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
Applicant's election with traverse of Group I, claims 1-7 and 13-15, in the reply filed on 05/07/2026 is acknowledged. The traversal is on the ground(s) that the pending claims are linked by a common technical feature of the claimed klotho isoform and its associated therapeutic use. This is not found persuasive because the claimed Klotho isoform of SEQ ID NO: 1 as described in claim 1 is taught by Tarsio et al (US11932676B2) who teaches a sequence represented by SEQ ID NO: 2 of Tarsio which is 98% identical to the instant SEQ ID NO: 1.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-12 and 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/07/2026.
Status of the Claims
Claims 1-7 and 9-18 are currently pending.
Claims 1-7 and 9-15 are amended.
Claims 9-12 and 16-18 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claim 8 is cancelled.
New claims 16-18 have been added.
Claims 1-7 and 13-15 have been considered on the merits.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-7 and 13-15 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 claimed invention.
Claim 1 recites the limitation “or a variant thereof consisting of a sequence at least 85% identical to SEQ ID NO: 1”. The specification describes “a polypeptide consisting of sequence SEQ ID NO: 1” (pg. 3 of Spec), but does not describe a sequence which is at least 85% identical to SEQ ID NO: 1.
The concept of any polypeptide sequence encoding a spliced variant of the Klotho protein consisting of greater than 85% identity to SEQ ID NO: 1, as recited in claim 1, lacks written description other than the polypeptide sequence that is 100% identical to SEQ ID NO: 1. Additionally, dependent claim 5 further limits wherein the polypeptide consists of a sequence having 88% identity to SEQ ID NO: 1. Further, dependent claim 6 further limits wherein the polypeptide consists of a sequence having 98% identity to SEQ ID NO: 1. The art at the time and since the time of filing taught sequences encoding a variant of Klotho that are 100% identical to SEQ ID NO: 1 (See A_Geneseq search results list for SEQ ID NO: 1). The specification does not correlate SEQ ID NO: 1 to any other polypeptide sequences having at least 85% identity that still encode a Klotho protein with the same structural and functional characteristics of SEQ ID NO: 1. The specification teaches that SEQ ID NO: 1 is a 70 KDa size protein containing just the KL1 domain and 15 additional amino acids at the C-terminus (pg. 2). The specification describes that SEQ ID NO: 1 is a spliced variant of the Klotho protein which was “highly unexpected” to provide a benefit to bone density because the art demonstrates that administration of the full length Klotho protein has been known to cause bone toxicity in animals (see pg. 3). The specification does not appear to provide guidance on specific amino acid regions or substitutions which can be made to SEQ ID NO: 1, while retaining the structural and functional characteristics. Further, without guidance it cannot be readily envisioned which 15% can be altered and still retain structure and function. Therefore, the specification demonstrates that without guidance pointing to specific sequences which are at least 85% identical to SEQ ID NO: 1 and retain the same structural and functional characteristics of SEQ ID NO: 1, the concept lacks written description.
There is no evidence on the record of a relationship between the structures of the polypeptide coding for the spliced variant of Klotho and the polypeptide sequence set forth by SEQ ID NO: 1 that would provide any reliable information about the structure of proteins within the genus of variants. The claimed invention as a whole is not adequately described if the claims require essential or critical elements that are not adequately described in the specification and that is not conventional in the art as of applicants effective filing date.
Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641,1646 (1998).
With the exception of the sequence referred to above, the skilled artisan cannot envision the
detailed chemical structure of the encompassed polynucleotides or polypeptides, and therefore
conception is not achieved until reduction to practice has occurred regardless of the complexity or
simplicity of the method of isolation. The skilled artisan cannot envision the detailed chemical structure
of the encompassed nucleic acid molecules and therefore conception is not achieved until reduction to
practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate
written description requires more than a mere statement that it is part of the invention and reference to
a potential method of isolating it. The nucleic acid itself is required. See Fiers v. Revel, 25 USPQ2d 1601
at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483.
In Fiddes, claims directed to mammalian FGF' s were found to be unpatentable due to lack of written
description for that broad class. The specification provided only the bovine sequence.
In view of the above considerations one of skill in the art would not recognize that applicant was
in possession of the necessary common features or attributes possessed by any member of the genus of
the corresponding variants and portions encompassed by the claims. Therefore, only the spliced variant of Klotho encoded by SEQ ID NO: 1, but not the full breadth of the claims meet the written description
provision of 35 U.S.C. §112, first paragraph.
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that “to fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude “the inventor invented the claimed invention”.
Claim Rejections - 35 USC § 112(d)
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 7 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 7 depends from claim 1. Claim 1 recites the limitation of a “polypeptide consisting of sequence SEQ ID NO: 1, or a variant thereof consisting of a sequence at least 85% identical to SEQ ID NO: 1”. The language “consisting of” is closed language and limits claim 1 to sequences which both (i) at least 85% identical to SEQ ID NO: 1 and (ii) are equal to or shorter in length than SEQ ID NO: 1. Claim 7 recites “wherein the polypeptide consists of SEQ ID NO: 2”. SEQ ID NO: 2 is one amino acid longer than SEQ ID NO: 1 and thus is broader than the limitation of claim 1 requiring that the polypeptide be “a variant thereof consisting of a sequence at least 85% identical to SEQ ID NO: 1”.
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.
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.
Claims 1-6 and 13-15 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Tarsio et al (US20200181224A1).
Regarding claim 1, Tarsio teaches a method of treating a bone disorder ([0033]) and/or preventing a bone disorder ([0485] and [0493]) comprising administering a therapeutically effective amount of a polypeptide encoded by SEQ ID NO: 2 of Tarsio which consists of a sequence with 98% identity to SEQ ID NO: 1 and Tarsio teaches that the residues may be specifically residues 1-549 of SEQ ID NO: 2 which meets the closed language of claim 1 (See SEQ ID NO: 2 of Tarsio and [0044]).
Regarding claim 2, Tarsio teaches wherein the bone disorder is bone degeneration and/or bone loss or loss of bone density ([0210]).
Regarding claim 3, Tarsio teaches wherein the bone disorder is age related bone degeneration and/or bone loss ([0210]).
Regarding claim 4, Tarsio teaches wherein the bone disorder is osteopenia and/or osteoporosis ([0380]).
Regarding claim 5, Tarsio teaches administering a therapeutically effective amount of a polypeptide encoded by SEQ ID NO: 2 of Tarsio which consists of a sequence with 98% identity to SEQ ID NO: 1 and Tarsio teaches that the residues may be specifically residues 1-549 of SEQ ID NO: 2 which meets the closed language of claim 1 (See SEQ ID NO: 2 of Tarsio and [0044]).
Regarding claim 6, Tarsio teaches administering a therapeutically effective amount of a polypeptide encoded by SEQ ID NO: 2 of Tarsio which consists of a sequence with 98% identity to SEQ ID NO: 1 and Tarsio teaches that the residues may be specifically residues 1-549 of SEQ ID NO: 2 which meets the closed language of claim 1 (See SEQ ID NO: 2 of Tarsio and [0044]).
Regarding claim 13, Tarsio teaches that the polypeptide is administered in the form of a pharmaceutically acceptable carrier ([0378]).
Regarding claim 14, Tarsio teaches wherein the pharmaceutical composition is administered intravenously ([0189]).
Regarding claim 15, Tarsio teaches wherein the polypeptide is administered in combination with another active agent ([0018]).
Therefore, Tarsio anticipates the claims.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Tarsio et al (US20200181224A1), as applied to claims 1-6 and 13-15 in the 102 rejection above, and in view of Sun et al (US20160120959A1).
Regarding claim 7, the limitations of the independent claim 1 are taught above.
Tarsio does not teach that the polypeptide consists of SEQ ID NO: 2 as required by claim 7.
However, Tarsio teaches that the Klotho polypeptide is administered to treat various conditions including adult onset, age related diabetes along with bone density disorders ([0034]).
Sun teaches that the Klotho protein is known in the art as an anti-aging gene ([0005]). Sun teaches a method of treating a diabetic condition in a patient using a spliced Klotho protein of SEQ ID NO: 9 (see A_Genseq results for instant SEQ ID NO: 2; and Claim 1 of Sun). SEQ ID NO: 9 of Sun is 550 amino acids in length and contains a 99.8% identity to the instant SEQ ID NO: 2 (See A_Geneseq results for instant SEQ ID NO: 2). There is a single conservative substitution in SEQ ID NO: 9 of Sun where Leucine at position 536 is conservatively substituted with valine. The MPEP states at 2144.08(II)4(c) that “the replacement in a protein of one amino acid by another, chemically similar, amino acid... [which] is generally expected to lead to either no change or only a small change in the properties of the protein." Dictionary of Biochemistry and Molecular Biology 97 (John Wiley & Sons, 2d ed. 1989)” (See MPEP 2144.08(II)4(c)). Thus, the single conservative substitution of L536V would be expected to lead to no change or only a small change in the properties of the protein and SEQ ID NO: 9 of Sun renders the instant SEQ ID NO: 2 obvious.
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the method of treating age related disorders including diabetes and bone disorders employing a Klotho protein variant taught by Tarsio with the method of treating diabetic conditions employing a Klotho protein variant taught by Sun to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because both Tarsio and Sun teach the use of a klotho protein variant including the Klotho domain 1 to treat diabetic conditions (see Tarsio [0034] and Sun Claim 1, [0005]) and relate the Klotho protein to anti-aging. One of ordinary skill in the art would have a reasonable expectation of success when combining Tarsio with Sun because both teach administration of a similar variant of the Klotho protein for diabetic disorders and for anti-aging treatments.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
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