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 .
This action is in response to the Appeal Brief filed on 08/27/2025 and the claims filed on 06/11/2024. After considering Appellant’s arguments presented in the Appeal Brief, the Final Rejection mailed on 09/25/2024 has been withdrawn. Claims 27-35, 37-44, 46, and 47 are pending. Claims 27 and 41 are independent.
Claim Objections
Claim 27 is objected to because of the following informalities:
Claim 27, line 5, “a side port of an irrigation line” should be amended to --a side port or an irrigation line-- to correct the typo to avoid new matter issue because the specification describes “a side port or an irrigation line.”
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: “a lockout mechanism configured to prevent an actuator configured to retract the expandable structure from being actuated when the expandable structure is in an expanded state” in claim 39. Based on the specification (Para. 0077]), the lockout mechanism is a blocking segment or protrusion 140.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 37-40 and 46 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 37 recites the limitation "the vessel wall" in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 38, line 3, the limitation “a vessel wall of the arteriotomy” should be amended to --the vessel wall--. Otherwise, claim 37 should amend "the vessel wall" to --a vessel wall of arteriotomy--. So, the limitation “a vessel wall of the arteriotomy” in claim 38 can be amended to --the vessel wall of arteriotomy--.
Claim 37 recites the limitation "the expandable structure" in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 39 recites the limitation "the expandable structure" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. The limitation "the expandable structure" appears two times in line 2 of claim 39. Claim 40 also recites "the expandable structure" in line 3 of the claim.
Claim 46 recites the limitation "the vessel wall" in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 46 recites the limitation "the expandable structure " in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim.
The art rejection(s) below is/are made as best understood by the examiner because of the 35 U.S.C. 112 stated above.
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) 27, 28, 30, and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maruyama et al. (US Pub. No.: 2009/0270885).
Regarding claims 27, 28, 30, and 31, Maruyama discloses a closure system (1, Figs. 34-39) for closing an arteriotomy, the closure system comprising: a handle portion (9, Fig. 39); a sheath adapter (inner tube portion 311, Figs. 34-39; alternatively, the whole connector 31, Figs. 34-39 and Para. [0190]) comprising an attachment structure (structure of 311 defining the slot 313, Fig. 34 and Paras. [0191] and [0194]; alternatively, the structure of 31 defining the slot 314, Fig. 34 and Para. [0191] and [0194]) defining a passageway (slot 314, Fig. 34) configured to engage a side port (e.g. 53, Fig. 34 and Para. [0194]) of an irrigation line / a side port (e.g. 53, Fig. 34 and Para. [0194]) or an irrigation line of a procedural sheath (5, Fig. 34) for releasable attachment to the procedural sheath (Para. [0194]); an outer catheter (6, Figs. 6(a) and 10) extending distally from the handle portion, the outer catheter comprising a proximal section (proximal section of 6, Fig. 5) and a distal section (distal section of 6, Figs. 6(a) and 10); an inner catheter (7, Figs. 5 and 30) extending through the outer catheter, the outer catheter axially movable with respect to the inner catheter (Para. [0059]); and a sealant (4, Figs. 6A, clip 4 is a sealant because it seals the puncture, Para. [0052]) positioned in the distal section of the outer catheter;
[claim 28] wherein the sheath adapter comprises a proximal flange (such as a proximal flange at the proximal end of 311, Figs. 31 and 34) configured to engage the handle portion;
[claim 30] wherein the distal section of the outer catheter comprises an inner sleeve (inner sleeve layer of distal section of outer catheter 6, Fig. 6) and an outer sleeve (outer sleeve layer of distal section of outer catheter 6, Fig. 6) surrounding the inner sleeve; and
[claim 31] wherein the proximal section of the outer catheter comprises a single layer (Figs. 5 and 6).
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 (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 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.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maruyama et al. (US Pub. No.: 2009/0270885).
Regarding claim 29, Maruyama discloses all the limitations of claim 27 but fails to disclose that the sheath adapter and the handle portion are integral. However, it would have been obvious to one of ordinary skill in the art before the filing of the claimed invention to modify the sheath adapter, such as the inner tube portion 311, and the handle portion of Maruyama to be integral, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. See MPEP 2144.04 V
Allowable Subject Matter
Claims 41-44 are allowed. The following is an examiner’s statement of reasons for allowance on claims 41-44: the prior art fails to teach or render obvious closure system for closing an arteriotomy, the closure system comprising, inter alia, the distal section of the outer catheter comprising an inner sleeve and an outer sleeve surrounding the inner sleeve, the inner sleeve comprising a first slit, the outer sleeve comprising a second slit circumferentially displaced from the first slit; and a sealant positioned in the distal section of the outer catheter.
Claims 37-40 and 46 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 32-35 and 47 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and overcoming the claim objection stated above.
Response to Arguments
Applicant’s arguments with respect to claim(s) 27-31, 37, 38, and 46 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Maruyama et al. (US Pub. No.: 2009/0216266) discloses a tissue closing device comprising a handle, sheath adapter, outer catheter, inner catheter, and a sealant.
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/JING RUI OU/ Primary Examiner, Art Unit 3771