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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Korea on 09 March 2023. It is noted, however, that applicant has not filed a certified copy of the Korean application as required by 37 CFR 1.55.
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.
Claims 2-6 and 10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 2 recites the limitation “a first contact channel portion” in line 7. However, independent claim 1 already requires “a first contact channel portion”. It is unclear if the recitation in claim 2 is intended to refer back to the first contact channel portion set forth in claim 1 or is intended to introduce a new first contact channel portion. It is unclear how many contact channel portions are required by the claim.
Claim 2 recites the limitation "the other side" in lines 4 and 8. There is insufficient antecedent basis for this limitation in the claim. It is unclear if “the other side” refers to another side of a channel, the chip, or something else.
Claim 4 recites the limitation "the other side" in lines 4 and 8. There is insufficient antecedent basis for this limitation in the claim. It is unclear if “the other side” refers to another side of a channel, the chip, or something else.
Claim 4 recites the limitation “a second contact channel portion” in line 7. However, independent claim 1 already requires “a second contact channel portion”. It is unclear if the recitation in claim 2 is intended to refer back to the second contact channel portion set forth in claim 1 or is intended to introduce a new second contact channel portion. It is unclear how many contact channel portions are required by the claim.
Claim 10 recites the limitation "the second guide channel" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the second open channel" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wikswo (US 20060154361) in view of Jury (US 20040121454) and Takahashi (US 20100003745).
With respect to claims 1 and 8, Wikswo discloses a biochip and a method of manufacturing a biochip. Wikswo teaches that the biochip includes a chip body comprising a first channel (Figure 1A:102) configured to culture cells and/or biological tissues. The first channel includes a first contact channel portion formed on one side of a membrane (Figure 1A:104). A second channel is disposed on an opposite side of the membrane and includes a second channel (Figure 1A:103) configured to culture a different kind of cell and/or biological tissue. The second channel includes a second channel portion in contact with a second side of the membrane. This is described in paragraphs [0127]-[0137]. At least paragraphs [0017]-[0019], [0119]-[0126], [0146] and [0158] state that the first and second channels may be characterized by culture conditions designed to produce a blood vessel simulation chip and a tumor culture chip. Wikswo, however, does not state that the chip body is cut and divided into a first chip body comprising the first channel and a second chip body comprising the second channel.
Jury discloses a biochip and method of manufacturing a biochip. Jury teaches that the biochip (Figure 1:10) is cut into different chip body portions (Figure 1:12, 14, 16, 18) that are modular and connectable. See especially paragraph [0052]. Paragraphs [0028] and [0034]-[0047] state that the chip body portions are manufactured using known microfabrication techniques that involve cutting (i.e., etching).
Takahashi discloses a biochip and method of manufacturing a biochip. Takahashi states that the chip is cut and divided into a first chip body having a first channel (Figure 2:3) and a first contact channel portion and a second chip body having a second channel (Figure 2:3’) and a second contact channel portion. The first and second chip bodies are in close contact via an adaptor (Figure 2:12). See Fig. 9.
Before the effective filing date of the claimed invention, it would have been obvious to separate and cut the Wikswo biochip to create first and second chip bodies that are in close contact across the membrane. Jury and Takahashi teach that such a modular construction would facilitate co-culture operations by allowing different chip bodies supporting different cell types to be interchangeably combined. Jury and Takahashi each indicate that detachable chip bodies would also improve cell and product recovery. As evidenced by the references, microfabrication techniques that involve substrate cutting are well known in the cell culture biochip art.
With respect to claims 2 and 4, Wikswo, Jury and Takahashi disclose the combination as described above. Wikswo further shows that the chip body includes a first inlet (Figure 1A:105) connected to a first guide channel (Figure 1A:112) and a first outlet (Figure 1A:111). Similarly, Wikswo the chip body includes a second inlet (Figure 1A:106) connected to a second guide channel (Figure 1A:107) and a second outlet (Figure 1A:109). When modified in view of Jury and Takahashi, the Wikswo first chip body would be further characterized by a first contact channel portion having a first open channel communicating with the outside, and the second chip body would be further characterized by second contact channel portion having a second open channel communicating with the outside.
PNG
media_image1.png
767
717
media_image1.png
Greyscale
With respect to claims 3, 5, 9 and 10, Wikswo, Jury and Takahashi disclose the combination as described above. At least paragraphs [0017]-[0019], [0119]-[0126], [0146] and [0158] of Wikswo state that the first and second channels may be characterized by culture conditions designed to produce a blood vessel simulation chip and a tumor culture chip. Wikswo discloses a membrane (Figure 1A:104) that would function as a base membrane for vascular endothelial cell culture of the simulated blood vessel in the first chip portion of the modified device.
With respect to claim 6, Wikswo, Jury and Takahashi disclose the combination as described above. Wikswo further teaches that sample is retrievable through the second open channel of the second contact channel portion either directly or using a plurality of ports (Figure 1:105, 106, 115, 117).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wikswo (US 20060154361) in view of Jury (US 20040121454) and Takahashi (US 20100003745) as applied to claim 1, and further in view of Summersgill (US 20050255003).
Wikswo, Jury and Takahashi disclose the combination as described above, however do not expressly show a bonding maintenance tray configured to accommodate and move the first chip body and second chip body.
Summersgill discloses a biochip comprising at least fist and second chip bodies (Figure 3:35, 36, 37) that are cut apart and separated in order to subsequently arrange the multiple chip bodies as modular units that are recombined and reconnected in different patterns to produce different combinations. This is described in paragraphs [0059]-[0072]. The at least first and second chip bodies are disposed on a bonding maintenance tray (Figure 3:31) that supports the chip bodies and allows the chip bodies to move into a bonding state.
Before the effective filing date of the claimed invention, it would have been obvious to disposed the modified Wikswo chip body on a bonding maintenance tray configured to facilitate bonding between the first and second chip bodies. Takahashi (see Fig. 9) and Summersgill each show that the different chip bodies must be moved relative to each other in order to maintain a bonding state and that this procedure should be automated for purposes of efficiency and precision.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Rogers (US 20060019333), Tanaami (US 20090186403), Orr (US 20080293135) and Lacombe (US 20220243160) references disclose the state of the art regarding biochips comprising bonded first and second chip bodies.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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.
/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
Prosecution Insights