Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
Claims 10-29 are pending. Claims 13, 15-16, 19, 26 and 29 are rejected. Claims 21 and 28 are objected to. Claims 10-12, 14, 17-18, 20, 22-25 and 27 are allowed.
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/JP2023/002625 filed 01/27/2023, which claims priority under 35 U.S.C. 119(a-d) to PRO 63/303,564 filed 01/27/2022. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statement filed 11/07/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Since a copy of the NPL document “PARK et al. ‘Lysophosphatidylserine Stimulates L2071 Mouse Fibroblast Chemotactic Migration via a Process Involving Pertussis Toxin-Sensitive Trimeric G-Proteins,’ Molecular Pharmacology, 69(3): 1066-1073 (2006)” is missing, it has been placed in the application file, but the information referred to therein has not been considered.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 26 and 29 are rejected under 35 U.S.C. 112(b) being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 26 recites the limitation "the pharmaceutical composition" in the preamble. There is insufficient antecedent basis for this limitation in the claim since parent claim 24 is drawn to a method and does not recite a pharmaceutical composition. Applicant may amend the claim or change its dependency to appropriately reference a pharmaceutical composition.
Claim 29 recites the limitation "the pharmaceutical composition" in the preamble. There is insufficient antecedent basis for this limitation in the claim since parent claim 27 is drawn to a method and does not recite a pharmaceutical composition. Applicant may amend the claim or change its dependency to appropriately reference a pharmaceutical composition.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13, 15-16, 19, 26 and 29 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 13, 15 and 16 recite a limitation wherein R1 and/or R2 may be trifluoromethyl, however their parent claim 10 species that that the aliphatic hydrocarbon group “may have a substituent” and since three fluoro groups is more than a single substituent as described in the parent claim, the dependent claims appear to be beyond the scope of their parent. Applicant may overcome the rejection by, for example, amending the dependent claims to delete “trifluoromethyl,”.
Regarding claim 19, drawn to a pharmaceutical composition comprising the compound of claim 17 with the intended use “for treating or preventing fibrosis,” the dependent claim does not appear to limit independent claim 17. The phrase “for treating or preventing fibrosis” in claim 19 is interpreted as an intended use and is therefore considered non-limiting, per MPEP 2111.02 (II). Since Applicant has demonstrated that both compound (II) and (III) recited in the parent claim are able to be used for fibrosis treatment and/or prevention (see specification Examples 8-10, pages 82-89), claim 19 does not set forth a further limitation of the subject matter claimed as required.
Regarding claims 26 and 29, as discussed in the rejection under 35 USC 112(b) above, the claims recite the limitation "the pharmaceutical composition" in the preamble. They do not properly limit parent claims 24 and 27 which are drawn to methods and does not recite a pharmaceutical composition. Applicant may amend the claim or change its dependency to appropriately reference a pharmaceutical composition.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 10-29 are free of the prior art.
Claims 21 and 28 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art is from Owada et al. in JP 2016179959 A and Ohwada et al. in US 9,856,278 B2.
Ohwada et al. in JP ‘959 teach lysophospatidylserine derivatives of formula (I):
PNG
media_image1.png
148
674
media_image1.png
Greyscale
. See first page of JP 2016179959 and page 3 of the appended English Machine Translation. As an example, JP ‘959 teaches compound 1,
PNG
media_image2.png
153
536
media_image2.png
Greyscale
(see page 16), which is nearly embraced by instant formula (I) of claim 10,
PNG
media_image3.png
277
588
media_image3.png
Greyscale
, wherein n is 3, m is 2, and L is -O(C=O)-. Compound 1 of the prior art differs in that a phenoxybenzyloxy moiety is used as opposed to the biphenylphenoxy of the present claims. Further, there is no teaching, suggestion, or motivation to modify the prior art compounds in such a way as to arrive at the presently claimed invention or to use them for treating or preventing fibrotic diseases.
Ohwada et al. in US ‘278 teach lysophospatidylserine derivatives of formula (I):
PNG
media_image4.png
151
468
media_image4.png
Greyscale
. See col. 2 lines 47-60. The exemplary compounds taught in the reference patent nearly read on instant formula (I) of claim 10,
PNG
media_image3.png
277
588
media_image3.png
Greyscale
, at least except wherein US ‘278 requires the A group to be either phenylene or ethynylene and the instant claims do not have an anticipatory or obvious alternative for the -CH2- linker or L of instant formula (I). For example, US ‘278 recites compound 16,
PNG
media_image5.png
307
1015
media_image5.png
Greyscale
, (see col. 15-16) which is nearly embraced by the instant formula wherein n is 0, L is -O(C=O)-, and m is 2. Compound 16 differs in that an additional phenylene group is included in the linkage between the phosphatidyl group and “L” as well as the phenoxybenzyloxy moiety as opposed to the biphenylphenoxy of the present claims.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/J.H.F./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
Prosecution Insights