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
RESPONSE TO ELECTION/RESTRICTION
Applicant’s election without traverse of group I, drawn to compounds of the formula I and simple compositions thereof and elected species:
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in the reply filed on 10/29/2025 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2,10-12,19,22-25,28 and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
An action on the merits of claims 1,3-9,13-18,20-21 and 26 is contained herein. Applicant’s elected species was found free of the art and the search extended to cover compounds wherein X, X’ = -NR, combinations of either of variables R1-4 do not form additional ring systems, C = -NH, and B is -C(O) or S(O)2.
Priority
This application claims priority benefit of PCT International Application No.
PCT/CN2020/130512, filed November 20, 2020.
Information Disclosure Statement
The examiner has considered the references cited in the information disclosure statement filed of record.
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 1,3-9,13-18,20, and 26 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 pre-AIA the applicant regards as the invention.
In the instant claim 1 Applicant recites the following language regarding variable Z:
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(in particular the language “provided that at least one Z”). The latter language is unclear since formula I recites that there is only one variable Z which is firmly set as being selected from one embodiment (e.g. heterocyclyl, etc.). This variable may be part of a repeating group set by variable n if greater than 1 and thus may have several units containing this only variable Z. Thus, what does Applicant intend by the “at least one Z”? This could imply that variable Z could possibly embrace different embodiments for Z in the formula I wherein n is greater than 1 (i.e. a combination of repeating linkers where Z is not constant but is different). Thus the language is ambiguous and the claim and claims dependent on it which do not rectify the issue are considered indefinite. In terms of prior art and interpretation, the examiner will assume for the time being that Z can only be set as one particular embodiment if n is greater than 1. See In re Zletz, 13 USPQ2d 1320, 1322, “An essential purpose of patent examination is to fashion claims that are precise, clear, correct and unambiguous.”
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 21 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 21 does not further limit claim 1 with respect to the following chemical species wherein the variable Z in the repeating unit Z-B does not contain a constant group for said variable but appears to be a combination of various embodiments for Z (e.g. heteroaryl and alkyl):
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. As stated earlier regarding claim interpretation, the examiner will assumes that Z can only be set as one particular embodiment if n is greater than 1 as defined by formula I.
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 – Improper Markush Grouping Rejection
Claims 1,3-9,13-18,20,21, and 26 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 706.03(y).
In re Harnish, 206 USPQ 300, 305, says, “ …we think it should be clear from our actions in Weber and Haas II that we there recognized the possibility of such a thing as an "improper Markush grouping." The court went on to reverse the rejection, (which had been made by the Board under Rule 196(b)) but not on the lack of a specific statutory basis but rather, “Clearly, they are all coumarin compounds which the board admitted to be "a single structural similarity." We hold, therefore, that the claimed compounds all belong to a subgenus, as defined by appellant, which is not repugnant to scientific classification (see claim 1 below for pictorial example):
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.
Under these circumstances we consider the claimed compounds to be part of a single invention so that there is unity of invention…” Thus, the rejection was overturned because of the specific facts in the case. The Markush group was held proper in that case, as was the case also in Ex parte Price 150 USPQ 467, Ex parte Beck and Taylor, 119 USPQ 100, and Ex parte Della Bella and Chiarino 7 USPQ2d 1669. Cases where the Markush group was held improper include Ex Parte Palmer, 7 USPQ 11, In re Winnek, 73 USPQ 225, In re Ruzicka, 66 USPQ 226, Ex parte Hentrich, 57 USPQ 419, Ex parte Barnard, 135 USPQ 109, Ex parte Reid, 105 USPQ 251, Ex parte Sun and Huggins, 85 USPQ 516, In re Thompson and Tanner, 69 USPQ 148, In re Swenson, 56 USPQ 180, and In re Kingston, 65 USPQ 371.
Indeed, as was stated in Ex parte Haas, 188 USPQ 374, “The rejection of a claim as containing an improper Markush grouping has a relatively long history in Office practice. The Court of Customs and Patent Appeals, at least as far back as 1942, has recognized that a rejection may be based upon the Examiner's holding that the claim has an improper Markush group. See In re Swenson, 30 CCPA 764, 132 F.2d 336, 56 USPQ 180 , citing Ex parte Palmer, 398 OG 707, 1930 CD 3.”
It should be noted that in Harnish, there was a substantial structural feature from which the common use flowed and that the claimed compounds all belong to a subgenus. That is exactly what is lacking in this case, as there is no substantial structural feature when viewing the compound as a whole. The Markush grouping is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
For example the following chemical class of compounds as a whole may be obtained:
1) wherein X, X’ = -NR and combinations of either of variables R1-4 do not form additional ring systems: (classified as substituted benzimidazoles, C07D 235/04+);
2) wherein X, X’ = O and combinations of either of variables R1-4 do not form additional ring systems: (classified as substituted benzoxazoles, C07D 263/54+);
This list is not exhaustive and clearly classifying the above groups as one subgeneric group would be repugnant to scientific classification. Thus, the first requirement is not met as described above. Secondly, there is little evidence provided that the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
The examiner recommends that the claims should be amended to include only species that share a single structural similarity and a common use (e.g. drawn to compounds of the formula I wherein X, X’ = -NR and combinations of either of variables R1-4 do not form additional ring systems) to overcome the rejection.
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.
Claims 1, 3, 4, 6-9, 13-15, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over US Patent 5,633,388.
US Patent 5,633,388 teach the following compound and compositions thereof (see col. 9, example 2, lines 45-55, washed with water.
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wherein x,x’,y,y’= 0, n =1, X,X’ = -NH, Z = phenyl, C = bond, and A, B selected from either -C(O)NH or -NHC(O). Thus the claims are anticipated.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624