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
Claims 1-4, 8-18, 20 and 22-25 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I,
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in the reply filed on January 29, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-18, 20, 22 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on
January 29, 2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement filed on March 1, 2024. The submission is in compliance with the provisions of
37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
in claim 1, under the definition of variable A, an “and” should be added before “heterocycle” for proper Markush language format (line 3 of page 3); and
in claim 1, after the definition of variables R and R’, the “and” should be changed to “or” (line 4 of page 3).
Appropriate correction is required.
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 1-4, 8, 9, 24 and 25 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 1 is unclear because of the phrase “any combination thereof” in this compound claim (line 3 of the claim). Claim 1 is directed to “A compound”. Therefore, it is not clear what is meant by the phrase “any combination thereof”. See compound claim 8 and newly added independent compound claim 24 for same. Therefore, claims 1, 8 and 24 are indefinite because the metes and bound of the claims cannot be ascertained.
This rejection can be overcome by deleting the phrase “any combination thereof” from each of the claims.
Claims dependent on independent claims 1 and 24 which do not resolve the problems in claims 1 and 24 are also found indefinite.
Claims 8 and 25 each claim specie, which compounds are only identified in the claims by a number. No nomenclature or chemical structure are found in claim 8 or claim 25 for the claimed compounds. The chemical structures which correspond to the compound numbers in claims 8 and 25 are found in the instant figures (i.e., Figures 2A, 2B, 3A, 3B, 4 and 5). Claims must, under modern claim practice, stand alone to define an invention, and incorporation into claims by express reference to the specification is not permitted. Ex parte Fressola, 27 USPQ 2d 1608 (1993). MPEP §2173.05(s) states, “Reference to Figures or Tables.
2173.05(s) Reference to Figures or Tables [R-10.2019]
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
This condition is not met here, since it is practical to define the invention in words, simply by putting the structures into the claim. See Ex parte Fressola,
27 USPQ2d 1608, 1609. Thus, claims 8 and 25 are considered indefinite.
This rejection can be overcome by adding the tables from the instant figures (identified above) of each of the chemical structures of the compounds to claim 8 and to claim 25.
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 (or as subject to pre-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.
Claims 1-4, 9 and 24 are rejected under
35 U.S.C. 102(a)(1) as being anticipated by Ivarsson et al. {US Patent 10,624,909}.
Ivarsson et al. disclose, for instance, Compound (IV f) in column 12,
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{a compound of instant formula I,
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wherein
R1 = OPO32-;
R3 = OPO32-;
R7 = OPO32-;
R11 = OPO32-;
R5 = -O(Alkyl)nX
where
n = 2,
each “Alkyl” = methyl;
X = -OR,
R = an alkyl group
(the “alkyl” can extend to alkyl groups
linked or bridged by hetero atoms per
definition in the instant specification on
page 14, paragraph [65]); and
R9 = -O(Alkyl)nX
where n = 2,
each “Alkyl” = methyl;
X = -OR,
R = an alkyl group
(the “alkyl” can extend to alkyl groups
linked or bridged by hetero atoms per
definition in the instant specification on
page 14, paragraph [65])}.
Ivarsson et al. disclose that his compounds “may be present in any form commonly used in pharmaceutical technology” and lists sodium salt (column 17, lines 29-37). Ivarsson et al. disclose formulations comprising his compounds together with pharmaceutically acceptable carriers and/or excipients (column 16, lines 8-28). Therefore, Ivarsson et al. anticipate the instant claimed invention.
Reminder to Applicant
As a reminder, Applicant should specifically point out the support in the original disclosure {i.e., page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. Making generic statements such as “all amendments are fully supported in the originally filed disclosure or the originally filed claims” without specifying page numbers and originally filed claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I).
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
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 acting supervisor,
James Alstrum-Acevedo can be reached on 571/272-5548. 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.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
May 6, 2026Book XXVII, page 89
Prosecution Insights