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 .
Claims status
Applicants reply filed 4/30/2026 is acknowledged.
Claims 2 is/are cancelled and claims 17, 18 is/are newly added. Claims 1, 3-18 is/are currently pending with claims 11-16 is/are withdrawn. Claims 1, 3-10, 17, 18 is/are under examination.
Withdrawn Objections
The objections presented herein represent the full set of objections currently pending in this application. Any objections not specifically reiterated are hereby withdrawn.
Claim Suggestion
Claim 1 is amended to recite “solution comprising cancer cells” in line 4 and “solution including cancer cells” in line 14. Although comprising and including are synonymous, for the sake of uniformity across the claim set, use of one or the other in this limitation is recommended. For example, the claim may be amended to recite “solution comprising cancer cells” in line 14”.
Claim Rejections - 35 USC § 112(b) – New, necessitated by claim amendment
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.
Previous rejection of Claims 1-10 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of claim amendment (claims 5, 6) or cancellation (for claim 2).
Claims 1, 3-10, 17, 18 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 1 is amended to recite a main tube that “is configured to stop the flow of the solution including cancer cells when the solution including cancer cells comes in contact with a culture medium”. Thus, the claimed main tube is required to have structure that allows for the stopping of the flow of the solution including cancer cells at least when the solution including cancer cells comes in contact with a culture medium. However, the claimed product does not comprise a culture medium or recite where the said culture medium is to be present such that it is unclear where in the claimed product does the solution come in contact with culture medium. Furthermore, it is unclear what structure allows the main tube to perform this function in the presence of a culture medium. In other words, it is unclear how is the main tube configured to perform said function. The plain meaning of the word tube is a cylinder that may or may not have one or more openings. The structure of the “main tube” disclosed has two sub-components, as claimed in claim 3, a smaller diameter first main tube in communication with a larger diameter second main tube (see #16 in figures). However, it is unclear if this is the configuration that allows for the said function.
On page 9, last para, the specification discloses “The main injection part 14 is formed in the body part 11 so that a cancer cell solution 21 is injected and configured to stop the flow of the cancer cell solution 21 when the cancer cell solution 21 comes into contact with a culture medium 24. In this case, the cancer cell solution 21 maintains a hanging state from the main injection part 14 due to self-aggregation.”
On page 11, para 1, the specification discloses that “The main tube 16 communicates with the main inlet part 15 and is configured to stop the flow of the cancer cell solution 21 when the cancer cell solution 21 comes into contact with the culture medium 24. When the cancer cell solution 21 enters the main inlet part 15, the cancer cell solution 21 flows down through the main tube 16. In this case, when one side of the cancer cell solution 21 comes into contact with the culture medium 24 accommodated in the culture chamber 122, the cancer cell solution 21 no longer flows down in the main tube 16 due to self-aggregation of the cancer cell solution 21. Therefore, cancer cells positioned at one side of the cancer cell solution 21 may be cultured in a hanging state from the cancer cell solution 21.”
On page 11, para 2, the specification discloses “The main tube 16 includes: a first main tube 16a which is connected to one side of the main inlet part 15 and formed to have an inner diameter smaller than that of the main inlet part 15; and a second main tube 16b which is connected to one side of the first main tube 16a and formed to have a diameter larger than that of the first main tube 16a. Since the first main tube 16a is formed to have a diameter smaller than that of the second main tube 16b, as the frictional force of the cancer cell solution 21 increases in the first main tube 16a, the cancer cell solution 21 may maintain a hanging state in the first main tube 16a.”
Of note, culture medium 24 is shown in figure 9 wherein it is introduced in the spheroid generator by injecting into the main inlet (#14) and then travels through the main tube washing the cells out of the main tube into the bottom of the culture chamber. However, description above from page 11, places the medium in the culture chamber.
The description provided on page 9 (last para) and page 11 (para 1) appear to disclose that a contact between the cancer cells and a culture medium results in self-aggregation which stops the flow of cancer cells. However, no clear structure to the main injection part or the main tube is provided that configure them to perform the claimed function. The description provided on page 11 (para 2) appear to disclose the structure of the main tube, claimed in claim 3, that may allow for the cells to be in a hanging state however it remains unclear how this structure stops the flow of the solution including cancer cells, especially how this structure performs the sad function after the solution including cancer cells comes in contact with a culture medium present above or below the spheroid generator. Taken together, it appears no distinct configuration is required for the main tube, including its sub-components, for the flow of cancer cells to stop since this property is achieved due to the cells itself (self-aggregation) and/or the interaction between the cells and the medium.
Claims 3-10, 17, 18 is/are rejected due their dependence on claim 1 because they do not clarify the 112b issue noted with claim 1.
Claim Rejections - 35 USC § 112(a) - Withdrawn
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Rejection of Claims 1-10 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn since U.S.C. 112(f) interpretation of the claims is withdrawn.
Claim Interpretation – Updated to address claim amendments
Claim 1 is directed to an apparatus with an intended use recited in the preamble as “spheroid generator”. According to MPEP 2111.02, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. In the instant case, the body of the claim provides the structural limitations for the claimed apparatus and its intended use as a spheroid generator does not provide any additional structure.
The apparatus of claim 1 comprises a body part, a main injection and a sub-injection part, wherein the main and the sub-injection parts are “formed in the body part” i.e. are both components within the body part. The structure for the main and the sub-injection parts is provided partly by functional language (“to allow for injection” of recited solutions). A claim term is functional when it recites a feature "by what it does rather than by what it is". See MPEP 2173.05(g).
For example, the claimed main injection part has a function of allowing injection of cancer cells and thus, requires a size that allows for flow of cells the size of a generic cancer cell. Similarly the claimed sub-injection part has a function of allowing injection of stromal cells or anticancer substances and thus embraces a range of sizes; from a small size appropriate for injection of small molecules to a much larger size that allows for flow of cells the size of a generic stromal cell.
Further, the main injection part comprises at least a main inlet part which communicates with the sub-injection part and a main tube. The structure for the main inlet part and the main tube is provided partly by functional language. Herein again, the main inlet part has a function of allowing injection of cancer cells and thus, requires a size that allows for flow of cells the size of a generic cancer cell. The claim also recites that the main tube “is configured to” stop the flow of solution comprising cancer cells after they come in contact with culture medium. This functional language is indefinite (see U.S.C. 112b rejection above). It appears that no distinct configuration is required for the main tube, including its sub-components, for the flow of cancer cells to stop since this property is achieved due to the cells itself (self-aggregation) and/or the interaction between the cells and the medium. However, the claimed product comprises neither cancer cells nor culture medium. Thus, this functional limitation does not provide any additional structure to the claimed main tube.
Claims 5 and 6 recite “sub-injection part(s) is formed around the main inlet”. The term around embraces both a meaning wherein the sub-injection parts surround the main inlet but also a meaning wherein the sub-injections parts are merely present around i.e. near the main inlet. The second interpretation is also supported by the specification. See Figures 3-5.
Claim 9 recites a product-by-process limitation (“manufactured by 3D printing”). According to MPEP 2113, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.” The process steps recited in claim 9 do not appear to impart any structure to the claimed product. Thus, a prior art(s) that anticipates and/or renders obvious the product of claim 1, meets the limitation of clam 9.
Claim Rejections - 35 USC § 102 – New, necessitated by claim amendment
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.
Rejection of Claim(s) 1-7, 9 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et. al. (Journal of Laboratory Automation, 2015, Vol. 20(3) 274-282) is withdrawn in light of claim amendment (claims 1, 5, 6) or cancellation (for claim 2).
Claim(s) 1, 3-7, 9 and 10, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et. al. (Journal of Laboratory Automation, 2015, Vol. 20(3) 274-282).
Regarding claim 1, in view of U.S.C. 112b rejection above and claim interpretation, Kim teaches an apparatus comprising a body part that comprises a funnel-like structure used for injection of microtissues (=claimed main injection part formed in the body part that has size that allows for injection of cells the size of a cancer cell) and ports for the application of culture medium i.e. culture-medium ports (=sub-injection injection part formed in the body part that has size that allows for injection of cells the size of a stromal cell or a drug such as anticancer substance) (See Figure 3). Furthermore, the culture-medium ports (i.e. sub-injection injection part) communicate via a channel with the funnel-like structure used for injection of microtissues (i.e. main injection part) (see arrow in channel in Figure 3d).
Kim’s main injection part comprises a funnel-like opening (= claimed main inlet part) and tube below the opening (= claimed main tube) wherein the opening and the tube are in communication, and communicate with the sub-injection part via communication channel (Figure 3; see arrow in channel in Figure 3d).
See Figure 3d from Kim copied below with parts equivalent to claimed structures labelled.
In Kim’s apparatus, the apparatus comprises barriers that allow for the microtissue to stop flowing (= configured to stop flow of cells when in contact with culture medium; see barrier in figure 3).
Regarding claim 3, Kim’s main tube comprises a first main tube has an inner diameter smaller than the funnel-like main inlet (shown in gray in Figure 3d) and is connected to a second main tube (shown in pink in Figure 3d) that has an inner diameter greater than the first main tube. See Figure 3d from Kim copied below with parts equivalent to claimed structures labelled.
Regarding claim 4, a communication channel connects the funnel-like main inlet with the culture-medium ports (see arrow in channel in Figure 3d).
Regarding claims 5 and 6, Kim’s apparatus comprises at least two (= claimed plurality) culture-medium ports (= claimed sub-injection parts) near (= claimed around) the main inlets. See two culture-medium ports present on either sides of the funnel-like ports in Figure 3d.
Regarding claim 7, in Kim’s apparatus the culture-medium ports (= claimed sub-injection parts) appear to have the same inner diameter.
Regarding claim 9, in teaching an apparatus of claim 1, Kim anticipates the apparatus of claim 9 which has the same structure as the apparatus of claim 1. See claim interpretation for claim 9 above.
Regarding claim 10, Kim teaches a platform (=claimed kit) which comprises reservoirs for culture medium (= claimed culture tank; See Figure 1a), a culture plate below i.e. one side of the reservoirs and with plurality of chambers wherein the funnel-like structure and the culture-medium ports are present in. Figure 1b shows 11 separate “spheroid generators” that are equivalent to claim 1.
Regarding claim 17, since the first main tube and the second main injection are in the part of the main injection part and these components are in the same axis, thus in Kim’s apparatus the first main tube and the second main injection are in the same axis as the main injection part.
Therefore, Kim anticipates the claimed apparatus.
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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.
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.
Rejection of Claim(s) 8 under 35 U.S.C. 103 as being unpatentable over Kim is withdrawn because rejection relied upon U.S.C. 102 rejection over Kim that is now withdrawn.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim.
The teachings from Kim as detailed in the U.S.C. 102 rejection of claim 1, 6, 7 are relied upon for the instant rejection.
Regarding claim 1, as noted above, Kim teaches the claimed apparatus (Figure 3).
Regarding claim 6, Kim’s apparatus comprises at least two (= claimed plurality) culture-medium ports (= claimed sub-injection parts) near (= claimed around) the main inlets. See two culture-medium ports present on either sides of the funnel-like ports in Figure 3d.
Kim teaches the culture-medium ports (= claimed sub-injection parts) to have the same inner diameter.
Kim does not explicitly teach the culture-medium ports (= claimed sub-injection parts) to have the different inner diameter, as required by claim 8.
However, change in size of a claimed element such as the claimed sub-injection parts is prima facie obvious.
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. MPEP 2144.04(IV)(A). In the instant case, the only difference between the Kim’s sub-injection parts and claimed sub-injection parts is the relative dimensions of the sub-injection parts i.e. they have different inner diameters in relation to each other. However, sub-injection parts with same or different inner diameters are capable of performing similarly i.e. allowing the injection of small molecules and/or stromal cells. There is no requirement that different diameters render the sub-injection parts to perform different functions. The different diameters could be similar enough that each sub-injection part performs the same function.
See also In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). MPEP 2144 (IV)(A). In the instant case, the claimed sub-injection parts with different diameters is merely involving change in from and/or proportion of the various sub-injection parts that are perform the same function as Kim’s sub-injection parts with the same inner diameters. There is not even any evidence that the claimed sub-injection parts with different diameters performs better than Kim’s sub-injection parts with the same inner diameters.
Therefore, in teaching sub-injection parts with the same inner diameters, Kim renders the claimed sub-injection parts with different inner diameters prima facie obvious.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in
the art at the effective time of filing of the invention, especially in the absence of evidence to the
contrary.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim.
The teachings from Kim as detailed in the U.S.C. 102 rejection of claim 1, 4 are relied upon for the instant rejection.
Regarding claim 1, as noted above, Kim teaches the claimed apparatus (Figure 3).
Regarding claim 4, Kim’s apparatus comprises a communication channel that connects the funnel-like main inlet with the culture-medium ports (= claimed sub-injection parts) (see arrow in channel in Figure 3d).
In Kim’s configuration the communication channel directly connects the culture-medium ports (= claimed sub-injection parts) to the second main tube and through this it indirectly connects the main inlet to the culture medium port.
Thus, in Kim’s configuration the communication channel does not directly connect to the main inlet, as recited in claim 18.
However, rearrangement of claimed elements such as placing a communication channel in direct communication with the main inlet or indirect communication with the main inlet is prima facie obvious.
See In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice) MPEP 2144.04(VI)(C). In the instant case, although Kim positions the communication channel in contact with the second tube to supply the culture medium to the cells at the bottom of the culture plate, an ordinary artisan could rearrange the location of the communication channel, as long as the culture medium reaches the cultured cells. Such an alternative configuration is a matter of design choice, since various configurations could be designed wherein the communication channel communicates with other elements of the culture apparatus, as long as the culture medium reaches the cultured cells. Furthermore, Kim teaches methods to make molds to make the apparatus with desired configurations (Figure 2).
Therefore, in teaching a communication channel that indirectly connects to the main inlet, Kim renders the claimed communication channel in direct connection with the main inlet prima facie obvious.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in
the art at the effective time of filing of the invention, especially in the absence of evidence to the
contrary.
Response to Arguments
Applicant’s traverses the 35 U.S.C. 112(f) interpretation of the claims and provides a rebuttal that the “main tube […] configured to” is not a nonce word and should not be construed under 112(f) (page 8, last para).
In response, this rebuttal is acknowledged and 35 U.S.C. 112(f) interpretation of the claims is withdrawn.
Applicant’s arguments with respect to the U.S.C. 112(b) rejection of claim(s) 1-10 have been considered but are moot because the new U.S.C. 112(b) rejection necessitated by claim amendments.
Arguments pertinent to instant U.S.C. 112(b) rejection of claims 1, 3-10, 17 and 18 are discussed below.
Applicant argue that U.S.C. 112(b) only requires “a reasonable degree of clarity” and allege that “the present Application including the drawings provides sufficient descriptions to satisfy the degree of reasonableness required by the MPEP rules” pointing to para 59-61 in the PG-PUB (page 9, para 1-3). Applicant assert that “This hanging state stops the flow of the cancer cell solution when the cancer cell solution comes into contact with a culture medium”.
In response, the claimed structure does not include cancer cells or culture medium. Further, the claims do not recite which structure would comprise the culture medium. The key question to address is what is the structure of the main tube required by the claim. It is this structure that must be met by the prior art. Once clearly identified, such a structure would perform the claimed function.
Applicant appear to argue that the structure disclosed in para 59-61, specifically the first and the second main tube, that allow for at least cancer cells to potentially self-aggregate and form an hanging drop provides the claimed function of stopping the flow of cancer cells when in contact with culture medium (see the use of “may maintain”, “may be cultured” in each para when discussing hanging state). However, it appears that the function performed by the structure of the main tube disclosed is generation of a hanging drop and not ‘stopping’ the flow of cells. Figure 9 shows that culture medium introduced into the main inlet actually washes out the cells i.e. the flow of cells is not stopped.
Applicant’s arguments with respect to the U.S.C. 102 rejection of claim(s) 1-7, 9, 10 and U.S.C. 103 rejection of claim 8 have been considered but are moot because the new ground of rejection necessitated by claim amendments.
Applicant do not present separate arguments for these rejections.
Arguments pertinent to instant U.S.C.102 rejection of claims 1, 3-7, 9 and 10, 17 and instant U.S.C. 103 rejection of claim 8 and 18 are discussed below.
Applicant allege that “Kim discloses that the loading port receives pre-formed solid microtissues (MTs)” and “Thus, the loading port of Kim does not correspond to the claimed main inlet part "which allows for the injection of the solution including cancer cells," as recited in claim 1.” (page 10, last para). Further, Applicant allege that “the medium of Kim flows continuously through the perfusion channel by gravity-driven hydrostatic pressure, and at no point is any flow stopped when a cancer cell solution comes into contact with a culture medium. Therefore, the alleged combination of Kim including the MT compartment does not correspond to the claimed main tube that "configured to stop the flow of the solution including cancer cells when the solution including cancer cells comes into contact with a culture medium," as recited in claim 1. ” (page 11, para 3).
In response, Kim’s apparatus has the structure claimed with each of its components. Kim’s loading port meets the claimed limitation regarding main injection port because it is formed in the main body of Kim’s apparatus and would perform the claimed function of allowing injection of cancer cells since it has a size that allows for flow of cells through it. See claim interpretation above for detailed analysis of functional language in the claims.
Further, the limitation pertaining to the configuration required by the claims for the main tube that stops the flow of cells when they contact culture medium remains indefinite. In arguendo, if the structure is that of first main tube and the second main tube, as noted by the Applicant in their response on page 9 and disclosed in para 59-61, then Kim also teaches this structure.
Of note, the medium in Kim’s apparatus does not continuously flow. Only when placed on a tilting plate (as described on pg. 277, col. 2, para 2), the medium flows in the direction of the tilt however Kim’s apparatus has the structure that would generate a hanging drop and thus stop the flow of cells when in contact with culture medium.
Conclusion
NO claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATASHA DHAR whose telephone number is (571)272-1680. The examiner can normally be reached M-F 8am-4pm (EST).
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/MATASHA DHAR/Examiner, Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
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