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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-21 and 23 is/are pending. Claim(s) 16-21 is/are withdrawn. Claim(s) 22 is/are canceled.
Response to Arguments
Applicant’s arguments, filed 12/22/2025, with respect to claim objection have been fully considered and are persuasive. The claim objection of claim 15 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments, filed 12/22/2025, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive, except that at #16 in the 9/23/2025 Office action. The 35 USC 112(b) rejections of claim 1-15, except that for claim #14 at #16 in the 9/23/2025 Office action, has/have been withdrawn due to the Applicant’s amendments.
Applicant's arguments filed 12/22/2025 with respect to the prior art have been fully considered but they are not persuasive.
Applicant argues Armstrong does not teach a knit constraint with multiple release zones and instead has multiple sleeves positioned along the device at separate locations (Applicant's Response on 12/22/2025, herein "Response," page 7).
The first and second zones are shown in Armstrong’s Figure 4. Specifically, the first release zone (e.g. Figure 4, formed by strands #s 32, 26, in the body of the cover) and the second release zone (e.g. Figure 4, #s 28, 30, in the body of the cover). These zones are not in multiple sleeves as they are part of a single sleeve as shown in Figure 4. Further the zones are at separate locations since they are different zones. The Examiner is unclear on how two different zones are co-located in the same location, which would be a single zone. Regardless, the Examiner notes the noted prior art zones meet the claimed limitations.
Applicant argues new claim 23 is not taught by the prior art (Response, page 8). The Examiner notes claim 23 is met by Armstrong as noted below in the prior art rejection section.
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.
Claim 14 is 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 14 recites the limitation "the implantable medical device". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “the medical device”.
Claim Rejections - 35 USC § 102
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.
Functional language and intended use language is presented in italicized font.
Claim(s) 1-15 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Armstrong, et al (Armstrong) (US 6,224,627 B1).
Regarding Claim 1, Armstrong teaches a medical device (e.g. Figure 1) comprising:
an expandable member (e.g. Figure 1, #12; column 6, lines 49-61; self-expanding stent or column 13, line 42 to column 14, line 47, Example 1, balloon) configured to radially expand from a first diameter toward a second diameter (e.g. column 6, line 62 to column 7, line 7; self-expanding tubular device is able to transition between the two claimed diameters or for Example 1, column 14, 28-47, expansive force); and
a knit constraining member (e.g. Figure 1, #10) positioned around the expandable member to constrain the expandable member at the first diameter (e.g. column 6, line 62 to column 7, line 7), the knit constraining member having a first release zone (e.g. Figure 4, formed by strands #s 32, 26, in the body of the cover) configured to disengage the knit constraining member from the expandable member (e.g. column 6, line 62 to column 7, line 7), a first deployment line (e.g. Figure 3, within #14, formed by strands #s 32, 26 in Figure 4; the respective zone comprises its respective knits which are part of the respective deployment line; thus, the strands forming the deployment line and the zone are the same strands) operable to activate the first release zone (e.g. column 6, line 62 to column 7, line 7), a second release zone (e.g. Figure 4, #s 28, 30, in the body of the cover) configured to disengage the knit constraining member from the expandable member (e.g. column 6, line 62 to column 7, line 7), and a second deployment line (e.g. Figure 3, #14, formed by strands #s 28, 30 in Figure 4) operable to activate the second release zone (e.g. column 6, line 62 to column 7, line 7),
wherein the constraining member is configured to disengage from the expandable member by substantially simultaneously tensioning the first deployment line and the second deployment line (e.g. Figure 3, both the first and second deployment lines are within #14, thus both are pulled at the same time; e.g. column 6, line 62 to column 7, line 7).
Regarding Claim 2, the constraining member comprises a first body stand (e.g. Figure 4, #32) and a second body strand (e.g. Figure 4, #26) interwoven (e.g. Figures 3-4) to form the first deployment line (discussed supra for claim 1) and a third body strand (e.g. Figure 4, #28) and a fourth body strand (e.g. Figure 4, #30) interwoven (e.g. Figures 3-4) to form the second deployment line (discussed supra for claim 1).
Regarding Claim 3, the first body strand, the first deployment line, the second body strand, and the second deployment line are all interwoven (e.g. column 6, line 62 to column 7, line 7; also, discussed supra for claim 1).
Regarding Claim 4, the first body strand, the first deployment line, the second body strand, and the second deployment line are warp knit (e.g. column 6, line 62 to column 7, line 7).
Regarding Claim 5, the first body strand and the first deployment line form a first plurality of knits along at least a first portion of a longitudinal length of the constraining member (e.g. Figure 4, knits formed between strand #s 32 and 26) and the second body strand and the second deployment line form a second plurality of knits along at least a second portion of a longitudinal length of the constraining member (e.g. Figure 4, knits formed between strand #s 28 and 30).
Regarding Claim 6, the first release zone comprises the first plurality of knits and the second release zone comprises the second plurality of knits (e.g. Figure 4, the components of each zone are discussed supra for claim 1).
Regarding Claim 7, the first plurality of knits are sequentially unraveled when a first threshold tension is applied across the first deployment line and the second plurality of knits are sequentially unraveled when a second threshold tension is applied across the second deployment line (e.g. column 7, lines 23-35 describes sequential unraveling of each strand and describes tension being applied; there is no claim requirement regarding the relationship between the first and the second thresholds).
Regarding Claim 8, the first deployment line is interwoven with the second deployment line and the second body strand (e.g. column 6, line 62 to column 7, line 7) such that the second plurality of knits are operable to unravel when corresponding knits of the first plurality of knits are unraveled by advancing the first deployment line away from the first release zone (e.g. column 7, lines 23-35).
Regarding Claim 9, the second deployment line is interwoven with the first deployment line and the first body strand (e.g. column 6, line 62 to column 7, line 7) such that the first plurality of knits are operable to unravel when corresponding knits of the second plurality of knits are unraveled by advancing the second deployment line away from the second release zone (e.g. column 7, lines 23-35).
Regarding Claim 10, the first deployment line and the second deployment line each include free ends (e.g. Figure 3, #14; column 6, lines 49-61), wherein the free ends of the first deployment line and the second deployment line are coupled to form a unitary deployment line (e.g. Figure 3, #14; column 6, lines 49-61).
Regarding Claim 11, the first release zone and the second release zone are configured to deploy substantially simultaneously (e.g. column 7, lines 23-35).
Regarding Claim 12, the first deployment line, the first body strand, the second deployment line, and the second body strand comprise polytetrafluroethylene (e.g. column 10, lines 17-33).
Regarding Claim 13, the first release zone and the second release zone are configured to provide resistance to an outward expansion of the expandable member when undeployed (e.g. column 3, lines 45-57).
Regarding Claim 14, the [] medical device has a radial force at a delivery diameter of the expandable member (e.g. column 6, lines 49-61; the self-expandable stent provides a radially expansive force when compressed by the cover) and the first deployment line and the second deployment line are configured to be removed with a deployment force applied to the first deployment line and the second deployment line (e.g. column 7, lines 23-35) and a ratio of the radial force to the deployment force is between about 100 and about 500 (e.g. column 14, lines 28-47; the maximum radial force = 100 psi and the maximum deployment force = 1.2 lbf; 1.2 lbf = 0.0083 psi; the maximum ratio of radial force:deployment force = 100/0.0083 = 12000; since the pressure of the balloon (numerator) is built up from 0 to a maximum of 100 psig, the pressure passes through 0.833 to 4.17 psig (which correspond to ratios of 100 and 500, respectively); thus, at those points in time the claimed ratio is met).
Regarding Claim 15, a ratio of expandable member delivery diameter to deployment diameter is less than 0.3 (for the Example 1 option discussed supra for claim 1, e.g. column 14, lines 28-47; delivery diameter = 0.6 mm and deployment diameter = 2.5 mm, thus the claimed ratio is 0.24, which is less than 0.3).
Regarding Claim 23, the first release zone extends along a longitudinal length of the expandable member and the second release zone extends along the longitudinal length of the expandable member (e.g. Figure 4, both zones extend along the same length of the expandable member).
Conclusion
THIS ACTION IS MADE FINAL. 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 LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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, THOMAS BARRETT can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 3/13/2026