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. 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 for the cited rejections 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.
3. Response to Election/Restriction filed on 9/19/2025 is acknowledged.
4. Claim filed on 12/9/2022 is acknowledged.
5. Claims 1-13 are pending in this application.
6. Claims 8-13 are withdrawn from consideration as being drawn to non-elected species.
7. Claims 1-7 are under examination.
Priority
8. The instant application claims foreign priority to Republic of Korea application No. 10-2020-0071658 filed on 6/12/2020. Even though a certificated copy of the Republic of Korea application is provided, Applicant fails to provide an English-translated copy of the Republic of Korea application. Therefore, the filing date of the priority document has not been perfected. Applicant is required to file an English language translation of the foreign application with a statement that the translation of the certified copy is accurate (see MPEP § 215).
Since the filing date of the priority document has not been perfected, the effective filing date of instant claims 1-7 is the filing date of PCT/KR2021/007322, which is 6/11/2021.
Election/Restrictions
9. Applicant’s election without traverse of a pharmaceutical composition for the prevention or treatment of atopic dermatitis in the form of external preparations as species of composition in the reply filed on 9/19/2025 is acknowledged. Since the elected species of composition is a subgenus, not a species; the Examiner telephoned Applicant’s representative, James A. Larson, for further species election. Applicant’s representative stated on the phone that a pharmaceutical composition for the prevention or treatment of atopic dermatitis in the form of cream as the elected species of composition on 10/1/2025 (see PTO-413 mailed on 10/2/2025). The requirement is made FINAL in this office action.
The instant claims 1-13 are drawn to a pharmaceutical composition for the prevention or treatment of allergic diseases comprising a pentapeptide consisting of the amino acid sequence of SEQ ID NO: 1 as an active ingredient; and a cosmetic composition for the prevention or improvement of allergic diseases comprising a pentapeptide consisting of the amino acid sequence of SEQ ID NO: 1 as an active ingredient. A search was conducted on the elected species; and prior art was found. Claims 8-13 are withdrawn from consideration as being drawn to non-elected species. Claims 1-7 are examined on the merits in this office action.
Objections
10. The specification is objected to for failing to comply with 37 CFR 1.821(d). The instant specification discloses the peptide KFLIK on page 4, paragraph [23] and many others throughout the specification. However, it is missing the respective sequence identifier. Applicant is therefore required to amend the specification to comply with 37 CFR 1.821(d).
Please note: The specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification (see MPEP § 608.01).
11. The drawings are objected to for the following minor informality:
Figure 1b is described with respect to color in the drawings filed on 12/9/2022. Reference to specific colors should be removed.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
12. Claim 1 is objected to for the following minor informality: Applicant is suggested to amend claim 1 as “A pharmaceutical composition for preventing or treating allergic disease comprising…”.
13. Claim 2 is objected to for the following minor informality: Applicant is suggested to amend claim 2 as “…wherein the allergic disease is selected form the group consisting of edema…”.
14. Claim 4 is objected to for the following minor informality: Claim 4 contains the acronyms “IL-4”, “IL-13”, “TNF-α”, “IL-1β”, “IL-6” and “IL-8”. An acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, for example, interleukin-4 (IL-4). The abbreviations can be used thereafter.
Furthermore, Applicant is suggested to amend claim 4 as “…wherein the pentapeptide inhibits i) the expression of…, and ii) the release of…”.
15. Claim 5 is objected to for the following minor informality: Applicant is suggested to amend claim 5 as “The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition further comprises a pharmaceutically acceptable carrier, excipient or diluent”.
16. Claim 6 is objected to for the following minor informality: Applicant is suggested to amend claim 6 as “The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is in the form of…”.
17. Claim 7 is objected to for the following minor informality: Applicant is suggested to amend claim 7 as “…wherein the external preparation is selected from the group consisting of cream, gel, ointment, emulsion, suspension, spray and transdermal delivery patch”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
18. 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.
19. Claim 7 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 pre-AIA the applicant regards as the invention.
20. Claim 7, which depends on claim 5, recites the limitation “the external preparation”. There is insufficient antecedent basis for this limitation in the claim. Claim 5 does not mention an external preparation. It is not clear to what the said phrase is referring.
Claim Rejections - 35 U.S.C. § 102(a)(2)
21. 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.
22. Claims 1-7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chung et al (WO 2020138674 A1, filed with IDS, machine translation used and enclosed pages 1-67).
The instant claims 1-7 are drawn to a pharmaceutical composition for the prevention or treatment of allergic diseases comprising a pentapeptide consisting of the amino acid sequence of SEQ ID NO: 1 as an active ingredient.
Chung et al, throughout the patent, teach a pharmaceutical composition comprising a peptide of SEQ ID NO: 1 consisting of the amino acid sequence KFLIK (identical to the pentapeptide of instant SEQ ID NO: 1) and a pharmaceutically acceptable carrier, excipient or diluent; wherein the pharmaceutical composition is in the form of cream, ointment and many other, for example, page 20, paragraph [0060]; page 23, paragraph [0068]; and pages 35-36, paragraph [0107]. It meets all the structural limitations of the pharmaceutical composition recited in instant claims 1-7.
With regards to the intended use limitation “for the prevention or treatment of allergic diseases” recited in instant claim 1; and the intended use limitations recited in instant claims 2 and 3, in the instant case, the intended use limitations do not patentably distinguish the instant claimed composition from the prior art composition, since such intended use does not create a structural difference between the claimed composition and the prior art composition. In order to be limiting, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation (see MPEP § 2111.02). In the instant case, there is no evidence that the prior art composition is not capable of preforming the intended use recited in instant claims 1-3. Therefore, the pharmaceutical composition comprising a peptide of SEQ ID NO: 1 consisting of the amino acid sequence KFLIK (identical to the pentapeptide of instant SEQ ID NO: 1) and a pharmaceutically acceptable carrier, excipient or diluent in the form of cream in Chung et al reads on a pharmaceutical composition for the prevention or treatment of atopic dermatitis in the form of cream as the elected species of composition; and it meets the limitations of instant claims 1-3 and 5-7.
With regards to the limitation recited in instant claim 4, since the peptide of SEQ ID NO: 1 consisting of the amino acid sequence KFLIK in Chung et al is identical to the pentapeptide of instant SEQ ID NO: 1, the peptide of SEQ ID NO: 1 consisting of the amino acid sequence KFLIK in Chung et al would necessarily have the same properties and functionality of the pentapeptide of instant SEQ ID NO: 1. Therefore, the peptide of SEQ ID NO: 1 consisting of the amino acid sequence KFLIK in Chung et al would have the property of inhibiting the expression of IL-4, IL-13, TNF-α, IL-1β, IL-6 or IL-8, and the release of β-hexosaminidase. And 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). 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 1-7; the reference anticipates instant claims 1-7.
Claim Rejections - 35 U.S.C. § 102(a)(1)
23. 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.
24. Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chung et al (WO 2020138674 A1, filed with IDS, machine translation used and enclosed pages 1-67).
The instant claims 1-7 are drawn to a pharmaceutical composition for the prevention or treatment of allergic diseases comprising a pentapeptide consisting of the amino acid sequence of SEQ ID NO: 1 as an active ingredient.
Chung et al, throughout the patent, teach a pharmaceutical composition comprising a peptide of SEQ ID NO: 1 consisting of the amino acid sequence KFLIK (identical to the pentapeptide of instant SEQ ID NO: 1) and a pharmaceutically acceptable carrier, excipient or diluent; wherein the pharmaceutical composition is in the form of cream, ointment and many other, for example, page 20, paragraph [0060]; page 23, paragraph [0068]; and pages 35-36, paragraph [0107]. It meets all the structural limitations of the pharmaceutical composition recited in instant claims 1-7.
With regards to the intended use limitation “for the prevention or treatment of allergic diseases” recited in instant claim 1; and the intended use limitations recited in instant claims 2 and 3, in the instant case, the intended use limitations do not patentably distinguish the instant claimed composition from the prior art composition, since such intended use does not create a structural difference between the claimed composition and the prior art composition. In order to be limiting, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation (see MPEP § 2111.02). In the instant case, there is no evidence that the prior art composition is not capable of preforming the intended use recited in instant claims 1-3. Therefore, the pharmaceutical composition comprising a peptide of SEQ ID NO: 1 consisting of the amino acid sequence KFLIK (identical to the pentapeptide of instant SEQ ID NO: 1) and a pharmaceutically acceptable carrier, excipient or diluent in the form of cream in Chung et al reads on a pharmaceutical composition for the prevention or treatment of atopic dermatitis in the form of cream as the elected species of composition; and it meets the limitations of instant claims 1-3 and 5-7.
With regards to the limitation recited in instant claim 4, since the peptide of SEQ ID NO: 1 consisting of the amino acid sequence KFLIK in Chung et al is identical to the pentapeptide of instant SEQ ID NO: 1, the peptide of SEQ ID NO: 1 consisting of the amino acid sequence KFLIK in Chung et al would necessarily have the same properties and functionality of the pentapeptide of instant SEQ ID NO: 1. Therefore, the peptide of SEQ ID NO: 1 consisting of the amino acid sequence KFLIK in Chung et al would have the property of inhibiting the expression of IL-4, IL-13, TNF-α, IL-1β, IL-6 or IL-8, and the release of β-hexosaminidase. And 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). 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 1-7; the reference anticipates instant claims 1-7.
25. Please note: During the search for the elected species, prior art was found for the non-elected species of pharmaceutical composition.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Otterlei et al (US 2016/0289272 A1, filed with IDS).
The instant claims 1-7 are drawn to a pharmaceutical composition for the prevention or treatment of allergic diseases comprising a pentapeptide consisting of the amino acid sequence of SEQ ID NO: 1 as an active ingredient.
Otterlei et al, throughout the patent, teach an oligopeptidic compound; and a pharmaceutical composition comprising such oligopeptidic compound and a pharmaceutically acceptable carrier, excipient or diluent, wherein the oligopeptidic compound can be a peptide of SEQ ID NO: 269 consisting of the amino acid sequence KFLIK (identical to the pentapeptide of instant SEQ ID NO: 1), and wherein the pharmaceutical composition is in a form suitable for oral, parenteral, topical, rectal, genital, subcutaneous, transurethral, transdermal, intranasal, intraperitoneal, intramuscular and/or intravenous administration and/or for administration by inhalation, such as in the form of emulsion, spray and many others, for example, Abstract; page 11, paragraph [0182]; SEQ ID NO: 269 on page 15; page 16, paragraph [0185]; and page 26, paragraph [0272] and [0280]. It meets all the structural limitations of the pharmaceutical composition recited in instant claims 1-7.
Furthermore, the Examiner would like to point out that the only active component in the pharmaceutical composition recited in instant claims 1-4 and 6 is the pentapeptide consisting of the amino acid sequence of instant SEQ ID NO: 1. Therefore, the peptide of SEQ ID NO: 269 consisting of the amino acid sequence KFLIK (identical to the pentapeptide of instant SEQ ID NO: 1) in Otterlei et al meets all the structural limitations of the pharmaceutical composition recited in instant claims 1-4 and 6.
With regards to the intended use limitation “for the prevention or treatment of allergic diseases” recited in instant claim 1; and the intended use limitations recited in instant claims 2 and 3, in the instant case, the intended use limitation does not patentably distinguish the instant claimed composition from the prior art composition, since such intended use does not create a structural difference between the claimed composition and the prior art composition. In order to be limiting, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation (see MPEP § 2111.02). In the instant case, there is no evidence that the prior art composition is not capable of preforming the intended use recited in instant claims 1-3. Therefore, the pharmaceutical composition comprising a peptide of SEQ ID NO: 269 consisting of the amino acid sequence KFLIK (identical to the pentapeptide of instant SEQ ID NO: 1) and a pharmaceutically acceptable carrier, excipient or diluent in the form of emulsion or spray in Otterlei et al meets the limitations of instant claims 1-3 and 5-7.
With regards to the limitation recited in instant claim 4, since the peptide of SEQ ID NO: 269 consisting of the amino acid sequence KFLIK in Otterlei et al is identical to the pentapeptide of instant SEQ ID NO: 1, the peptide of SEQ ID NO: 269 consisting of the amino acid sequence KFLIK in Otterlei et al would necessarily have the same properties and functionality of the pentapeptide of instant SEQ ID NO: 1. Therefore, the peptide of SEQ ID NO: 269 consisting of the amino acid sequence KFLIK in Otterlei et al would have the property of inhibiting the expression of IL-4, IL-13, TNF-α, IL-1β, IL-6 or IL-8, and the release of β-hexosaminidase. And 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). Since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
Furthermore, the MPEP states the following: A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (See MPEP § 2131.02).
Since the reference teaches all the limitations of instant claims 1-7; the reference anticipates instant claims 1-7.
Claim Rejections - 35 U.S.C. § 103
26. 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.
27. 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.
28. Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Otterlei et al (US 2016/0289272 A1, filed with IDS) in view of Mayba et al (Journal of Cutaneous Medicine and Surgery, 2018, 22, pages 207-212).
The instant claims 1-7 are drawn to a pharmaceutical composition for the prevention or treatment of allergic diseases comprising a pentapeptide consisting of the amino acid sequence of SEQ ID NO: 1 as an active ingredient.
Otterlei et al, throughout the patent, teach an oligopeptidic compound; and a pharmaceutical composition comprising such oligopeptidic compound and a pharmaceutically acceptable carrier, excipient or diluent, wherein the oligopeptidic compound can be a peptide of SEQ ID NO: 269 consisting of the amino acid sequence KFLIK (identical to the pentapeptide of instant SEQ ID NO: 1), and wherein the pharmaceutical composition is in a form suitable for oral, parenteral, topical, rectal, genital, subcutaneous, transurethral, transdermal, intranasal, intraperitoneal, intramuscular and/or intravenous administration and/or for administration by inhalation, such as in the form of emulsion, spray and many others, for example, Abstract; page 11, paragraph [0182]; SEQ ID NO: 269 on page 15; page 16, paragraph [0185]; and page 26, paragraph [0272] and [0280]. It meets all the structural limitations of the pharmaceutical composition recited in instant claims 1-7.
With regards to the intended use limitation “for the prevention or treatment of allergic diseases” recited in instant claim 1; and the intended use limitations recited in instant claims 2 and 3, in the instant case, the intended use limitation does not patentably distinguish the instant claimed composition from the prior art composition, since such intended use does not create a structural difference between the claimed composition and the prior art composition. In order to be limiting, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation (see MPEP § 2111.02). In the instant case, there is no evidence that the prior art composition is not capable of preforming the intended use recited in instant claims 1-3. Therefore, the pharmaceutical composition comprising a peptide of SEQ ID NO: 269 consisting of the amino acid sequence KFLIK (identical to the pentapeptide of instant SEQ ID NO: 1) and a pharmaceutically acceptable carrier, excipient or diluent in the form of emulsion or spray in Otterlei et al meets the limitation of instant claims 1-3 and 5-7.
With regards to the limitation recited in instant claim 4, since the peptide of SEQ ID NO: 269 consisting of the amino acid sequence KFLIK in Otterlei et al is identical to the pentapeptide of instant SEQ ID NO: 1, the peptide of SEQ ID NO: 269 consisting of the amino acid sequence KFLIK in Otterlei et al would necessarily have the same properties and functionality of the pentapeptide of instant SEQ ID NO: 1. Therefore, the peptide of SEQ ID NO: 269 consisting of the amino acid sequence KFLIK in Otterlei et al would have the property of inhibiting the expression of IL-4, IL-13, TNF-α, IL-1β, IL-6 or IL-8, and the release of β-hexosaminidase. And 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). 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 1-7 is that the reference does not explicitly teach a pharmaceutical composition for the prevention or treatment of atopic dermatitis in the form of cream as the elected species of composition.
However, Mayba et al, throughout the literature, teach cream as a form for topical drug preparation, for example, page 208, left column, Section “Creams”.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Otterlei et al and Mayba et al to develop a pharmaceutical composition comprising a peptide consisting of the amino acid sequence KFLIK (identical to the pentapeptide of instant SEQ ID NO: 1) and a pharmaceutically acceptable carrier, excipient or diluent; wherein the pharmaceutical composition is in a form suitable for oral, parenteral, topical, rectal, genital, subcutaneous, transurethral, transdermal, intranasal, intraperitoneal, intramuscular and/or intravenous administration and/or for administration by inhalation, such as in the form of emulsion, spray or cream. It reads on a pharmaceutical composition for the prevention or treatment of atopic dermatitis in the form of cream as the elected species of composition.
One of ordinary skilled in the art would have been motivated to combine the teachings of Otterlei et al and Mayba et al to develop a pharmaceutical composition comprising a peptide consisting of the amino acid sequence KFLIK (identical to the pentapeptide of instant SEQ ID NO: 1) and a pharmaceutically acceptable carrier, excipient or diluent; wherein the pharmaceutical composition is in a form suitable for oral, parenteral, topical, rectal, genital, subcutaneous, transurethral, transdermal, intranasal, intraperitoneal, intramuscular and/or intravenous administration and/or for administration by inhalation, such as in the form of emulsion, spray or cream, because Mayba et al teach cream as a form for topical drug preparation.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Otterlei et al and Mayba et al to develop a pharmaceutical composition comprising a peptide consisting of the amino acid sequence KFLIK (identical to the pentapeptide of instant SEQ ID NO: 1) and a pharmaceutically acceptable carrier, excipient or diluent; wherein the pharmaceutical composition is in a form suitable for oral, parenteral, topical, rectal, genital, subcutaneous, transurethral, transdermal, intranasal, intraperitoneal, intramuscular and/or intravenous administration and/or for administration by inhalation, such as in the form of emulsion, spray or cream.
Obviousness Double Patenting
29. 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.
30. Claims 1-5 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of US patent 11306121 B2.
31. Instant claims 1-5 are drawn to a pharmaceutical composition for the prevention or treatment of allergic diseases comprising a pentapeptide consisting of the amino acid sequence of SEQ ID NO: 1 as an active ingredient.
32. Claims 1-11 of US patent 11306121 B2 are drawn to various methods of administering a pharmaceutical composition comprises a peptide comprising the amino acid sequence set forth in SEQ ID NO: 1.
The peptide of SEQ ID NO: 1 recited in claims of US patent 11306121 B2 is identical to the pentapeptide of instant SEQ ID NO: 1.
In the instant case, claims 1-11 of US patent 11306121 B2 are in possession of a pharmaceutical composition comprising a pentapeptide of instant SEQ ID NO: 1 and a pharmaceutically acceptable carrier, excipient or diluent.
With regards to the intended use limitation “for the prevention or treatment of allergic diseases” recited in instant claim 1; and the intended use limitations recited in instant claims 2 and 3, in the instant case, the intended use limitation does not patentably distinguish the instant claimed composition from the prior art composition, since such intended use does not create a structural difference between the claimed composition and the prior art composition. In order to be limiting, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation (see MPEP § 2111.02). In the instant case, there is no evidence that the pharmaceutical composition used in the methods recited in claims 1-11 of US patent 11306121 B2 is not capable of preforming the intended use recited in instant claims 1-3. Therefore, the pharmaceutical composition used in the methods recited in claims 1-11 of US patent 11306121 B2 meets the limitation of instant claims 1-3 and 5-7.
With regards to the limitation recited in instant claim 4, since the peptide of SEQ ID NO: 1 recited in claims of US patent 11306121 B2 is identical to the pentapeptide of instant SEQ ID NO: 1, the peptide of SEQ ID NO: 1 recited in claims of US patent 11306121 B2 would necessarily have the same properties and functionality of the pentapeptide of instant SEQ ID NO: 1. Therefore, the peptide of SEQ ID NO: 1 recited in claims of US patent 11306121 B2 would have the property of inhibiting the expression of IL-4, IL-13, TNF-α, IL-1β, IL-6 or IL-8, and the release of β-hexosaminidase. And 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). Since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
33. For the same and/or similar reasoning/rational as the rejection set forth in Sections 30-32 above, instant claims 1-5 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of co-pending application No. 18/009373, and claims 1 and 4-10 of co-pending application No. 19/136449.
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