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 .
Election/Restrictions
Applicant's election with traverse of Group III and the species of PARP3, Neil3, Nthl1, Nbn, Rbbpb, and Rad45l in the reply filed on 11/10/2025 is acknowledged. The traversal is on the ground(s) that a declaration for Mazumder et al. was provided on 11/10/2025 such that the declaration states that the other authors did not make an inventive contribution to the invention (p. 2-3). This is not found persuasive because the restriction requirement is based solely on publication dates. As the reference was published prior to the filed application the restriction has been maintained. Furthermore, the technical feature is also addressed in the 35 USC 103(a) set forth below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 15, 48-58, 65, and 70 are pending. Claims 2-14, 16-47, 59-64, 66-69 and 71-75 are cancelled.
Claims 1 and 15 are withdrawn as being drawn to a nonelected claim.
An action on the merits is set forth below.
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 48-58, 65, and 70 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 48-58, 65, and 70 are indefinite over “the susceptible African American subject” in claim 48. This phrase is unclear as it is not clear if the claim intends that the subject has ER positive breast cancer or if the phrase intends that the subject has some other association as it is not clear what “susceptible” is intending to mean in the claim. The metes and bounds are unclear.
Claims 56 and 70 are indefinite. These claims contain the trademark/trade name of the inhibitors recited in the lists of 56 and 70. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe inhibitors and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 112
Improper Markush
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.
Claims 48-58, 65, and 70 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).
The Markush groupings of the combinations of at least one of the genes HR pathway and at least one of the genes of BER pathway in claim 48 are 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 is first noted that MPEP 706.03(y) states that “A Markush claim may be rejected under judicially approved “improper Markush grouping” principles when the claim contains an improper grouping of alternatively useable members. A Markush claim contains an “improper Markush grouping” if either: (1) the members of the Markush group do not share a “single structural similarity” or (2) the members do not share a common use. Supplementary Guidelines at 7166 (citing In re Harnisch, 631 F.2d 716, 721-22, 206 USPQ 300, 305 (CCPA 1980)). “ Members of a Markush group share a “single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class (prong 1) and the members of a Markush group share a common function or use when they are disclosed in the specification or known in the art to be functionally equivalent (prong 2).
The phrase “significant structural element is shared by all of the alternatives” refers to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity.
A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein “there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved” (see MPEP 706.03(y)IIA).
Herein, the recited alternative species do not share a single structural similarity, as each gene has a different chemical structure in that it consists of a different nucleotide sequence. The only structural similarity present is that all of the comprise the generic structure of nucleotides. The fact that the genes have a generic structure per se does not support a conclusion that they have a common single structural similarity because the structure of comprising nucleotides alone is not essential to the asserted common activity of the being correlated to breast cancer and they do not share a substantial structural similarity essential to this activity.
Further, the recited genes do not belong to a chemical or art-recognized class because there is no expectation from the knowledge in the prior art that genes behave in the same manner and can be substituted for one another with the same intended result achieved. There is no evidence of record to establish that it is clear from their very nature that the recited sequences possess the common property of being associated with urine cancer treatment. There is no evidence of record to establish that it is clear from their very nature that the recited markers possess the common property of being having a relationship of susceptible to treatment.
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.
Claim(s) 48,50-55,57,58,65,70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knudsen et al. (Oncotarget August 2016 Vol 7 p. 69111) as evidenced by Kalady et al. (US Patent Application Publication 2019/0376145 December 12, 2019) in view of Craig et al. (US Patent Application Publication 2014/0024539 January 23,2014).
With regard to claim 48, Knudsen et al. teaches screening human samples for expression with the Affymetrix U133 gene chip (p. 69120 last paragraph). Knudsen et al. does not teach PARP3, Neil3, Nthl1, Nbn, Rbbpb, and Rad45l however as evidenced by Kalady the Affymetrix U133 gene chip comprises these genes (para 54 and table 2). Knudsen et al. teaches comparison to a control (figure 3).
Knudsen et al teaches human tissues of ER positive breast cancer was measured (p. 69120) but does not specifically describe the human population.
Knudsen et al. teaches administering to the subject CDKN2 inhibitors of CDK4 and CDK6 (p. 69112 2nd column). The claim does not require any particular expression level, rather, the claims require treating a subject with a CDKN2 inhibitor wherein a sample of the subject had expression measured.
With regard to claim 51, Knudsen et al. teaches human tissue (biopsy) (p. 69120 last two paragraphs).
With regard to claim 52, as the sample is from a breast cancer subject, that subject would have had to be clinically diagnosed with breast cancer and therefore have had performed a breast test.
With regard to claim 54, Knudsen et al. teaches a method of using a microarray (p 69120 last parpaghra).
With regard to claim 57, Knudsen et al. teaches administering endocrine therapy (p. 69111 1st paragraph).
With regard to claim 58, Knudsen et al. teaches a luteinizing hormone releasing agent (figure 1 legend).
With regard to claim 65, Knudsen et al. teaches using a method that includes florescence (figure 3).
With regard to claim 70, Knudsen et al. teaches the use of palbociclib (p. 69112 1st column last full paragraph).
However Knudsen et al. does not describe the human subject treated.
With regard to claims 48, 50, Craig et al. teaches obtaining a sample from an ER positive breast cancer human subject considered to be an African American for expression analysis (para 68, 118).
With regard to claim 53,55 Craig et al. teaches that the sample can be from a patient with recurrent breast cancer which would be considered a poor survival rate (para 61).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the sample of Knudsen so that the sample is from a known subject including the human subjects of Craig et al. It would be obvious to one of ordinary skill in the art to use samples from any human subject from a human population in order to screen expression and treat that subject with a known treatment (CDKN2 inhibitor) with breast cancer.
Claim(s) 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knudsen et al. (Oncotarget August 2016 Vol 7 p. 69111) as evidenced by Kalady et al. (US Patent Application Publication 2019/0376145 December 12, 2019) and Craig et al. (US Patent Application Publication 2014/0024539 January 23,2014) as applied to claims 48,50-55,57,58,65,70 and in view of Band et al. (US Patent Application 2015/0203588 July 23, 2015).
Knudsen et al teaches human tissues of ER positive breast cancer was measured (p. 69120) but does not specifically describe the human population. Knudsen et al. teaches administering to the subject CDKN2 inhibitors of CDK4 and CDK6 (p. 69112 2nd column). The claim does not require any particular expression level, rather, the claims require treating a subject with a CDKN2 inhibitor wherein a sample of the subject had expression measured. Craig et al. teaches obtaining a sample from an ER positive breast cancer human subject considered to be an African American for expression analysis (para 68, 118).
Knudsen and Craig do not teach administration of endocrine therapy that comprise the inhibitors of Dinaciclib.
With regard to claim 56, Band et al. teaches that ER positive breast cancer subjects can be treated with the CDK2 inhibitor of dinaciclib (para 8).
Therefore it would be prima facie obvious to modify the method of Knudsen and Craig to treat the subjects with a known inhibitor of dinaciclib as taught by Band et al. As Knudsen et al. teaches administrations of CDKN2 inhibitors to treat breast cancer patients, it would be obvious to use any of the finite number of these inhibitors including dinaciclib as taught by Band et al to effectively treat a patient with breast cancer. The ordinary artisan would be motivated to use any of these known CDKN2 inhibitors to treat and Ban et al. teaches that dinaciclib can be used to treat ER positive breast cancer patients.
Conclusion
No claims are allowed.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682