DETAILED ACTION
Claim 1 is amended. Claims 2-5 are newly added claims. A complete action on the merits of pending claims 1-5 appears below.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/01/2026 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
Acknowledgment is made to Applicant’s amendments filed on 04/30/2026 which are entered. With regards to the drawing and specification objections documented in the Non-Final Office Action sent on 10/31/2025, all are overcome through Applicant’s amendments and are withdrawn (A new abstract objection is presented below in view of Applicant’s amendment). With regards to the non-statutory double patenting rejection documented in the Non-Final Office Action sent on 10/31/2025, it is overcome and withdrawn through Applicant’s amendment of claim 1. Examiner notes, with regards to claim 2-5, the status indicator, “(new)” is not listed in the required/recommended format, claim status identifiers must follow the claim number in parentheses (e.g., “2. (new) The filter system of claim 1, wherein the guide catheter is a pigtail catheter.”).
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because:
The amended abstract filed on 04/30/2026 is only 20 words in length. The abstract should be within the range of 50 to 150 words in length.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-3 and 5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
With regards to claims 2 and 3, claim 2 recites that “the guide catheter is a pigtail catheter.” Claim 3 depends from claim 2 and further requires that “the pigtail catheter includes a lumen for delivery of contrast injections.” While the specification describes a single organization catheter (15) having two distal exit ports for delivery of the respective filters (see Paragraphs [0033] and Figure 11), it does not describe or show this organization catheter itself being a pigtail catheter. Paragraph [0033] merely states that other catheters used in the procedure “would include pigtail catheters used for contrast injections.” This is insufficient to demonstrate possession of an embodiment in which the guide catheter performing the dual-filter delivery function is a pigtail catheter. No structural details are provided regarding how a pigtail configuration would be compatible with the required lateral openings, spacing for carotid ostia access, or filter deployment mechanics while maintaining the pigtail shape and contrast lumen functionality.
Claim 3 is also rejected by virtue of its dependency on claim 2.
With regards to claim 5, it recites that “the guide catheter is a balloon catheter.” The specification contains no disclosure that the guide catheter (15) performing the dual lateral opening filter delivery is or can be a balloon catheter. The single reference to balloon catheters in paragraph [0033] again refers only to other devices that may be introduced into the aortic arch alongside the organization catheter. There is no description of a balloon-equipped version of the claimed guide catheter that satisfies the dual-filter delivery limitations of claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1 and 4 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Galdonik (US 2009/0326575 A1), in view of Ruiz (US 6,261,273 B1).
Regarding claim 1, Galdonik discloses, embolic filters placed in blood vessels during percutaneous heart valve replacement. Galdonik teaches, a filter system (Figure 4, filtration system (242)) for preventing foreign material from traveling into carotid circulation (Paragraphs [0040]-[0041] and [0058]-[0060]), the system comprising:
a guide catheter (Figure 4, catheter (244)) having a proximal end (End outside the patient/closest to the user (not shown)) and a distal end (Figure 4, end at distal port (258)), the guide catheter having a first opening (Figure 4, distal port (258)) and a second lateral opening (Figure 4, side port (260)) proximal of the first opening (Paragraphs [0068]-[0069]);
a first filter (Figure 4, second filter device (248); Paragraph [0068]); and
a second filter (Figure 4, first filter device (246); Paragraph [0068]);
wherein the guide catheter (catheter (244)) is configured to deliver the first filter (second filter device (248)) into a left common carotid artery (Figure 4, left carotid artery (114)) by way of the first opening (distal port (258)) and expand the first filter (Figure 4; Paragraphs [0068]-[0069]); and
wherein the guide catheter (catheter (244)) is configured to deliver the second filter (first filter device (246)) into a right common carotid artery (Figure 4, right carotid artery (112)) by way of the second lateral opening (side port (260)) and expand the second filter (Figure 4; Paragraphs [0068]-[0069]).
Galdonik fails to explicitly teach, the guide catheter having a first lateral opening proximal of the distal end and a second lateral opening proximal of the first lateral opening.
Ruiz discloses, a delivery sheath or catheter that may be used to position medical devices within two or more branches of a branched vessel. Ruiz teaches, a guide catheter (Figure 5, main tubular member (42)) having a proximal end (Figure 5, proximal end (42)) and a distal end (Figure 5, distal end (43)), the guide catheter having a first lateral opening proximal of the distal end (Figure 5, lateral opening (47) proximal of distal end (43)) and a second lateral opening proximal of the first lateral opening (Figure 5, any of the remaining two lateral openings (47) proximal of the lateral opening (47) proximal of distal end (43)) (Col. 5, line 8-17).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify/substitute the guide catheter of Galdonik such that it comprises first lateral opening proximal of the distal end and a second lateral opening proximal of the first lateral opening, as taught by Ruiz, as both references and the claimed invention are directed to positioning medical devices within two or more branches of a branched vessel. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify/substitute the guide catheter of Galdonik such that it comprises first lateral opening proximal of the distal end and a second lateral opening proximal of the first lateral opening, as taught by Ruiz, as such a modification would have been predictable, namely, provides simultaneous access to multiple branches of a multi-branched vessel (Col. 5, line 15-17 of Ruiz).
Regarding claim 4, Galdonik further teaches, wherein the first filter (second filter device (248)) is mounted on a first guidewire (Figure 4, tether or guide structure (254)) and the second filter (first filter device (246)) is mounted on a second guidewire (Figure 4, tether or guide structure (250)) (Paragraph [0068]).
Claims 2-3 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Galdonik, in view of Ruiz, and further in view Hobbs (US 5,163,928 A).
Regarding claim 2 as best understood in view of 112(a) rejection above, Galdonik teaches, aspects of the filter system as claimed in claim 1 (See above rejection of claim 1).
Galdonik fails to teach, wherein the guide catheter is a pigtail catheter.
Ruiz teaches, the guide catheter(main tubular member (42)) with the first and second lateral openings (lateral openings (47)).
Hobbs discloses, an elongated tubular catheter adapted for use in an artery or vein. Hobbs teaches, a guide catheter (Figure 1, catheter (10)) having a proximal end (Figure 1, proximal end (12)) and a distal end (Figure 1, distal end (14)/where first opening (22) is located on end portion (20) (see Figure 3)) (Col. 2, line 18-38), the guide catheter comprising a plurality of lateral openings proximal of the distal end (Figure 2, openings (24); Col. 2, line 39-42 and line 63-64). Hobbs further teaches, wherein the guide catheter is a pigtail catheter (Col. 1, line 62-Col. 2, line 5 and Col. 1, line 12-21).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the guide catheter of Ruiz which was substituted for the guide catheter of Galdonik to include a distal pigtail configuration, as taught by Hobbs, as all the references and the claimed invention are directed to elongated tubular catheters adapted for use in blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guide catheter of Ruiz which was substituted for the guide catheter of Galdonik to be a pigtail catheter, as taught by Hobbs, as such a modification would have been predictable, namely, centers the guide catheter in the lumen of the vessel such that inadvertent contact between the vessel wall and the guide catheter/end portion of the guide catheter is avoided, preventing damage to either the catheter/end portion of the catheter or the vessel wall (Col. 2, line 30-38 of Hobbs).
Regarding claim 3 as best understood in view of 112(a) rejection above, modified Galdonik teaches, wherein the pigtail catheter includes a lumen for delivery of contrast injections (Col. 2, line 42-49 of Ruiz; One of ordinary skill would be motivated to do so for real-time fluoroscopic angiography (mapping the branches with contrast fluid) and ensuring proper deployment in the exact target zone (Predictable results)).
Claim 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Galdonik, in view of Ruiz, and further in view Parodi (US 2001/0044598 A1).
Regarding claim 5 as best understood in view of 112(a) rejection above, Galdonik teaches, aspects of the filter system as claimed in claim 1 (See above rejection of claim 1).
Galdonik fails to teach, wherein the guide catheter is a balloon catheter.
Ruiz teaches, the guide catheter(main tubular member (42)) with the first and second lateral openings (lateral openings (47)).
Parodi discloses, apparatus and methods for protecting against embolization during vascular intervention. Parodi teaches, a guide catheter (Figure 3A, arterial catheter (41); Paragraph [0047]) comprising a balloon on its distal end (Figure 3A, distal occlusion element (42); Paragraphs [0048] and [0052]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the guide catheter of Ruiz which was substituted for the guide catheter of Galdonik to include a balloon feature on its distal end, as taught by Parodi, as all the references and the claimed invention are directed to elongated tubular catheters adapted for use in blood vessels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guide catheter of Ruiz which was substituted for the guide catheter of Galdonik to include a balloon feature on its distal end, as taught by Parodi, as such a modification would have been predictable, namely, protects against embolization (Paragraph [0063] of Parodi).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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.
See updated rejections above.
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 OSAMA NEMER whose telephone number is (571)272-6365. The examiner can normally be reached Monday-Friday 7:30-5:00.
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, Jackie Ho can be reached at (571)272-4696. 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.
/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights