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 .
Status of the Claims
1. Claims 1-22 are the original claims filed 12/13/2023. In the Preliminary Amendment of 7/22/2024, claims 1-19 and 22 are canceled and new claims 23-38 are added. Claims 20-21 and 23-38 are all the claims.
Priority
2. 18/538,279, filed 12/13/2023, is a Divisional of 15/225,423, filed 08/01/2016, now U.S. Patent # 11884720, and having 4 RCE-type filing therein, 15/225,423 Claims Priority from Provisional Application 62/290,861, filed 02/03/2016, 15/225,423 Claims Priority from Provisional Application 62/199,939, filed 07/31/2015. USAN 19/022,048, filed on 01/15/2025 is a Continuation of 18/538,279, filed on 12/13/2023.
Information Disclosure Statement
3. As of 8/3/2026, a total of eight (8) IDS are filed: 8/5/2024; 8/5/2024; 8/5/2024; 8/5/2024; 8/5/2024; 2/26/2025; 9/18/2025; and 2/13/2026. The corresponding initialed and dated 1449 form is considered and of record.
Objections
Drawings
4. The drawing sheets for Figures 4-10 and 15-17 are objected to because the use of the term BiTE, which is a trade name or a mark used in commerce. 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.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
5. The abstract of the disclosure is objected to because it contains legal phraseology, i.e., “said”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
6. The disclosure is objected to because of the following informalities:
a) The use of the term ATCC, GenBank, Alexa, BODIPY, Triton, Tween, Tris, nanobody, Exactive, Zorbax, Acquity, Nanostar, TSKgel, BiTE, Unicorn, GraphPad, FACSCanto, FACSDiva, Ficoll, Dynal, XenoMouse, BIACore, FASTA, BakerBond, MEDDRA, 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.
b) The specification contains peptides > 4 amino acids in length that are required to be identified by sequence identifier pursuant to 37 CFR 1.821-1.825. See [00122].
c) The text after each of the figure legends at [00287-00288 and 00290] is not punctuated. The POSA cannot reasonably ascertain whether the description is complete.
Appropriate correction is required.
Claim Objections
7. Claim 21 is objected to because of the following informalities:
a) Amend claim 21 to replace “forgoing” with “foregoing.” Foregoing means going before or previously stated (e.g., "the foregoing species in the claim"). Forgoing means abstaining or giving up (e.g., "forgoing a patent application").
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 20-21 and 23-38 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.
a) Claims 20-21 and 23-38 are indefinite for the antibodies of the invention to be purposeful in the treatment of the solid tumor or the metastatic cancer disease. There is no correlation made between the binding to “a target cell” as to the solid tumor and/or the metastatic cancer disease for the 1st binding domain of claim 20. Likewise Claim 36 refers to “a target cell” that is indefinite as to whether it is the same target cell of claim 20, and again, there is no correlation made between the binding to “a target cell” as to the solid tumor and/or the metastatic cancer disease for the 1st binding domain.
b) Claims 36-38 are drawn to the first binding domain (anti-human MSLN) further binds to macaque MSLN of a target cell (claim 36), the second binding domain (anti-human CD3 epsilon) further binds to Callithrix jacchus, Saguinus oedipus or Saimiri sciureus CD3 epsilon on the surface of a T cell (Claim 37), and the first binding domain further binds to macaque CD3 epsilon on the surface of a T cell (Claim 38). Claims 36-38 depend from Claim 20 that is drawn to treating any subject with an anti-human MSLN and an anti-human CD3 epsilon bispecific antibody. Barring the subject of claim 20 is a hybrid of a human/ macaque or human/ Callithrix jacchus, Saguinus oedipus or Saimiri sciureus, it is inconceivable how the anti- macaque and anti- Callithrix jacchus, Saguinus oedipus or Saimiri sciureus antibodies can be administered to the same subject of the method invention receiving anti-human antibodies of claim 20, assuming, arguendo, the subject of claim 20 is Homo sapiens.
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.
Enablement
9. Claims 20-21 and 23-38 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.
Claim interpretation
Claims 20-21 and 23-38 are drawn to a method of treating a solid tumor or a metastatic cancer disease in any subject using a bispecific anti-human MSLN x anti-CD3E antibody.
“treat”/”treatment”: the specification is unequivocal in its teaching that the meaning of treatment encompasses both therapy and prophylaxis of the solid tumor or metastatic tumor disease in the subject:
[0410] The formulations described herein are useful as pharmaceutical compositions in the treatment, amelioration and/or prevention of the pathological medical condition as described herein in a patient in need thereof. The term “treatment” refers to both therapeutic treatment and prophylactic or preventative measures.
[0417] The terms “subject in need” or those “in need of treatment” includes those already with the disorder, as well as those in which the disorder is to be prevented. The subject in need or “patient” includes human and other mammalian subjects that receive either prophylactic or therapeutic treatment.
The POSA could reasonably conclude that the application as filed is bereft of any examples showing the prevention for any solid tumor and any metastatic cancer disease with any one of the claimed species of bispecific anti-human MSLN x anti-CD3E antibody by way of in vitro or in vivo testing.
The Patent Act requires that patent applicant describes the invention in explicit terms to enable any person skilled in the art to make and use the invention. 35 U.S.C. 112. Applicants seek the prevention of any solid tumor or any metastatic cancer disease irrespective of the solid tumor and the metastatic cancer disease for any subject using anyone of the bispecific antibodies of generic claim 20. The enablement requirement is a crucial aspect of the patent “bargain”: an inventor is granted limited protection from competition in exchange for publicly disclosing their new technology. See the decision in Morse, Incandescent Lamp, and Holland Furniture, establishing the requirement that if a patent claims an entire class or genus of processes, machines, or compositions of matter, the specification must enable a person skilled in the field to make and use the entire class. If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims. The more one claims, the more one must enable. See §112(a); see also Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U. S. 405 (1908) (“[T]he claims measure the invention.”).
Conclusion
10. No claims are allowed.
11. The claims of claims 23-39 of copending Application No. 19/022,048 (reference application US 20250282863) are pertinent to the instant claims but are not effective as art nor under non-statutory double patenting. The ref claims are drawn to a distinct species or clone, MS_7 (see Table on p. 131), for the MSLN antibody comprised within the bispecific construct with an anti-CD3 binding aspect and that is NOT claimed in the instant claim set.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Julie can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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