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 Non-final office action filed on 8/3/2026 is acknowledged.
3. Claim filed on 8/3/2026 is acknowledged.
4. Claims 2, 3 and 11 have been cancelled.
5. New claim 12 has been added.
6. Claims 1, 4-10 and 12 are pending in this application.
7. Claims 4-10 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Claim 12 is withdrawn from consideration as being drawn to non-elected species.
8. Applicant elected without traverse of Group 4 (claims 1 and 11) and elected 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.
Restriction requirement was deemed proper and made FINAL in the previous office action. Group 4 is drawn to a method for preventing or treating a disease associated with vascular calcification in a subject in need thereof, wherein the method is comprised of administering to the subject a therapeutically effective amount of a peptide, and, wherein said peptide is chosen from the group consisting of: SEQ ID NOs. 2 and 5-13. 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. Claim 12 is withdrawn from consideration as being drawn to non-elected species. Claim 1 is examined on the merits in this office action.
Withdrawn Objections and Rejections
9. Objection to claim 11 is hereby withdrawn in view of Applicant’s amendment to the claim.
10. Rejection to claims 1 and 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is hereby withdrawn in view of Applicant’s amendment to the claim.
11. Rejection to claims 1 and 11 under 35 U.S.C. 101 is hereby withdrawn in view of Applicant’s amendment to the claim.
12. Rejection to claims 1 and 11 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (written description) is hereby withdrawn in view of Applicant’s amendment to the claim.
13. Rejection to claims 1 and 11 under 35 U.S.C. 102(a)(1) as being anticipated by Salem (A dissertation filed with IDS, 2012, pages 1-110) is hereby withdrawn in view of Applicant’s amendment to the claim.
Maintained/Revised Objections
14. (Revised due to Applicant’s amendment to the specification) The specification remains 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: 1 instead of SEQ ID NO1.
15. (Revised due to Applicant’s amendment to the specification) The specification remains 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, the amino acid sequence of SEQ ID NO: 1 in Table 1.
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).
16. (Revised due to Applicant’s amendment to the claim) Claim 1 remains objected to for the following minor informality: Applicant is suggested to amend claim 1 as “…wherein the method comprises administering to the subject a therapeutically effective amount of a peptide selected from the group consisting of SEQ ID NOs: 2 and 5-13”.
Response to Applicant's Arguments
17. Applicant fails to address all the minor issues in the specification and claim 1, and/or Applicant’s amendments to the claim introduces additional minor issues into instant claim 1. Therefore, these objections are deemed proper and are hereby maintained.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Scope of Enablement
18. 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.
19. (Revised due to Applicant’s amendment to the claim) Claim 1 remains 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 selected from the group consisting of instant SEQ ID NOs: 2 and 5-13, does not reasonably provide enablement for a method of preventing ANY disease associated with vascular calcification with a peptide selected 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 claim 1 is drawn to a method for preventing or treating a disease associated with vascular calcification in a subject in need thereof, wherein the method is comprised of administering to the subject a therapeutically effective amount of a peptide, and, wherein said peptide is chosen from the group consisting of: SEQ ID NOs. 2 and 5-13.
With regards to “preventing”, the instant specification fails to define it.
The term “preventing” implies a perfect blocker from getting any disease associated with vascular calcification.
(2) The state of the prior art and (4) The predictability or unpredictability of the art:
With regarding to using the instant claimed peptide for preventing a disease associated with vascular calcification, the art is unpredictable.
Salem (A dissertation filed with IDS, 2012, pages 1-110) teaches similar to peptides of instant SEQ ID NOs: 2 and 5-13, 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. Salem further teaches such peptide is a component of human plasma, for example, page 2, Abstract. And human still get a disease associated with vascular calcification.
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 prevent a disease associated with vascular calcification.
(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 claimed peptide for preventing 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. However, the instant specification fails to provide any guidance on how to prevent a disease associated with vascular calcification. There is no clear guidance as to how to determine the patient population. The disease associated with vascular calcification 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 claimed peptide for preventing any disease associated with vascular calcification. Applicant's limited disclosure is noted but is not sufficient to justify claiming a method of using the instant claimed peptide for preventing 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 claimed peptide for preventing a disease associated with vascular calcification.
Response to Applicant's Arguments
20. Applicant argues that “As amended, claim 1 no longer refers to a generic medicament, and all of the peptides recited in the method are exemplified for their ability to decrease the centration of Ca2+ content of cultivated human aortic smooth muscle cells.”
21. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant's arguments about instant rejection, the Examiner would like to point out that Applicant’s amendment to the claim and Applicant’s arguments fail to address the scope of enablement rejection on preventing a disease associated with vascular calcification with instant claimed peptide. Therefore, the rejection is deemed proper and is hereby maintained.
New Rejections
Claim Rejections - 35 U.S.C. § 102(a)(1)
22. 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.
23. Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hudson et al (US 2003/0100510 A1), and as evidenced by Liu et al (Medicine, 2025, 104, pages 1-7).
The instant claim 1 is drawn to a method for preventing or treating a disease associated with vascular calcification in a subject in need thereof, wherein the method is comprised of administering to the subject a therapeutically effective amount of a peptide, and, wherein said peptide is chosen from the group consisting of: SEQ ID NOs. 2 and 5-13.
Hudson et al teach peptide of formula VII (SEQ ID NO: 103), such as peptide EGQE (SEQ ID NO: 107, identical to the peptide of instant SEQ ID NO: 8); and a method of treating artery occlusion in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of such peptide, for example, page 11, paragraph [0180]; and claims 1, 7 and 9. And as evidenced by Liu et al, artery occlusion is a disease associated with vascular calcification (see for example, Title and Abstract). 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 claim 1.
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 claim 1; the reference anticipates instant claim 1.
Claim Rejections - 35 U.S.C. § 103
24. 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.
25. 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.
26. In the event that Applicant disagrees with how the Examiner interpretates Hudson et al (US 2003/0100510 A1), claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Hudson et al (US 2003/0100510 A1), and as evidenced by Liu et al (Medicine, 2025, 104, pages 1-7).
The instant claim 1 is drawn to a method for preventing or treating a disease associated with vascular calcification in a subject in need thereof, wherein the method is comprised of administering to the subject a therapeutically effective amount of a peptide, and, wherein said peptide is chosen from the group consisting of: SEQ ID NOs. 2 and 5-13.
Hudson et al teach peptide of formula VII (SEQ ID NO: 103); and a method of treating artery occlusion in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of such peptide, for example, claims 1, 7 and 9. And as evidenced by Liu et al, artery occlusion is a disease associated with vascular calcification (see for example, Title and Abstract). 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 the subject recited in instant claim 1. Hudson et al further teach the peptide of formula VII (SEQ ID NO: 103) can be peptide EGQE (SEQ ID NO: 107, identical to the peptide of instant SEQ ID NO: 8 recited in instant claim 1), for example, page 11, paragraph [0180].
The difference between the reference and instant claim 1 is that the reference does not explicitly teach a specific example of treating artery occlusion in a subject in need thereof with peptide EGQE (identical to the peptide of instant SEQ ID NO: 8).
However, in view of the teachings of Hudson et al as a whole, it would have been obvious to one of ordinary skilled in the art to develop a method of treating artery occlusion (a disease associated with vascular calcification) in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of peptide EGQE (identical to the peptide of instant SEQ ID NO: 8).
In view of the teachings of Hudson et al as a whole, one of ordinary skilled in the art would have been motivated to develop a method of treating artery occlusion (a disease associated with vascular calcification) in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of peptide EGQE (identical to the peptide of instant SEQ ID NO: 8), because Hudson et al teach peptide EGQE (identical to the peptide of instant SEQ ID NO: 8) as an example of the peptide of formula VII (SEQ ID NO: 103) that is used in a method of treating artery occlusion (a disease associated with vascular calcification) in a subject in need thereof.
In view of the teachings of Hudson et al as a whole, a person of ordinary skilled in the art would have reasonable expectation of success in developing a method of treating artery occlusion (a disease associated with vascular calcification) in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of peptide EGQE (identical to the peptide of instant SEQ ID NO: 8).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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