DETAILED ACTION
The following Office Action is in response to the Amendment filed on September 17, 2025. Claims 1-20 are currently pending.
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
Concerning the “I. § 112 Indefiniteness Rejections” section on page 5 of the Applicant’s Response filed on September 17, 2025, the amendment to claims 19 and 20 to address the issues of indefiniteness have obviated the necessity of the rejections to the claims. Therefore, the rejections are withdrawn.
Response to Arguments
Concerning the “II. § 102 Novelty Rejections over Mirizzi: A. Novelty Rejection of Claim 1 and its Dependent Claims” section on pages 5-9 of the Applicant’s Response filed on September 17, 2025, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the Mirizzi reference does not teach the limitation of the implant being “in a first looped condition, and a looped portion of the implant includes a plurality of loops”, arguing that the claim requires that the implant itself is configured in the shape of a plurality of loops. However, the examiner asserts that the applicant has too narrowly interpreted the limitation. Firstly, the examiner notes that the implant has not been positively recited in the claims. Thus, the claims do not require the implant or the specified structure. The claims simply require that the packaging be capable of being used with an implant that is in a first looped condition with a looped portion including a plurality of loops. Furthermore, even if the implant was positively recited, the implant of the Mirizzi reference may still be interpreted as anticipating the claims. The claims do not state that the looped structure or the looped portion define a plurality of loops or form a plurality of loops, rather, the claim simply states that the looped structure and looped portion includes loops. Because the Mirizzi reference includes the implant forming a loop, and the length of the implant defines a looped portion, said looped portion including a plurality of loops tied around the body, the Mirizzi reference may be interpreted as anticipating the claims. Therefore, the rejections of claim 1 and its dependent claims as being anticipated by Mirizzi under 35 U.S.C. §102(a)(1) stand.
Concerning the “II. § 102 Novelty Rejections over Mirizzi: B. Novelty Rejection of Claim 11 and its Dependent Claims” section on pages 5-9 of the Applicant’s Response filed on September 17, 2025, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the Mirizzi reference does not teach the added limitation of the first packaging tube being at least partially positioned within the channel. However, the limitation of the channel has now been interpreted as the channel created by the two recesses of the half shells 210 and 212, wherein the first packaging tube exists within portion 264 of the channel created. Therefore, the rejections of claim 11 and its dependent claims as being anticipated by Mirizzi under 35 U.S.C. §102(a)(1) stand.
Concerning the “III. § 102 Novelty Rejections over Hunter” and “III. § 103 Obviousness Rejections over Hunter in view of Perell references” sections on pages 9-10 of the Applicant’s Response filed on September 17, 2025, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
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.
Claim(s) 1-14 and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mirizzi et al. (US 2010/0160946, hereinafter Mirizzi).
Concerning claim 1, the Mirizzi et al. prior art reference teaches a packaging for a vascular implant (Figures 26-41: 190 defines a system in which an implant is stored, therein defining it as packaging) comprising: a first packaging tube (Figure 26; 202 defines a tube associated with the packaging, therein defining it as a packaging tube) and a holder (Figure 26; 204), the implant positioned within the holder in a looped configuration (Figure 26; 10), and a looped portion of the implant includes a plurality loops (Figure 48; tacks 314, 320, 322 define loops/rings tied around the body of the implant) receivable in at least one recess (Figure 34; implant and loops received in cavity 252 in shell halves 210, 212, each shell half defining a recess), wherein the implant is movable from the holder into the first packaging tube and maintained within the first packaging tube in a more linear condition (Figure 40; 10).
Concerning claim 2, the Mirizzi reference teaches the packaging of claim 1, further comprising a delivery sheath having a lumen (Figure 32; 22) and a delivery member positioned within the lumen (Figure 37; 156), the delivery sheath positioned within the first packaging tube (Figure 37; 22, 202), and the implant pulled into the delivery sheath by the delivery member to be maintained within the delivery sheath within the first packaging tube (Figure 41).
Concerning claim 3, the Mirizzi reference teaches the packaging of claim 1, further comprising a second packaging tube having a first end and a second opposite end (Figure 27; 270), and the first packing tube has a first end adjacent the holder (Figure 26; distal end of 202) and a second opposite end (Figure 26; proximal end of 202), the first end of the packaging tube is spaced from the second end of the first packaging tube to form a gap between the first and second packaging tubes (Figure 30; 262).
Concerning claim 4, the Mirizzi reference teaches the packaging of claim 1, wherein the holder includes at least one arcuate channel to receive the first packaging tube in a lumen therein (Figure 30; 264).
Concerning claim 5, the Mirizzi reference teaches the packaging of claim 1, wherein the at least one recess comprises a plurality of spaced apart recesses (Figure 28 & 29; recess defined in shell 210 and recess defined in shell 212).
Concerning claim 6, the Mirizzi reference teaches the packaging of claim 5, wherein adjacent recesses are connected by an opening (Figure 28; 224, shells may be connected via projections and bosses, the bosses defining openings).
Concerning claim 7, the Mirizzi reference teaches the packaging of claim 5, wherein the plurality of recesses are longitudinally aligned (Figure 30; 210, 212 recesses will share the same longitudinal axis when the shells are connected).
Concerning claim 8, the Mirizzi reference teaches the packaging of claim 5, wherein each of the plurality of recesses is a same size (Figure 30; shells are the same size, therein defining recesses that are the same size).
Concerning claim 9, the Mirizzi reference teaches the packaging of claim 5, wherein at least one of the plurality of recesses is a different size than another of the plurality of recesses (Figure 28; recess 40 may be defined as a recess within the larger recess of shell 210, which would define recesses of different sizes).
Concerning claim 10, the Mirizzi reference teaches the packaging of claim 2, wherein lateral movement of the delivery sheath is constrained within the holder by a friction element (Figure 10; walls of slot 122 may define a friction element given it is capable of providing a frictional fit | [¶ 0320]).
Concerning claim 11, the Mirizzi et al. prior art reference teaches a packaging for a vascular implant (Figures 26-41: 190 defines a system in which an implant is stored, therein defining it as packaging) comprising: (a) a container (Figure 26; 204) having (i) a plurality of recesses (Figures 28-29; cavity 252 in shell halves 210, 212, each shell half defining a recess) each dimensioned to receive a looped portion of the implant (Figure 26; 10), (ii) a channel extending from at least one of the plurality of recesses to a proximal end of the container (Figure 26; channel defined by cavity 252 of both combined half shells including the portion defined by 264), (b) a first packaging tube at least partially positioned within the channel (Figure 30; 202 defines a tube associated with the packaging, therein defining it as a packaging tube, which is positioned in portion 264 of the channel), and (c) a first member engageable with an end region of the implant (Figure 26; 150).
Concerning claim 12, the Mirizzi reference teaches the packaging of claim 11, wherein the container comprises an arcuate channel (Figure 30; 264) to receive a portion of a packaging tube (Figure 30; 202 defines a tube associated with the packaging, therein defining it as a packaging tube).
Concerning claim 13, the Mirizzi reference teaches the packaging of claim 12, wherein the packaging tube receives the first member (Figure 31; 150, 202).
Concerning claim 14, the Mirizzi reference teaches the packaging of claim 11, wherein the recesses are longitudinally aligned (Figure 30; 210, 212 recesses will share the same longitudinal axis when the shells are connected).
Concerning claim 18, the Mirizzi reference teaches the packaging of claim 11, wherein the plurality of recesses are connected by longitudinally extending recesses (Figure 28; 224, shells may be connected via projections and bosses, wherein the bosses define recesses that extend longitudinally, perpendicular to the outer walls of the shell).
Concerning claim 19, the Mirizzi reference teaches the packaging of claim 11, further comprising a second packaging tube (Figure 27; 570), wherein a first end of the second packaging tube is spaced from a second end of the first packaging tube to form a gap between the first and second packaging tubes (Figure 30; 262), and wherein an exposed position of the first member is exposed within the gap between the first and second packaging tubes (Figure 30; 156).
Concerning claim 20, the Mirizzi reference teaches the packaging of claim 19, wherein application of a pulling force to the first member is capable of pulling the vascular implant from the container where it is held in an unconstrained condition into a delivery sheath so the vascular implant has a reduced transverse dimension (Figure 40).
Claim(s) 11 and 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barney et al. (US 5,944,709, hereinafter Barney).
Concerning claim 11, the Barney et al. prior art reference teaches a packaging for a vascular implant (Figures 1-2; 10 | drug administered into blood stream may be interpreted as a vascular implant, and the container may be interpreted as packaging; furthermore, the examiner notes that the implant has not been positively recited, and thus the container must simply be capable of holding a vascular implant) comprising (a) a container (Figure 2; 10) having (i) a plurality of recesses (Figure 2; compartments 18 and 20 may define recesses) each dimensioned to receive a looped portion of the implant (the implant is not positively recited and the container must simply be capable of receiving a looped portion of an implant i.e. a microscopic looped drug structure may pass through each compartment as it is administered into the vasculature of a patient), and ii) a channel extending from at least one of the recess to a proximal end of the container (Column 26, Lines 22-41; a channel connects the plurality of compartments, therein defining a channel spanning the length of the container defined by the compartments and connection channels), b) a first packing tube at least partially positioned within the channel (Figure 2; 30 defines a tube associated with the packaging, therein defining it as a packaging tube), and c) a first member engageable with an end region of the implant (Figure 2; 32).
Concerning claims 15 and 17, the Barney reference teaches the packaging of claim 11, wherein the recesses are dome shaped and have covers to form bulbs (Figure 2; sheets 12 and 14 define covers that form bulbs and dome shaped recesses).
Concerning claim 16, the Barney reference teaches the packaging of claim 15, wherein the bulbs are transparent (Column 9, Lines 11-18).
Conclusion
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 MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
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/MARTIN T TON/Examiner, Art Unit 3771 12/11/2025