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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/13/2026 has been entered.
No claims have been amended, newly added or newly canceled.
Claims 1, 6, 28, 30, 37-40 and 48, are currently pending.
Claims 28, 30, 37-40 and 48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/17/2025.
Applicant’s amendment to claim 6 filed 06/10/2025 has allowed for the specie restriction required to be withdrawn for claim 6 and thus claim 6 has been rejoined for examination.
Claims 1 and 6 have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. 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 § 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 and 6 remain rejected under 35 U.S.C. 103 as being unpatentable over Clevers et al (WO 2012/168930-previously cited) in view of Seo et al (WO 02/089586-previously cited), Leiner et al (American Journal of Respiratory Cell and Molecular Biology 2006-previously cited) and Jerde et al (Science Signaling 2009-previously cited).
Regarding claims 1 and 6, Clevers disclose culture media for stem cells, particularly epithelial stem cells, for expansion (page 2 lines 14-22), including an embodiment that comprises a serum-free medium and an extracellular matrix component (page 26, lines 1-6 and lines 20-35, page 27 lines 1-33). In some embodiments the culture medium comprises Advanced DMEM/F12 supplemented with penicillin/streptomycin (antibiotic), 10 mM HEPES, Glutamax, 1x N2, 1x B27 and 1mM N-acetylcysteine (page 28 lines 1-3). Specific inhibitors are suggested for addition to the culture medium and include SB431542 (between 100 nM and 40 µM) (page 11 lines 25-27), BIRB796 (1 µM) (page 11 lines 19-21), CHIR99021 (3 µM) (page 17 lines 30-31, page 18 lines 1-3) and Y-27632 (10 µM) (page 20 lines 8-10). Specific mitogenic growth factors are suggested for addition and include EGF (at least 50 ng/ml) and FGF10 (at least 10 ng/ml (page 19, lines 5-7, 14-16, 19, 28-31) and may be human recombinant or mouse recombinant (pages 127-128 Table 3). Specific proteins to be added include insulin and transferrin (page 14 lines 10-13) and trace elements such as selenium (page 26 lines 11-12). The culture media composition includes embodiments that do not include an undefined component (chemically defined and stroma free)(page 26 lines 1-3).
The limitations regarding “type 2 alveolar epithelial cell culture expansion medium” are interpreted as related to the intended use of the culture medium and are given limited weight in that they require that the culture medium be suitable for such use which the medium disclosed by Clevers is deemed to meet.
The specific combination of features claimed is disclosed within the broad genera of inhibitors, growth factors and additives taught by Clevers, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any specific teaching to select this specific combination of variables, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen 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”. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 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.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have selected various combinations of inhibitors, growth factors and additives from within the disclosure of Clevers to arrive at culture media compositions “yielding no more than one would expect from such an arrangement”.
With regard to the concentrations of basal medium, extracellular matrix components, inhibitors, growth factors and additives in the culture medium composition, 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).
While Clevers does not disclose each and every claimed concentration and ratio as claimed, the selection of specific 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 with the culture medium would have been affected by these concentrations.
Clevers includes the addition of an antibiotic to their culture media as described above, but are silent with regard to the inclusion of an antimycotic.
Seo disclose a method of providing an epithelial cell line (page 9 lines 12-13) and disclose that conventional and routine techniques are used to culture the epithelial cells (page 20 lines 21-25, lines 34-35) and include the addition of a 1% antibiotic-antimycotic to the culture medium during expansion of the epithelial cells (page 29 lines 23-25).
One of ordinary skill in the art would have been motivated to include an antimycotic as well as an antibiotic in the culture medium of Clevers because Seo teach and suggest that it is routine to include 1% antibiotic-antimycotic to a culture medium intended for the culture and expansion of epithelial cells. An antimycotic would have provide the benefit of reducing any fungal contamination in the culture medium. One of ordinary skill in the art would have had a reasonable expectation of success because both Clevers and Seo are directed to culturing epithelial cells and Clevers is already including an antibiotic in their culture medium to reduce bacterial contamination in the culture medium.
Clevers do not include heparin in their epithelial culture medium composition.
Leiner teach that the stimulation of pulmonary alveolar type 2 epithelial cell capacity to biosynthesize, store, and secrete surfactant proteins are modulated to a great extent by growth factors, extracellular matrix components and hormones (abstract, page 617). The type 2 epithelial cells are the progenitors of type 1 cells in vivo and replace injured or damaged type 1 cells and are capable of proliferating to maintain stable cell populations in the alveolus (page 611, column 2). Heparin at low concentrations of 5 µg/ml was shown to enhance the effects of various fibroblast growth factors such as FGF2 and FGF7 (abstract, page 616, column 1). Heparin plays a significant role in modulating alveolar epithelial cell phenotype in vitro in a dose dependent manner (abstract, page 617).
One of ordinary skill in the art would have been motivated to include heparin at 5 µg/ml in the epithelial stem cell culture medium of Clevers because Leiner teach and suggest that heparin at low concentrations of 5 µg/ml was shown to enhance the effects of various fibroblast growth factors, such as FGF2 and FGF7 (abstract, page 616, column 1), when culturing epithelial stem cells in vitro. One of ordinary skill in the art would have had a reasonable expectation of success because Clevers and Leiner are both directed to the culture and expansion of epithelial stem cells with growth factors, such as FGF, and Clevers teach that one or more additional agents previously reported to improve stem cell culture may be included in their composition as well (page 26 lines 17-18).
The combined teachings of Clevers, Seo and Leiner render obvious the claimed culture medium as described above, but do not mention the addition of IL-1β to the culture medium.
Jerde disclose that IL-1 induces epithelial and stromal expansion and organogenesis in serum-free medium (page 3, column 1, Fig 2). Growth induction was concentration dependent and robust effects were seen at concentrations generally considered physiologic (1 to 10 ng/ml) (page 3 column 1). IL-1beta treated tissue showed outgrowths and showed a selective proliferative effect on progenitor containing cell populations (page 3 column 2).
One of ordinary skill in the art would have been motivated to include IL-1beta at a concentration of 10 ng/ml in the epithelial stem cell culture medium of Clevers because Jerde teach that IL-1 beta treated epithelial cells showed a selective proliferative effect on progenitor containing cell populations (epithelial stem cell) at this concentration.
One of ordinary skill in the art would have had a reasonable expectation of success because Clevers and Jerde are both culturing epithelial cells in a serum free defined medium and Clevers teach that one or more additional agents previously reported to improve stem cell culture may be included in their composition as well (page 26 lines 17-18).
Therefore, the combined teachings of Clevers et al, Seo et al, Leiner et al, and Jerde et al render obvious Applicant’s invention as claimed.
Response to Arguments
Applicant's arguments filed 03/13/2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art does not teach or suggest that the claimed media would permit stable type 3 alveolar epithelial cell expansion. Applicant asserts that their working examples surprisingly demonstrate that inclusion of IL-1β in the claimed culture media resulted in significantly enhanced organoid numbers and size -which reflects growth rate and point to paragraphs 249 and 250 of their disclosure as evidence.
This is not found persuasive. The limitations regarding “type 2 alveolar epithelial cell culture expansion medium” are interpreted as related to the intended use of the culture medium and are given limited weight in that they require that the culture medium be suitable for such use which the medium disclosed by Clevers is deemed to meet.
In addition, Clevers specifically state that their culture media are to be used with human epithelial stem cells and are not to be limited to the example tissue types that they have listed (page 47 lines 20-31). Clevers state that the cells may be isolated from any suitable source (page 61) and any tissue of interest (page 102 lines 16-21).
In addition, Jerde disclose that IL-1 induces epithelial and stromal expansion and organogenesis in serum-free medium (page 3, column 1, Fig 2). Growth induction was concentration dependent and robust effects were seen at concentrations generally considered physiologic (1 to 10 ng/ml) (page 3 column 1). IL-1beta treated tissue showed outgrowths and showed a selective proliferative effect on progenitor containing cell populations (page 3 column 2). One of ordinary skill in the art would have been motivated to include IL-1beta at a concentration of 10 ng/ml in the epithelial stem cell culture medium of Clevers because Jerde teach that IL-1 beta treated epithelial cells showed a selective proliferative effect on progenitor containing cell populations (epithelial stem cell) at this concentration.
Applicant argues that impermissible hindsight was used for determining obviousness.
This is not found persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In the current case the obviousness rejection is based on the teachings of the cited prior art references as described above.
A. Applicant argues that the skilled person would not consider Clevers intestinal epithelial cell media to be predictive of successful culture and expansion of alveolar epithelial cells.
Applicant argues that Clevers is directed to culture media for expanding and differentiating populations of stem cells and particularly tissue specific culture media for various different tissue cell types, but does not specifically mention lung cells or alveolar epithelial cells as claimed. Applicant asserts that the Office improperly generalizes the teaching of Clevers from intestinal epithelium to alveolar epithelium, and argues that these cells are biologically distinct. Applicant argues that a person of ordinary skill in the art would be well aware of this distinctness and would understand that a media for one would not necessarily be appropriate for another.
This is not found persuasive. Clevers specifically state that their culture media are to be used with human epithelial stem cells and are not to be limited to the example tissue types that they have listed (page 47 lines 20-31). Clevers state that the cells may be isolated from any suitable source (page 61) and any tissue of interest (page 102 lines 16-21).
Applicant argues that there are a vast number of basal media and components thereof are generically described in Clevers. Applicant asserts that depending on the tissue types certain components may or may not be included in the culture media. Applicant asserts that the skilled person would have no way to predict which of the components to select or leave out when culturing alveolar epithelial cells to obtain the significantly enhanced organoid numbers and size as obtained applicant’s expansion medium. Applicant asserts that there are not a finite number of predictable solutions to the problem or a reasonable expectation of success to arrive at the claimed culture medium.
This is not found persuasive. A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")).
B. Applicant argues that the skilled person would be taught away from the inclusion of BIRB796 in the claimed culture medium based upon the disclosure of Clevers.
Applicant argues that because Clevers utilizes different p38 inhibitors in their examples that the skilled person would be motivated to select a different p38 inhibitor and ignore BIRB796. Applicant argues that the mere mention of BIRB796 is insufficient to render obvious the claims and asserts that there must be a reason to select BIRB796 out of the list of 7 options provided by Clevers. Applicant asserts that because there are other options in addition to BIRB796 that a skilled person would be taught away from the selection of BIRB796 in favor of the other options and because Clevers did not use BIRB796 for their examples.
This is not found persuasive. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCРА 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994).
Applicant argues that Seo does not remedy the short comings of Clevers as Seo is not directed to a culture medium and is directed to a novel lung epithelial cell line. Applicant argues that Seo does not mention p38 inhibitors at all and that the skilled person would not be motivated to combine Clevers and Seo to arrive at the claimed culture media.
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).
In the current case, Seo is relied upon as evidence that using an antibiotic/antimycotic additive in an epithelial expansion culture is routine and beneficial in order to reduce the risk of contamination.
Applicant argues that Leiner is even less relevant than Seo because Leiner teaches the culture of type 2 alveolar cells in media including serum and subsequently in a serum-free media that is without EGF which is in contrast to the claimed media of the current application. Applicant also argues that Leiner further teaches the inclusion of FGF-1, FGF-2, FGF7 in their media as relevant growth factors due to their known distribution to the lung in contrast to the claimed media of the current application which requires FGF10.
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).
In the current case, Leiner is relied upon as evidence that heparin at low concentrations was show to enhance the effect of various fibroblast growth factors such as FGF2 and FGF7. Leiner also teaches that heparin plays a significant role in modulating alveolar epithelial cell phenotype in vitro in a dose dependent manner (abstract, page 617). One of ordinary skill in the art would have been motivated to include heparin at 5 ug/ml in the epithelial stem cell culture medium of Clevers (which also contains FGFs) because of the teachings and suggestions of Leiner.
Applicant argues that the Office appears to be picking and choosing disparate references simply because they include one or more of the claimed media components without regard to what the skilled person would understand about the components and their application in culture and expansion media.
This is not found persuasive. The references cited in the obviousness rejection were all selected based on the fact that they are all related to the optimization of cell culture and demonstrated that the limitations missing from the Clevers reference culture medium were well known in the art of cell culture.
C. Applicant argues that the skilled person would be taught away from the inclusion of IL-1β in the claimed culture medium based upon the disclosure of the cited art.
Applicant argues that neither Clevers nor Leiner mentions IL-1β in their disclosures. Applicant argues that Seo does not specifically mention IL-1β and IL-1 is equated with six other interleukins among a range of other cytokines, lymphokines and chemokines.
This is not found persuasive. The motivation to include Il-1beta in the culture medium of Clevers is provided by the Jerde reference as previously described.
Applicant argues that Yanagisawa, which was cited in a previous action, disclose the preparation of cell cultures and provides that in contrast to TNF α, that IL-1β inhibited GEC proliferation and indicated in their Fig 7 that IL-1β had no effect. Applicant asserts that this means that based on Yanagisawa the skilled person would be taught away from the inclusion of IL-1β in a cell culture media for epithelial cells.
This is not found persuasive. The motivation to include IL-1β is much stronger based on the teaching of Jerde. Jerde disclose that IL-1 induces epithelial and stromal expansion and organogenesis in serum-free medium (page 3, column 1, Fig 2). Growth induction was concentration dependent and robust effects were seen at concentrations generally considered physiologic (1 to 10 ng/ml) (page 3 column 1). IL-1beta treated tissue showed outgrowths and showed a selective proliferative effect on progenitor containing cell populations (page 3 column 2). One of ordinary skill in the art would have been motivated to include IL-1beta at a concentration of 10 ng/ml in the epithelial stem cell culture medium of Clevers because Jerde teach that IL-1 beta treated epithelial cells showed a selective proliferative effect on progenitor containing cell populations (epithelial stem cell) at this concentration.
Applicant argues that Jerde teaches that IL-1 activates inflammatory signaling cascades including p38 MAPK. Applicant asserts that the skilled person understood that the effects of IL-1 to be mediated through p38 and that given that BIRB796 is a potent p39 inhibitor the skilled person would have expected p39 inhibition to blunt IL-1 signaling. Applicant asserts that the prior art discourages simultaneous use of IL-1β and a p38 inhibitor in an epithelial expansion system.
This is not found persuasive. There is nothing in the Jerde reference that states that p38 MAPK signaling is the reason for proliferative effects of IL-1 on epithelial cell cultures. There is also nothing on record that states that BIRB796 should not be combined with IL-1 in a cell culture medium.
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.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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