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 .
DETAILED ACTION
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 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.
Response to Amendments
Applicant’s amendments, and response filed Apr. 8, 2026 have been received and entered into the case. The corrected specification filed Apr. 8, 2026 has not been enter as explained below.
Note to Applicant
Applicant’s representative, Mark Joy, at 312-616-5600 and 630-346-6148, was contacted to discuss amendments to the claims 19 and 20 to place them in condition for allowance. In a phone message on Jun. 25, 2026, Attorney Joy recommended filing an office action given the limited amount of time the Examiner had for a response.
Status of the Claims
Claims 1, 4, 6-9 and 11-24 are currently pending.
Claims 1, 7, 19 and 20 are amended.
Claims 9 and 11-18 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 2, 3, 5 and 10 are cancelled.
Claims 22-24 are new.
Claims 1, 4, 6-8, and 19-24 have been considered on the merits.
Specification
The substitute specification filed Apr. 8, 2026 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because: the substitute specification needs to include the same-day amendments that were included with the originally filed application. Specifically, the amendment to include the priority claims to the first paragraph of the specification should be contained within any subsequent filed substitute specifications.
Specification Objections
Specification objections are maintained, since the specification amendments are not being entered. However, the amendments would overcome the objection once the previous amendments are included.
The disclosure is objected to because of the following informalities: the use of trademarks.
The use of the terms: Ecoflex® on pg. 7 line 1, pg. 21 lines 11-13, 21, 24, pg. 23 line 9, pg. 24 line 2, 8, 13, 15, 21-23, pg. 25 line 21, pg. 26 line 8, pg. 27 line 1, 7, 14, 26, pg. 28 line 29, pg. 29 line 1, pg. 30 line 14, pg. 32 line 6, pg. 33 lines 13, 14, 23, 24, pg. 34 lines 24-25, 26, 28-29, 31, pg. 35 lines 2, 6, 9, pg. 35 lines 17, 19-20; Pluronic® on pg. 16 line 31, pg. 30 line 12, pg. 37 lines 31 and 33, pg. 38 lines 2 and 4; Glutamax™ on pg. 17 line 10, pg. 30 line 23; Matrigel® on pg. 25 line 16, pg. 30 line 1, 4, 10, pg. 37 line 22 and 27; TrypLE™ reagent on pg. 29 line 30; Triton®-X on pg. 30 lines 31 and 33; and Tween® 20 on pg. 31 line 1 and 3; Alexa Fluor® 488 on pg. 31 line 2, which are a trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
The claim objections are withdrawn due to amendment.
Claim Rejections - 35 USC § 112 (b)
The majority of claim rejections under 35 USC § 112, (b) or second paragraph (pre-AIA ), are withdrawn due to amendment and one rejection is maintained. New claim rejections under 35 USC § 112, (b) or second paragraph (pre-AIA ) have been added to address the 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.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 20, lines 5-6, the phrase: “antibiotics, fetal bovine serum (FBS) and fibroblast growth factor 2 (FGF2), in a concentration of 80-120 ng/ml”, renders the claim and its dependents indefinite, since it is unclear whether the concentration between the two commas is referring to the FGF2, the FBS and/or the antibiotics. For the purposes of compact prosecution, the phrase in the claim will be interpreted to mean “and fibroblast growth factor 2 (FGF2)[[
In claim 20, lines 18-19, the phrase:
“wherein the culture medium is:
initially a proliferation medium comprising antibiotics, FBS, FGF2 in a concentration of 80-120 ng/ml, and either 6-aminocaproic acid in a concentration of 0.5-5 mg/ml or aprotinin in a concentration of 60-100 µg/ml, and
after 1.5-3 days, is replaced by a differentiation medium, comprising antibiotics, insulin-transferrin-selenium-ethanolamine (ITS-X) in a concentration of 0.5-2.5% v/v, knock-out serum replacement in a concentration of 0.5-2.5% v/v, L-glutamine, and either 6-aminocaproic acid in a concentration of 0.5-5 mg/ml or aprotinin in a concentration of 60-100 µg/ml”,
renders the claim and its dependents indefinite, since it is unclear whether these are steps that are intended to be performed or intended uses of the proliferation and differentiation media.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b) and 35 USC § 101
New claim rejections under 35 USC § 112, (b) or second paragraph (pre-AIA ) and 35 USC § 101 have been added to address the 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.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 19 and 20 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 19 provides for the use of the manufactured microstructure, but, since the claim does not set forth any steps involved in the method/process of using of the device, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. It is not clear from the steps of the claim how the device system is being used. The “wherein” clauses are not active method steps. The only recited step is “using the manufactured microstructure to generate muscle tissue”.
Claim 19 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Since claim 20 depends from indefinite claim 19 and does not clarify the above points of confusion, claim 20 must also be rejected under 35 U.S.C. § 112, 35 USC § 112, (b) or second paragraph (pre-AIA ) and 35 USC § 101.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The claim rejections under 35 USC § 103 are withdrawn due to amendment and Applicant’s argument being persuasive, see Remarks filed Apr. 8, 2026, pgs. 12-20.
Proposed Examiner’s Amendments
The following claims 19 and 20 are drafted by the examiner and considered to distinguish patentably over the art of record in this application and overcome the present set of rejections, are presented to applicant for consideration:
Claim 19:
The method according to claim 1, further comprising using the manufactured microstructure to generate muscle tissue,
providing the microchamber
culturing the myogenic progenitor cells
Claim 20:
The method according to claim 19,
wherein the hydrogel comprises:
0.2-4 mg/ml fibrinogen,
extracellular matrix protein, and
a myogenic progenitor proliferation medium comprising antibiotics, fetal bovine serum (FBS) and fibroblast growth factor 2 (FGF2)[[,]] in a concentration of 80-120 ng/ml,
wherein the myogenic progenitor cells are added to the microchamber in a concentration of 10^6 - 10^9 cells/ml, and
wherein the culturing of the myogenic progenitor cells to generate the muscle tissue further comprises;
initially culturing the cells in a proliferation medium comprising antibiotics, FBS, FGF2 in a concentration of 80-120 ng/ml, and either 6-aminocaproic acid in a concentration of 0.5-5 mg/ml or aprotinin in a concentration of 60-100 µg/ml, and
after 1.5-3 days, replacing the proliferation medium with a differentiation medium, comprising antibiotics, insulin-transferrin-selenium-ethanolamine (ITS-X) in a concentration of 0.5-2.5% v/v, knock-out serum replacement in a concentration of 0.5-2.5% v/v, L-glutamine, and either 6-aminocaproic acid in a concentration of 0.5-5 mg/ml or aprotinin in a concentration of 60-100 µg/ml.
Response to Arguments
Applicant’s arguments, Remarks filed Apr. 8, 2026, pgs. 12-20, with respect to the rejections of claims 1, 4, 6-8, and 19-24 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration and due the amendments, new grounds of rejection are being made under 35 USC § 112(b) and 35 USC § 101 for claims 19 and 20.
Allowable Subject Matter
Claims 1, 4, 6-8 and 21-24 are allowed.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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