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 .
Applicant’s amendment and remarks filed on 6/17/2026 are acknowledged. Claim 38 is amended.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 6/17/2026 is acknowledged.
Claims 1-5, 11, 13, 15, 17, 19, 21-22, 28, 33, 35, 38, 43-44, 61, 71-72, 74, and 98-99 are pending. Claims 71-72 and 74 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-5, 11, 13, 15, 17, 19, 21-22, 28, 33, 35, 38, 43-44, 61, and 98-99 are currently under examination.
Information Disclosure Statement
The information disclosure statements filed on 8/22/2024 and 12/9/2025 have been considered. Signed copies are enclosed.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pages 117-122. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 33 and 44 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.
Claim Rejections - 35 USC § 112
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 21-22, 35, 38, and 99 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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 21 is indefinite because it is not clear how a fungal cell can be a species from more than one genus.
Claim 22 is indefinite because it is dependent on an unspecified claim.
Claims 35 and 38 are indefinite because they require the product to undergo a process. A claim cannot be drawn to both a product and a process.
Claim 99 is indefinite because it is dependent on the method of claim 1. However, claim 1 is not drawn to a method.
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.
Claim 2 is rejected under 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. Claim 2 requires that the kin therapeutic is secreted from the fungal cell by a secretory pathway. However, the parent claim requires that the fungal cell is engineered to secrete the skin therapeutic. The therapeutic cannot be secreted unless it is secreted by a secretory pathway. Therefore, claim 2 does not further limit the parent claim. 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 11, 13, 15, 17, 21, 43, 61, and 98-99 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lakey (US Patent Application Publication 2015/0299272).
The instant claims are drawn to pharmaceutical compositions comprising a live fungal cell engineered to express and secrete a skin therapeutic and a pharmaceutically acceptable carrier.
Lakey discloses pharmaceutical compositions comprising a hydrogel for treatment of wounds (see paragraphs 0023-0026). The composition is created by growth of Saccharomyces or Pichia cells engineered to express proteins (see paragraph 0295-0296). These cells are engineered to produce growth factors, extracellular matrix proteins, cytokines, or chemokines as well as the polysaccharide of the hydrogel (see paragraph 0160). With regard to claims 98-99, there are no particular components required by the claims for the kit. Therefore, the composition is considered enough to be a kit.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 13, 19,21-22, 28, 61, and 98-99 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6, 9, 12-15, 18-19, 22, 24, 26, and 60-64 of copending Application No. 17738799 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to pharmaceutical compositions comprising a live fungal cell engineered to express and secrete a skin therapeutic and a pharmaceutically acceptable carrier.
The copending claims are drawn to pharmaceutical compositions designed for skin use comprising engineered fungal cells which produce therapeutic components. Each of the limitations of the instant claims is recited in the copending claims. Therefore, the instant claims are anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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