DETAILED NOTICE
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 the Claims
Applicant’s submission filed 09 April 2026 has been entered. Claims 1-2 and 4-15 are pending. Claims 1-2 and 4-9 have been amended, while claim 3 has been cancelled without prejudice or disclaimer and claims 10-15 have been newly added. Therefore, prosecution on the merits continues for claims 1-2 and 4-15 as being drawn to the elected invention. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Objection to the Drawings
The replacement drawing sheets filed 09 April 2026 are acknowledged and entered into the application file. The replacement drawing sheets have an improved resolution and thus obviate the objection of record regarding the clarity of Figures 1, 3-5, and 7-10.
Therefore, the objection is withdrawn.
RE: Objection of claims 4-9
Applicant’s amendments to each of instant claims 4-9 obviate the objections of record.
Therefore, the objections are withdrawn.
RE: Rejection of claims 2-9 under 35 USC 112(b)
The cancellation of instant claim 3 renders the rejection moot for that claim. For the remaining claims, Applicant’s amendment to each of instant claims 2, 4, 6, and 8 obviate the rejections of record.
Therefore, the rejections are withdrawn.
RE: Rejection of claims 1-2, 4, and 7-8 under 35 USC 102(a)(1) over Yanaga et al
Applicant’s amendments to independent claim 1 incorporating the limitation previously recited in now cancelled claim 3, and to independent claim 4 broadly requiring the limitation recited in instant claim 6 obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-5 and 7-8 under 35 USC 103 over Yanaga et al in view of Lafont et al
Applicant’s arguments have been fully considered but are not found persuasive.
The cancellation of claim 3 renders the rejection moot for that claim. For the remaining claims, Applicant has traversed the rejection, asserting in Pages 9-10 of the Remarks filed 09 April 2026 that Yanaga et al do not disclose or suggest any cytokine expression profile, or the relationship between IL-8, GRO, MCP-1, VEGF, and IL-6. Applicant furthers this assertion by stating that Lafont et al fail to the teach or suggest what is missing in Yanaga et al. In response, the Examiner respectfully submits that the claims are to a method comprising a single active method step. Such method step in independent claim 1 comprises, as amended, culturing a cartilage, in an environment of 2% to 15% of carbon dioxide and 1% to 10% of oxygen, using a first culture medium comprising hydrocortisone and FGF-2. Likewise, the method step in independent claim 4 comprises, as amended, culturing a cartilage in a first culture medium comprising hydrocortisone and FGF-2, which then results in obtaining a composition containing the mature chondrocytes and a conditioned medium. Therefore, the expression profile of the mature chondrocytes and/or conditioned medium appears to be a contingent limitation that necessarily flows from the completion of the active method step in either independent claim. See MPEP § 2111.04 and 2112. As such, since the method of Yanaga et al as modified by Lafont teaches the active step as recited in the instant claims, and there is no evidence to the contrary that the produced mature chondrocytes as taught by Yanaga et al and Lafont et al are capable of expressing the profile of the claimed mature chondrocytes, a proper rejection need not render obvious the contingent step.
Applicant has further traversed the rejection, asserting in Page 10 of the Remarks filed 09 April 2026 that the disclosures of Yanaga et al and Lafont et al address different biological objectives, and that the ordinary artisan would not have been motivated to combine the references. In response, the Examiner respectfully submits that that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In the instant case, the ordinary artisan would have been motivated to combine Yanaga et al and Lafont et al since both disclose the culturing of articular chondrocytes in hypoxic conditions.
Therefore, the rejection is maintained and amended to encompass the claims as written.
RE: Rejection of claims 1-2, 4, and 6-8 under 35 USC 103 over Yanaga et al in view of Shastri et al
Applicant’s arguments have been fully considered but are not found persuasive.
Applicant has traversed the rejection, asserting in Page 11 of the Remarks filed 09 April 2026 that Yanaga et al do not disclose or suggest any cytokine expression profile, or the relationship between IL-8, GRO, MCP-1, VEGF, and IL-6. Applicant furthers this assertion by stating that Shastri et al fail to the teach or suggest what is missing in Yanaga et al, namely that the cytokine expression is at least four times higher than that of IL-6. In response, the Examiner respectfully submits that at least independent claim 4 does not require the asserted expression relationship as recited in independent claim 1, and instead only requires the conditioned medium to comprise at least one selected from the group consisting of IL-8, GRO, MCP-1, and VEGF.
Therefore, the rejection is maintained and amended to encompass the claims as written.
RE: Rejection of claims 1-2, 4, and 7-9 under 35 USC 103 over Yanaga et al in view of Hu et al
Applicant’s amendments to independent claim 4 broadly requiring the limitations presented in instant claim 6 obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-9 on the grounds of nonstatutory double patenting over claims 1 and 4 of US Patent No. 11,427,808 B2 in view of Lafont et al, Shastri et al, Yanaga et al, and Hu et al
The terminal disclaimer filed 09 April 2026 over US Patent No. 11,427,808 B2 obviates the rejection of record.
Therefore, the rejection is withdrawn.
New/Maintained Grounds of Rejection
Drawings
The drawings are objected to because the drawings containing color drawings without a granted
petition (See FIG. 1, 3-5, 7-10).
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The substitute Specification filed 09 April 2026 is acknowledged but is not entered into the application file since the petition for colored drawings remains outstanding. Once the petition is granted, Applicant must resubmit the substitute Specification.
Claim Interpretation
Independent claim 1 is directed to a method of producing a mature chondrocyte, comprising:
a culturing step of culturing a cartilage, in an environment of 2% to 15% of carbon dioxide and 1% to 10% of oxygen, using a first culture medium to obtain the mature chondrocyte,
wherein the first culture medium comprises hydrocortisone and FGF-2, and
wherein the mature chondrocyte expresses at least one selected from the group consisting of interleukin-8, growth-related oncogene, monocyte chemoattractant protein-1, and vascular endothelial growth factor at a level at least four times higher than that of interleukin-6.
In the instant claim, the only active step of the method is the culturing of a cartilage in an environment of 2% to 15% of carbon dioxide and 1% to 10% of oxygen, using a first culture medium comprising hydrocortisone and FGF-2. With that, the expression profile of the mature chondrocyte as expressing at least one selected from the group consisting of interleukin-8, growth-related oncogene, monocyte chemoattractant protein-1, and vascular endothelial growth factor at a level at least four times higher than that of interleukin-6 is being interpreted as an inherent result of, or to necessarily flow, from the culturing of the cartilage in an environment of 2% to 15% of carbon dioxide and 1% to 10% of oxygen, using a first culture medium comprising hydrocortisone and FGF-2. See MPEP § 2111.04 and 2112. Therefore, the prior art will read on the claim as instantly written if it discloses culturing a cartilage in an environment of 2% to 15% of carbon dioxide and 1% to 10% of oxygen using a culture medium comprising hydrocortisone and FGF-2, even if the prior art reference does not explicitly disclose the expression profile of the resulting mature chondrocyte.
Likewise, for independent claim 4, the only active step of the method is the culturing of a cartilage using a first culture medium comprising hydrocortisone and FGF-2. With that, the expression profile of the mature chondrocyte in the conditioned medium as comprising at least one selected from the group consisting of interleukin-8, growth-related oncogene, monocyte chemoattractant protein-1, and vascular endothelial growth factor is being interpreted as an inherent result of, or to necessarily flow, from the culturing of the cartilage in a first culture medium comprising hydrocortisone and FGF-2. See MPEP § 2111.04 and 2112. Therefore, the prior art will read on the claim as instantly written if it discloses culturing a cartilage in a culture medium comprising hydrocortisone and FGF-2, even if the prior art reference does not explicitly disclose the expression profile of the resulting mature chondrocyte and/or conditioned medium.
In addition, instant claims 7-8 each recite an intended use limitation. Intended use limitations are considered only in so far as they physically limit the claimed composition. Therefore, even if a composition of the prior art is not explicitly disclosed as being utilized for the recited applications, so long as the prior art composition is physically capable of being used for those applications it will thereby read on the claimed composition produced by the method of claim 4.
The Examiner would also like to note that the transitional term “contain” or “containing” is synonymous with “comprise” or “comprising”. Therefore, the claim language is inclusive or open-ended and may include additional, unrecited elements or method steps. See MPEP § 2111.03(I).
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.
Claims 1-2, 4-8, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Yanaga et al (US 2017/0306294 A1, of record on IDS filed 22 May 2023) in view of Lafont et al (Journal of Biological Chemistry, 2007, of record).
It is of note that although Yanaga et al share the same joint inventors and Assignee as the instant application, Yanaga et al was published more than one year prior to the effective filing date of the instant invention. Therefore, Yanaga et al is considered prior art under 35 USC 102(a)(1). Lafont et al is considered prior art under 35 USC 102(a)(1).
Regarding claims 1, 4-5, and 12: Yanaga et al disclose methods for the serum-free culture of human cartilage cells, or mature chondrocytes, wherein the mature chondrocytes are cultured in a serum-free culture medium comprising FGF-2 and hydrocortisone (Abstract; Paragraphs [0054], [0057], [0065], [0077], [0087], [0095]).
Yanaga et al further disclose that the chondrocytes are cultured in 5% CO2 and under hypoxic conditions (Paragraph [0058]).
Yanaga et al further disclose that the mature chondrocytes are allowed to sit in the culture medium and will inherently release factors (Paragraphs [0029]-[0035], [0059]).
Yanaga et al further disclose that the chondrocytes can be isolated from articular cartilage (Paragraphs [0046], [0064]).
Yanaga et al do not disclose that the hypoxic conditions include 1% to 10% oxygen, as required by instant claim 1.
Lafont et al, however, disclose the culturing of chondrocytes in a hypoxic environment of 1% O2, wherein the hypoxic conditions allow for the chondrocytes to have an articular phenotype (Pages 4779, 4784).
Lafont et al further disclose that the hypoxic chondrocytes have an upregulated expression of VEGF (Page 4780; Table 1).
Therefore, it would have been prima facie obvious to have modified the methods of Yanaga et al such that the mature chondrocytes are cultured in a hypoxic environment of 5% CO2 and 1% O2, as detailed in Lafont et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to culture the chondrocytes in an environment having 1% O2, as it allows for the chondrocytes to have an articular phenotype with an enhanced expression of VEGF, and would have had a reasonable expectation of success given that the methods of Yanaga et al suggest culturing the chondrocytes in a hypoxic environment. See MPEP § 2143(I)(G).
Consequently, Yanaga et al as modified by Lafont et al render obvious methods for the serum-free culture of mature chondrocytes, wherein the mature chondrocytes are cultured in a serum-free culture medium comprising FGF-2 and hydrocortisone, and in a hypoxic environment of 5% CO2 and 1% O2 (claim 5). As the mature chondrocytes have an upregulated expression of VEGF in hypoxic conditions, which will necessarily be comprised in a conditioned medium (claim 12) at a level four times higher than that of interleukin-6, this therefore renders obvious the methods of instant claims 1 and 4. See Claim Interpretation section above.
Regarding claim 2: Following the discussion of claim 1, Yanaga et al further disclose that that mature chondrocytes can be isolated from auricular cartilage (Paragraphs [0036], [0038]-[0039], [0046], [0085], [0104]-[0106]). This therefore reads on the method of the instant claim.
Regarding claims 6 and 14: As aforementioned in the discussion of claim 4, Yanaga et al as modified by Lafont et al teach the active step of the recited method, which comprises the culturing of cartilage in a first culture medium comprising hydrocortisone and FGF-2. Given the claim interpretation above – see Claim Interpretation – this therefore renders obvious the methods of instant claims 6 and 14 since the mature chondrocytes will necessarily express interleukin-8, growth-related oncogene, monocyte chemoattractant protein-1, and vascular endothelial growth factor at a level higher than that of interleukin-6.
Regarding claims 7-8: Following the discussion of claim 4, Yanaga et al further disclose that the mature chondrocytes are utilized as transplants in the repair of cartilage within subjects (Paragraphs [0028], [0036], [0060], [0083]-[0107]). As the mature chondrocytes are physically capable, or suitable, for use in the complete regeneration of cartilage with perichondrium (claim 7) for a mandibular construction (claim 8), for example, this therefore reads on the methods of the instant claims for the same reasons as discussed in the rejection of instant claim 4. See Claim Interpretation section for the discussion of the intended use limitation.
Regarding claim 13: As aforementioned in the discussion of claim 1, Yanaga et al as modified by Lafont et al render obvious the culturing of cartilage-derived mature chondrocytes in a hypoxic environment of 5% CO2 and 1% O2. The oxygen level of 1% O2 is merely close to the instantly claimed range of “2% to 10% oxygen”. Therefore, a prima facie case of obviousness exists, particularly in the absence of evidence the claimed range yields critical or unexpected results. See MPEP § 2144.05(I). This therefore renders obvious the method of the instant claim.
Claims 1-2, 4-9, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yanaga et al (US 2017/0306294 A1, of record on IDS filed 22 May 2023) in view of Lafont et al (Journal of Biological Chemistry, 2007, of record), and further in view of Hu et al (Dev Dyn, 2016, of record).
The discussion of Yanaga et al as modified by Lafont et al regarding claim 4 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Yanaga et al as modified by Lafont et al render obvious claims 1-2, 4-8, and 12-14. Hu et al is considered prior art under 35 USC 102(a)(1).
Regarding claims 9 and 15: As aforementioned in the discussion of claim 4 above, Yanaga et al as modified by Lafont et al render obvious a method for the serum-free culture of mature chondrocytes, wherein the mature chondrocytes are cultured in a serum-free culture medium comprising FGF-2 and hydrocortisone in a hypoxic environment of 5% CO2 and 1% O2, and allowed to inherently secrete factors within culture – including VEGF.
Yanaga et al further disclose that the chondrocytes can be used to repair bone fractures (Paragraph [0060]).
The combination of Yanaga et al and Lafont et al fail to teach that the mature chondrocytes are comprised within a revascularization promoter composition further comprising VEGFR2-positive cells and cells comprising a vascular inducer, as required by instant claim 9.
Hu et al, however, disclose that chondrocytes express VEGF in a hypoxia-induced manner (Pages 228-229). Hu et al further disclose that VEGF expression within chondrocytes allows for the promotion of revascularization of defected bone (Pages 230-231).
With that, Hu et al disclose that VEGFR2 is the major receptor for transducing VEGF signaling, and that VEGFR2 mediates angiogenesis and promotion of vessel permeability in response to VEGF (Pages 228; 231-232).
Therefore, it would have been prima facie obvious to have modified the method of Yanaga et al and Lafont et al such that the mature chondrocytes are further comprised in a composition with cells that express VEGFR2 to allow for the revascularization of bone fractures, as detailed in Hu et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to generate a composition comprising mature chondrocytes that express VEGF and cells that express VEGFR2, as VEGF and VEGFR2 are critical factors for the survival of chondrocytes and their ability to repair bone defects (Hu et al: Pages 228, 230), and would have had a reasonable expectation of success given the combined disclosures of Yanaga et al, Lafont et al, and Hu et al. See MPEP § 2143(I)(G).
Consequently, Yanaga et al as modified by Lafont et al and Hu et al render obvious a method of using mature chondrocytes to promote the revascularization of bone defects (claim 15), wherein the mature chondrocytes are cultured under hypoxic conditions to allow for the expression of VEGF, and further cultured with cells expressing VEGFR2 to allow for the revascularization of the bone defects. This therefore renders obvious the method of instant claim 9, as VEGF is a known vascular inducer. See Paragraph [0014] of instant Specification filed 22 May 2023.
Claims 4 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Yanaga et al (US 2017/0306294 A1, of record on IDS filed 22 May 2023) in view of Shastri et al (US 2020/0103409 A1, of record).
It is of note that although Yanaga et al share the same joint inventors and Assignee as the instant application, Yanaga et al was published more than one year prior to the effective filing date of the instant invention. Therefore, Yanaga et al is considered prior art under 35 USC 102(a)(1). Shastri et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claim 4: Yanaga et al disclose methods for the serum-free culture of human cartilage cells, or mature chondrocytes, wherein the mature chondrocytes are cultured in a serum-free culture medium comprising FGF-2 and hydrocortisone (Abstract; Paragraphs [0054], [0057], [0065], [0077], [0087], [0095]).
Yanaga et al further disclose that the mature chondrocytes are allowed to sit in the culture medium and will inherently release factors (Paragraphs [0029]-[0035], [0059]).
Yanaga et al do not disclose that the culture medium comprises IL-8, growth related gene, MCP-1, or VEGF, as required by instant claim 4.
Shastri et al, however, disclose that chondrocytes secrete each of IL-8, GRO, MCP-1, and VEGF (Paragraphs [0009], [0017], [0097]; Table 1; Figure 1).
Therefore, it would have been prima facie obvious to have substituted the mature chondrocytes of Yanaga et al with the chondrocytes of Shastri et al that inherently secrete each of IL-8, GRO, MCP-1, and VEGF, as doing so would have been a simple substitution of one mature chondrocyte for another. See MPEP § 2143(I)(B). One of ordinary skill in the art before the effective filing date of the invention would have recognized that the two chondrocytes are functionally comparable, as both are derived from articular cartilage (Yanaga et al: Paragraphs [0046], [0064]; Shastri et al: Paragraph [0089]), and thereby would have been able to substitute the mature chondrocytes with predictable results.
Consequently, Yanaga et al as modified by Shastri et al render obvious a method of culturing mature chondrocytes, wherein the mature chondrocytes are cultured in a serum-free culture medium comprising FGF-2 and hydrocortisone, and allowed to secrete each of IL-8, GRO, MCP-1, and VEGF, such that IL-8, GRO, MCP-1, and VEGF are comprised within a conditioned culture medium. This therefore renders obvious the method of the instant claim.
Regarding claims 7-8: Following the discussion of claim 4, Yanaga et al further disclose that the mature chondrocytes are utilized as transplants in the repair of cartilage within subjects (Paragraphs [0028], [0036], [0060], [0083]-[0107]). As the mature chondrocytes are physically capable, or suitable, for use in the complete regeneration of cartilage with perichondrium (claim 7) for a mandibular construction (claim 8), for example, this therefore reads on the methods of the instant claims for the same reasons as discussed in the rejection of instant claim 4. See Claim Interpretation section for the discussion of the intended use limitation.
Claims 1-2, 4-8, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Yanaga (US 20030180943 A1, of record on IDS filed 22 May 2023) in view of Lafont et al (Journal of Biological Chemistry, 2007, of record).
It is of note that although Yanaga shares the same inventor as the instant application, Yanaga was published more than one year prior to the effective filing date of the instant invention. Therefore, Yanaga is considered prior art under 35 USC 102(a)(1). Lafont et al is considered prior art under 35 USC 102(a)(1).
Regarding claims 1, 4-5, and 12: Yanaga discloses methods for the culture of human cartilage cells, or mature chondrocytes, wherein the mature chondrocytes are cultured in a culture medium comprising FGF-2, hydrocortisone, and FBS (Abstract; Paragraphs [0020], [0029], [0043]).
Yanaga further discloses that the chondrocytes are cultured in conditions suitable for the cultivation of chondrocytes, including in an environment of 10% CO2 (Paragraphs [0031], [0054]).
Yanaga further discloses that the chondrocytes can be isolated from articular cartilage (Paragraph [0015]).
Yanaga et al do not disclose that the conditions suitable for the cultivation of chondrocytes include 1% to 10% oxygen, as required by instant claim 1.
Lafont et al, however, disclose the culturing of chondrocytes in a hypoxic environment of 1% O2, wherein the hypoxic conditions allow for the chondrocytes to have an articular phenotype (Pages 4779, 4784).
Lafont et al further disclose that the hypoxic chondrocytes have an upregulated expression of VEGF (Page 4780; Table 1).
Therefore, it would have been prima facie obvious to have modified the method of Yanaga such that the mature chondrocytes are cultured in a hypoxic environment of 1% O2, as detailed in Lafont et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to culture the chondrocytes in an environment having 1% O2, as it allows for the chondrocytes to have an articular phenotype with an enhanced expression of VEGF, and would have had a reasonable expectation of success given that the methods of Lafont et al show that chondrocytes can suitably be cultured in hypoxic environments. See MPEP § 2143(I)(G).
Consequently, Yanaga as modified by Lafont et al render obvious methods for the culture of mature chondrocytes, wherein the mature chondrocytes are cultured in a culture medium comprising FGF-2, hydrocortisone, and FBS (claims 10-11), and in a hypoxic environment of 10% CO2 and 1% O2 (claim 5). As the mature chondrocytes have an upregulated expression of VEGF in hypoxic conditions, which will necessarily be comprised in a conditioned medium (claim 12) at a level four times higher than that of interleukin-6, this therefore renders obvious the methods of instant claims 1 and 4. See Claim Interpretation section above.
Regarding claim 2: Following the discussion of claim 1, Yanaga furthers disclose that that mature chondrocytes can be isolated from auricular cartilage (Paragraphs [0015], [0033], [0044], [0057], [0059]). This therefore reads on the method of the instant claim.
Regarding claims 6 and 14: As aforementioned in the discussion of claim 4, Yanaga as modified by Lafont et al teach the active step of the recited method, which comprises the culturing of cartilage in a first culture medium comprising hydrocortisone and FGF-2. Given the claim interpretation above – see Claim Interpretation – this therefore renders obvious the methods of instant claims 6 and 14 since the mature chondrocytes will necessarily express interleukin-8, growth-related oncogene, monocyte chemoattractant protein-1, and vascular endothelial growth factor at a level higher than that of interleukin-6.
Regarding claims 7-8: Following the discussion of claim 4, Yanaga further discloses that the mature chondrocytes are utilized as transplants in the repair of cartilage within subjects (Paragraphs [0011], [0037], [0063]-[0074]). As the mature chondrocytes are physically capable, or suitable, for use in the complete regeneration of cartilage with perichondrium (claim 7) for a mandibular construction (claim 8), for example, this therefore reads on the methods of the instant claims for the same reasons as discussed in the rejection of instant claim 4. See Claim Interpretation section for the discussion of the intended use limitation.
Regarding claim 13: As aforementioned in the discussion of claim 1, Yanaga as modified by Lafont et al render obvious the culturing of cartilage-derived mature chondrocytes in a hypoxic environment of 10% CO2 and 1% O2. The oxygen level of 1% O2 is merely close to the instantly claimed range of “2% to 10% oxygen”. Therefore, a prima facie case of obviousness exists, particularly in the absence of evidence the claimed range yields critical or unexpected results. See MPEP § 2144.05(I). This therefore renders obvious the method of the instant claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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, Christopher Babic can be reached at (571) 272-8507. 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.
/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
Prosecution Insights