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 .
Status of Claims
Claims 1-10 are pending.
Priority
Claims 1-10 have priority to CHINA 202311314999.2 filed on October 11, 2023.
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 1 is 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 recites “at least one of the following steps”. As written, this language is unclear given the claim could require any single recited step, a combination of any two of the steps, or all of the recited steps. Additionally, at least one of the recited steps appears to depend on the performance of preceding step, e.g. transfer of skin residue and subsequent processing of digested skin tissue. However, the “at least one” language permits selection of individual steps without any additional preceding or subsequent step. Because of this, a person of ordinary skill would not be able to determine the metes and bounds of the claimed 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 and 4-9 are rejected under 35 U.S.C. §103 as being unpatentable over Harris [US 6623959 B2, 2003], in view of Fisher [US 6890309 B2, 2005], in view of Qiu et al. [Microfluidic filter device with nylon mesh membranes efficiently dissociates cell aggregates and digested tissue into single cells, Lab Chip., 2018], in view of Quick et al. [US 2016 024450 A1].
For claim 1, Harris teaches a device made up of a tissue digestion chamber, cell isolation unit, and associated chambers for processing and recovering isolated cells, e.g. autologous skin cells [Para starting with “Among the numerous methods and devices disclosed for isolating living cells”]. Harris specifically teaches a single vessel that consists of three chambers that include digestion chamber where the tissue is treated with a tissue degrading material [Id.], where the tissue is then transferred to an isolation chamber, similar to applicant’s second cell separation chamber [Id.]. Additionally, Harris teaches washing of isolated cells and transfer of the recovered cells into a downstream collection chamber [Fig. 5 & 6]. However, Harris does not teach a first cell separation unit with conduit groove, i.e. a cell scraper.
For the claimed limitation of a first cell separation unit with a conduit groove, Fisher discloses a tissue scraping device having a scraping member configured to remove biological material from tissue [Summary of the Invention ¶ 1]. Fisher further teaches the scraping member includes a channel/slot, i.e. conduit groove, formed in association with the scraping structure [Figure 1]. Although not positioned in a similar manner to the drawing provided by Applicant, Applicant’s specification specifically states “the conduit groove 330 can be defined on the incline plane 320 randomly, namely that the conduit groove 330 only needs to be disposed above the opening defined on the second cell separation unit 400” [Applicant’s Specification ¶ 0033]. The Fisher scraping device channel is capable of facilitating collection and transport of scraped biological material, i.e. autologous skin cells, away from the scraping region [Para starting with “As drawn, the cut that forms sharp edges” and Figure 11]. Qui et al. further discloses tissue dissociation and cell recovery can be improved by employing sequential stages. Qui et al. specifically teaches that multiple filtration membranes that operate of different size fractions where larger tissue fragments are retained by an initial filtration stage with smaller aggregates being further processed by a subsequent filtration stage, e.g. preparing the digested skin tissue by using the second cell separation unit to obtain a third skin cell suspension [Abstract]. Given this, there would have been a reasonable expectation of success for a person of ordinary skill to combine the teachings of Harris that disclosed a single device for isolating and recovering cell isolates with the scraper device that included a channel/conduit groove for scraping and/or collecting skin cells to be cultured with the additional teachings of Qui et al. that discloses a sequential method of culturing cells, e.g. autologous skin cells, that are further filtrated down to in order to isolate the skin cells collected from a scraper device into cell suspensions. Because of this, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods of Harris with the additional teachings of Fisher and Qui et al. to develop and multistage culturing device that included a scraper for cell collection where the scraper included a slot/conduit groove that allowed the scraped cells to accumulate making it easier to transfer the collected cells into a second cell separation unit for the cells to be washed where the collected cells could be further isolated into a third cell suspension.
For claim 4 where prior to the scraping, to-be-digested skin tissue is digested in the digesting unit along with a digestive enzyme where the digested skin tissue is then washed that includes using a digestive enzyme termination solution, Harris teaches digesting a to-be-digested skin tissue by using the digestion to obtain a digestive enzyme contained digestive skin tissue where Harris uses an enzymatic digestion of tissue in a digestion chamber [Para starting with “Among the numerous methods and devices discloses”] to produce enzymatically digested tissue in a digestion chamber [Id.]. Harris further discloses the use of a digestive enzyme within the digestive chamber. Harris discloses washing the digested tissue [Figure 5]. This removes the processing materials used for enzymatic treatment. This washing also functions as the enzyme termination solution.
For claims 5 and 6 where the skin tissue residue is transferred to the second cell separation unit using the conduit groove and placing the skin on a filter screen then grinding the skin tissue residue by using the grinding rod to obtain a second cell suspension, Harris teaches all of the limitations except placing a filter screen to capture the skin tissue residue and the use of a grinder. For these limitations, Quick et al. discloses using a filter that can be situated between the disintegrator, e.g. grinder, and the cell collection chamber for filtering the processed tissue to remove large aggregates [¶ 0017]. The filter can be alternatively or additionally situated between the cell collection chamber and the applicator that further allows the cell suspension to remove large aggregates [Id.]. Here, it would have been prima facie obvious to a person of ordinary skill in the art to modify the systems and methods of Harris that teaches a sequential cell isolation method that involves subjecting harvested cells to digestion chamber that includes enzymes followed by washing to remove said digestion enzymes with the further teachings of Quick et al. where cells can then further be processed more by using a grinder and/or applicator for breaking up cell aggregates that are then filtered through a filter situated between the disintegrator and the cell collection chamber. Given this, there is a reasonable expectation of success that a person of ordinary skill in the art would be able to combine the teachings of both Harris and Quick et al. to develop a method of culturing cells that involve subjecting harvested cells to an enzyme for further processing in a digestion chamber followed by a washing where the cells are further processed by using a grinding rod where a filter screen is placed in the second cell unit to further prepare and/or isolate the cells to further obtain a more processed skin cell suspension.
For claim 7 where the preparation device contains a heating assembly, Quick et al. discloses that the assembly may include a heating coil [¶ 0139].
For claim 8 where the preparation device further contains a circuit control assembly connected to the heat assembly capable of controlling heating time and heating temperature of the heating assembly, Quick et al. discloses the inclusion of a computer controlled microcontroller capable of controlling actuators, such as motors and/or heating assemblies, that are controlled and monitored by the microcomputer via digital output circuits, as well as other sensors capable of measuring important physical parameters to include internal temperature [¶ 0147].
For claim 9 where the digestive conditions of the digestion unit comprise 20-25 minutes of digestion and 37 degrees Celsius of digestion temperature, Quick et al. teaches the enzyme solution is brought to a temperature of 37 degrees Celsius [¶ 0074]. Quick et al. further discloses that cell suspension delivery to applicator can be within 20 minutes with standard process without further operator action [¶ 0246 “There are two separate workflows”]. Here, it would have been prima facie obvious to a person of ordinary skill in the art to modify the systems and methods of Harris that provided a sequential cell isolation protocol that involved separate chambers, enzyme digestion, and washing, with the teachings of Fisher that taught an apparatus that included a channel used for scraping cells, e.g. autologous skin cells, with the further teachings of Quick et al. that disclosed the use of a grinding rod and filter for further separating and/or isolating skin cells after initial culturing. Because of this, a person of ordinary skill in the art would have a reasonable expectation of success to combine the elements of a scraping device that included a slot and/or conduit groove, as disclosed by Fisher, that functioned in a manner as to allow scraped cells to congregate in conjunction with a device, as taught by Harris, that contains a sequential cell isolation method that involves subjecting harvested cells to digestion chamber that includes enzymes followed by washing to remove said digestion enzymes with a grinding rod as taught by Quick et al. into a single device where the device also contains a circuit board capable of maintaining and/or monitoring various parameters that are required in isolating, culturing, and maintaining cells that include autologous skin cells.
The Supreme court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable varition..103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims Free of the Art
Claim 2 is free of the art. The art does not teach the first separation unit is a cell separation operation table.
Claim 3 is free of the art. The art does not teach the cell operation table comprises an operation plane and in incline plane extending outwards from the operation plane; the conduit groove is defined on the incline plane.
Claim 10 is free of the art. The art does not teach an opening defined on the second cell separation unit is lower than an opening defined on the digestive enzyme washing unit.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN DAVID MOORE whose telephone number is (703)756-1887. The examiner can normally be reached M-F 8-5.
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/JOHN DAVID MOORE/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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