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 .
Claim Status
Claims 23-40 are pending.
Claim 34 is withdrawn.
Claims 23-33 and 35-40 are under examination.
New Claim Objections
Claim 39 is objected to because of the following informalities:
Claim 39 recites “the tissue construct contacts only the frame body consists of” which is grammatically improper and should include a relative pronoun (such as “that” or “which”) in between “frame body” and “consists of.”
Appropriate correction is required.
Examiner’s Remark on Previous Claim Interpretation
35 U.S.C. 112(f)
It is noted that Applicant’s amendment to claim 26 no longer invokes 35 U.S.C. 112(f).
New Claim Interpretation
35 U.S.C. 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
New claim 38 is being interpreted under 35 U.S.C. 112(f).
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In the instant case, new claim 38 is being interpreted under 35 U.S.C. 112(f) for the following reasons:
Regarding (A), the claim limitation uses a term used as a substitute for “means” (configuration) that is a generic placeholder for performing the claimed function (an opening configuration).
Regarding (B), the generic placeholder is modified by functional language (configuration that enables).
Regarding (C) the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Therefore, regarding new claim 38, the phrase “has an opening configuration that enables a circle with a diameter of 2.5 mm or larger to be inscribed in the opening” is interpreted as a means-function limitation under 35. U.S.C. 112f because it contains the generic placeholder “configuration” that is modified by the functional language “that enables” and is not modified by sufficient structure, material, or acts for performing the claimed function because there are no other elements recited in the claim.
It is noted that the instant specification states “The opening of the frame body having "an opening configuration that enables a circle to be inscribed in the opening" used herein means an opening where a circle having a diameter of a given size can fit inside the opening configuration (e.g., a rectangular or polygonal configuration) of the opening, in contact with the opening at one or more points. For example, an opening with a rectangular configuration (longer side: 20 mm; shorter side: 2.5 mm) enables a circle with a diameter of up to 2.5 mm to be inscribed in the opening. In the present invention, an opening configuration of the opening of the frame body can be defined at positions on the opening where the opening has the smallest opening area. For example, such configuration can be defined on any plane (e.g., a plane) including the opening edge.” (instant specification para. [0055]). Instant claim 38 is interpreted accordingly.
New Claim Rejections - 35 USC § 112a
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 39-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the amendment filed on 10th, March, 2026, new claims 39-40 were added which each recite the limitation that “the tissue construct contacts only the frame body” which appears to be new matter.
A review of the originally filed specification by the Examiner did NOT find any specific basis for the recited limitation. The disclosure (including the specification, claims and sequence listing) as originally filed, does not contain a specific or explicit recitation of the limitation
The closest support for such a limitation is the disclosure of the frame body and contacting the frame body (“in contact with the opening at one or more points “ para. [0054, 0106]). General disclosure of the frame body which is contacted by the tissue construct does not provide support for excluding all other possible contacts.
The limitation of “contacts only the frame body” is an exclusionary proviso because it excludes the tissue construct from contacting things other than the frame body. Applicant is directed to MPEP section 2173.05(i) which states any negative limitation or exclusionary proviso must have basis in the original disclosure. As stated above, this negative limitation was not found to have basis in the original disclosure.
Applicant has not provided the location of support for this amendment. When filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure.") The claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported (see MPEP 2163 (I), and therefore the limitation appears to be new matter.
As noted by MPEP 608.04(a), new matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. In the instant case one skilled in the art would NOT consider excluding all possible contacts to be explicitly, implicitly, or inherently supported by Applicant’s disclosure.
Hence, there is insufficient written descriptions support for the instantly claimed limitation of and Applicant has not shown possession of the invention.
Response to Arguments
Applicants arguments, filed 10th, March, 2026, have been fully considered and are not found persuasive.
Applicant argues “Support for the claim amendments and the new claims can be found throughout the specification and drawings, including, but not limited to, paragraphs [0060], [0061], [0064], [0091], [0095], [0103], [0163] and [0168], Figures 1-11, 22 and 24-30 and previously pending claims” (pg. 6).
In response, paragraphs [0060], [0061], [0064], [0091], [0095], [0103], [0163] and [0168], Figures 1-11, 22 and 24-30 are silent to specific support of excluding all possible contacts, as discussed above.
As stated above, Applicant has not provided the location of support for this amendment. When filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure.") The claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not specifically pointed out where the limitation at issue is supported (see MPEP 2163 (I), and therefore the limitation appears to be new matter.
Withdrawn Claim Rejections - 35 USC § 112b
The rejection of claims 23-33 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
New Claim Rejections - 35 USC § 112b
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 39-40 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 39-40 each recite “the tissue construct contacts only the frame body.” The scope of the limitation is unclear because claims 39 and 40 require a device with a hollow portion and a frame body that forms the hollow portion. Because the hollow portion of the device encompasses body tissue materials that the construct would contact during and after the formation of the tissue construct, and the tissue construct would also contact the external space of the device that encompasses body tissue materials that the construct would contact during and after the formation of the tissue construct, it is unclear how the tissue construct can only contact the frame body as claimed, and the metes and bound of the claims are unclear.
Withdrawn Claim Rejections - 35 USC § 112d
The rejection of claim 32 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Withdrawn Claim Rejections - 35 USC § 102
The rejection of claims 23-24, 30 and 32-33 under 35 U.S.C. 102(a)(1) as being anticipated by Nakayama et al. (JP-2016136984-A; see IDS filed 27th, August, 2024; citations refer to attached translation; henceforth “Nakayama”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claims 23-33 under 35 U.S.C. 102(a)(1) as being anticipated by Nakayama et al. (US-2019/0083225-A1; henceforth “Nakayama2”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
New Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 23, 30, 32-33, 35-36 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakayama et al. (JP-2013090696-A; See IDS filed 27th, August, 2024; henceforth “Nakayama3”).
Regarding claim 23, Nakayama3 discloses a method for producing a tissue construct, wherein the method comprises placing a device in an environment comprising body tissue materials (“environment in which a biological tissue material is present” claim 1; see alco claims 3-8; para. [0005, 0010, 0016, 0018, 0041, 0049]) to produce the tissue construct, the device comprising:
a hollow portion; and
a frame body that forms the hollow portion,
wherein the frame body has an opening that communicates from the hollow portion to an
external space of the device,
wherein the device does not comprise a rod-like member within the hollow portion (the hollow portion contains liquid and not a rod like member; see annotated Figure 2 below)
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(annotated Figure 2 of Nakayama3).
Regarding the limitation of “the tissue construct produced by the method comprises a core portion having a recess and composed of fibrous connective tissue, and loose fibrous, somatic stem cell-accumulated tissue comprising type III collagen and somatic stem cells which is formed in the recess” of claim 23, this is present as part of a wherein clause, and does not recite any additional active method steps, but simply state a characterization or conclusion of the results of process step positively recited. Therefore, the "wherein" clause is not considered to further limit the method defined by the claim and has not been given weight in construing the claims. See Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171,26 USPQ2d 1018, 1023 (Fed Cir. 1993) ("A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim."). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited."). See also MPEP 2111.04 that a “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure” and a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Furthermore, as stated above, Nakayama3 discloses the active method steps of the instantly claimed method and therefore the functional result claimed in the wherein clause “the tissue construct comprises a core portion having a recess and composed of fibrous connective tissue, and loose fibrous, somatic stem cell-accumulated tissue comprising type III collagen and somatic stem cells which is formed in the recess”) recited in the wherein clause would inherently follow the recitation of the disclosed steps. Furthermore, it is noted that Nakayama3 also specifically disclosed the method results in forming biological tissue material which “include living cells such as fibroblasts, various proteins (collagen, elastin), sugars such as hyaluronic acid, smooth muscle cells, endothelial cells, hepatocytes, ES cells, iPS cells, various physiologically active substances, and the like” (para. [0020]).
Regarding claim 30, further to the discussion of claim 23 above, the opening in the device disclosed by Nakayama3 has an elliptic opening edge (see Figure 1, annotated below).
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Regarding claim 32, further to the discussion of claim 23 above, as stated above, Nakayama3 discloses the active method steps of the instantly claimed method and therefore the result of the somatic stem cells comprising mesenchymal stem cells would inherently follow the recitation of the disclosed steps.
Regarding claim 33, further to the discussion of claim 23 above, Nakayama3 discloses the environment comprising body tissue materials comprises a living body or an isolated body tissue (“the "environment in which a biological tissue material is present" refers to an artificial environment containing a biological tissue material in a living body of an animal (a mammal such as a human, a dog, a cow, a pig, a goat, or a sheep, a bird, a fish, or another animal) (for example, subcutaneous or intraperitoneal implantation of a limb, a waist, a back, or an abdomen) or outside the living body of the animal” para. [0022]; see also ; abstract; para. [0006, 0010-0011, 0018, 0023, 0035-0036]).
Regarding claim 35, further to the discussion of claim 23 above, Nakayama3 discloses the base material has diameter of 5 mm and a longitudinal size of 30 mm (para. [0041]), the hollow portion is withing the longitudinal of the base material (see figure above), and therefore the 30 mm length and 5 mm diameter which is greater than the “depth of at least 2 mm” meets instant claims.
Regarding claim 36, further to the discussion of claim 23 above, as stated above, Nakayama3 discloses the active method steps of the instantly claimed method and therefore the result of the somatic stem cells comprise cells expressing at least either pluripotent stem cell marker SSEA3 or SSEA4 would inherently follow the recitation of the disclosed steps. Furthermore, it is noted that Nakayama3 also specifically disclosed the method results in forming biological tissue material which includes ES cells and/or iPS cells (para. [0020]), which are pluripotent cells and would express at least either pluripotent stem cell marker SSEA3 or SSEA4.
Regarding claim 40, further to the discussion of claim 23 above, Nakayama3 discloses the tissue construct forms on the surface of the frame body (“form the tissue body on the substrate surface” abstract; see also pg. 2; claims 1, 3, 5 and 8; para. [0006-0007, 0009, 0011-0014, 0018, 0024, 0027, 0031, 0033, 0036, 0040-0042]) and therefore contacts only the frame body during production of the tissue construct.
Accordingly, Nakayama anticipates instant claims.
Claims 23-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horvath et al. (Circ Res. 2002 Mar 8;90(4):488-94.; henceforth “Horvath”) as evidenced by Butany et al. (J Clin Pathol. 2005 Aug;58(8):795–804.; henceforth “Butany”).
Regarding claim 23, Horvath discloses a method comprising placing a device (stent) in an environment comprising body tissue materials (“Six male cynomolgus monkeys (Macaca fascicularis) underwent balloon dilatation and stent implantation” pg. 488).
Regarding claim 23, the device of Horvath is a stent, which is balloon-expandable 7-mm stent (“7-mm stent (half of a 15-mm CS15-030, Palmaz-Schatz Crown balloon-expandable stent, Cordis Corp.)”; pg. 489 col. 1 2nd para.) and therefore comprises a hollow portion and a frame body that forms the hollow portion and does not comprise a rod-like member within the hollow portion. The body of a stent has openings on both ends that communicate to the external space of the stent.
Regarding the preamble of “for producing a tissue construct” and the limitation “to produce a tissue construct,” the method of Horvath places the stent to model In-Stent Restenosis and therefore meets the broadest reasonable interpretation of producing a tissue construct. The method also results in “in-stent neointimal hyperplasia” (pg. 492 col. 2; Figures 4-5) which is the production of tissue.
Regarding the limitation of “wherein the tissue construct produced by the method comprises a core portion having a recess and composed of fibrous connective tissue, and loose fibrous, somatic stem cell-accumulated tissue comprising type III collagen and somatic stem cells which is formed in the recess” of claim 23, this is present as part of a wherein clause, and does not recite any additional active method steps, but simply state a characterization or conclusion of the results of process step positively recited. Therefore, the "wherein" clause is not considered to further limit the method defined by the claim and has not been given weight in construing the claims. See Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171,26 USPQ2d 1018, 1023 (Fed Cir. 1993) ("A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim."). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited."). See also MPEP 2111.04 that a “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure” and a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Furthermore, as stated above, Horvath discloses the active method steps of the instantly claimed method and therefore the functional result claimed in the wherein clause “the tissue construct comprises a core portion having a recess and composed of fibrous connective tissue, and loose fibrous, somatic stem cell-accumulated tissue comprising type III collagen and somatic stem cells which is formed in the recess”) recited in the wherein clause would inherently follow the recitation of the disclosed steps.
Regarding claim 24, further to the discussion of claim 23 above, the claim does not recite an additional active method step, and therefore the method of Horvath, which discloses all the active method steps of the claimed method, would inherently result in “the frame body defines the shape of the tissue construct formed in the hollow portion.”
Regarding the limitation of “when the device is placed in the environment comprising body tissue materials, fibrous connective tissue is formed to stretch from the surface of the frame body toward the inside of the hollow portion, thereby causing the core portion having a recess recessed from the opening toward the hollow portion to be formed, and loose fibrous tissue where somatic stem cells are accumulated is formed in the recess” this is not an active method step. Additionally, claim 23, upon which claim 24 depends, already recites placing the device to produce a tissue construct. As stated above (see claim 23 rejection above), because Horvath discloses the active method steps of the instantly claimed method, the claimed functional result of “fibrous connective tissue is formed to stretch from the surface of the frame body toward the inside of the hollow portion, thereby causing the core portion having a recess recessed from the opening toward the hollow portion to be formed, and loose fibrous tissue where somatic stem cells are accumulated is formed in the recess would inherently follow the recitation of the steps disclosed by Horvath.
Regarding claims 25-26, further to the discussion of claim 23 above, Horvath discloses the device is a balloon-expandable 7-mm stent, which is half of a 15-mm CS15-030 (pg. 489 col. 1 2nd para.). Butany evidences 15 mm stents have a diameter of 2.5–5.5 mm (pg. 797 col. 2). The range of 2.5–5.5 mm is an opening width of at least 2.5 mm and is also an opening dimension that enables a circle with a diameter of 2.5 mm or larger to be inscribed in the opening.
Accordingly, Horvath anticipates instant claims.
Claims 37-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakayama et al. (US-2019/0083225-A1; published 21st, March, 2019; henceforth “Nakayama2”).
Regarding claim 37, Nakayama2 discloses a method,
wherein the method comprises placing a device for producing a tissue construct (“tissue body formation device” labeled as “10” in Figure 1; para. [0024]) in an environment comprising body tissue materials(“implanted in a living body” para. [0052]; see also para. [0002, 0007, 0011, 0026, 0040, 0053-0056, 0107] ; Figures 1,3) to produce the tissue construct, comprising:
a hollow portion(“the hollow gap between the tissue forming surface of the inner member” para. [0013]); and a frame body that forms the hollow portion,
wherein the frame body has a plurality of elongated members spaced from a center part of the device and spaced from a center part of a tissue construct to be formed and has an opening that communicates from the hollow portion to an external space of the device; (see labeled Figure 1 of Nakayama2 below)
and forming said tissue construct in said environment.
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Regarding the limitation of “the tissue construct formed in said environment comprises a central core portion, located around a center point of the device formed from connective tissue that extends from said plurality of elongated members to the center part of the tissue construct and said tissue construct having a plurality of recesses around the center part which is composed of said fibrous connective tissue, and loose fibrous, somatic stem cell accumulated tissue comprising type III collagen and somatic stem cells which is formed in the plurality of recesses,” this is not an active method step and is present as part of a wherein clause, and does not recite any additional active method steps, but simply state a characterization or conclusion of the results of process step positively recited. Therefore, the "wherein" clause is not considered to further limit the method defined by the claim and has not been given weight in construing the claims. See Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171,26 USPQ2d 1018, 1023 (Fed Cir. 1993) ("A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim."). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited."). See also MPEP 2111.04 that a “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure” and a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Furthermore, as stated above, Nakayama2 discloses the active method steps of the instantly claimed method and therefore the functional result claimed in the wherein clause would inherently follow the recitation of the disclosed steps.
Regarding claim 38, further to the discussion of claim 37 above, Nakayama2 discloses the opening has an opening width of 2.5 mm (Figure 9).
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Because the opening width disclosed is 2.5 mm, it is an opening has an opening configuration that enables a circle with a diameter of 2.5 mm or larger to be inscribed in the opening.
Accordingly, Nakayama2 anticipates instant claims.
Response to Arguments
The previous rejections of record under 35 U.S.C. 102 are withdrawn in view of Applicant’s amendments. For the sake of compact prosecution, Arguments considered pertinent to the new grounds of rejection above are considered below.
Applicant’s arguments, filed 10th, March, 2026, have been fully considered but are not found persuasive.
Applicant argues “the devices disclosed in Nakayama and Nakayama2 must have the inner member positioned within the outer member”(pg. 9-10).
In response, new claim 37 does not exclude an inner rod-like member.
Applicant argues “Both devices disclosed in the cited references, Nakayama and Nakayama2, are for producing a "tubular" connective tissue body” (pg. 9) and “The tissue construct according to
the present invention is not tubular ( does not have a hollow central portion) but, rather, has a central
core portion 25 composed of fibrous connective tissue 22 and a peripheral portion with recesses
24 in the periphery. See, e.g., "22", "24" and "25" in Fig. 22, reproduced below, as well as the
related descriptions in paragraphs [0066], [0105] and [0188]” (pg. 10).
In response, this is not found persuasive because Applicant is not appreciating the broadest reasonable interpretation of the claims. Instant claim 37 and its dependents do not exclude tubular tissues that also meet the recited claims limitations. The specific tissue construct cited by applicant from the specification is narrower than the instant claims. Furthermore, Nakayama2 discloses the active method steps of the instantly claimed method above, so the claimed functional result of the tissue construct would inherently result from the recitation of the steps.
New Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 25-26 rejected under 35 U.S.C. 103 as being unpatentable over Nakayama et al. (JP-2013090696-A; See IDS filed 27th, August, 2024; henceforth “Nakayama3”). The teachings of Nakayama3 above are hereby incorporated herein in their entirety.
Regarding claims 25-26, further to the discussion of claim 23 above, although Nakayama3 discloses the opening has a width of 0.5 mm (para. [0040]), and Nakayama3 teaches the opening (pore diameter can be adjusted to control the release rate of the aqueous medium (para. [0028]), Nakayama3 is silent to an opening width of at least 2.5 mm, which would be a dimension that enables a circle with a diameter of 2.5 mm or larger to be inscribed in the opening.
Nevertheless, regarding claims 25-26, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to increase the opening width for routine optimization as taught by Nakayama3 to increase the release rate of the aqueous medium (para. [0028]). Regarding the reasonable expectation of success, Nakayama3 evidences preparation of the device with openings and one of ordinary skill would be able to prepare the device with an increased opening size by routine practice.
Hence, the claimed invention as a whole was prima facie obvious.
New Claim Objections
Claims 27-29 and 31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Examiner’s Remark
Claim 39 is free of the prior art. However, claim 39 is not allowable because claim 39 is objected to above, and claim 39 is rejected under 35 U.S.C. 112a and 35 U.S.C. 112b above.
Pertinent Art
The prior art of Nakayama et al. (JP-2006255288-A; see IDS filed 15th, December, 2022; henceforth “Nakayama 4”) is not relied upon but is considered pertinent to Applicant’s disclosure.
Nakayama4 discloses a method for producing a tissue construct, wherein the method comprises: placing a device in an environment comprising body tissue materials to produce the tissue
construct, the device comprising:
a hollow portion; and
a frame body that forms the hollow portion (stent; see claim 1 and Figure 1). The device of Nakayama4 comprises a rod-like member within the hollow portion (“a stent body is mounted on an outer periphery of a rod is embedded in a living body”; claim 1).
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.
No claim is allowable.
Correspondence
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632 /VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
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