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 .
DETAILED ACTION
Election/Restrictions
1. Applicant’s election without traverse of Group I (claims 1-14) in the reply filed on 10/27/25 is acknowledged.
2. The requirement is still deemed proper and is therefore made FINAL.
3. Claims 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/27/25. Currently claims 1-14 are under consideration.
Priority
4. The instant application has a priority date of December 26, 2019. This application is a 371 of PCT/IB2020/062434 filed on 12/24/2020, U.S. Provisional Application No. 62/953,685 filed 12/26/2019, and Foreign Application No. 10-2020-0173808 filed on 12/11/2020 in the REPUBLIC OF KOREA.
Information Disclosure Statement
5. 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 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper."
Therefore, unless the Examiner on form PTO-892 or Applicant on PTO-1449 cited the references they have not been considered.
6. The Information disclosure Statements (IDSs) filed on 6/24/22 and 10/27/25 have been considered as to the merits before the First Action.
Claim Objections
7. Claims 1-11, 13, and 14 are objected to because of the following informalities: The claims utilizes several acronyms “Fc, VH3, IgG, and scFv” without first defining what it represents in the independent claim. While the claims can reference acronyms, the material presented by the acronym must be clearly set forth at the first use of the acronym. Although the term may have art recognized meaning, it is necessary to define the acronym to clearly set forth Applicant’s intent. For example, Fc is fragment crystallizable as defined on page 3 of the specification. However, Applicant is cautioned not to introduce new matter into the claims. Appropriate correction is required
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.
8. Claims 1-14 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 pre-AIA the applicant regards as the invention.
A. Claim 1 is vague and indefinite because it is not clear as to how many human VH3 domains are in the 2nd Fc containing bioactive peptide. The claim states that the 2nd Fc “includes at least one more human VH3 domain compared to the 1st Fc containing bioactive peptide. It is not clear if the 1st Fc containing bioactive peptide has a human VH3 or does not have a human VH3. On pages 5 of the specification, the 1st Fc-VH3 is defined by n (wherein n is an integer greater than or equal to 0). However, n is not included in claim 1. Please clarify the human VH3 component of the 1st Fc compound.
B. Claim 6 is vague and indefinite in reciting that the “Fc is an Fc to which a mutation affecting binding to wild-type protein A is not introduced”. The wording is ambiguous because claim 1 contains several references to a Fc. Claim 1 is drawn to a method that comprises a mixture of Fc containing bioactive proteins that include a first Fc-containing bioactive peptide and a second Fc-containing bioactive peptide. It is not clear if Applicant intends to mean claim 6 is directed to the mixture of Fc, the first Fc, the second Fc, or all three Fcs in the method. In order to obviate the rejection the claim should recite “the mixture of Fc-containing bioactive peptides is a Fc….” It is suggested that consistent language is utilized throughout the claims to remove ambiguity. Appropriate correction is required. Please clarify the intended claim scope.
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.
9. Claims 1-6, 9-12, and 14 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 methods purifying Fc containing bioactive peptides with VH3 regions from Ch11F11, hu11F11, ChE34, andti-BACE, and anti-IGF1R (sequences identification numbers 1-11), it does not reasonably provide enablement for the purification of any and all Fc containing bioactive VH3 peptides. 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.
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.
Claims 1-6, 9-12, and 14 are rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claims 1-6, 9-12, and 14 are drawn to a method of purifying Fc containing bioactive peptides from a mixture of Fc containing peptides based on the VH3 composition. The written description is not commensurate in scope with the claims drawn to the claimed "myomesin fragments and/or fragments thereof”. Neither the specification nor the claims teach how to define or obtain "the claimed fragments”. For example, the claims do not appear to require a specific binding partner with binding affinity for a portion of the peptide fragment of interest. Accordingly it is not known what will encompass the intended analyte. There is no guidance as to what the "myomesin fragments” read on the instant claims. There is no guidance as to what the "peptide fragments” can or cannot be used in the method being claimed. The specification does not include structural examples of "the measured myomesin peptide fragments”. And how will the fragment(s) be distinguished from the full length construct. The full length will comprise the same binding epitopes.
Thus, the resulting recited "peptide fragments’ could result in complexes not taught and enabled by the specification. Vas-Cath lnc. 11". Mahurkar, 19 USPQ2d 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 [he or she] invented what is claimed." (See Vas-Cath at page 1116). Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision (see page 115).
The skilled artisan cannot envision the detailed structure of the claimed composition, thus conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. An adequate description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it.
The court indicated that while Applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a representative number of molecules falling within the scope of the claimed genus. Therefore the full breadth of the claims, do not meet the written description provision of 35 USC 112, first paragraph.
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.
10. Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claims as a whole, the claims are determined to be directed to a law of nature/natural principle. The rationale for this determination is explained below:
A claim that focuses on use of a natural principle (method/process) must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966.
To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope. The analysis turns on whether the claim has added enough to show a practical application. See id. at 1968.
In other words, the claim cannot cover the natural principle itself such that it is effectively standing alone. A bare statement of a naturally occurring correlation, albeit a newly discovered natural correlation or very narrowly confined correlation, would fail this inquiry. See id. at 1965, 1971.
It is not necessary that every recited element or step integrate or relate to the natural principle as long as it is applied in some practical manner. However, there must be at least one additional element or step that applies, relies on or uses the natural principle so that the claim amounts to significantly more than the natural principle itself.
Along with integration, the additional steps must be sufficient to ensure that the claim amounts to significantly more than the natural principle itself by including one or more elements or steps that limit the scope of the claim and do more than generally describe the natural principle with generalized instructions to “apply it.” See id. at 1965, 1968. The additional elements or steps must narrow the scope of the claim such that others are not foreclosed from using the natural principle (a basic tool of scientific and technological work) for future innovation.
Elements or steps that are well-understood, purely conventional, and routinely taken by others in order to apply the natural principle, or that only limit the use to a particular technological environment (field-of-use), would not be sufficiently specific. See id. at 1968.
In the present case, the claims are directed to a naturally occurring correlation, namely the naturally occurring measurement of myomesin and/or myomesin fragments.
However, the combination of steps recited in the claims, taken as a whole, is not sufficient to qualify as a patent-eligible practical application because the steps are not sufficiently specific to ensure that the claims amount to significantly more than the natural principle itself. Rather, in this case the claims would cover every substantial practical application of the correlation.
In particular, the “detecting, measuring and/or determining” step is recited at a high level of generality and is not sufficient to ensure that the claims amount to significantly more than the naturally occurring correlation itself.
This is because every application of the correlation would require determining peptides/proteins and antibody/peptide complexes; and also because the “detecting, measuring and/or determining” step does not relate to the natural principle in a significant way to impose a meaningful limit on the claim scope (for example, the claims are not clearly limited to any particular testing technique). While "reference level” are recited in the claims they have not been properly defined.
Limitations that are necessary for all practical applications of the natural principle, such that everyone practicing the natural principle would be required to perform those steps or every product embodying that natural principle would be required to include those features, would not be sufficient to confer patent eligibility.
In addition, appending conventional steps, specified at a high level of generality, to a natural principle does not make the claim patent-eligible. Steps that amount to instructions that are well-understood, routine, conventional activity, previously engaged in by those in the field add nothing specific to the natural principle that would render it patent-eligible.
In this case, it was known to employ measured peptide binding complexes or antibody/peptide complexes in the claimed assay procedures. For example see Schoenauer et al. (J Mol. Biol. 2008, Vol.376, pages 338-351) and Koebis et al. (Genes to Cells, 2011, Vol.16. pages 961 -972).
The step of determining Myomesin complexes is therefore insufficient to render the claim patent eligible, since it represents well-understood, routine, and conventional activity that was previously engaged in by those in the field.
Furthermore, the additional elements set forth in the dependent claims also represent well-understood, routine, conventional activity that was previously engaged in by those in the field.
The claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Additionally, claim(s) 13-20 is/are directed to an abstract idea. The claimed invention is not directed to patent eligible subject matter. Based upon consideration of all of the relevant factors with respect to the claim as a whole, claim(s) 13-20 is/are determined to be directed to an abstract idea.
The rationale for this determination is explained below: The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the instant claims are directed to a single molecule detection means (i.e. myomesin) that evaluates muscular dystrophy. In the method a clinical biomarker (myomesin) is compared (absence/presence) to a reference level.
Comparing information regarding a sample or test subject to a control or target data reads on “An Idea ‘Of Itself’” as when given its broadest reasonable interpretation, such a comparison would read on a mental process that could be performed in the human mind, or by a human using pen and paper. See July 2015 Update, Quick Reference Guide.
Similar mental processes (monitoring treatment) have been held by the courts to be abstract ideas, e.g., collecting and comparing known information in Classen, or comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad CAFC.
The specific information that is being compared (in this case, myomesin levels) merely narrows the abstract idea, which does not make the comparison step less abstract and is not sufficient to provide eligibility on its own.
Obtaining a sample in order to perform tests is well-understood, routine and conventional activity for those in the field of diagnostics. Further, the step is recited at a high level of generality such that it amounts to insignificant activity, e.g., a mere data gathering step necessary to use the correlation. Determining the level of a biomarker merely instructs a scientist to use any detection technique.
When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or a transformation of a particular article, in this step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant’s invention, and at the time the application was filed, e.g., the routine and conventional techniques of detecting proteins in a sample.
Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)).
In summary, the claims do not include additional elements/steps or a combination of elements/steps that are sufficient to ensure that the claims amount to significantly more than a natural principle itself. This is because (1) the claims would cover every substantial practical application of the correlation and (2) the additional steps recited in the claim were previously taken by those in the field.
When the claims are considered as a whole, the steps taken together amount to no more than recognizing the law of nature itself.
A claim setting forth the relationship between peptide fragments and antibody/peptide complexes measurement in assay procedures would require additional steps that do significantly more to apply this principle than conventional marker testing or general diagnostic activity based on such testing.
Such additional steps could involve, for example, a testing technique or treatment steps that would not be conventional or routine.
Claim Rejections - 35 USC § 102
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.
11. Claim(s) 1, 4, 9, 10, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ollier et al. (MABS, 2019, Vol.11, No.8, pages 1464-1478).
Ollier et al. initially designed an IgG that included a VH3 variable domain having Hc constant domains in: IgG1 CH1, IgG1 hinge, IgG3 CH2, and IgG3 CH3. In these constructs the IgG was still able to bind PA in spite of having the CH2 and CH3 domains of human IgG3 (Figure 2(a)). The researchers deduced that the avidity created by the two VH3-Fab portions was sufficient to restore PA binding and set out to mutate PA binding in the VH3 domains. Although substitutions at Kabat position 57 in complementarity determining region (CDR)-H2 have been reported to abrogate MabSelect™ SuRe™ binding of VH3-F(ab’)2 fragments, this result prompted further engineering of the framework region of the VH3 subfamily in order to find a more systematic, framework-embedded solution. As a starting point for engineering, the researchers used the crystal structure of a Fab from the VH3 subfamily bound to the D domain of PA (Figure S1). In the complex, the Fab interacts with the α helices II and III of the D domain via a surface composed of four VH3 framework β-strands, mainly hydrophilic, involving polar interactions and salt bridges. Based on amino acid sequence differences between the VH3 subclass and all other subclasses (Figure S2) and known PA interacting residues, various single substitutions were designed and tested. See page 1466.
The researchers disclosed that the main challenge was to define a pH window to separate the elution of the heterodimer, which only binds PA through one Fc chain (1st Fc containing bioactive peptide), from the scFv-Fc homodimer, which binds PA through both Fc chains (2nd Fc containing bioactive peptide). While, the non-PA binding homodimer (IgGdA) should be in the unbound fraction (apart of the Fc mixture). During development, it was determined that, when run at room temperature(RT), the best elution conditions used an eluent at pH 4.1 followed by a strip buffer at pH 3.0, with the pH of the heterodimer main peak fraction measured at 4.1 and the pH of the PA-binding homodimer main peak fraction measured at 3.5 (reading on claim 4). When run at 4°C, the elution of the heterodimer could be performed at pH 4.2 instead of 4.1; thereby adding 0.1 units to the pH window between bound species. These conditions, at 4°C and at RT, allowed baseline-resolution between the elution peaks of the two bound species (Figure 3(b)). Heterodimer purity was at 93.5% as determined by RP HPLC-MS(Figure3(c)). See page 1469.
12. For reasons aforementioned, no claims are allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa Cook whose telephone number is 571-272-0816. The examiner works a flexible schedule but can normally be reached on Monday-Friday from 9am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached at telephone number 571-270-3505. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lisa V. Cook
Patent Examiner
Art Unit 1642
Remsen
571-272-0816
2/7/26
/LISA V COOK/Primary Examiner, Art Unit 1642