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 .
Reissue: 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 1-24 were previously cancelled; claims 25-38 are pending. The amendments and arguments filed Jul. 30, 2026 are acknowledged and have been fully considered.
OBJECTIONS/REJECTIONS WITHDRAWN
The objections to the 12/06/2023 claims are withdrawn in light of the explanation of support filed 07/30/2026.
The rejection of claims 25-38 under 35 U.S.C. 251, as being based on a defective reissue declaration, is withdrawn in light of the new declaration filed 07/30/2026.
The rejection of claim 37 under 35 U.S.C. 112(b) is withdrawn in light of the claim amendments filed 07/30/2026.
OBJECTIONS/REJECTIONS MAINTAINED
The objection to the Consent of Assignee is maintained as discussed below.
The rejection of claims 25-38 under 35 U.S.C. 251, for improper recapture of surrendered subject matter, is maintained as discussed below.
Information Disclosure Statement
The references cited on the information disclosure statement(s) were considered and have been made of record to the extent that each was provided.
Specification Objection (New)
This substitute specification filed 07/30/2026 is improper. See MPEP § 608.01(q) states:
"A substitute specification is not permitted in a reissue application or in a reexamination proceeding. 37 CFR 1.125(d)."
All amendments submitted under 37 CFR 1.173(b)(1)(i), which include any deletions or additions, must be made by submission of the entire text of each added or rewritten paragraph with markings (single brackets and underlining), except that an entire paragraph of specification text may be deleted by a statement deleting the paragraph without presentation of the text of the paragraph. Applicant must indicate the precise point where any added or rewritten paragraph is located. All bracketing and underlining is made in comparison to the original patent, not in comparison to any prior amendment in the reissue application. Thus, all paragraphs which are newly added to the specification of the original patent must be submitted as completely underlined each time they are re-submitted in the reissue application. See MPEP § 1453(I).
The substitute specification filed 07/30/2026 has not been entered because substitute specifications are not permitted in reissue applications.
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 Kelly S. Parsons, identified as "Director of Technology Commercialization". 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 Kelly S. Parsons also signed the new Reissue Declaration (filed 07/30/2026). This declaration includes a statement that the signer (Kelly S. Parsons) is authorized to act on behalf of the assignee. However, the declaration is not dated as the date field says “(Optional)”. It is therefore unclear whether Kelly S. Parsons was authorized to act on behalf of the applicant as of the date the Consent of Assignee was signed (07/06/2026).
Response to Arguments
Applicants' arguments have been fully considered but are not persuasive. Applicants argue that a revised Consent of Assignee has been filed. However, the new Consent of Assignee (filed 07/30/2026) suffers from the same issue as the original Consent of Assignee (filed 12/06/2023). Specifically, the Consent of Assignee is signed by Kelly S. Parsons, identified as "Director of Technology Commercialization", which is not a title recognized by the Office as having authority to act on behalf of the assignee. As discussed above, the authority of the person signing the Consent of Assignee as of the date of signature is not clear. 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).
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.
Response to Arguments
Applicants' arguments have been fully considered but are not persuasive. Applicants argue that the limitations in question are not surrender generating limitations (SGLs) because the claims were not immediately allowed in response to the amendment (response, pgs. 10-11).
However, whether allowance immediately follows the addition of a limitation is not the standard that defines a SGL. MPEP § 1412.02(I) states that a SGL is a limitation "presented, argued, or stated to make the claims patentable (in the original application) and "generates" the surrender of claimed subject matter. An SGL or surrendered subject matter can be created by presentation of new/amended claims to define the invention over the art or an argument/statement by applicant that a limitation of the claim(s) (including a limitation in an original claim) defines the invention over the art. A patent owner (reissue applicant) is bound by the argument that applicant relied upon to overcome an art rejection in the original application for the patent to be reissued, regardless of whether the Office adopted the argument in allowing the claims. Greenliant Systems, Inc. v. Xicor LLC, 692 F.3d 1261, 1271, 103 USPQ2d 1951, 1958 (Fed. Cir. 2012). An SGL or surrendered subject matter can also be created by presentation of new/amended claims or an argument/statement to obviate a rejection based on other grounds. In re McDonald, 43 F.4th 1340, 1348, 2022 USPQ2d 745 (Fed. Cir. 2022)." (emphasis added)
Applicants emphasize the phrase "to make the claims patentable" in the above definition of SGLs, and argue that relying of a limitation "to make the claims allowable" means that it must have immediately resulted in allowance (response, pgs. 11-13).
Applicants are pointed to the other sections of MPEP § 1412.02. For example, the definition of SGL states: An SGL or surrendered subject matter can be created by presentation of new/amended claims to define the invention over the art or an argument/statement by applicant that a limitation of the claim(s) (including a limitation in an original claim) defines the invention over the art. A patent owner (reissue applicant) is bound by the argument that applicant relied upon to overcome an art rejection in the original application for the patent to be reissued, regardless of whether the Office adopted the argument in allowing the claims. (emphasis added) See also MPEP § 1412.02(II)(B)(1):
"With respect to whether applicant surrendered any subject matter, it is to be noted that a patent owner (reissue applicant) is bound by the argument that applicant relied upon to overcome, for example, an art rejection in the original application for the patent to be reissued, regardless of whether the Office adopted the argument in allowing the claims. Greenliant Systems, Inc. v. Xicor LLC, 692 F.3d 1261, 1271, 103 USPQ2d 1951, 1958 (Fed. Cir. 2012). As pointed out by the court, "[i]t does not matter whether the examiner or the Board adopted a certain argument for allowance; the sole question is whether the argument was made."
In this case, in order to overcome the rejections of claim 14 (and claims dependent thereon), applicants narrowed claim 14 to primary gastrointestinal epithelial cells (see the amended claims filed 11/19/2018). Applicants further 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). Applicants are now bound by that argument.
Applicants' deliberate amendment was made for the purpose of overcoming the applied prior art (applicants argued exactly that in the underlying case), and to ultimately obtain allowable claims. Whether allowance was secured immediately after the amendment was made is irrelevant. The totality of all the deliberate amendments made in the underlying application (including the limitation that the cells be primary gastrointestinal cells) ultimately resulted in allowable claims. Applicants admit this in the last full paragraph on p. 12 of the response:
"… the totality of the claim elements added to make a claim patentable constitute the SGL."
The totality of the claim amendments includes amendments made (and argued) to overcome the prior art, even if subsequent amendments were required to secure allowance. In other words, the fact that further amendments were made before allowance of the claims does not mean that the earlier amendments were not also SGLs.
Applicants cite Medtronic, Inc. v. Guidant Corp., 465 F.3d 1360 (Fed. Cir. 2006) as supporting their position. (Reply at p. 12.) A review of that case, however, reveals that its facts are inapposite to those in this prosecution. In Medtronic, the court observed that neither the examiner nor the prosecuting attorney “considered the [alleged SGL] to be a part of the invention.” Id. at 1375. Instead, the alleged SGL was added by the original examiner “to add ‘minor wording changes’” and thus constituted an error suitable for cure by reissue in that case. Id. Here, as discussed above, applicants admit that the “primary” limitation is part of “the totality of the claim elements amended to make a claim patentable.” (Reply at p. 12.) It was not added or viewed by the original examiner as merely a “minor wording change,” as in Medtronic; rather, the amendment is “part of the invention.” See 465 F.3d at 1375. As such, removing the “primary” limitation during this reissue proceeding is improper recapture. See also In re Youman, 679 F.3d 1335, 1344 (Fed. Cir. 2012) (“We have consistently held that when a patentee narrows the original claim in an effort to overcome a prior art rejection and makes arguments in support, the patentee surrenders the subject matter broader than the patented claim.” (emphasis added)). “[C]laims that are "broader than the original patent claims in a manner directly pertinent to the subject matter surrendered during prosecution" are impermissible.” In re Clement, 131 F.3d 1464, 1468 (Fed. Cir. 1997) (emphasis added) (quoting Mentor Corp. v. Coloplast, Inc., 998 F.2d 992, 996 (Fed. Cir. 1993)).) There is thus no requirement that only an amendment made immediately before a notice of allowability can constitute a surrender-generating limitation. All that is necessary under Youman and Clement is that the limitation be made “in an effort to overcome” a prior-art rejection and that it be “directly pertinent” to the surrendered subject matter. Both requirements are met here.
Summary/Conclusion
Claims 25-38 remain rejected.
THIS ACTION IS MADE FINAL. Applicants are 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 extension fee 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 date of this final action.
Contact Information
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.
Information regarding the status of applications may be obtained from Patent Center. Patent Center is available to registered users regarding unpublished application information. To file and manage patent submissions, visit: https://patentcenter.uspto.gov and for more information visit https://www.uspto.gov/patents/apply/patent-center and https://www.uspto.gov/patents/docx. The fax number for the organization where this application is assigned is (571) 273-8300. For additional questions, contact the Electronic Business Center (EBC) at (866) 217-9197. If you would like assistance from a USPTO Customer Service Representative, call (800) 786-9199 or (571) 272-1000.
/Kevin S Orwig/ Patent Reexamination Specialist, Art Unit 3991
Conferees:
/LBD/ Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/ SPRS, Art Unit 3991
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