Prosecution Insights
Last updated: September 17, 2026
Application No. 19/286,707

EpigenAU/11: A NATURAL MATRIX WITH THERAPEUTIC ACTIVITY THROUGH A PHYSIOLOGICAL NETWORK MECHANISM OF ACTION (NOT PHARMACOLOGICAL) FOR RESTORING HOMEOSTASIS IN TISSUES INFILTRATED BY CANCER CELLS

Final Rejection §112
Filed
Jul 31, 2025
Priority
Jun 17, 2024 — divisional of 18/744,862 +4 more
Examiner
MI, QIUWEN
Art Unit
1655
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Bios-Therapy Physiological Systems For Health S P A
OA Round
4 (Final)
68%
Grant Probability
Favorable
5-6
OA Rounds
1y 5m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 68% — above average
68%
Career Allowance Rate
1094 granted / 1601 resolved
+8.3% vs TC avg
Strong +50% interview lift
Without
With
+49.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 6m
Avg Prosecution
40 currently pending
Career history
1634
Total Applications
across all art units

Statute-Specific Performance

§101
10.2%
-29.8% vs TC avg
§103
44.2%
+4.2% vs TC avg
§102
22.4%
-17.6% vs TC avg
§112
18.8%
-21.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1601 resolved cases

Office Action

§112
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 Applicant’s amendment in the reply filed on 7/22/26 is acknowledged. Claims 28-32 are pending. Claims 28-32 are examined on the merits. Any rejection that is not reiterated is hereby withdrawn. Claim Rejections –35 USC § 112, 2nd 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 28-32 remain rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. This rejection is maintained for reasons of record set forth in the Office Action mailed out on 4/22/26, repeated below, slightly altered to take into consideration Applicant’s amendment filed on 3/23/26. Applicants’ arguments filed have been fully considered but they are not deemed to be persuasive. Claim 28 recites “A method for determining the presence of native natural intelligence in in one or more batches of an anti-cancer product…” at lines 1-2; and “wherein native natural intelligence is the ability to self-organize and adapt to environment stimuli without artificial intervention” at last two lines. The recitation is very confusing, it is not clear what Applicant means by “wherein native natural intelligence is the ability to self-organize and adapt to environment stimuli without artificial intervention”. What “self” refers to here? The claimed product or the subject who is being administered with the claimed product? Does “ability to self-organize” mean the claimed product could dust itself on a daily basis? Does “without artificial intervention” mean the product could automatically feed the subject in need thereof? Applicant is recommended to recite “A method for determining biological and physical-chemical properties of a product…” instead of “determining the presence of native natural intelligence”. Therefore, the metes and bounds of claims are rendered vague and indefinite. The lack of clarity renders the claims very confusing and ambiguous since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired. All other cited claims depend directly or indirectly from rejected claims and are, therefore, also, rejected under U.S.C. 112, second paragraph for the reasons set forth above. Applicant argues that “Although the term native natural intelligence is clearly defined in the specification, and that Applicant is allowed to be its own lexicographer, Applicant has amended the claims to clearly define what is meant by the term. Accordingly, Applicant respectfully asserts that the metes and bounds of the claims are clear and request that the rejection be reconsidered and withdrawn” (page 1, last paragraph). This is not found persuasive. The term “by determining biological and physical-chemical properties of said product” still does not explain what native natural intelligence is, and what it means by “wherein native natural intelligence is the ability to self-organize and adapt to environment stimuli without artificial intervention”. Although Applicant is allowed to be its own lexicographer, claim language has to make sense. Applicant's arguments have been fully considered but they are not persuasive, and therefore the rejections in the record are maintained. Conclusion No claim is allowed. THIS ACTION IS MADE FINAL. 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 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 mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Qiuwen Mi/ Primary Examiner, Art Unit 1655
Read full office action

Prosecution Timeline

Show 1 earlier event
Oct 28, 2025
Non-Final Rejection mailed — §112
Dec 30, 2025
Response Filed
Jan 22, 2026
Final Rejection mailed — §112
Mar 23, 2026
Request for Continued Examination
Mar 25, 2026
Response after Non-Final Action
Apr 22, 2026
Non-Final Rejection mailed — §112
Jul 22, 2026
Response Filed
Aug 10, 2026
Final Rejection mailed — §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

5-6
Expected OA Rounds
68%
Grant Probability
99%
With Interview (+49.9%)
2y 6m (~1y 5m remaining)
Median Time to Grant
High
PTA Risk
Based on 1601 resolved cases by this examiner. Grant probability derived from career allowance rate.

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