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 .
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.
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of 1) selecting a patient for more frequent screening, 2) cancer of the throat, 3) cells of the throat, 4) ZNF773, 5) infected with papillomavirus, and 6) MSP in the reply filed on 6/16/26 is acknowledged.
Claims 1, 4-5, 9-11, 13, 15-17, 23, 25, 28, 31, 32, and 34-36 are pending. Claims 1, 4-5, 9-11, 13, 15-17, 23, 25, 28, 31, and 35-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/16/26.
Applicant states that all of the pending claims encompass the elected species. This is not persuasive because the first elected species—selecting a patient for more frequent screening—is not part of independent claim 1 and the dependent claims thereof. This species is only recited in claims 32 and 34. Rather, independent claim 1 and the dependent claims thereof are drawn to the non-elected species of determining the risk for developing cancer or determining likelihood/diagnosing cancer.
Claims 32 and 34 are under examination.
Drawings
The drawings are objected to because Figures 2 and 3 identify four of the five bars using what appears to be the same shade of grey. This makes the graph unclear as to which bar is associated with which label. 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 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 32 and 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 32 and 34 recite the word “preferably”. In one case, these are meant to be claim limitations in which case it is unclear why these limitations are preceded by “preferably”. In another case, these are not claim limitations in which case it is unclear why the preferences are in the claim at all. See MPEP § 2173.05(d) which states that “[d]escription of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim."
Further, the scope of the claim is unclear. The preamble is “a method for selecting a patient to undergo more frequent screening for developing a cancer of the head and neck”. As written, the method is for “selecting a patient” while the “for” is an intended use and not a limitation of the method itself. This is further supported by the only active step of the method being “selecting a human patient”; no screening step or instructions to implement more frequent screening is part of the claimed method. However, claim 34 is solely directed to the frequency of such screening. It is unclear how the selection process in claim 32 differs when the subject is selected for “every 12 months” versus “every 6 months” when there is no screening step as part of the claimed method. This overall makes it unclear if the method of claim 32 requires a screening step or not.
Additionally, the step of “selecting a human patient” is followed by “in which the genomic region between the gene ZNF823 and the gene ZNF833 on chromosome 19 in a biological sample obtained from the patient is methylated”. There is no method step which ascertains whether or not this region in the patient is methylated. In one interpretation, this statement implies that, at some point, a biological sample was obtained and determined to be methylated at the claimed region, though in this case it is further unclear whether such determination is part of the claimed method or if one merely needs to be aware of the methylation to meet the scope of the claim. In another interpretation, this is describing a property of the human patient. In this case, the scope of the claim is met if such a human patient is selected whether or not the person making the selection is aware of the methylation.
Therefore, claims 32 and 34 are indefinite. The broadest, reasonable interpretation is that the claim scope is defined when a patient with the inherent methylation property is selected. This interpretation does not require the biological sample to be tested, only that if such a sample were tested, the sample would possess the claimed methylation. Further, the claim does not require any screening as this is an intended use for the selected patient in the preamble and does not appear to require the patient actually be screened in such a manner.
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.
Claim 34 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 32 is a method of selecting a patient for more frequent screening comprising selecting a patient with certain methylation. Claim 34 is directed entirely to the frequency of the screening. The screening is not a step in the method and claim 34 solely modifies the preamble of claim 32. The same patient is selected based on the same criteria in both claims. When reading the preamble in the context of the entire claim, the recitation of the frequency of screening is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02. Further, even if the preamble were to be given weight, selecting the patient “for” 12 month screening is not a further limitation compared to the same selection for a different frequency of screening because the screening does not take place within the method.
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 - 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 32 and 34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Step 1: It must first be determined if the claim is to a statutory category and, if so, proceed to step 2A prong 1. Claims 32 and 34 are methods and fall within the statutory category of a process.
Step 2A, prong 1: Prong 1 requires the Examiner to evaluate whether the claim recites a judicial exception and, if so, proceed to prong 2. In this case, the claims recite the step of selecting a patient. This is a mental process and is an enumerated abstract idea.
Step 2A, prong 2: Prong 2 requires the Examiner to evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception and, if not, proceed to step 2B. In order to integrate the recited judicial exception into a practical application, the claim will apply, rely on, or use the judicial exception that imposes a meaningful limit such that the claim is more than a drafting effort to monopolize the judicial exception. Examiners evaluate integration by identifying additional elements in the claim beyond the judicial exception and evaluating those elements individually and in combination to determine whether they integrate the exception in to a practical application. Examples that have been found by the Courts in which the exception was not integrated into a practical application include:
Mere instructions to implement an abstract idea on a computer
Adding generic instructions that the judicial exception should be used ("apply it")
Adding insignificant extrasolution activity to the exception ("mere data gathering")
Generally linking the use of the exception to a particular technological environment or field of use
In this case, there are no steps other than mentally selecting the patient. The patient is selected to undergo more frequent screening but the claim does not recite nor require the screening step. The patient is selected based on a property of the patient, e.g., methylation on chromosome 19 in a biological sample obtained from the patient; however, neither the obtaining of the sample nor the detection of the methylation are steps in the method as claimed. As noted above, it is unclear if any detection step need have occurred at any point and, even if such steps are necessary, they occur outside the scope of the claim and at most represent the required data gathering (insignificant extrasolution activity). Rather, the claim solely requires the selection step, which is the judicial exception. The claim does not contain any other elements and so does not contain elements to integrate the exception.
Step 2B: Where a claim does not integrate the exception, a claim may nevertheless be patent eligible, for example where additional elements are “significantly more” than the exception such that the additional elements were unconventional in combination. Considerations include whether or not the claim adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present. In this case, as above, there are no elements beyond the judicial exception itself as claimed and so there are no elements to provide significantly more.
Therefore, claims 32 and 34 are not patent eligible.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 32 and 34 is/are rejected under 35 U.S.C. 102(a)(1-2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lewin (WO2020165359; IDS 8/25/23 FOR citation 2).
Lewin teaches “screening a population of subjects for HNC” (p. 28) where HNC is head and neck cancer. These subjects preferably have HNC or an increased risk for HNC. HNC is taught as referring to all cancers that start in the head or neck (p.24). The subject is human (p.25 L7).
In teaching the screening of a population, this meets the criteria of selecting a human patient because the term “subject” is defined as a human individual by Lewin and by screening the subject, that subject has necessarily been mentally “selected”. As above, the phrase “to undergo more frequent screening” is found solely in the preamble and the body of the claim provides a complete method. As such, this portion of the preamble does not further define the method.
With respect to the limitation of methylation between the ZNF823 and ZND833 genes on chromosome 19, as noted above, this is a characteristic of the subject and is not determined by the claimed method. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). In this case, the “product” is a human patient though the rationale still applies. These subjects being selected in Lewin inherently have some DNA methylation and whether or not those subjects in the prior art inherently possessed the claimed methylation pattern is something the Office is not equipped to determine. However, the evidence tends to suggest that these subjects had such methylation. Instant figure 2 demonstrates that even control subjects have a non-zero detection rate of methylation at the claimed area, while having cancer (such as taught by Lewin) significantly increases this potential. Inherency is not established on probability but the subjects being screened by Lewin is not a matter of probability. Rather, the subjects either did or did not have the necessary methylation pattern and that inherent fact is unknown. Given that the subjects being screened are those with head and neck cancer, including HPV+ cancer, and the teachings that these subjects have the disclosed methylation pattern, the evidence supports the conclusion that the method of selection (screening) taught by Lewin anticipates including those subjects with the claimed methylation pattern whether such pattern was recognized or not. This anticipates the claimed method.
However, in the alternative, it would have been obvious to include such subjects in the method of Lewin. Lewin discusses the fact that DNA methylation is an indication of cancer (e.g., p.1). While Lewin is silent regarding the particularly claimed region of DNA, Lewin teaches that DNA methylation patterns “are being used to diagnose all sorts of cancers” (p.1). See MPEP 2141(II)(C): "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. Given the teachings above, it would have been obvious to select a human patient for increased screening for head and neck cancer and who displays one of the abnormal methylation patterns indicative of increased risk of HNC as described by Lewin. It would have been obvious that this selection would include those that have the instantly claimed methylation pattern (whether or not this region was tested) because the known methylation pattern taught by Lewin provides the necessary reasoning for selecting that subject.
Therefore, claims 32 and 34 are anticipated by or obvious over Lewin.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Weidner/ Primary Examiner, Art Unit 1675
