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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/04/2019 is incompliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 5 is objected to because of the following informalities: the term “3D” should be clearly spelled in the claim followed by parentheses of the abbreviated term. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: a comma “,” should be inserted after “13” in claim 14, line 1.
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 8-9, 12 and 15-16 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.
The term “about” in claims 8-9, 12, and 15-16 are a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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, 6-10, and 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2013/0164838 A1-Zech.
Regarding claim 1, Zech discloses a sperm wash device (device for the selection of spermatozoa from a seminal fluid, para. [0095], lines 8-9, device shown in Fig. 2) comprising: a first chamber section for holding an unwashed semen sample (chamber 1, for receiving a seminal fluid medium containing the spermatozoa, para. [0095], lines 12-13, Fig. 2);
Zech discloses a second chamber section for holding sperm wash media disposed over and attached to the first chamber section (second chamber 2, for receiving the selected spermatozoa the selected spermatozoa in a further medium, para. [0095], lines 14-15, Fig. 2);
Zech discloses a ledge separating the first chamber section from the second chamber section, the ledge having a slot therein that is configured be filled with sperm wash media that does not get recovered (ledge—bridge element 3, shown in Fig. 3 separating chambers 1 and 2, further the bridge element 3 has a slot—element number 23, shown in Fig. 3 for introduction of medium 12a; and
Zech discloses a slider (element number 15, shown in Fig. 2 and 3) is placed on the ledge (bridge element 3, shown in Fig. 2), the slider being moveable between a first position and a second position, wherein at the first position, the slider allows fluid communication between the first chamber section and the second chamber section and at the second position, the slider blocks fluid communication between the first chamber section and the second chamber section (when the slider—element 15 is placed on element 27, which comprises both chambers 1 and 2, fluid communication is blocked between the two chambers, shown in Fig. 2),
And Zech discloses wherein during operation, the unwashed semen sample is placed in the first chamber section with the slider at the first position and then the slider is positioned in the second position, the sperm wash media is introduced into the second chamber section, after the sperm wash media is added, the slider is repositioned in the first position thereby allowing sperm to travel from the first chamber section to the second chamber section (the spermatozoa can travel via said fluid bridge from the seminal fluid of the first chamber to the nutrient solution of the second chamber, para. [0054], lines 1-3).
Regarding claim 2, Zech discloses wherein the second chamber section includes a slit adapted to receive the slider when positioned at the first position (Fig. 3 of Zech shows a small slit in the second chamber—second chamber 2, also shown below in annotated Fig. 3, where the slider—bridge element 3 fits into element 27, which comprises second chamber 2 of the device).
PNG
media_image1.png
323
419
media_image1.png
Greyscale
Regarding claim 3, Zech discloses wherein the first chamber section and the second chamber section are composed of a plastic (the device can be constructed of materials such as plastic, para. [0087], lines 1-2).
Regarding claim 6, Zech discloses wherein the first chamber section includes a first plurality of sidewalls that define a first cavity for holding the unwashed semen sample (first chamber 1, shown in Fig. 3, includes more than one sidewall of the chamber, thus defining a cavity for holding the sample.
Regarding claim 7, Zech discloses wherein the second chamber section includes a second plurality of sidewalls that define a first cavity for holding the sperm wash media (second chamber 2, shown in Fig. 3, includes more than one sidewall of the chamber, thus, defining a cavity for holding the media.
Regarding claim 8, Zech discloses wherein the first chamber section includes a first cavity having a volume from about 0.2 ml to 3 ml (the device as disclosed, the used minimum volume of the seminal fluid is about 1 milliliter, para. [0092], lines 1-3).
Regarding claim 9, Zech discloses wherein the second chamber section includes a second cavity having a volume from about 0.2 ml to 3 ml (the device as disclosed, the used minimum volume of the seminal fluid is about 1 milliliter, para. [0092], lines 1-3).
Regarding claim 10, Zech discloses wherein the slider has a bottom section attached to a side section, the bottom section configured to cover the slot when the slider is positioned at the second position (slider—element 15 has a bottom section attached to a side section, that is, the bottom portion of element 15 is attached to a side wall of element 15, also shown below in annotated Fig. 3; further, the bottom section of element 15 cover the slot of bridge element 3, as shown in Figures 2 and 3).
PNG
media_image2.png
270
793
media_image2.png
Greyscale
Regarding claim 13, Zech discloses a method for collecting motile sperm with the sperm wash device of claim 1 (abstract; para. [0001]), the method comprising:
introducing the unwashed semen sample into the first chamber section while the slider is in the first position (para. [0001], lines 13-18; slider—element 15 is in a first position, as shown in Figs. 2-3);
moving the slider to the second position (Fig. 3 shows element 15 can be mounted, thus, moved to a different or second position).
introducing the sperm wash media into the second chamber section (para. [0001], lines 18-19);
positioning the slider to the first position (Fig. 3 shows element 15 can be mounted, thus, moved to a different or to a first position);
allow sperm to swim from the first chamber section to the second chamber section for a predetermined period of time (para. [0129]); further Zech discloses the method of the present invention is carried out preferably in a time period of 20 to 120 minutes, more preferably of 25 to 100 minutes, even more preferably 30 to 60 minutes, most preferably 30 to 40 minutes (para. [0089]).
positioning the slider in the second position (Fig. 3 shows element 15 can be mounted, thus, moved to a different or to a second position);
collecting the sperm wash media having motile sperm therein (a fluid bridge between the first and second chamber occurs. This technique allows the DNA strand break-free, para. [0001], lines 21-24).
Regarding claim 14, Zech discloses wherein the sperm wash device is heated during collection of the motile sperm (the invention method may be carried out at a temperature between 19°C to 37°C, para. [0053]).
Regarding claim 15, Zech discloses wherein the sperm wash device is heated to a temperature from about 28°C to 45° C during collection of the motile sperm (the invention method may be carried out at a temperature between 19°C to 37°C, para. [0053]).
Regarding claim 16, Zech discloses wherein the predetermined period of time is from about 10 to 90 minutes (the method of the present invention is carried out preferably in a time period of 20 to 120 minutes, more preferably of 25 to 100 minutes, para. [0089]).
Regarding claim 17, Zech discloses wherein the predetermined period of time is about 30 minutes (the method of the present invention is carried, most preferably 30 to 40 minutes (para. [0089]).
Regarding claim 18, Zech discloses wherein the unwashed semen sample is liquified prior to being introduced into the first chamber section (para. [0048], lines 1-3).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0164838A1-Zech.
Regarding claim 4, Zech discloses the claimed invention except for the plastic is selected from the group consisting of polystyrene, polyolefins, nylon, and combinations thereof. It would have been obvious to one having ordinary skill in the art to include the device being made of polystyrene, polyolefins, nylon, and combinations thereof, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP §2144.07. Further, Zech suggests materials such as plastic can be flexible and non-toxic to spermatozoa, in particular for the artificial reproductive technology is prefer ably in vitro fertilization (IVF) and/or insemination (para. [0120] and para. [0121]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0164838A1-Zech as applied to claim 3 above, and further in view of US 9,757,726 B2-Sharpe et al. (hereinafter Sharpe).
Regarding claim 5, Zech teaches the invention discussed above in claim 3. Further, Zech teaches the device is comprised of plastic. However, Zech does not explicitly teach the plastic is 3D printable.
For claim 5, Sharpe teaches an invention relating to an apparatus and method for sorting particles, and in particular, to sorting of sperm cells in a microfluidic chip (col. 1, lines 5-7) and Sharpe teaches the core stream forming geometry 400, which is an interior surface of flow channel 418 of chip 80, may be fabricated in plastics and 3D printing (col. 17, lines 48-52), which reads on the instant claim limitation of 3D printable plastic.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the device Zech and further incorporate 3D print plastic as taught by Sharpe, because Sharpe teaches 3D printing of the device allows for improved flow capabilities and thus improved focusing capabilities (col. 17, lines 58-60).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0164838A1-Zech as applied to claim 10 above, and further in view of US 2012/0052485 A1-Shany et al. (hereinafter Shany).
Regarding claim 11, Zech teaches the invention discussed above in claim 10. Further, Zech teaches a bottom section of the slider, also discussed above. However, Zech does not explicitly teach wherein the bottom section is comprised of a mesh.
For claim 11, Shany teaches an invention relating to a device and method for processing a biologic sample, capable of sperm cells separation and/or preparation for treatment and/or diagnosis (para. [0002]), and Shany teaches a lip 335 having a bottom portion (shown in Fig. 1E) may be a perforated disk or mesh (para. [0307], lines 5-6), which reads on the instant claim limitation of a bottom section comprises of a mesh.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the bottom section of the slider of Zech to further include a mesh portion as taught by Shany, because Shany teaches the lip 335, which as discussed above, can be a perforated disk or mesh, allows for facilitating the flow of the separation-enabling agent (para. [0306], lines 1-3).
Regarding claim 12, Zech teaches the invention discussed above in claim 11. Further, Zech teaches a bottom section of the slider, also discussed above. However, Zech does not explicitly teach wherein the mesh includes openings having a diameter from about 20 microns to 100 microns.
For claim 12, Shany teaches an invention relating to a device and method for processing a biologic sample, capable of sperm cells separation and/or preparation for treatment and/or diagnosis (para. [0002]), and Shany teaches a lip 335 having a bottom portion (shown in Fig. 1E) may be a perforated disk or mesh (para. [0307], lines 5-6), where the mesh size in a range of 5x5 micron sq up to 3000x3000 micron void size (para. [0307], lines 7-8), which reads on the instant claim limitation of wherein the mesh includes openings having a diameter from about 20 microns to 100 microns.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the bottom section of the slider of Zech to further include wherein the mesh includes openings having a diameter from about 20 microns to 100 microns as taught by Shany, because Shany teaches the lip 335, which as discussed above, can be a perforated disk or mesh, allows for facilitating the flow of the separation-enabling agent (para. [0306], lines 1-3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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, Michael Marcheschi can be reached at (571) 272-1374. 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.
/L.A.A./ Examiner, Art Unit 1799
/MICHAEL L HOBBS/ Primary Examiner, Art Unit 1799