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 without traverse of Group I (claims 1, 4, 11, 21-22, 30, and 35) in the reply filed on 8/15/2025 is acknowledged.
Claims 2, 6, 8, 12, 18-19, 23, 25, 27, 29, 31 and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/31/2022 and 4/26/2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to because Figure 2 is not legible. 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 Objections
Claim 4 is objected to because of the following informality: in line 2, “and optionally the control comprises,” should read “wherein the control optionally comprises.” Appropriate correction is required.
Claim 11 is objected to because of the following informalities: in line 2, “more Xloc13 lincRNA sequence” should read “more Xloc lincRNA sequence(s).” Additionally in line 2, “which is optionally” should read “wherein the sequence(s) is/are optionally”. Finally, the semicolons in line 3 should be changed to commas. Appropriate correction is required.
Claim 21 objected to because of the following informalities: in line 2, “sequence” should read “sequences(s).” Additionally, the semicolons in lines 3-4 should be changed to commas. Appropriate correction is required.
Claim 30 is objected to because of the following informalities: there should be a space between “SEQ ID NO:” and “1” in line 2. Additionally, in the optional wherein clause in parentheses, “the fragment is” should read “the fragment(s) is/are.” Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) - Enablement
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, 4, 11, 21-22, 30, and 35 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 enablement requirement. The claims contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not reasonably provide enablement for detecting follicular thyroid cancer based on analyzing the presence or amount of an Xloc13 lincRNA transcript, an Xloc13 lincRNA intron, or one or more fragments thereof.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). These factors include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. Each of these factors is discussed below.
Nature of the Invention
Claims 1, 4, 11, 21-22, 30, and 35 are drawn to a diagnostic method for detecting thyroid cancer using an Xloc13 lincRNA biomarker. Due to Applicant’s species election of follicular thyroid cancer, these claims are specifically drawn to a diagnostic method for detecting follicular thyroid cancer.
The claimed methods are classified in the unpredictable arts of molecular biology and biochemistry.
Breadth of the Claims
Claim 1 encompasses a variety of specific biomarkers related to Xloc13, though the method overall is recited with open language (i.e. the method comprises the listed step). As noted above, the thyroid cancer is limited to follicular thyroid cancer.
Claim 4 details a pattern of Xloc13 expression in a sample that must be compared to a control, but the method overall is still recited with open language.
Claims 11, 21, and 30 further limit the Xloc13 biomarkers that may be examined, but the method overall is still recited with open language.
Claim 22 limits the type of thyroid cancer that may be examined, but the method overall is still recited with open language.
Claim 35 further limits the method by comprising a treatment step, but the method overall is still recited with open language.
Level of Skill in the Art
The ordinary artisan typically holds at least a master’s degree has several years of experience.
State of the Prior Art & Unpredictability
Concerning the claimed invention, what was (and is) unpredictable in the art is whether a biomarker encompassed by the claims (i.e. an Xloc13 lincRNA transcript, an Xloc13 lincRNA intron, and/or one or more fragments thereof) is capable of detecting follicular thyroid cancer. No prior art discussing these biomarkers in conjunction with follicular thyroid cancer could be found.
It is noted that the prior art does distinguish between follicular thyroid cancer and papillary thyroid cancer. For instance, ThyCa (Thyroid Cancer Survivors' Association, 2018) notes that these two cancers are different, and although papillary thyroid cancer does have a follicular variant, this is still different from follicular thyroid cancer (see Overview, bullets 1-3 and 5-7).
Guidance in the Specification and Examples
Generally in the instant specification, follicular thyroid cancer is mentioned in a list of cancers that may be examined by the instant invention (see page 3, para. 6 and page 9, para. 3). Follicular thyroid cancer is not discussed alone.
In one of the working examples of the invention, Applicant analyzes treatment of papillary thyroid cancer cells, and on page 12, para. 1, notes that their results “provide novel insights and options for overcoming resistance in any type of follicular-derived thyroid carcinoma.” However, it is unclear how this example relates to follicular thyroid cancer, as it does not examine follicular thyroid cancer cells. This example also does not deal with biomarker expression levels. Furthermore, none of Applicant’s drawings appear to be related to follicular thyroid cancer cells.
In view of the unpredictability in the art discussed above, it is not clear that Applicant’s specification has successfully demonstrated the use of the currently claimed biomarkers.
Quantity of Experimentation
The ordinary artisan would have to conduct a very large quantity of highly unpredictable experimentation before being able to successfully practice the full scope of the claimed methods. Specifically, the ordinary artisan would have to determine that any of the biomarkers recited by the instant claims correlates with follicular thyroid cancer in a measurable and consistent manner such as to act as a diagnostic biomarker for said cancer. Based on the lack of teachings in the art, this would be an inventive and unpredictable undertaking, requiring extensive experimentation in which there is no guarantee of success. The large quantity of experimentation and its unpredictability constitute undue experimentation.
Conclusion
In view of the foregoing, it is clear that the specification fails to enable the full scope of the claimed methods, and claims 1, 4, 11, 21-22, 30, and 35 are rejected under 35 U.S.C. 112(a) for failing to comply with the enablement requirement.
Claim Rejections - 35 USC § 112(b)
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 11 and 22 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.
Regarding claim 11, MPEP 2173.05(s) states, “Where possible, claims are to be
complete in themselves…Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims.” Claim 11 recites Figure 1B of the drawings. These claims do not also recite the relevant elements within the figure, and so these claims are indefinite. As well, there is no particular reason why the information in the figure cannot be presented in the claims.
Claim 22 is rejected because the claim is intended to be a list of various types of thyroid cancers, but also lists “genetic fusions inhibitors.” This is not a type of thyroid cancer, and appears to be a treatment for thyroid cancer. It is unclear whether this item was placed in this list in error or if the list is also intended to recite treatments for thyroid cancer.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4, 11, 21-22, 30, and 35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite a natural law.
Claim 1 is directed to a diagnostic method for detecting follicular thyroid cancer in a subject via measuring an Xloc13 biomarker. The natural law recited is the expression level of the biomarker and the presence of follicular thyroid cancer in a sample. This judicial exception is not integrated into a practical application because there is no required active treatment step or other step that integrates the judicial exception into a practical application. See MPEP 2106.04(d)(2). The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than well-understood, routine, and conventional activity in view of Cao et al. (Neoplasma, 2019; cited in a previous Office Action). This reference teaches measuring the expression level of lncRNAs, including Xloc13, via qRT-PCR (Abstract, Table 1, and page 246, column 2, para. 4). This qRT-PCR utilized commercially available reagents and equipment. Thus, claim 1 is directed to a judicial exception without significantly more.
Claim 4 depends on claim 1 and recites a specific expression level pattern for the Xloc13 biomarker. This only serves to further limit the judicial exception of claim 1. As with claim 1, the judicial exception is not integrated into a practical application because there is no required particular treatment step or other step that integrates the judicial exception into a practical application. See MPEP 2106.04(d)(2). The claim does not include additional elements or steps relative to claim 1, and so does not include elements that are sufficient to amount to significantly more than the judicial exception for the same reasons described above for claim 1. Thus, claim 4 is directed to a judicial exception without significantly more.
Claim 11 depends on claim 1 and specifies that more than one Xloc13 sequence must be detected. This only serves to further limit the judicial exception of claim 1. As with claim 1, the judicial exception is not integrated into a practical application because there is no required particular treatment step or other step that integrates the judicial exception into a practical application. See MPEP 2106.04(d)(2). The claim does not include additional elements or steps relative to claim 1, and so does not include elements that are sufficient to amount to significantly more than the judicial exception for the same reasons described above for claim 1. Thus, claim 11 is directed to a judicial exception without significantly more.
Claim 21 depends on claim 1 and specifies the Xloc13 sequences that must be detected. This judicial exception is not integrated into a practical application because there is no required active treatment step or other step that integrates the judicial exception into a practical application. See MPEP 2106.04(d)(2). The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than well-understood, routine, and conventional activity in view of GenBank (Accession # AL044456, 2003). This reference teaches an RNA sequence that aligns with a fragment of each of instant SEQ ID NOs: 1-5. Thus, claim 21 is directed to a judicial exception without significantly more.
Claim 22 depends on claim 1 and specifies the types of cancer that may be examined in the method. This only serves to further limit the judicial exception of claim 1. As with claim 1, the judicial exception is not integrated into a practical application because there is no required particular treatment step or other step that integrates the judicial exception into a practical application. See MPEP 2106.04(d)(2). The claim does not include additional elements or steps relative to claim 1, and so does not include elements that are sufficient to amount to significantly more than the judicial exception for the same reasons described above for claim 1. Thus, claim 4 is directed to a judicial exception without significantly more.
Claim 30 depends on claim 1 and specifies the Xloc13 sequences that must be detected. This judicial exception is not integrated into a practical application because there is no required active treatment step or other step that integrates the judicial exception into a practical application. See MPEP 2106.04(d)(2). The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than well-understood, routine, and conventional activity in view of GenBank (Accession # AL044456, 2003). This reference teaches an RNA sequence that aligns with a fragment of each of instant SEQ ID NOs: 1-5. Thus, claim 30 is directed to a judicial exception without significantly more.
Claim 35 depends on claim 1 and includes a method for treating patients. As with claim 1, the judicial exception is not integrated into a practical application because there is no required particular treatment step or other step that integrates the judicial exception into a practical application. Though a treatment step is generally recited, it is noted that this is not a particular treatment step, as no specific treatment is given. See MPEP 2106.04(d)(2). The claim does not include additional elements or steps relative to claim 1, and so does not include elements that are sufficient to amount to significantly more than the judicial exception for the same reasons described above for claim 1. Thus, claim 35 is directed to a judicial exception without significantly more.
Conclusion
No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANCESCA F GIAMMONA whose telephone number is (571)270-0595. The examiner can normally be reached M-Th, 7-5pm.
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/F.F.G./Examiner, Art Unit 1681
/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681