DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant's election with traverse of formula II and alopecia in the reply filed on December 8, 2025 is acknowledged. The traversal is on the ground(s) that Chen et al. does not disclose the elected species and the disease, and as such the elected species is considered to be a special technical feature. This is not found persuasive the claims are directed to any PCSK9 inhibitor which does not share a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
3. Examination followed guidelines provided by MPEP 803.02. The elected species appeared to be novel and nonobvious over the prior art. Therefore, the search and examination was extended. Prior art was found that makes obvious a nonelected species. Furthermore, prior art was found that anticipates the broad Markush claims. Therefore, the Markush claims were rejected and claims to nonelected species were withdrawn from further consideration. The claims were searched to the extent of the elected species (compound of formula II and alopecia) and to the nonelected species below (compound of formula II and pulmonary fibrosis).
Priority
4. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
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.
(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.
5. Claim(s) 1, 2 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020160518 (publication date August 6, 2020). The present claims have an effective filing date of June 30, 2021 and priority claim to foreign applications dated July 1, 2020, October 14, 2020, November 6, 2020 and March 25, 2021. However, the claims cannot be granted the priority date because English translations of the priority documents have not been provided such that support under 35 USC 112 can be ascertained.
The reference teaches a method of treating senescence associated diseases including pulmonary fibrosis. Paragraph [0027]. The administration of PCSK9 is disclosed for the treatment of pulmonary fibrosis, co-administered with engineered immune cells.
6. Claim(s) 1, 2 and 10 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2020160518 (filing date January 31, 2020). The present claims have an effective filing date of June 30, 2021 and priority claim to foreign applications dated July 1, 2020, October 14, 2020, November 6, 2020 and March 25, 2021.
The reference teaches a method of treating senescence associated diseases including pulmonary fibrosis. Paragraph [0027]. The administration of PCSK9 is disclosed for the treatment of pulmonary fibrosis, co-administered with engineered immune cells.
Claim Rejections - 35 USC § 103
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, 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.
The factual inquiries 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.
7. Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020160518 (publication date August 6, 2020) as applied to claims 1-12 above, and further in view of US 2018312607 (publication date November 1, 2018) as evidenced by Heukels et al. (publication date 2019). The present claims have an effective filing date of June 30, 2021 and priority claim to foreign applications dated July 1, 2020, October 14, 2020, November 6, 2020 and March 25, 2021.
Determining the scope and contents of the prior art
WO2020160518 teaches a method of treating senescence associated diseases including pulmonary fibrosis. Paragraph [0027]. The administration of PCSK9 inhibitors is disclosed for the treatment of pulmonary fibrosis, co-administered with engineered immune cells as a therapeutic agent. Paragraphs [0020] and [0029]. Pulmonary fibrosis is recognized in the state of the art to be an immune and inflammatory disease. Heukels et al.
US 2018312607 teaches the administration of PCSK9 inhibitors for the treatment of inflammatory immune diseases. The reference teaches the administration of the compound that is Applicant’s elected species of formula II. Figure 12. Heukels et al. teaches that pulmonary fibrosis is an inflammatory immune disease.
Ascertaining the differences between the prior art and the claims at issue
The reference of WO 20200160518 does not teach the administration of specific small molecule inhibitors of PCSK9, including the species of formula II, for the treatment of the diseases claimed.
Resolving the level of ordinary skill in the pertinent art - considering objective evidence present in the application indicating obviousness
MPEP 2143.I.B. provides the following rationale which is applied to the present claims:
A finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components
WO2020160518 teaches a method of treating pulmonary fibrosis (claims 1, 2, 10) using a combination of engineered immune cells and PCSK9 inhibitors.
A finding that the substituted components and their functions were known in the art
US 2018312607 teaches small molecule PCSK9 inhibitors (Formula II as claimed) for the treatment of inflammatory immune diseases.
A finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable
One of ordinary skill has the possession of Formula II as a small molecule PCSK9 inhibitor for the treatment of inflammatory immune diseases. The person of ordinary skill also has the teaching for the treatment of pulmonary fibrosis with, generically, a PCSK9 inhibitor. The skilled artisan thus can substitute Formula II in the treatment of pulmonary fibrosis (claims 1-12) with a reasonable expectation that this substitution will result in the treatment.
For this reason, the present claims are found to be prima facie obvious over the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUN JAE YOO whose telephone number is (571)272-9074. The examiner can normally be reached Mon-Fri 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUN JAE YOO/Primary Examiner, Art Unit 1621