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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/14/2025 has been entered.
Election/Restrictions
Applicant's elected Group II – claims 1-7 with traverse in the reply filed 12/20/2022. Claims 5-8 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/20/22. The restriction requirement mailed 09/22/2022 is still deemed proper, as detailed in the Non-Final Office Action mailed 3/2/2023.
Applicant's elected species Psoriasis in claim 3, Cathepsin G in claims 4 and 7, and Cathepsin G inhibitor I in claim 5 without traverse in the reply filed 12/20/2022.
The non-elected species in claim 3 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/20/22.
Application Status
This action is written in response to applicant’s correspondence received 10/14/2025. Claims 1 and 9 are amended. Claims 1, 3, and 5-9 are currently pending. Claims 5-8 are withdrawn from prosecution as being drawn to non-elected subject matter. Accordingly, claims 1, 3, and 9 are examined herein.
Any rejection or objection not reiterated herein has been overcome by amendment. Applicant’s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
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.
Claim 9 is 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.
Claim 9 recites “a serine protease inhibitor or a cysteine protease inhibitor wherein the serine protease inhibitor or cysteine protease inhibitor consists of: … b) a peptide consisting of 3 to 7 consecutive amino acids, wherein the 3 to 7 consecutive amino acids consist of: Lys-Ala-Leu-CMK (KAL-CMK)”. However, the claimed amino acid sequence of KAL only consists of 3 amino acids rather than the claimed 4, 5, 6, or 7 consecutive sequences. The term “CMK” refers to the chemical modification of “chloromethyl ketones” as described in the instant specification on pages 11 and 18.
Response to Arguments
Applicant's arguments filed 10/14/2025 have been fully considered but they are
not persuasive. Applicant argues that the amendment "a peptide consisting of 3 to 4 consecutive amino acids" should overcome the indefiniteness rejection.
This argument is not persuasive because the amendment to parts a) and c) is only sufficient to overcome the indefiniteness of parts a) and c). No amendment was made to claim 9 part b), which remains indefinite, for the reasons detailed above. Therefore, the 112(b) rejection of claim 9 is maintained.
Claim Rejections - 35 USC § 102 - maintained
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, and 9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by “Kim" (Kim et al. US20140348859A1; published November 27, 2014, priority to January 10, 2013).
Regarding claim 1, Kim teaches a method of treatment for inflammatory skin disorders in a subject in need thereof comprising administering an effective amount of the serine protease inhibitor alpha-1 antitrypsin (AAT) (see abstract and paras 0004-0005 and 0063-0064). Kim teaches that the serine protease inhibitor AAT can comprise fragments and subfragments as small as “about 5 AAs” (see para 0005, claim 1).
Kim teaches treatments including the pentapeptides of AAT comprising the 3 consecutive amino acids of Phe-Leu-Phe (FLF), Lys-Ala-Leu (KAL), or Ala-Pro-Leu (APL) (see paras 0096 and 0099-0105; SEQ ID NO: 32 encoding AAT-Fc2-full-length AAT, a leader sequence and an Fc portion/fragment of an immunoglobulin molecule; and SEQ ID NO: 33 encoding naturally-occurring AAT of 394 amino acids).
Regarding claim 3, Kim teaches AAT therapy for treatment of plaque psoriasis, guttate psoriasis pustular psoriasis, erythrodermic psoriasis, inverse psoriasis, psoriatic arthritis, lichen planus, Bullous pemphigoid, dermatomyositis, and dermatitis (see paras 0063-0064).
Regarding claim 9, Kim teaches a method of treatment for inflammatory skin disorders in a subject in need thereof comprising administering an effective amount of the serine protease inhibitor alpha-1 antitrypsin (AAT) (see abstract and paras 0004 and 0063-0064). Kim teaches treatments including the pentapeptides of AAT comprising a peptide consisting of 3 to 8 consecutive amino acids, wherein the 3 to 8 consecutive amino acids consist of Phe-Leu-Phe (FLF), Lys-Ala-Leu (KAL), or Ala-Pro-Leu (APL) (see paras 0096 and 0099-0105; SEQ ID NO: 32 encoding AAT-Fc2-full-length AAT, a leader sequence and an Fc portion/fragment of an immunoglobulin molecule; and SEQ ID NO: 33 encoding naturally-occurring AAT of 394 amino acids).
Response to Arguments
Applicant's arguments filed 10/14/2025 have been fully considered but they are not persuasive. Applicant refers to paragraph 0096 and argues that Kim explicitly teaches pentapeptides and fails to teach a peptide consisting of three consecutive amino acids, wherein the three consecutive amino acids comprise Phe-Leu- Phe (FLF). SEQ ID NOs: 8-11, 15, 16 of Kim do not consist of three consecutive amino acids, wherein the three consecutive amino acids consist of Phe-Leu-Phe (FLF). Applicant argues that instant claims also recite a peptide consisting of 3 to 8 consecutive amino acids, wherein the 3 to 8 consecutive amino acids comprise Lys-Ala-Leu (KAL)/(-CMK).
Applicant further argues that Kim makes no teaching of a peptide consisting of 3 to 8 consecutive amino acids, wherein the 3 to 8 consecutive amino acids comprise Lys-Ala-Leu (KAL)/(-CMK). Kim teaches a peptide consisting of the amino acid sequence of SEQ ID NO:32 as including KAL. SEQ ID NO:32 of Kim does not consist of 3 to 8 consecutive amino acids, wherein the 3 to 8 consecutive amino acids comprise Lys-Ala-Leu (KAL), with or without-CMK. Applicant argues that instant claims recite a peptide consisting of 3 to 8 consecutive amino acids, wherein the 3 to 8 consecutive amino acids comprise Ala-Pro-Leu (APL).
Applicant argues that based on SEQ ID NOs 31 and 33 taught in Kim, that Kim therefore does not teach the peptides having 3 to 9 amino acids. Finally, Applicant points to paragraph 0005 of Kim arguing that a fragment of the last 80 AAs or subfragments thereof (e.g. about 40, about 30, about 20or about 10 AAs, or about 5 AAs) of the molecule associated with one or more immune molecule to form a construct for compositions, methods and uses disclosed herein, which is a fragment of the last 80 AAs of the 394 AA naturally occurring AAT (SEQ ID NO. 33; SEQ ID NO:1 AAs 314-394). The last 80 AAs of the 394 AA naturally occurring AAT (SEQ ID NO. 33) neither teaches nor suggests any peptide as is instantly claimed. Applicant thus argues that Kim fails to teach or suggest any of the peptides recited by the instant claims.
This argument is not persuasive. As discussed in the 35 U.S.C. 102(a)(2) rejection above, Kim does teach at least FLF, KAL, and APL (see paras 0096 and 0099-0105; SEQ ID NO: 32 encoding AAT-Fc2-full-length AAT, a leader sequence and an Fc portion/fragment of an immunoglobulin molecule; and SEQ ID NO: 33 encoding naturally-occurring AAT of 394 amino acids). Applicant is reminded of the range of length of the peptides claimed in the instant claims being 3 to 8, such that the peptides of claim 1a) can be 3, 4, 5, 6, 7, and 8 amino acids in length and also comprise the 3 or 4 amino acid peptides of claim 1a). The range of length of the peptides claimed include pentapeptides. Furthermore, Kim teaches that the serine protease inhibitor AAT can comprise fragments and subfragments (see para 0005). Kim further teaches examples of lengths for the subfragments as small as “about 5 AAs”, such that one could envision fragments shorter than 5 amino acids in length. Therefore, the 35 U.S.C. 102(a)(2) rejection is maintained.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHALEDA B HASAN whose telephone number is (571)272-0239. The examiner can normally be reached IFP, Monday - Friday 7:30am-5pm.
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/KHALEDA B HASAN/Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636