DETAILED ACTION
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 .
Claim Objections
Claim 12 is objected to because of the following informalities: there should be an “and” between the last 2 members of the group B. There should also be an “and” before the phrase “w is an integer from 1 to 19”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: there should be an “and” before the phrase “w is an integer from 1 to 19”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: there should be an “or” between the last two compounds. 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 1-2, 10-16, 18, and 21 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 indefinite wherein the claim defines X, X1, X2, and Y as each a backbone structure in a triple branched form; however, there is no “X” group in the compounds as this was deleted when deleting formula I. As such, it is unclear what “X” is referring to.
Claim1 is indefinite wherein the claim states:
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As such, are a1, a2, a3, and a4 necessarily present based on the second line, or are they optionally absent as in the 1st line? The examiner believes the second line to read “wherein when a1, a2, a3, and a4 are present, a1 to a4 are selected from…”.
Claim 11 is indefinite wherein the claim stats various requirements such as “where a1-4 are all present A1 and A2 are each…”; “where a1-4 are all absent, A1 and A2 are selected from…”; “where a1 and a2 are present…”; “where a3 and a4 are present….”. As such, the claim states various contradictory possible groupings but does not provide any alternatives for the groups as they must all be present. It is unclear what is intended by the claim.
Claim 13 is indefinite wherein the claim comprises the variable M1 but there is no definition for this variable in the claim nor the claims from which it depends and thus it is unclear what is embraced by the claim.
Claim 16 is indefinite wherein the claim is drawn to the use of the ligand of claim 1, but it is unclear what is being claimed as there are no additional structural features nor methodological steps required in the claim.
Claim 18 is indefinite where the claim limits formula III in the 3rd to last line, but also deleted formula III from the claim. What is formula III?
Claim 21 is indefinite wherein the claim contains multiple undefined variables. None of the T, T’, G, G’, X, Y, or Z groups are defined. Also, the claim states that a1-a4 are present in step 3, but there are no structures with these undefined variables present.
All claims which depend from an indefinite claim are also indefinite. Ex parte Cordova, 10 U.S.P.Q. 2d 1949, 1952 (P.T.O. Bd. App. 1989).
Claim Rejections - 35 USC § 112
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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. Claim 2 provides various limitations to the compound of formula I of claim 1. However, formula I has been deleted and is not present in claim 1, and thus claim 2 cannot further limit claim 1 as it “limits” the cancelled portion of the claim. 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.
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 (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 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.
Claim(s) 1-2, 10-13, 15-16, 18, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2019/027015.
‘015 discloses the compounds such as:
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(see page 233),
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(page 239)
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(see page 123) and
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on page 116 which anticipate the present compounds of formula II which require a central branching point which is linked to an additional two branching points which each have 2 tethers to the glycosyl ligands. The compounds have the same three branching-groups claimed herein, which are required to also each be triple-branching points. The compounds are taught to have the same conjugate linkers (see [0088] on pages 47-48) and tethers claimed herein (see compounds/species therein). Also – compound D7 above comprises the same (A-7) group of present claim 11. The methods of making are correlative to those methods claimed herein additionally.
Claim(s) 1-2, 10-13, 15-16, 18, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO14/179629.
‘629 discloses compounds such as:
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on page 234 which anticipate the present compounds of formula II which require a central branching point which is linked to an additional two branching points which each have 2 tethers to the glycosyl ligands. The compounds have the same three branching-groups claimed herein, which are required to also each be triple-branching points. The compounds are taught to have the same linkers claimed herein (see pages 55-64); the same branching groups (see pages 65-69); the same tethers claimed herein (see pages 70-72); and the same sugar ligands (see page 72-75). The methods of making the compounds therein are correlative to those methods claimed herein.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 10-16, 18, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2019/027015 as applied to claims 1-2, 10-13, 15-16, 18, and 21 above.
The claims of the present application are drawn to various conjugate compounds comprise a cell targeting moiety which comprises a ligand (saccharide) attached to a tether where two tethers are linked to two different branches of a main branching group. Certain species include compounds such as:
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on page 233. This compound is very similar to compound TEC07 claimed in claim 14 herein having the formula:
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and appears to use various obvious modifications of the arts compounds to arrive at those presently claimed. Applicants have not shown anything unexpected or surprising about their compounds, and it is noted that unexpected results must be commensurate in scope with the present claims are represent the scope claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693
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