DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1, 3-8 and 10-21, drawn to a method of assessing whether a patient has adenomyosis.
Group II, claim 9, drawn to a computer-implemented method.
The inventions listed as groups I-II do not relate to a single general inventive Concept under PCT Rule 13.1 because, under PCT Rule 13.2 they lack the same or corresponding special technical features for the following reasons. Group I is directed to a method comprising determining the amount or concentration of sFRP4 and Group II does not require this limitation. Group II requires receiving at a processing unit a value for the level of sFRP4 and also requires processing the value from a memory one and Group I does not require this limitation. Therefore, there are two different methods requiring different method steps. Under Rule 13 Applicant is entitle to one product, one method of making and one method of using.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Applicant’s election without traverse of Group I, claims 1, 3-8 and 10-21 in the during a telephone conversation with Ryan Hiler, Attorney on February 4th, 2026 is acknowledged.
Currently, claims 1 and 3-21 are pending. Claim 9 is withdrawn as being directed to a non-elected invention. Accordingly, claims 1, 3-8 and 10-21 are 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 present 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 20 is objected to because of the following informalities: Claim 20 the acronym VAS should be spelled out in its first instance. It is recommended to amend the claim to recite --Visual Analog Scale (VAS)--. 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, 3-8 and 10-21 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
Claim 1 describes an abstract idea, law of nature, or natural phenomenon in the preamble of the claim by requiring assessing whether a patient has adenomyosis or is at risk of developing adenomyosis and/or selecting a patient for a therapy of adenomyosis. Claim 4 describes an abstract idea, law of nature, or natural phenomenon in the preamble of the claim by requiring monitoring a patient suffering from adenomyosis or being treated for adenomyosis. The claims are directed to a naturally occurring correlation between the levels of the sFRP4 in a 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 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 “determining the amount of concentration..”. The “determining” statement 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. No active method steps are invoked or clearly required; the “determining” statement does 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 the art below it is well known routine and conventional in the art to measure the amount of sRFP4 in a sample 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, 3-8 and 10-21 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 '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 ‘sample’ represents a genus and encompasses tears, semen, liver, urine, kidney, brain, peritoneal fluid, sputum, synovial fluid, lung tissues or vomit. 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 1 discloses that adenomyosis is a heterogenous gynaecologic condition (Thus, the specification is disclosing disease/condition having to do with the female reproductive system and diseases specific to women and girls). 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 any and all patients 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 all patients such as males, 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 biomarker exists in samples such as lung tissue, kidney tissue, stool, saliva, tears, sputum, CSF or liver tissue or that a correlation of these biomarkers exist in such patients with suspected sepsis. 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 any and all patients wherein any amount, increase, decrease or even equal amount of the biomarker is directed correlated with adenomyosis or therapy of adenomyosis.
Scope of Enablement
Claims 1, 3-8 and 10-21 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for assessing adenomyosis and therapy of adenomyosis in a female human patient comprising measuring an amount of concentration of sFRP4 in a blood, serum or plasma sample from the female human patient and comparing the level to that of a reference wherein an increased amount indicated adenomyosis in the patient. 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 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
One cannot extrapolate the teaching of the specification to the enablement of the claims because other than detecting sFRP4 in a female human blood, serum or plasma sample and comparing to a reference and determining an increased level as compared to the reference as indicating adenomyosis in the patient.
A review of the instant specification indicates the following. The specification on page 1 discloses that adenomyosis is a heterogenous gynaecologic condition (Thus, the specification is disclosing disease/condition having to do with the female reproductive system and diseases specific to women and girls). 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 any and all patients 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 all patients such as males, 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 biomarker exists in samples such as lung tissue, kidney tissue, stool, saliva, tears, sputum, CSF or liver tissue or that a correlation of these biomarkers exist in such patients with suspected sepsis. 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. Thus, one 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, 3-8 and 10-21 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 indefinite in reciting “determining the amount of concentration of sFRP4..” because the term “determining” appears to be a mental step; hence, it is unclear if the applicant actually intends a positive active method step in the claim. It is suggested but not required to delete the term “determining” and replace it with --detecting--.
Claim 3 is indefinite in reciting “wherein a therapy is” because it appears to make reference to a therapy but claim 1 does not recite a therapy. Therefore, it is unclear if a therapy has been given to the patient, if a therapy has been or is intended to be selected for the patient or if the applicant intends something else. Please clarify.
Claim 4, is indefinite in reciting “determining the amount of concentration of sFRP4..” because the term “determining” appears to be a mental step; hence, it is unclear if the applicant actually intends a positive active method step in the claim. It is suggested but not required to delete the term “determining” and replace it with --detecting--.
Claim 18, the recitations “(or fragment thereof)” is vague and indefinite because it is unclear if the recitation contained within the parenthesis () are a part of the claim or not.
Claim 20, the recitation “the VAS scale” there is insufficient antecedent basis for this limitation.
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 1, 3-8, 10-15 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bobadilla et al (WO 2007/128429) (submitted in the IDS filed 11/16/23).
Bobadilla et al discloses a method for diagnosis of a disorder associated with endometrial proliferation in a patient (e.g. abstract, pgs 1-2). Bobadilla et al discloses that the disorder can be adenomyosis (e.g. pg 2). Bobadilla et al discloses determining the level of a protein such as secreted frizzled-related protein 4 (pgs 6-7) and comparing to that of a reference value (e.g. pgs 13, 38). Bobadilla et al discloses that the level can be determined by the use of antibodies and by sandwich immunoassay wherein immobilized antibody is contacted with the sample and incubated and then a second labeled antibody is added to the assay (e.g. pgs 9-10). Bobadilla et al discloses that the sample can be blood, serum or plasma (e.g. page 11). Bobadilla et al discloses that the patient can be a woman (human female) (e.g. para’s 03, 07, 64-69). Bobadilla et al discloses providing a therapy or treatment (e.g. para’s 74-75, 85).
With respect to the recitations “of assessing whether a patient has adenomyosis or is at risk of developing adenomyosis and/or selecting a patient for a therapy of adenomyosis” and “of monitoring a patient suffering from adenomyosis or being treated for adenomyosis”” as recited in claims 1 and 4 respectively. These limitation occurs in the preamble of the claims and thus has not been given patentable weight. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). In the instant case, Bobadilla et al discloses a method of determining the level of SFRP4 for a patient and comparing the determined level to that of a reference. Thus, Bobadilla et al performs every active method step and when every active method step has been performed the prior art method is met.
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.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bobadilla et al in view of Jandreski (Laboratory Medicine, 1998, Vol. 29, No. 9, pages 555-560.
See above for the teachings of Bobadilla et al.
Bobadilla et al differ from the instant invention in failing to teach the detectable label is a chemiluminescent dye such as ruthenium.
Jandreski teaches that it is known and conventional in the art to use 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 method of Bobadilla et al 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 cos 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 method of Bobadilla et al.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Bobadilla et al in view of Jandreski as applied to claims 1, 3-8, 10-17 and 21 above and further in view of Walz (US 2011/0229895) and Diamandis et al., (Immunoassay, Chapter, 11, The Avidin-Biotin System, 1996, pages 237-267).
See above for the teachings of Bobadilla et al and Jandreski.
Bobadilla et al and Jandreski differ from the instant invention in failing to teach both the first and second antibodies are monoclonal antibodies. Bobadilla et al and Jandreski also fails to teach the first antibody is biotinylated.
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 modified method of Bobadilla 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 modified method of Bobadilla et al.
Bobadilla et al, Jandreski 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 Bobadilla 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 Bobadilla et al.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bobadilla et al in view of Georgopoulou et al (US 2022/0155315).
See above for the teachings of Bobadilla et al.
Bobadilla et al differ from the instant invention in failing to teach assessing dysmenorrhea according to VAS scale.
Georgopoulou et al discloses methods of assessing adenomyosis (e.g. para’s 0016-0017, 0103, 0128, 0160). Georgopoulou et al discloses combining the detection of a biomarker with the assessment of dysmenorrhea to provide for the diagnosis (e.g. para 0021, 0092). Georgopoulou et al discloses the dysmenorrhea is assessed by the use of a VSA scale (e.g. para 00920115). Georgopopoulou et al discloses that this allows for increased diagnostic performance (e.g. para 0021).
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 the assessment of dysmenorrhea such as taught by Georgopoulou et al into the method of Bobadilla et al because Georgopoulou et al teaches that this provides for increased diagnostic performance. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating the assessment of dysmenorrhea such as taught by Georgopoulou et al into the method of Bobadilla et al.
Conclusion
No claims are allowed.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678