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 with traverse of invention I (claims 1-8, 17-20), species 1a (primary stent of figures 1-7b), 1a1 (cylindrical primary stent), 2a (circular cross section of the pocket), 3a (lumen of the pocket is inwardly tapered), 4a (prosthesis is for an iliac bifurcation), and 4a2 (the prosthesis is for implantation as is shown in figures 16a-b), in the reply filed on 11/19/25 and 02/13/26 is acknowledged. The traversal is on the ground(s) that it would not be a burden on the Examiner to search all the species and subspecies. This is not found persuasive because the Examiner explained how there is a search burden on page 6 of the election/restriction requirement mailed 07/09/25. Notably, the search for different structural features (projections versus partial sleeves), and all the distinct structural embodiments require distinct search queries and class/subclass searches.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/19/25 and 02/13/26.
Further, claim 6 is withdrawn for being drawn towards non-elected species 3b.
Claim 19 is also withdrawn for being drawn towards non-elected species 2b.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2 is objected to for referring to “the diameter of the pocket lumen”, and “the diameter of the secondary stent graft” with improper antecedent basis.
Further, the claim is objected to for referring to a “fluid tight seal” when it is believed a hyphen is missing.
Appropriate correction is required.
Specification
The title of the invention is not descriptive, since a method of manufacture is not claimed. A new title is required that is clearly indicative of the invention to which the claims are directed.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “fixation feature” in claims 3-4. Paragraph [0045] and [0052] of the specification indicates that these can be “protruding barbs, sharpened protruding barbs, an adhesive, inflatable portions, flared portions, strut hooks, or any combination thereof”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 7-8, 17, 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yamaguchi (US 20160324670 A1).
Regarding claim 1 Yamaguchi discloses a bifurcated endovascular prosthesis (Figure 10 item 900) comprising:
a primary stent graft (900) comprising:
a body (Figure 10 item 910) comprising a proximal portion (912) and a distal portion (914), wherein the proximal portion is configured to be disposed in a diseased vessel and the distal portion is configured to be disposed within a first branch vessel (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an 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. See MPEP 2111.02 (II). In this case, the patented structure of Yamaguchi was considered capable of performing the cited intended use of being positioned with the proximal portion 912 in a diseased vessel and the distal portion 914 in a first branch vessel, if desired.),
a bore disposed through the body (through from end 914 to end 912; [0006]), and
a pocket disposed within the bore (Figure 10 item 930) and coupled to a body wall (Figure 10, left figure shows the attachment of the pocket 930 to the side wall of 910),
wherein the pocket comprises a proximal opening (932), a distal opening (934), and a pocket lumen disposed between the proximal and distal openings (Figure 10 shows the opening between ends 932 and 934), and
wherein the distal opening is disposed in the body wall (Figure 10 shows how the opening 934 forms the opening in the wall 910), and
a secondary stent graft (Figure 10 item 940) comprising:
a proximal portion disposable within the pocket lumen (Figure 10 shows the proximal (bottom) portion of secondary stent graft 940 within the pocket 930), and
a distal portion (Figure 10 shows the distal (top) portion of the secondary stent graft 940 extending outward and away from the body 910 and pocket 930) configured to be disposed within a second branch vessel (this is also stated as an “intended use” of the distal portion of the secondary stent graft (see the explanation regarding intended use statements above). The top, distal portion of stent graft 940 is understood to be positionable within a branch vessel since it extends outward and away from the main stent body 910. See also for example, Figure 12),
wherein the distal portion extends from the distal opening of the pocket (Figure 10).
Regarding claim 7 Yamaguchi discloses the prosthesis of claim 1 substantially as is claimed,
wherein Yamaguchi further discloses the pocket further comprises a distal end wall disposed at an angle relative to a longitudinal axis of the primary stent graft (the distal end wall is considered to be the distalmost end of the main body stent graft 914 which marks the distal end 914, which is relatively thin and is seen to be perpendicular to the longitudinal axis of the prosthesis (Figure 10)), the angle ranging from 30-90 degrees (Figure 10).
Regarding claim 8 Yamaguchi discloses the prosthesis of claim 1 substantially as is claimed,
wherein Yamaguchi further discloses the body comprises a wire structure ([0043] the main body is a tubular metal web), and
wherein the body is free of the wire structure in an area surrounding the distal opening (Figure 10).
Regarding claim 17 Yamaguchi discloses a primary stent graft (Figure 10, left figure item 900) of a bifurcated endovascular prosthesis (Figure 10, right figure) comprising;
a body (Figure 10 item 910) comprising a proximal portion (912) and a distal portion (914), wherein the proximal portion is configured to be disposed in a diseased vessel (this is stated as an “intended use” of the proximal portion of the body of the primary stent graft (see the explanation regarding “intended use” statements in the rejection to claim 1 above. The proximal portion is disposed in a diseased vessel, if desired. See also [0003] which describes how stent grafts are disposed in vessels with aneurysms) and the distal portion is configured to be disposed within a first branch vessel (This is also stated as an “intended use” of the distal portion of the primary stent graft (see the explanations above). The distal portion is understood to be capable of being positioned in a first branch vessel, if desired.),
a bore disposed through the body (through from end 914 to end 912; [0006]), and
a pocket disposed within the bore (Figure 10 item 930) and coupled to a body wall (Figure 10, left figure shows the attachment of the pocket 930 to the side wall of 910),
wherein the pocket comprises a proximal opening (932), a distal opening (934), and a pocket lumen disposed between the proximal and distal openings (Figure 10 shows the opening between ends 932 and 934), and
wherein the distal opening is disposed in the body wall (Figure 10 shows how the opening 934 forms the opening in the wall 910).
Regarding claim 20 Yamaguchi discloses the primary stent graft of claim 17 substantially as is claimed,
wherein Yamaguchi further discloses the pocket further comprises a distal end wall disposed at an angle relative to a longitudinal axis of the body (the distal end wall is considered to be the distalmost end of the main body stent graft 914 which marks the distal end 914, which is relatively thin and is seen to be perpendicular to the longitudinal axis of the prosthesis (Figure 10)), the angle ranging from 30-90 degrees (Figure 10).
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 2-3, 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi as is applied above in view of Goicoechea et al. (EP 0783873 A2), hereinafter known as Goicoechea
Regarding claim 2 Yamaguchi discloses the prosthesis of claim 1 substantially as is claimed,
but is silent with regards to the diameter of the pocket lumen relative to the diameter of the secondary stent graft.
However, regarding claim 2 Goicoechea teaches that a diameter of a pocket lumen within a stent graft is smaller than or equal to a diameter of a secondary stent graft which attaches thereto (Column 2 lines 36-43 the two stent grafts would not resist separation if the secondary stent graft were smaller than the primary stent graft; see also Figures 1a-b, 6 which shows the diameter of the secondary stent graft being significantly larger than the primary stent graft’s pocket), and so the secondary stent graft is configured to form a fluid-tight seal with the pocket (Column 14 lines 48-59). Yamaguchi and Goicoechea are involved in the same field of endeavor, namely stent grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the prosthesis of Yamaguchi by having the pocket lumen be the same/smaller than the diameter of the secondary stent graft which is inserted therein as is taught by Goicoechea in order to facilitate coupling of the two parts of the prosthesis together and ensure they do not decouple during use, which increase patient safety and device success.
Regarding claim 3 Yamaguchi discloses the prosthesis of claim 1 substantially as is claimed,
but is silent with regards to the secondary stent graft including a proximal fixation feature at its proximal end that is configured to couple with the proximal end of the pocket to prevent axial movement.
However, regarding claim 3 Goicoechea teaches a prosthesis wherein a secondary stent graft comprises a proximal fixation feature disposed at a proximal end which is configured to couple with a proximal end of a pocket to prevent the secondary stent graft from distal axial movement relative to a primary stent graft (Column 15 lines 8-14; “barbs”).Yamaguchi and Goicoechea are involved in the same field of endeavor, namely stent grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the prosthesis of Yamaguchi by having a fixation feature on the proximal end of the secondary stent graft as is taught by Goicoechea in order to facilitate coupling of the two parts of the prosthesis together and ensure they do not decouple during use, which increase patient safety and device success.
Regarding claim 5 Yamaguchi discloses the prosthesis of claim 1 substantially as is claimed,
wherein Yamaguchi further discloses the pocket is inwardly tapered from a proximal end to a distal end ([0010]), and
wherein the secondary stent graft is selectively secured within the pocket ([0014])
but is silent with regards to whether the proximal portion of the secondary stent graft is also inwardly tapered, to prevent axial displacement of the secondary stent graft relative to the primary stent graft.
However, regarding claim 5 Goicoechea teaches a prosthesis wherein the shape of a secondary stent graft (Figure 6 item 88) matches the shape of the opening into which is inserted (Figure 6 item 78) to prevent axial displacement of the second stent graft relative to the primary stent graft (Column 2 lines 36-43). Yamaguchi and Goicoechea are involved in the same field of endeavor, namely stent grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the prosthesis of Yamaguchi by having the shape of the secondary stent graft match the shape of the pocket into which it is being inserted (e.g. inwardly tapered from a proximal end toward a distal portion, as is taught by Yamaguchi [0010]) as is taught by Goicoechea in order to facilitate coupling of the two parts of the prosthesis together and ensure they do not decouple during use, which increase patient safety and device success.
Claim 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi as is applied above in view of Quinn (US 6645242 B1).
Regarding claim 4 Yamaguchi discloses the prosthesis of claim 1 substantially as is claimed,
wherein Yamaguchi further discloses the pocket comprises a fixation feature configured to couple with the secondary stent graft ([0010] a frustoconical shape is considered to be a “flared portion” (see 112f interpretation above).),
but is silent with regards to whether or not this prevents proximal or distal axial movement of the secondary stent graft relative to the primary stent graft.
However, regarding claim 4 Quinn teaches a prosthesis wherein a fixation feature is configured to prevent proximal or distal axial movement of the secondary stent graft relative to a primary stent graft (Column 8 line 67 -Column 9 line 4). Yamaguchi and Quinn are involved in the same field of endeavor, namely stent grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the prosthesis of Yamaguchi by having a fixation feature on the proximal end of the secondary stent graft as is taught by Quinn in order to facilitate coupling of the two parts of the prosthesis together and ensure they do not decouple during use, which increase patient safety and device success.
Claim 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi as is applied above.
Regarding claim 18 Yamaguchi discloses the primary stent graft of claim 17 substantially as is claimed,
wherein Yamaguchi further teaches a diameter of the pocket lumen is from 10-90% of a diameter of the bore of the body (Figure 10; while the Examiner does not understand the figures to be drawn to-scale, it is not understood that they should be drawn completely inaccurately either. Accordingly, the person of ordinary skill in the art, in viewing figure 10, would find it obvious to modify the primary stent graft of Yamaguchi so that the diameter of the pocket lumen is from 10-90% of the diameter of the bore of the body, since the figure appears to show the diameter of the primary stent graft body 910 to be about 4.5x the width of the pocket lumen 930 (e.g. the figures appear to show the pocket lumen being about 45% of the diameter of the bore of the body), which falls within the range of the claim).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 03/05/26