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
This action is in response to the papers filed June 22, 2026.
Election/Restrictions
Applicant’s response filed 06/22/2026 to the Requirement for Restriction/Election mailed 12/23/2025 is acknowledged.
Applicant elected without traverse:
Invention II, claims 36-38, drawn to a composition comprising a genetically modified plasma cell;
Factor IX, as the molecule expressed by the modified plasma cell;
CCR5, as the genomic locus modified;
an enzyme deficiency, as the condition treated; and
BAFF, as the molecule expressed by the second B cell.
Claims 21-35, 39-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 06/22/2026.
Claim Listing
The claim listing filed 06/22/2026 is acknowledged. No amendments have been made relative to the immediate prior version of the claims.
Claims 1-20 have been cancelled.
Claims 21-40 are pending.
Claims 21-35, 39-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 36-38 are under examination.
Priority
The instant application 18/441,393 filed 02/14/2024. This application is a continuation (CON) of U.S. Application No. 15/921,353 filed 03/14/2018, claiming priority based on U.S. Provisional Application Nos. 62/571,918 filed 10/13/2017, 62/549,385 filed 08/23/2017, and 62/472,493 filed 03/16/2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/07/2024 has been considered.
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 § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, or by applicant in an information disclosure statement (IDS), they have not been considered.
Improper Markush Grouping Rejection
Claims 36-38 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a "single structural similarity" and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a "single structural similarity" and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 706.03(y).
The Markush grouping of claim 36 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
In the case, claim 36 defines the following Markush grouping: a molecule selected from an enzyme, neutralizing antibody or binding portion thereof, cytokine, cytokine receptor, complement protein, inhibitory protein, anti-fibrotic molecule, therapeutic antibody or binding portion thereof, anti-thrombotic molecule, glucose response element, or a monoclonal antibody or binding portion thereof. The alternative members defined by the Markush grouping do not share both a single structural similarity and a common use because the alternatives are not all members of the same recognized physical or chemical class or the same art-recognized class. The alternative members share no substantial structural feature and diversely range from antibody molecules to cytokines and their receptors to glucose response elements. Consequently, the alternative members are neither functionally equivalent nor share a common use. Rather, the alternative members would possess different and distinct functional properties when introduced into a plasma cell, and, therefore, the alternative members would be used differently in practice, e.g., for the treatment of different and distinct diseases or conditions.
Dependent claims are included in the basis of the rejection because they do not correct the deficiencies of the claim upon which they depend.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claims 36-38 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 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 36 recites a plasma cell genetically modified to express a molecule selected from an enzyme, neutralizing antibody or binding portion thereof, cytokine, cytokine receptor, complement protein, inhibitory protein, anti-fibrotic molecule, therapeutic antibody or binding portion thereof, anti-thrombotic molecule, glucose response element, or a monoclonal antibody or binding portion thereof. Dependent claim 37 further recites a second B cell that secretes a molecule that induces tolerance of any peptide or the engraftment of the plasma cell.
Accordingly, the claims are directed a broad genus of genetic modifications functionally defined as inducing the expression of a diverse range of molecules, including any enzyme, any neutralizing antibody or binding portion thereof, any cytokine, any cytokine receptor, any complement protein, any inhibitory protein, any anti-fibrotic molecule, any therapeutic antibody or binding protein thereof, any glucose response element or any monoclonal antibody or binding portion thereof. Dependent claim 37 further encompasses the any molecule that induces the tolerance of any peptide or the engraftment of a plasma cell.
An adequate written description for a functionally-defined genus of molecules and genetic modifications requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it; what is required is a description of the reagents required to do so and the structure of the genetic modification. It is not sufficient to define a molecule or genetic modification solely by its desired biological property because disclosure of no more than that, as in the instant case, is simply a wish to know the identity of any molecule, genetic modification and the reagents that are capable of causing the desired outcome. Also, naming a type of material generically known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material. Thus, without defining what means will do, the claims are not in compliance with the description requirement.
The specification as filed is found to neither describe a representative number of species for each of the claimed genera of functionally-diverse molecules nor the genetic modifications required to do so.
For example, the specification describes that the inhibitory protein may be Il1 receptor antagonist or a complement inhibitory protein, such as Factor H or Factor I (see, par. 333); however, this limited number of species is not representative of any protein that may be inhibitory of any other protein or cellular process. Moreover, besides inhibiting Il1 receptor or the complement system, the specification does not adequately describe the vast scope of any and all proteins or cellular processes which may be inhibited by claimed genus of inhibitory proteins.
For example, the specification describes that the anti-fibrotic molecule may be SCGB1A1 (see, par. 90); however, SCGB1A1 is not representative of any molecule which may inhibit or reduce fibrosis. Moreover, SCGB1A1 is described as effective against pulmonary fibrosis, but the claimed genus of anti-fibrotic molecules includes any molecule effective against cystic fibrosis, Idiopathic pulmonary fibrosis, liver cirrhosis, atrial fibrosis, endomyocardial fibrosis, myocardial infarction, glial scars of the brain, arterial stiffness, Arthrofibrosis, Crohn's Disease, Dupuytren's contracture, Keloid, Mediastinal fibrosis, Myelofibrosis, Peyronie's disease, Nephrogenic systemic fibrosis, Progressive massive fibrosis, Retroperitoneal fibrosis, Scleroderma/systemic sclerosis and adhesive capsulitis.
For example, the specification therapeutic antibody or binding portion thereof may include anti-IL-1 antibodies, anti-TNF antibodies, anti-IL-33 antibodies or anti-C5 antibodies (see, par. 335); however, this limited number of species is not representative of any and all antibodies that may be used to treat any disease, disorder or condition, as claimed. Moreover, the disclosed species are only described as effective against periodic fever and autoinflammatory syndromes, inflammatory arthritis and bowel disease, asthma, or paroxysmal nocturnal hemoglobinuria and atypical HUS (see, par. 335), but the claims broadly encompass antibodies therapeutically-effective against any disease, disorder or condition, including any autoimmune disorder, any autoinflammatory disorder, any immune dysregulation and any cancer (see, par. 335).
For example, the specification does not describe any species of the claimed genus of glucose response elements.
For example, the specification describes that the anti-thrombotic molecule may be APLN (par. 336); however, APLN is not representative any molecule which may inhibit or reduce blood clots and/or platelet function.
For example, the specification describes that the second B cell molecule functionally-defined as inducing the tolerance of any peptide or the engraftment of plasma cells may be IFN-alpha, BAFF, APRIL, IL-10 or IL-6 (see, par. 219); however, this limited number of species is not representative of any molecule that may induce the tolerance of any peptide or the engraftment of plasma cells, as claimed. Moreover, even when considering this limited number of species, the specification does not describe which peptide each species is capable of inducing tolerance for, or whether the molecule induces plasma cell engraftment instead.
Finally, the specification is not found to adequately describe the broad genus of genetic modifications that provide the expression and/or secretion of the functionally-diverse range of molecules, which broadly includes the introduction of exogenous nucleic acids or transgenes into the host cells, modulation of the regulatory regions of endogenous genes, epigenetic regulation and chromatin remodeling, inhibiting or activating biochemical cascades, signaling pathways or transcription factors, etc. Such a broad and structurally-diverse range of possible genetic modifications that may be discovered is not found to possess sufficient written description in the specification as originally filed.
Accordingly, this limited information is not deemed sufficient to reasonably convey to one skilled in the art that the applicant is in possession of the broadly claimed genera of molecules and genetic modifications at the time the application was filed.
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.
(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 36-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2012/0157662 A1 to Beaumont et al.
Beaumont discloses means of modulating the occurrence of comatic hypermutations in antibody producing plasmablast-like B-cells. See, Abstract.
A memory B-cell is isolated from a subject and modified so that antibody producing plasmablast-like B-cells are obtained. The plasmablast-like B-cells are modified to express an anti-apoptotic nucleic acid, such as Bcl-xL or Mcl-1, and an inactivated activation induced cytidine deaminase (AID) gene. See, e.g., par. 9-11, 23-25.
Accordingly, Beaumont is found to disclose a composition comprising a plasma cell genetically modified to express a protein that inhibits apoptosis and possess an inactivated AID gene, reading on claims 36 and 38. Claim 37 is also included in the basis of this rejection because the secreted second B cell molecule broadly reads on molecules endogenously expressed by the B cells or plasma cells, as the claim positively recites no further genetic modification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES J GRABER whose telephone number is (571)270-3988. The examiner can normally be reached Monday-Thursday: 9:00 am - 4:00 pm.
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, James D Schultz can be reached at (571)272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES JOSEPH GRABER/Examiner, Art Unit 1631
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