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 .
1. Formal Matters
A. In the response filed 5/18/26, Applicants elected Group II, drawn to the indicated species, and traversed on the grounds that it would not be undue to search Group I as well. First, as discussed on page 4 of the restriction dated 3/18/26, Rijs teaches TEM1, which is also known as endosialin/CD248, is a biomarker for MPNST. Further discussion is seen below. Furthermore, even if Rijs does not anticipate, or make obvious the instant invention, Groups I and II do not meet one of the below criteria (also stated on page 3 of the restriction) since the claims are two distinct processes -
When Claims Are Directed to Multiple Categories of Inventions
As provided in 37 CFR 1.475(b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Finally, the argument that a special technical feature does exist between the Groups is not persuasive. In the instant claims, Group I is drawn to a diagnostic method for measuring specifically identified markers. Group II is drawn to a method for screening actual “material”, which is distinct from, or at least not limited to, the specific biomarkers of Group I. Furthermore, Group II is drawn to measuring activity of numerous pathways, none of which is required in Group I, nor, again, are the markers required, or necessarily encompassed by the pathways of Group II. While one or more biomarker may be involved to some degree in one or more of the pathways of Group II, there is no identified link among any other “material” to MPNST in the claims, nor specification. In other words, for example, identifying a new material “X” would be different from endosialin, CPARC-like protein and neutrophil collagenase.
Therefore, the restriction is deemed proper and is made FINAL.
B. Claims 7-9 and 11-18 are pending. Claims 13-16 are withdrawn as being drawn to a non-elected invention. Claims 7-9, 11, 12, 17 and 18 are the subject of this Office Action.
2. Specification
A. The use of at least the term Q-ExactiveTM (page 44, line 13), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
B. Applicant is advised that embedded hyperlinks and/or other forms of browser-executable code are impermissible and require deletion. The attempt to incorporate subject matter into the patent application by reference to a hyperlink and/or other forms of browser-executable code is considered to be an improper incorporation by reference. See MPEP 608.01(p), paragraph I regarding incorporation by reference. It is noted that the recitation of “www.” alone, as opposed to “http://www.”, is also active and should not be used. A hyperlink appears on at least page 49, line 12.
C. The specification has not been checked to the extent necessary to determine the presence of all possible minor errors, embedded hyperlinks, or improperly referenced trademarks. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware.
3. 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 7-9, 11, 12, 17 and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The claims are drawn to diagnosing MPNST based on expression levels of one of three proteins, or their encoding mRNA. Claim 18 is further directed to treatment.
As written, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons discussed below.
In January 2019, the USTPO issued revised guidance on patent subject matter eligibility (79 FR 74618). Similar to the previous December 2014 guidance, the new guidelines require a 2-part analysis for determination of subject matter eligibility under 35 U.S.C. 101. S
Step 1 asks if the claim(s) is to a process, machine, manufacture, or composition of matter. In the instant case, the claims are directed to a process.
Step 2(a) asks if the claim is directed to a law of nature, a natural phenomenon, or an abstract idea (a judicially recognized exception). The revised patent subject matter eligibility guidance issued in January 2019 sets forth a two-part inquiry to determine if a claim(s) is directed to a judicial exception. The first part asks if the claim(s) recite an abstract idea, law of nature, or natural phenomenon. In the instant case, the claims recite a law of nature, namely that patients with MPNST express higher levels of one of the three proteins recited in claim 7. Furthermore, the claims can also be interpreted as reciting a law of nature, specifically the relationship between protein/mRNA expression and MPNST.
If the claims are determined to recite a judicial exception, then the second part of the January 2019 guidance asks if there is any element(s) recited in the claims beyond the judicial exception which integrates the exception into a practical application. In the instant case, the judicial exceptions discussed above are not integrated into a practical application because the claims merely read on methods of obtaining a sample from a patient, determining protein/mRNA levels in said sample, and then making a judgement based on the measured levels. In claim 8, the step of comparing the level to that of an NF-1 patient is merely a mental exercise performed in the human mind. Furthermore, once the measuring, comparison, and identification steps are completed, the claims do not require any further actions. In other words, the claims read on a method of measuring levels in a sample from a patient (claim 7), comparing the level to that of a different patient (claim 8), identifying a patient as having MPNST, and then doing nothing else. Given this interpretation, the claims do not recite any limitation or element which integrates the recited judicial exceptions into any type of practical application. Though claim 18 recites treatment, this is routine in the prior art as evidenced by Rajs (see 35 USC 103 below).
If the analysis in Step 2(a) indicates that the claim(s) is directed to a judicially recognized exception, then one must proceed to the analysis of Step 2(b), which asks if the claim recites additional elements which amount to significantly more than the judicial exception. In the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Specifically, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, as obtaining a sample from a patient and performing an assay to determine protein/mRNA levels are merely routine data-gathering steps used to test for the correlation between a marker and a condition. These steps are routine and well-known to one of ordinary skill in the art. See also Maier et al. cited below in paragraph C under 35 USC 103.
It is also noted that the claims do not appear to recite any specific instructions or steps that would apply the results of the assay. As written, the claims merely read on obtaining a sample from a patient, determining protein/mRNA levels, and then nothing else (other than claim 18). There are no recited steps or guidance as to what one should do if the subject is determined to have elevated levels, or alternatively, what one should do if the subject does not exhibit elevated levels. In this interpretation of the claims, the claims only recite a natural correlation/law of nature, with no instructions on how to apply or use the law of nature.
Therefore, the claims recite method steps in a very general matter, wherein the steps are routine and conventional, and do not specify any additional elements or steps that amount to significantly more than the judicial exception of a naturally occurring phenomenon/law of nature.
4. 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 7, 9, 11 and 12 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. Claim 7 recites a method of differential diagnosing. However, it does not recite limitations to identify how to make such a diagnosis (i.e. an increase or decrease in levels would be indicative of a successful method.
5. 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.
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.
A. Claims 7, 8, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Rjis et al. (reference 24 on the IDS filed 9/22/23).
The claims are essentially drawn to differential diagnosis of MPNST based on expression of endosialin. Rijs teaches that TEM1 (endosialin) is used as a biomarker due to its expression in MPNST (page 7; Table A1), meeting claims 7 and 8.
Regarding claim 11, Rajs teaches that TEM1 can be targeted in NIRF imagine using an antibody conjugated to NIRF (last paragraph of page 7)
Regarding claim 18, Rajs teaches the use of NIRF imaging and protein expression as a tool for fluorescence-guided surgery (Abstract; Conclusion). See also the first biomarker in Table 2 (TEM1 with onthuxizumab as a treatment).
B. Claims 8, 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Rjis et al. in view of Ingham et al. Rijs does not teach patients diagnosed with NF-1. However, Ingham teaches that MPNST is common in NF-1 patients (Abstract; Introduction). Therefore, it would have been obvious at the time of the instant invention to have screened for MPNST in these patients.
C. Claims 11and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Rjis et al. in view of Maier et al. Rijs does not teach these well-known protein or mRNA expression techniques. However, Maier do teach numerous techniques, including PCR (Section 2.1) and Western blotting (Section 2.2.3).
6. Conclusion
No claim is allowable.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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, Joanne Hama, can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
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