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 .
Nucleotide and/or Amino Acid Sequence Disclosures
Although inventor states that a sequence listing in xml CRF format has been submitted with the 1/26/2026 Response, there is no such file of record.
112(b) Rejections Withdrawn
The rejection of claim 1 under 35 USC 112(b) or 35 USC (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate.
The rejection of claim 6 under 35 USC 112(b) or 35 USC (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
The rejection of claims 10-18 under 35 USC 112(b) or 35 USC (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. With respect to claims 12-15, the amendment cancels the claims. With respect to the remaining claims, the amendment clarifies the claims as appropriate.
The rejection of claims 2-5 and 7-9 under 35 USC 112(b) or 35 USC (pre-AIA ), second paragraph, outlined in the previous Office Action (indefinite from indefinite), is withdrawn. The rejection is moot. (The amendment cancels claims 3-5.)
Claim Rejections - 35 USC § 112(d), NEW
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 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth 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. In the present instance, the claim fails to further limit the subject matter of the claim upon which it depends (claim 1).
Independent claim 1 is a product-by-process claim. Dependent claim 2, a process claim, merely recites this identical process. But this repeated recitation in claim 2 does not, and cannot, further limit the product-by-process engineered exosome of claim 1.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
The examiner respectfully suggests that claim 2 should be rewritten as an independent claim.
Claim 11 and 16-18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth 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. In the present instance, the claims fail to further limit the subject matter of the claims upon which they depend.
Dependent claim 11, for instance, is drawn to a method of administering the engineered exosome. Dependent claim 2, the claim upon which claim 11 is immediately dependent, is drawn to a process of making the engineered exosome. However, the process of administering the engineered exosome does not, and cannot, further limit the process of making the exosome. Analysis of claims 16-18 (“…treating HTS…”) is similar.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
The examiner respectfully suggests that claims 11 and 16-18 should be rewritten as independent claims.
103 Rejections Withdrawn
The rejection of claims 1 and 10 under 35 USC 103, outlined in the previous Office Action, has been overcome by inventor’s amendment and arguments. Inventor’s amendment and arguments have been carefully considered and are persuasive.
The rejection of claims 2-9 and 11-18 under 35 USC 103, outlined in the previous Office Action, has been overcome by inventor’s amendment and arguments. With respect to claims 3-6 and 12-15, the amendment cancels the claims. With respect to the remaining claims, inventor’s amendment and arguments have been carefully considered and are persuasive.
Allowable Subject Matter
Claims 1 and 10 are allowed. Claim 7-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 3/27/2026