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 .
This action is responsive to papers filed 12/12/2025.
Claims 1 and 14 have been amended. Claim 8 has been newly canceled and no claims have been newly added.
Claims 1-7 and 9-14 are currently pending and have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 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 contains the trademark/trade name “B27” cell culture supplement. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a culture supplement and, accordingly, the identification/description is indefinite.
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.
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(s) 1-7, 9-11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2019-528690 (hereinafter “JP ‘690” - from IDS filed 06/26/2024, from a machine translation) in view of JP 2018526025 (hereinafter “JP ‘025”-from IDS filed 06/26/2024-using a machine translation), Sheng-Tien et al (JP 2019-064996-from IDS filed 06/26/2024) and Efe et al (US 2017/0159019).
Regarding claims 1-2 and 5, JP ‘690 disclose a method of separating an olfactory stem cell (an adult multipotent stem cell) from human olfactory mucosal tissue. The tissue explants are collected by cutting human olfactory mucosal tissue collected from the vicinity of the nasal septum into pieces, put into a buffer at room temperature, and centrifuged to collect tissue explants, and tissue sediment is reconstituted with DMEM/F12 media containing heparin, FGF2, EGF, and penicillin/streptavidin. It is described that an adult multipotent relay stem cell was obtained by suspending a tissue explant in a cell culture dish, culturing it for 5 to 7 days at 5% CO2, 37˚C, growing the cells out of the explant, separating the adherent cells of the first generation (page 4). The cells are produced under aseptic (strict sterile) conditions.
While JP ‘690 do not specifically disclose harvesting the cultured cells 75-90% confluence this is a well-known culturing tactic as it allows for the collection of the maximum expanded cells prior to contact inhibition at 100% confluence.
While JP’690 do not specifically disclose the removal of loose layers of surface and base membrane of the olfactory mucosal tissue blocks after pretreatment, this does not appear to be any more than removing extraneous tissue that does not contain the desired cell type and thus a matter of routine optimization and experimentation.
JP ‘690 does not specifically indicate that the source of the mucosal tissue is from between upper and middle nasal turbinate.
JP ‘025 discloses a method of obtaining olfactory mucosal cells and indicate that a suitable cell source for olfactory nerve cells is isolated from the upper and middle turbinate with specimen tissue forceps and placed into an ice box (page 3, page 5) with a size of 1 mm3 and is pretreated, washed and digested with a protease at 37˚C prior to culture (page 5).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to isolate the olfactory mucosal tissue from the upper and middle nasal turbinate, including between the upper and middle turbinate using tissue forceps and placing in an ice box, because JP ‘025 teach and suggest that this is a suitable location in the olfactory mucosal tissue and a suitable manner in which to obtain cells destined to produce olfactory nerve sheath cells.
JP ‘690 does not specifically disclose wherein the pretreatment includes using a trypsin/EDTA solution for 5 to 15 minutes.
Sheng-Tien disclose a method of making a pharmaceutical composition for improving olfactory function by isolating olfactory neuroepithelium using a solution of trypsin/EDTA for enzymatic digestion of the isolated tissue for 30 minutes at 37˚C to produce a cell suspension that can be seeded for culture (page 5 of the machine translation).
One of ordinary skill in the art would have been motivated to use trypsin/EDTA at 37˚C for the digestion of isolated olfactory mucosal tissue in the method of JP ‘690 because Sheng-Tien disclose that trypsin/EDTA is a suitable and beneficial protease for the digestion of olfactory tissue. Trypsin/EDTA is a well-known alternative to collagenase for the breakdown of sold tissue to a cell suspension suitable for further culture and expansion of the desired cells. One of ordinary skill in the art would have been motivated to optimize the digestion time (to 5-15 minutes) and the concentration of the protease using as little time and concentration as possible to cause as little damage to the cells as possible. Cutting the tissue into smaller block sizes (such as 1mm3 as suggested by JP ‘025) would also have allowed for a shorter protease digestion time to effectively breakdown the tissue. One of ordinary skill in the art would have had a reasonable expectation of success because JP ’690 and Sheng-Tien are both digesting olfactory tissue for further culture and expansion of the cells.
JP ‘690 does not specifically include a culture medium containing all the claimed components (DMEM/F12, EGF, FGF, N2, B27, BSA, glutamine and NEAA).
Efe disclose methods of culturing neural/stem progenitor cells using a culture medium that contains Advanced DMEM/F12 (which contains NEAA), EGF, FGF, N2 cell culture supplement, B27 cell culture supplement, BSA (bovine serum albumin), and Glutamax (which contains glutamine) (page 29 para 319).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to utilize the neural progenitor culture medium of Efe in the culture of the olfactory mucosal stem cells of JP ‘690 because both Efe and JP ‘690 are culture cells desired to be neural progenitor cells used in the repair of neural tissue. Also JP ‘690 also disclose using DMEM/F12, FGF and EGF as well in their culture medium which overlaps with the ingredients used in Efe which adds to the motivation and reasonable expectation of success as well.
With regard to the concentrations of each of the culture medium ingredients, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05).
The selection of specific culture medium concentrations clearly would have been a routine matter of optimization and experimentation on the part of the artisan of ordinary skill, said artisan recognizing that the amount and viability of the cells cultured would have been affected by these concentrations.
Regarding the harvesting steps of claim 1 step (5), JP ‘025 disclose the collection of the cells after subculture (page 5) (harvesting of the cell culture). The lifting of adherent cells from a culture requires a process of lifting the cells from the surface which requires the removal of the serum-containing culture medium, rinsing of the culture with a non-serum containing solution, such as basal medium, trypsinization of the cells to break the bonds of the cells to the surface, and then collecting the cells to prepare a cell suspension. Trypsinization of adherent cells is described by Sheng-Tien (page 5).
Regarding claims 3 and 10, the additional step of reducing the sizes of the tissue blocks to a smaller size (0.2-0.4 mm3) with a different well-known antibiotic, such as gentamicin, is an obvious modification and addition. This serves to allow the protease to further breakdown the tissue to a single cell suspension for culturing and the gentamicin provides additional reduction of potential microbes that might not be responsive to the pen/strep used by JP ‘690. The process of rinsing small tissue blocks and then centrifuging them, removing the supernatant, and then re-suspending the tissue blocks (oscillating them) in the same rinse solution and then repeating the process is a routine technique in tissue culture to breakdown the tissue and prepare it for suspension in cell culture. The centrifugation speed of 1000 rpm and time of 10 minutes is routinely used in this process and thus the claimed ranges are merely a matter of routine optimization.
Regarding claim 4, the additional step of pre-wetting the culture device surface with a serum stock solution before the culturing of adherent cells is well-known in the art of cell culture and allows for the enhancement of cell attachment to the culture surface.
Regarding claims 6 and 9, while the cited references are silent with regard to the feeding schedule of the cell cultures, how often the cell culture medium is to be changed, and the passaging and subculture of the cells, these are deemed to be a matter of routine optimization and experimentation on the part of the artisan of ordinary skill, said artisan recognizing that the amount and viability of the cells cultured would have been affected by the frequency of culture medium changes and the number of passages and generations subcultured.
Regarding claims 7 and 13, while the cited references do not specifically disclose the replating of small pieces of tissue that have been explanted on a culture surface to seed them to a new culture device, this is a well-known tactic in the art of cell culture in order to allow for backup cultures to be created for additional expansion of the cells. The performing of this replating at a cell confluence of 55-85% is a matter of routine optimization and experimentation as this will affect the number of cells obtained for further expansion. Repeating this procedure multiple times (5-7 times) to create multiple batches of cells allows for the beneficial repeated use of the isolated cells.
Regarding claim 14, JP ‘025 disclose the collection of the cells after subculture (page 5) (harvesting of the cell culture). The lifting of adherent cells from a culture requires a process of lifting the cells from the surface which requires the removal of the serum-containing culture medium, rinsing of the culture with a non-serum containing solution, such as basal medium, trypsinization of the cells to break the bonds of the cells to the surface, and then collecting the cells to prepare a cell suspension. Trypsinization of adherent cells is described by Sheng-Tien (page 5). Since the inoculation of cells is described by JP ‘025 to be 1 x 10 4 cells/ml (page 5), the collected cell number after culture would be expected to be more than that after the cells are expanded. The cell density of 1x105 /ml to 1 x 106 /ml would have been a matter of routine optimization and experimentation the person of ordinary skill in the art motivated to expand the cells to provide sufficient cells for therapeutic applications and research.
Regarding claim 11, cell cultures are routinely protected from light in incubators and routinely performed under 37˚C and 5% CO2.
Therefore, the combined teachings of JP ‘690, JP ‘025, Sheng-Tien et al and Efe et al render obvious Applicant’s invention as claimed.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over JP 2019-528690 (hereinafter “JP ‘690” - from IDS filed 06/26/2024, from a machine translation) in view of JP 2018526025 (hereinafter “JP ‘025”-from IDS filed 06/26/2024-using a machine translation), Sheng-Tien et al (JP 2019-064996-from IDS filed 06/26/2024) and Efe et al (US 2017/0159019) as applied to claims 1-7, 9-11 and 13-14 above, and further in view of Shahar et al (US 2007/0280989) and Keric et al (WO 2012/098260).
Regarding claim 12, the combined teachings of JP ‘690, JP ‘025, Sheng-Tien et al and Efe et al render obvious Applicant’s invention as described above, but do not specifically include a P53 inhibitor, such as pifithrin, in the culture medium.
Shahar disclose compositions and methods for the expansion and differentiation of stem cells and partially committed progenitor cells (page 2 para 23), including nasal olfactory mucosa cells (page 6 para 73, page 8 para 90-91). The protective compound of pifithrin-α was found to be neuroprotective and beneficial for the survival, growth and maturation of neurons in culture as well as after implantation (page 9 para 108).
Keric disclose that Pifithrin -α is an exemplary reversible inhibitor of p53 (page 14 line 1) and the preferable concentration is about 5-20 µM (page 44 claim 7).
One of ordinary skill in the art would have been motivated to utilize pifithrin-α, or any of its derivatives that also function in the same manner as a p53 inhibitor, in the culture medium of JP ‘690 because Shahar teach and suggest that it is neuroprotective and beneficial in the survival, growth and maturation of cells and suitable for use with nasal olfactory mucosa cells. One of ordinary skill in the art would have been motivated to use a concentration of about 5-20 µM because Keric teach and suggest that this is a preferred concentration for pifithrin-α when used in cell culture. One of ordinary skill in the art would have had a reasonable expectation of success because Shahar and JP ‘690 are both drawn to the culture of olfactory mucosa progenitor cells.
Therefore, the combined teachings of JP ‘690, JP ‘025, Sheng-Tien et al, Efe et al, Shahar et al and Keric et al render obvious Applicant’s invention as claimed.
Response to Arguments
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive. Applicant’s arguments have been addressed in so far as they relate to the rejections above.
Applicant argues that B27 supplement has now become a well-known technical term in the field with its main components and mechanism of action clearly defined and point to the references cited in the 103 rejections above as evidence that the term is not indefinite.
This is not found persuasive. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982).
Applicant argues that the cited references fail to teach or suggest the method of amended claim 1, particularly the specified single cell harvesting step as was previously cited in claim 8 and now added to amended claim 1. Applicant argues that the D1 reference (JP 2019-528690) does not teach the method of claim 1 and that this reference is limited to the use of pluripotent olfactory stem cells and cells taken from the nasal septum unlike the claimed method.
This is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the current case, JP ‘025 disclose the collection of cells after subculture (page 5) (harvesting of the cell culture). Sheng-Tien describe the details of trypsinizing the cells to prepare a cel suspension as described above. The features of harvesting of cells are very routine in the art of cell culture and thus very well known.
Applicant argues that JP 2019-528690 does not teach the steps before culturing as recited in claim 1. Applicant argues that JP 2019-528690 do not teach the composition of the culture medium as recited in claim 1. Applicant argues that JP-2019-528690 does not teach the harvest of single cells and the preparation of cell suspension as recited in claim 1. Applicant asserts that these are distinguishing features that are not obvious to a person skilled in the art.
This is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the current case, those features not explicitly disclosed by JP 2019-528690 are either well known in the prior art and easily arrived at through routine optimization as described above or taught by JP ‘025 and Sheng-Tien as described above. JP ‘025 disclose obtaining olfactory mucosal cells and indicate a suitable cell source is the upper and middle turbinate with specimen tissue forceps as described above. Sheng-Tien disclose the use of trypsin/EDTA to isolate olfactory cells as described above.
Applicant argues that the D2 reference (JP 2018/526025) provides a preparation method for olfactory ensheathing cells rather than olfactory progenitor cells. Applicant asserts that according to the background art of the present application that olfactory ensheathing cells are differentiated from olfactory progenitor cells so they are different from each other. Applicant also asserts that this reference does not teach the same sampling site as recited in amended claim 1.
This is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the current case, JP ‘025 disclose that a suitable cell source of olfactory nerve cells is isolated from the upper and middle turbinate of olfactory mucosal tissue as described above. JP ‘690 is also isolating olfactory stem cells from olfactory mucosal tissue as well and as such would be directed to this specific site of that tissue by JP’025 as described above.
Applicant argues that the D3 reference (JP2019-064996) does not actually relate to the preparation of cells because it discloses a composition for improvement of olfactory function. Applicant asserts that starting from this reference which does not aim to prepare or isolate cells a person skilled in the art would not envisage preparing olfactory mucosa tissue and selecting the sampling site as recited in amended claim 1.
This is not found persuasive. The obviousness rejection does not start from this reference. The obviousness rejection starts from the primary reference of JP’690 as described above and Shen-Tien is included as a secondary reference to demonstrate that certain claim limitations not disclosed in JP’690 were in fact well known in the prior art as described above.
Applicant argues that the D4 reference (US 2017/0159019) focuses on the impacts of the ingredients of a medium on the culture of olfactory progenitor cells, but is silent on the sampling of the cells. Applicant asserts that the distinguishing feature of the claimed method is not obvious to a person skilled in the art in view of the cited documents D1-D4.
This is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the current case, Efe is relied upon for the teaching regarding a specific culture medium as described above and not for the sampling of the cells.
Applicant argues how references D2-D4 do not describe the method of amended claim 1 with regard to distinguishing feature (2) (the steps before culturing).
This is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the current case, the steps before culturing are addressed as described above.
Applicant argues that the two distinguishing features of (1) and (2) should be considered as a whole because they lead to the reduction of contamination of hematopoietic stem cells and fibroblasts and the improvement of cell purity. Applicant argues that none of references D1-D4 discloses these features as recited in amended claim 1.
This is not found persuasive. The reduction of contamination and improvement of cell purity are very well-known techniques in the art of cell isolation and cell culture.
The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues how references D2-D4 do not describe the method of amended claim 1 with regard to distinguishing feature (3) (the composition of the cell culture medium). Applicant argues that the culture medium of these references are missing elements such as BSA, glutamine, NEAA and N2 for example.
This is not found persuasive. The Efe reference discloses culture medium that contains these ingredients as described above. DMEM/F12 inherently contains NEAA as evidenced by Lyra-Leite (Stem Cell Reports, 2023, page 1371).
Applicant argues that while the Examiner contends that the D4 reference discloses the use of neural progenitor cell culture medium for culturing the cells of the D1 reference, that the cells that the D4 reference cultures with their culture media are different from the cells of D1. Applicant asserts that a person skilled in the art would not have been motivated to combine the method of D1 with the method of D4 to solve technical problems of in vitro culture and efficient expansion of olfactory progenitor cells as described in this application.
This is not found persuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The obviousness rejection does not rely on the bodily incorporation of the method of D1 and D4 as asserted by Applicant.
Applicant argues that the reference of D4 does not disclose that Advanced DMEM/F12 contains NEAA wherein NEAA is added to the knockout DMEM, but not included in the culture medium used for reprogramming neural/stem progenitor cells. Applicant asserts that the D4 reference fails to disclose the addition of NEAA cell culture additives to DMEM/DF12 culture medium for culturing olfactory progenitor cells.
This is not found persuasive. DMEM/F12 inherently contains NEAA as evidenced by Lyra-Leite (Stem Cell Reports, 2023, page 1371).
Applicant argues how references D1-D4 do not describe the method of amended claim 1 with regard to distinguishing feature (4) (the harvest of single cells and the preparation of cell suspension). Applicant asserts that as set forth in paragraph 26 of the present application that by using 0.05% trypsin and 0.2 mmol/L EDTA for enzymatic digestion and passage that the damage to cells is reduced and that none of the cited references discloses this technical effect or function.
This is not found persuasive. The optimization of trypsinizing cell cultures by adjusting the time of exposure and the concentrations to reduce the damage that trypsin can have on cells is well known in the art and a matter of routine optimization and experimentation. Brown (Biomaterials 2007) indicate that the use of mild trypsinization conditions in cell detachment from culture surfaces is desired and well-known in the prior art (Title).
Applicant argues that the claimed preparation method can result in unexpected technical effects. Applicant asserts that the optimization of the tissue sampling leads to the reduction of contamination and the use of claimed trypsin and EDTA can reduce damage to the cells. Applicant asserts that the claimed preparation method can achieve a repeated explant culture and obtain cells and saving the source of the tissue specimens. Applicant asserts that by using the claimed method the cell expansion rate, biological activity, and purity are improved by the olfactory progenitor cell culture medium. Applicant asserts that the cells obtained according to the claimed to the claimed preparation method have strong targeting properties and regenerative ability and can be obtained by the primary culture and passaged at a ratio of 1:3 for more than 11 generations and still have a high purity, and the cells obtained can be allotransplanted and can reduce the preparation cost and increase safety and effectiveness of application research and have a broad application prospect. Applicant asserts that Examples 1-5 of the present application demonstrate the above technical effects.
This is not found persuasive. In submitting evidence asserted to establish unobvious results, there is a burden on an applicant to indicate how the examples asserted to represent the claimed invention are considered to relate to the examples intended to represent the prior art and, particularly, to indicate how those latter examples do represent the closest prior art. See In re Borkowski, 595 F.2d 713, 184 USPQ 29 (CCPA 1974); In re Goodman, 339 F.2d 228, 144 USPQ 30 (CCPA 1964).
The evidence relied upon should also be reasonably commensurate in scope with the subject matter claimed and illustrate the claimed subject matter "as a class" relative to the prior art subject matter "as a class." In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971 ); In re Hostettler, 429 F.2d 464, 166 USPQ 558 (CCPA 1970). See, also, In re Lindner, 457 F.2d 506, 173 USPQ 356 (CCPA 1972).
It should also be established that the differences in the results are in factunexpected and unobvious and of both statistical and practical significance. In reMerck, 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986); In re Longi, 759 F. 2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Klosak, 455 F2d 1077, 173 UAPQ 14 (CCPA 1972); In re D'Ancicco, 429 F.2d 1244, 169 USPQ 303 (CCPA 1971 ). Ex parte Gelles, 22 USPQ2d 1318 (BPAI 1992).
Applicant argues that the deficiencies of references D1-D4 are not remedied by the teachings of references D5 (US 2007/0280989) or D6 (WO 2012/098260) as neither D5 nor D6 discloses or suggests the distinguishing features identified above.
This is not found persuasive because references D1-D4 are not found to be deficient as described above.
Applicant argues that Japanese Patent No. JP7556025B2, which is the counterpart and corresponds to the present application, has been issued with claims substantially the same in scope as those now pending in the present application.
This is not found persuasive as each patent application is prosecuted on its own merits and what was done in another patent office examination does not constitute imprimatur for the prosecution of other patent applications.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lyra-Leite et al., “Nutritional requirements of human induced pluripotent stem cells”, Stem Cell Reports, June 2023, Vol. 18, pp. 1371–1387.
THIS ACTION IS MADE FINAL. 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 LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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, James (Doug) Schultz can be reached at 571-272-0763. 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.
LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631