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 .
Election/Restrictions
1. Applicant’s election without traverse of LEKTI-D5 as the bioactive agent species in the reply filed on 12/17/2025 is acknowledged.
Claims 9 and 12-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1-8, 10, 11, and 18-20 are under examination.
Claim 2 is drawn to a composition. For examination purposes, the recitation “disposed on the skin of a person” is reasonably interpreted as being an intended use, i.e., for topical administration.
Claims 7 and 8 are examined to the extent that they pertain to the elected species LEKTI-D5.
Claim Objections
3. Claim 19 should recite “the predetermined time” in line 2. Furthermore, the recitation “(Original)” in line 2 should be deleted.
Claim Rejections - 35 USC § 112(b)
3. 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.
4. Claims 5, 10, and 20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 5, 10, and 20, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 20 recites the limitations "the concentration of glucose and glycerol" an “the moisturizer” in lines 2-3. There is insufficient antecedent basis for these limitations in the claim.
Claim Rejections - 35 USC § 112(d)
5. 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.
6. Claim 2 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.
As noted above, the recitation “disposed on the skin of a person” is only an intended; this intended use does not set forth any further limitation differentiating the claimed formulation from the one recited in the parent claim 1. Thus, Claim 2 does not further limit the subject matter of the parent claim 1.
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 § 103
7. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
8. Claims 1-8, 10, 11, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Whitfill et al. (WO 17/232300), in view of all Gallo et al. (WO 19/046801; cited on the IDS filed on 11/16/2024), Uhde et al. (Appl. Microbiol. Biotechnol., 2013, 97: 1679-1687), and Deraison et al. (Mol. Biol. Cell., 2007, 18: 3607-3619).
Whitfill et al. teach treating a subject for Netherton syndrome by applying to the skin of the subject a composition comprising living population of bacteria genetically engineered to express LEKTI-D6, and inhibitor of the serine proteases KLK5 and KLK7; the bacteria are adapted to live for a predetermined duration on the skin surface to provide a continuous supply of LEKTI-D5 or LEKTI-D6 (claims 1-3, 7, 8, 10, 11, and 18) (see Abstract; [0002]; [0012]; [0020]; [0035]-[0036]; [0046]; [0117]). Whitfill et al. teach that the composition comprises a moisturizer and a humectant such as glycerol (claims 4 and 5) (see [0089]; [0102]).
Although Whitfill et al. teach that the bacteria could be a Corynebacterium, (see [0044]), Whitfill et al. do not specifically teach Corynebacterium glutamicum (claim 1) nor do they teach nutrients such as sugars (claims 1 and 6). Gallo et al. teach that genetically engineered Corynebacterium glutamicum could be used to deliver therapeutic agents to the skin (see [0003]; [0011]-[0012]; [0015]; [0020]; [0091]). Corynebacterium glutamicum is disclosed within a broad genus and Gallo et al. do not provide a motivation to specifically select Corynebacterium glutamicum. However, Uhde et al. teach that Corynebacterium glutamicum has been widely used for the production of a variety of compounds of interest. Uhde et al. teach Corynebacterium glutamicum is a biotin auxotroph and utilizes sugars and organic acids as sole source of carbon and energy (see p. 1679). Based on these teachings, one of skill in the art would have reasonably concluded that Corynebacterium glutamicum could be used for efficient LEKTI-D6 production and also that, since Corynebacterium glutamicum is a biotin auxotroph, biotin could be used to control the duration of LEKTI-D5 or LEKTI-D6 production, as required by Whitfill et al. One of skill in the art would have found obvious to obtain s genetically engineered Corynebacterium glutamicum expressing LEKTI-D6 and further formulate it with a medium comprising biotin and sugars to achieve the predictable results of obtaining a composition suitable to be used in the method of Whitfill et al.
With respect to claims 18 and 20, one of skill in the art would have found obvious to adjust biotin concentration to achieve the predictable result of providing a continuous supply of LEKTI-D6 for a predetermined duration of time.
With respect to claim 19, Whitfill et al. teach applying the composition once or twice daily to once or twice weekly (see [0099]). Thus, one of skill in the art would have found obvious to use routine experimentation to determine the concentration of biotin and/or sugars necessary to keep the genetically engineered Corynebacterium glutamicum alive for at least 12 h or 24 h (i.e., once or twice daily administration). Routine optimization is not considered inventive and no evidence has been presented that the selection the claimed predetermined times was other than routine or that the results should be considered unexpected in any way as compared to the closest prior art (see MPEP 2144.05 II).
With respect to the elected species LEKTI-D5, Whitfill et al. teach that other LEKTI domains (including D5), can be used in the method (see [0052]; Example 5). Deraison et al. teach that LEKTI-D5 is a more efficient inhibitor of KLK5 and KLK7 (see p. 3613, column 2). Thus, replacing LEKTI-D6 with LEKTI-D5 would have been obvious to one of skill in the art to achieve the predictable result of obtaining a composition for treating Netherton syndrome.
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
9. No claim is allowed. No claim is free of prior art.
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/ILEANA POPA/Primary Examiner, Art Unit 1633