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
Reissue: Non-Final Office Action
Status of the Claims
On 12/07/2021 US Patent 11,193,110 issued to Allbritton et al. with claims 1-24. Claims 25-38 are currently pending and are the subject of this Office Action. Claims 1-24 have been cancelled, and claims 25-38 are newly presented in this reissue application. This is the first Office Action on the merits of the claims in reissue Application No. 18/530,761.
Maintenance Fees
Applicant is reminded of the requirement to pay all applicable maintenance fees on the original patent. See MPEP § 1415.01.
Ongoing Duty To Disclose
Applicant(s) is/are reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent 11,193,110 is or was involved. These proceedings would include any trial at the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Information Disclosure Statement
Regarding the IDSs dated 03/28/2024, MPEP § 1406 states that in reissue applications references that have been cited during original prosecution of the patent are considered. However, should applicants wish to ensure that all of the references which were cited in the original patent are considered and cited in the reissue application, an information disclosure statement (IDS) in compliance with 37 CFR 1.97 and 1.98 should be filed in the reissue application. Note that 37 CFR 1.98 requires copies of foreign patents and other (e.g., NPL) publications to be provided. No such copies were provided with the instant reissue application. References lined-through on the information disclosure statement(s) were not considered because they were not provided.
Consent of Assignee
This application is objected to under 37 CFR 1.172(a) as lacking the written consent of all assignees owning an undivided interest in the patent. The consent of the assignee must be in compliance with 37 CFR 1.172. See MPEP § 1410.01.
Specifically, the Consent of Assignee is signed by Jacqueline Quay, identified as "Director of Licensing". The MPEP states that an officer (chief executive officer, president, vice-president, secretary, or treasurer) is presumed to have authority to sign on behalf of the organization. The signature of the chairman of the board of directors is acceptable, but not the signature of an individual director. Modifications of these basic titles are acceptable, such as vice-president for sales, executive vice-president, assistant treasurer, vice-chairman of the board of directors. In foreign countries, a person who holds the title "Manager" or "Director" is normally an officer and is presumed to have the authority to sign on behalf of the organization. A person having a title (administrator, general counsel) that does not clearly set forth that person as an officer of the assignee is not presumed to have authority to sign the submission on behalf of the assignee. The Office recommends that when a person with such a title is authorized to act on behalf of the assignee, the submission should clearly indicate that person's authority. See MPEP § 324(V).
In this case, the authority of the person signing the Consent of Assignee is not clear, and the individual does not hold a title recognized by the Office as presumed to have such authority. The person who signed the submission establishing ownership interest is not recognized as an officer of the assignee, and the person who signed it has not been established as being authorized to act on behalf of the assignee. See MPEP § 324 (for applications filed before September 16, 2012) and § 325 (for applications filed on or after September 16, 2012). A proper assent of the assignee in compliance with 37 CFR 1.172 and 3.73 is required in reply to this Office action.
It is noted that Jacqueline Quay also signed the Power of Attorney filed 12/6/2023. This Power of Attorney includes a statement that the undersigned (Jacqueline Quay) is authorized to act on behalf of the applicant. However, the Power of Attorney is not dated as the date field says “(Optional)”. It is therefore unclear if Jacqueline Quay was authorized to act on behalf of the applicant as of the date the Consent of Assignee was signed (11/30/2023).
Official Gazette Publication
The Official Gazette (O.G.) publication date for this reissue application was 01/02/2024.
Claim Objections
The claim set filed 12/06/2023 is objected to because it is not accompanied by an explanation for support in the disclosure for the newly presented claims.
Pursuant to 37 CFR 1.173(c), each claim amendment must be accompanied by an explanation of the support in the disclosure of the patent for the amendment (i.e., support for all changes made in the claims, whether insertions or deletions). While the amendment includes a paper listing the amendments between the claims, applicant has not pointed to where support can be found in the specification for the deleted material in the amended claims.
Appropriate correction is required.
Defective Declaration/Oath
The reissue oath/declaration filed with this application is defective because it fails to sufficiently identify at least one error which is relied upon to support the reissue application. See 37 CFR 1.175 and MPEP § 1414.
The error statement in the reissue declaration is insufficient because patentee does not identify a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid. Moreover, patentee fails to identify a claim that the application seeks to broaden. See MPEP § 1414 I and II, which state, in relevant part:
What is needed for the oath/declaration statement as to error is the identification of “at least one error” relied upon. For an application filed on or after September 16, 2012 that seeks to enlarge the scope of the claims of the patent, the reissue oath or declaration must also identify a claim that the application seeks to broaden. A general statement, e.g., that all claims are broadened, is not sufficient to satisfy this requirement. In identifying the error, it is sufficient that the reissue oath/declaration identify a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid.
A statement in the oath/declaration of "…failure to include a claim directed to…" and then reciting all the limitations of a newly added claim, would not be considered a sufficient "error" statement because applicant has not pointed out what the other claims lacked that the newly added claim has, or vice versa. Such a statement would be no better than saying in the reissue oath or declaration that "this application is being filed to correct errors in the patent which may be noted from the change made by adding new claim 10." In both cases, the error has not been identified.
(Emphasis added.) The declaration merely indicates:
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The declaration fails to point out which limitations have been removed or why they “are not necessary for patentability.” Thus, it is unclear why the original patent is wholly or partially inoperative or invalid because the patentee claimed less than he had the right to claim in the patent.
Applicants have not pointed out what the original claims lacked that the newly added claims have, or vice versa. Applicants are advised that they must be specific in pointing out these differences (i.e., the new or deleted features) and in explaining how they broaden the claims. Further, applicants must be clear in pointing out at least one claim that the reissue application seeks to broaden. The examiner suggests expressly pointing to claim 1 as a claim intended to be broadened, and then specifically stating how the new claims are broader than claim 1 by specifically detailing what limitations the new claims lacked that the newly added claims have, or vice versa.
In addition, the reissue declaration refers to “new claims 25-41,” but only claims 25-38 have been presented in this application.
CLAIM REJECTIONS - 35 USC § 251
Claims 25-38 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office Action.
Broadening Reissue
The instant reissue application was filed on 12/06/2023, which is within two years of the issue date of US Patent 11,193,110 (issued on 12/07/2021); has a broadened claim (e.g., claim 25 is broader than patented claim 1); and has clear intent to broaden the claim.
Claims 25-38 are rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based.
A broadening aspect is present in the reissue application which was not present in the patent under reissue. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
See Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984).
In accordance with MPEP 1412.02 (and case law cited therein) we apply the recapture rule as a three-step process:
(1) Determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims.
(2) Determine whether the broader aspects of the reissue claims related to subject matter surrendered in the original prosecution; and
(3) Determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.
In the instant case,
(1) Reissue claims 25-38 are broader in scope than the original patent claims.
Patented claim 11 (corresponding to original claim 14 in application 15/545,456, and instant claim 31) recited a live cell construct comprising elements (a) and (b). Element (b) required a self-renewing monolayer of live primary gastrointestinal epithelial cells comprising at least some undifferentiated cells. Claim 31 of this reissue application only requires that the cells in the self-renewing monolayer of element (b) are epithelial cells comprising at least some undifferentiated cells. Thus, claim 31 is broader than patented claim 11 by eliminating the requirements that the cells in element (b) are 1) primary cells and 2) gastrointestinal cells. A similar analysis holds for patented claim 1 and instant claim 25 (method claims).
(2) The broader aspect of the reissue of claims 25-38 is related to subject matter surrendered in the original prosecution.
During prosecution of application 15/545,456 that issued as Patent 11,193,110, element (b) of original claim 14 (see the claims of 10/06/2017) recited live gastrointestinal epithelial cells. In the Office action dated 08/28/2018, the Examiner rejected claim 14 (and related claims dependent thereon) under 35 U.S.C. 102 and 103. In order to overcome the rejections of claim 14 (and claims dependent thereon), applicant narrowed claim 14 to primary gastrointestinal epithelial cells (see the amended claims filed 11/19/2018). Applicant argued that the limitation of primary gastrointestinal epithelial cells overcame the prior art applied in the rejections under 35 U.S.C. 102 and 103 (see pgs. 7-9 of the response filed 11/19/2018 in application 15/545,456). The new claims presented in the instant reissue application eliminate the requirement for the cells to be primary cells, which is a limitation the applicant surrendered in the prosecution of application 15/545,456, which application issued at US Patent 11,193,110, to gain the allowance of claims 1-24.
(3) There is no evidence of record that the reissue claims were materially narrowed in other respects so that the claims may not have been enlarged, and hence avoid the recapture rule.
The claims do not contain any other limitations beyond those present in the patented claims that could be considered to materially narrow their scope.
Claim Rejections - 35 USC § 112(b) or (pre-AIA ) 35 USC § 112 (2nd Par.)
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.
Claim 37 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 37 recites "the wells". However, there is insufficient antecedent basis for this limitation in the claim as no "wells" are recited in claim 31, from which claim 37 depends. See MPEP § 2173.05(e).
Conclusion
Claims 25-38 are rejected. No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin S Orwig whose telephone number is (571)270-5869. The examiner can normally be reached Mon.-Fri. 8AM-5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Engle can be reached at (571) 272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-9900.
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.
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Central Reexam Unit
By mail to: Mail Stop Reexam/Reissue
Central Reexamination Unit
Commissioner for Patents
United States Patent & Trademark Office
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/Kevin S Orwig/Patent Reexamination Specialist, Art Unit 3991
Conferees:
/LBD/Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991