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/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-6, drawn to a liquid storage container.
Group II, claim(s) 7-8, drawn to a method of manufacturing a liquid storage container.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of:
a liquid storage container including a puncture port puncturable by a puncture instrument including a needle tube portion having a through hole provided therein, the liquid storage container comprising a liquid accommodation portion, a liquid discharge portion, a first partition and a second partition provided in the port main body portion,
this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Domkowski et al. (US 2006/0276769).
Domkowski discloses a liquid storage container (fluid container 12 in Figs. 1-2) including a puncture port (port closure assembly 88 and port 16 collectively, Figs. 1, 3A, and 12) puncturable by a puncture instrument including a needle portion (syringe needle 18 or piercing pin set 20) having a through hole (Fig. 9 shows how the pin 20 has a side opening near the piercing tip), the liquid storage container comprising:
a liquid accommodation portion that accommodates a liquid (within container wall 3; ¶ 113); a liquid discharge portion (either of fluid ports 14 and 16), a first partition and a second partition (diaphragm 110 and seal washer 118 respectively, Fig. 12).
During a telephone conversation with Yu-Te Chen on 3/5/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-6. Affirmation of this election must be made by applicant in replying to this Office action. Claims 7-8 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-3 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Domkowski et al. (US 2006/0276769).
Regarding claim 1, Domkowski discloses a liquid storage container (fluid container 12 in Figs. 1-2) including a puncture port (port closure assembly 88 and port 16 collectively, Figs. 1, 3A, and 12) puncturable by a puncture instrument including a needle portion (syringe needle 18 or piercing pin set 20) having a through hole provided therein (Fig. 9 shows how the pin 20 has a side opening near the piercing tip), the liquid storage container comprising:
a liquid accommodation portion that accommodates a liquid (within container wall 3; ¶ 113); a liquid discharge portion (either of fluid ports 14 and 16) that discharges the liquid accommodated in the liquid accommodation portion (¶ 57 in training characteristics of tubes 13 and 15 which are attached to the fluid ports 14 and 16),
the puncture port including:
a cylindrical port main body portion (Figs. 1-2 show how the puncture port is cylindrical); and
a first partition and a second partition (diaphragm 110 and seal washer 118 respectively, Fig. 12) provided in the cylindrical port main body portion being joined with the liquid discharge portion at a boundary portion between the liquid accommodation portion and the liquid discharge portion (Fig. 3A best shows how the partitions are provided within the cylindrical port main body portion, adjacent the container 12),
wherein a distance between the first partition and the second partition in a puncture direction is longer than at least a length of an opening portion of the through hole at a tip portion of the needle tube portion in the puncture direction (implied in Figs. 2, 9, & 12).
Regarding claim 2, Domkowski further discloses wherein the puncture port includes a cylindrical first port member having one and portion closed by the first partition and a cylindrical second port member having one end portion closed by the second partition (ports 14, 16 represent a first port member that is closed by the first partition, e.g. diaphragm 121, and tubes 13, 15 represent a second port member, closed by diaphragm 110), a portion of the second port member is provided at the boundary portion inside the first port member (Figs. 3A-3B show how the ports 14, 16 and tubes 13, 15 are adjacent one another, and thus the second port member is provided at a boundary portion and is inside the first port member), and the first port member, the second port member, and the liquid discharge portion are welded at the boundary portion (¶s 59 and 85-86 indicates welding of the various elements).
Regarding claim 3, Domkowski further discloses the first port member and the second port member are provided in the liquid discharge portion such that an opening on one other end portion of each of the first port member and the second port member faces the liquid accommodation portion (Figs. 3A-3B show continuous fluid connection with the container 12 plus comprising openings that face and connect the first and second port members to the liquid accommodation portion for fluid communication).
Regarding claim 5, Domkowski further discloses the liquid accommodation portion is provided by welding peripheral edge portions of a set of sheet-shaped members provided in an opposite manner (¶ 59) and the set of sheet -shaped members, the first port members, and the second port members are made of the same material (¶ 88 describes how the materials must comprise similar molecular properties in order to be joined together with welding; ¶s 9 and 87-89 describes how all the elements are made of polymers).
Regarding claim 6, the limitations of a distance between the first partition and the second partition in a puncture direction is longer than at least a length of an opening portion of the through hole at a tip portion of the needle tube portion in the puncture direction are considered functional language, as preceding claim 1 discloses the needle as an element intended to be used with the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Domkowski has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. it is capable of being used with a needle which has a length of an opening portion of a through hole at a tip of said needle such that a distance between the first partition and second partition in the puncture direction is longer than said needle length).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Domkowski as applied to claim 2 above, and further in view of Kang (US 2018/0050185 A1).
Regarding claim 4, Domkowski further teaches the port members and liquid discharge portions being welded to one another (¶s 59 and 85-86).
Domkowski does not explicitly teach the second port member includes a small diameter portion having an outer diameter substantially equal to an inner diameter of the first port member at the one end portion of the second port member, and a large diameter portion which is continuous with the small diameter portion and has an outer diameter substantially equal to the outer diameter of the first port member at the other end portion of the second port member.
However, Kang teaches a liquid storage infusion system (Fig 1; Abstract), thus being in the same field of endeavor, which uses port numbers in which a second port member comprises a smaller diameter having an outer diameter substantially equal to an inner part of a first port member at one and of the second port member, and a large diameter portion which is continuous with the small diameter portion and has an outer diameter substantially equal to the outer diameter of a first port member (Fig. 3, chamber 210 comprising the second port member and connector 300 and tubing 220 comprising the first port member).
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 first and second port members for the second port member to include a smaller diameter portion having an outer diameter substantially equal to an inner diameter of the first port member at the one end portion of the second port member, and a large diameter portion which is continuous with the small diameter portion and has an outer diameter substantially equal to an outer diameter of the first port member at the other end portion of the second port member, as taught by Kang. Doing so would also comprise the second port member being welded to the liquid discharge portion at the large portion. Doing so would be advantageous in forming a lock between said port members (¶ 33 of Kang).
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 and 5-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/286,519 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claim 1 recites all details of the current claim 1, including a cylindrical port main body portion, first and second partitions.
Although current claim 1 recites a discharge portion not found in the copending application ‘519, said discharge portion is comprised of the same ports that are found in copending application ‘519.
Double Patenting
Corresponding Claims
Instant Application
Claim 1
Claim 3
Claim 6
U.S. Patent No. 10,973,962
Claims 1, 2
Claim 5
Claim 1
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALESSANDRO R DEL PRIORE/ Examiner, Art Unit 3781
/GUY K TOWNSEND/ Primary Examiner, Art Unit 3781