DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the claims
The preliminary amendment filed 06/08/23 is acknowledged and has been entered. Claim 1 has been canceled. Claims 2-7 have been amended. New claim 8 has been added. Accordingly, claims 2-8 are pending and under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (e.g. page 9, line 14). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 5 the recitation “one GPI-Aps” should be --one GPI anchored proteins (GPI-Aps) in order to provide a clear indication of what the acronym AGP-AP stands for. 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 2-8 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 diagnosing an inherited glycosylphosphatidylinositol (GPI) deficiency comprising the active method step of measuring a biomarker. The claims are directed to a naturally occurring correlation between the expression of the recited biomarker in a subject with inherited GPI deficiency.
Step 2A, Prong 2
The additional elements of detecting expression of Emm antigen in a sample does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
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 applicant on page 4 of the current specification it is well known routine and conventional in the art to detect the expression of Emm antigen in a sample.
Although the claim invokes administering a Histone deacetylase (HDCA) inhibitor to the subject identified as having an alteration of the expression of the Emm antigen. The claim currently appears to allow for a scenario wherein an alteration would not identify the subject as having inherited GPI deficiency because the alteration can be an increase or decrease and both cannot be an indication of diagnosis. Thus, the claim is open to an embodiment wherein the treatment step would not be performed. Further, the claim as currently recited does not specifically require identifying a specific alteration such as a decrease in the subject and positively diagnosing the subject and then treating the diagnosed subject. Therefore, this scenario does not recite something significantly more than the judicial exception.
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 2-8 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 diagnosing an inherited glycosylphosphatidylinositol (GPI) deficiency in any and all subjects and administering a HDCA inhibitor to the subject having any and all alterations of expression of Emm antigen. 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. Also, the current claim broadly allows for the determination of any and all alterations such as increases, decreases, presence, absence or equal amounts of the biomarker for diagnosing inherited GPI deficiency. 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 the determination of any and all alterations of Emm antigen as being specifically correlated with inherited GPI deficiency 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 9-10 discloses that the inventors shows that the decrease in Emm expression in several IGD patients is indicative of GPI defects and that the findings establish Emm as a novel blood group system and have important implications for understanding the biological function of human free GPI. The specification on page 3, lines 12-14 discloses the present invention is particularly suitable for diagnosing an inherited GPI deficiency when the expression of GPI-anchored proteins is however decreased in the red blood cells of the subject. The specification on page 13 discloses the demonstration that free GPIs are expressed at the human red cell surface. The specification on page 13 discloses that flow cytometry analysis of RCs form a patient showed a strong decrease in Emm expression. Page 15 discloses that the Emm antigen is caried by free GPI at the RBC surface and establish Emm as a novel human blood group system.
The specification does not provide data, testing or examples with a showing that any all and all subjects provide the Emm antigen at any and alterations of expression of Emm can be specifically correlated with inherited glycosylphophatidylinsoitol (GPI) deficiency. 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 subjects that are human and the detection of decreased expression of Emm antigen for a specific diagnosis of inherited GPI deficiency. The specification does not disclose that the Emm antigen which appears in red blood cells of humans also appear in such subjects as cows, dogs, horses, snakes, crickets etc. As stated supra the specification appears to be limited to subjects that are human and the detection of decreased expression of Emm antigen for a specific diagnosis of inherited GPI deficiency.
The specification also fails to provide for a correlation of the recited biomarkers in all patients such as dogs, cats, cows, monkey, horse, rabbit squirrel and mice (as shown supra by Torzewski and Van Der Vekens different species of mammal have different expression of biomarkers and do not correlate to the same condition/disease). The examples in the specification appear to subjects that are human and the detection of decreased expression of Emm antigen for a specific diagnosis of inherited GPI deficiency. 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 Emm antigen in any and all subjects wherein any amount, increase, decrease, presence or absence of the biomarkers is directed correlated with inherited GPI deficiency.
Scope of Enablement
Claims 2-8 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for diagnosing an inherited GPI deficiency in a human subject and treating the subject comprising detecting the expression of Emm antigen in a sample of red blood cells obtained from the subject; detecting a decreased expression of the Emm antigen in the subject in comparison to a reference and administering a Histone deacetylase (HDCA inhibitor) to the subject having the decreased expression of the Emm antigen. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Enablement requires that the specification teach those in the art to make and use the invention without undue experimentation. The factors that must be considered in determining undue experimentation are set forth in In re Wands USPTQ2d 14000. Factors to be considered in determining whether a disclosure would require undue experimentation include (1) the nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the quantity of experimentation necessary, (7) the relative skill of those in the art, and (8) the breadth of the claims.
The instant claims are directed to a method of diagnosing an inherited glycosylphosphatidylinositol (GPI) deficiency in any and all subjects and administering a HDCA inhibitor to the subject having any and all alterations of expression of Emm
One cannot extrapolate the teaching of the specification to the enablement of the claims because other than detecting decreased expression levels of Emm antigen in a human red blood cell sample and comparing to a reference to detect the decreased expression for the diagnosis of inherited GPI deficiency.
A review of the instant specification indicates the following. The specification on page 2, lines 9-10 discloses that the inventors shows that the decrease in Emm expression in several IGD patients is indicative of GPI defects and that the findings establish Emm as a novel blood group system and have important implications for understanding the biological function of human free GPI. The specification on page 3, lines 12-14 discloses the present invention is particularly suitable for diagnosing an inherited GPI deficiency when the expression of GPI-anchored proteins is however decreased in the red blood cells of the subject. The specification on page 13 discloses the demonstration that free GPIs are expressed at the human red cell surface. The specification on page 13 discloses that flow cytometry analysis of RCs form a patient showed a strong decrease in Emm expression. Page 15 discloses that the Emm antigen is caried by free GPI at the RBC surface and establish Emm as a novel human blood group system.
The specification does not provide data, testing or examples with a showing that any all and all subjects provide the Emm antigen at any and alterations of expression of Emm can be specifically correlated with inherited glycosylphophatidylinsoitol (GPI) deficiency. 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 subjects that are human and the detection of decreased expression of Emm antigen for a specific diagnosis of inherited GPI deficiency. The specification does not disclose that the Emm antigen which appears in red blood cells of humans also appear in such subjects as cows, dogs, horses, snakes, crickets etc. As stated supra the specification appears to be limited to subjects that are human and the detection of decreased expression of Emm antigen for a specific diagnosis of inherited GPI deficiency.
The specification also fails to provide for a correlation of the recited biomarkers in all patients such as dogs, cats, cows, monkey, horse, rabbit squirrel and mice (as shown supra by Torzewski and Van Der Vekens different species of mammal have different expression of biomarkers and do not correlate to the same condition/disease). The examples in the specification appear to subjects that are human and the detection of decreased expression of Emm antigen for a specific diagnosis of inherited GPI deficiency. 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 2-8 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 2 the recitation “the subject identified as having” there is insufficient antecedent basis for this limitation.
Allowable Subject Matter
Claims 2-8 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a), and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and 35 U.S.C. 101. The prior art of record does not teach nor fairly suggest detecting Emm antigen in inherited glycosylphophtdylinositiol deficiency subjects and treating the subjects with HDCA inhibitor.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yazer et al., (Transfusion, Vol 46, September 2006, pages 1537-1542) discloses flow cytometric techniques to detect Emm antigen (e.g. abstract).
Daniels et al (Transfusion, Vol. 27, No. 4, 1987, pages 319-321) discloses the EMM antigen and patients having or lacking the antigen (e.g. pages 319-321).
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