DETAILED ACTION
The following Office Action is in response to the Request for Continued Examination filed on June 16, 2026. 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 16, 2016 has been entered.
Response to Amendment
Concerning the “I. Objection” section on page 5 of the Applicant’s Response filed on June 16, 2026, the amendment to claim 11 to address the informality has obviated the necessity of the objection to the claim. Therefore, the objection is withdrawn.
Concerning the “II. § 112 Indefiniteness Rejections” section on page 5 of the Applicant’s Response filed on June 16, 2026, the amendment to claims 12 and 13 to address the issues of indefiniteness have obviated the necessity of the rejections of the claims under 35 U.S.C. §112(b). Therefore, the rejections are withdrawn.
Response to Arguments
Concerning the “III. § 102 Novelty Rejections over Mirizzi: A. Novelty Rejection of Claim 1 and Its Dependent Claims” section on pages 6-8 of the Applicant’s Response filed on June 16, 2026, the applicant’s arguments have been fully considered, but they are not persuasive.
The applicant first argues that claim 1 sets forth defined structural features and spatial arrangements that control how the packaging is configured with respect to the implant, therein defining the structural and positional relationship between the implant and the packaging. However, this still is not a positive recitation of the implant. The claims still recite “a packaging for a vascular implant”, wherein the packaging is not claimed to comprise the implant itself. Thus, although the structural and positional relationship between the implant and the packaging may be included within the scope of the claims, the specific structures with regards to the implant itself are not within the scope of the claims, given the implant has not been positively recited and the packaging may be used with a different implant that may have a different structure but may have the same structural and positional relationship with the packaging. Regardless, the examiner asserts that the Mirizzi reference still teaches an implant including the same claimed structure.
The applicant argues that the implant does not teach the limitation of an implant in a looped configuration and comprises a plurality of loops, arguing that there is no component in the present invention which wraps around the implant as in Mirizzi, but rather, the implant is wrapped around itself. However, the examiner asserts that the applicant has too narrowly interpreted the claim language. The applicant assumes that a looped condition and a looped portion including plurality of loops must be interpreted as an implant that is itself wrapped around itself multiple times, but this is not distinguished in the claim language. The claims simply recite a looped configuration, wherein the given the implant may be formed as a ring/loop, it may be interpreted as being in a loop configuration (Figure 26; 10). Furthermore, the tacks of 314, 320, and 322 may be defined as rings/loops that are associated with the implant, therein defining a plurality of loops, wherein these loops are on a portion of the implant, therein defining a looped portion. The looped portion and the plurality of loops have not been defined as specifically defining the looped configuration as wrapping the implant around itself, and thus the examiner’s interpretation is proper given the broad nature of the claim language. Therefore, the rejections of claim 1 and its dependent claims as being anticipated by Mirzzi stand.
Concerning the “III. § 102 Novelty Rejections over Mirizzi: B. Novelty Rejection of Independent Claim 11 and Its Dependent Claims” section on pages 8-9 of the Applicant’s Response filed on June 16, 2026, the applicant’s arguments have been fully considered, but they are not persuasive.
The applicant argues that the interpretation of Mirizzi is improper because the channel as interpreted by the examiner is not a narrow opening which extends from at least one of the plurality of recesses to the proximal end of the container. However, the examiner first argues that the channel has not been defined as a narrow opening, and the applicant has improperly read this structure into the claim language. Rather a channel is simply defined as “a passage or conduit” <thefreedictionary.com/channel>. The two recesses defined by the inner walls of half shells form a passage or conduit, therein defining a channel, wherein said channel may be interpreted as extending from the recesses, given the the recesses define the channel, wherein said channel extends to a proximal end of the container given the half shells themselves additionally define the proximal end of the container such that the recess transitions to a curved proximal end of the container.
The applicant then argues that coupler assembly 202, which the examiner has interpreted as being the packaging tube, is integrally formed with the coupler portion 264, therein failing to teach the first packaging tube at least partially positioned within the channel. However, the examiner asserts that the Mirizzi reference clearly states that this an alternate embodiment of the coupler assembly, given it states that the structure “therefore may alternately be considered part of the implant storage unit” [emphasis added]. This alternate embodiment therein shows that there is an alternative embodiment where the coupler assembly 202 is a separate component that is inserted into the channel of the housing at coupler portion 264 as shown in Figures 26-27, therein teaching that the packaging tube is at least partially positioned within the channel as claimed, therein teaching the limitation. Therefore, the rejections of claim 11 and its dependent claims as being anticipated by Mirizzi stand.
Concerning the “IV. § 102 Novelty Rejections over Barney” section on pages 10-11 of the Applicant’s Response filed on June 16, 2026, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the Barney reference does not teach the recesses being “dimensioned to receive a looped portion of the implant”, arguing that the Barney reference does not teach a structure for receiving or positioning an implant within the container. However, the examiner asserts that the implant has not been positively recited and may be of any size or structure. The implant may even be looped microscopic structures that are suspended in a liquid, wherein the compartments of the Barney reference are dimensioned as to receive looped portions of such an implant. Although there is no disclosure as such, the examiner notes that that the limitation is only functional in nature, wherein a recitation of functional language must result in a structural difference between the claimed invention and the prior art in order to patently distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the function, then it meets the claim. As described by the examiner, given the implant may be of any size or structure, the Barney reference is capable of receiving a looped portion of a vascular implant. Therefore, the rejections of claim 11 and its dependent claims as being anticipated by Barney stand.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-20 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of copending Application No. 18/091,462 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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 the first 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 first 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
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN T TON/Examiner, Art Unit 3771 9/2/2026
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