DETAILED ACTION
Response to Arguments
1. Applicant's arguments filed June 18, 2026 have been fully considered but they are not persuasive.
a) Applicant argues the amendments to claim 15 overcome the outstanding grounds of rejection over Fazi.
Examiner asserts Fazi still anticipates the amended claim. See detailed rejection below.
b) Applicant argues Fazi fails to teach the magnet is disposed in the septum.
Examiner asserts the argument is narrower than that which is explicitly claimed; claim 15 makes no limitations as to the location of the magnet in a septum.
c) Applicant argues Fazi fails to teach the magnet located in a fragile area.
Examiner notes the ground of rejection identified the fragile area as pierceable septum 141 and that the magnet 125 is located “in the area” meaning nearby, as seen in Fazi Fig. 1 therein.
Claim Objections
2. Claim 1 is objected to because of the following informalities:
Regarding claim 1, the phrase “connected to lid” should be “connected to the lid”.
Appropriate correction is required.
Double Patenting
3. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
4. Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,145,782 (“the ‘782 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘782 patent anticipate the instant claims. See claim-by-claim analysis below:
Claims 1-13 of the ‘782 patent
Instant claims 1-14
1. A sealing structure comprising:
1. A sealing structure comprising:
a lid comprising a first lid face,
a lid comprising a first lid face,
a second lid face opposite to the first lid face, and
a second lid face opposite to the first lid face, and
a fragile area between the first lid face and the second lid face;
a fragile area between the first lid face and the second lid face;
a cover comprising a first cover face facing the second lid face and covering the fragile area, and
a cover comprising a first cover face facing the second lid face and covering the fragile area, and
a second cover face opposite to the first cover face,
a second cover face opposite to the first cover face,
a connector configured to connect the lid and the cover…
a connector configured to connect the lid and the cover,
wherein the cover further comprises:
a proximal end portion connected to lid through the connector;
a distal end portion opposite to the proximal end portion; and
an extension portion extending along the second lid face between the proximal end portion and the distal end portion,
wherein the extension portion decreases in thickness from the proximal end portion to the distal end portion …
wherein the cover further comprises:
a proximal end portion connected to lid through the connector;
a distal end portion opposite to the proximal end portion; and
an extension portion extending along the second lid face between the proximal end portion and the distal end portion, and
wherein the extension portion decreases in thickness from the proximal end portion to the distal end portion.
1. … wherein the cover further comprises: a proximal end portion connected to lid through the connector; a distal end portion opposite to the proximal end portion; and an extension portion extending along the second lid face between the proximal end portion and the distal end portion, wherein the extension portion decreases in thickness from the proximal end portion to the distal end portion, and wherein the gap is maintained from the proximal end portion to the distal end portion.
2. The sealing structure of claim 1, wherein the cover further comprises: a first end portion; a second end portion opposite to the first end portion; and an extension extending along the second lid face between the first end portion and the second end portion.
2. The sealing structure of claim 1, wherein the extension portion is configured to deform based on the proximal end portion.
3. The sealing structure of claim 2, wherein the extension is configured to deform based on the first end portion.
3. The sealing structure of claim 1, wherein the cover further comprises a seat connected to the distal end portion and configured to contact the second lid face.
4. The sealing structure of claim 2, wherein the cover further comprises a seat connected to the second end portion and configured to contact the second lid face.
4. The sealing structure of claim 3, wherein the second lid face and the seat are separated from each other by a gap therebetween.
5. The sealing structure of claim 4, wherein the second lid face and the seat are separated from each other by a gap therebetween.
5. The sealing structure of claim 3, wherein the second lid face and the seat are configured to be in contact with each other, and wherein the second lid face and the seat are not physically restrained to each other.
6. The sealing structure of claim 4, wherein the second lid face and the seat are configured to be in contact with each other, and wherein the second lid face and the seat are not physically restrained to each other.
6. The sealing structure of claim 3, wherein the cover further comprises an adhesive portion provided between the second lid face and the seat, the adhesive portion being configured to bond the second lid face and the seat.
7. The sealing structure of claim 4, wherein the cover further comprises an adhesive portion provided between the second lid face and the seat, the adhesive portion being configured to bond the second lid face and the seat.
7. The sealing structure of claim 1, wherein the connector is positioned between the second lid face and the first cover face and the connector has a thickness smaller than the second distance between the first cover face and the second cover face.
8. The sealing structure of claim 1, wherein the connector is positioned between the second lid face and the first cover face and the connector has a thickness smaller than the second distance between the first cover face and the second cover face.
8. The sealing structure of claim 1, further comprising: a protrusion protruding from the second lid face or the connector.
9. The sealing structure of claim 1, further comprising: a protrusion protruding from the second lid face or the connector.
9. The sealing structure of claim 1, wherein the cover further comprises a coating layer provided on the first cover face.
10. The sealing structure of claim 1, wherein the cover further comprises a coating layer provided on the first cover face.
10. The sealing structure of claim 1, wherein the connector comprises: a support structure provided on the second lid face; and an elastic body connected to the support structure and the second cover face.
11. The sealing structure of claim 1, wherein the connector comprises: a support structure provided on the second lid face; and an elastic body connected to the support structure and the second cover face.
11. The sealing structure of claim 10, wherein the support structure comprises: a wall portion extending from the second lid face in a first direction; and a base portion extending from the wall portion in a second direction intersecting with the first direction to be connected to the elastic body.
12. The sealing structure of claim 11, wherein the support structure comprises: a wall portion extending from the second lid face in a first direction; and a base portion extending from the wall portion in a second direction intersecting with the first direction to be connected to the elastic body.
12. The sealing structure of claim 1, wherein the connector comprises a support structure provided on the second lid face, the support structure having a pivot to which the cover is rotatably connected.
13. The sealing structure of claim 1, wherein the connector comprises a support structure provided on the second lid face, the support structure having a pivot to which the cover is rotatably connected.
1. … wherein the cover further comprises: a proximal end portion connected to lid through the connector; a distal end portion opposite to the proximal end portion; and an extension portion extending along the second lid face between the proximal end portion and the distal end portion, …
…
13. The sealing structure of claim 12, wherein the cover further comprises: a weight provided on the extension portion.
14. The sealing structure of claim 13, wherein the cover further comprises: a first end portion; a second end portion opposite to the first end portion; an extension extending along the second lid face between the first end portion and the second end portion to be connected to the pivot; and a weight provided on the extension.
Claim Rejections - 35 USC § 102
5. 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.
6. Claims 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0030286 (Fazi).
Regarding claim 15, Fazi teaches a sealing structure comprising:
a lid (120) comprising a first lid face (bottom face of 120; see annotated Figure 1 below), a second lid face (upper face of 120; see annotated Figure 1 below) opposite to the first lid face, a fragile area between the first lid face and the second lid face (141; Examiner notes para. [0003] stating the collar “may include a septum” which is known in the art to be pierced by a needle in order to extract the contents of the vial), and a first pole element provided in the fragile area and configured to exhibit a first polarity (magnets may be embedded in collar 120, thus making them “in the fragile area”; para. [0021]); and
a cover (100) comprising a first cover face (bottom face of 103) connected to the second lid face, a second cover face opposite to the first cover face (upper face of 103), and a second pole element (102) configured to exhibit a second polarity opposite to the first polarity (explicitly taught to magnetically connect with 120, thus comprising an opposite polarity; see para. [0023]),
wherein the first cover face faces the second lid face and overlaps the fragile area (explicitly stated that cap 100 is held in contact with collar 120 by the magnetic connection; see para. [0023]), and
wherein a magnetic coupling of the first pole element and the second pole element is configured to increase a restoring force to restore the cover to an original position after a perforation is formed in the fragile area (the magnetic attraction between cover magnet 102 and lid magnet 125 serves to pull the cover back to its original after perforation of the fragile area 141; Examiner notes the claim lacks any limitation about automated return, and thus the broad amendment does not preclude the cover being reapplied by other means e.g. human hand).
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Regarding claim 16, the lid and the cover are formed of substantially a same material (Examiner notes para. [0024] teaches the collar 120, which is read as the claimed lid, is the same element as 220; para. [0032] teaches forming the collar 220 of “polymeric material” or “metal”; para. [0039] teaches cap 100, which is read as the claimed cover, is the same element as cap 400; para. [0041] teaches cap 400 may be formed of “polymeric material, metal, composite material, or combinations thereof”).
Regarding claim 17, the lid is formed of a first material and the cover is formed of a second material different from the first material (Examiner notes in view of the teaching above, the lid and cover i.e. the collar and cap of Fazi can be formed of different materials e.g. one of polymeric material and the other of metal, while still providing magnets in order to secure to each other).
7. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0030286 (Fazi) as applied above under 35 USC 102(a)(1) to claim 15, in view of US 9,815,601 (Browne).
Regarding claim 18, Fazi fails to explicitly teach the cover further comprises:
a first end portion connected to the second lid face; a second end portion opposite to the first end portion; and an extension extending along the second lid face between the first end portion and the second end portion, and configured to deform based on the first end portion.
Browne, analogous to sealing vials, teaches
a first end portion (unlabeled; see annotated Figure 6 below) connected to the second lid face (top surface of collar 50 in a similar interpretation as that used in Fazi above with respect to claim 15);
a second end portion (unlabeled; see annotated Figure 6 below) opposite to the first end portion; and
an extension (the portion of 62 located radially inside of legs 70) extending along the second lid face between the first end portion and the second end portion (spans the first and second portions, and extends along the second lid face e.g. the top surface of the collar), and configured to deform based on the first end portion (lifting of one end of flip cover 60 deforms the other end, as seen in the bending of leg 76 in Figure 5), for purposes of maintaining the sterility of the contents (col. 2, lines 55-59).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Fazi, providing a clip cover as taught by Browne, motivated by the benefit of maintain the sterility of the contents. See KSR International Co. v. Teleflex Inc. et al. No. 04-1350, 550 U.S. (2007) at 13, lines 22-25 which states, “When a work is available in one field of endeavor, design incentives ...can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious”.
Allowable Subject Matter
8. Claims 1 and 3-10 are allowed upon filing of a Terminal Disclaimer to overcome the outstanding ground of rejection above under nonstatutory double patenting. Claims 11-14 are withdrawn pending cancellation or rejoinder. Examiner notes claim 19, from which claim 20 depends, does not currently depend from any allowable independent claim, and thus is not indicated allowable.
9. The following is an examiner’s statement of reasons for allowance:
Regarding claim 1, from which claims 2-14 depend, none of the cited prior art teaches the claimed sealing structure whereby an extension portion decreases in thickness from a proximal first end adjacent the connection portion to distal second end. Examiner notes Fazi fails to teach any structure which can meet such a description; US 5,810,189 (Baker) appears to teach a constant thickness in cover (25). Additionally, Examiner has considered US 2012/0103470 (Terwilliger) but the reference does not anticipate, or otherwise render obvious the claimed invention. Specifically, claim 1 limits the extension portion as decreasing in thickness from a proximal end portion to a distal end portion. Conversely, Terwilliger (embodiments of Figures 3-11) teaches an extension portion (76, 170) which has a steady thickness, and a thicker plug member (64, 177) on the distal end; the embodiment of Figures 16-19 also fails to teach the extension portion (252) decreasing in thickness.
No motivation could be found to modify the prior art in order to arrive at the claimed invention.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 JAMES N SMALLEY whose telephone number is (571)272-4547. The examiner can normally be reached M-F 9:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nathan Jenness can be reached at (571) 270-5055. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES N SMALLEY/Examiner, Art Unit 3733
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