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 .
2. This action is in response to papers filed 3/16/2026.
3. Applicant’s election without traverse of the species of the entirety of the combination of table 2 and the combination of del95q); del(7q); del(13q); del(20q); abn(17p) complex karyotype; trisomy 8, trisomy 12, monosomal karyotype in the reply filed on 8/29/2025 is acknowledged.
4. Claims 1-2, 5, 7-8, 10, 12-13, 15-16, 19-20, 23, 25-26, 28, 30-32 are pending.
5. Claims 3-4, 6,9, 11, 14, 17, 21-22, 24, 27, 29, 33-34 have been cancelled.
6. The following rejections are maintained with response to arguments following.
7. This action is FINAL.
Withdrawn Objections and Rejections
The 35 USC 101 made in the previous office action is withdrawn based upon amendments to the claims.
The species of the entire combination of the genes listed in claim 1 is free of the art. It is noted that this is based upon the election response of 8/29/2025. Because of the rejection of the claims set forth below the elected species is not in condition in the art and therefore the next species has not been searched.
Modified Drawings
The drawings are objected to because Figures 1-2 submitted on 3/16/2026 contain color drawings without a petition for color drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5, 7-8, 10, 12-13, 15-16, 19-20, 23, 25-26, 28, 30-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-2, 5, 7-8, 10, 12-13, 15-16 are drawn to methods for identifying a subject diagnosed with cancer or suspected of having cancer as falling within a treatable prognostic group comprising providing a biological sample, determination copy number of one or more target genes or fragments of the target genes, identifying the prognosis group based upon the presence of one or more chromosomal abnormalities as having cancer with an adverse, intermediate or favorable prognosis, and qualifying the subject for chemotherapy or immunotherapy based upon the adverse, intermediate or favorable prognosis.
Claims 19-20, 23, 25-26, 28, 30-32 are drawn to treating a subject with a cancer comprising providing a biological sample, determining copy number of one or more target genes of fragments of the target genes, comparing the copy numbers to determine one or more chromosomal abnormalities, identifying the prognostic group of adverse, intermediate or favorable prognosis, qualifying for adjunct therapy and administering a therapeutic amount of a chemotherapeutic or immunotherapeutic agent qualified by adject therapy in the adverse, intermediate or favorable prognosis groups.
As such the grouping of claims are drawn to functionality identifying prognostic groups based upon copy number of any of the one or more target genes or fragments of cfDNA fragments. Although the specification teaches the method steps (see p 3-4), the specification does not provide any guidance for which target gene or gene fragments would provide the functionality for prognostic groups. The claims are drawn to any target genes to correlated chromosomal abnormality to this functionality. However, the specification has not provided or described which target genes have the critical structure for chromosomal abnormality to functionally detect prognostic groups.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure.
The specification provides detection of specific abnormalities from specific target genes (see p. 32 and 42-43), however, the specification does not provide the critical guidance as to which other target genes or fragments would have chromosomal abnormalities that functionally provide prognostic groups. Rather the specification provides a list of 275 genes that were screened for copy number variations (see p 42-43).
In analysis of the claims for compliance with the written description requirement of 35 U.S.C. 112, first paragraph, the written description guidelines note regarding genus/species situations that "Satisfactory disclosure of a ``representative number'' depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed." (See: 'Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.) In the instant case, the specification fails to teach the necessary common attributes or features of the samples and controls consistently in view of the species disclosed. As such, one of skill in the art would not recognize that applicant was in possession of breath of any target gene or fragment.
Response to Arguments
The reply traverses the rejection. A summary of the arguments is provided below with response to arguments following. The reply asserts that the claims have been amended to require the 275 genes that were screened for copy number variations and therefore is not an open ended genus (p. 23-24).
These arguments have been reviewed but have not been found persuasive.
It is noted that the example pointed to in the reply is different in scope as the claimed method. In particular the claims are drawn to measuring copy number in one or more of these genes or fragments of these genes and determination of chromosomal abnormalities to determine adverse, intermediate or favorable prognosis in order to identify and treat. The specification provides detection of specific abnormalities from specific target genes (see p. 32 and 42-43), however, the specification does not provide the critical guidance as to which other target genes or fragments would have chromosomal abnormalities that functionally provide prognostic groups. In particular, for example, the claims encompass the copy number of a fragment of one gene listed however, the specification has not provided which prognosis group the patient would be placed. It is noted that the specification does provide the entire combination of genes and the specific prognosis listed in the specification.
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, 5, 7-8, 10, 12-13, 15-16, 19-20, 23, 25-26, 28, 30-32 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, 5, 7-8, 10, 12-13, 15-16 are indefinite over step c of claim 1. The step is unclear as the step identifies the prognostic group based upon the presence of one or more chromosomal abnormalities, however, it is not clear which groups (adverse, intermediate, or favorable prognosis) the samples are placed in based upon the presence of one of more chromosomal abnormalities. As such it is not clear how to identify the prognostic groups. Further, it is not clear the metes and bounds of the term “qualifying” in step d. The claims indicate that “qualifying” occurs based upon the prognostic group, however, it is not clear what the term “qualifying” is attempting to indicate. It is not clear if this term is indicating rather to treat or if the term in encompassing a particular change in the amount of treatment. Therefore the metes and bounds are unclear.
Claims 19-20, 23, 25-26, 28 and 30-32 are indefinite over step c of claim 19. The step is unclear as the step identifies the prognostic group based upon the presence of one or more chromosomal abnormalities, however, it is not clear which groups (adverse, intermediate, or favorable prognosis) the samples are placed in based upon the presence of one of more chromosomal abnormalities. As such it is not clear how to identify the prognostic groups. Further, it is not clear the metes and bounds of the term “qualifying” in step d. The claims indicate that “qualifying” occurs based upon the prognostic group, however, it is not clear what the term “qualifying” is attempting to indicate. It is not clear if this term is indicating rather to treat or if the term in encompassing a particular change in the amount of treatment. Therefore the metes and bounds are unclear.
Claims 16 and 32 is indefinite over the chromosomal abnormalities . These abnormalities are unclear as the abnormalities appear to encompass particular genes abnormalities wherein the dependent claim requires detection of any target gene. As such it is not clear how to identify these abnormalities based upon the selection of any target gene. The abnormalities are abbreviated in such a way that is it is not clear what the abnormality would encompass. For example, it is not clear “GATA2” is encompasses particular deletions or duplications or if the term is encompassing any fragment of that gene. Further, examples would be MECOM(EVII), t(6;9)(p23;q34), DEK-NUP214. The specification has not explicitly described these abnormalities other than the language used in the claims. Therefore the metes and bounds of the claims are unclear
Response to Arguments
The reply traverses the rejection. A summary of the arguments is provided below with response to arguments following. The reply points the paragraphs 250-255 as to what is meant by adverse, favorable, and intermediate (p. 26-27). The reply asserts that the claims have been amended to identifying (p. 27-28). The reply asserts that the chromosomal regions are well known in the art and recites the recitation in the art (p. 28-32)
This argument has been reviewed but has not been found persuasive.
First it is noted that the specification does not provide specific definitions. Further, the recitation of the abnormalities listed in the specification are not required to be determined in the independent claims. Lastly the specification does not even specifically list the terms to these chromosomal abnormalities as it recites that these abnormalities are “included” but are not limited to such a detection. As such the rejection has been maintained. The recitation of identifying does not overcome the rejection as it is still not clear what would be considered adverse, intermediate or favorable. It is noted that the recitation of the art has not been submitted on the record using an IDS form and as such the references have not been fully considered. Furthermore the reply asserts limitations that are not recited in the specification. For example the reply assets a combination of GATA2, MECOM(EV11, however, it is not clear that both of these genes are combined. Rater the claim could include only GATA2. Further, the reply points to KMT2A rearrange to require a particular translocation, however, the term is not limited to this translocation and could encompass any number of other rearrangement of the gene. Therefore although some of the list might be clearly defined (such as trisomy 8) the genus encompasses abnormalities that are not described clearly in the specification as a limiting group.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682
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