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 .
This is the First Office Action on the Merits of US18/596,744 filed on March 6, 2024 which claims US priority benefit of US Provisional 63/489,566 filed on March 10, 2023.
Claims 1-20 are pending and under examination.
Specification
The disclosure is objected to because of the following informalities: In the “Brief Description of the Drawings” section reference is made to the set of Color Drawings, such as indicating (green) or (red) in paragraph 0017. Unless a request for Color Drawings is made and approved, all references in the specification to color drawings should be removed.
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.
Independent claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims recites a method of diagnosing Alzheimer’s disease by measuring the bone marrow density or bone thickness of a subject’s skull, where a reduced BMD or bone thickness compared to a control BMD or bone thickness is indicative of the subject having AD or having an increased risk of AD. The correlation of such physical properties of the subject and AD is considered to be a naturally occurring phenomenon. See the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019).
This judicial exception is not integrated into a practical application because the combination of additional elements fails to integrate the judicial exception into a practical application. For example, the claim is directed to a method of using a naturally occurring correlation to diagnose AD in a subject. The measuring the BMD or bone thickness steps are considered to be data gathering steps required to use the correlation and do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
Further, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements are measuring (data gathering steps) and comparing (mental steps) and, when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception. For example, measuring BMD or bone thickness of a subject’s skull and comparing these values to a control value are well-understood, routine, conventional procedures and mental steps as recognized by the court decisions listed in MPEP § 2106.05(d).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 8 fails to include all the limitations of claim 1 upon which it depends. Claim 1 requires administering to the AD subject a therapeutically effective amount of a parathyroid hormone type 1 receptor (PTH1R) agonist. However, dependent claim 8 appears to require that the administering step is conditional on the results of measuring the BMD or bone thickness of the subject skull compared to a control. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Written Description
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.
Claims 1-6, 8-16, and 18-19 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the full-scope of the claimed invention.
Claims are drawn to a method of treating Alzheimer's disease (AD) in a subject comprising administering to the subject a therapeutically effective amount of at least one parathyroid hormone type 1 receptor (PTH1R) agonist.
Thus, claims require the critically essential element of a genus of PTH1R agonists having the property of being able to treat Alzheimer's disease (AD) in a subject. The treating includes: to increase cognitive function and/or inhibit one or more AD brain pathologies in the subject (claims 2 , 12). The one or more AD brain pathologies include astrocyte senescence, glial cell activation, expression of brain inflammatory cytokines, brain inflammation, systemic inflammation, dystrophic neurites, Aβ accumulation and Aβ deposition (claims 3, 13).
The claims recite a subgenus of the PTHR1 agonist comprises parathyroid hormone (PTH), or a PTH analog (claim 6, 16).
The instant specification is considered to show possession for the structure of the species of PTHR1 agonist which is the human PTH which is an 84-amino acid peptide hormone that is secreted from the parathyroid gland and for the species of PTH analog called PTH1-34 peptide (aka teriparatide) (see instant claims 7 & 17) because these species are well-documented in the state of the prior art as evidenced by Chen et al “Parathyroid hormone and its related peptides in bone metabolism” (Biochemical Pharmacology 2021 Vol 192, No. 114669). See Table 3 & entire article for species of PTH analogs.
However, neither the instant specification nor the state of the prior art discloses a representative set of PTHR1 agonists, including a representative set of types of PTH analogs, so that one of ordinary skill in the art would be able to envision whether a given structure of such species of agonists would possess the required functional properties of the present claims.
The genus of PTHR1 agonists is defined only by the function of binding a PTHR1 but with no structural requirements. The fact pattern in the present case is that even the subspecies of PTH analogs has been determined to be unpredictable regarding the correlation of the structure of a PTH analog to the required function. For example, Chen et al (above) disclose the parathyroid hormone (PTH) is an 84-amino acid peptide hormone that is secreted from the parathyroid gland. Chen et al teaches that “PTH has different administration modes in bone tissues through which it promotes bone formation (intermittent administration) and bone resorption (continuous administration) and has great potential for application in bone defect repair”. Chen et al teaches that PTH regulates bone metabolism by binding to PTH1R. Chen et al teaches that PTH(1-34), aka teriparatide, “has been clinically used but still has some disadvantages” Chen et al state that developing “improved PTH-related peptides is a potential solution to teriparatide’s short-comings”. Chen et al informs that the “action mechanism of these PTH-related peptides is not exactly the same as that of PTH”. (See Abstract; entire article.)
“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.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “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. The invention is, for purposes of the ‘written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that the inventor(s) invented what is claimed.” (See Vas-Cath at page 1116).
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eh Lily & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) (‘In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. ..."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
The court and the Board have repeatedly held (Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.,18 USPQ2d 1016 (CA FC, 1991); Fiers v. Revel, 25 USPQ2d 1601 (CA FC 1993); Fiddes v. Baird, 30 USPQ2d 1481 (BPAI 1993) and Regents of the Univ. Calif. v. Eh Lilly & Co., 43 USPQ2d 1398 (CA FC, 1997)) that an 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, irrespective of the complexity or simplicity of the method; what is required is a description of the nucleic acid itself.
The limited disclosure of the specification in view of the vast genus of PTH1R agonists encompassed by the claims does not adequately describe the entire genus of molecules encompassed by the claims. Thus, one of skill at the time of the invention could not have concluded that the inventor(s) were in possession of the genus of PTH1R agonists as required by the presently claimed invention.
Scope of enablement
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of determining whether a subject has a reduced or decreased bone mass density or bone thickness in the subject’s skull compared to control values of such, does not reasonably provide enablement for diagnosing Alzheimer's disease in a subject by performing such measurements and comparisons. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The Applicants do not teach how to diagnose Alzheimer's disease in a living subject.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors: 1) the quantity of experimentation necessary, 2) the amount of direction or guidance provided, 3) the presence or absence of working examples, 4) the nature of the invention, 5) the state of the prior art, 6) the relative skill of those in the art, 7) the predictability of the art, and 8) the breadth of the claims.
In the present case, the nature of the invention is diagnosing Alzheimer's disease in a living subject.
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
These Wands factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). In the present case, the unpredictability is high as evidenced by the instant Specification. For example, the Specification explicitly states that “[u]nambiguous diagnosis of AD requires clinical findings of cognitive deficits consistent with AD and post-mortem identification of brain pathologies consistent with AD”. (See para 0100.) The Specification states that the term "probable Alzheimer's disease" “is used when a subject demonstrates clinical characteristics of AD and when other possible biological causes of dementia (e.g. Parkinson's disease or stroke) are excluded”. (See para 0100.)
The amount of direction or guidance provided and the presence or absence of working examples: The Specification provides guidance to determining indications of AD in mouse models by measuring bone densities and bone thickness. Specifically,
The bone phenotypes of the AD mouse model and wild-type mice were examined using computed tomography (CT) and evaluated by measuring serum bone formation and resorption markers. It was found that AD-relevant mouse model mice demonstrate an increase in skeletal bone deficits compared to wild-type animals. Bone deficits found to be increased in mouse models of AD compared to wild type animals include reduced bone mass, a decrease in bone formation, a decrease in bone thickness, and an increase in bone resorption. Thus, it is contemplated that the presence of, or measured level of, one or more bone deficits in a subject can be indicative of a subject having or having an increased risk of Alzheimer's disease
The Specification provides no working example of the method of claim 20 for a human subject. The mention of the method of claim 20 is only prophetic.
The quantity of experimentation necessary is considered to be undue because of the known unpredictability of the art (as discussed above) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept the assertion that the method comprising measuring the bone marrow density (BMD) or bone thickness of a subject's skull, wherein a reduced BMD or bone thickness compared to a control BMD or bone thickness is indicative of the subject having Alzheimer's disease or having an increased risk of Alzheimer's disease would in fact diagnose Alzheimer's disease in the subject.
Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and ‘patent protection’ is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable” (42 USPQ 2d 1001, Fed. Circuit 1997).
Accordingly, the instant claims do not fully comply with the enablement requirement of 35 U.S.C. § 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success at diagnosing Alzheimer's disease.
Claims 1-6, 8-16, and 18-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating Alzheimer's disease (AD) in a mouse model subject comprising administering to the subject a therapeutically effective amount of at least one parathyroid hormone type 1 receptor (PTH1R) agonist which is the species of PTH analog called PTH1-34 peptide, does not reasonably provide enablement for the breadth of the treating methods encompassed by the present claims. 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 and use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors: 1) the quantity of experimentation necessary, 2) the amount of direction or guidance provided, 3) the presence or absence of working examples, 4) the nature of the invention, 5) the state of the prior art, 6) the relative skill of those in the art, 7) the predictability of the art, and 8) the breadth of the claims.
In the instant case, the nature of the invention is in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). Claims are drawn to a method of treating Alzheimer's disease (AD) in a subject comprising administering to the subject a therapeutically effective amount of at least one parathyroid hormone type 1 receptor (PTH1R) agonist. The treating includes: to increase cognitive function and/or inhibit one or more AD brain pathologies in the subject (claims 2 , 12). The one or more AD brain pathologies include astrocyte senescence, glial cell activation, expression of brain inflammatory cytokines, brain inflammation, systemic inflammation, dystrophic neurites, Aβ accumulation and Aβ deposition (claims 3, 13).
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
The breadth of the claims: The claims are broad to administering any generic PTH1R agonist to treat Alzheimer's disease (AD) in a subject. PTH1R agonists include PTH analogs.
State of the prior art and level of predictability in the art: The unpredictable state of the art, specifically the unpredictable nature of PTH analogs, is evidenced in Chen et al “Parathyroid hormone and its related peptides in bone metabolism” (Biochemical Pharmacology 2021 Vol 192, No. 114669). The fact pattern in the present case is that even the subspecies of PTH analogs has been determined to be unpredictable regarding the correlation of the structure of a PTH analog to the required function. For example, Chen et al disclose the parathyroid hormone (PTH) is an 84-amino acid peptide hormone that is secreted from the parathyroid gland. Chen et al teaches that “PTH has different administration modes in bone tissues through which it promotes bone formation (intermittent administration) and bone resorption (continuous administration) and has great potential for application in bone defect repair”. Chen et al teaches that PTH regulates bone metabolism by binding to PTH1R. Chen et al teaches that PTH(1-34), aka teriparatide, “has been clinically used but still has some disadvantages” Chen et al state that developing “improved PTH-related peptides is a potential solution to teriparatide’s short-comings”. Chen et al informs that the “action mechanism of these PTH-related peptides is not exactly the same as that of PTH”. (See Abstract; entire article.)
The Guidance in the Specification and Working Example(s): The instant specification is considered to show possession for the structure of the species of PTHR1 agonist which is the human PTH which is an 84-amino acid peptide hormone that is secreted from the parathyroid gland and for the species of PTH analog called PTH1-34 peptide (aka teriparatide) (see instant claims 7 & 17). However, all working Examples are limited to the use of the PTH1-34 peptide in mouse models for AD.
Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and ‘patent protection’ is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable” (42 USPQ 2d 1001, Fed. Circuit 1997).
Accordingly, the instant claims do not fully comply with the enablement requirement of 35 U.S.C. § 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success at treating Alzheimer's disease commensurate with the scope of claimed invention.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim interpretation: The term “subject” is explicitly described in the instant specification as including laboratory animals, including rats and mice (see para 0042).
Regarding the preamble which recites treating Alzheimer's disease a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps 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). M.P.E.P. § 2111.02 informs:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
Claims 1, 4-6, and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al “Parathyroid Hormone Derivative with Reduced Osteoclastic Activity Promoted Bone Regeneration via Synergistic Bone Remodeling and Angiogenesis” Small 16 (6) 2020 e1905876).
Regarding claim 1, Huang et al discloses a method comprising administering to the subject a therapeutically effective amount of the parathyroid hormone type 1 receptor (PTH1R) agonist, specifically a PTH analog PTHrP-2. (See entire document, Abstract; Fig 6).
Regarding claim 4, Huang et al discloses that the PTH1R agonist is administered at an amount effective to increase bone mass, bone density, bone thickness, and bone formation, or decrease bone resorption in the subject. (See entire document, Abstract; Fig 6).
Regarding claim 5, Huang et al discloses that the PTH1R agonist is intermittently administered to the subject. (See entire document, Abstract; Fig 6).
Regarding claim 6, Huang et al discloses that the PTHR1 agonist comprises parathyroid hormone (PTH), or the PTH analog PTH (1-34). (See entire document, Abstract; Fig 6).
Regarding claim 9, Huang et al discloses measuring the Bone Mineral Density or bone thickness by CT analysis. (See Fig 6).
Regarding claim 10, Huang et al discloses subcutaneous injection to the subject. (See page 12; page 1 para 3; page 2, left col..)
Thus, Huang et al anticipates claim 1, 4-6, and 9-10 as presently written.
Claims 1, and 4-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silva et al Parathyroid hormone: anabolic and catabolic actions on the skeleton, Curr Opin Pharmacol, 22 (2015) pages 41-50.
Silva et al discloses a method comprising administering to the subject a therapeutically effective amount of the parathyroid hormone type 1 receptor (PTH1R) agonist, specifically PTH (page 1, para 1 of “Introduction”) and the PTH analog PTH(1-34). (See page 43, Section: “Anabolic actions of PTH: increase in bone formation”; entire document).
Regarding claim 4, Silva et al discloses that the PTH1R agonist is administered at an amount effective to increase bone mass, bone density, bone thickness, and bone formation, or decrease bone resorption in the subject. (See page 43, Section: “Anabolic actions of PTH: increase in bone formation” ; entire document).
Regarding claim 5, Silva et al discloses that the PTH1R agonist is intermittently administered to the subject. (See page 43, Section: “Anabolic actions of PTH: increase in bone formation” ; entire document).
Regarding claim 6, Silva et al discloses that the PTHR1 agonist comprises parathyroid hormone (PTH), or the PTH analog PTH (1-34). (page 41, right col; entire document).
Regarding claim 7, Silva et al discloses that the PTH analog comprises a PTH1-34 peptide. (page 41, right col; entire document).
Thus, Silva et al anticipates claim 1, and 4-7 as presently written.
Claims 1, and 4-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al “Parathyroid hormone and its related peptides in bone metabolism” (Biochemical Pharmacology 2021 Vol 192, No. 114669).
Regarding claim 1, Chen et al discloses a method comprising administering to the subject a therapeutically effective amount of the parathyroid hormone type 1 receptor (PTH1R) agonist, specifically PTH (page 1, para 1 of “Introduction”). Chen et al states that studies have shown that continuous PTH stimulation can lead to bone resorption, whereas intermittent PTH stimulation can lead to bone formation. (page 1, para 1 of “Introduction”).
Regarding claim 4, Chen et al discloses that the PTH1R agonist is administered at an amount effective to increase bone mass, bone density, bone thickness, and bone formation, or decrease bone resorption in the subject. (page 1, para 1 of “Introduction”).
Regarding claim 5, Chen et al discloses that the PTH1R agonist is intermittently administered to the subject. (page 1, para 1 of “Introduction”).
Regarding claim 6, Chen et al discloses that the PTHR1 agonist comprises parathyroid hormone (PTH), or the PTH analog PTH (1-34). (page 1, para 1 of “Introduction”).
Regarding claim 7, Chen et al discloses that the PTH analog comprises a PTH1-34 peptide. (page 1, para 1 of “Introduction”).
Thus, Chen et al anticipates claim 1, and 4-7 as presently written.
Independent claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silva et al Parathyroid hormone: anabolic and catabolic actions on the skeleton, Curr Opin Pharmacol, 22 (2015) pages 41-50.
Regarding independent claim 20, Silva et al discloses a method comprising measuring the bone marrow density (BMD) or bone thickness of a subject's skull. See entire article; page 43 Section Headed: Anabolic actions of PTH: increase in bone formation.
Claim interpretation: The reference does not disclose diagnosing Alzheimer's disease but a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps 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). M.P.E.P. § 2111.02 informs:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
Further, regarding the wherein clause which recites “wherein a reduced BMD or bone thickness compared to a control BMD or bone thickness is indicative of the subject having Alzheimer's disease or having an increased risk of Alzheimer's disease”, note that this clause does not actually recite an active method step of comparing the measurements of the subject’s skull with the control. As written, this phrase is interpreted as describing an inherent property and is generally not afforded patentable weight for purpose of applying prior art.
Thus, Silva et al anticipates claim 20 as presently written.
Conclusion
No claim is allowed.
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CATHERINE S. HIBBERT
Primary Examiner
Art Unit 1658
/CATHERINE S HIBBERT/ Primary Examiner, Art Unit 1658
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