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 of Group I (claims 17-25) in the reply filed on 3/13/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
2. The requirement is still deemed proper and is therefore made FINAL.
3. Claims 26-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 3/13/26. Currently claims 17-25 are under consideration.
Priority
4. The instant application has a priority date of May 8, 2020. The application is a 371 of PCT/EP2021/061949 filed on 05/06/2021, which claims priority to Foreign Application No. EP 20173658.4, filed May 8, 2020.
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 (IDS) filed on 3/3/25 and 11/8/22 have been considered as to the merits before the First Action.
Specification
7. The use of the term TWEEN (i.e. see section 090), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
8. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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. See sections 083 and 094.
Claim Objections
9. Claims 17, 20, 21, 22, and 24 are objected to because of the following informalities: The claims utilize several acronyms “3D, Å, Ala, and Fc” 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. For example, Ala is “Alanine” as defined in Table 1(section 013). However, Applicant is cautioned not to introduce new matter into the claims. Appropriate correction is required.
10. A typo appears in claim 19. “Reside” should be residue. 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.
11. Claims 17-25 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 17 step b recites the limitation "3D structural data " in claim 17 step a. There is insufficient antecedent basis for this limitation in the claim. The wording should appropriately be “3D structure information”. Consistent language should be utilized in order to eliminate ambiguity. Please correct.
B. In claim 17, step c, it is not clear as to how the selection of a single residue will lead to 1 or 2 residues for further analysis. The claim is directed to “c) for each of the identified amino-acid residues selecting 1 or 2 amino-acid residues which are within a predetermined distance from the identified amino-acid residue and are within the accessible surface area, whereby such a combination of the amino-acid residues forms a patch of 2 or 3 amino acids correspondingly;” Does the resulting patch include the identified amino acid residue along with 1 or 2 residues at a predetermined distance and accessible surface area? Please clarify.
C. In claim 17, the phrases “within an assessable surface area” and “within a predetermined distance” are vague and indefinite because the phrases include relative terms which renders the claim indefinite. The parameters are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
More specifically, it is not clear as to what Applicant will consider an acceptable “assessable surface area” or what will be an acceptable “predetermined distance”. As such the metes and bounds of the claim cannot be determined. It is suggested that the actual units of measurement are included in order to obviate the rejection. Appropriate correction is required.
D. Claim 17 step d is indefinite in the recitation of “selecting a large number….that cover a majority” since the intended scope is not clear. [M.P.E.P. § 2173.05(d)] Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. It is suggested that “a large number and majority are defined in the claim in order to obviate this rejection.
E. Claim 19 is vague and indefinite because a “selected” amino acid reside is not made in the previous claims. In other words an amino selection was not previously made. As such the wording lacks antecedence basis and need to be clarified.
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.
12. Claims 17-25 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Enablement requires that the specification teach those in the art to make and use the invention without undue experimentation. 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.
In particular, claims 17-25 are drawn to methods employing 3D imagery to identify amino-acid residues on a target protein that form a binding site of a molecule of interest. However, the method does not clearly identify how said residues will be measured and determined therein not providing a nexus between the measured residues and the target protein binding sites.
As claimed, the method does not clearly set forth the means for obtaining, identifying, selecting, producing, measuring, and relating the parameters to a binding site of the molecule of interest.
Claim 17, recites - A method of identifying amino-acid residues on a target protein that form a binding site of a molecule of interest, said method comprising: a) obtaining 3D structure information for the target protein; b) identifying, using obtained 3D structural data, the amino-acid residues which are within an accessible surface area; c) for each of the identified amino-acid residues selecting 1 or 2 amino-acid residues which are within a predetermined distance from the identified amino-acid residue and are within the accessible surface area, whereby such a combination of the amino-acid residues forms a patch of 2 or 3 amino acids correspondingly; d) selecting, from a large number of generated possible patches, a set of representative patches that cover a majority of the accessible surface area of the target protein, while minimizing a number of patches likely to cause the target protein to misfold by eliminating patches that result in: i. a breakage of 3 or more hydrogen bonds in the target protein; ii. a breakage of 2 or more salt bridges in the target protein; and iii. an exposure of hydrophobic surface of the target protein above a predetermined threshold. e) producing a set of mutant proteins, wherein each of the mutant proteins comprises a mutated sequence of the target protein, wherein each of the mutated sequences comprises a single mutated patch of amino acids identified in step (d), and wherein each of the amino acids of the patch is substituted by another amino-acid; f) measuring binding properties of each of the mutant proteins; and g) identifying the patches that demonstrate decreased binding properties of the molecule of interest to corresponding mutant protein comprising such patch, wherein the amino-acid residues in such patches are identified as being a part of a binding site of the molecule of interest.
The present application refers to a method using multiple substitutions of amino acids located in close proximity on the solvent-accessible surface area of a protein by another amino-acid, e.g Ala, by mutating more than one surface residue, for example in 2 and 3 alanine arrays, thereby creating an alanine patch. The method allows to determine the residues that are important for binding of a molecule of interest or otherwise form a part of an epitope for such molecule of interest. In particular such molecule of interest is a protein or a peptide, such as, for example, a ligand or a receptor of the target protein. However, the claims do not clearly identify the reactants and their relationship to intended method.
In other words, a means for determining the claimed binding sites has not been recited in the claims.
The skilled artisan cannot envision the detailed structure of the infinite possible amino acid residues or amino acid sequences, 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. The amino acid structure is required. See Fiers v. Revel, 25 USPQ 2d 1601 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Lts., 18 USPQ2d 1016.
Even where there is an actual reduction to practice; which may demonstrate possession of an embodiment of an invention, it does not necessarily describe what the claimed invention is.
The instant specification and claims describe a production protocol, however this description does not describe the claimed antibody itself. See also, In The Reagents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), where the court held that a generic statement which defines a genus of a compound/seq.id/etc. by only their functional activity does not provide an adequate written description of the genus.
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, usually defined by a sequence, falling within the scope of the claimed genus. At section B(1), the court states that "An adequate written description ...'requires a precise definition, such as by structure, formula, chemical name, or physical properties', not a mere wish or plan for obtaining the claimed chemical invention".
Thus a skilled artisan cannot envision all the contemplated recognition sequence sites by the detailed chemical structure of the claimed residues, therefore conception cannot be achieved until reduction to practice has occurred.
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.
The nature of the invention- the invention is directed to an unidentified amino acid residues that are bound by an unknown binder.
The state of the prior art- the prior art of record fails to disclose the particular constructs meeting the claimed limitations.
The predictability or lack thereof in the art- there is no predictability based on the instant specification that the amino acids and its structure can be readily identified because the specific compositions which are determined are not clear.
The amount of direction or guidance present- appropriate guidance is not provided by the specification for the claimed protein/peptide complexes.
The presence or absence of working examples- working examples are not provided in the specification that identify and/or exemplify the claimed amino acids being measure in the claimed method.
The quantity of experimentation necessary- it would require undue amount of experimentation for the skilled artisan to make and use the amino acids as claimed; further demonstrating differentiation in the claimed method.
The relative skill of those in the art-the level of skill in the art is high.
The breadth of the claims- as recited, the instant claims are directed to any and all amino acids, but does not teach the actual peptide sequence deemed crucial to the claimed method. Therefore, it is not clear as to what is actually measured.
While it is not necessary to show working examples for every possible embodiment, there should be sufficient teachings in the specification that would suggest to the skilled artisan that the breadth of the claimed amino acid method is enabled. This is not the case in the instant specification.
In view of the teachings of In re Wands, 8 USPQ2d 1400, it has been determined that the level of experimentation required to enable the breadth of the claims is undue.
Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966).
While every aspect of a generic claim does not have to be carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention. Genetech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001. That requirement has not been met in this specification with respect to a method identifying amino acid patches and mutations as claimed.
Therefore, in view of the insufficient guidance in the specification, extensive experimentation would be required to enable the claims and to practice the invention as claimed.
13. For reasons aforementioned, no claims are allowed.
14. 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, Thursday, and 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
5/30/26
/LISA V COOK/Primary Examiner, Art Unit 1642
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