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 1-13, drawn to a method for diagnosis of Alzheimer’s Disease (AD).
Group II, claims 14-15, drawn to use of a product.
The groups of inventions listed above 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: The groups do not have a common technical feature. Group II requires Y box binding protein-1 and Group I, claim 1 does not even require this feature.
Further, as shown by Mertens (US 2008/0311116) products comprising YB-1 are known in the art (e.g. abstract).
There are no special technical features tying the inventions together.
During a telephone conversation with Ashley Gregory on behalf of Christopher Nichols, Attorney on 02/10/26 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 1 is objected to because of the following informalities: Claim 1, step (i), the recitation “determining level” should be --determining a level--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Claim 1, step (iI), the recitation “derived from subject” should be --derived from a subject--. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: Claim 5, line 2, the recitation “selected from the group of” should be --selected from the group consisting of--. 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 1-13 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 is directed to a naturally occurring correlation between the levels of antibodies against Y-box binding protein-1 (YB-1) in a subject with Alzheimer’s disease compared to that of a control level.
Step 2A, Prong 2
The additional elements of comparing to a control does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Further, given its broadest reasonable interpretation “comparing” reads on a mental step and thus is an abstract idea.
Also, with respect to the recitation “wherein an increased level in the sample from the subject to be diagnosed as compared to the control level is indicative of AD in the subject to be diagnosed”. The “wherein” 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 level of YB-1 antibodies being correlated with Alzheimer’s disease. No active method steps are invoked or clearly required; the “wherein” 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 both Morgenroth et al (Cancers 2020, 12, 3507, pages 1-17) and Woody (2024/0228623) it is well known, routine and conventional in the art to determine a level of YB-1 autoantibodies as compared to that of a control (e.g. Morgenroth et al abstract, pg. 5) (Woody, para’s 00174-00178, Fig 1).
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 1-13 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 for diagnosis of Alzheimer’s Disease (AD) in any and all subjects by determining a level of antibodies against YB-1 in any and all samples from the any and all subjects and comparing the level in the sample to that of a control level wherein an increased level is indicative of AD. The limitation 'subject’ 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 and vomit to name a few. 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 ‘subject’ and ‘sample’ 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 2, lines 15-16 discloses to date meaningful biomarkers for diagnosis of AD e.g. blood samples are missing. The specification on page 3, lines 8-11 discloses that the anti-YB-1 auto-antibodies are detected are typically whole blood, serum or plasma samples. However, the samples may also be cerebrospinal fluid. The specification on page 10 discloses the sample as plasma or serum. The specification on page 5, line 30, and pages 6-7 discloses that the subject is human. The specification on page 15, lines 15-30 discloses the subject is human. The examples on pages 22-23 in the specification all appear to be directed to patients that are human and the detection of increased anti-YB-1 antibodies in serum samples obtained from the subject for diagnosing Alzheimer’s Disease (AD). The specification does not provide data, testing or examples with a showing that any all and all biological samples from any and all subjects provide the recited antibodies at levels which can be specifically correlated with AD. 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 human patients and the detection of YB-1 autoantibodies in blood, serum, plasma or cerebrospinal fluid (CSF) samples from the patients for diagnosing AD. The specification does not disclose that the recited antibodies which appear in blood, serum, plasma or CSF also appear in samples such as stool, tears lung, brain, sputum, plural fluid etc. or that such antibodies would be expected to be shed, excreted into or found in these samples and correlated with AD. As stated supra the specification appears to be limited to human patients and the detection of YB-1 autoantibodies in blood, serum, plasma or cerebrospinal fluid (CSF) samples from the patients for diagnosing AD.
The specification also fails to provide for a correlation of the recited antibodies 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 lung tissue, kidney tissue, stool, saliva, tears, sputum, or liver tissue or that a correlation of these biomarkers exist in such patients with AD. Further, it is not well known in the art that these samples provide for the recited antibodies and that a correlation exists between such antibodies in the samples to AD. The examples in the specification appear to be limited to human patients and the detection of YB-1 autoantibodies in blood, serum, plasma or cerebrospinal fluid (CSF) samples from the patients for diagnosing AD. 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 antibodies in any and all samples from any and all subjects/patients wherein increased levels compared to that of a control are indicative of AD.
Scope of Enablement
Claims 1-13 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for detecting the level of YB-1 autoantibodies in a human patient suffering from AD comprising obtaining a blood, serum, plasma or cerebrospinal fluid sample from the patient, comparing the level to that of a control level of YB-1 autoantibodies; wherein an increased level in the sample from the subject compared to that of the control indicates AD. 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 for diagnosis of Alzheimer’s Disease (AD) in any and all subjects by determining a level of antibodies against YB-1 in any and all samples from the any and all subjects and comparing the level in the sample to that of a control level wherein an increased level is indicative of AD.
One cannot extrapolate the teaching of the specification to the enablement of the claims because other than detecting B2MG in a human serum or plasma sample and comparing to a control survivor patient suffering from cardiogenic shock and determining an increased level as compared to the control as indicating mortality risk in the patient.
A review of the instant specification indicates the following. The specification on page 2, lines 15-16 discloses to date meaningful biomarkers for diagnosis of AD e.g. blood samples are missing. The specification on page 3, lines 8-11 discloses that the anti-YB-1 auto-antibodies are detected are typically whole blood, serum or plasma samples. However, the samples may also be cerebrospinal fluid. The specification on page 10 discloses the sample as plasma or serum. The specification on page 5, line 30, and pages 6-7 discloses that the subject is human. The specification on page 15, lines 15-30 discloses the subject is human. The examples on pages 22-23 in the specification all appear to be directed to patients that are human and the detection of increased anti-YB-1 antibodies in serum samples obtained from the subject for diagnosing Alzheimer’s Disease (AD). The specification does not provide data, testing or examples with a showing that any all and all biological samples from any and all subjects provide the recited antibodies at levels which can be specifically correlated with AD. 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 human patients and the detection of YB-1 autoantibodies in blood, serum, plasma or cerebrospinal fluid (CSF) samples from the patients for diagnosing AD. The specification does not disclose that the recited antibodies which appear in blood, serum, plasma or CSF also appear in samples such as stool, tears lung, brain, sputum, plural fluid etc. or that such antibodies would be expected to be shed, excreted into or found in these samples and correlated with AD. As stated supra the specification appears to be limited to human patients and the detection of YB-1 autoantibodies in blood, serum, plasma or cerebrospinal fluid (CSF) samples from the patients for diagnosing AD.
The specification also fails to provide for a correlation of the recited antibodies 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 lung tissue, kidney tissue, stool, saliva, tears, sputum, or liver tissue or that a correlation of these biomarkers exist in such patients with AD. Further, it is not well known in the art that these samples provide for the recited antibodies and that a correlation exists between such antibodies in the samples to AD. The examples in the specification appear to be limited to human patients and the detection of YB-1 autoantibodies in blood, serum, plasma or cerebrospinal fluid (CSF) samples from the patients for diagnosing AD. 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 1-13 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, step (i) is indefinite in reciting “determining the level of antibodies…” because the term “determining” appears to intend a mental step; hence, it is unclear if 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 5 contains the trademark/trade name luminex. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe immunoassays and, accordingly, the identification/description is indefinite.
Claim 5, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(h). The term optionally means "not required or mandatory". For example, a composition comprising A, B, C, and optionally D means that component D can or cannot be present (D is not required to be present). In the rejected claim 5, however, it appears the use of "optionally" is an attempt to define "preferred" embodiments or limitations. For example, claim 5 states “…optionally a luciferase assay”. In this instance, the term optionally does not make sense given the definition of optionally (not required or mandatory). Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
Claim 9 recites a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation10-19, and the claim also recites 12-19 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 9 recites a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation10-30, and the claim also recites 12-24 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 9, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(h). The term optionally means "not required or mandatory". For example, a composition comprising A, B, C, and optionally D means that component D can or cannot be present (D is not required to be present). In the rejected claim 9, however, it appears the use of "optionally" is an attempt to define "preferred" embodiments or limitations. For example, claim 9 states “…optionally 12 to 19” and “optionally 12 to 24”. In this instance, the term optionally does not make sense given the definition of optionally (not required or mandatory). Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
Allowable Subject Matter
Claims 1-13 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, 35 U.S.C. 112(a), and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. The prior art of record does not teach nor fairly suggest detecting antibodies against Y-box protein-1 (YB-) antibody levels and correlating increased levels with AD as currently recited.
Conclusion
No claims are allowed.
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