8Notice 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 without traverse of Group II (7-12) in the reply filed on 8/27/26 is acknowledged.
Claim Interpretation
Examiner notes that the limitation “measurement reagent” as used by Applicant is defined to not include the urine in the biological sample, as stated in Applicant’s disclosure in paragraph 005 in the PreGrant Publication US 20240369543.
“The measurement reagent of the present invention does not include urine itself or diluted urine for diluting a biological sample. Those in which the uric acid content is adjusted by adding uric acid or a salt thereof to urine are within the scope of the present invention.” Para. 0059.
Claim Objections
Claim 7 is objected to because of the following informalities: “uric acid or its salt, or a reagent containing uric acid or its salt” should be –a measurement reagent comprising uric acid or its salt--. Appropriate correction is required.
Examiner notes that while “measurement reagent” as used by Applicant in the specification is defined to not include the urine in the biological sample, using this term [the “measurement reagent”] in the claims will make more clear that the uric acid or its salt is not from the urine or biological sample itself. Also using the term –comprising-- [rather than “containing”] would make more clear whether the limitation is open or closed to other materials.
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.
Claim 10 is 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claims require an antibody that binds to a cross-linked N-telopeptide of type I collagen or an antibody fragment thereof.
The specification does not describe which amino acid residues, nucleic acid residues or other molecular components are responsible for the functions claimed. Rather, the specification states that these potential agents must first be screened in an assay to ascertain if the agents have the functions required by the instant claims. Although the specification provides a few examples of potential generic agents, it fails to disclose the structures common to all members of the genus of peptides encompassed by the broad definition provided by applicant. The specification does not disclose the structure of all of the claimed variant agents and fails to disclose which regions of the agents are responsible for the functions claimed. In the absence of a known or disclosed correlation between structure and function, claims which encompass variants defined by their function are generally not considered described.
Applicant is directed to MPEP § 2163 for guidelines on compliance with the written description requirement. Here, applicant has not described a reasonable number of members of the genus of agents that bind to a cross-linked N-telopeptide of type I collagen, i.e. the required starting materials for the claims, but rather has presented the public with an idea of how to perform an assay that might identify some peptides that fall within the scope of the claim. Of course, depending on what agents are used in the screening assay, it may well identify none. The Court of Appeals for the Federal Circuit addressed claims of this sort in great detail in University of Rochester v. G.D. Searle and Co. (69 USPQ 2nd 1886, CAFC 2004). In Rochester, the Federal Circuit upheld the district court's ruling that patent claims which recited administration of compounds not disclosed, but rather to be identified in a screening assay, were invalid on their face.
Regarding the scope of the claims that includes antibodies that bind to a cross-linked N-telopeptide of type I collagen, the specification does not describe the structure of the full genus of antibodies responsible for each of the functions claimed. The Federal Circuit has clarified Written Description as it applies to antibodies in the recent decision Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. 112(a) (or pre-AIA first paragraph) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called “newly characterized antigen” test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the “newly characterized antigen” test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad, 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of an antigen alone is not considered adequate written description of a claimed antibody to that antigen, even when preparation of such an antibody is routine and conventional. Id.
While generically the structure of antibodies is known, the structure of the presently recited antibodies can vary substantially within the above given claimed recitations. As noted in Amgen, knowledge that an antibody binds to a particular epitope on an antigen tells one nothing at all about the structure of the antibody, wherein “instead of analogizing the antibody-antigen relationship to a ‘key in a lock,’ it [is] more apt to analogize it to a lock and ‘a ring with a million keys on it.” (Internal citations omitted). The relevant antibody art confirms this quandary, indicating that “knowledge of an epitope or antigen used to generate a monoclonal antibody is insufficient for making the original antibody available, even if suitable in vitro test systems for screening are used.” See p. 8, lines 3-5 of WO 2009/033743 A1. Therefore, those of skill in the art would not accept that the inventor had been in possession of the full genus of antibodies presently claimed.
Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Abbvie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (759 F.3d 1285 (Fed. Cir. 2014). “When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005).
Consequently, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of binding agents (including antibodies) nor guidance as to which of the myriad of molecules encompassed by the binding agents would meet the limitations of the claims. Further, given the well-known high level of polymorphism of immunoglobulins and antibodies, the skilled artisan would not have recognized that applicant was in possession of the vast repertoire of antibodies encompassed by the claimed invention.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991), 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 [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed chemical structure of the genus of binding agents, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of identification. 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 compound 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 (Fed. Cir. 1991). Therefore, the instant claims do not meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Claim Rejections - 35 USC § 112
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 7-14 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 7 recites:
“An immunoassay method for a cross-linked N-telopeptide of type I collagen, comprising:
a contacting step of bringing a biological sample into contact with uric acid or its salt, or a reagent containing uric acid or its salt.
However, claim 7 does not recite any step for assaying “cross-linked N-telopeptide of type I collagen” (such as step(s) recited in claim 10.
Thus it is not clear as to whether or not the method of claim 7 requires step(s) that actually detect the presence or quantity of cross-linked N-telopeptide of type I collagen, and what those steps include. Therefore claim 7 is vague and indefinite.
Claims 8-12 do not cure this deficiency, and therefore are vague and indefinite for the same reasons.
Examiner notes that claim 10 recites steps of contacting the biological sample with an antibody that binds to cross-linked N-telopeptide of type I collagen and a labeling substance. However, the claim remains unclear as to a detection step [for example, the claim remains unclear as to whether the claim encompasses mere detection of cross-linked N-telopeptide of type I collagen and/or its quantity.]
Claim 11 recites “during antibody-antigen reaction” in line 2. The claim is vague as to whether and what antibody-antigen reaction is required.
Claim 12 recites in lines 1-2 “the signal or a measured value of the cross-linked N-telopeptide of type I collagen”. The claim lacks antecedent basis for this limitation.
For examination purposes, claims 7-12 are interpreted to require a step of measuring a labeling substance to detect the presence of a cross-linked N-telopeptide of type I collagen.
Claim Rejections - 35 USC § 103
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(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 2098864 (hereinafter “Takahashi”).
Applicant’s claim 13 recites:
“A method for preparing a measurement reagent for a cross-linked N-telopeptide of type I collagen, comprising: adding uric acid or its salt to a solvent.”
Examiner notes that claim 13 does not actually require detecting cross-linked N-telopeptide of type I collagen. Examiner notes that claim 13 merely requires preparing the recited reagent, which is capable of performing the intended use of being a reagent for a cross-linked N-telopeptide of type I collagen, which Examiner notes is broad and does not require the ability to allow for detection of cross-linked N-telopeptide of type I collagen.
Claim 14 recites “wherein the solvent is a buffer.”
Thus the disclosures of Takahashi below meets Applicant’s claims 13 and 14.
Takahashi teaches the following.
“Further, the present invention provides a method for immunologically measuring the quantity of a urine component, comprising the following steps:
(a) adding a reaction reagent to a urine sample or a mixed solution of a urine sample and a diluting solution to generate a reaction solution and then measuring either the change caused by immunological reaction or the reaction product;
(b) adding the reaction reagent to a standard solution or a mixed solution of a standard solution and a diluting solution to generate a reaction solution and then measuring either the change caused by immunological reaction or the reaction product; and
(c) comparing the measurement results of (a) to the measurement results of (b) to determine the quantity of the urine component in the urine sample,
wherein at least one reagent selected from the group consisting of the diluting solution, the standard solution and the reaction reagent contains at least one substance selected from the group consisting of urea, potassium thiocyanate, guanidinium hydrochloride, imidazole, hydantoin, hippuric acid and sodium urate, and the above-mentioned substance is contained in the reaction solution generated in (b).” Para. 0013 (emphasis added).
Examiner notes that the Takahashi reaction reagent being urea meets Applicant’s claimed limitation of uric acid since urea comprises uric acid. The Takahashi dilution solution meets Applicant’s claimed limitation of a solvent (as recited in claim 13).
As to Applicant’s claim 13, Takahashi discloses in paragraph 0049:
“When a reaction reagent containing the above-mentioned substances is used as a reagent for measuring urine components, purified water, normal saline or a buffer solution may be used to dilute the urine sample.” Thus Takahashi discloses adding urea [which contains uric acid] to a solvent that is a buffer.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Osteomark NTx Urine. 2019 [reference cited by Applicant in IDS of 3/27/24].
This reference discloses an Enzyme-linked immunosorbent assay for the measurement of cross-linked N-telopeptides of Type I Collagen (NTx) in human urine (see title and first page). However, Examiner does not find that this reference teaches providing uric acid or its salt to a biological sample or urine sample in a method that detects the presence or quantity of cross-linked N-telopeptides of Type I Collagen (NTx).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Montgomery whose telephone number is (571)272-0894. The examiner can normally be reached Mon-Fri, 9-5:30 PM PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Greg Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Ann Montgomery/Primary Examiner, Art Unit 1678
Prosecution Insights