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 .
Status of the claims
The preliminary amendment filed 07/13/23 is acknowledged and has been entered. Claims 1-7, 9-18 and 20-21 have been amended. Claims 8, 19 and 23-24 have been canceled. Accordingly, claims 1-7, 9-18 and 20-22 are pending and under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The instant abstract utilized implied phrases see “The invention relates to”. This language should be avoided.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 11 is objected to because of the following informalities: Claim 11 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 5. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, It is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP 706.03(k). In the instant claims, the method of claim 5 requires the lung cancer is early-stage lung cancer. Appropriate correction is required.
Claims 13-14 are objected to because of the following informalities: Claims 13-14 are objected to under 37 CFR 1.75 as being a substantial duplicate of claims 6-7. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, It is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP 706.03(k). Appropriate correction is required.
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 1-7, 9-18 and 20-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and/or to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
The claims are directed to a naturally occurring correlation between the levels of the recited biomarkers in a subject with lung cancer.
Step 2A, Prong 2
The additional elements of detecting or measuring CEA, H3K27Me3 and H3K36Me3 do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Also, with respect to the recitations “using the levels detected in the body fluid sample to diagnose lung cancer or to monitor lung cancer” and “using the levels detected or measured in the body fluid sample to determine if the patient has lung cancer. The “using” statements at best articulates the judicial exception, amounting only to a general instruction to apply or use the judicial exception. This could read on mental activity being performed solely in a practitioner’ head, e.g. A mental appreciation of the recited biomarkers being correlated with lung cancer in a patient. No active method steps are invoked or clearly required; the “using” statements do not include any activity that would constitute a practical application, i.e. steps that apply, rely on or use the natural principle in a manner such that the claims amount to significantly more that the natural principal itself.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
As shown by Micallef et al below it is well known routine and conventional in the art to detect and measure the recited biomarkers.
With respect to the “administering a treatment to the patient if the patient is determined to have lung cancer..” as recited in claim 21. Although the claim invokes administering a treatment to the patient the claim as currently recites “to determine if the patient has lung cancer”. The recitation of “if” allows for the scenario when the levels do not lung cancer and thus allows for an embodiment wherein treatment is administered. Therefore, this scenario does not recite something significantly more than the judicial exception. Also, the claim as recited allows for any generic treatment known or conventional in the art and even reads on rest.
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
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.
Written Description
Claims 1-7, 9-18 and 20-21 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed to a method of diagnosing or monitoring lung cancer by using the levels of H3K27Me3, H3K36Me3 and CEA from any and all samples from any and all patients by using any increases, decreases or equal amounts, presence or absence with a correlating to lung cancer. The limitation 'patient’ represents a genus and encompasses human and non-human including mouse, monkey, dog, rat, pig, insects, kangaroo, horse, canine and snake to name a few. The limitation ‘body fluid sample’ represents a genus and encompasses tears, semen, urine, synovial fluid, peritoneal fluid, sputum, diarrhea or vomit. Also, the current claim broadly allows for the determination of any and all increases, decreases, presence, absence or equal amounts of the biomarkers in diagnosis of the patient with lung cancer. However, there is inadequate written description in the instant specification for a method of such broad scope as claimed currently.
In order to fulfill the written description requirements set forth under 35 U.S.C § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, each member correlated with the requisite function, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicants have possession the claimed invention. Applicants have not described and established structure-function correlation for a representative number of species within the broad genus of at least the recited ‘patient’, ‘body fluid sample’, and the levels of the biomarkers such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the full scope of the claimed invention at the time the application was filed.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. When there is substantial structural variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
A review of the instant specification indicates the following. The specification on page 1 discloses that the invention finds particular use in the detection of lung cancer and therefore can be used in combination with lung cancer screening methods such as LDCT scanning, as a simple confirmation blood-test to rule in or rule out cancer. The specification on page 3 discloses the need for a simple routine cancer blood test. The specification on page 5 discloses a novel blood-based test could offer a simple follow-up confirmation approach to help discriminate between lung cancer and non-malignant nodules. The specification on page 23 discloses obtaining plasma samples from patients (all of which appear to be human). The specification on page 13 discloses that individual assay cut-off levels are used and the patient is considered positive in the panel test if the individual assay results are above the assay cut-offs. The examples in the specification all appear to be directed to the subject being a human and the body fluid sample as being blood, plasma or serum for the detection of the recited biomarkers and a specific correlation of increased levels of all the biomarkers compared to a cut-off as diagnosing lung cancer The specification does not provide data, testing or examples with a showing that any all and all body fluid samples from any and all patients provide the recited biomarkers at levels which can be specifically correlated with lung cancer. Also, Torzewski et al, (Hindawl Publishing Corporation, Mediators of Inflammation, Vol 2014, Articles ID 683598, pages 1-7) teaches for example that CRP (biomarker) is an acute phase reactant in humans but not an acute phase reactant in a mouse (e.g. page 1). Van Der Vekens et al., (Cardiovascular Endocrinology, 2013, Vol 2, No. 4,pages 67-76) teaches that markers between human and equine show important species differences, which can be explained by variations in physiology or pathophysiology and also teaches pathological differences in the species (e.g. abstract).
The only examples utilized in the specification appears to be limited to blood, serum or plasma from a human patient and the measurement of the recited biomarkers wherein increased levels as compared to cut-offs provides for specific correlation to lung cancer. The specification does not disclose that the recited biomarkers which appear in blood also appear in samples such as tears, diarrhea, sputum, plural fluid etc. or that such biomarkers would be expected to be shed, excreted into or found in these samples and correlated with lung cancer. As stated supra the specification appears to be limited to blood, serum or plasma from a human patient and the measurement of the recited biomarkers wherein increased levels as compared to cut-offs provides for specific correlation to lung cancer.
The specification also fails to provide for a correlation of the recited biomarkers in all patients such as dogs, cats, cows, monkey, horse, rabbit squirrel and mice (as shown supra by Torzewski and Van Der Vekens different species of mammal have different expression of biomarkers and do not correlate to the same condition/disease) The specification also fails to provide that the recited biomarkers exist in samples such as saliva, tears, sputum, CSF or diarrhea or that a correlation of these biomarkers exist in such patients with lung cancer. Further, it is not well known in the art that these samples provide for the recited biomarkers and that a correlation exists between such biomarkers in the samples to lung cancer. The examples in the specification appear to be limited to blood, serum or plasma from a human patient and the measurement of of the recited biomarkers wherein increased levels as compared to cut-offs provides for specific correlation to lung cancer. The purpose of the ‘written description; requirement is broader than to merely explain how to ‘make and use’, Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
It must be noted that "[t]he applicant must . . . convey to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention." Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir.1991). The invention, is for purposes of the ‘written description’ inquiry, whatever is now claimed.” See page 1117. The specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicants were in possession of the full scope of the claimed invention at the time of filing. The Written Description Guidelines state: There is an inverse correlation between the level of predictability in the art and the amount of disclosure necessary to satisfy the written description requirement. For example, if there is a well-established correlation between the structure and function in the art, one skilled in the art will be able to reasonably predict the complete structure of the claimed invention from its function. Furthermore, the written description provision of 35 U.S.C § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, paragraph 1, ‘Written Description’ Requirement (66 FIR 1099-1111, January 5,2001) state, ‘[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention’ (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. Factual evidence of an actual reduction to practice has not been disclosed in the instant specification, nor has Applicant shown the invention was ‘ready for patenting’. The Guidelines further state, ‘[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus' (Id. at 1106). For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. Instant claims are viewed as not meeting the written description provision of 35 U.S.C § 112, first paragraph. The specification fails to disclose the detection of the recited biomarkers in any and all samples from any and all patients wherein any amount, presence or absence of the biomarkers is directed correlated with lung cancer.
Scope of Enablement
Claims 1-7, 9-18 and 20-21 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of diagnosing lung cancer by measuring the levels of H3K27Me3, H3K36Me3 and CEA in a blood plasma or serum sample from a human patient and comparing the levels to that of cut-offs to detect increased levels wherein the increased levels of the recited biomarkers is correlated with lung cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Enablement requires that the specification teach those in the art to make and use the invention without undue experimentation. The factors that must be considered in determining undue experimentation are set forth in In re Wands USPTQ2d 14000. Factors to be considered in determining whether a disclosure would require undue experimentation include (1) the nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the quantity of experimentation necessary, (7) the relative skill of those in the art, and (8) the breadth of the claims.
The instant claims are directed to a method of diagnosing or monitoring lung cancer by using the levels of H3K27Me3, H3K36Me3 and CEA from any and all samples from any and all patients by using any increases, decreases or equal amounts, presence or absence with a correlating to lung cancer.
One cannot extrapolate the teaching of the specification to the enablement of the claims because other than measuring the levels of H3K27Me3, H3K36Me3 and CEA in a human blood, serum or plasma sample and comparing to a cut-off to detect elevated levels of the recited biomarkers, the specification does not teach that any and all samples from any and all patients contain the recited biomarkers which correlate with lung cancer.
A review of the instant specification indicates the following. The specification on page 1 discloses that the invention finds particular use in the detection of lung cancer and therefore can be used in combination with lung cancer screening methods such as LDCT scanning, as a simple confirmation blood-test to rule in or rule out cancer. The specification on page 3 discloses the need for a simple routine cancer blood test. The specification on page 5 discloses a novel blood-based test could offer a simple follow-up confirmation approach to help discriminate between lung cancer and non-malignant nodules. The specification on page 23 discloses obtaining plasma samples from patients (all of which appear to be human). The specification on page 13 discloses that individual assay cut-off levels are used and the patient is considered positive in the panel test if the individual assay results are above the assay cut-offs. The examples in the specification all appear to be directed to the subject being a human and the body fluid sample as being blood, plasma or serum for the detection of the recited biomarkers and a specific correlation of increased levels of all the biomarkers compared to a cut-off as diagnosing lung cancer The specification does not provide data, testing or examples with a showing that any all and all body fluid samples from any and all patients provide the recited biomarkers at levels which can be specifically correlated with lung cancer. Also, Torzewski et al, (Hindawl Publishing Corporation, Mediators of Inflammation, Vol 2014, Articles ID 683598, pages 1-7) teaches for example that CRP (biomarker) is an acute phase reactant in humans but not an acute phase reactant in a mouse (e.g. page 1). Van Der Vekens et al., (Cardiovascular Endocrinology, 2013, Vol 2, No. 4,pages 67-76) teaches that markers between human and equine show important species differences, which can be explained by variations in physiology or pathophysiology and also teaches pathological differences in the species (e.g. abstract).
The only examples utilized in the specification appears to be limited to blood, serum or plasma from a human patient and the measurement of the recited biomarkers wherein increased levels as compared to cut-offs provides for specific correlation to lung cancer. The specification does not disclose that the recited biomarkers which appear in blood also appear in samples such as tears, diarrhea, sputum, plural fluid etc. or that such biomarkers would be expected to be shed, excreted into or found in these samples and correlated with lung cancer. As stated supra the specification appears to be limited to blood, serum or plasma from a human patient and the measurement of the recited biomarkers wherein increased levels as compared to cut-offs provides for specific correlation to lung cancer.
The specification also fails to provide for a correlation of the recited biomarkers in all patients such as dogs, cats, cows, monkey, horse, rabbit squirrel and mice (as shown supra by Torzewski and Van Der Vekens different species of mammal have different expression of biomarkers and do not correlate to the same condition/disease) The specification also fails to provide that the recited biomarkers exist in samples such as saliva, tears, sputum, CSF or diarrhea or that a correlation of these biomarkers exist in such patients with lung cancer. Further, it is not well known in the art that these samples provide for the recited biomarkers and that a correlation exists between such biomarkers in the samples to lung cancer. The examples in the specification appear to be limited to blood, serum or plasma from a human patient and the measurement of of the recited biomarkers wherein increased levels as compared to cut-offs provides for specific correlation to lung cancer. Further, the information of the levels appears to be stuck in a vacuum because the claims do not provide for the use and thus one of skill would not understand how the levels are specifically correlated with lung cancer. Thus, for the reasons stated above one of skill in the art cannot practice the claimed invention without undue experimentation.
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 1-7, 9-18 and 20-21 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 1 is vague and indefinite because although the body of the claim recites “measuring a panel of biomarker levels in a bodily fluid sample” the claim fails to make clear who or what the bodily fluid sample is from. It is unclear if the applicant intends the patient recited in the preamble of the claim or if the applicant intends something else. Applicant is reminded that although the claims are read in light of the specification limitations from the specification are not read into the claims and that the claims must stand on their own merits.
Claim 1 provides for the use of the levels detecting in the body fluid sample,
but, since the claim does not set forth any steps involved in the diagnosis of lung cancer or monitoring of lung method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Thus, it is unclear if the applicant is comparing the levels to something, if specific levels of each biomarker are diagnostic or if the applicant intends something else. See also deficiencies found in claims 9 and 21.
Claim Rejections - 35 USC § 102
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 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.
Claim 22 is rejected under pre-AIA 35 U.S.C. (a)(1) as being anticipated by Foster et al (US 4,444,879).
Foster et al disclose a kit comprising buffer wash solutions (reagents), positive and negative controls (reagents) (e.g. col 15, Fig. 6).
With respect to the recitation “to detect H3K27Me3, H3K36Me3 and CEA" as recited in claim 22 this is intended use of the kit and a recitation of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art and since Foster et al teaches the same components (reagents) as in the instantly recited claims then the kit of Foster et al is capable of use in detecting H3K27Me3, H3K36Me3 and CEA). Thus for the reasons stated above Foster et al reads on the instantly recited claims.
Claim 22 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Micallef et al (WO 2018/0198827) (submitted in the IDS filed 02/12/24).
Micallef et al discloses methods and a kit comprising detecting one or more of CEA and epigenetic features of a cell-free nucleosome such as histone post-translational modification wherein the histone modification is H3K27Me3 and H3K36Me3 (e.g. pgs 5, 27-28, 39). Micallef et al discloses the kit can comprise ligands or specific binders for CEA and the epigenetic feature of the cell free nucleosomes (e.g. pg 39).
Allowable Subject Matter
Claims 1-7, 9-18 and 20-21 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a), and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and 35 U.S.C. 101 set forth in this Office action. The prior art of record does not teach nor fairly suggest detecting the recited biomarkers and specifically correlating the results with lung cancer.
Conclusion
No claims are allowed.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678