in diameter – 20% to 40%
• 8.0 cm in diameter or greater – 30% to 50% (paragraph bridging pages 11-2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to inhibit the progression of an arterial aneurysm in an artery such as a carotid artery, aorta, or abdominal aorta utilizing the method of Schreck with a reasonable expectation of success because Schreck teaches that the method treats vulnerable plaque by treating the tissue of the arterial wall including in the coronary artery and aorta, Cleveland Clinic teaches that that atherosclerosis, a gradual buildup of plaque in the wall of arteries, is a known cause of aneurysms and Aggarwal teaches that aneurysms including abdominal aortic aneurysms, as they grow, increase the risk of rupture. One of ordinary skill in the art would have reasonably expected that treating an arterial wall having plaque, which is known to cause aneurysms that can eventually rupture, would thereby inhibit the progression of an arterial aneurism such as an abdominal aortic aneurysm.
Regarding instant claim 12, Schreck, Cleveland Clinic and Aggarwal teach the elements discussed above including that rupture risk begins at about 4 cm (Aggarwal at paragraph bridging pages 11-2). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat an aneurysm having a diameter of greater than about 4 cm utilizing the method of Schreck/Cleveland Clinic/Aggarwal with a reasonable expectation of success because Aggarwal teaches that the rupture risk increases when the aneurysm is 4 cm or higher. One of ordinary skill in the art would have reasonably expected that treating an aneurysm having a diameter of 4 cm or higher would slow the expansion of the aneurysm and improve the rupture risk.
Regarding instant claims 19 and 20, Schreck, Cleveland Clinic and Aggarwal teach the elements discussed above. Schreck further teaches that the wavelength of the irradiation energy is desirably between about 200 and 500 nm, and more preferably 220-225 nm, 266 nm, 371 nm, 444 nm, or 475 nm ([0020]). MPEP states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Because the claimed range of about 300 to about 400 nm lies inside the range of about 200 to about 500 disclosed by the prior art, a prima facie case of obviousness exists. Further, the wavelength of 371 nm disclosed by the prior art falls within the claimed range as well as reads on the claimed wavelength of about 365 nm. It is noted that the instant specification defines the term “about” to mean up to a 15% variation of the recited value. Thus, the claimed “about 365 nm” is being given its broadest most reasonable interpretation to mean 310.25 nm to 419.7 nm.
Thus, the combined teachings of Schreck, Cleveland Clinic and Aggarwal render the instant claims prima facie obvious.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Schreck et al. (US 2004/0230156 A1, Nov. 18, 2004, hereafter as “Schreck”) in view of Cleveland Clinic (“Aneurysm”, Apr. 16, 2002, hereafter as “Cleveland Clinic”) and Aggarwal et al. (“Abdominal aortic aneurysm: A comprehensive review”, Exp Clin Cardiol. 2011 Spring;16(1):11–15; hereafter as “Aggarwal”) as evidenced by Cleveland Clinic (“Atherosclerosis”, Feb. 15, 2024, hereafter as “Cleveland Clinic 2”), as applied to claim 1 above, and further in view of Lower, James ("Aortic Aneurysm" (2019). Nursing Student Class Projects (Formerly MSN). 358; hereafter as “Lower”).
The claimed invention is described above.
Schreck, Cleveland Clinic and Aggarwal teach the elements discussed above.
Schreck, Cleveland Clinic and Aggarwal are silent to “wherein the rupture is associated with weakening of the tunica adventitia.
However, Lower teaches that the wall of the aorta is divided into three layers: the innermost layer is the tunica intima, the middle layer is the tunica media, and the outermost layer is the tunica adventitia (1st column). Lower also teaches that a true aneurysm involves all three layers whereas a false aneurysm (pseudoaneurysm) does not involve all three layers (1st column).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to inhibit the rupture of an artery wherein the rupture is associated with weakening of the tunica adventitia with a reasonable expectation of success because Lower teaches that aneurysms can involve any or all three layers of the aorta (tunica intima, tunica media, tunica adventitia). One of ordinary skill in the art would have reasonably expected the inhibition of a rupture in an artery due to a weakening in the tunica intima, the tunica media, and/or the tunica adventitia depending on whether the aneurysm is a true or false aneurysm.
Thus, the combined teachings of Schreck, Cleveland Clinic, Aggarwal and Lower render the instant claim prima facie obvious.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
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, Sue Liu can be reached on 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CASEY S HAGOPIAN/Examiner, Art Unit 1617
Prosecution Insights