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 .
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 4, 5, 8, 9, 12, 18 and 19 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.
Claim 4 recites the limitation "the connection end" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the connection end" in line 3. There is insufficient antecedent basis for this limitation in the claim. The Examiner suggests amending the claims to recite “the connection end of the hollow needle”.
Claim 5 recites the limitation "the free end" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the free end" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the free end" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the free end" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the free end" in line 3. There is insufficient antecedent basis for this limitation in the claim. The Examiner suggests amending the claims to recite “the free end of the hollow needle”.
Inventorship
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 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.
Claims 1-6, 8-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kruger et al. (US 2022/0288626) in view of Fox et al. (US 2013/0343965).
Krueger teaches a device for depositing liquid droplets onto a carrier. The device is best shown in Figures 1-2 and described in Paragraphs 0018-0089.
Regarding claims 1-3 and 15-17 – Kruger teaches an apparatus comprised of a picodroplet generator (nozzle 4) configured to output a picodroplet and a biochip (carrier 2) corresponding in position to the picodroplet generator (nozzle 4) configured to carry the picodroplets. The picodroplet generator (nozzle 4) may be comprised of a glass capillary (see Table provided with Example – located between Paragraphs 0094 and 0095 of Krueger) having a connection end and free end for receiving and dispensing liquids and a piezoelectric member (vibrator 7) disposed on an outer surface of the hollow needle (see Paragraphs 0032,0054, 0084, and 0095) configured to squeeze the needle (nozzle 4) and cause the liquid to flow from the free end of the hollow needle (nozzle 4). See Paragraphs 0084-0089 and 0098-0122 for a description and listing of the elements show in the Figures. Kruger does not teach a container connected to the hollow needle wherein an inner diameter of the container is within a range from 5 times to 30 times of an inner diameter of the hollow needle. Kruger also does not teach a piezoelectric member in a ring-shaped arrangement on the lateral side of the container.
Fox teaches a nozzle assembly as an injection needle (Abstract). Fox teaches the nozzle assembly (Figs. 1-2) includes a container (body portion 102 including nozzle cavity 104) and a top piezoelectric member disposed on the container (piezoelectric vibrator 118), the container receives the liquid specimen (Figs. 1-2 teaches body portion 102 and nozzle cavity 103 allows for fluid communication of the injection needle to the nozzle tip, therefore the container is capable of receiving a liquid specimen), and a hollow needle (Figs. 1-2, nozzle tip 106) is in fluid communication with the container by being connected to a bottom side of the container (Figs. 1-2), and wherein the top piezoelectric member is configured to vibrate the container for enabling the biological particles in the container to be arranged along a predetermined path of the hollow needle (paragraph [0014] teaches piezoelectric vibrator 118 provides a resonant vibration to the body portion 102 that causes the stream of fluid exiting the nozzle tip 106 to break off into droplets in a consistent manner; (paragraph [0017] teaches vibrations by the piezoelectric vibrator are efficiently transferred to sheath fluid and sample fluid in the nozzle tip). The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the container having liquid and a surface with a piezoelectric member for vibration of a sample fluid from the droplet generator of Fox with the device of Kruger. One of ordinary skill in the art would provide the container and piezoelectric member to vibrate the container and enable the biological particles in the container to be arranged along the predetermined path before entering the nozzle as taught by Fox.
Regarding the limitation of the inner diameter of the container being from 5-30 times the inner diameter of the hollow needle – Kruger and Fox are silent as to the volume of the nozzle and the volume of the container and ratio between the two volumes. The Examiner takes the position that the difference between the prior art and the claims is a recitation of a difference in relative dimensions (distances) which would not result in the claimed dimensions performing differently than the prior art with respect to providing a predetermined path in the container and nozzle to form and dispense picoliter droplets. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The Examiner further submit it would have been obvious to one of ordinary skill in the art to determine the optimal ratio between the container volume and nozzle or needle volume in order to provide a desired picodroplet through routine experimentation. See MPEP 2144.05, Section II.
Regarding claims 4, 5, 18 and 19 – Kruger and Fox are silent as to the distance from the first piezoelectric member to the connection end of the needle and also as to the distance from the second piezoelectric member to the free end of the needle. The Examiner takes the position that the difference between the prior art and the claims is a recitation of a difference in relative dimensions (distances) which would not result in the claimed dimensions performing differently than the prior art with respect to acting on the container and nozzle to form and dispense picoliter droplets. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The Examiner further submit it would have been obvious to one of ordinary skill in the art to determine the optimal distance from the first piezoelectric member to the connection end of the hollow needle and the optimal distance from the second piezoelectric member to the free end of the hollow needle in order to provide a desired picodroplet through routine experimentation. See MPEP 2144.05, Section II.
Regarding claims 6 and 20 – Figures 1 and 2 of Fox show the piezoelectric element (118) connected (via thread section of body portion 102) to and covering between 20% to 85% of the container (120).
Regarding claims 8 and 9 – Kruger discloses a camera for detection of droplet material at the end of the droplet generator by providing a microscopic image of the droplet and then controlling the droplet generator based on the image in Paragraphs 0038-0041 and 0051-0055.
Regarding claims 10 and 11– Kruger teaches a movable platform (holding device 1) for holding and moving biochip (carrier 2) and also a transport device (13b) for moving the droplet generator (4) in Figures 1-2 and Paragraphs 0021-0030 and 0084.
Regarding claim 12 – Kruger teaches additional carriers (2) on the holding device (1) in Paragraphs 0057-0061. The Examiner submits any of them may be used as a specimen container as recited in claim 12.
Regarding claim 13 – Kruger teaches controlling pressure in the droplet generator (4) in Paragraphs 0035, 0053 and 0095.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kruger et al. (US 2022/0288626) in view of Fox et al. (US 2013/0343965), and further in view of Huang (US 2021/0293778).
Kruger and Fox as combined in Paragraphs 11-20 above teach every element of claim 7 except for the plurality of capturing arms connected to the bottom layer of the biochip wells to capture a target.
Huang teaches a catcher, a capture device, and a method for capturing at least one target biological particle (abstract; paragraph [0001]). Huang teaches a biochip (Figs. 1, 6, 7, 12, 13) includes a bottom layer (10), a plurality of capturing arms (20) connected to the bottom layer and spaced apart from each other (Fig. 1), and a surface modification layer that is formed on ends of the capturing arms (paragraph [0060] teaches the protruding structures 20 is modified with a molecular cluster that is configured to couple with a target biological particle), and wherein, in a capturing step, the biochip is configured to capture the at least one target biological particle through the capturing arms and the surface modification layer (Fig. 12 and paragraph [0065] teaches a target biological particle is trapped by at least two capture arms; paragraph [0060] teaches the protruding structures 20 is modified with a molecular cluster that is configured to couple with a target biological particle). Huang teaches how to increase the capture rate of rare cells and to effectively obtain a single intact rare cell through improvement of a structural design for overcoming the above issues has become one of the important topics that need to be solved in this field (paragraph [0006]), wherein the captured device and method effectively improve the issues associated with conventional catchers (paragraph [0007]).
The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the capturing arms from Huang with the modified device of Kruger and Fox, one of ordinary skill in the art would add the capturing arms to capture specific biological particles as taught by Huang.
Allowable Subject Matter
Claim 14 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.
Claim 14 recites a pressure balance mechanism that includes an air pump; a switch connected to the air pump; a pressure balance bottle being in fluid communication with the air pump and the switch; and a liquid injection bottle being in fluid communication with the switch and the container. The Examiner submit the cited prior art does not teach or suggest this additional feature.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 May 02, 2026
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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