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 .
Response to Amendment
It is noted that claims 8-9 and 17 are withdrawn from consideration as discussed in the Non-Final Rejection mailed on 3/11/2026. Amendments to the claims need to be provided with the proper status identifier. Therefore, claims 8-9 and 17 should be identified as (Withdrawn) in order to avoid a Notice of Non-Compliant Amendment.
Response to Arguments
The previous objection of claim 11 due to minor informalities has been withdrawn in light of applicant’s amendments made 6/11/2026.
The previous rejection of claim(s) 19-20 over 35 U.S.C. 112(b) as being indefinite has partially been overcome in light of the amendments made to claim(s) 19-20 on 6/11/2026. While it is clear based on the amendment to claim 20 that the coupling means includes the elastic sleeve, additional rejections are made below based on the amendments filed 6/11/2026.
Applicant’s arguments, see page 6, filed 6/11/2026, with respect to Gerbi (US 2007/0249939) have been fully considered and are persuasive. The rejection of claims 1 and 7 has been withdrawn.
Applicant’s arguments, see page 7, filed 6/11/2026, with respect to Gerbi in view of Owens (US 2019/0350648) and Gerbi in view of Owens in view of Mccaffrey (US 2020/0129196) have been fully considered and are persuasive. The rejection of claims 2-6, 10, 12-16 and 19-20 has been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “an interventional medical device” in line 11 which should read “the interventional medical device”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: Claim 19 recites “an interventional medical device” in line 11 which should read “the interventional medical device”. 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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: coupling means in claim 20.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 2-6 and 19-20 are 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 2 recites “the at least one coupler includes an elastic sleeve…the elastic sleeve including a sleeve lumen.” Claim 2 depends from claim 1 which recites “a lumen of the at least one coupler” in lines 9-10. It is unclear if the lumen of the at least one coupler is intended to be the same or in addition to the sleeve lumen of the elastic sleeve of the at least one coupler.
Claim 3 recites “the sleeve lumen” and is unclear for the same reasons discussed above with respect to claim 2.
Claim 3 recites “an introducer sheath” in line 2. Claim 3 ultimately depends from claim 1 which recites “a peel-away introducer sheath”. It is unclear if the introducer sheath of claim 3 is intended to be the same or in addition to the peel-away introducer sheath of claim 1.
Claims 4-6 depend from rejected claim 2; therefore, are also rejected.
Claim 19 recites the limitation “a peel-away introducer sheath” and a “means for deploying the interventional medical device”. According to the 112(f) interpretation the “means for deploying” is the introducer sheath. Therefore, it is unclear if the peel-away introducer sheath is the same means for of claim 20 or in addition thereto. For the purposes of examination, the two are interpreted as the same introducer sheath.
Claim 20 recites “wherein the coupling means includes an elastic sleeve and comprising an introducer sheath.” Claim 20 depends from claim 19 which recites “coupling means for…and a peel-away introducer sheath”. It is unclear if the introducer sheath of claim 20 is intended to be a part of the coupling means and/or if the introducer sheath of claim 20 is intended to be the same or in addition to the peel-away introducer sheath of claim 19.
Claim 20 recites “wherein the coupling means includes an elastic sleeve…a sleeve lumen of the elastic sleeve.” Claim 20 depends from claim 19 which recites “a lumen of the coupling means” in lines 9-10. It is unclear if the lumen of the coupling means is intended to be the same or in addition to the sleeve lumen of the elastic sleeve of the coupling means.
Allowable Subject Matter
Claims 1, 7, 10, 12-16 and 18 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art Gerbi et al. (US 2007/0249939 A1), Owens et al. (US 2019/0350648 A1) and Mann et al. (US 2005/0136385 A1) fails to disclose a peel-away introducer sheath, sized and shaped to be inserted into the sleeve lumen while expanding the inner diameter of the sleeve lumen, the peel-away introducer sheath configured to receive the interventional medical device, the peel-away introducer sheath configured to be removeable such that an interventional medical device remains within and is gripped by the sleeve lumen.
Gerbi is silent to any additional sleeves being inserted into guide 44 and peel-away sheaths.
Owens discloses a second tube may be inserted into the elastic sleeve (first tube 115), the second tube having a different inner lumen geometry than the first, thereby aiding in the insertion of one or more of a plurality of instruments ([0094]), but fails to disclose the second tube being a peel-away introducer sheath stretching or expanding the elastic sleeve or first tube.
Mann teaches peel-away sheaths are well known in the art ([0121]), but the peel-away sheath (67) is not inserted into an elastic sleeve to expand the elastic sleeve and hold another medical device therein. It would not have been obvious to insert a peel-away sheath introducer into the elastic sleeve of Owens to expand or stretch the sleeve lumen without additional teachings in the art because the stretched or expanded elastic sleeve would hinder peeling away the peel-away sheath introducer therein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Galdonik et al. (US 2022/0257910 A1) is noted for teaching a peel-away introducer that is inserted through a sleeve, but the lumen of the sleeve does not grip an interventional medical device therein when the peel-away introducer is removed.
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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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