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 amendment filed 05/20/26 is acknowledged and has been entered. Claims 1, 3-5, 7-8, 11-14, 18 and 20 have been amended. Claims 6 and 10 have been canceled. Claim 2 was previously canceled. Claims 22-25 have been added. Claim 9 remains withdrawn as being directed to a non-elected invention. Accordingly, claims 1, 3-5, 7-8 and 11-25 are under examination.
Withdrawn Rejections
All rejections not reiterated herein, have been withdrawn.
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, 3-5, 7-8 and 11-21 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 sFRP4 in a female human subject with adenomyosis as compared to a reference or to an abstract idea of determining the amount or concentration of sFRP4.
Step 2A, Prong 2
The additional elements of determining the amount or concentration of sFRP4 by contacting the body fluid with at least one antibody that specifically binds to sFRP4 and comparing to a reference does 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 recitation “assessing whether the female human patient has adenomyosis” and “monitoring the female human subject”. The “assessing” and “monitoring” 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 value of sFRP4 or observation of the patient and values without any medical intervention. No active method steps are invoked or clearly required; the “assessing” and “monitoring” 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.
With respect to the recitation “selecting a therapy..” (as recited in claim 3). The “selecting” reads on a mental step or thinking of what therapy to use and also allows for verbal communication and does not provide a positive medical intervention of the patient.
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 the art below it is well known routine and conventional in the art to measure the amount of sRFP4 in a sample by immunoassay and compare it to a reference.
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, 3-5, 7-8 and 11-21 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 instant claims are directed to a method of assessing whether any patient has adenomyosis or is at risk of developing adenomyosis and/or selecting any patient for a therapy of adenomyosis or monitoring any and all patients suffering from adenomyosis by determining the amount or concentration of sFRP4 in any and all samples from any and all subjects and comparing the amount or concentration to a reference. The limitation ‘body fluid sample’ represents a genus and encompasses tears, semen, urine, pericardial fluid, peritoneal fluid, synovial fluid, liquid stool sweat and saliva to name a few. Also, the current claim broadly allows for the determination of any and all increases, decreases or equal amounts of sFRP4 for assessing adenomyosis, risk for adenomyosis, selection for therapy or monitoring of adenomyosis. 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’, ‘sample’, and the comparison amount of the biomarker 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 3 discloses that a non-invasive blood test would allow medical assessment of adenomyosis without a need for imaging device. The specification on page 6, lines 23-25 discloses that we show for the first time that sFRP4 measured in blood is increased in women with adenomyosis compared to controls. The specification on page 24 discloses that an elevated amount of sFRP4 is indicative of the presence or the risk of developing adenomyosis and discloses that the sample is a whole blood, serum or plasma sample. The specification on pages 33-34 discloses the testing of serum in women (humans) for sFRP4 and a correlation with adenomyosis. The specification does not provide data, testing or examples with a showing that any all and all samples from from females provide the recited biomarker at levels which can be specifically correlated with adenomyosis. 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 female patients that are human and the detection of sFRP4 in blood, serum or plasma samples from the patients for analyzing adenomyosis wherein an increased level or concentration compared to a reference indicates adenomyosis. The specification does not disclose that sFRP4 which appears in blood, serum or plasma also appears in samples such as stool, tears lung, brain, sputum, plural fluid etc. or that such proteins would be expected to be shed, excreted into or found in these samples and correlated with adenomyosis. As stated supra the specification appears to be limited to human female patients and the detection of sFRP4 levels in blood, serum or plasma samples from the patients wherein an increased level or concentration compared to a reference indicates adenomyosis.
The specification also fails to provide for a correlation of the recited biomarker in in samples such as tears, semen, urine, pericardial fluid, peritoneal fluid, synovial fluid, liquid stool sweat and saliva or that a correlation is provided in all body fluid sample with adenomyosis. 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 adenomyosis. The examples in the specification appear to be limited to female patients that are human and the detection of sFRP4 in blood, serum or plasma samples from the patients for analyzing adenomyosis wherein an increased level or concentration compared to a reference indicates adenomyosis. 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 measurement of sFRP4 in any and all samples from female human patients wherein any amount, increase, decrease or even equal amount of the biomarker is directed correlated with adenomyosis or therapy of adenomyosis.
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.
Claims 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schuitemaker et al (US 2018/0059122).
Schuitemaker et al discloses a method of quantifying sFRP4 in a body fluid sample from a female human patient (e.g. abstract, para’s 0013, 0029). Schuitemaker et al discloses that the sample can be a serum sample (e.g. para’s 0011, 0025, 0036, 0039). Schuitemaker et al discloses obtaining the sample from the patient and detecting the level of the sFRP4 by performing a sandwich immunoassay comprising a first antibody specific for sFRP4 and a second specific antibody which can be detectably labeled (e.g. 0029). Schuitemaker et al discloses that the antibodies to be used can be monoclonal antibodies (e.g. para’s 0052, 0066). Schuitemaker et al teaches that the level can be compared to that of a reference (e.g. para 0004).
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.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Schuitemaker et al in view of further in view of Walz (US 2011/0229895) and Diamandis et al., (Immunoassay, Chapter, 11, The Avidin-Biotin System, 1996, pages 237-267) and further in view of Jandreski (Laboratory Medicine, 1998, Vol. 29, No. 9, pages 555-560.
See above for the teachings of Schuitemaker et al.
Schuitemaker et al differs from the instant invention in failing to explicitly teach both antibodies are monoclonal and that the first antibody is biotinylated. Schuitemaker et al also fails to teach the detectable label is a chemiluminescent dye such as ruthenium.
Walz teaches immunoassays for the detection of sFRP4 in a sample (e.g. para 0026, 0028). Walz teaches the immunoassay can be a sandwich immunoassay (e.g. para’s 0025, 0037). Walz teaches that monoclonal antibodies can be used for the detection of sFRP4 and that monoclonal antibodies are the preferred antibodies (e.g. para 0026).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate monoclonal antibodies such as taught by Walz into the method of Schuitemaker et al because Walz teaches that monoclonal antibodies for sFRP4 are known and conventional in the art and are preferred to that of polyclonal antibodies. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating monoclonal antibodies for the capture and detection antibodies in the method of Schuitemaker et al.
Schuitemaker et al, and Walz fail to teach the first antibody is biotinylated.
Diamandis et al disclose methods of developing immunoassays utilizing binding components such as avidin/biotin. Diamandis et al disclose biotinylated capture antibody which is immobilized to a solid support by avidin (e.g. p. 259, Fig. 11.8). Diamandis et al discloses that at least two molecules of biotin are possessed by the antibody (fig 11.8). Diamandis et al discloses that the use of such reagents improves greatly the performance of immunoassay systems usually manifested in either by substantial amplification of the signal and consequent sensitivity of the assay or simply by convenience (p. 237). Diamandis et al also teaches that the use of such reagents also provides for more control over the immobilization procedure (p. 255) and also improves the general applicability and versatility of a given assay (p. 255-256).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate biotin and avidin such as taught by Diamandis et al for the solid support and capture antibody in the modified method of Schuitemaker et al because Diamandis et al shows that it is known in the art of immunoassays to incorporate such reagents to greatly improve the performance of immunoassay systems and to provide for more control over the immobilization procedure and also improve the general applicability and versatility of a given assay and to improve signal. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating biotin and avidin such as taught by Diamandis et al for the solid support and capture antibody in the modified method of Schuitemaker et al.
Schuitemaker et al., Walz et al and Diamandis et al differ from the instant invention in failing to teach the detectable label is a chemiluminescent dye such as ruthenium that is electrogenerated.
Jandreski teaches that it is known and conventional in the art to use electrogenerated chemiluminescence immunoassays for the detection of a biomolecule (e.g. abstract). Jandreski teachers that it is known and conventional to use a chemiluminescent label such as ruthenium (e.g. pages 557 and 559). Jandreski teaches that this provides for a detection system that offers high sensitivity, a large linear response, relative high speed for analysis, reagent stability, low cos and low toxicity of reagents involved (e.g. conclusion pg 560).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate chemiluminescent immunoassays such as taught by Jandreski into the modified method of Schuitemaker et al because Schuitemaker et al teaches that the assay can be chemiluminescent and because Jandreski shows that it is well known and conventional and provides for a detection system that offers high sensitivity, a large linear response, relative high speed for analysis, reagent stability, low cost and low toxicity of reagents involved. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating chemiluminescent immunoassays such as taught by Jandreski into the modified method of Schuitemaker et al.
Response to Arguments
Applicant's arguments filed 05/20/26 have been fully considered but they are not persuasive.
101 Rejections:
Applicant argues independent claims 1 and 4 to explicitly recite an in vitro method requiring that the amount or concentration of sFRP4 be determined "by contacting the body fluid sample with at least one antibody, or antigen-binding fragment thereof, that specifically binds sFRP4." These amendments make clear that the determining step is a concrete laboratory procedure requiring physical reagents, physical contact between a biological sample and a specifically-binding antibody, and the formation of a detectable antibody-antigen complex - not a mental process.
This argument is not found persuasive because although the amended claim now makes clear that the determining step is not a mental step, the determining step as now recited is considered an additional element that does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Applicant further argues that the amended claims impose meaningful limits on any judicial exception that go well beyond merely observing a natural correlation. The claims require: (1) an in vitro method context excluding in vivo or mental processes; (2) physical contact between a body fluid sample from a defined patient population (female human) and a specifically-binding antibody reagent; (3) a quantitative determination of sFRP4 amount or concentration; (4) a comparison of the determined amount or concentration to a defined reference; and (5) an affirmative assessment/monitoring step based on the result of the comparison. This multi-step in vitro workflow, applied to a clinically defined patient population and directed toward a specific clinical output, integrates any judicial exception into a practical application. This is precisely the type of practical application that Step 2A, Prong Two is designed to protect.
This argument is not found persuasive because as stated supra the step of determining the concentration of sFRP4 in a body fluid sample by contacting with an antibody is considered to be an additional element that does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The comparing step is in and of itself an abstract idea because for example determining an increase or decrease can be performed mentally. Further, as shown by the art it is well known routine and conventional to compare a level to that of a reference. No active method steps are invoked or clearly required; the “assessing” and “monitoring” 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.
Applicant argues that the dependent claims add specific limitations that further support patent eligibility. Applicant states that claim 5 recites the specific clinical correlation (elevated amount indicative of adenomyosis presence), tying any judicial exception to a specific clinical output. Claim 7 restricts the body fluid sample to blood, serum, or plasma, anchoring the claimed method to the specific sample types validated in the working example. Claims 11-17 require the additional physical steps of performing an immunoassay, including specifically sandwich immunoassay formats with detectably labeled antibodies, adding further concrete physical limitations to the method. Claim 18 requires biotinylated and ruthenylated monoclonal antibodies, anchoring the method to a specific antibody architecture. Claim 21 specifies particular immunoassay types (ELISA, EIA, RIA, and assays based on detection of luminescence, fluorescence, chemiluminescence, or electrochemiluminescence) Claims 19 and 20 add a further physical clinical assessment (dysmenorrhea and/or lower abdominal pain assessment, by Visual Analog Scale per amended claim 20). These additional limitations further integrate any judicial exception into a practical application and/or constitute significantly more than any judicial exception.
This argument and statements are not found persuasive because the specific clinical correlation is the judicial exception. The remaining elements of immunoassays and detectable labels and antibodies are all considered to be additional elements and taken as a whole, are considered insignificant extra-solution activity and are insignificant steps of gathering data and the use of such immunoassays and reagents for determining the levels of sFRP4 are all known and conventional steps. These additional elements do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Written Description 112(a) rejections:
Applicant argues that the amended claims are fully supported by the specification and that the amendments directly address the Office’s concerns regarding the breadth of “sample” and that the body fluid limitations is expressly disclosed in para’s 0101, 0124, 0146 and identifies the unmet clinical need addressed by a non-invasive body-fluid-based test.
This argument is not found persuasive because the instant claims are directed to a method of assessing whether a patient has adenomyosis and broadly reads on embodiment of measuring the sFRP4 in samples such as tears, semen, urine, pericardial fluid, peritoneal fluid, synovial fluid, liquid stool sweat and saliva to name a few. The instances of paragraphs 0101, 0124, 0146 may mention body fluid but does not provide any other example other than that of blood, serum or plasma. As stated supra and in the previous office action the specification does not provide data, testing or examples with a showing that any all and all samples from females provide the recited biomarker at levels which can be specifically correlated with adenomyosis. The specification on page 6, lines 23-25 discloses that we show for the first time that sFRP4 measured in blood is increased in women with adenomyosis compared to controls. The specification does not provide evidence that a biomarker such as sFRP4 which is increased in human female subjects is also expected to be increased at levels in body fluid samples such as tears, pericardial fluid, synovial fluid etc. The instant claims are not merely directed to a method of detection but also much have the very specific limitation of being correlated with adenomyosis and the Applicant has not shown possession of such a broad genus of body fluids that provide the unique capability of having increased levels of sFRPe with a specific correlation with adenomyosis. All examples are specifically directed to the use of serum, blood or plasma. Also, the Applicant has failed to address that the currents claim broadly allows for the determination of any and all increases, decreases or equal amounts of sFRP4 for assessing adenomyosis, risk for adenomyosis, selection for therapy or monitoring of adenomyosis. The only examples in the specification are limited to determining increased levels as compared to that of a control for the assessment of adenomyosis. The specification does not provide a single example of determining an equal amount to the reference or a decrease compared to the reference and providing a very specific correlation with adenomyosis. Therefore, the currently amended claims are not supported by the current specification. To be supported it would need to provide evidence, data or examples of body fluid different than that of blood, serum or plasma and why one would expect a biomarker found in blood, serum or plasma to be elevated in any and all possible body fluids and that any and all increases, decreases, equal amounts compared to that of a reference are specifically and unequivocally correlated with adenomyosis.
Applicant remaining arguments are moot in view of the new grounds of rejection.
Allowable Subject Matter
Claims 1, 3-5, 7-8 and 10-21 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a), and 35 U.S.C. 101, set forth in this Office action. The prior art of record does not teach nor fairly suggest detecting the amount or concentration of sFRPE comparing to a reference and correlating the results with adenomyosis as currently recited.
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 GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678
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