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.
Claim 6 is rejected under 35 U.S.C. 112 (b) for lacking antecedent basis since “the interface” is not previously referred to in the claim, or claim 1, from which claim 6 depends. Correction/clarification is required.
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, 2, 6, 7, 8, and 9 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Ramsay (US Publication 2021/0113974).
Regarding claim 1, Ramsay teaches a nano lipid particles manufacturing chip (paragraph teaches nanoparticles including lipids, however materials being worked upon are considered intended use, figure 12a), comprising: a first raw material supply flow path configured for supplying a first raw material (paragraph 241 teaches mixing a first and second liquid which would inherently require a first raw material supply flow path, figure 10 shows inlet reservoirs which feed raw material through piping to microfluidic chips); a second raw material supply flow path configured for supplying a second raw material (paragraph 241 teaches mixing a first and second liquid which would inherently require a second raw material supply flow path, figure 10 shows inlet reservoirs which feed raw material through piping to microfluidic chips); and a mixer portion (Figure 12A paths a-d are considered forming the mixer portion) connected to the first raw material supply flow path and the second raw material supply flow path the mixer portion configured for mixing the first raw material supplied through the first raw material supply flow path and the second raw material supplied through the second raw material supply flow path (paragraph 241 teaches mixing at least a first and second liquid which would inherently require a supply being fed of each liquid into the mixer) the mixer portion comprising: a first stabilizing unit (path A and B are considered forming the stabilizing unit); and a first mixing unit connected to the first stabilizing unit (path C and D are considered forming the first mixing unit), the first mixing unit configured for mixing the first raw material and the second raw material with each other (Path C and D are taught as a toroidal mixing element in paragraph 241 and mix the first and second liquid), wherein the first mixing unit is configured for mixing of the first raw material and the second raw material performed more in the first mixing unit than in the first stabilizing unit (the mixing is a function of the fluid flow and material being worked upon, and Path C and D are considered capable of mixing the material more than Path A and B based on the flow rate through the microfluidic chip).
Regarding claim 2, Ramsay teaches wherein the first stabilizing unit comprises a left stabilizing flow path having a first width and a first length and a right stabilizing flow path having the first width and the first length (Path A and Path B each have a length and a width, path A is considered reading on a left stabilizing flow path and the path B is considered reading on a right stabilizing flow path).
Regarding claim 6, Ramsay teaches wherein the first stabilizing unit is connected to the first raw material supply flow path and the second raw material supply flow path (path A and Path B are connected upstream with two raw materials, see figure 10 which shows materials feeding to the microfluidic chips), and wherein the first raw material sequentially flows through the first raw material supply flow path, the first stabilizing unit, and the first mixing unit (figure 10 shows multiple materials feeding through, Path A and Path B are the first stabilizing unit, and Path C and Path D are the first mixing unit), and the second raw material sequentially flows through the second raw material supply flow path, the first stabilizing unit, and the first mixing unit (figure 10 shows multiple materials feeding through, Path A and Path B are the first stabilizing unit, and Path C and Path D are the first mixing unit), and mixing of the first raw material and the second raw material occurs at the interface between the first raw material and the first raw material (material contacts upstream of paths C and D and are considered having a degree of mixing), but more mixing of the first raw material and the second raw material occurs in the first mixing unit than in the first stabilizing unit (the mixing is a function of the fluid flow and material being worked upon, and Path C and D are considered capable of mixing the material more than Path A and B based on the flow rate through the microfluidic chip).
Regarding claim 7, Ramsay teaches wherein the first mixing unit is connected to the first raw material supply flow path and the second raw material supply flow path (material in figure 10 feeds to the microfluidic chip, and is considered fluidly connected to Path C and D), and wherein the first raw material sequentially flows through the first raw material supply flow path, the first mixing unit, and the first stabilizing unit (figure 10 shows multiple materials feeding through, Path A and Path B are the first stabilizing unit, and Path C and Path D are the first mixing unit), and the second raw material sequentially flows through the second raw material supply flow path, the first mixing unit, and the first stabilizing unit (figure 10 shows multiple materials feeding through, Path A and Path B are the first stabilizing unit, and Path C and Path D are the first mixing unit).
Regarding claim 8, Ramsay teaches wherein the mixer portion further comprises a second stabilizing unit connected to the first mixing unit (see paragraph 12b which shows a third downstream loop including two paths, which are considered reading on a second stabilizing unit and is downstream and connected to the second loop which is considered reading on the first mixer unit); and a second mixing unit connected to the second stabilizing unit (see paragraph 12b which shows a fourth downstream loop including two paths formed downstream and connected to the third loop).
Regarding claim 9, Ramsay teaches a nano lipid particles manufacturing system (figures 1 and 12 show a nanoparticle manufacturing system, paragraph 2 teaches lipids, however the material being worked upon are considered intended use), comprising: a first raw material supply unit configured to supply a first raw material (first of items 104); a second raw material supply unit configured to supply a second raw material (second of items 104); a nano lipid particles manufacturing chip (shown as 110 in figure 1, and figure 12a) comprising a mixer potion configured to mix the first raw material and the second raw material to form a mixed solution (Paths A, B, C and D are considered forming the mixer portion); and a lipid nanoparticle obtaining unit to obtain lipid nanoparticles manufactured from the lipid nanoparticle manufacturing chip (see paragraph 38, item 128 final nanoparticle product collection), and wherein the mixer portion of the nano lipid particles manufacturing chip comprises a first stabilizing unit (Path A and B are considered forming a first stabilizing unit); and a first mixing unit is connected to the first stabilizing unit and configured for mixing the first raw material and the second raw material with each other (Path B and C are considered forming a first mixing unit).
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 3, 4, 5, and 10, are rejected under 35 U.S.C. 103 as being unpatentable over Ramsay (US Publication 2021/0113974).
Regarding claim 3, Ramsay teaches a left flow path (Path A) and right flow path (Path B) forming a circular shape (path A and B form a path). Regarding claim 3, Ramsay is silent to the paths being symmetrical which would require the orientation of the upstream feed stream being opposite the downstream outlet stream. Regarding claim 3, absent any unexpected results, it would have been obvious to one of ordinary skill in the art to rearrange the orientation of the inlet in order to obtain the desired degree of mixing within the circular pathway since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 4, Ramsay teaches wherein the first mixing unit comprises a left mixing flow path having a second width (see path D which has a second width) and a right mixing flow path having a third width (see path C which has a third width). Regarding claim 4, while Ramsay teaches a range of widths (paragraph 93), Ramsay is silent to the second width and the third width are different from each other. Regarding claim 4, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the size of the pathways to obtain the desired degree of mixing since it is well settled that it is an obvious matter of design choice to change the general shape or size of a known element in the absence of a disclosed non-obvious advantage associated with the change. Gardner vs. TEC Systems Inc., 725 F.2d 1338, 1349-50 (Fed. Cir. 1984); In re Kuhle, 526 F.2d 553, 555 (CCPA 1975); In re Dailey, 357 F.2d 669, 672 (CCPA 1966).
Regarding claim 5, Ramsay teaches the left mixing flow path and the right mixing flow path of the first mixing unit form an oval or circular shape (Path D and Path C form a circular shape).
Regarding claim 10, Ramsay teaches wherein the first mixing unit comprises a left mixing flow path having a second width (see path D which has a second width) and a right mixing flow path having a third width (see path C which has a third width). Regarding claim 10, while Ramsay teaches a range of widths (paragraph 93), Ramsay is silent to the second width and the third width are different from each other. Regarding claim 10, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the size of the pathways to obtain the desired degree of mixing since it is well settled that it is an obvious matter of design choice to change the general shape or size of a known element in the absence of a disclosed non-obvious advantage associated with the change. Gardner vs. TEC Systems Inc., 725 F.2d 1338, 1349-50 (Fed. Cir. 1984); In re Kuhle, 526 F.2d 553, 555 (CCPA 1975); In re Dailey, 357 F.2d 669, 672 (CCPA 1966).
Allowable Subject Matter
Claims 11-13 are allowed. Regarding claim 11, the prior art does not teach or fairly suggest the nano lipid particle manufacturing method with the combination of the filtering and filling the solution containing the nano lipid particles into individual containers, the stabilizing unit having the same width on the left and right flow paths, and the mixing unit having a left flow path and right flow path having different widths.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANSHU BHATIA whose telephone number is (571)270-7628. The examiner can normally be reached Monday - Friday 11 a.m. to 7:30 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at (571)270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANSHU BHATIA/Primary Examiner, Art Unit 1774
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