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 .
This office action is responsive to the amendment filed on 12/18/2024. As directed by the amendment: claims 17-20 have been withdrawn. Thus, claims 1-2- are presently pending in this application and claims 1-16 are presently under examination.
Election/Restrictions
Applicant’s election without traverse of Claims 1-16 in the reply filed on 12/18/2024 is acknowledged.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/18/2024.Thus, claims 1-16 are presently under consideration for examination.
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 10-11 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 10-11 is 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 § 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.
Claims 1-7, 10, 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 20150105813 A1) in view of Holmes et al. (US 20170023546 A1).
Regarding Claim 1, Li teaches a blood sample collection device ('lancing device 3', fig.1, ¶ 39; "blood collecting apparatus", ¶ 30), comprising:
PNG
media_image1.png
437
586
media_image1.png
Greyscale
Annotated Figure 1 of Li
a distal barrel coupled with a proximal barrel (see annotated figure 1);
PNG
media_image2.png
403
633
media_image2.png
Greyscale
Annotated Figure 2 of Li
an actuator (see annotated figure 2) longitudinally disposed throughout the distal barrel and the proximal barrel (see annotated figure 1);
a biasing mechanism ('spring 61', fig.2, ¶ 49, 52) for retaining the distal end 232 within an interior of the distal barrel (see annotated figure 1) ("the lancet holder 5 compresses the spring 61 to use a spring force of the spring 61 to provide the triggering force needed for moving the lancet holder 5 to the triggered position", ¶ 52); and
a push button ('releasing device 62a', figs.1 and 2, ¶ 52) coupled with a proximal end of the actuator (see annotated figure 2) for extending the one or more frits through a distal opening (see annotated figure 1) of the distal barrel.
Li fails to teach one or more frits disposed within a distal end of the actuator. Holmes teaches one or more frits ('the anti-leakage devices 1194 are frits', fig.11I, ¶ 282).
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 blood collecting apparatus of Li to include one or more frits, as taught by Holmes, that would be disposed within a distal end of the actuator, in order to contain fluid samples within the vessels for collection.
Regarding Claim 2, Li fails to teach the distal barrel is coupled to the proximal barrel by way of a plurality of threads.
Holmes teaches the distal barrel is coupled to the proximal barrel by way of a plurality of threads (“the cap and/or the sample vessel body may be threaded to permit a screw-type engagement”, ¶ 380, 391; “Some Luer connectors may use a press-fit to engage other connectors while some embodiments of the connector 2102 may include threads to facilitate engagement”, ¶ 430).
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 blood collecting apparatus of Li such that the distal barrel would be coupled to the proximal barrel by way of a plurality of threads, as taught by Holmes, such that the push button would be configured to be pushed in a distal direction to extend the one or more frits through the distal opening, in order to permit and facilitate a screw-type engagement (¶ 380).
Regarding Claim 3, Li teaches the biasing mechanism 61 is disposed between an interior of the distal barrel (see annotated figure 1) and a circumferential lip comprising the actuator (see annotated figure 2).
Regarding Claim 4, Li teaches the push button 62a is configured to be pushed is a distal direction (towards distal opening) through the distal opening (see annotated figure 1) ("The triggering force providing device 61 provides a triggering force needed for moving the lancet holder 5 from the to-be-triggered position to the triggered position; the releasing device 62 releases the lancet holder 5 from the to-be-triggered position to let the triggering force move the lancet holder 5 to the triggered position", ¶ 51). Li fails to teach the push button is configured to be pushed is a distal direction to extend the one or more frits through the distal opening. Holmes teaches one or more frits ('the anti-leakage devices 1194 are frits', fig.11I, ¶ 282).
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 blood collecting apparatus of Li to include one or more frits, as taught by Holmes, such that the push button would be configured to be pushed in a distal direction to extend the one or more frits through the distal opening, in order to contain fluid samples within the vessels for collection.
Regarding Claim 5, Li teaches the biasing mechanism 61 is configured to withdraw through the distal opening when the push button is released ("When the lancet holder 5 has reached its maximum moving distance, the push force from the spring 61 vanishes, while the elastic elements 571 and 572 release the accumulated elastic force to pull back the lancet holder 5, thereby retracting the lancet holder 5 and the lancet 2 to the to-be-withdrawn position", ¶ 49).
Li fails to teach the biasing mechanism is configured to withdraw the one or more frits through the distal opening when the push button is released. Holmes teaches one or more frits ('the anti-leakage devices 1194 are frits', fig.11I, ¶ 282).
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 blood collecting apparatus of Li to include one or more frits, as taught by Holmes, such that the biasing mechanism would be configured to withdraw the one or more frits through the distal opening when the push button would be released, in order to contain fluid samples within the vessels for collection.
Regarding Claim 6, Li fails to teach the one or more frits are each configured to intake a blood sample and store the blood sample in a dried state. Holmes teaches the one or more frits ('the anti-leakage devices 1194 are frits', fig.11I, ¶ 282) are each configured to intake a blood sample and store the blood sample in a dried state ("a processing step on the sample had not been performed; using a processor to perform or re-perform a step. Optionally, the method further comprises a single-step loading of the sample vessel(s) into the tray and then a single-step loading of the tray into the transport container", ¶ 36; "the anti-leakage devices 1194 are frits which may be slidably moved from a first position where they prevent sample from leaking out from the adapters 1150 and 1152", ¶ 282; NOTE: it would be obvious that the samples would be dry when stored and processed for transport).
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 blood collecting apparatus of Li to include one or more frits, as taught by Holmes, such that the one or more frits would each be configured to intake a blood sample and store the blood sample in a dried state, in order to contain fluid samples within the vessels for collection.
Regarding Claim 7, Li teaches the distal end of the actuator (see annotated figure 2). Li fails to teach the one or more frits comprise four individual frits that are removably coupled with the distal end of the actuator. Holmes teaches the one or more frits ('the anti-leakage devices 1194 are frits', fig.11I, ¶ 282) that are removably coupled with the distal end of the actuator (NOTE: 1194 can be removed as part of base 1140; see fig.11I arrows indicating removability).
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 blood collecting apparatus of Li to include one or more frits, as taught by Holmes, in order to contain fluid samples within the vessels for collection. Li/Holmes teaches the invention substantially as claimed by Applicant with the exception of the one or more frits comprise four individual frits.
However, this limitation is interpreted as a duplication of parts, which does not provide patentability unless a new and unexpected result is produced. One would have been motivated to have the one or more frits comprise four individual frits since it would allow for more collection of fluids. Therefore, a new and unexpected result would not be produced by having the one or more frits comprise four individual frits. See MPEP 2144.04 (VI)(B).
Regarding Claim 10, Li fails to teach any one or more of the one or more frits is configured to hold a volume of blood that is greater than about 1.0 pL. Holmes teaches any one or more of the one or more frits ('the anti-leakage devices 1194 are frits', fig.11I, ¶ 282) is configured to hold a volume of blood that is greater than about 1.0 pL ("the sample volume is about 1 mL or less", ¶ 5).
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 blood collecting apparatus of Li to include one or more frits, as taught by Holmes, such that any one or more of the one or more frits would be configured to hold a volume of blood that is greater than about 1.0 pL, in order to contain fluid samples within the vessels for collection.
Regarding Claim 12, Li teaches the distal end of the actuator (see annotated figure 2), and the blood sample collection device 3. Li fails to teach the actuator is configured to be removed from the blood sample collection device to enable retrieving filled frits from the distal end of the actuator. Holmes teaches the actuator is configured to be removed from the blood sample collection device ("the penetrating member is removed from the slit or opening", ¶ 191) to enable retrieving filled frits ('the anti-leakage devices 1194 are frits', fig.11I, ¶ 282) from the distal end of the actuator ("the base may be removed from the sample collection device, and the vessels may be transferred along with the base. Alternatively, the base may be removed from the sample collection device to provide access to the vessels, and the vessels may be removed from the device and transmitted", ¶ 201).
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 blood collecting apparatus of Li to include one or more frits, as taught by Holmes, such that the actuator is configured to be removed from the blood sample collection device to enable retrieving filled frits from the distal end of the actuator, in order to contain fluid samples within the vessels for collection.
Regarding Claim 13, Li teaches the actuator (see annotated figure 2) includes a tubular casing ('lancet holder 5', fig.2, ¶ 43) that houses an extractor ("lancet holder 5 is provided for inserting the lancet 2, and the lancet holder 5 can move from a to-be-triggered position to a triggered position to trigger the lancet 2 to collect blood; then the lancet holder 5 can retract to a to-be-withdrawn position after blood is collected", ¶ 43).
Regarding Claim 14, Li teaches a distal end of the extractor is configured to eject from the actuator when a proximal end of the extractor is pressed in a distal direction ("lancet holder 5 is provided for inserting the lancet 2, and the lancet holder 5 can move from a to-be-triggered position to a triggered position to trigger the lancet 2 to collect blood; then the lancet holder 5 can retract to a to-be-withdrawn position after blood is collected", ¶ 43). Li fails to teach a distal end of the extractor is configured to eject the filled frits from the actuator when a proximal end of the extractor is pressed in a distal direction. Holmes teaches the filled frits ('the anti-leakage devices 1194 are frits', fig.11I, ¶ 282).
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 blood collecting apparatus of Li to include one or more frits, as taught by Holmes, such that a distal end of the extractor would be configured to eject the filled frits from the actuator when a proximal end of the extractor would be pressed in a distal direction, in order to contain fluid samples within the vessels for collection.
Regarding Claim 15, Li fails to teach each of the one or more frits is accompanied by a window disposed in the distal end. Holmes teaches each of the one or more frits ('the anti-leakage devices 1194 are frits', fig.11I, ¶ 282) is accompanied by a window disposed in the distal end ("the collection device body may be formed from a transparent or translucent material", ¶ 153; "the body comprises an opaque material but an opening and/or a window can be formed in the body to show fill levels therein", ¶ 153).
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 blood collecting apparatus of Li to include one or more frits, as taught by Holmes, such that each of the one or more frits would be accompanied by a window disposed in the distal end, in order to visualize the fill level of the device so that the fluid samples can be collected when the frits are full.
Regarding Claim 16, Li fails to teach the window facilitates blood being drawn into an adjacent frit without leaking or spreading into neighboring frits. Holmes teaches the window ("window", ¶ 153) facilitates blood being drawn into an adjacent frit ('the anti-leakage devices 1194 are frits', fig.11I, ¶ 282) without leaking or spreading into neighboring frits (¶ 160).
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 blood collecting apparatus of Li to include one or more frits, as taught by Holmes, such that the window facilitates blood being drawn into an adjacent frit without leaking or spreading into neighboring frits, in order to visualize the fill level of the device so that the fluid samples can be collected when the frits are full.
Claims 8-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Holmes and Dorian et al. (US 20210330873 A1).
Regarding Claim 8, Li fails to teach any one or more of the one or more frits includes a desiccant for causing the dried state. Holmes teaches one or more frits ('the anti-leakage devices 1194 are frits', fig.11I, ¶ 282).
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 blood collecting apparatus of Li to include one or more frits, as taught by Holmes, in order to contain fluid samples within the vessels for collection.
Li/Holmes fail to teach any one or more of the one or more frits includes a desiccant for causing the dried state. Dorian teaches a desiccant for causing the dried state ("a volume of desiccant for mixing with the fluid. This fluid and desiccant mixture may be passed between the first and second reservoirs until one or more components from the fluid are absorbed by the desiccant", ¶ 27).
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 blood collecting apparatus of Li/Holmes such that any one or more of the one or more frits would include a desiccant for causing the dried state, as taught by Dorian, in order to contain fluid samples within the vessels for collection.
Regarding Claim 9, Li teaches the collection device 3, but Li/Holmes fail to teach the collection device is coated with a desiccant to cause the dried state. Dorian teaches the collection device is coated with a desiccant to cause the dried state (¶ 27-28; ¶ 37).
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 blood collecting apparatus of Li/Holmes such that the collection device would be coated with a desiccant to cause the dried state, as taught by Dorian, in order to contain fluid samples within the vessels for collection.
Regarding Claim 11, Li fails to teach any one or more of the one or more frits is configured to store a volume of about 60 pL of blood in a dried state. Holmes teaches any one or more of the one or more frits is configured to store a volume of about 60 pL of blood ("the sample volume is about 1 mL or less", ¶ 5).
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 blood collecting apparatus of Li to include one or more frits, as taught by Holmes, such that any one or more of the one or more frits would be configured to store a volume of about 60 pL of blood, in order to contain fluid samples within the vessels for collection.
Li/Holmes fail to teach any one or more of the one or more frits is configured to store a volume of about 60 pL of blood in a dried state. Dorian teaches any one or more of the one or more frits is configured to store a volume of about 60 pL of blood in a dried state ("a volume of desiccant for mixing with the fluid. This fluid and desiccant mixture may be passed between the first and second reservoirs until one or more components from the fluid are absorbed by the desiccant", ¶ 27).
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 blood collecting apparatus of Li/Holmes such that any one or more of the one or more frits would be configured to store a volume of about 60 pL of blood in a dried state, as taught by Dorian, in order to contain fluid samples within the vessels for collection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachel O'Connell whose telephone number is (571)272-7583. The examiner can normally be reached Monday - Friday, 7:30 am - 3:30 pm.
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, Rebecca Eisenberg can be reached on (571) 270-5879. 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.
/RACHEL O'CONNELL/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
Prosecution Insights