DETAILED ACTION
Claims 1-44 are currently pending in the instant application.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to claims 1-34 and election of species
PNG
media_image1.png
228
386
media_image1.png
Greyscale
in the reply filed on 04/20/2026 is acknowledged.
Claims 35-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/20/2026.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. 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 reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
Applicant's elected species appears allowable over the prior art of record. Therefore, the search of the Markush-type claim has been extended to the non-elected species of
PNG
media_image2.png
176
390
media_image2.png
Greyscale
,
PNG
media_image3.png
184
304
media_image3.png
Greyscale
and
PNG
media_image4.png
240
360
media_image4.png
Greyscale
.
As prior art has been found which anticipates the above identified nonelected species, the Markush-type claims are rejected as follows and the subject matter of the claims drawn to nonelected species held withdrawn from consideration. Claims 1-3, 7-8, 10-11, 14-15, 22-26 and 28-34 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since art was found on the nonelected species, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
The remaining subject matter of claims 4-6, 9, 12-13, 16-21 and 27 that are not drawn to the above elected invention stand withdrawn under 37 CFR 1.142(b) as being non-elected subject matter. The remaining compounds which are not within the elected invention are independent and distinct from the elected invention as they differ in structure and composition. Therefore the compounds, which are withdrawn, have been restricted as the withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference, which anticipates one group, would not render obvious the other. Thus all claims containing compounds falling outside the search strategy of the elected compound and structure shown above are heretofore directed to non-elected subject matter and are withdrawn from consideration under 35 U.S.C. § 121 and 37 C.FR. § 1.142(b). A complete reply to the non-final rejection must include cancellation of non-elected claims include cancellation of non-elected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b). If one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Priority
PNG
media_image5.png
44
366
media_image5.png
Greyscale
Information Disclosure Statement
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claim 33 is objected to because of the following informalities: Claim 33 recites “[a] pharmaceutical composition comprising one or compound(s) of claim 1”. It appears that the word “more” was omitted from the claim between “or” and “compounds”. Appropriate correction is requested.
Claim Rejections – Improper Markush Grouping
Claims 1-3 and 33-34 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 § 2117.
The Markush grouping of
PNG
media_image6.png
116
164
media_image6.png
Greyscale
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: It cannot be said that all members of the Markush group have a single structural similarity. Specifically, the species of the Markush group do not share a “single structural similarity” because there are no required structural features in common such that each member of formula I would have at least one structural feature, which feature is essential to the activity/function of the claimed compounds. The variables A and B prevent the core structure from being an art-recognized physical or chemical class. For example, A is recited to be an aryl group or heterocyclic group or substituted derivative or analog thereof while B is recited to be alkyl groups, phenyl groups, alkoxylphenyl groups, N-aryl alkylamide groups, N-alkyl alkylamide groups and substituted derivatives and analogs thereof. A wide array of core structures are encompassed by these definitions such that there is no substantial core structure that is shared by all species within
PNG
media_image6.png
116
164
media_image6.png
Greyscale
. Rather, there are multiple core structures and variety of species that are structurally distinct due to their unique core structures.
In addition, each alternatively usable member of the Markush group does not share a common use. Rather, the specification discloses that the compounds act as APT1 and/or APT2 inhibitors. However, there is no common core in the compounds of formula I that is known to impart the activity of being capable of inhibiting APT1 and/or APT2.
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.
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. Note In re Milas 71 USPQ 212 in which the structural difference between vitamin A and D was sufficient to uphold the improper Markush rejection. Also see In re Winnek 73 USPQ 225 and In re Ruzicka 66 USPQ 226 in which structural differences were small and yet a similar holding was maintained. All these cases involved compounds in the pharmaceutical art known to be structure-sensitive. Of particular interest is Ex Parte Hozumi, 3 USPQ2d 1059, which reversed an improper Markush rejection “in view of the relatively large proportion of the structure of the compounds in the claimed class which is common to the entire class.” Here, by contrast, the amount in common is none, relative to the entire molecule.
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, 7-8, 10-11, 14-15, 29, 31 and 33-34 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.
Claims 1-2 recite the limitation "substituted derivative or analog". The specification fails to limit and clearly delineate what can be considered a "substituted derivative or analog". Although the Specification recites that “analog” can be a compound or group that can be envisioned to arise from another compound or group, respectively, if one atom or group of atoms, functional groups, or substructures is replaced with another atom or group of atoms, functional groups, or substructures and “derivative” is a compound or group that is envisioned to or is derived form a similar compound or group, respectively, by a chemical reaction, where the compound or group is modified or partially substituted such that at least one structural feature of the original compound or group is retained. However, multiple derivatives or analogs of the claimed compound having various functional groups and chemical reactivity are encompassed by the instant claims. The “substituted derivative or analog” of the A or B group are not defined by a structural formula so as to know the metes and bounds of the claims. Such language fails to clearly define the subject matter being claimed. Thus, the term "substituted derivative or analog" of Claims 1-2 are not defined in the claims so as to know the metes and bounds of the claims, and therefore claims 1-2 are indefinite. As claims 3, 7-8, 10-11, 14-15 and 33-34 do not fix the issue, they have been rejected as well. It is suggested that if Applicant intends that the A or B group may be a substituted or unsubstituted aryl or heterocyclic group instead, Applicant amend the claims accordingly.
Claim 31 refers to compounds by names such as APT-MY1, APT-MY2, etc. It is unclear what is meant without referring to the Specification. 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. See Ex parte Fressola, 27 USPQ 2d 1608 (1993). MPEP 2173.05(s) states that incorporation by reference is a necessity doctrine, not for Applicants convenience. Here, there is no necessity demonstrated for incorporating by reference the information contained in the figures of the instant specification. Examiner notes that molecular structures are included throughout the instant claims. As such, it is requested that Applicants import the appropriate molecular structures into claim 31 to make the claim complete in itself.
Claim 29 recites the limitation "Rg" in the 2nd line of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 29 depends on claim 28 which does not recite a Rg but only a Rh variable.
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, 7-8, 11, 14-15, 22-24, 31-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CA Reg No. 890819-51-9, entered into STN on 07/06/2006. CA Reg No. 890819-51-9 is compound
PNG
media_image2.png
176
390
media_image2.png
Greyscale
which corresponds to compound of claims 31 (KW05217) and 32.
Regarding the compositions of claim 33-34, comprising the anticipatory compounds and an excipient, the Registry entry for Registry no. 890819-51-9 discloses a mass solubility of 0.0 g/L, in unbuffered water at pH 7.002. This teaching of water anticipates the claimed composition, wherein the compounds are present with an excipient (i.e., water).
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
Claim(s) 1-2, 10-11, 14-15, 28 and 33-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by French Patent No. 4144, issued 06/13/1966 with corresponding CAPlus Document Number 67:100156. FR Patent No. 4144 teaches
PNG
media_image7.png
80
256
media_image7.png
Greyscale
, see p. 2. CA Plus DN 67:100156 teaches compound as useful as antispasmoids and local anesthetics.
Claim(s) 1-3, 11, 14, 25-26 and 33-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat. No. 5,081,112, pub. 01/14/1992. US Patent No. 5,081,112 teaches compound
PNG
media_image4.png
240
360
media_image4.png
Greyscale
(see col. 25, compound 57).
Allowable Subject Matter
Claims 29-30 objected to as being dependent upon a rejected base claim, but would be allowable over the prior art of record once the 112(b) issues were overcome and if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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, Adam Milligan can be reached at 571-270-7674. 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.
/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
Prosecution Insights