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 1-9 are pending.
Claims 1-9 are under examination.
Withdrawn Objections to Specification
Browser-executable Code
The objection to the specification due to browser-executable code as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Withdrawn Claim Objections
The objection to claim 8 as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Claim Objections
Claims 1, 3 and 9 are objected to because of the following informalities:
Claim 1 remains objected to because it includes periods before the end of the claim (e.g. “i.)”). Periods are only allowed at the end of a claim. Applicant is directed to MPEP 608.01(m) which states “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i).”
To overcome this objection it is recommended that Applicant amend all instances of periods before the end of the claim to parentheses.
Claims 3 and 9 are objected to because they recite the following limitations which are already recited in claim 1, upon which they depend, and are therefore unnecessarily redundant.
Claim 3 recites “culturing said epicardial cells under suitable conditions in the presence of a first extracellular matrix protein in a serum-free basal medium,” and “the presence of a second extracellular matrix protein in a serum-free basal medium” which are already recited in claim 1, upon which they depend, and are therefore unnecessarily redundant.
Claim 9 recites “the presence of a first extracellular matrix protein in a serum-free basal medium,” “a second extracellular matrix protein in a serum-free basal medium” and “in the presence of at least one third extracellular matrix protein in a serum-free basal medium” which are already recited in claim 1, upon which they depend, and are therefore unnecessarily redundant.
Claims 3 and 9 are objected to because they recite method steps enumerated as “a1)” and “a2)” which appear to correspond to steps a1 and a2 as recited in claim 1, upon which these claims depend. Claim 9 also recites method step ii) which appears to correspond to step ii) of claim 1. To improve the clarity and readability of the claims, it is recommended that claims 3 and 9 refer back to steps recited in claim 1 and then indicate the additional limitations, rather than enumerate the step again or repeat limitations of claim 1. A recommended way to do this would be to recite “wherein the serum free basal medium of step a1) further comprises” followed by reciting the additional limitations.
Claims 3 and 9 enumerate cell culture media component limitations as (a)- (f). To improve the neatness and readability of the claims, it is recommended to list out the limitations without enumeration. For example, the list of limitations of “(a) FGF2, (b) vascular endothelial growth factor (VEGF), (c) glutamine and (d) a GSK-3 inhibitor” of claim 3 would be written as “FGF2, vascular endothelial growth factor (VEGF), glutamine and a GSK-3 inhibitor.”
Claim 9 recites steps of i*) and i**). While it is clear that i*) and i**) enumerate steps, it is recommended that Applicant amend to i’) and i’’) to improve the clarity and readability of the claim because an asterisk (*) has multiple uses in grammar other than enumeration.
Claim 9 recites “basic fibroblast growth factor (FGF2).” Because basic fibroblast growth factor is the same thing as FGF2, also known as fibroblast growth factor 2, the scope is clear. However, since FGF2 is not the abbreviation for basic fibroblast growth factor, it is recommended that Applicant amend to either “basic fibroblast growth factor (bFGF)” or “fibroblast growth factor 2 (FGF2).”
Withdrawn Claim Rejections - 35 USC § 112(a)
Scope of Enablement
The rejection of claims 1-9 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification did not enable the full scope of the claims is withdrawn in view of Applicant’s amendments and arguments of record.
Claim Rejections - 35 USC § 112(b)
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 1-9 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 1 recites the narrow limitation of “on plates coated with a first extracellular matrix protein” as well as the broader limitation of culturing “in the presence of a first extracellular matrix protein.” Similarly, claim 1 also recites the narrow limitation of “plates coated with a second extracellular matrix protein” as well as the broader limitation “in the presence of a second extracellular matrix protein” and the narrow limitation of “plates coated with at least one third extracellular matrix protein” as well as the broader limitation “at least one third extracellular matrix protein.”
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
Claim 1 recites culturing “on plates coated with a first extracellular matrix protein” as well as culturing “in the presence of a first extracellular matrix protein.” Similarly, claim 1 also recites the “plates coated with a second extracellular matrix protein” as well as “in the presence of a second extracellular matrix protein” and the “plates coated with at least one third extracellular matrix protein” as well as at least one third extracellular matrix protein.” These limitations each recite “first extracellular matrix protein,” “a second extracellular matrix protein” and “third extracellular matrix protein” two times, which makes it unclear what the scope of these encompass, because it is unclear whether each first, second or third extracellular matrix protein are required to be the same extracellular matrix protein or whether they may encompass different extracellular matrix proteins.
Claim 3 recites “step (i) a1) comprises” steps labeled as “a1” and “a2” which appear to correspond to “a1” and “a2” in claim 1. This is indefinite because it is unclear how the components of “a1” and “a2” as recited in claim 3 are incorporated into the step of a1) of claim 1. Furthermore, it is unclear whether step a2 of claim 3 is part of step a1 of claim 1, or is intended to correspond to step a2 of claim 1.
Claims 3 and 9 recites steps of a1 and a2 appear to correspond to steps a1 and a2 of claim 1 which each require plates coated with a first, second and third extracellular matrix protein under suitable conditions in the presence of a first, second and third extracellular matrix protein in a serum-free basal medium which is more specific than the first, second and third “extracellular matrix protein in a serum-free basal medium” of step a1 of claims 3 and 9. Therefore, because the condition of coated plates is narrower than a1 and a2 recited in claims 3 and 9, which appear to recite alternative a1 and a2 steps and do not recite coated plates, it is unclear what the scope of claims 3 and 9 is intended to encompass. As set forth above, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
Claim 9 recites steps i* and i** which are steps of culturing pluripotent stem cells. However, claim 1, upon which claim 9 depends, requires “epicardial cells obtained by differentiation of pluripotent stem cells” which is product-by process language and does not require pluripotent stem cells or steps of differentiation of pluripotent stem cells. Therefore, the scope of the claim is unclear. Because pluripotent stem cells are not required by claim 1, and there is no link between the recited pluripotent stem cells of claim 9 and the method of claim 1, it is unclear how the method steps of i* and i**, which are steps of differentiating pluripotent stem cells into epicardial cells claim 9 are integrated into the method of claim 1.
Examiner’s Remark
In claim 9, it appears that Applicant intends to claim additional steps of obtaining the starting epicardial cells of the method of claim 1. As stated above, the claim remains indefinite because it does not clearly link these steps to the method of claim 1. To overcome the rejection of claim 9 under 35 U.S.C. 112b as set forth above, it is recommended that Applicant amend the claim to include “The method of claim 1, wherein the epicardial cells are obtained by a method comprising” and then include the steps of making the epicardial cells from the pluripotent stem cells.
Response to Arguments
Applicant’s arguments, filed 23rd, March, 2026, have been fully considered but are not found persuasive.
Applicant argues “Claim 9 has been amended to address antecedent basis relating to recitation of ‘pluripotent stem cells’” (pg. 15).
In response, this is not found persuasive because claim 1 still does not require pluripotent stem cells, and further the claims as amended do not have a clear link or nexus for how the steps of i* and i** which are steps of culturing pluripotent stem cells are integrated into the method of claim 1 which does not require pluripotent stem cells.
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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632 /VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
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