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 .
Drawings
The drawings are objected to because “Prior Art” label in Figures 4-7, 9d, 10a-10b and 11b should be deleted. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
A substitute specification including the claims is required pursuant to 37 CFR 1.125(a) because there are numerous words without spacing. For example, page 1 under Cross Reference to Related Application, the following appears: “ThisapplicationisacontinuationofU.S.ApplicationNo.:17/261,286filedlanuary19,2021,whichisaNationalStageEntryofPCT/IL2019/050871,FiledonAugust1,2019,”.
A substitute specification must not contain new matter. The substitute specification must be submitted with markings showing all the changes relative to the immediate prior version of the specification of record. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. An accompanying clean version (without markings) and a statement that the substitute specification contains no new matter must also be supplied. Numbering the paragraphs of the specification of record is not considered a change that must be shown.
Claim Objections
Claims 4-7 are objected to because of the following informalities:
-Claim 4, Line 4: “needlevalve” should be corrected to “needle valve”.
-Claim 5, Line 11: “blockedconfiguration” should be corrected to “blocked configuration”.
-Claim 6, Line 1: “claim4” should be corrected to “claim 4”.
-Claim 6, Line 1: “septumis” should be corrected to “septum is”.
-Claim 7, Line 4: “of that” should be corrected to “of the septum that”.
Appropriate correction is required.
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.
Claims 1, 4-5 and 7 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 is indefinite because the expression 'at the end of a movement that brings them to their closest position to each other' is not clear, since neither the movement, nor the location of the precisely closest position of the parts is defined.
Recitations of “the seat” on line 3 of claim 4, “the unblocked configuration” on line 9 of claim 5, “theblockedconfiguration” on line 11 of claim 5, “the disk shaped septum seat” and “the outer diameter” on line 3 of claim 7 and “the lower edge” on line 4 of claim 7 lack positive antecedent basis.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/183031 A1 to Kriheli et al. (hereinafter “Kriheli”) in view of US 2017/0189619 A1 to Constantineau et al. (hereinafter “Constantineau”).
Kriheli discloses a septum holder (158) located inside of the cylindrical body of the connector section, the septum holder comprising at least two parts, wherein the at least two parts of the septum holder comprise a body part (160) and a septum support (208) that are moveable in relation to each other (page 19, lines 25-33) and a septum (172) attached to the septum support.
Claim 1 differs from Kriheli in reciting that the body part and septum support are configured to be locked to each other at the end of a movement that brings them to their closest positions to each other.
However, Constantineau teaches the feature of locking of the body part and septum well known in the art (see paragraph 78) and the feature of the closest position is unclear and in any case a feature which has no surprising or unexpected effect and it does not solve any particular problem. Hence, it would have been obvious to a person of ordinary skill in the art to modify Kriheli to include the body part and septum support configured to be locked to each other at the end of a movement that brings them to their closest positions to each other to prevent exposure of the extended needle.
Regarding claim 2, Kriheli teaches that the septum holder (158) is part of a connector
section (92) for a liquid transfer apparatus, the connector section comprising: an outer body (78) having a proximal end adapted to be attached to syringe and an open distal end (fig. 13).
Regarding claim 3, Kriheli teaches that the body part (160) and the septum support (208) comprise components configured to releasably hold the septum support in an unblocked configuration and to allow it to be moved relative to the body part and to be locked in a blocked configuration (see Figure 13 to Figure 14).
Regarding claim 4, Kriheli teaches that the septum support (208) comprises a septum seat and the body part and septum support comprising openings to accommodate an insert (168) comprising at least one bore (170) that forms the seat of a needle valve (see Figure 13; page 19, lines 22-24).
Regarding claim 5, Kriheli teaches that the septum seat comprises at least one resilient elongated arm (162), terminating with a tooth shaped element (163) that projects downward through the body part and the body part comprises projecting elements (202) comprising at least one upper window through their interiors and at least one lower slot or window at their bottom section into which the tooth shaped elements at the bottom of at least one arm of the septum support can enter, wherein the at least one resilient elongated arm is configured to allow the tooth shaped element to click into the upper window to releasably hold the septum holder in the unblocked configuration and to allow the tooth shaped element to click into the lower slot or window to lock the septum holder in the blocked configuration (see Figure 13 to Figure 14; page 19, line 17 – page 20, line 16).
Regarding claim 6, Kriheli teaches that the septum (172) is attached to the septum support (208).
Regarding claim 7, Kriheli teaches that the septum (172) comprises an upper part comprising a hollow interior in the form of a cylindrical recess (206) having an inner diameter larger than that of the outer diameter of the disk shaped septum seat (202) and a lower part of that extends downward beyond the lower edge of the septum support of the septum holder (158)(see Figure 13; page 19, lines 26-31).
Double Patenting
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.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12,011,417 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The claim comparison table below discusses that the corresponding claims of U.S. Patent No. 12,011,417 B2 that anticipates the instant claims of U.S. Patent Application No. 18/663528.
Claims of
U.S. Patent Application No. 18/663,528
Claims of
U.S. Patent No. 12,011,417
Comparison
1
1
Narrow claim 1 anticipates broad instant claim 1 and contains all the limitations of claim 1.
2
1
Narrow claim 1 anticipates broad instant claim 2 and contains all the limitations of claim 2.
3
2/1
Narrow claim 2/1 anticipates broad instant claim 3 and contains all the limitations of claim 3.
4
3/1
Narrow claim 3/1 anticipates broad instant claim 4 and contains all the limitations of claim 4.
5
4/1
Narrow claim 4/1 anticipates broad instant claim 5 and contains all the limitations of claim 5.
6
5/3/1
Narrow claim 5/3/1 anticipates broad instant claim 6 and contains all the limitations of claim 6.
7
6/5/3/1
Narrow claim 6/5/3/1 anticipates broad instant claim 7 and contains all the limitations of claim 7.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, INSUK BULLOCK can be reached on 571-272-5954. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/John Kim/Primary Examiner, Art Unit 1777
JK
7/21/26
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