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 office action is in response to the reply filed on 12/19/2025 (which was in reply to the Non0Final Rejection mailed 11/3/2025), wherein claims 2, 7, 9-11 and 18 were amended; claims 4-6, 8, 12-13 and 21-22 were canceled; and claims 23-34 were added. Claims 2-3, 7, 9-11, 18-20 and 23-34 are pending.
Claim Rejections - 35 USC § 103
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.
Claims 2-3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Rinaldi et al. (US 6,379,740) in view of Murad et al. (US 2012/0290079).
Regarding claim 2, Rinaldi discloses a packaging system (See Fig. 3) storing a prosthetic heart valve (V), the packaging system comprising: a cup (4) containing the prosthetic heart valve (V), wherein the prosthetic heart valve is unconstrained within the cup; and a lid (5); wherein the lid is securable to the cup to provide a sterile environment for the prosthetic heart valve; and further wherein securement of the lid to the cup is characterized by the absence of a threaded interface between the lid and the cup, wherein the lid is a thin film that capable of being heat sealed to the cup. Rinaldi discloses the claimed invention except for a volume of a sterilization solution contained in the cup. However, Murad teaches a heart valve storage system (See Fig. 1) comprising a cup (at 22) and a lid (at 24), wherein a volume of a sterilization solution (glutaraldehyde) is contained in the cup for the purpose of preserving the heart valve ([0062]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the cup of Rinaldi with a volume of a sterilization solution as taught by Murad in order to better preserve the heart valve.
Regarding claim 3, Rinaldi discloses the lid is capable of being removed from the cup by peeling the lid away from the cup.
Regarding claim 7, Rinaldi discloses a flask (12) sized to receive the cup containing the prosthetic heart valve; and a cap (13) configured for securement over an open end of the flask.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Rinaldi et al. (US 6,379,740) in view of Murad et al. (US 2012/0290079) as applied to claim 7 above, and further in view of Rajpara et al. (US 2017/0056149). As described above, Rinaldi-Murad discloses the claimed invention except for the temperature indicator. However, Rajpara teaches a medical device packaging (at 50 in Fig. 11A) comprising a temperature indicator device including a temperature sensor (at 52), wherein the temperature indicator device includes a display visible from an exterior of the packaging and configured to convey information from the temperature sensor indicative of temperature conditions experience by the packaged item, for the purpose of indicating if the packaged item has been subjected to unacceptable temperatures ([0097]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the device of Rinaldi-Murad with a temperature indicator as taught by Rajpara in order to indicate if the heart valve has been subjected to unacceptable temperatures.
Further comprising claim 11, the color of the temperature indicator can be considered a data logger since it records temperature information from the temperature sensor over a period of time before the use of the item.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rinaldi et al. (US 6,379,740) in view of Murad et al. (US 2012/0290079) and Debbs et al. (US 6,622,864).
Regarding claims 18-20, Rinaldi discloses a packaged prosthetic heart valve (See Fig. 3) comprising: a cup (4); a prosthetic heart valve (V) contained in the cup, wherein the prosthetic heart valve is unconstrained within the cup; and a peelable lid film (5) sealed to a rim of the cup to provide a sterile environment for the prosthetic heart valve (column 3, lines 23-26 describes the sealing disc 5 formed from a material able to form a sterile barrier). Rinaldi discloses the claimed invention except for a volume of a sterilization solution contained in the cup and the lid being heat sealed to the rim of the cup.
Regarding the solution, Murad teaches a heart valve storage system (See Fig. 1) comprising a cup (at 22) and a lid (at 24), wherein a volume of a sterilization solution (glutaraldehyde) is contained in the cup for the purpose of preserving the heart valve ([0062]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the cup of Rinaldi with a volume of a sterilization solution as taught by Murad in order to better preserve the heart valve.
Regarding the heat seal, Debbs teaches a container (12) and lid (at 70), wherein the lid is heat sealed to the container by an adhesive having high tack and peelable seal quality for the purpose of moisture resistant and microbial contaminant resistant sterile environment (column 10, lines 24-40). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a heat seal between the cup and the lid of Rinaldi-Murad as taught by Debbs in order to form a moisture resistant and microbial contaminant resistant sterile environment.
Claims 23-25, 27-29, 31 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Rinaldi et al. (US 6,379,740) in view of Murad et al. (US 2012/0290079) and Rajpara et al. (US 2017/0056149).
Regarding claims 23 and 25, Rinaldi discloses a packaging system storing a prosthetic heart valve (at V), the packaging system comprising: a packaged prosthetic heart valve (at 3) comprising a cup (at 4) containing the prosthetic heart valve (V), and a lid (5) secured to the cup to provide a sterile environment for the prosthetic heart valve (column 3, lines 23-26 describes the sealing disc 5 formed from a material able to form a sterile barrier); a flask (at 12) sized to receive the packaged prosthetic heart valve; a cap (at 13) configured for fluid-tight securement over an open end of the flask, wherein the packaged prosthetic heart valve is configured to be received within a vacuum chamber defined by the flask and the cap. Rinaldi discloses the claimed invention except for a volume of a sterilization solution contained in the cup and the temperature indicator device.
Regarding the volume of a sterilization solution, Murad teaches a heart valve storage system (See Fig. 1) comprising a cup (at 22) and a lid (at 24), wherein a volume of a sterilization solution (glutaraldehyde) is contained in the cup for the purpose of preserving the heart valve ([0062]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the cup of Rinaldi with a volume of a sterilization solution as taught by Murad in order to better preserve the heart valve.
Regarding the temperature indicator device, Rajpara teaches a medical device packaging (at 50 in Fig. 11A) comprising a temperature indicator device (at 52) in form of a view port in the packaging (as shown in Fig. 11A) to convey temperature information to an exterior location of the packaging, for the purpose of indicating if the packaged item has been subjected to unacceptable temperatures ([0097]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the device of Rinaldi-Murad with a temperature indicator device as taught by Rajpara in order to indicate if the prosthetic heart valve has been subjected to unacceptable temperatures.
Further regarding claim 24, the color of the temperature indicator of Rinaldi-Murad-Rajpara can be considered a data logger since it records temperature information from the temperature sensor over a period of time before the use of the item.
Regarding claims 27-28, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the temperature indicator device on any part of the packaging system of Rinaldi-Murad-Rajpara such as the wet packaged prosthetic heart valve or the lid in order to allow for convenient viewing by the user. The temperature indicator device would perform the same function regardless of its location on the packaging system. It has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claims 29 and 31, the opening in the packaging (50) as taught by Rajpara that surrounds the temperature indicator device (at 52) can be considered a light guide since it guides and allows transmission of light from the temperature indicator device to the exterior of the packaging.
Regarding claim 33, Rinaldi discloses the lid comprises a thin film (as shown in Fig. 3).
Regarding claim 34, Rinaldi discloses thin film is capable of being heat sealed to the cup, due to the Tyvek material of the film.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Rinaldi et al. (US 6,379,740) in view of Murad et al. (US 2012/0290079) and Rajpara et al. (US 2017/0056149) as applied to claim 23 above, and further in view of Kansakoski et al. (US 2013/0017609). As described above, Rinaldi-Murad-Rajpara discloses the claimed invention except for the specifics of the temperature indicator device. However, Kansakoski teaches it is well known in the art for a temperature indicator device on a packaging to comprise a chemical sensor (indicator formed by a chemical reaction) for indicating a change in temperature has occurred. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the temperature indicator device of Rinaldi-Murad-Rajpara to be a chemical sensor as taught by Kansakoski in order to more accurately indicate temperature change.
Allowable Subject Matter
Claims 30 and 32 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.
Response to Arguments
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive.
Applicant argues that neither Rinaldi, nor Murad, either alone or in combination, teach or suggest “the lid is securable to the cup to provide a sterile environment” as defined in claim 2. Referring to FIG. 2, Rinaldi further discloses a vacuum bell (11) comprising a holding body (12) with associated closure cover (13). (Col. 3, lines 47-58). As discussed in col. 5, lines 41 through col. 6, line 9), in operation, the container (3) with prosthesis (V) in the cup-like body (12) with permeable seal (5) is positioned within the bell. The cover (13) is closed and then clamp (17) is locked with closure device (21). A vacuum pump (27) is activated to reach a predetermined sub- atmospheric pressure. Then, valve (24) is switched to switch from duct (26) to duct (25) before opening safety claim (28). Then liquid (inert liquid such as physiological saline, or an active liquid comprising one or more drugs) flows from the bag (23) into the chamber of the bell 11, thereafter penetrating into the container but passing across the permeable seal (5). The liquid, now within the cup-like body (4) completely saturates the prosthesis (V) therein and air bubbles are drawn out and replaced by the liquid due to the under pressure. Once completed, the clamp (17) is opened and to gain access to the container (3). The seal (5) can then be removed to obtain access to the prosthesis (V) that is ready to use.
Regarding Applicant’s argument, as described in the rejection of claim 2 above, Rinaldi discloses a lid (seal 5) that is securable to the cup (4) to provide a sterile environment for the contents of the cup (See column 3, lines 23-24 which describes the lid as forming a sterile barrier – “Sealing disc 5 is usually formed from a material able to form a sterile, although fluid-permeable, barrier”). It is noted that the features upon which applicant relies (i.e., the lid being fluid-impermeable) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that the objective evidence suggests that the fluid permeability of the permeable seal (5) necessary to allow liquid to penetrate the seal (5) when exposed to an under pressure would prevent the body (4) and permeable seal (5) from achieving a sterile environment. Any attempt to render the seal (5) of Rinaldi impermeable to fluid would destroy the functionality of Rinaldi's ability to allow an under pressure to permit inert liquid to permeate the seal (5) to treat the prosthesis (V) therein.
Regarding Applicant’s argument, as described in the rejection above, Examiner is not attempting to modify the seal (5) of Rinaldi to be impermeable, nor is Examiner attempting to modify the seal (5) of Rinaldi in any way. As described in the rejection of claim 2 above, Rinaldi discloses a lid (seal 5) that is securable to the cup (4) to provide a sterile environment for the contents of the cup (See Rinaldi column 3, lines 23-24 which describe the lid as forming a sterile barrier – “Sealing disc 5 is usually formed from a material able to form a sterile, although fluid-permeable, barrier”). The claims do not define the lid as being fluid-impermeable, as Applicant is appearing to argue. The claims only require the lid to be securable to the cup to provide a sterile environment, which lid 5 of Rinaldi does. It is noted that the features upon which applicant relies (i.e., the lid being fluid-impermeable) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that regarding claim 18, the permeable seal (5) of Rinaldi is required to be fluid permeable to allow fluid to pass in an under pressure environment. The objective evidence therefore suggests that the fluid permeable seal of Rinaldi is not capable of forming a sterile environment as fluid may pass through the permeable seal (5). The Office alleges that it would have been obvious to modify the seal of Rinaldi-Murad as taught by Debbs in order to form a moisture resistant and microbial contaminant resistant sterile environment. However, given that the permeable seal (5) of Rinaldi is required for proper functioning of the device, any attempt to modify the permeable seal (5) of Rinaldi to render it a "moisture resistant" seal would destroy the functionality of Rinaldi and render it inoperable for its intended purpose. At least for this reason, Applicant respectfully requests withdrawal of the corresponding rejection and allowance of claim 18.
Regarding Applicant’s argument, as described above, the lid (5) of Rinaldi forms a sterile barrier (See column 3, lines 23-24) while being fluid permeable. The claims do not require the lid to be fluid impermeable. It is noted that the features upon which applicant relies (i.e., the lid being fluid-impermeable and/or moisture resistant) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 STEVEN A REYNOLDS whose telephone number is (571)272-9959. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Stashick can be reached at (571) 272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN A. REYNOLDS/Primary Examiner, Art Unit 3735