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 .
Claims status
Applicant’s reply filed 4/29/2026 is acknowledged.
Claims 1, 2, 10, 14-20, 26 is/are cancelled and claims 27-29 are newly added. Claims 21-23, 25, 27-29 is/are currently pending and is/are under examination.
Claim Rejections - 35 USC § 112(b) – New, necessitated by claim amendments
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 28 and 29 are 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 28 recites the injection needle to be 23G or more. Claim 28 depends from claim 21 that recites an injection needle of 18G or less. Taken together, claim 28 recites an injection needle that is both 23G or any size bigger and also a size 18G or any size smaller. It is unclear how the injection could be both 23G or any size bigger and also a size 18G or any size smaller. For the purpose of compact prosecution, the claim(s) 28 is/are interpreted as “injection needle has a thickness of 18G to 23G
Claim 29 recites the injection needle has an outer diameter of 0.6mm or more. Claim 28 depends from claim 21 that recites an injection needle of 18G or less, which have an outer diameter of about 1.2mm. Taken together, claim 29 recites an injection needle that has an outer diameter of both 0.6mm or more and also a 1.2mm or less. It is unclear how the injection could be both 0.6mm or more and also a 1.2mm or less. For the purpose of compact prosecution, the claim(s) 28 is/are interpreted as “injection needle has an outer diameter of 0.6 mm to 1.2 mm
Claim Interpretation – Updated to incorporate claim amendments
Claim 21 is a product claims that recites an intended use of the claimed product as “suitable for intra-articular injection”. According to MPEP 2111.02, “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.)”. Therefore, only language that clearly defines structural limitations is considered with respect to patentability analysis. In the instant claim, the intended use of the product of claim 1 as suitable for intra-articular injection does not provide any additional structural limitation to the structure of the product positively recited in the claim. Thus prior art that anticipates or renders obvious a cell sheet with the claimed structure also meets the intended use limitation.
Claim 21 is a product claims that recites a process step(s) therefore this claim is interpreted as product-by-process claim. Additionally, claim 25 limits the product-by-process limitations of claim 21. According to MPEP 2113, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)”.
Claim 21 is directed to the following product: a syringe comprising a cell microsheet of area 0.02-20mm2 comprising chondrocytes, chondroblasts or cartilage-like cells derived from articular cartilage of an animal with polydactyly. Claim 25 recites an additional process step.
The process steps recited in claims 21 are “said microsheet being formed from a culture of cells” , “wherein the microsheet is formed by a process consisting of culturing cells on a surface of a cell cultureware to form said microsheets, a stimulus-responsive polymer being immobilized on the surface of the cell cultureware, the surface having divisions 20 mm2 or less formed by grid walls, and detaching formed microsheets from the cell cultureware”, and “wherein said culturing cells consists of two-dimensional cultivation without three- dimensional cultivation”
The process step recited in claim 25 is “wherein said stimulus-responsive polymer is a temperature-responsive polymer and wherein cells are separated from the temperature responsive polymer without use of proteolytic enzyme by allowing the microsheets to stand at room temperature for 30 minutes or more”.
The structure implied by the process step(s) is that the generated microsheet is a two-dimensional structure i.e. a sheet and would have an area less than 20mm2 and the cells that form the microsheet are derived from a specific source i.e. articular cartilage tissue of an animal with polydactyly. The structural limitation pertaining to the size of the cell microsheet is already positively recited to limit the structure of the product i.e. the cell microsheet is required to be 0.02-20mm2.
Therefore, in the absence of evidence to the contrary, the recited process steps provide the following structure to the product of claim 21 and 25: a syringe comprising a cell microsheet of area 0.02-20mm2 comprising chondrocytes, chondroblasts or cartilage-like cells derived from articular cartilage tissue of an animal with polydactyly.
Finally, claim 21 also recites additional functional features of the cell sheet contained in the claimed syringe as “being capable of passing through an injection needle which is 18G or thinner”. Similarly, claims 27-29 recites additional functional features of the cell sheet contained in the claimed syringe as being capable of passing through an injection needle which has an outer diameter of 0.6mm or more, 1.2mm or less or 23G or more. These functional features of the cell sheet arise from its structure and are inherent to its structure. A cell sheet of claim 21 with a size of 0.02-20mm2 is inherently capable of these functions. Thus prior art that anticipates or renders obvious a cell sheet of size of 0.02-20mm2 is inherently capable of passing through an injection needle with the recited sizes in claims 21, 27-29.
Claim Rejections - 35 USC § 103 – New, necessitated by claim amendments
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.
Rejection of Claim(s) 1, 2, 14-20 under 35 U.S.C. 103 as being unpatentable over Mori (Journal of Hard Tissue Biology, 2014; ref of record) in view of Sato (US 2018/0243476 A1, Aug. 30, 2018) is moot due to claim cancellation.
Rejection of Claim(s) 22, 23, 25 under 35 U.S.C. 103 as being unpatentable over Mori (Journal of Hard Tissue Biology, 2014; ref of record) in view of Sato (US 2018/0243476 A1, Aug. 30, 2018) is withdrawn due to amendment to these claims necessitating new grounds of rejection.
Rejection of Claim(s) 10, and 26 under 35 U.S.C. 103 as being unpatentable over Mori (Journal of Hard Tissue Biology, 2014; ref of record) in view of Sato (US 2018/0243476 A1, Aug. 30, 2018) as applied to claims 1, 20 and 25 above, and further in view of Wang et al (Cardiovascular Research, 2008; ref of record) and Akahane et al (J Tissue Eng Regen Med 2010; 4: 404–411; ref of record) is moot due to claim cancellation.
Rejection of Claim(s) 21 under 35 U.S.C. 103 as being unpatentable over Mori (Journal of Hard Tissue Biology, 2014; ref of record) in view of Sato (US 2018/0243476 A1, Aug. 30, 2018) as applied to claims 1, 20 and 25 above, and further in view of Wang et al (Cardiovascular Research, 2008; ref of record) and Akahane et al (J Tissue Eng Regen Med 2010; 4: 404–411; ref of record) is withdrawn due to withdrawal of rejection of claim 1, 20 and 25 that the instant rejection relied upon.
Claim(s) 21-23, 25, 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung et al (US 2008/0166329 A1, July 10, 2008; IDS 2/27/2026) in view of Sato (US 2018/0243476 A1, Aug. 30, 2018; ref of record).
Regarding claim 21 and 25, Sung teaches a syringe comprising a cell sheet (Figure 15, [0099]). Regarding the cell sheet, Sung teaches that cells comprised in the cell sheet comprise chondrocytes [0018, 0026, 113] wherein in some embodiments the chondrocytes are human i.e. mammalian [0026, 113] and in some embodiments, the cell sheet is planar with a size of about 50-500um [0066]. Thus, the area of Sung’s cell sheets is 0.0025 to 0.25mm2, in case the cell sheet is a square, or about 0.002 to 0.2mm2, in case the cell sheet is circular.
Taken together, in view of claim interpretation presented above regarding the intended use and product-by-process limitations, Sung teaches a syringe comprising a cell microsheet of area 0.002 to 0.25mm2 comprising mammalian chondrocytes.
Regarding claims 22 and 23, as noted above, Sung teaches a cell sheet with an area of 0.002 to 0.25mm2 [0066] which overlaps 0.02-15 and also 0.02-10 mm2.
Regarding claims 27-29, in view of the claim interpretation presented above, since Sung teaches a cell sheet with the claimed size, Sung’s cell sheet is inherently capable of passing through a needle of the recited sizes.
Although, Sung teaches the cell microsheet comprising mammalian chondrocytes, Sung does not disclose the source of the chondrocytes is from articular cartilage of an animal with polydactyly. However methods to deriving chondrocytes from articular cartilage of an animal with polydactyly were known.
Sato teaches deriving chondrocytes from articular cartilage of a human with polydactyly (=mammal, primate, human; [0110]). Sato also teaches the use of their chondrocytes in a method for preparing cell sheet wherein the cell sheet is prepared by culturing the chondrocytes on a temperature-responsive culture dish, same as Sung (Figure 15, [0013, 0016]). Sato also teach the use of their cell sheets for cartilage repair in vivo ([0157], Table 2), same as Sung ([008, 0068, 107]).
The combination of prior art cited above under 35 U.S.C. 103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007): See MPEP 2143 for Exemplary rationales that may support a conclusion of obviousness.
In the present situation, rationale B) “Simple substitution of one known element for another to obtain predictable results” is applicable. MPEP 2143 guides that for rationale B “Office personnel must articulate the following: (1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components; (2) a finding that the substituted components and their functions were known in the art; (3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and (4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness”.
In the instant case:
(1) The prior art of Sung teaches the base product which differs from the claimed product by the substitution of the following components: substituting Sung’s chondrocytes in the preparation of the cell microsheet with the chondrocytes that are derived from articular cartilage of an animal with polydactyly in the claimed cell microsheet.
(2) The substituted components were known in the art as taught by Sato ([110]).
(3) An ordinary artisan would have substituted Sung’s chondrocytes with Sato’s chondrocytes derived from articular cartilage of an animal with polydactyly because, same as Sung’s that cultured chondrocytes on temperature-responsive culture dish, Sato also teaches culturing their chondrocytes on temperature-responsive culture dish. Thus, an ordinary artisan would have predicted that Sato’s chondrocytes that are derived from articular cartilage of an animal with polydactyly could be used to generate cell microsheets when substituted in Sung’s method.
Therefore, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR. Therefore, it would be obvious to a person of ordinary skill in the art to substitute Sung’s chondrocytes with Sato’s chondrocytes derived from articular cartilage of an animal with polydactyly to yield a predictable a cell microsheet wherein the cells are chondrocytes derived from articular cartilage of an animal with polydactyly.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments with respect to U.S.C. 103 rejection of claim(s) 1, 2, 14-20 over Mori in view of Sato have been considered but are moot because of claim cancellation.
Applicant’s arguments with respect to U.S.C. 103 rejection of claim(s) 22, 23 and 25 over Mori in view of Sato have been considered but are moot because the new ground of rejection necessitated by claim amendments. These claims were directed to a cell sheet previously and are not directed to a syringe containing a cell sheet.
Applicant’s arguments with respect to U.S.C. 103 rejection of claim(s) 10, 21 and 26 over Mori in view of Sato, further in view of Wang and Akhane have been considered but are moot because the new ground of rejection necessitated by claim amendments. New grounds of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Of note the remarks filed 4/29/2026 regarding size of Mori’s cell sheets, Applicant alleges that Mori’s cell sheets are 300-800um and that inner diameter of 18G needle is 0.84mm such that Mori’s cell sheets would not be capable of passing through an 18G needle (page 6, para 1-3).
In response, 0.84mm inner diameter equates to 840um which is greater than the alleged size of the largest cell sheets prepared by Mori and significantly greater than the alleged size of the smallest cell sheets prepared by Mori (1000um=1mm).
Conclusion
No claim is allowed.
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 MATASHA DHAR whose telephone number is (571)272-1680. The examiner can normally be reached M-F 8am-4pm (EST).
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/MATASHA DHAR/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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