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 species A in the reply filed on 22 June 2026 is acknowledged. The arguments are persuasive, the restriction is withdrawn.
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 127 and 132 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.
In re claim 127, “the plunger” lacks antecedent basis. It should depend from claim 128 and has been interpreted as such.
In re claim 132, “the sheath cap” lacks antecedent basis. The claim should depend on claim 131, not claim 130. The claim has been interpreted as such.
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.
(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.
Claim(s) 108-110, 118-121, 125-128 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raines (2015/0238749).
In re claim 108, Raines discloses a medical device system (figs.1-3) comprising:
a first container (100); and
a second container (175),
wherein the first container comprises:
a first container outer body (110), wherein the first container outer body defines a first interior space (120) connected to a first opening (opening closed by slit septum) of the first container; and
a first container-side valve (142) configured to be activated, upon connection of the second container to the first container, from a normally closed position that relatively reduces flow through the first opening of the first container into the first interior space to an activated position that relatively increases flow through the first opening of the first container into the first interior space (para.23), and
wherein the second container comprises:
a second container outer body (body of syringe) that defines a second container interior space; and
a stem (181) fluidly connected to the second container interior space, wherein, upon connection of the second container to the first container, the first container-side valve is configured to be brought into contact with the stem and the stem is configured to activate the first container-side valve from the normally closed position to the activated position (para.23).
In re claim 109, Raines discloses the medical device system according to claim 108, wherein the second container interior space extends along a longitudinal direction (fig.1), wherein at a first end portion of the second container interior space along the longitudinal direction, a width of the second container interior space decreases towards a first end opening of the second container interior space (fig.1), and wherein the stem is fluidly connected to the first end opening of the second container interior space and extends along the longitudinal direction (fig.1).
In re claim 110, Raines discloses the medical device system according to claim 109, wherein the stem is connected to the second container outer body to be stationary relative to the second container interior space (fig.1).
In re claim 118, Raines discloses the medical device system according to claim 108 wherein the first container further comprises a plunger seal (160) arranged within the first interior space, wherein the plunger seal is configured to receive a force to move the plunger seal within the first interior space to change a volume of space within the first interior space between the plunger seal and the first container-side valve (160 moves further within space 120 thereby changing the volume within when suction is applied via the syringe).
In re claim 119, Raines discloses the medical device system according to claim 118, further comprising a “plunger” (150, 155), wherein the plunger is configured to be removably connected to the plunger seal (para.26 “separately formed structures”).
In re claim 120, Raines discloses the medical device system according to claim 118, further comprising a “plunger” (150, 155) configured to apply the force to the plunger seal to move the plunger seal within the first interior space to change the volume of space within the first interior space between the plunger seal and the first container-side valve (para.26).
In re claim 121, Raines discloses the medical device system according to claim 108, further comprising: a “movable body” (150, 155) arranged within the first interior space of the first container outer body and configured to move within the first interior space.
In re claim 125, Raines discloses the apparatus as claimed, see the rejection of claim 108, supra.
In re claim 126, see the rejection of claim 118, supra.
In re claim 127, see the rejection of claim 119, supra.
In re claim 128, see the rejection of claim 120, supra.
In re claim 133, the method is anticipated by the normal use of the device as rejection in claim 118, supra.
Claim(s) 108, 111-113, 125, and 129 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zinger (2008/0249479).
In re claim 108, Zinger discloses a medical device system (fig.1) comprising:
a first container (22); and
a second container (21),
wherein the first container comprises:
a first container outer body, wherein the first container outer body defines a first interior space connected to a first opening of the first container (opening closed by stopper 24); and
a first container-side valve (13) configured to be activated, upon connection of the second container to the first container, from a normally closed position that relatively reduces flow through the first opening of the first container into the first interior space to an activated position that relatively increases flow through the first opening of the first container into the first interior space, and
wherein the second container comprises:
a second container outer body (outer surface of 21) that defines a second container interior space; and
a stem (34) fluidly connected to the second container interior space, wherein, upon connection of the second container to the first container, the first container-side valve is configured to be brought into contact with the stem and the stem is configured to activate the first container-side valve from the normally closed position to the activated position.
In re claim 111, Zinger discloses the medical device system according to claim 108, wherein the first container further comprises a sheath (17) defining a sheath interior space, and wherein at least a portion of the first container outer body is configured to be removably inserted within the sheath interior space.
In re claim 112, Zinger discloses the medical device system according to claim 111, wherein the sheath is configured to protect the contents of the first container from contamination and the first container is at least partially insertable within the sheath to protect the contents of the first container from contamination (figs.1, 11a-11h).
In re claim 113, Zinger discloses the medical device system according to claim 111, wherein the first container-side valve is configured to be connected to a first end portion of the sheath, and wherein the first container outer body is configured to be arranged within the sheath interior space to contact the first container-side valve such that upon activation of the first container-side valve from the normally closed position to the activated position the flow through the first opening of the first container into the first interior space is relatively increased (figs. 1, 5-7).
In re claim 125, Zingler discloses the apparatus as claimed, see the rejection of claim 108, supra.
In re claim 129, see the rejection of claim 111, supra.
Claim(s) 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 121, 125, 126, 129, 130, 131, 132, and 133 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kriesel (5,569,236).
In re claims 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 121, 125, 126, 129, 130, 131, 132, and 133 Kriesel discloses:
System/apparatus (figs.15-18)
first container (104)
second container (BC)
1st outer body or barrel (body of 104)
1st valve (slit septum valve 216a)
2nd body (barrel of syringe BC)
Stem (214)
Sheath or 1st outer body (200, 200a, 200b)
Sheath cap (220)
Vent (220a)
Filter (164)
Valve cap (204)
Plunger seal/moveable body (P). All of the function is shown in figs.s15-18 and/or described in the corresponding disclosure section.
Claim Rejections - 35 USC § 103
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 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(s) 122 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raines combined with the following reasons.
In re claim 122, Raines fails to explicitly disclose the claimed material.
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to select stainless steel as the material for the moveable body, since it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07
Claim(s) 121-123, and 124 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zinger in view of Xerox (JP2007000719, cited on IDS).
In re claim 121, Zinger fgails to explictyl disclose the limitation of claim 121.
Xerox discloses a medical device system comprising: a movable body arranged within the first interior space of the first container outer body and configured to move within the first interior space (figs.1-3 and paras.15-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the teachings of Xerox in Zinger for the purpose of ensuring fine particle dispersion.
In re claim 123, Xerox further teaches the medical device system according to claim 121, wherein the movable body is configured to be moved within the first interior space by a magnetic force exerted from outside of the first container (figs.1-3 and paras.15-18).
In re claim 124, Xerox further teaches the medical device system according to claim 121, wherein the movable body defines one or more through holes connecting a first side of the movable body facing the first container-side valve and a second side of the movable body opposite to the first side of the movable body (figs.1-3 and paras.15-18, once modified).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Timothy P. Kelly whose telephone number is (571)270-7615. The examiner can normally be reached from 8:30 a.m. to 4:30 p.m. (ET) on Monday, Thursday, and Friday.
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, Craig M Schneider can be reached at (571) 272-3607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Timothy P. Kelly/Primary Examiner, Art Unit 3753
Prosecution Insights