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 .
Response to Amendment
A preliminary amendment was filed on 09/08/2023. Claims 6-7 have been amended. Currently, claims 1-7 are pending and are being examined on the merits.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a holding mechanism configured to hold the engaging part in an engaged state with the lock collar” and “a release mechanism configured to release holding of the engaged state between the engaging part and the lock collar in the holding mechanism due to the syringe and the vial being moved relatively closer to each other to be placed in communication by the double-ended needle” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Notably, the holding mechanism will be interpreted as a means of engaging parts with concave grooves of a lock collar or equivalent structures thereof (see instant specification, paragraph 0066), and “a release mechanism configured to release holding of the engaged state…” will be interpreted as a structure intended to release convexo-concave engagement of the cap holder and lock collar or equivalent structures thereof (see instant specification, paragraph 0018)
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 5-7 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Kubo (JP 2014079331).
Regarding claim 1, Kubo discloses a coupler comprising:
a syringe attachment part (72) configured to detachably receive a syringe (18) including a nozzle part (32) (fig, 1, syringe 18 with a distal end opening portion 32), the nozzle part having a lock collar (fig. 1, cylindrical coupling portion 34);
a vial attachment part (44) configured to receive a vial (fig. 1, vial attachment part 44);
a double-ended needle (52) configured to place the syringe and the vial in communication (fig. 1, double ended needle member 52);
a cap holder including an engaging part (80) configured to engage with the lock collar (fig. 1, female screw portion 80 interpreted as engaging part)
a cap (36) configured to cover the nozzle part of the syringe, the cap being attached to the cap holder (see translation, abstract, “locking projections 92 provided to allow the syringe attachment part 72 to lock with the lid member 36”);
a holding mechanism configured to hold the engaging part in an engaged state with the lock collar (fig.1, holding mechanism interpreted as the walls that the female screw portion 80 is placed on); and
a release mechanism (60) configured to release holding of the engaged state between the engaging part and the lock collar in the holding mechanism due to the syringe and the vial being moved relatively closer to each other to be placed in communication by the double-ended needle (fig. 6 shows the process of the syringe and the vial being moved closer to each other, followed by them being separated leaving the lid member 36 behind, which is performed using partial screw portion 60 distinct from female screw portion 80).
Regarding claim 2, Kubo discloses the device further comprising a cap retaining mechanism (92) configured to hold the cap attached to the nozzle part of the syringe in the syringe attachment part, the cap retaining mechanism being configured to retain the cap separated from the nozzle part when the syringe is detached from the syringe attachment part (paragraph 0052, “As a result, the lid member 36 is disengaged from the tip opening 32 of the syringe 18 and held behind the syringe mounting portion 72 as it is”).
Regarding claim 5, Kubo discloses wherein the double-ended needle (52) is configured to be subjected to pushing force by insertion of the vial, and the pushing force causes the double- ended needle to move in the direction of getting closer to the syringe to puncture the cap (fig. 7 demonstrates the process of having the vial 16 pressed up against the needle member 52, sliding needle member 52 upwards to puncture the cap of the vial 18).
Regarding claim 6, Kubo discloses further comprising a housing member (74) having a tubular shape and configured to receive the syringe and the vial respectively (fig. 1, portion 74) on a first axial opening side and a second axial opening side (fig. 1, second axial opening receives vial at the bottom via cylindrical body portion 40, and syringe enters through a first axial opening on the opposite side), wherein the double-ended needle is attached to the housing member movably in an axial direction (fig. 1, needle portions 48 and 66 attached and movable up and down), a first locking mechanism is provided on the first axial opening side of the housing member, the first locking mechanism permitting insertion of the cap and the cap holder while preventing detachment of the cap and the cap holder (fig. 1, syringe detachment preventing members 56 to hold the cap), and a second locking mechanism is provided on the second axial opening side of the housing member, the second locking mechanism permitting insertion of the vial while preventing detachment of the vial (fig. 1, taper surface 67 as part of the housing to hold onto a vial 16 and prevent detachment).
Regarding claim 7, Kubo discloses a drug preparation device comprising:
the coupler according to claim 1 (see analysis of claim 1); and
the syringe (18) combined with the coupler (fig. 5 shows the syringe coupled with the coupler of claim 1), the syringe being detachable with respect to the syringe attachment part (fig. 7 shows the syringe being attachable and detachable) and comprising:
a syringe main body (fig. 1, barrel 28); and
the lock collar (78) that is a separate component from the syringe main body and is fixedly attached to the nozzle part of the syringe main body (fig. 1, lock collar is a distinct feature from the barrel 28, and is attached to the tip opening part).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kubo in view of Sanders (US 20180200498).
Regarding claim 3, Kubo discloses wherein the engaging part of the cap holder is configured to come into convexo-concave engagement with an outer circumferential surface of the lock collar (fig. 1, convexo-concave engagement caused by the male and female luer interaction), but does not teach wherein the holding mechanism comprises a deformation limiting part that is arranged on a radially outer side of the engaging part and is configured to limit radially outward deformation of the engaging part thereby holding the engaging part in the engaged state with the outer circumferential surface of the lock collar.
However, Sanders teaches a connector for fluid transfer (abstract) that utilizes a connecting means (60) and a holding mechanism comprising a deformation limiting part (fig. 1, structure part of second end 20 of housing 16) arranged on a radially outer side of the engaging part (fig. 1, noted structure radially outside of the locking member 60) and is configured to limit radially outward deformation of the engaging part (fig. 1, the structure at second end 20 limits deformation of locking member 60 by obstructing the path of deformation outward) thereby holding the engaging part in the engaged state with the outer circumferential surface of a structure (figs. 31-32 shows a patient connector 172 to be inserted into the locking member 60, the deformation limiting part as interpreted allowing the connection between the two).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Kubo such that the holding mechanism comprises a deformation limiting part that is arranged on a radially outer side of the engaging part and is configured to limit radially outward deformation of the engaging part thereby holding the engaging part in the engaged state with the outer circumferential surface of the lock collar, as taught by Sanders, for the purpose of providing a suitable structure that defines a means of having a first position where connection is allowed, and a second position where connection is restricted using a collet (see Sanders, paragraph 0064).
Allowable Subject Matter
Claim 4 is 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 4, Kubo, as modified by Sanders, does not teach the deformation limiting part is integrally provided with the double-ended needle, and due to the double-ended needle being moved in a direction of getting closer to the syringe to puncture the cap, the deformation limiting part is configured to move to a position away from the engaging part of the cap holder attached to the syringe such that the detachment of the engaging part from the lock collar is allowed by the radially outward deformation of the engaging part to constitute the release mechanism.
There does not appear to be a strong motivation to modify the deformation limiting part to be integrally provided with double-ended needle, as there is already a collect that already moves up and down.
Kriheli (US 20170258682) teaches a connector section that limits the movement of arms configured to attach to a structure, and appears to show the connector section integral with at least one needle, but does not appear to teach the deformation limiting part moving away from the engaging part such that detachment of the engaging part from the lock collar is allowed by radially outward deformation. In fact, as the part gets closer to the syringe, the engaging part appears to move upwards into the connector section and further limit detachment.
For these reasons, claim 4 is indicated as having allowable subject material.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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/Brandon W. Levy/Examiner, Art Unit 3781
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