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 .
Status of the Claims
Applicant’s submission filed 01 May 2026 has been entered. Claims 1-2, 4, 6-8, 10, 12, 14, 17, 23-24, 29-30, 32-34, 37, 40, and 86 are pending. Claim 1 has been amended. Therefore, prosecution on the merits continues for claims 1-2, 4, 7-8, 10, 12, 14, 17, 23-24, 29-30, 32-34, 37, 40, and 86 as being drawn to the elected invention and species, with claim 6 withdrawn for reading on the non-elected species. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 1-2, 4, 7-8, 10, 12, 14, 17, 23, 30, 32-34, 37, 40, and 86 under 35 USC 103 over Berenson et al in view of Kaiser et al and Wahl et al
Applicant’s amendments to independent claim 1 requiring the mechanical stimulation to be a
continuous oscillatory stimulation provided between 150 rotations per minute (rpm) and 500 rpm for at least 12 hours obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-2, 4, 7-8, 10, 12, 14, 17, 23-24, 30, 32-34, 37, 40, and 86 under 35 USC 103 over Berenson et al in view of Kaiser et al and Wahl et al, and further in view of Trickett et al
Applicant’s amendments to independent claim 1 requiring the mechanical stimulation to be a
continuous oscillatory stimulation provided between 150 rotations per minute (rpm) and 500 rpm for at least 12 hours obviate the rejection of record.
Therefore, the rejection is withdrawn.
New Grounds of Rejection
Claim Objections
Claim 86 is objected to because of the following informalities:
Regarding claim 86: The instant claim is objected to for reciting “wherein the immune cell is a regulatory (Treg)” instead of “wherein the immune cell is a regulatory T cell (Treg)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 37 is rejected 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.
Regarding claim 37: The instant claim recites the limitation “wherein the mechanical stimulation is provided for at least 12 hours”. As parent claim 1 has been amended to recite that “the mechanical stimulation is a continuous oscillatory stimulation provided between 150 rotations per minute (rpm) and 500 rpm for at least 12 hours” (emphasis added), instant claim 37 does not further limit parent claim 1 from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Appropriate correction is required.
Election/Restrictions
Claims 1-2, 4, 6-8, 10, 12, 14, 17, 23-24, 29-30, 32-34, and 40 are allowable. The restriction requirement between species, as set forth in the Office action mailed on 02 August 2024, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 02 August 2024 is partially withdrawn. Claim 6, directed to a species of biological samples, is no longer withdrawn from consideration because the claim requires all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Allowable Subject Matter
Claims 1-2, 4, 6-8, 10, 12, 14, 17, 23-24, 29-30, 32-34, and 40 are allowed. The following is a statement of reasons for the indication of allowable subject matter:
Upon consideration of the prior art of record, the Examiner finds that Berenson et al, alone or in combination with Kaiser et al, Wahl et al, and Trickett et al, do not adequately teach or suggest the presently claimed method. In particular, the cited art does not reasonably suggest the continuous oscillatory stimulation of a mixture comprising immune cells and antibody-coated microparticles having a stiffness between 10 kPa and 30 kPa for at least 12 hours at 150 rpm to 500 rpm – as is claimed. Therefore, a prima facie case of obviousness does not exist.
In addition, Applicant has persuasively argued within the Remarks and declaration filed under 37 CFR 1.132 by co-inventor Manish Butte on 01 May 2026 that the effects of a substrate’s stiffness in a static culture are not transferable to an agitated bead culture, especially in relation to T cell activation. More specifically, Applicant cites in the declaration at Paragraphs 8-10 that there are different contact areas or geometries for the beads versus static culture, and that the effects seen in the disclosure of Wahl et al are actually relating to T cell spreading and not activation. Applicant further supports this assertion by citing Judokusumo et al (of record on IDS filed 01 May 2026), who teach that T cell activation is enhanced with a higher substrate stiffness (100 kPa) and is lacking at lower stiffnesses (10 kPa, 25 kPa). See Pages 9-10 of the Remarks filed 01 May 2026. Therefore, a prima facie case of obviousness does not exist.
Accordingly, although the cited references disclose certain individual claim elements, the record does not support a conclusion that the claimed method as a whole would have been obvious to a person of ordinary skill in the art.
Examiner’s Comment
The Examiner attempted to reach Applicant’s representative, Christine M. Emnett, on the dates of 25 June 2026, 26 June 2026, and 29 June 2026 in order to correct the aforementioned claim deficiencies via Examiner’s Amendment. Applicant’s representative could not be reached, and no voicemail was able to be left.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
Prosecution Insights