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 Group I in the reply filed on 8/31/2026 is acknowledged.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4-5, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsuura (US 2008/0065033).
Regarding Claim 1, while Matsuura teaches a kit for a sample (Abstract, Figs. 18-23), comprising:
a sample device (Figs. 18-23, [0209] sperm collecting apparatus 1), comprising:
a body having a first open end and a second open end (Figs. 18-21, [0209] container main unit 3 / body having a first open end / opening portion 4a and a second open end / opening portion 4b);
a first cap configured to removably couple to the body at the first open end (Figs.18-21, [0209] cap 5a / first cap detachably coupled to the container main unit 3 / body at the first open end / opening portion 4a); and
a second cap configured to removably couple to the body at the second open end (Figs.18-21, [0209] cap 5b / second cap detachably coupled to the container main unit 3 / body at the second open end / opening portion 4b),
wherein at least one of the first and second caps comprises a first opening and a removable seal sized and dimensioned to seal the first opening ([0213] small hole for degassing / first opening and an unshown removable seal provided at caps 5a and 5b for both ends),
Matsuura fails to teach the removable seal being a removable plug.
However Matsuura teaches a sealing mechanism when coupled the caps and the body may include a plug structure to seal the open ends of the body (Figs. 18-21, [0045], [0162], [0234] projecting portions 51 of caps 5a, 5b plug respective insertion ports 11a, 11b).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the unshown sealing structure of the small holes of the caps of Matsuura may comprise a removable seal with a projecting plug as taught by Matsuura as a known structure to accomplish the sealing of opening, providing the unnamed detail in Matsuura and enabling standardization of construction for the invention.
Regarding Claim 4, Matsuura teaches the kit of claim 1, wherein the first cap comprises a first end portion and a first sealing portion that extends from the first end portion (See Claim 1 Rejection, Figs. 23(a)-(23(c), [0234] caps 5a, 5b comprise supporting plate 52 at first end portion and a first sealing portion / projecting portion 51 that extends from the first end portion).
Regarding Claim 5, Matsuura teaches the kit of claim 4, wherein the first sealing portion comprises a ring shape and is sized and dimensioned to be securely received by the first open end of the body (See Claim 4 Rejection, Fig. 23(a)-23(b) [0234] projecting portion 51 / sealing portion comprises a ring shape and is sized and dimensioned to be securely received by the first open end of the body at the insertion ports 11a, 11b).
Regarding Claim 7, Matsuura teaches the kit of claim 1, wherein the plug comprises a sealing portion and a handling portion, wherein the first opening has a first diameter, wherein the handling portion has a second diameter that is larger than the first diameter, and wherein the sealing portion has a third diameter that is smaller than the first diameter (See Claim 1 Rejection, Examiner will refer to Figures 23(a)-23(c) as reference for a plug for the small hole. Here, insertion port 11a corresponds to the first opening with a first diameter, the supporting plate 52 would correspond to the handling portion with a second diameter, and the projecting portion 51 corresponds to the sealing portion with a first diameter, reflecting that a plugging structure will necessitate the handling portion’s diameter to be greater than the opening’s diameter, and the opening’s diameter will need to be greater than the sealing portion’s diameter. In applying this plugging structure to the small hole, these dynamics would remain consistent).
Claim(s) 2, 6, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsuura in view of Sanchez Serrano et al (US 2012/0078136) (“Sanchez”).
Regarding Claim 2, while Matsuura teaches the kit of claim 1, Matsuura fails to teach wherein the first opening is sized and dimensioned for receiving at least a portion of a pipette.
However Sanchez teaches a device for semen collection (Figs. 1-3, Abstract, [0019]-[0021] with the semen collector having a sealed opening by way of a tearable sector 6) comprising
a cap configured to removably couple to the body ([0019] a cap / closure cover 4 configured to removably couple to the body / tube by threaded connection),
wherein the cap may comprises an opening to enable the passage of a pipette for collection of a semen sample (Figs. 1-3, [0019] –[0021] in use, cap / closure cover 4 will have an opening through sheet 12 based on pipette’s piercing, to allow pipette to withdraw the collected semen sample).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that a central cap opening for a pipette of Sanchez can be added to the cap of Matsuura ensure the secure collection of semen of Matsuura will also still enable a secure pipette acquisition of semen after a collected semen has been delivered to an appropriate location. This ensures the intended functionality of Matsuura, collection for medical purposes ([0002]), can be fulfilled.
Regarding Claim 6, while Matsuura teaches the kit of claim 4, Matsuura fails to teach wherein the first end portion comprises a pull tab.
However Sanchez teaches a device for semen collection (Figs. 1-3, Abstract, [0019]-[0021] with the semen collector having a sealed opening by way of a tearable sector 6) comprising
a cap configured to removably couple to the body ([0019] a cap / closure cover 4 configured to removably couple to the body / tube by threaded connection),
wherein the cap comprises a top end portion with a pull tab ([0019] pull tab 7).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the cap of Matsuura comprises a pull tab at a first end portion as Sanchez teaches this can be an actuation mechanism to enable access to the first opening.
Regarding Claim 18, while Matsuura teaches a sample device (Figs. 18-23, [0209] sperm collecting apparatus 1), comprising:
a body having a first open end and a second open end (Figs. 18-21, [0209] container main unit 3 / body having a first open end / opening portion 4a and a second open end / opening portion 4b);
a first cap configured to couple to the body at the first open end (Figs.18-21, [0209] cap 5a / first cap detachably coupled to the container main unit 3 / body at the first open end / opening portion 4a), wherein the first cap comprises an opening ([0213] a small hole for degassing),
a second cap configured to couple to the body at the second open end (Figs.18-21, [0209] cap 5b / second cap detachably coupled to the container main unit 3 / body at the second open end / opening portion 4b), and
a seal configured to seal the central opening ([0213] small hole for degassing / first opening and an unshown removable seal provided at caps 5a and 5b for both ends),
Matsuura fails to teach the seal configured to seal the opening being a plug
However Matsuura teaches a sealing mechanism when coupled the caps and the body may include a plug structure to seal the open ends of the body (Figs. 18-21, [0045], [0162], [0234] projecting portions 51 of caps 5a, 5b plug respective insertion ports 11a, 11b).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the unshown sealing structure of the small holes of the caps of Matsuura may comprise a removable seal with a projecting plug as taught by Matsuura as a known structure to accomplish the sealing of opening, providing the unnamed detail in Matsuura and enabling standardization of construction for the invention.
Yet Matsuura fails to teach the opening being a central opening.
However Sanchez teaches a device for semen collection (Figs. 1-3, Abstract, [0019]-[0021] with the semen collector having a sealed opening by way of a tearable sector 6) comprising
a cap configured to removably couple to the body ([0019] a cap / closure cover 4 configured to removably couple to the body / tube by threaded connection),
wherein the cap may comprises a central opening to enable the passage of a pipette for collection of a semen sample (Figs. 1-3, [0019] –[0021] in use, cap / closure cover 4 will have an opening through sheet 12 based on pipette’s piercing, to allow pipette to withdraw the collected semen sample).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that a central cap opening for a pipette of Sanchez can be added to the cap of Matsuura ensure the secure collection of semen of Matsuura will also still enable a secure pipette acquisition of semen after a collected semen has been delivered to an appropriate location. This ensures the intended functionality of Matsuura, collection for medical purposes ([0002]), can be fulfilled.
Regarding Claim 19, Matsuura and Sanchez teach the sample device of claim 18, and Sanchez teaches wherein the first end portion comprises a pull tab ([0019] pull tab 7).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the cap of Matsuura comprises a pull tab at a first end portion as Sanchez teaches this can be an actuation mechanism to enable access to the first opening.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsuura in view of Cassou et al (US 5,582,602) (“Cassou”).
Regarding Claim 3, while Matsuura teaches the kit of claim 1, wherein the first opening is sized and dimensioned for receiving at least a portion of an air pump tube.
However Cassou teaches a semen collector (Abstract, Fig. 1) where a vial for collecting semen may include a cap with a hole for an air pump tube to enable the collection of the semen (Abstract, Fig. 1, Col. 2, L. 28- Col. 3, L. 53)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that an opening for air pump tube of Cassou be added to the cap of Matsuura as structure that ensure the secure collection of semen of Matsuura will also still enable a secure air pump acquisition of semen after a collected semen has been delivered to an appropriate location. This ensures the intended functionality of Matsuura, collection for medical purposes ([0002]), can be fulfilled.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsuura in view of Schmitt et al (US 2019/0358012) (“Schmitt”).
Regarding Claim 8, while Matsuura teaches the kit of claim 1, Matsuura fails to teach the body is made from a clear plastic.
However Schmitt teaches a device for collecting semen (Fig. 1, Abstract) where a collection cup is made of a transparent plastic ([0049]-[0051] enables an immediate judgement of quantity and quality of semen).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the device of Matsuura to utilize a clear plastic for the body of the sample device as taught by Schmitt to benefit from the same visual advantages as Schmitt’s [0049]-[0051].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsuura in view of Prien et al (US 2021/0401410) (“Prien”).
Regarding Claim 9, while Matsuura teaches the kit of claim 1, further comprising: a packaging containing a preservative suitable for preserving the sample for a period of at least 12 hours.
However Prien teaches a sperm collection device (Fig. 1, Abstract) comprising the step of adding a preservative suitable for preserving the sample for a period of time of at least 12 hours ([0186]-[0187] antioxidant incorporated into the surface contacting biological fluids [0236], [0274], [0305], [0319], [0322], [0324], [0330] where such modifications can lead to preserving the sample for a period of time of at least 12 hours).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the kit of Matsuura to further include a preservative suitable for preserving the sample for a period of time of at least 12 hours as taught by Prien to ensure the sample remains viable as it is delivered to the appropriate medical facility.
Regarding Claim 11, Matsuura and Prien teach the kit of claim 9, wherein the preservative is suitable for preserving the sample at room temperature for a period of at least 12 hours (See Claim 9 Rejection, Prien: [0319] testing for the preservative done above room temperature to create an accelerated simulation, indicating the positive results seen at 6 hours in [0322] teach suitability for preserving the sample at room temperature for at least 12 hours).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsuura in view of Prien and further in view of Hwang et al (KR 20150101498) (“Hwang”) and further in view of Weikart et al (WO 2024/054494) (“Weikart”).
Regarding Claim 10, while Matsuura and Prien teach the kit of claim 9, wherein the preservative comprises an antioxidant (See Claim 9 Rejection), their combined efforts fail to teach the antioxidant is a curcumin powder.
However Hwang teaches a composition for the preservation of sperm (Abstract) that comprises curcumin (Abstract) and Weikart teaches biological sample preservatives (Abstract) and how they can be delivered as powders and then reconstituted in biological sample body fluids ([0075]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the preservative as Prien specifically as curcumin as taught by Hwang as this is a compound that has shown efficacy with sperm specifically (Hwang: Abstract). Furthermore, it would be obvious to have the curcumin in the powder format as taught by Weikart as a standardized way of delivering a preservative to body fluid for suitable combining.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsuura in view of Ericsson et al (US 5,068,089) (“Ericsson”).
Regarding Claim 12, while Matsuura teaches the kit of claim 1, Matsuura fails to teach the kit further comprising a stand for the sample device.
However Ericsson teaches a kit containing a semen sample device (Abstract, Fig. 1) where the kit may include a stand for the sample device (Col. 8, L. 33-45, support 13).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include a stand of Ericsson as part of the kit of Matsuura as a way to provide a component that frees a user’s hands during the sampling process and enables the ejaculate to collect at a bottom of the vial due to gravity (Col. 8, L. 46-64).
Claim(s) 13-14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsuura in view of Ericsson and further in view of McGhie (US 2012/0265098) and further in view of Kindt et al (US 2015/0315564) (“Kindt”).
Regarding Claim 13, while Matsuura and Ericsson teach the kit of claim 12, wherein the stand comprises:
a base portion (Fig. 1, support 13’s legs that extend to the ground);
a holder portion comprising at least one holder sized and dimensioned to hold at least one sample device of the one or more sample devices (Fig. 1, hole 23 holds sample device / tube 10); and
a support portion extending between the base portion and the holder portion (Fig. 1, the top wall between the hole 23 and the legs of the support 13), their combined efforts fail to teach the holder portion comprising at least one holder sized and dimensioned such that the at least one sample device is positioned above the base.
However McGhie teaches a biological sampler where the tube for biological sample can interface with a stand for the sampler device (Abstract, Figs. 1 and 3, [0017]-[0018], [0033]) comprising
a base portion (Figs. 1 and 3, [0017]-[0018], [0033] base 20 with first arm 23 and second arm 26);
a holder portion comprising at least one holder sized and dimensioned to hold at least one sample device of the one or more sample devices (Figs. 1 and 3, [0017]-[0018], [0033] holes 136 that hold sample devices by snap-fit connection) such that the at least one sample device is positioned above the base; and
a support portion extending between the base portion and the holder portion (Figs. 1 and 3, [0017]-[0018], [0033] boom 122).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the stand of McGhie as part of the kit of Matsuura as a way to provide a stand component that frees a user hands during the sampling process. And despite the fact that the system of McGhie is related to biopsies, Kindt teaches that vials for collecting biological samples may be externally structured the same for both biopsies and semen ([0055]-[0057]).
Regarding Claim 14, Matsuura, Ericsson, McGhie, and Kindt teach the kit of claim 13, wherein the sample device further comprises a first coupling component, and wherein the at least one holder comprises a second coupling component complementary to the first coupling component (See Claim 13 Rejection, external wall of Matsuura acts a first coupling component, holes of McGhie’s stand acts as a second coupling component).
Regarding Claim 16, Matsuura, Ericsson, McGhie, Kindt, and Nakamura teach the kit of claim 13, wherein the at least one holder comprises a C-shaped portion extending about perpendicularly from the support portion (See Claim 13 Rejection, McGhie: holes 136 extend perpendicularly from one side of the support portion).
Claim(s) 15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsuura in view of Ericsson and further in view of McGhie and further in view of Kindt and further in view of Nakamura (US 2021/0401409).
Regarding Claim 15, while Matsuura, Ericsson, McGhie, and Kindt teach the kit of claim 13, and wherein the at least one holder is sized and dimensioned to hold the sample device such that the sample device does not contact the base (See Claim 13 Rejection), their combined efforts fail to teach wherein at least one of the sample device and the holder comprises a gripping material.
However Nakamura teaches a sperm collecting device (Abstract, sperm collector 200) where a separate device holds onto the sample device with the holder portion comprises a gripping material (Abstract, [0036] sperm collector driving device 100 holds onto sperm collector 200 through holding unit 120, the holding unit 120 interfacing with a side packing 122 that grips the sample device).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to for the holes of McGhie to include gripping material as taught by Nakamura to provide trust in the holding mechanism of the sample device of Matsuura.
Regarding Claim 17, while Matsuura, Ericsson, McGhie, and Kindt teach the kit of claim 16, their combined efforts fail to teach wherein the C-shaped portion comprises at least one of flexible end portions, a gripping material, and a compressible material.
However Nakamura teaches a sperm collecting device (Abstract, sperm collector 200) where a separate device holds onto the sample device with the holder portion comprises a gripping material (Abstract, [0036] sperm collector driving device 100 holds onto sperm collector 200 through holding unit 120, the holding unit 120 interfacing with a side packing 122 that grips the sample device).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to for the holes of McGhie to include gripping material as taught by Nakamura to provide trust in the holding mechanism of the sample device of Matsuura.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
Prosecution Insights