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
Election/Restriction
Applicant elected, without traverse, Group I invention, and the species, compound of formula 2 with each of X2 and X3 being hydrogen and X1 being
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, in the reply filed on 05/13/2026.
Claims 1-7 and 22-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions.
The elected species is Compound 8 disclosed by instant specification (See page 62 of US 2024/0287105 A1), having following structure,
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Claim 8-11, 20-21 and 30 read on the elected invention and species.
Claims 12-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The elected species, compound 8 as disclosed in instant specification, has CAS# 3051714-89-4 and entered STN on August 12, 2024.
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To practice compact prosecution, the search has been expanded to non-elected species wherein X2 and X3 are hydrogen, X1 is
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, R12 is phosphate or COOH, which are rejected under following 35 USC 102 and 103 section. Other non-elected species are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reconsidered. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reconsideration that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
Status of Claims
Claims 1-28 and 30 are pending in the instant application.
Claims 1-7, 12-19 and 22-28 are withdrawn.
Claims 8-11, 20-21 and 30 are currently under examination.
Priority
This instant application 18/416,389 filed 01/18/2024 claims benefit of US provisional application 63/440,034 filed on 01/19/2023.
Information Disclosure Statement
The information disclosure statement dated 03/19/2024 and 07/02/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the reference listed in IDS are being considered by the Examiner.
Claim Objections
Claims 8, 9 and 20 are objected to because carbon / CH2 inside the parathesis are missing in figures, e.g.
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, etc.
Appropriate correction is required.
Specification
Instant specification discloses vast variety of compounds with multiple stereo centers. The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings are objected to because Fig. 14A, 14B and 15 disclose a formula
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. It’s not clear if this formula is instantly claimed formula 2 because different R groups are used instead of X1, X2, X3.
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.
Claim Rejections - 35 USC § 112
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.
Claims 8, 10 and 21 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites compound of formula (2) wherein the definition of X1, X2, X3 are not clear, especially the negative limitation when X1 is hydrogen. For example, “wherein X1 is hydrogen and one of X2 and X3 being
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with R11 being an unsubstituted C1-C8 alkyl group, the other of X2 and X3 is not hydrogen and X2 or X3 are not the same”. Compound of formula (2) comprising R11 being an unsubstituted C1-C8 alkyl group and X2/X3 is not hydrogen already falls within the recitation X2 and X3 are not the same. The scope of X2 and X3 comprising C1-C8 alkyl group as R11 when X1 is hydrogen is not clear. The lack of clarity renders the claims indefinite since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
Claims 10 and 21 are also rejected due to dependency on claim 8.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection 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.
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.
Claims 8-11 are rejected under 35 U.S.C. §102(a)(1) as being anticipated by compounds CAS# 2615044-06-7, CAS# 1965310-86-4, and CAS# 1965310-88-6.
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Compound (CAS# 2615044-06-7) is compound of formula (2) wherein X2 and X3 are H, X1 is
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, R12 is phosphate, q is 1.
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Compound (CAS# 1965310-86-4) is compound of formula (2) wherein X2 and X3 are H, X1 is
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, R12 is COOH, q is 1.
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Compound (CAS# 1965310-88-6) is compound of formula (2) wherein X2 and X3 are H, X1 is
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, R12 is COOH, q is 3.
Claims 8-11 and 21 are rejected under 35 U.S.C. §102(a)(1) and (a)(2) as being anticipated by Phares et al. (US 2021/0054009 A1, hereafter “Phares’009”, published on 02/25/2021, Applicant’s IDS dated 03/19/2024, Cite# A77).
Phares’009 discloses prodrugs/analogs of treprostinil, or pharmaceutical acceptable salt thereof, preparation thereof, pharmaceutical composition comprising treprostinil prodrugs/analog, and method of treating pulmonary hypertension with aforementioned compounds (See abstract, [0014]-[0036], [0252], Figures 1A-1Y, Table 2, Examples 1-8, claims 47-75)
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Phares’009 discloses compound species that are encompassed by or very similar to instant claimed formula (2) (See Table 2, [0252], page 84, 89, 110,116, claims 70, 71, 74, etc.). For example, compound XVIII is compound of instant formula (2) wherein X2 and X3 are H, X1 is
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, R12 is phosphate, q is 1.
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Compound XVIII is compound of instant formula (2) wherein X2 and X3 are H, X1 is
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, R12 is phosphate, q is 1.
Regarding claim 21, Phares’009 teaches pharmaceutical composition comprising treprostinil prodrugs/analogs and pharmaceutical acceptable carrier (See [0266]-[0267], claim 48).
Phares’009 discloses treprostinil prodrugs/analogs that read on instant compound of formula (2). Phares’009 teaches pharmaceutical composition comprising treprostinil prodrugs/analogs and pharmaceutical acceptable carrier. Thus, Phares’009 anticipates instantly claimed invention.
Claims 8-11 and 21 are rejected under 35 U.S.C. §102(a)(1) and (a)(2) as being anticipated by Zhang et al. (US 9394227 B1, Applicant’s IDS dated 07/02/2024, Cite # B1).
Zhang discloses treprostinil prodrug/analogs compound of Formula I, II, or pharmaceutical acceptable salt thereof, pharmaceutical composition comprising treprostinil analog/prodrugs, and method of treating pulmonary hypertension with aforementioned compounds (See abstract, Col. 1, lines 40-67; Col. 2, lines 1-67; Col. 8-29, lines 1-67 ; Examples 1-6; Embodiments 1-51, claims 1-24).
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It’s noted R1/R2 in compound of Formula I of Zhang read on X2/X3 group of instant compound of formula (2) wherein R11 is C1-C8 alkyl group, one or more carbon atoms of said C1-C8 alkyl group may be optionally replaced with O, one or more hydrogen atoms of said C1-C8 alkyl group may be optionally replaced with halogen;
Zhang discloses compound species that are encompassed by or very similar to instant claimed formula (2) (See Col.23, lines 20- 35, Col.24, lines 1-67; Col. 13-18, 25-27; claim 11,18), for example, compound Ia-12, Ib-6, Ib-12, II-1, II-4, II-5, etc.
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Compound II-1, 4, 5 read on instant claimed formula (2) wherein X1 is
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, R12 is COOH, , q is 1, 2, or 3; X2 and X3 are hydrogen.
Regarding claim 21, Zhang teaches pharmaceutical composition comprising treprostinil prodrugs/analogs and pharmaceutical acceptable carrier (See Col. 31, lines 27-67; Col. 32-34, lines 1-67; claim 19 and 22).
Zhang discloses treprostinil prodrugs/analogs that read on instant claimed compound of formula (2). Phares’009 teaches pharmaceutical composition comprising treprostinil prodrugs/analogs and pharmaceutical acceptable carrier. Thus, Zhang anticipates instantly claimed invention.
Claims 8-11 and 21 are rejected under 35 U.S.C. §102(a)(1) and (a)(2) as being anticipated by Phares et al. (WO 2022/132655 A1, hereafter “Phares’655”, Applicant’s IDS dated 03/19/2024 , Cite# A88).
Phares’655 discloses prodrugs/analogs of treprostinil, or pharmaceutical acceptable salt thereof, preparation thereof, pharmaceutical composition comprising treprostinil prodrugs/analog, and method of treating g a disease or condition(e.g. pulmonary hypertension ) with aforementioned compounds (See abstract, page 29-31, lines 5-17 ; page 30-31; lines 1- 17; Fig 1A-1Y; claims 21-32).
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Phares’655 discloses compound species that are encompassed by or very similar to instant claimed formula (2) (See Fig1A-1Y, etc.). For example, compound XVIII is compound of instant formula (2) wherein X2 and X3 are H, X1 is
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, R12 is phosphate, q is 1.
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Regarding claim 21, Phares’655 teaches pharmaceutical composition comprising treprostinil prodrugs/analogs and pharmaceutical acceptable carrier (See page 51-53).
Phares’655 discloses treprostinil prodrugs/analogs that read on instant compound of formula (2). Phares’655 teaches pharmaceutical composition comprising treprostinil prodrugs/analogs and pharmaceutical acceptable carrier. Thus, Phares’655 anticipates instantly claimed invention.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) for the rejection 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.
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.
Claims 8-11, 20-21 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Phares’009 (US 2021/0054009 A1, Applicant’s IDS dated 03/19/2024, Cite# A77).
The collective teachings of Phares’009 are elaborated in preceding 102 rejections and applied as before. Phares’009 discloses treprostinil prodrugs/analogs that are encompassed by or very similar to instant claimed formula (2). For example, compound XVIII is compound of instant formula (2) wherein X2 and X3 are H, X1 is
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, R12 is phosphate, q is 1. The difference between Compound XVIII taught by Phares’009 and instant elected species is q is 1 verse q is 2. Compound XVIII taught by Phares’009 is considered as homolog of instant elected species.
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According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
As stated in MPEP 2144 .09 II. Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
It would have been obvious to one of ordinary skill in the art to further explore more treprostinil prodrugs/analogs based on combined teachings of Phares’009 and general knowledge of structure similarity and bioisosteric modification and treprostinil prodrugs/analogs, and arrive at instantly claimed invention with reasonable expected success. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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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.
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/L.M./ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
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