Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Detailed Action
This is in response to the amendment filed 01/05/2025.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/05/2026 has been entered.
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 negatived 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.
Claim 1 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication Number 2006/0293706 (Shimon et al.) in view of U.S. Patent Publication Number 2003/0187474 (Keegan et al.), U.S. Patent Publication Number 2006/0135977 (Thompson et al.)
Regarding claim 1, Shimon et al. discloses as shown in Figure 1an embolic protection device having an upstream end and a downstream end (shown in annotated Figure 1 provided below), said embolic protection device comprising: a cylindrical outer sleeve (external structure 2, see paragraph [0053]) comprising a filter mesh material wherein the cylindrical outer sleeve is capable of being implanted in a patient’s aortic arch to cover the patient’s aortic vessels ; and an inner structure comprising (filter or net 16, see paragraph [0047]) a filter mesh material and a seal (valve 18, see paragraph [0056]) having a plurality of flaps; wherein a downstream end of the inner structure is attached to a downstream end of the cylindrical outer sleeve; see paragraph [0047] and wherein emboli generated upstream of the embolic protection device is capable of flowing into and be trapped within a collection chamber defined between the cylindrical outer sleeve and base of the inner structure.
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Shimon fails to disclose the seal is resilient seal having a plurality of semi-circular flaps configured to form a sliding seal around a catheter shaft as the catheter shaft is introduced through a downstream end of the embolic protection device, and the resilient seal of the inner structure is located at an upstream end of the inner structure.
Keegan et al., from the same filed of endeavor teaches a similar an embolic protection device as shown in Figures 91, 92 where the embolic protection device includes a resilient seal (seal 161, see paragraph [0545]) having a plurality of flaps configured to form a sliding seal around a catheter shaft as the catheter shaft is introduced through a downstream end of the embolic protection device, and the resilient seal of the inner structure is located at an upstream end of an inner structure, for the purpose of preventing embolic material passing through an opening. see paragraphs [0545], [0548].
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify embolic protection device disclosed by Shimon by substituting the seal disclosed by Shimon for the one disclosed by Keegan et al. such that it had a resilient seal having a plurality of flaps configured to form a sliding seal around a catheter shaft as the catheter shaft is introduced through a downstream end of the embolic protection device, and the resilient seal of the inner structure is located at an upstream end of the inner structure because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Thompson et al., from a related field of endeavor teaches a similar seal as shown in Figures 3-10, where the seal comprises semicircular flaps (seal segments 26a, 26b described as semicircular, see paragraph [0046], [0047])
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the shape of the flaps disclosed by Shimon in view of Keegan for the semicirular shape of the flaps taught by Thomspon because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Alternatively, 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 shape of the flaps disclosed by Shimon in view of Keegan such that they were semi-circular as a matter of engineering design choice. Applicant has not disclosed that the shape of the flaps provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0030].
One of ordinary skill in the art, furthermore, would have expected Shimon in view of Keegan’s flaps, and applicant’s invention, to perform equally well with either the shape taught by Shimon in view of Keegan or the claimed semicircular shape because both spacing dimensions would perform the same function of forming a seal around a shaft equally well considering the relative dimensions disclosed.
Response to Arguments
Applicant's arguments filed 01/05/2026, see pages 3-7 have been fully considered but are not persuasive. The applicant argues Keegan fails to disclose the claimed flaps because Keegan discloses sealing elements are slits. In response the Office respectfully disagrees. Paragraph [0548] of Keegan specifically characterizes seal 161 as formed by flaps:
“The distal seal 61 is in the form of a tubular member with two or more, and in this case seven, circumferentially overlapping flaps, as illustrated in FIG. 92. This seal 161 is also closable down to seal the guidewire lumen 158.”
The argues Keegan allegedly characterizes the slits are flaps. In response, the Office respectfully disagrees. Keegan does not “allegedly” the slits are flaps, Keegan uses the term flaps which is the same term the applicant uses in the claim.
The applicant further argues that Thompson does not cure the deficiencies Shimon and Keegan because Thompson merely discloses flat semi-circular discs. In response, the Office respectfully disagrees. Segments 26a, 26b are structures which are broad or flat and thin and flexible that hang loose or project freely which is the plain an ordinary meaning of the term flap (according to webster’s dictionary) which is a definition which is not inconsistent with the specification. Segments 26a, 26b are also described to be part of a seal. See paragraph [0046]. Thus, applicant’s argument that the segments 26a,26b are not configured to form a sliding seal is contradicted by the specification.
The Office will note that the Office is only relying on Thompson for teaching the shape of the flaps, which the applicant admits that it does. The Office limitations are taught by Keegan (flaps, which are resilient). One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The applicant argues there is no teaching, suggest, or motivation absent hindsight to provide Shimon with the claimed seal. In response, the Office respectfully disagrees. The Office articulated it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify embolic protection device disclosed by Shimon by substituting the seal disclosed by Shimon for the one disclosed by Keegan et al. such that it had a resilient seal having a plurality of flaps configured to form a sliding seal around a catheter shaft as the catheter shaft is introduced through a downstream end of the embolic protection device, and the resilient seal of the inner structure is located at an upstream end of the inner structure because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the shape of the flaps disclosed by Shimon in view of Keegan for the semicirular shape of the flaps taught by Thomspon because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Neither of those two reasons are actually addressed by the applicant or refer to the applicant’s specification and are thus not impermissible hindsight.
Additionally, the applicant does not address the Office’s position that making the flaps taught by Keegan would have been obvious as matter of design choice.
Since the applicant does not address the complete grounds of rejection, their remarks cannot be considered persuasive.
Conclusion
This is a continuation of applicant's earlier Application No. 17167699. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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.
/RICHARD G LOUIS/ Primary Examiner, Art Unit 3771