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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/16/2026 has been entered.
DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Amendment after Final office action filed on 3/16/2026 is acknowledged.
3. Claim filed on 3/16/2026 is acknowledged.
4. Claims 1-76, 79-81, 83, 92 and 101 have been cancelled.
5. New claim 102 has been added.
6. Claims 77, 78, 82, 84-91, 93-100 and 102 are pending in this application.
7. Claims 85-91 and 97-100 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim.
8. Applicant elected without traverse of Group 2 (claims 76-84, 93 and 94) and elected without traverse of a pharmaceutical composition consisting essential of a protein comprising the amino acid sequence of SEQ ID NO: 29 in a reduced state, water and sodium chloride as species of pharmaceutical composition in the reply filed on 6/18/2025 is acknowledged. Since the elected species of pharmaceutical composition is a subgenus, not a species, the Examiner telephoned Applicant’s representative, Sangil Lee, on 6/30/2025; and Applicant’s representative states on the phone that a pharmaceutical composition in a solution form consisting essential of a protein consisting of the amino acid sequence of SEQ ID NO: 29 in a reduced state, water and sodium chloride as the elected species of pharmaceutical composition (see PTO-413 dated 7/3/2025).
Please note: Due to Applicant’s amendment to the claim, for the purpose of this examination, the elected species of pharmaceutical composition is interpretated as a pharmaceutical composition in a solution form consisting of a protein consisting of the amino acid sequence of SEQ ID NO: 29 in a reduced state, water and sodium chloride. Otherwise, the elected species of pharmaceutical composition would not read on any claim in the elected Group 2.
Restriction requirement was deemed proper and made FINAL in the previous office actions. Group 2 is drawn to a pharmaceutical composition consisting of: a) a protein or peptide comprising a thioredoxin monocysteinic active site in a reduced state; and b) a diluent. A search was conducted on the elected species; and prior art was found. Claims 77, 78, 82, 84, 93-96 and 102 are examined on the merits in this office action.
Withdrawn Objections and Rejections
9. Objection to the specification is hereby withdrawn in view of Applicant's amendment to the specification.
10. Rejection to claim 96 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is hereby withdrawn in view of Applicant's amendment to the claim.
New Rejections
Claim Rejections - 35 U.S.C. § 102(a)(1)
11. 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.
12. Please note: During the search for the elected species, prior art was found for the non-elected species of pharmaceutical composition.
Claims 77, 78, 82, 84, 93-96 and 102 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Falk et al (Pediatric Pulmonology, 2016, 51, pages 292-293, filed with IDS).
The instant claims 77, 78, 82, 84, 93-96 and 102 are drawn to a pharmaceutical composition consisting of: a) a protein or peptide comprising a thioredoxin monocysteinic active site in a reduced state; and b) a diluent.
Falk et al teach ORP-100S having the tradename Theradux (a human thioredoxin variant) exhibits increasing disulfide-reducing activity; and a pharmaceutical composition comprising Theradux (ORP-100S) for treating human cells, wherein DTT is used as positive control and PBS is used as negative control, for example, the whole document. Therefore, in view of the teachings of Falk et al as a whole, one of ordinary skilled in the art would reasonably understand and immediately envision a pharmaceutical composition consisting of Theradux (ORP-100S) and PBS that is suitable for oral administration to a patient, wherein Theradux (ORP-100S) in such pharmaceutical composition is in reduced state. And as evidenced by instant specification, the protein of instant SEQ ID NO: 29 is identical to Theradux (ORP-100S) in Falk et al (see page 20, the 2nd paragraph of instant specification). Therefore, the pharmaceutical composition consisting of Theradux (ORP-100S) in a reduced state and PBS in Falk et al meets the limitations of instant claims 77, 78, 84, 93-96 and 102.
With regards to the limitation recited in instant claim 82, in the instant case, Theradux (ORP-100S) in reduced state in Falk et al is identical to a protein consisting of the amino acid sequence of instant SEQ ID NO: 29 in a reduced state and meets all the structural limitations of the protein or peptide recited in instant claim 78. Therefore, Theradux (ORP-100S) in reduced state in Falk et al would necessarily have the same properties and functionality of a protein consisting of the amino acid sequence of instant SEQ ID NO: 29 in a reduced state and/or the protein or peptide recited in instant claim 78. Thus, Theradux (ORP-100S) in reduced state in Falk et al is operable to activate one or more endogenous antimicrobial peptides, wherein the activation results in a therapeutically effective reagent to treat or prevent infectious diseases. Furthermore, the MPEP states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP § 2112.01 II). And, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
Since the reference teaches all the limitations of instant claims 77, 78, 82, 84, 93-96 and 102; the reference anticipates instant claims 77, 78, 82, 84, 93-96 and 102.
13. Please note: During the search for the elected species, prior art was found for the non-elected species of pharmaceutical composition.
Claims 78, 82, 84, 93, 94, 96 and 102 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heifetz (US 2016/0230149 A1, filed with IDS).
The instant claims 78, 82, 84, 93, 94, 96 and 102 are drawn to a pharmaceutical composition consisting of: a) a protein or peptide comprising a thioredoxin monocysteinic active site in a reduced state; and b) a diluent.
Heifetz, throughout the patent, teaches modified thioredoxin comprising a thioredoxin monocysteinic active site in a reduced state; the advantage of such modified thioredoxin; and a pharmaceutical composition comprising such modified thioredoxin and a pharmaceutically acceptable excipient/carrier, for example, Abstract; page 3, paragraphs [0014]-[0016] and [0019]; and page 6, paragraph [0040]. It meets the limitations of a protein or peptide comprising a thioredoxin monocysteinic active site in a reduced state recited in instant claims 78 and 93. Heifetz further teaches such modified thioredoxin is human thioredoxin with Cys at position 35 replaced by Ser, wherein the human thioredoxin consists of the amino acid sequence of SEQ ID NO: 12, for example, page 5, paragraph [0035]. The human thioredoxin with C35S substation in Heifetz consists of the amino acid sequence that is 96% identical to the amino acid sequence of instant SEQ ID NO: 28, as shown below with Query being instant SEQ ID NO: 28, and Sbjct being the human thioredoxin with C35S substation in Heifetz:
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. It meets the limitations of instant claims 94 and 96. Heifetz also teaches a pharmaceutical composition consists of the human thioredoxin with C35S substation in reduced state and isotonic saline, phosphate-buffered saline (PBS, pH 7.2) or Tris buffer as a diluent, for example, page 21, paragraph [0130]; page 22, paragraph [0142]; and page 25, paragraph [0172]. It meets the limitations of the pharmaceutical composition recited in instant claims 78, 93, 94, 96 and 102. Furthermore, Heifetz teaches the pharmaceutical composition is formulated for oral administration, for example, page 3, paragraph [0015]. It meets the limitation of instant claim 84.
With regards to the limitation recited in instant claim 82, in the instant case, the human thioredoxin with C35S substation in reduced state in Heifetz meets all the structural limitations of the protein or peptide recited in instant claim 78. Therefore, the human thioredoxin with C35S substation in reduced state in Heifetz would necessarily have the same properties and functionality of the protein or peptide recited in instant claim 78. Thus, the human thioredoxin with C35S substation in reduced state in Heifetz is operable to activate one or more endogenous antimicrobial peptides, wherein the activation results in a therapeutically effective reagent to treat or prevent infectious diseases. Furthermore, the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP 2112.01 I). In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
Since the reference teaches all the limitations of instant claims 78, 82, 84, 93, 94, 96 and 102; the reference anticipates instant claims 78, 82, 84, 93, 94, 96 and 102.
Claim Rejections - 35 U.S.C. § 103
14. 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 of this title, 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.
15. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
16. Claims 77, 78, 82, 84, 93-96 and 102 are rejected under 35 U.S.C. 103 as being unpatentable over Heifetz (US 2016/0230149 A1, filed with IDS) in view of Yodoi (EP 0853088 A2, filed with IDS), and as evidenced by the Difference between isotonic saline and normal saline document (from Google, 2025, page 1, cited and enclosed in the previous office action).
The instant claims 77, 78, 82, 84, 93-96 and 102 are drawn to a pharmaceutical composition consisting of: a) a protein or peptide comprising a thioredoxin monocysteinic active site in a reduced state; and b) a diluent.
Heifetz, throughout the patent, teaches modified thioredoxin comprising a thioredoxin monocysteinic active site in a reduced state; the advantage of such modified thioredoxin; and a pharmaceutical composition comprising such modified thioredoxin and a pharmaceutically acceptable excipient/carrier, for example, Abstract; page 3, paragraphs [0014]-[0016] and [0019]; and page 6, paragraph [0040]. It meets the limitations of a protein or peptide comprising a thioredoxin monocysteinic active site in a reduced state recited in instant claims 78 and 93. Heifetz further teaches such modified thioredoxin is human thioredoxin with Cys at position 35 replaced by Ser, wherein the human thioredoxin consists of the amino acid sequence of SEQ ID NO: 12, for example, page 5, paragraph [0035]. The human thioredoxin with C35S substation in Heifetz consists of the amino acid sequence that is 96% identical to the amino acid sequence of instant SEQ ID NO: 28, as shown below with Query being instant SEQ ID NO: 28, and Sbjct being the human thioredoxin with C35S substation in Heifetz:
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. It meets the limitations of instant claims 94 and 96. Heifetz also teaches a pharmaceutical composition consists of the human thioredoxin with C35S substation in reduced state and isotonic saline, phosphate-buffered saline (PBS, pH 7.2) or Tris buffer as a diluent, for example, page 21, paragraph [0130]; page 22, paragraph [0142]; and page 25, paragraph [0172]. It meets the limitations of the pharmaceutical composition recited in instant claims 78, 93, 94, 96 and 102. Furthermore, Heifetz teaches the pharmaceutical composition is formulated for oral administration, for example, page 3, paragraph [0015]. It meets the limitation of instant claim 84.
With regards to the limitation recited in instant claim 82, in the instant case, the human thioredoxin with C35S substation in reduced state in Heifetz meets all the structural limitations of the protein or peptide recited in instant claim 78. Therefore, the human thioredoxin with C35S substation in reduced state in Heifetz would necessarily have the same properties and functionality of the protein or peptide recited in instant claim 78. Thus, the human thioredoxin with C35S substation in reduced state in Heifetz is operable to activate one or more endogenous antimicrobial peptides, wherein the activation results in a therapeutically effective reagent to treat or prevent infectious diseases. Furthermore, the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP 2112.01 I). In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
The difference between the reference and instant claims 77, 78, 82, 84, 93-96 and 102 is that the reference does not teach a pharmaceutical composition in a solution form consisting of a protein consisting of the amino acid sequence of SEQ ID NO: 29 in a reduced state, water and sodium chloride as the elected species of pharmaceutical composition; and the limitations of instant claims 77 and 95.
However, Yodoi, throughout the patent, teaches thioredoxin (TRX) has difficulty in handling because it has a plurality of cysteine residues in its molecules so that it tends to precipitate by forming a multimer; and a thioredoxin variant which is stable, wherein at least one or all Cys residues are substituted by other amino acid residues except that Cys residues in the active center remain unmodified, for example, Abstract; and page 2, column 2, lines 54-56. Yodoi further teaches TRXC62S/C69S/C73S (substitution of serine for each of Cys62, Cys69 and Cys73 of human TRX) as a thioredoxin variant, wherein such substitutions do not affect the activity of TRX, for example, page 3, column 4, lines 43-44; page 4, column 5, lines 8-9; and page 7, column 12, lines 2-5.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Heifetz and Yodoi to develop a modified human thioredoxin comprising a thioredoxin monocysteinic active site in a reduced state, wherein each of Cys35, Cys62, Cys69 and Cys73 in human thioredoxin is substituted with Ser; and a pharmaceutical composition consisting of such modified human thioredoxin in reduced state and isotonic saline, phosphate-buffered saline (PBS, pH 7.2) or Tris buffer as a diluent. The modified human thioredoxin with each of Cys35, Cys62, Cys69 and Cys73 is substituted with Ser is identical to the protein of instant SEQ ID NO: 29. And as evidenced by the Difference between isotonic saline and normal saline document, isotonic saline is the same as normal saline, which consists of water and sodium chloride (see page 1, the 1st paragraph). Therefore, a pharmaceutical composition consisting of such modified human thioredoxin in reduced state and isotonic saline (the same as normal saline) reads on a pharmaceutical composition in a solution form consisting of a protein consisting of the amino acid sequence of SEQ ID NO: 29 in a reduced state, water and sodium chloride as the elected species of pharmaceutical composition; and it is a composition suitable for injection.
With regards to the limitation recited in instant claim 82, in the instant case, the modified human thioredoxin in reduced state developed from the combined teachings of Heifetz and Yodoi above is identical to the protein consisting of the amino acid sequence of instant SEQ ID NO: 29 in a reduced state and meets all the structural limitations of the protein or peptide recited in instant claim 78. Therefore, the modified human thioredoxin in reduced state developed from the combined teachings of Heifetz and Yodoi above would necessarily have the same properties and functionality of the protein consisting of the amino acid sequence of instant SEQ ID NO: 29 in a reduced state and/or the protein or peptide recited in instant claim 78. Thus, the modified human thioredoxin in reduced state developed from the combined teachings of Heifetz and Yodoi above is operable to activate one or more endogenous antimicrobial peptides, wherein the activation results in a therapeutically effective reagent to treat or prevent infectious diseases. Furthermore, the MPEP states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP § 2112.01 II). And, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
One of ordinary skilled in the art would have been motivated to combine the teachings of Heifetz and Yodoi to develop a modified human thioredoxin comprising a thioredoxin monocysteinic active site in a reduced state, wherein each of Cys35, Cys62, Cys69 and Cys73 in human thioredoxin is substituted with Ser; and a pharmaceutical composition consisting of such modified human thioredoxin in reduced state and isotonic saline, phosphate-buffered saline (PBS, pH 7.2) or Tris buffer as a diluent, because Yodoi, throughout the patent, teaches thioredoxin (TRX) has difficulty in handling because it has a plurality of cysteine residues in its molecules so that it tends to precipitate by forming a multimer; and a thioredoxin variant which is stable, wherein at least one or all Cys residues are substituted by other amino acid residues except that Cys residues in the active center remain unmodified. Yodoi further teaches TRXC62S/C69S/C73S (substitution of serine for each of Cys62, Cys69 and Cys73 of human TRX) as a thioredoxin variant, wherein such substitutions do not affect the activity of TRX.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Heifetz and Yodoi to develop a modified human thioredoxin comprising a thioredoxin monocysteinic active site in a reduced state, wherein each of Cys35, Cys62, Cys69 and Cys73 in human thioredoxin is substituted with Ser; and a pharmaceutical composition consisting of such modified human thioredoxin in reduced state and isotonic saline, phosphate-buffered saline (PBS, pH 7.2) or Tris buffer as a diluent.
Obviousness Double Patenting
17. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
18. Claims 77, 78, 82, 84, 93-96 and 102 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3-7, 9, 11-14, 16 and 17 of co-pending Application No. 18/349112 in view of either Falk et al (Pediatric Pulmonology, 2016, 51, pages 292-293, filed with IDS) or Heifetz (US 2016/0230149 A1, filed with IDS).
19. The instant claims 77, 78, 82, 84, 93-96 and 102 are drawn to a pharmaceutical composition consisting of: a) a protein or peptide comprising a thioredoxin monocysteinic active site in a reduced state; and b) a diluent.
20. Claims 1, 3-7, 9, 11-14, 16 and 17 of co-pending Application No. 18/349112 are drawn to various treatment methods of administering an effective amount of a composition comprising a monocysteinic thioredoxin, wherein the monocysteinic thioredoxin is a protein or peptide comprising SEQ ID NO: 1 or 2, wherein the N-terminal methionine residue is optionally not present, wherein the sequence optionally comprises one or more post-translational modifications, and wherein for SEQ ID NO:1, X represents a residue of any amino acid other than cysteine; and a composition comprising a monocysteinic thioredoxin formulated for administration by a route selected from the group consisting of intravenous infusion, subcutaneous injection, intramuscular injection, intraperitoneal injection, and topical inhalation, wherein the monocysteinic thioredoxin is a protein or peptide comprising SEQ ID NO: 1 or 2, wherein the N-terminal methionine residue is optionally not present, wherein the sequence optionally comprises one or more post-translational modifications, and wherein for SEQ ID NO:1, X represents a residue of any amino acid other than cysteine.
In view of the combined teachings of claims 1, 3-7, 9, 11-14, 16 and 17 of co-pending Application No. 18/349112, it would have been obvious to one of ordinary skilled in the art to develop a pharmaceutical composition comprising a protein or peptide comprising SEQ ID NO: 2 (as a monocysteinic thioredoxin) in a reduced state and a pharmaceutically acceptable excipient, wherein the pharmaceutical composition is formulated for administration by a route selected from the group consisting of intravenous infusion, subcutaneous injection, intramuscular injection, intraperitoneal injection, and topical inhalation.
The protein of SEQ ID NO: 2 recited in claims of co-pending Application No. 18/3491122 is identical to the protein of instant SEQ ID NO: 29.
21. The difference between the pharmaceutical composition developed from the combined teachings of claims 1, 3-7, 9, 11-14, 16 and 17 of co-pending Application No. 18/349112 above and the pharmaceutical composition recited in instant claims 77, 78, 82, 84, 93-96 and 102 is that it does not teach the limitations recited in instant claims.
However, in view of either the teachings of Falk et al as set forth in Section 12 above or the teachings of Heifetz as set forth in Sections 13 and 16 above, it would have been obvious to one of ordinary skilled in the art to modify the pharmaceutical composition developed from the combined teachings of claims 1, 3-7, 9, 11-14, 16 and 17 of co-pending Application No. 18/349112 above and develop the pharmaceutical composition recited in instant claims 77, 78, 84, 93-96 and 102.
With regards to the limitation recited in instant claim 82, in the instant case, the protein of SEQ ID NO: 2 in reduced state recited in claims of co-pending Application No. 18/34911228 is identical to the protein consisting of the amino acid sequence of instant SEQ ID NO: 29 in a reduced state and meets all the structural limitations of the protein or peptide recited in instant claim 78. Therefore, the protein of SEQ ID NO: 2 in reduced state recited in claims of co-pending Application No. 18/34911228 would necessarily have the same properties and functionality of the protein consisting of the amino acid sequence of instant SEQ ID NO: 29 in a reduced state and/or the protein or peptide recited in instant claim 78. Thus, the protein of SEQ ID NO: 2 in reduced state recited in claims of co-pending Application No. 18/34911228 is operable to activate one or more endogenous antimicrobial peptides, wherein the activation results in a therapeutically effective reagent to treat or prevent infectious diseases. Furthermore, the MPEP states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP § 2112.01 II). And, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
This is a provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
22. For the same/similar reasoning/rational as the rejection set forth in Sections 18-21 above, instant claims 77, 78, 82, 84, 93-96 and 102 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3 of co-pending Application No. 18/349113, and claims 1-12 of co-pending Application No. 18/349114; and in view of either the teachings of Falk et al (Pediatric Pulmonology, 2016, 51, pages 292-293, filed with IDS) as set forth in Section 12 above or the teachings of Heifetz (US 2016/0230149 A1, filed with IDS) as set forth in Sections 13 and 16 above.
These are all provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
23. Claims 77, 78, 82, 84, 93-96 and 102 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of US patent 9168290 B2, and in view of Heifetz (US 2016/0230149 A1, filed with IDS) and Yodoi (EP 0853088 A2, filed with IDS).
24. The instant claims 77, 78, 82, 84, 93-96 and 102 are drawn to a pharmaceutical composition consisting of: a) a protein or peptide comprising a thioredoxin monocysteinic active site in a reduced state; and b) a diluent.
25. Claims 1-17 of US patent 9168290 B2 are drawn to a method to decrease viscoelasticity of mucus or sputum in a patient that has excessively viscous or cohesive mucus or sputum, comprising contacting the mucus or sputum of the patient with a composition comprising a protein or peptide containing a thioredoxin monocysteinic active site in a reduced state effective to decrease the viscoelasticity of the mucus or sputum as compared to prior to the step of contacting, wherein the thioredoxin monocysteinic active site comprises an amino acid sequence selected from the group consisting of C-X-X-S (SEQ ID NO:24), C-X-X-X (SEQ ID NO:17), X-C-X-X-X-X (SEQ ID NO:19), X-C-G-P-X-X (SEQ ID NO:21), W-C-G-P-X-K (SEQ ID NO:23), X-C-X-X-S-X (SEQ ID NO:25), X-C-G-P-S-X (SEQ ID NO:26), and W-C-G-P-S-K (SEQ ID NO:27), wherein the C residue is in a reduced state, and wherein the X residues are any amino acid residue other than cysteine.
In view of the combined teachings of claims 1-17 of US patent 9168290 B2, it would have been obvious to one of ordinary skilled in the art to develop a pharmaceutical composition comprising a protein or peptide containing a thioredoxin monocysteinic active site in a reduced state, wherein the thioredoxin monocysteinic active site comprises an amino acid sequence selected from the group consisting of C-X-X-S (SEQ ID NO:24), C-X-X-X (SEQ ID NO:17), X-C-X-X-X-X (SEQ ID NO:19), X-C-G-P-X-X (SEQ ID NO:21), W-C-G-P-X-K (SEQ ID NO:23), X-C-X-X-S-X (SEQ ID NO:25), X-C-G-P-S-X (SEQ ID NO:26), and W-C-G-P-S-K (SEQ ID NO:27), wherein the C residue is in a reduced state, and wherein the X residues are any amino acid residue other than cysteine, and a pharmaceutically acceptable excipient, wherein the pharmaceutical composition is suitable for inhalation.
26. The difference between the pharmaceutical composition developed from the combined teachings of claims 1-17 of US patent 9168290 B2 above and the pharmaceutical composition recited in instant claims 77, 78, 82, 84, 93-96 and 102 is that it does not teach the “consisting of” recited in instant claim 78; the protein or peptide recited in instant claims 77 and 94-96; and the limitations of instant claims 82 and 102.
However, in view of the combined teachings of Heifetz and Yodoi as set forth in Section 16 above, it would have been obvious to one of ordinary skilled in the art to modify both the protein and the pharmaceutically acceptable excipient in the pharmaceutical composition developed from the combined teachings of claims 1-17 of US patent 9168290 B2 above and develop the pharmaceutical composition recited in instant claims 77, 78, 84, 93-96 and 102.
With regards to the limitation recited in instant claim 82, in the instant case, the modified protein in reduced state in the pharmaceutical composition developed above is identical to the protein consisting of the amino acid sequence of instant SEQ ID NO: 29 in a reduced state and meets all the structural limitations of the protein or peptide recited in instant claim 78. Therefore, the modified protein in reduced state in the pharmaceutical composition developed above would necessarily have the same properties and functionality of the protein consisting of the amino acid sequence of instant SEQ ID NO: 29 in a reduced state and/or the protein or peptide recited in instant claim 78. Thus, the modified protein in reduced state in the pharmaceutical composition developed above is operable to activate one or more endogenous antimicrobial peptides, wherein the activation results in a therapeutically effective reagent to treat or prevent infectious diseases. Furthermore, the MPEP states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP § 2112.01 II). And, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
27. For the same/similar reasoning/rational as the rejection set forth in Sections 23-26 above, instant claims 77, 78, 82, 84, 93-96 and 102 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of US patent 12390511 B2; and in view of the combined teachings of Heifetz (US 2016/0230149 A1, filed with IDS) and Yodoi (EP 0853088 A2, filed with IDS) as set forth in Section 16 above.
28. For the same/similar reasoning/rational as the rejection set forth in Sections 23-26 above, instant claims 77, 78, 82, 84, 93-96 and 102 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 43-56 of co-pending Application No. 18/733200, and claims 1-54 of co-pending Application No. 19/292329; and in view of the combined teachings of Heifetz (US 2016/0230149 A1, filed with IDS) and Yodoi (EP 0853088 A2, filed with IDS) as set forth in Section 16 above.
These are all provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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