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 .
Priority
This application claims priority from provisional application 63/625,576 filed 01/26/2024.
Status of Claims
Claims 58-66 are pending.
Claim 66 has been withdrawn from consideration.
Claims 1-57 have been cancelled.
Election/Restrictions
Applicant’s election without traverse of Invention II (Apparatus) and Species 3 (Figures 3A-C) in the reply filed on 02/13/2026 is acknowledged.
The applicant failed to identify what claims read upon both the Kit and Species 3. Upon further review claim 66 has been withdrawn as being directed at a non-elected embodiment. The original disclosure only describes and discloses the embolic protection device distal of the secondary occlusion element 202/204/206 in FIGS. 1A-1E, FIGS. 2A-2C which are represented by non-elected Species 1 and 2. There is no specific disclosure that the elected embodiment includes the embolic protection devices in this specific location.
The applicant states that they elected without traverse but then goes on to address claim 58 as being generic. This is being interpermeated as a general statement that has no bearing on the election made. Furthermore, the applicant argues that the election is made with the understanding that a finding of non-obviousness between each group of claims is being made. It is unclear what the applicant intended by this argument. By electing Group II and Species 3, the applicant has identified the invention and species that are being examined. Only the elected embodiments are being examined at this time with respect to all standards including non-obviousness.
Information Disclosure Statement
The Information Disclosure Statement filed on 10/08/2025 has been considered by the examiner.
Claim Objections
Claims 58-66 are objected to because of the following informality: inconsistent terminology with the original disclosure of the specification. The claims refer to the kit components with language not provided within the specification. For example: the specification refers to tubes as catheter tubes and the claims refer to cannula tubes, the specification defines the main inflation tube and the claims refer to a main perfusion tube, main perfusion lumen is never recited within the original specification it is not considered new matter because the language was present within originally filed claims. However, the claims must be amended to be consistent in terminology with the remainder of the disclosure.
Claim 58 is objected to for lack of clarity of the term “therethrough” in lines 6 and 11. The term “therethrough” should be replaced with --through the main cannula tube-- in line 6 and --through the secondary cannula tube-- in line 11.
Claim 63 is objected to for unnecessarily confusing language. The first three lines define a first secondary cannula and a second secondary cannula, but this is unnecessarily long and wordy. The applicant is advised to delete this phrasing and just say that the kit includes a third cannula tube.
Claim 64 is objected to for the same reasons, which should just be introducing a fourth cannula tube. The same goes for the perfusion lumen and occluding elements in both claims.
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.
Claim(s) 58-65 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lombardi WO 2023/215303 A1.
58. Lombardi discloses a kit 100 for perfusing one or more arteries of a patient (Figure 10 and 8M), the kit comprising:
a main cannula tube (shown within the vascular prosthesis 200 in Figures 8A-M and depicted as a whole component in the bottom right corner of Figure 10) having a proximal portion (couplings at the very bottom left of the component in Figure 10) configured to be fluidly coupled to a cardiopulmonary bypass machine (any tubular structure is capable of being coupled to a CPB, which as noted above is not positively claimed and the intended use is not recited), a distal portion (tip holding the implant in Figures 8AB and separately in Figure 10) configured to be positioned in the patient's descending aorta (as explained above this is considered to be a recitation of intended use and the main cannula tube of Lombardi is fully capable of being further advanced into a descending aorta), and
a main perfusion lumen (lumen extending through narrow tube connecting the balloon to the rear handle and couplings in the bottom right of Figure 10) extending therethrough (this lumen extends through entire man cannula tube);
a main occlusion element (240 Figures 8B and 10) at the distal portion of the main cannula tube (Figures 8AB);
a secondary cannula tube (311B Figures 8F-M) having a proximal portion configured to be fluidly coupled to the CPB (the rear couplings of each cannula tube are fully capable of being connected to any tubular structure including a CPB), a distal portion (314B) configured to be positioned in one of the innominate artery, the left carotid artery, or the left subclavian artery of the patient (as explained above due to the flexible and narrow shape of the cannula tubes of Lombardi they are fully capable of being inserted into any of these arteries), and
a secondary perfusion lumen (the inner open space within cannula tube 311B) extending therethrough; and
a secondary occlusion element (313B Figure 8F) at the distal portion of the secondary cannula tube (Figures 8F-M).
It is noted that in their current for the claims do not positively claim the CPB as part of the kit, and only require the cannula tubes to be capable of connecting to one, which almost any cannula is capable of doing. Additionally, the claim limitations directed at the location of the implant site and the intended function of each component are considered to be recitations of intended use. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case the main cannula and additional cannula tubes of Lombardi are fully capable of being advanced further through the vasculature to position the main cannula tube in the descending aorta and the additional cannula tubes within the innominate artery, the carotid artery, and the subclavian artery because they have a similar sizing/spacing and flexibility to allow them to be positioned accordingly.
59. Lombardi discloses the main occlusion element is a balloon [0051].
60. Lombardi discloses the secondary occlusion element is a balloon [0044].
61. Lombardi discloses a graft pre-loaded over the main cannula tube (200 [0061] Figure 8B-C).
62. Lombardi does not specifically call his graft a hemi-arch graft, but the applicant has failed to provide a specific definition for a hemi-arch graft. The broadest reasonable interpretation of this terminology is a graft that can fit within a hemi-arch. Due to the flexible materials and open mesh framework of the stent graft of Lombardi it is inherently capable of being flexed fit within the hemi-arch of the aorta making it read on a hemi-arch graft.
63. Lombardi discloses the kit further comprises: a second secondary cannula tube (311C) configured to be positioned in a second artery of the patient, the second artery being another one of the innominate artery, the left carotid artery, or the left subclavian artery (as explained above due to the flexible and narrow shape of the cannula tubes of Lombardi they are fully capable of being inserted into any of these arteries), wherein the second secondary cannula tube has a second secondary perfusion lumen (the inner open space within the cannula tube), a second secondary occlusion (313C) element at a distal region (Figure 8F), and a proximal end configured to be fluidly coupled to the CPB (the rear couplings of each cannula tube are fully capable of being connected to any tubular structure including a CPB), and wherein the second secondary cannula tube is configured to be positioned such that a distal end of the second secondary perfusion lumen is located distally beyond the second secondary occlusion element (Figure 8F shows the tube and lumen extending beyond the balloon).
64. Lombardi discloses the kit further comprises a third secondary cannula tube (311D) configured to be positioned in a third artery of the patient, the third artery being another one of the innominate artery, the left carotid artery, or the left subclavian artery (as explained above due to the flexible and narrow shape of the cannula tubes of Lombardi they are fully capable of being inserted into any of these arteries), wherein the third secondary cannula tube has a third secondary perfusion lumen (the inner open space within the cannula tube), a third secondary occlusion element (313D) at a distal region (Figure 8F), and a proximal end configured to be fluidly coupled to the CPB (the rear couplings of each cannula tube are fully capable of being connected to any tubular structure including a CPB), and wherein the third secondary cannula tube is configured to be positioned such that a distal end of the third secondary perfusion lumen is located distally beyond the third secondary occlusion element (Figure 8F shows the tube and lumen extending beyond the balloon).
65. Lombardi discloses an expandable stent 200 configured to be positioned in the thoracic aorta (as explained above due to the flexible and open mesh shape of the stent graft of Lombardi it is fully capable of being inserted into the thoracic aorta) and operatively coupled to the main occlusion element (Figures 8A-B), wherein the expandable stent is configured to be in a collapsed configuration when the main occlusion element is in a deflated state (Figure 8A), and wherein the expandable stent is configured to be in an expanded configuration when the main occlusion element is in an inflated state (Figure B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774