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 .
Election/Restrictions
Applicant’s election without traverse of Group I and Species 1 in the reply filed on 04/15/2026 is acknowledged.
Claims 51-65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/15/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/22/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 46 and 48-50 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.
Regarding claim 46, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 48, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 49, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 50, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 44-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson (US Patent Application Publication 2004/0043481) (already of record).
Regarding claim 44, Wilson discloses a device for vitrifying bioactive agents and delivering vitrified bioactive agents (Abstract), comprising:
a top housing (upper wall 30) having an inner surface, an outer surface, and a perimeter (para. 135) (Fig. 9, sheet 3 of 13);
a bottom housing (lower wall 30) having an inner surface, an outer surface, and a perimeter (para. 135, Fig. 9, sheet 3 of 13); and
an interconnect structure (called seal) operable to interconnect the top housing and the bottom housing to define an interior volume between the inner surface of the top housing and the inner surface of the bottom housing (para. 123, 135) (Fig. 9, sheet 3 of 13),
wherein the bottom housing is formed of a flexible material such that the bottom housing is deformable between a first configuration wherein the bottom housing is curved away from the top housing and a second configuration wherein the bottom housing is curved toward the top housing (para. 135, 149).
Regarding claim 45, Wilson discloses wherein the interior volume of the device with the bottom housing in the first configuration is larger than the interior volume of the device with the bottom housing in the second configuration (this function would necessarily occur when the bottom wall is “driven towards the cell attachment matrix”, see para. 149 and Fig. 9, sheet 3 of 13).
Regarding claim 46, Wilson discloses wherein the perimeter of the top housing and the perimeter of the bottom housing are interconnected (para. 123, 135) (Fig. 9, sheet 3 of 13). As to the limitation of the interconnect structure “preferably” including a lock element extending from the perimeter of the top housing, the bottom housing “preferably” including an engagement lip extending from the perimeter of the bottom housing, the engagement lip engaging with the lock element, this is understood to be a description of a preference rather than a required limitation and therefore the limitation does not introduce a patentable distinction over the prior art.
Regarding claim 47, Wilson discloses a substrate (called cell attachment matrix) disposed in the interior volume (para. 135) (Fig. 9, sheet 3 of 13).
Regarding claim 48, the limitation of the substrate “preferably” being held between the perimeter of the top housing and the perimeter of the bottom housing is understood to be a description of a preference rather than a required limitation and therefore the limitation does not introduce a patentable distinction over the prior art. Nonetheless, Wilson discloses wherein the substrate (cell attachment matrix 20) is held between the perimeter of the top housing and the perimeter of the bottom housing (Fig. 9, sheet 3 of 13).
Regarding claim 49, Wilson discloses wherein the top housing includes a central port (40) through which the interior volume is exposed (para. 135) (Fig. 9, sheet 3 of 13);
the device further comprising a connector (called septum) configured to receive a syringe (para. 124, 135).
Claims 44-48 and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coddaire et al. (US Patent Application Publication 2018/0242572) (already of record).
Regarding claim 44, Coddaire et al. discloses a device for vitrifying bioactive agents and delivering vitrified bioactive agents (Abstract, para. 32, 61-64), comprising:
a top housing (called cap) having an inner surface, an outer surface, and a perimeter (para. 34, 41) (Fig. 2A, sheet 2 of 7);
a bottom housing (called vial assembly) (para. 6) having an inner surface, an outer surface, and a perimeter (Fig. 5A, sheet 5 of 7); and
an interconnect structure operable to interconnect the top housing and the bottom housing to define an interior volume between the inner surface of the top housing and the inner surface of the bottom housing (para. 12, 31),
wherein the bottom housing is formed of a flexible material such that the bottom housing is deformable between a first configuration wherein the bottom housing is curved away from the top housing and a second configuration wherein the bottom housing is curved toward the top housing (para. 50) (Figs. 5A-5B, sheet 5 of 7).
Regarding claim 45, Coddaire et al. discloses wherein the interior volume of the device with the bottom housing in the first configuration is larger than the interior volume of the device with the bottom housing in the second configuration (para. 50) (Figs. 5A-5B, sheet 5 of 7).
Regarding claim 46, Coddaire et al. discloses wherein the perimeter of the top housing and the perimeter of the bottom housing are interconnected (para. 12, 31). As to the limitation of the interconnect structure “preferably” including a lock element extending from the perimeter of the top housing, the bottom housing “preferably” including an engagement lip extending from the perimeter of the bottom housing, the engagement lip engaging with the lock element, this is understood to be a description of a preference rather than a required limitation and therefore the limitation does not introduce a patentable distinction over the prior art. Nonetheless, Coddaire et al. discloses a lock element extending from the perimeter of the top housing and the bottom housing including an engagement lip extending from the bottom housing, the engagement lip engaging with the lock element (para. 12, 48, 65).
Regarding claim 47, Coddaire et al. discloses a substrate (called sample) disposed in the interior volume (para. 50).
Regarding claim 48, the limitation of the substrate “preferably” being held between the perimeter of the top housing and the perimeter of the bottom housing is understood to be a description of a preference rather than a required limitation and therefore the limitation does not introduce a patentable distinction over the prior art.
Regarding claim 50, Coddaire et al. discloses a basket disposed between the top housing and the bottom housing to form a seal between the top housing and the bottom housing when the top housing and the bottom housing are interconnected (para. 59). As to the limitation of the gasket “preferably” being hydrophobic and porous, this is understood to be a description of a preference rather than a required limitation and therefore the limitation does not introduce a patentable distinction over the prior art.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gustavsson (US Patent 7,771,768) is directed to a device comprising an upper surface and a lower surface wherein the lower surface is configured to flip between a convex state and a concave state based on a pressure within the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY KIPOUROS whose telephone number is (571)272-0658. The examiner can normally be reached M-F 8.30-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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