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 3/20/2026 is acknowledged.
4. Claim filed on 3/20/2026 is acknowledged.
5. Claims 2 and 3 have been cancelled.
6. Claims 1 and 4-11 are pending in this application.
7. Claims 4-10 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim.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. Claims 1 and 11 are under examination.
Priority
9. The application is a 371 of PCT/EP2021/087098 filed on 12/21/2021, which claims foreign priority to EP application No. 20306687.3 filed on 12/23/2020. The EP application is in English and provides support to instant claims 1 and 11. Therefore, the filing date of the priority document has been perfected. Since the instant application is being examined under the first inventor to file provisions of the AIA , the effective filing date of the instant application is the filing date of EP application No. 20306687.3, which is 12/23/2020.
Election/Restrictions
10. Applicant’s election without traverse of Group 4 (claims 1 and 11) and election without traverse of SEQ ID NO: 2 as species of peptide; and the prevention or the treatment of a disease associated with vascular calcification as species of usage in the reply filed on 3/20/2026 is acknowledged. The requirement is made FINAL in this office action.
Group 4 is drawn to a method for using a peptide as a medicament, wherein said peptide comprises a sequence of at least 3 amino acids; and wherein said sequence of at least 3 amino acids is chosen from the group consisting of: SEQ ID No2, SEQ ID No5, SEQ ID No6, SEQ ID No7, SEQ ID No8, SEQ ID No9, SEQ ID No10, SEQ ID No11, SEQ ID No12, and SEQ ID No13. A search was conducted on the elected species; and SEQ ID NO: 2 as the elected species of peptide appears to be free of prior art. However, prior art was found for the prevention or the treatment of a disease associated with vascular calcification as the elected species of usage. A search was extended to the genus of the peptide recited in instant claim 1; and prior art was found. Claims 1 and 11 are examined on the merits in this office action.
Objections
11. The specification is objected to for the following minor informality: The instant specification recites sequence identifier as SEQ ID No throughout the specification. Applicant is required to amend this recitation as “SEQ ID NO: “, as an example, SEQ ID NO: 2.
12. The specification is objected to for the following minor informality: The specification recites various amino acid sequences with space within the recited amino acid sequences throughout the specification. Applicant is suggested to remove all the spaces within the recited amino acid sequence. As an example, amend the recited “LEGQE EEEDN” on page 4, line 5 of instant specification as “LEGQEEEEDN”.
13. The specification is objected to for the following minor informality: The specification discloses the peptide LEGQEEEEDNRDSSMKLSF on page 20, line 23 of instant specification, but it is missing the 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).
14. Claim 1 is objected to for the following minor informality: Applicant is suggested to amend claim 1 as “A method…, wherein said peptide comprises the amino acid sequence selected from the group consisting of SEQ ID NOs: 2 and 5-13”.
15. Claim 11 is objected to for the following minor informality: Applicant is suggested to amend claim 11 as “The method of claim 1, wherein the method is for treating heart and blood vessel disease or a disease associated with vascular calcification”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
16. 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.
17. Claims 1 and 11 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.
18. Claims 1 and 11 attempt to claim a process without setting forth any steps involved in the process. Furthermore, it is unclear for what disease the instant claimed peptide is used in instant claim 1. Taken all these together, the metes and bounds of instant claims 1 and 11 are vague and indefinite.
Furthermore, for the purpose of this examination, the Examiner is interpretating instant claim 1 as “A method of preventing or treating a disease in a subject in need thereof, wherein the method comprised administering to the subject a therapeutically effective amount of a peptide, and wherein the peptide comprises the amino acid sequence selected from the group consisting of SEQ ID NOs: 2 and 5-13”; and instant claim 11 as “The method of claim 1, wherein the disease is heart and blood vessel disease or a disease associated with vascular calcification”.
Claim Rejections - 35 USC § 101
19 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
20. Claims 1 and 11 are rejected under 35 U.S.C. 101 because claims 1 and 11 do not purport to claim a process, machine, manufacture, or composition of matter.
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Written Description
21. The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
22. Claims 1 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient” (MPEP § 2163).
A claimed genus may be satisfied through sufficient description of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with a known or disclosed correlation between function and structure (MPEP § 2163(3)a(II)). The number of species that describe the genus must be adequate to describe the entire genus; if there is substantial variability, a large number of species must be described.
The analysis for adequate written description considers (a) actual reduction to practice, (b) disclosure of drawings or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure, and (d) representative number of samples.
In the instant case, claims 1 and 11 are drawn to a method for using a peptide as a medicament, wherein said peptide comprises a sequence of at least 3 amino acids; and wherein said sequence of at least 3 amino acids is chosen from the group consisting of: SEQ ID No2, SEQ ID No5, SEQ ID No6, SEQ ID No7, SEQ ID No8, SEQ ID No9, SEQ ID No10, SEQ ID No11, SEQ ID No12, and SEQ ID No13.
With regards to the term “medicament”, the instant specification discloses that “By "medicament" it is intended a "drug".” (see page 6, line 6 of instant specification).
The genus of instant claimed peptide is extremely broad, including any peptide comprising the amino acid sequence selected from the group consisting of instant SEQ ID NOs: 2 and 5-13.
The instant specification discloses that peptide of instant SEQ ID NO: 1 is a calcification blocking factor (CBF), and the peptides of instant SEQ ID NO: 2 and 5-13 are fragments of instant SEQ ID NO: 1 and exhibit calcification inhibitory effect.
The issue at question is whether a person of ordinary skilled in the art would be able to determine what structural feature/amino acid sequence is required for the instant claimed peptide to have the functional characteristics of being a drug, including one that exhibits calcification inhibitory effect.
(a) actual reduction to practice and (b) disclosure of drawings or structural chemical formulas:
In the instant case, the instant specification discloses that peptide of instant SEQ ID NO: 1 is a calcification blocking factor (CBF), and the peptides of instant SEQ ID NO: 2 and 5-13 are fragments of instant SEQ ID NO: 1 and exhibit calcification inhibitory effect.
The instant specification further discloses CBF of instant claim 1 is secreted by adrenal granules and is present in effective concentrations in human plasma.
The instant specification also discloses that the amino acid sequence EGQEEEED (SEQ ID NO: 15) are extremely important for the inhibitory effect on vascular calcification in vitro as well as ex vivo.
Furthermore, peptides of instant SEQ ID NOs: 1-13 are tested in the working examples in instant specification for the calcification inhibitory effect. Peptide of SEQ ID NO: 3, which comprises the amino acid sequence of instant SEQ ID NO: 6, 12 or 13, does not exhibit calcification inhibitory effect.
Taken all these together, other than the limited examples, the instant specification fails to describe a general correlation between structure and function for the claimed peptide to have the functional characteristics of being a drug, including one that exhibits calcification inhibitory effect.
(c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure:
As discussed above, in the instant case, based on the disclosure of instant specification, other than the limited examples, a person of ordinary skilled in the art would not be able to determine a general correlation between structure and function for the claimed peptide to have the functional characteristics of being a drug, including one that exhibits calcification inhibitory effect.
With regards to the instant claimed peptide to have the functional characteristics of being a drug, including one that exhibits calcification inhibitory effect, Davenport et al (European Journal of Endocrinology, 2015, 173, pages 53-61), throughout the literature, teach insulin liraglutide does not appear to affect coronary artery calcification (CAC), for example, Abstract; pages 57-58, Section “CAC increased in the group exposed to insulin but did not change in the group exposed to liraglutide” and Figure 4. And as evidenced by the Liraglutide document (enclosed pages 1-2, 2026, from https://www.genome.jp/dbget-bin/www_bget?drug:D06404), liraglutide is a peptide comprising the amino acid sequence LEGQ (identical to the amino acid sequence of instant SEQ ID NO: 7) (see page 1, Section “Structure”). Furthermore, it is well known in the art that liraglutide as a drug can only treat certain conditions.
Therefore, based on the state of art, a person of ordinary skilled in the art would not be able to determine a general correlation between structure and function for the claimed peptide to have the functional characteristics of being a drug, including one that exhibits calcification inhibitory effect
(d) representative number of samples:
In the instant case, the genus of instant claimed peptide is extremely broad, including any peptide comprising the amino acid sequence selected from the group consisting of instant SEQ ID NOs: 2 and 5-13.
And, as discussed in (a) and (b) above, the instant specification discloses that peptide of instant SEQ ID NO: 1 is a calcification blocking factor (CBF), and the peptides of instant SEQ ID NO: 2 and 5-13 are fragments of instant SEQ ID NO: 1 and exhibit calcification inhibitory effect.
The instant specification further discloses CBF of instant claim 1 is secreted by adrenal granules and is present in effective concentrations in human plasma.
The instant specification also discloses that the amino acid sequence EGQEEEED (SEQ ID NO: 15) are extremely important for the inhibitory effect on vascular calcification in vitro as well as ex vivo.
Furthermore, peptides of instant SEQ ID NOs: 1-13 are tested in the working examples in instant specification for the calcification inhibitory effect. Peptide of SEQ ID NO: 3, which comprises the amino acid sequence of instant SEQ ID NO: 6, 12 or 13, does not exhibit calcification inhibitory effect.
Considering the broadness of the genus of instant claimed peptide, the instant specification fails to provide sufficient examples to describe the entire genus of a peptide comprising the amino acid sequence selected from instant SEQ ID NOs: 2 and 5-13 to have the functional characteristics of being a drug, including one that exhibits calcification inhibitory effect claimed.
Taken all these together, considering the state of the art and the disclosure in instant specification, it is deemed that the instant specification fails to provide adequate written description for the claimed genus of a peptide comprising the amino acid sequence selected from instant SEQ ID NOs: 2 and 5-13 to have the functional characteristics of being a drug, including one that exhibits calcification inhibitory effect claimed; and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Scope of Enablement
23. The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
24. Claims 1 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification while being enabling for a method of treating a disease associated with vascular calcification with a peptide comprising the amino acid sequence selected from the group consisting of instant SEQ ID NOs: 2, 5 and 8-11 or a peptide consisting of the amino acid sequence selected from the group consisting of instant SEQ ID NOs: 6, 7, 12 and 13, does not reasonably provide enablement for a method of treating ALL disease or preventing ANY disease with a peptide comprising the amino acid sequence selection from the group consisting of instant SEQ ID NOs: 2 and 5-13. The specification does not enable any person skilled in the art to which it pertains to make and/or use the invention commensurate in scope with the claims.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the Examiner’s position that one skilled in the art could not practice the invention without undue experimentation.
(1) The nature of the invention and (5) The breadth of the claims:
The instant claims 1 and 11 are drawn to a method for using a peptide as a medicament, wherein said peptide comprises a sequence of at least 3 amino acids; and wherein said sequence of at least 3 amino acids is chosen from the group consisting of: SEQ ID No2, SEQ ID No5, SEQ ID No6, SEQ ID No7, SEQ ID No8, SEQ ID No9, SEQ ID No10, SEQ ID No11, SEQ ID No12, and SEQ ID No13.
The rejection to the recited peptide under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (written description) has been set forth in Section 22 above.
With regards to the term “medicament”, the instant specification discloses that “By "medicament" it is intended a "drug".” (see page 6, line 6 of instant specification).
With regards to “prevention”, the instant specification fails to define it.
The term “prevention” implies a perfect blocker from getting any disease, including heart and blood vessel disease or a disease associated with vascular calcification recited in instant claim 11.
(2) The state of the prior art and (4) The predictability or unpredictability of the art:
With regarding to using the instant claim peptide as a medicament for treating or preventing disease, including heart and blood vessel disease or a disease associated with vascular calcification, the art is unpredictable.
Salem (A dissertation filed with IDS, 2012, pages 1-110) teaches a peptide consisting of the amino acid sequence LEGQEEEEDNRDSSMKLSF as a calcification blocking factor (CBF); and a method of using such peptide for treating disease associated with vascular calcification, for example, page 2, Abstract. The peptide in Salem is identical to the peptide of instant SEQ ID NO: 1 and comprises the amino acid sequence of instant SEQ ID NOs: 2 and 5-13. Salem further teaches such peptide is a component of human plasma, for example, page 2, Abstract. And human still get all sort of diseases, including heart and blood vessel disease or a disease associated with vascular calcification.
Davenport et al (European Journal of Endocrinology, 2015, 173, pages 53-61), throughout the literature, teach insulin liraglutide does not appear to affect coronary artery calcification (CAC), for example, Abstract; pages 57-58, Section “CAC increased in the group exposed to insulin but did not change in the group exposed to liraglutide” and Figure 4. And as evidenced by the Liraglutide document (enclosed pages 1-2, 2026, from https://www.genome.jp/dbget-bin/www_bget?drug:D06404), liraglutide is a peptide comprising the amino acid sequence LEGQ (identical to the amino acid sequence of instant SEQ ID NO: 7) (see page 1, Section “Structure”). Furthermore, it is well known in the art that liraglutide as a drug can only treat certain conditions.
Taken all these together, considering the state of art, one of ordinary skilled in the art would understand and reasonably expect that the instant claimed peptide would not be able to treat all types of disease and/or prevent any type of disease, including heart and blood vessel disease or a disease associated with vascular calcification recited in instant claim 11.
(3) The relative skill of those in the art:
The related skill of those in the art is high.
(6) The amount of direction or guidance presented and (7) The presence or absence of working examples:
With regarding to using the instant claim peptide as a medicament for treating or preventing disease, including heart and blood vessel disease or a disease associated with vascular calcification, the instant specification discloses that peptide of instant SEQ ID NO: 1 is a calcification blocking factor (CBF), and the peptides of instant SEQ ID NO: 2 and 5-13 are fragments of instant SEQ ID NO: 1 and exhibit calcification inhibitory effect.
The instant specification further discloses CBP of instant claim 1 is secreted by adrenal granules and is present in effective concentrations in human plasma.
The instant specification also discloses that the amino acid sequence EGQEEEED (SEQ ID NO: 15) are extremely important for the inhibitory effect on vascular calcification in vitro as well as ex vivo.
Furthermore, peptides of instant SEQ ID NOs: 1-13 are tested in the working examples in instant specification for the calcification inhibitory effect. Peptide of SEQ ID NO: 3, which comprises the amino acid sequence of instant SEQ ID NO: 6, 12 or 13, does not exhibit calcification inhibitory effect.
In the instant case, the instant specification fails to provide any guidance on how to prevent disease. There is no clear guidance as to how to determine the patient population. The disease can be treated once it is diagnosed; however, it cannot be prevented since the patient population is unknown.
Taken all these together, the instant specification does not enable any person skilled in the art to which it pertains to make and/or use the invention commensurate in scope with the claims. There is a lack of adequate guidance from the specification or prior art with regard to the actual method of using the instant claim peptide as a medicament for treating or preventing disease, including heart and blood vessel disease or a disease associated with vascular calcification. Applicant's limited disclosure is noted but is not sufficient to justify claiming a method of using the instant claim peptide as a medicament for treating or preventing disease, including heart and blood vessel disease or a disease associated with vascular calcification.
(8) The quantity of experimentation necessary:
Considering the state of prior arts and the disclosure in instant specification, one of ordinary skill in the art would be burdened with undue experimentation to using the instant claim peptide as a medicament for treating or preventing disease, including heart and blood vessel disease or a disease associated with vascular calcification.
Claim Rejections - 35 U.S.C. § 102(a)(1)
25. 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.
26. Claims 1 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salem (A dissertation filed with IDS, 2012, pages 1-110).
The instant claims 1 and 11 are drawn to a method for using a peptide as a medicament, wherein said peptide comprises a sequence of at least 3 amino acids; and wherein said sequence of at least 3 amino acids is chosen from the group consisting of: SEQ ID No2, SEQ ID No5, SEQ ID No6, SEQ ID No7, SEQ ID No8, SEQ ID No9, SEQ ID No10, SEQ ID No11, SEQ ID No12, and SEQ ID No13.
Salem teaches a peptide consisting of the amino acid sequence LEGQEEEEDN RDSSMKLSF as a calcification blocking factor (CBF); and a method of using such peptide as a medicament for treating disease associated with vascular calcification, for example, page 2, Abstract. The peptide in Salem is identical to the peptide of instant SEQ ID NO: 1 and comprises the amino acid sequence of instant SEQ ID NOs: 2 and 5-13. It reads on for the prevention or the treatment of a disease associated with vascular calcification as the elected species of usage; and meets the limitations of instant claims 1 and 11.
Since the reference teaches all the limitations of instant claims 1 and 11; the reference anticipates instant claims 1 and 11.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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