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 April 22, 2026.
Amendments
Applicant's response and amendments, filed April 22, 2026, to the prior Office Action is acknowledged. Applicant has cancelled Claims 1-52, 54-56, 58, 61-63, and 65, amended Claims 53, 60, 64, and 67, withdrawn Claims 59 and 68, and added new claims, Claims 69-71.
Claims 53, 57, 59-60, 64, and 66-71 are pending.
Election/Restrictions
Applicant has elected with traverse the invention of Group I, Claims 53-58 and 60-67, drawn to a population of modified primary human B cells in which the variable regions of light and heavy chains of an endogenous B cell receptor have been substituted with variable regions of a heterologous light and heavy chains of a heterologous therapeutic antibody, classified in C12N 2510/02.
Within Group I, Applicant has elected the following species, wherein:
i) the alternative therapeutic monoclonal antibody target is TNFalpha, as recited in Claims 57 and 66; and
ii) the alternative engineered nuclease is Cas9, generically recited in Claim 56, specific embodiments disclosed in [0007, 63].
Response to Arguments
Applicant argues that regardless of the diseases, disorders, and/or conditions to be treated with the claimed product, the claimed process is the same: the product is administered to a patient, per Group II.
Applicant’s argument(s) has been fully considered, but is not persuasive. MPEP §803 states that "If the search and examination of all the claims in an application can be made without serious burden, the examiner must examine them on the merits, even though they include claims to independent or distinct inventions."
In the instant case a serious burden exists since a search of genetic modification of primary human B cells requires a separate, divergent, and non co-extensive search and examination of the as it relates to methods of immunotherapy treatments. Further, a search and examination of all the claims involves different considerations of novelty, obviousness, written description, and enablement for each claim. In view of these requirements, it is the Examiner's position that searching and examining all of the claims in the same application presents a serious burden on the Examiner for the reasons given above and in the previous Restriction Requirement.
Applicant argues that the product could be used in in vitro methods of measuring an immune response, detection assays, etc, is not germane because the Group II method is directed to administering the cells to a patient.
Applicant’s argument(s) has been fully considered, but is not persuasive. Applicant’s argument is not on point. As stated in the prior Office Action, the Group I product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h).
Applicant argues that in order to be prior art disclosing the claimed method, the cells used in the method first have to exist.
Applicant’s argument(s) has been fully considered, but is not persuasive. Applicant’s argument is not on point. The issue is that prior art teaching the Group I product does not necessarily lead to prior art teaching the Group II method. Further, a search and examination of all the claims involves different considerations of novelty, obviousness, written description, and enablement for each claim. In view of these requirements, it is the Examiner's position that searching and examining all of the claims in the same application presents a serious burden on the Examiner for the reasons given above and in the previous Restriction Requirement.
The requirement is still deemed proper and is therefore made FINAL.
As discussed in the prior Office Action, the Group II method is subject to rejoinder when the Group I product is found allowable. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claims 53, 57, 59-60, 64, and 66-71 are pending.
Claims 59 and 68 are pending but withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 53, 57, 60, 64, 66-67, and 69-71 are under consideration.
In light of the cited prior art below, the Examiner withdraws the antibody target molecule species election between elected TNFalpha and CD4, CEA, influenza, hepatitis C, HER2, HIV, MUC1, Staphylococcus aureus, and Rhesus factor.
Priority
This application is a continuation of application 15/161,213 filed on May 21, 2016, now abandoned, which is a continuation-in-part of PCT/US2016/025920 filed on April 4, 2016. Applicant’s claim for the benefit of a prior-filed application provisional application 62/142,882 filed on April 3, 2015 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 62/142,882, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
‘882 disclosure is silent to the limitations recited in instant Claims 61 and 64-65.
Applicant’s amendment to the independent claim encompasses an attempt to shift or otherwise change the broader genus of human subject/patient populations whose B cells are to be gene-edited and comprise naturally-occurring viral nucleic acids due to naturally-occurring viral infections to a subgenus of humans in which their B cells do not comprise any exogenous viral nucleic acids, as they have not experienced naturally-occurring viral infections, for which there is no support in the instant specification and/or priority documents.
See further discussion below in the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, New Matter rejection.
Accordingly, the effective priority date of the instant application is granted as April 28, 2023, the filing date of the instant application.
If applicant believes the earlier applications provide support for this disclosure, applicant should point out such support with particularity by page and line number in the reply to this Action.
Information Disclosure Statement
1. Applicant has not filed any Information Disclosure Statements with the instantapplication.
The Examiner cites below reference previously cited in Applicant’s co-pending application, e.g. 15/161,213 and 17/687,246, and/or cited in Applicant’s parent application IDS, e.g. 16/152,273, to wit:
Wang et al (RNA-guided endonuclease provides a therapeutic strategy to cure latent herpesviridae infection, PNAS 111(36): 13157-13162, available online August 25, 2014); and
Mandal et al (Efficient Ablation of Genes in Human Hematopoietic Stem and Effector Cells using CRISPR/Cas9, Cell Stem Cell 15: 643-652; available online November 6, 2014).
Applicant is reminded of their duty to disclose information material to patentability. See MPEP §2001 and 37 C.F.R. 1.56.
The individuals covered by 37 CFR 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question. As set forth by the court in Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972):
[W]e think that it is unfair to the busy examiner, no matter how diligent and well informed he may be, to assume that he retains details of every pending file in his mind when he is reviewing a particular application . . . [T]he applicant has the burden of presenting the examiner with a complete and accurate record to support the allowance of letters patent.
See MPEP §2001.06(b).
Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), a copy of the prior cited publication(s) are not provided with the instant Office Action because it is presumed that Applicant has a copy of the prior-cited publication(s), as such is routine practice in the art, and as evidenced by 16/152,273, and that Applicant has provided their representative with a copy of said publication(s) to establish a prosecution record.
However, if Applicant’s representative insists upon receiving a copy of the entire references, then the Examiner will make attempts to provide it in the next Office Action.
Claim Objections
2. Claim 60 is objected to because of the following informalities: the claim lacks the conjunction “and” before the ultimate ‘wherein’ clause.
Appropriate correction is required. See, for example, Claim 53.
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.
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
3. The prior rejections of Claims 54-56, 58, 62-63, and 65 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and/or under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, are withdrawn in light of Applicant’s cancellation of the claims.
4. The prior rejection of Claim 64 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of Applicant’s cancellation of “transfection”.
5. The prior rejections of Claim 67 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, and/or under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, are withdrawn in light of Applicant’s cancellation of “can be administered to a patient”.
6. Claim 64 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant has amended Claim 60 to recite a population of modified primary human B cells, comprising:
a population of primary B cells,
wherein the cells of the population are not immortalized;
wherein the cells of the population lack exogenous viral nucleic acids, and
wherein some of the primary B cells of the population have been gene-edited to insert variable regions of light and heavy chains of a heterologous antibody by a
double-stranded break in the genome of the primary B cells and substitute the variable regions of
an endogenous B cell receptor.
Applicant has amended Claim 64 to recite wherein the primary B cells are non-proliferative unless cultured in IL4, IL-21, CD40L, or combinations thereof.
Either this is an inherent functional property of (that naturally flows from) the gene-edited B cells [structure] of Claim 60, or it is not, and something structural the gene-edited B cells of independent Claim 60 must change.
To the extent it is an inherent property of (that naturally flows from) the product of the independent claim, then the instant claim fails to further limit the independent claim.
Furthermore, in regard to instant claims, it is noted that the “wherein the primary B cells are non-proliferative unless cultured in IL4, IL-21, CD40L, or combinations thereof” clause does not recite any additional structure(s) and/or active method step(s), but simply states a characterization or conclusion of the results of the gene-edited B cells of Claim 60.
Therefore, the "wherein" clause is not considered to further limit the method defined by the claim and has not been given weight in construing the claims. See Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171,26 USPQ2d 1018, 1023 (Fed Cir. 1993) ("A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim."). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.").
'Even if such a phrase did hold patentable weight, the phrase would likely be rejected under 35 USC 112(b) for being indefinite because such a phrase would amount to a 'functional limitation' whereby one of ordinary skill in the art would essentially need to 'guess' what steps must occur in the claim, in addition to the positively-recited method steps, in order to result in 'wherein the....' (the 'intended result' phrase in the claim).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
7. Claim 64 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 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.
Applicant has amended Claim 60 to recite a population of modified primary human B cells, comprising:
a population of primary B cells,
wherein the cells of the population are not immortalized;
wherein the cells of the population lack exogenous viral nucleic acids, and
wherein some of the primary B cells of the population have been gene-edited to insert variable regions of light and heavy chains of a heterologous antibody by a
double-stranded break in the genome of the primary B cells and substitute the variable regions of
an endogenous B cell receptor.
Applicant has amended Claim 64 to recite wherein the primary B cells are non-proliferative unless cultured in IL4, IL-21, CD40L, or combinations thereof.
Either this is an inherent functional property of (that naturally flows from) the gene-edited B cells [structure] of Claim 60, or it is not, and something structural the gene-edited B cells of independent Claim 60 must change.
To the extent it is not an inherent property of (that naturally flows from) the product of the independent claim, then the instant claim fails are considered to lack adequate written description for failing to recite the structural change(s) in the gene-edited primary B cells of Claim 60 that is/are necessary and sufficient to achieve the recited functional properties of dependent Claim 64.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. The disclosure of a single species is rarely, if ever, sufficient to describe a broad genus, particularly when the specification fails to describe the features of that genus, even in passing. (see In re Shokal 113USPQ283(CCPA1957); Purdue Pharma L.P. vs Faulding Inc. 56 USPQ2nd 1481 (CAFC 2000).
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997).
Furthermore, in regard to instant claims, it is noted that the “wherein the primary B cells are non-proliferative unless cultured in IL4, IL-21, CD40L, or combinations thereof” clause does not recite any additional structure(s) and/or active method step(s), but simply states a characterization or conclusion of the results of the gene-edited B cells of Claim 60.
Therefore, the "wherein" clause is not considered to further limit the method defined by the claim and has not been given weight in construing the claims. See Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171,26 USPQ2d 1018, 1023 (Fed Cir. 1993) ("A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim."). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.").
'Even if such a phrase did hold patentable weight, the phrase would likely be rejected under 35 USC 112(b) for being indefinite because such a phrase would amount to a 'functional limitation' whereby one of ordinary skill in the art would essentially need to 'guess' what steps must occur in the claim, in addition to the positively-recited method steps, in order to result in 'wherein the....' (the 'intended result' phrase in the claim).
The claims fail to recite, and the specification fails to disclose, a first gene-edited primary human B cell having the structural limitations of independent Claim 60 but do not have the functional properties of dependent Claim 64, as opposed to a second gene-edited primary human B cell having the structural limitations of independent Claim 60 that necessarily and predictably have the functional properties of dependent Claim 64, for example.
The claims fail to recite, and the specification fails to disclose, a population of primary human genome-edited B cells, wherein said cells are not immortalized and lack exogenous viral nucleic acids yet are not non-proliferative unless activated with IL-4, IL-21, CD40L, or combinations thereof.
The claims fail to recite, and the specification fails to disclose, a first population of primary human genome-edited B cells, wherein said cells are not immortalized and lack exogenous viral nucleic acids yet are not non-proliferative unless activated with IL-4, IL-21, CD40L, or combinations thereof, as opposed to a second population of primary human genome-edited B cells, wherein said cells are not immortalized and lack exogenous viral nucleic acids and are non-proliferative unless activated with IL-4, IL-21, CD40L, or combinations thereof, for example.
The claims fail to recite, and the specification fails to disclose, how to modify or otherwise transform a first population of primary human genome-edited B cells, wherein said cells are not immortalized and lack exogenous viral nucleic acids yet are not non-proliferative unless activated with IL-4, IL-21, CD40L, or combinations thereof, into a second population of primary human genome-edited B cells, wherein said cells are not immortalized and lack exogenous viral nucleic acids and are now, necessarily and predictably, non-proliferative unless activated with IL-4, IL-21, CD40L, or combinations thereof, for example.
Thus, for the reasons outlined above, it is concluded that the claims do not meet the requirements for written description under 35 U.S.C. 112, first paragraph.
MPEP 2163 - 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the “specification shall contain a written description of the invention ....” This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc)
8. Claim 70 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 60 recites a population of genome-edited primary human B cells.
Claim 70 recites wherein the cells of the population are either allogeneic or autologous to a subject into whom the population is transplanted.
As a first matter, the recitation “a subject” (Claim 70, line 2) is broader in scope than the Claim 60 primary human B cells, as it would appear to encompass non-human subjects (e.g. [000214], “A subject in the context of the present invention is preferably a mammal, … can be a non-human primate, mouse, rat, dog, …”). Those of ordinary skill in the art immediately recognize that human cells are not allogeneic nor autologous to non-human animals. Thus, the subject is broader in scope than the human of the independent claim.
As a second matter, those of ordinary skill in the art immediately recognize that primary human B cells (Claim 23) are inherently either allogeneic or autologous to human subjects, per natural law of biology. Thus, mere recitation of both embodiments fails to further limit the independent claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
9. Claims 53, 57, 67, and 69 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.
The phrase “correspond to” in Claims 53 and 67 is a relative term which renders the claim indefinite. The phrase “correspond to” is 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.
As a first matter, the phrase denotes an unrecited and undisclosed number of changes to the genome of the cells of the population of Claims 53 and/or 67 which “corresponds to” the genome of some unrecited and undisclosed reference cell, as opposed to an unrecited and undisclosed number of changes to the genome of the cells of the population which does not “corresponds to” the genome of some unrecited and undisclosed reference cell. Thus, that which does/does not “correspond to” is considered an arbitrary and subjective determination.
The recitation implies a genus of structurally unrecited and undisclosed genomes and/or unrecited and undisclosed non-immortalized cells, by which “correspond to” is to be determined and/or identified, thereby rendering the claim indefinite. A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)).
As a second matter, the claim recites the referenced non-immortalized cells at a high level of generality. Wikipedia (List of distinct cell types in the adult human body; Wikipedia.org/wiki/ List_of_distinct_cell_types_in_the_adult_human_body; last visited June 13, 2024; of record in co-pending application 17/687,246) evidences that there are at least 1000 different cell types.
Even if one considers the referenced non-immortalized cell to be a primary human B cell, the breadth of the claims encompass B cells in which the BCR genes have not yet been re-arranged, as well as B cells in which the BCR genes have been re-arranged. Thus, here too, the non-immortalized cell type which does/does not “correspond to” the cells of the population of Claim 23 is considered an arbitrary and subjective determination.
The recitation implies a genus of structurally unrecited and undisclosed non-immortalized cells, by which “correspond to” is to be determined and/or identified, thereby rendering the claim indefinite. A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)).
Dependent claims are included in the basis of the rejection because they do not correct the primary deficiencies of the independent claim(s).
10. Claim 67 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 60 has been amended to recite a population of genome-edited primary human B cells that are not immortalized and lack exogenous viral nucleic acids.
Claim 67 has been amended to recite wherein the genomes of the population of genome-edited primary human B cells correspond to that of non-immortalized cells and and lack exogenous viral nucleic acids.
Claim 67 fails to further limit Claim 60 because the claimed population of genome-edited primary human B cells of the independent claim are already not immortalized and lack exogenous viral nucleic acids, and thus necessarily correspond to at least the primary human B cells prior to the genome-editing.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
New matter
11. Claim(s) 53, 57, 59-60, 64, and 66-71 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant has amended Claims 53, 60, and 67, to recite a population of genome-edited B cells, wherein said cells…lack exogenous viral nucleic acids.
Clear support for the new limitation(s) cannot be found in the instant application or priority documents. Accordingly, the amendment(s) to Claim(s) 53, 60, and 67 is/are considered to constitute new matter.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application”. MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure” (emphasis added).
Applicant’s amendment to the independent claim encompasses an attempt to shift or otherwise change:
the broader genus of human subject/patient populations whose primary B cells are to be gene-edited and comprise naturally-occurring viral nucleic acids due to naturally-occurring viral infections to,
a subgenus of humans in which their B cells do not comprise any exogenous viral nucleic acids, as they have not experienced naturally-occurring viral infections,
for which there is no support in the instant specification and/or priority documents.
Those of ordinary skill in the art have long-recognized, for example, that the Epstein-Barr virus is naturally present in 19 out of 20 (syn. 95%) of the American human population, for example.
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The specification fails to disclose the primary human B cells with the negative limitation that are to be gene-edited are not infected with EBV, for example.
The specification fails to re-define the art-recognized exogenous EBV to be an endogenous (syn. not exogenous) viral nucleic acid, for example.
The specification is silent to “Epstein”, “Epstein-Barr”, “Epstein-Barr virus”, or “EBV”, for example.
The specification fails to disclose a step of selecting only those humans whose B cells do not comprise exogenous viral nucleic acids, from whom only this subpopulation of humans are to have their B cells genome-edited, for example.
The specification fails to disclose a step of selecting a subpopulation of primary human B cells that do not comprise exogenous viral nucleic acids from a heterogenous population of primary human B cells comprising B cells comprising exogenous viral nucleic acids to thereby only genome edit said subpopulation of primary human B cells that do not comprise exogenous viral nucleic acids, for example.
Applicant argues that support for the new limitation(s) is found in the specification because it does not disclose any steps for viral transformation of primary B cells.
Applicant’s argument is unpersuasive.
As a first matter, the negative limitation is not recited to be directed to the nucleic acid(s) by which the primary B cells are edited, let alone the exogenous transgene(s) encoding the exogenous heavy and/or light chain(s).
As a second matter, while the Product-by-Process step(s) “inserted by a double-stranded break” and “gene-edited to insert” is/are understood by the ordinary artisan to mean the gene editing system is introduced into the primary human B cells, Senis et al (CRISPR/Cas9-mediated genome engineering: An adeno-associated viral (AAV) vector toolbox, Biotechnol. J. 9: 1402-1412, DOI 10.1002/biot.201400046, available September 4, 2014; of record in co-pending application 17/687,246) is considered relevant prior art for having taught the introduction of a CRISPR/Cas9 gene editing system into the artisan’s desired host cell via liposomal transfection of an AAV vector plasmid or infection/transduction of an AAV virus whose genome comprises said CRISPR/Cas9 system (e.g. pg 1404, Section 2.4, Transfection or transduction of CRISPR constructs).
Thus, here too, the specification fails to disclose the negative limitation whereby the CRISPR/Cas9 gene editing system transfected or otherwise introduced into the primary human B cells is not a plasmid encoding a viral vector encoding one or more components of the CRISPR/Cas9 system and/or donor templates.
As a third matter, Claims 69(iii) and 71(iii) recite the presence of a non-native regulatory element, recited at a high level of generality, operably linked to the exogenous transgene(s) encoding the exogenous heavy and/or light chain(s). However, nowhere in the specification is it disclosed that the non-native regulatory element, recited at a high level of generality, cannot be a viral regulatory element, e.g. a viral promoter or enhancer.
Scholz et al (U.S. 2013/0143267; of record in co-pending application 17/687,246) is considered relevant prior art for having disclosed primary B cells expressing a heterologous therapeutic antibody, whereby the antibody transgene is operably linked to a viral promoter (e.g. [0057], “heterologous viral promoters”) and/or a viral enhancer (e.g. [0061]), for example.
Thus, here too, the specification fails to disclose the negative limitation whereby the non-native regulatory element, recited at a high level of generality, operably linked to the exogenous transgene(s) encoding the exogenous heavy and/or light chain(s) is not a viral non-native regulatory element, even more specifically, not a viral promoter and/or a viral enhancer.
Alternatively, if Applicant believes that support for the negative limitation(s) now recited in amended Claims 53, 60, and 67 is present and clearly envisaged in the instant application or earlier filed priority documents, applicant must, in responding to this Office Action, point out with particularity, where such support may be found.
Declarations and new references cannot demonstrate possession of a concept after the fact.
Applicant does not indicate where these limitations are supported by the original specification, or how, as is Applicant's burden. See MPEP §714.02, last sentence of the third paragraph from the end and MPEP §2163.06 (I) last sentence.
Thus, for the reasons outlined above, it is concluded that the claims do not meet the requirements for written description under 35 U.S.C. 112, first paragraph.
MPEP 2163 - 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the “specification shall contain a written description of the invention ....” This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc)
Dependent claims are included in the basis of the rejection because they do not correct the primary deficiencies of the independent claim(s).
12. Claim(s) 53, 57, 59-60, 64, and 66-71 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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. Evidence that, at least, Claims 53, 60, and 67 fail(s) to correspond in scope with that which the inventor or a joint inventor, or for pre-AIA applications the applicant regards as the invention can be found in the reply filed April 22, 2026. In that paper, the inventor or a joint inventor, or for pre-AIA applications the applicant has stated that the newly present negative limitation “lacks exogenous viral nucleic acids” is supported by the fact that no workflows disclosed in the application use viral vectors for gene transfer, e.g. pgs 9-10, joining para), and this statement indicates that the invention is different from what is defined in the claim(s) because instant Claims 53, 60, and 67 fail to recite the product-by-process step whereby the primary human B cells whose genomes are edited to encode an exogenous therapeutic antibody heavy and/or light chains are not transduced with a viral vector encoding said exogenous therapeutic antibody heavy and/or light chains and/or donor template(s) encoding the exogenous therapeutic antibody heavy and/or light chains.
Rather, the negative limitation “lack exogenous viral nucleic acids” is recited at a high level of generality.
See further discussion in the above 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, New Matter rejection.
Dependent claims are included in the basis of the rejection because they do not correct the primary deficiencies of the independent claim(s).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
13. The prior rejection of Claim(s) 53-55 and 57-58 under 35 U.S.C. 102(a)(1) as being anticipated by Scholz et al (U.S. 2013/0143267) is withdrawn in light of Applicant’s amendment to the independent claims to recite wherein the heterologous light and heavy chains substitute the variable regions of an endogenous B cell receptor, a limitation Scholz et al do not disclose.
14. The prior rejection of Claim(s) 53-55 and 57-58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hyde et al (U.S. 2013/0164277) is withdrawn in light of Applicant’s amendment to the independent claims to recite wherein the heterologous light and heavy chains substitute the variable regions of an endogenous B cell receptor, a limitation Hyde et al do not disclose.
15. Claim(s) 53, 57, 60, 64, 66-67, and 70 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jolly et al (U.S. 2004/0156832; of record).
With respect to Claims 53 and 60, Jolly et al is considered relevant prior art for having disclosed an isolated human B cells (e.g. [0033], lymphocytes, as opposed to lymphocyte cell lines), comprising one or more genomic modifications, wherein said genomic modification comprises inserting a nucleic acid sequence encoding an exogenous antibody [0012, 34-35], wherein the antibody is a therapeutic antibody (e.g. Abstract; [0184]).
With respect to the limitation whereby the heterologous therapeutic antibody variable regions substitute the variable regions of the primary human B cell, Jolly et al disclosed wherein the exogenous antibody heavy and/or light chain is introduced into the host cell’s genome via homologous recombination, thereby replacing the endogenous heavy and/or light chain variable regions (e.g. [0028, 145]).
With respect to the limitation whereby the genome of the primary human B cell lacks exogenous virus nucleic acids, per Applicant’s argument, “No workflows disclosed in the application use viral vectors for gene transfer” (e.g. pgs 9-10, joining para), the Examiner interprets the negative limitation to be directed to the use of a non-viral vector by which the therapeutic antibody nucleic acid is introduced into the target primary human B cell.
Jolly et al disclosed wherein the vector may be a plasmid vector (syn. not a viral vector) (e.g. [0024, 140]), and thus, upon homologous recombination with the endogenous heavy and/or light chain variable regions, the thus-edited human B cells are considered to “lack exogenous virus nucleic acids, per Applicant’s argument.
Jolly et al do not disclose the phrase “gene-edited to insert…”, as recited in Claim 60. However, the recitation of a process limitation in Claim 60 is not viewed as positively limiting the claimed product absent a showing that the “gene-edited” process of making recited at a high level of generality in Claim 60 imparts a novel or unexpected property to the claimed product, as it is assumed that equivalent products are obtainable by multiple routes. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced products. The method in which the primary human B cells whose endogenous B cell receptor variable regions are substituted with the light and heavy chain variable regions of a heterologous antibody were produced is immaterial to their patentability.
"Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
With respect to Claims 57 and 66, Jolly et al disclosed an antibody specific for Rhesus Factor (e.g. Examples 4-9).
With respect to Claim 64, such is considered to fail to further limit independent Claim 60. See 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, above.
To the extent Applicant argues otherwise, see 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejection above.
With respect to Claim 67, such is considered to fail to further limit independent Claim 60. See 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, above.
To the extent Applicant argues otherwise, see 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, rejection above.
With respect to Claim 70, such is considered to fail to further limit independent Claim 60. See 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, above.
Thus, Jolly et al anticipate the claims.
Response to Arguments
Applicant argues that Jolly et al only disclose primary human B cells in the context of fusing them to myeloma cells to form hybridomas.
Applicant’s argument(s) has been fully considered, but is not persuasive.
The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).
A reference contains an "enabling disclosure" if the public was in possession of the claimed invention before the date of invention. "Such possession is effected if one of ordinary skill in the art could have combined the publication's description of the invention with his [or her] own knowledge to make the claimed invention." In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985).
Jolly et al disclosed wherein the vector may be a plasmid vector (syn. not a viral vector) (e.g. [0024, 140]).
Buschle et al (Transfection and gene expression in normal and malignant primary B lymphocytes, J. Immunol. Methods 133: 77-85, 1990) is considered relevant prior art for having successfully introduced the artisan’s plasmid of interest into primary human B cells via, e.g. electroporation (e.g. pg 78, Methods, col. 1, Cell separations; col. 2, Electroporation; Figure 1).
Mullins et al (Optimizing the process of nucleofection for professional antigen presenting cells, BMC Res. Notes 8: e472, 7 pages, DOI 10.1186/s13104-015-1446-8; available online September 24, 2015) is considered relevant prior art for having successfully introduced the artisan’s plasmid of interest into primary human B cells via, e.g. nucleofection (e.g. Figure 8).
Thus, no undue experimentation is required.
Applicant provides no objective evidence that the undue experimentation is required to introduce the heterologous nucleic acid encoding the therapeutic antibody into primary human B cells.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
16. The prior rejection of Claims 53-55, 57-58, and 60-67 under AIA 35 U.S.C. 103 as being unpatentable over Hyde et al (U.S. 2013/0164277; of record) in view of Ando et al (U.S. 2008/0159996; of record), Gregory et al (U.S. 2014/0301990; priority to March 21, 2013; of record), and Zhang et al (U.S. 2014/0179770; filed December 12, 2013; of record) is withdrawn in light of Applicant’s amendments to Claims 53 and 60 to recite wherein the heterologous light and heavy chains substitute the variable regions of an endogenous B cell receptor, limitations Hyde et al, Ando et al, Gregory et al, nor Zhang et al disclose.
17. Claims 53, 57, 60, 64, 66-67, and 70 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Hyde et al (U.S. 2013/0164277; of record) in view of Ando et al (U.S. 2008/0159996; of record), Gregory et al (U.S. 2014/0301990; priority to March 21, 2013; of record), Zhang et al (U.S. 2014/0179770; filed December 12, 2013; of record), Buelow et al (U.S. 2007/0033661; of record), Wang et al (available online August 25, 2014; cited in Applicant’s co-pending application 17/687,246; of record), and Mandal et al (available online November 6, 2014; cited in Applicant’s co-pending application 17/687,246; of record).
Determining the scope and contents of the prior art, and Ascertaining the differences between the prior art and the claims at issue.
With respect to Claims 53 and 60, Hyde et al is considered relevant prior art for having disclosed primary human B cells whose genome comprises a nucleic acid sequence encoding the variable regions of light and heavy chains of a heterologous therapeutic antibody (e.g. [0116]).
Hyde et al do not disclose wherein the nucleic acid sequence encoding the variable regions of light and heavy chains of a heterologous therapeutic antibody is introduced into the genome of the primary human B cell via gene-editing.
However, prior to the effective filing date of the instantly claimed invention, Ando et al is considered relevant prior art for having disclosed the use of site-specific nucleases, e.g. zinc finger nucleases [0007-14], to introduce the artisan's heterologous nucleic acid of interest into the host cell's targeted genomic locus [0017], wherein the host cell is primary B lymphocytes, e.g. peripheral blood mononuclear cells [0016, 122].
Similarly, Gregory et al is considered relevant prior art for having disclosed the use of ZFN, TALEN, or CRISPR/Cas system [0015, 21] to introduce the artisan's heterologous nucleic acid of interest into the host cell's targeted genomic locus, wherein the host cell is primary lymphocytes (PBMCs), which inherently and naturally comprise primary B cells and primary T lymphocytes [0184].
Zhang et al is considered relevant prior art for having disclosed the use of CRISPR/Cas9 system [0010-11] to modify the genome of the target host cell with a heterologous nucleic acid encoding the artisan's protein of interest [0065], wherein the target host cell includes B cells [0261], including primary human B cells [0262, 566].
Hyde et al disclosed primary human B cells whose genome comprises a nucleic acid sequence encoding the variable regions of light and heavy chains of a heterologous therapeutic antibody (e.g. [0116]).
Hyde et al also disclosed a population of B cells isolated from an individual ([0037], “isolating human B cells from an individual”), whereby the endogenous immunoglobulin heavy and light genes encoding a B cell receptor are deleted, being replaced via homologous recombination with a heterologous nucleic acid encoding the artisan’s immunoglobulin heavy and light chain genes [0037, 73].
Thus, Hyde et al is considered to reasonably infer or suggest that the primary human B cells may also be gene-edited to replace the endogenous BCR loci with the heterologous heavy and light chain variable region nucleic acids.
Gregory et al disclosed editing the endogenous TCR gene in T cells, thereby stably integrating the heterologous nucleic acid in the edited TCR locus (e.g. [0020]).
Nevertheless, prior to the effective filing date of the instantly claimed invention, Buelow et al is considered relevant prior art for having disclosed a population of somatic cells in which a human immunoglobulin locus transgene is either randomly inserted (e.g. [0112]) in the host B cell genome or replaces the endogenous immunoglobulin locus, e.g. via homologous recombination (e.g. [0113]), wherein the transgenic immunoglobulin locus encodes an immunoglobulin heavy chain or an immunoglobulin light chain (e.g. [0107]), and wherein the human immunoglobulin transgene encodes a monoclonal antibody (e.g. [0051,55]). The exogenous immunoglobulins are expressed in B cells (e.g. [0038, 85]).
With respect to the ability of the ordinary artisan to edit the genome of primary human B cells with a reasonable expectation of success:
Ando et al disclosed the use of ZFNs to edit the genome of primary human T cells, thereby resulting in the targeted insertion of an exogenous nucleic acid sequence into a targeted location of the T cell genome (Example 5), and disclosed the ZFNs may also be used in B cells and other T cell subtypes [0122].
Wang et al is considered relevant prior art for having successfully demonstrated the use of the CRISPR/Cas9 system to edit the genome of human B cells, e.g. Raji cells (e.g. Figures 1-2).
Mandal et al is considered relevant prior art for having successfully demonstrated the ability of the ordinary artisan to use the CRISPR/Cas9 gene editing system to target and edit the artisan’s gene(s) of interest in primary human T cells and primary human hematopoietic stem cells (HSCs) (entire paper, Graphical Abstract; Summary, “primary human CD4+ T cells”).
With respect to the limitation whereby the genome of the primary human B cell lacks exogenous virus nucleic acids, per Applicant’s argument, “No workflows disclosed in the application use viral vectors for gene transfer” (e.g. pgs 9-10, joining para), the Examiner interprets the negative limitation to be directed to the use of a non-viral vector by which the therapeutic antibody nucleic acid is introduced into the target primary human B cell.
The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).
A reference contains an "enabling disclosure" if the public was in possession of the claimed invention before the date of invention. "Such possession is effected if one of ordinary skill in the art could have combined the publication's description of the invention with his [or her] own knowledge to make the claimed invention." In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985).
Hyde et al disclosed the use of a plasmid vector encoding the heterologous antibody (e.g. [0037], “plasmid targeting vectors to obtain targeted integration into the corresponding… chromosome”), introduced into the cell via, e.g. electroporation (e.g. [0074], “electroporation into the ... B cells….targeting vector plasmids”).
Ando et al disclosed any vector, including plasmids, may be used to introduce the genome-editing system into the target host cells (e.g. [0116]) via, e.g. electroporation (e.g. [0210], “electroporated with a…ZFN expressing plasmid”), or other methods known in the art for the introduction of exogenous molecules into cells (e.g. [0076], e.g. liposomes, direct injection, etc…).
Gregory et al disclosed any vector, including plasmids, may be used to introduce the genome-editing system into the target host cells (e.g. [0032], e.g. transfection with… ZFN plasmid), or other methods known in the art for the introduction of exogenous molecules into cells (e.g. [0085], e.g. electroporation, liposomes, direct injection, etc…).
Zhang et al disclosed any vector, including plasmids, may be used to introduce the genome-editing system into the target host cells (e.g. [0028], e.g. “viral or plasmid vector”), or other methods known in the art for the introduction of exogenous molecules into cells (e.g. [0612], e.g. electroporation, liposomes, direct injection, etc…).
Wang et al taught the nucleofection of a plasmid encoding the CRISPR/Cas9 editing system into the target host cells (e.g. pg 13157, col. 2; Figure 1; pg 13158, col. 1, “transfection efficiency”).
Mandal et al taught the transfection of a plasmid encoding the CRISPR/Cas9 editing system into the target host cells (e.g. 650, Methods, col. 2, Transfection of Cells).
Thus, it is considered that no undue experimentation is required to introduce the non-viral vector comprising a nucleic acid encoding the heterologous antibody into primary human B cells, from which to thereby substitute the variable regions of an endogenous B cell receptor.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The focus when making a determination of obviousness should be on what a person of ordinary skill in the pertinent art would have known at the time of the invention, and on what such a person would have reasonably expected to have been able to do in view of that knowledge. This is so regardless of whether the source of that knowledge and ability was documentary prior art, general knowledge in the art, or common sense. M.P.E.P. §2141.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning). See MPEP §2144.
Prior to the effective filing date of the instantly claimed invention, it would have been obvious to one of ordinary skill in the art to substitute a first vector genomic location in which to insert the artisan’s therapeutic antibody heavy and light chain genes, e.g. random integration, as disclosed by Hyde et al and Buelow et al, with a second genomic location in which to insert the artisan’s therapeutic antibody heavy and light chain genes, to wit, replacement of the endogenous immunoglobulin heavy and light chain genes, as disclosed by Buelow et al and Hyde et al, in primary human B cells with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06. An artisan would be motivated to substitute a first vector genomic location in which to insert the artisan’s therapeutic antibody heavy and light chain genes, e.g. random integration, with a second genomic location in which to insert the artisan’s therapeutic antibody heavy and light chain genes, to wit, replacement of the endogenous immunoglobulin heavy and light chain genes, in primary human B cells because those or ordinary skill in the art previously recognized and successfully reduced to practice the scientific and technical concepts of inserting the artisan’s therapeutic antibody heavy and light chain genes into the endogenous immunoglobulin heavy and light chain loci, and both Hyde et al and Buelow et al disclosed a population of somatic cells in which a human immunoglobulin locus transgene is either randomly inserted in the host B cell genome or replaces the endogenous immunoglobulin locus, e.g. via homologous recombination.
It is obvious to one of ordinary skill in the art to choose from a finite number of identified, predictable options because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipate success, it is likely that product not of innovation but of ordinary skill and common sense.” The ordinary artisan previously recognized that there is a finite list of potential options, e.g. random integration, safe harbor locus, or insertion into the endogenous immunoglobulin heavy and light chain loci, whereby the ordinary artisan could have pursued the known potential options with a reasonable expectation of success, as the antibody transgenes were successfully demonstrated by the cited prior art to be expressed from genetically modified B cells via genomic integration randomly or by replacing the endogenous BCR heavy and light chain loci, and the number of potential options from which to choose is neither astronomical nor insurmountable, and given the guidance of the cited prior art, it would only be routine experimentation to integrate the artisan’s therapeutic antibody heavy and light chain genes into the endogenous immunoglobulin heavy and light chain genes.
Those of ordinary skill in the art previously recognized and/or successfully reduced to practice gene editing technologies such as ZFN nucleases and CRISPR/Cas9 system are able to edit the genome of human immune cells, including T and B cells, including primary human immune cells. Thus, it is considered that those of ordinary skill in the art would have had a reasonable expectation of success for gene editing technologies such as ZFN nucleases and CRISPR/Cas9 system to edit the genome of primary human B cells, there being no objective evidence of undue experimentation in the art.
It is proper to "take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741,82 USPQ2d 1385, 1396 (2007). See also Id. At 1742, 82 USPQ2d 1397 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").
It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See the recent Board decision Ex parte Smith, —USPQ2d—, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925 .pdf).
With respect to Claims 57 and 66, Hyde et al disclosed an antibody specific for influenza, hepatitis C, Staphylococcus aureus (e.g. [0042, 112]; Examples 2 and 6).
Beulow et al disclosed wherein the antibody is specific for Staphylococcus aureus, RSV, HCV, HBV, CMV, HSV, HER2, CD19, CD20, and CD22 (e.g. [0123-126]).
With respect to Claim 64, such is considered to fail to further limit independent Claim 60. See 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, above.
To the extent Applicant argues otherwise, see 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejection above.
With respect to Claim 67, such is considered to fail to further limit independent Claim 60. See 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, above.
To the extent Applicant argues otherwise, see 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, rejection above.
With respect to Claim 70, such is considered to fail to further limit independent Claim 60. See 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, above.
The cited prior art meets the criteria set forth in both Graham and KSR, and the teachings of the cited prior art provide the requisite teachings and motivations with a clear, reasonable expectation of success. Thus, the invention as a whole is prima facie obvious.
18. Claims 57 and 66 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Hyde et al (U.S. 2013/0164277; of record) in view of Ando et al (U.S. 2008/0159996; of record), Gregory et al (U.S. 2014/0301990; priority to March 21, 2013; of record), Zhang et al (U.S. 2014/0179770; filed December 12, 2013; of record), Buelow et al (U.S. 2007/0033661; of record), Wang et al (available online August 25, 2014; cited in Applicant’s co-pending application 17/687,246; of record), and Mandal et al (available online November 6, 2014; cited in Applicant’s co-pending application 17/687,246; of record), as applied to Claims 53, 57, 60, 64, 66-67, and 70 above, and in further view of Balabashin et al (available online June 18, 2014; of record) and Le et al (U.S. Patent 5,919,452; of record).
Determining the scope and contents of the prior art, and Ascertaining the differences between the prior art and the claims at issue.
With respect to Claims 57 and 66, Hyde et al disclosed an antibody specific for influenza, hepatitis C, Staphylococcus aureus (e.g. [0042, 112]; Examples 2 and 6).
Beulow et al disclosed wherein the antibody is specific for Staphylococcus aureus, RSV, HCV, HBV, CMV, HSV, HER2, CD19, CD20, and CD22 (e.g. [0123-126]).
Neither Hyde et al, Ando et al, Gregory et al, Zhang et al, Buelow et al, Wang et al, nor Mandal et al teach/disclose wherein the antibody is specific for TNFalpha.
However, prior to the effective filing date of the instantly claimed invention, and with respect to Claim(s) 57 and 66, Balabashin et al is considered relevant prior art for having taught mammalian antibody producer cells transfected with nucleic acids encoding light and heavy chains of a monoclonal antibody specific for TNFalpha (entire paper; e.g. pg 762, col. 2, Methods, vectors).
Balabashin et al do not teach wherein the mammalian antibody producer cells are B cells.
However, Le et al disclosed mammalian antibody producer cells that express a monoclonal antibody specific for TNFalpha (e.g. col. 5, lines 39-40; col. 10, lines 2-3; col. 11, lines 15-23), wherein the mammalian producer cell is a B cell (e.g. col. 14, lines 9-11).
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The focus when making a determination of obviousness should be on what a person of ordinary skill in the pertinent art would have known at the time of the invention, and on what such a person would have reasonably expected to have been able to do in view of that knowledge. This is so regardless of whether the source of that knowledge and ability was documentary prior art, general knowledge in the art, or common sense. M.P.E.P. §2141.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning). See MPEP §2144.
Prior to the effective filing date of the instantly claimed invention, it would have been obvious to one of ordinary skill in the art to substitute a first monoclonal antibody-encoding nucleic acid, as disclosed by Hyde et al and Buelow et al, with a second monoclonal antibody-encoding nucleic acid, to wit, an anti-TNFalpha monoclonal antibody-encoding nucleic acid, as taught by Balabashin et al, in primary human B antibody producer cells with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06. An artisan would be motivated to substitute a first monoclonal antibody-encoding nucleic acid with a second monoclonal antibody-encoding nucleic acid, to wit, an anti-TNFalpha monoclonal antibody-encoding nucleic acid, in primary human B antibody producer cells because those of ordinary skill in the art had long-recognized that recombinant anti-TNFalpha monoclonal antibodies are produced in mammalian producer cells, including B cells (Le et al), and the genomic modifications to primary human B cells to produce therapeutic monoclonal antibodies is not restrictive to the target molecule that is to be recognized by the monoclonal antibody.
It is proper to "take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741,82 USPQ2d 1385, 1396 (2007). See also Id. At 1742, 82 USPQ2d 1397 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").
It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See the recent Board decision Ex parte Smith, —USPQ2d—, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925 .pdf).
The cited prior art meets the criteria set forth in both Graham and KSR, and the teachings of the cited prior art provide the requisite teachings and motivations with a clear, reasonable expectation of success. Thus, the invention as a whole is prima facie obvious.
19. Claims 57, 66, 69, and 71 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Hyde et al (U.S. 2013/0164277; of record) in view of Ando et al (U.S. 2008/0159996; of record), Gregory et al (U.S. 2014/0301990; priority to March 21, 2013; of record), Zhang et al (U.S. 2014/0179770; filed December 12, 2013; of record), Buelow et al (U.S. 2007/0033661; of record), Wang et al (available online August 25, 2014; cited in Applicant’s co-pending application 17/687,246; of record), and Mandal et al (available online November 6, 2014; cited in Applicant’s co-pending application 17/687,246; of record), as applied to Claims 53, 57, 60, 64, 66-67, and 70 above, and in further view of Fang et al (Stable antibody expression at therapeutic levels using the 2A peptide, Nature Biotechnol. 23(5): 584-590, 2005; cited in Applicant’s co-pending application 17/687,246; of record).
Determining the scope and contents of the prior art, and Ascertaining the differences between the prior art and the claims at issue.
With respect to Claims 57 and 66, Hyde et al disclosed an antibody specific for influenza, hepatitis C, Staphylococcus aureus (e.g. [0042, 112]; Examples 2 and 6).
Beulow et al disclosed wherein the antibody is specific for Staphylococcus aureus, RSV, HCV, HBV, CMV, HSV, HER2, CD19, CD20, and CD22 (e.g. [0123-126]).
Neither Hyde et al, Ando et al, Gregory et al, Zhang et al, Buelow et al, Wang et al, nor Mandal et al teach/disclose wherein the antibody further comprises an epitope tag.
However, prior to the effective filing date of the instantly claimed invention, and with respect to Claim(s) 57, 66, 69 and 71, Fang et al is considered relevant prior art for having taught mammalian antibody producer cells transfected with nucleic acids encoding light and heavy chains of a monoclonal antibody specific for VEGFR2 (entire paper; e.g. pg 584, col. 2), wherein the C-terminus of the antibody light chain is modified to comprise an epitope tag (e.g. pg 585, col. 2, “his-tag”).
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The focus when making a determination of obviousness should be on what a person of ordinary skill in the pertinent art would have known at the time of the invention, and on what such a person would have reasonably expected to have been able to do in view of that knowledge. This is so regardless of whether the source of that knowledge and ability was documentary prior art, general knowledge in the art, or common sense. M.P.E.P. §2141.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning). See MPEP §2144.
Prior to the effective filing date of the instantly claimed invention, it would have been obvious to one of ordinary skill in the art to substitute a first monoclonal antibody-encoding nucleic acid, as disclosed by Hyde et al and Buelow et al, with a second monoclonal antibody-encoding nucleic acid, to wit, an anti-VEGFR2 monoclonal antibody-encoding nucleic acid, as taught by Fang et al, in primary human B antibody producer cells with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06. An artisan would be motivated to substitute a first monoclonal antibody-encoding nucleic acid with a second monoclonal antibody-encoding nucleic acid, to wit, an anti-VEGFR2 monoclonal antibody-encoding nucleic acid, in primary human B antibody producer cells because those of ordinary skill in the art had long-recognized that recombinant anti-VEGFR2 monoclonal antibodies are produced in mammalian producer cells, and the genomic modifications to primary human B cells to produce therapeutic monoclonal antibodies is not restrictive to the target molecule that is to be recognized by the monoclonal antibody.
Prior to the effective filing date of the instantly claimed invention, it also would have been obvious to one of ordinary skill in the art to modify the heterologous light and/or heavy chain variable regions to comprise an epitope tag with a reasonable expectation of success because those of ordinary skill in the art previously recognized the scientific and technical concepts of appending their protein of interest, including an antibody (Fang et al) to further comprise an epitope tag.
Fang et al do not teach ipsis verbis that the epitope tag is present in the variable region of the antibody.
However, the "mere existence of differences between the prior art and an invention does not establish the invention's nonobviousness." Dann v. Johnston, 425 U.S. 219, 230, 189 USPQ 257, 261 (1976). The gap between the prior art and the claimed invention may not be "so great as to render the [claim] nonobvious to one reasonably skilled in the art."Id.
The specification discloses using the epitope tag to detect expression of the heterologous protein of interest (e.g. [00046], “shows FLAG expression”, “HA expression”; [000200], “tags to facilitate purification, detection”).
The purpose of modifying the artisan’s protein of interest to comprise an epitope tag is to allow the ordinary artisan to detect expression of and/or purify said protein of interest, as successfully demonstrated by Fang et al (e.g. pg 589, col. 1, Methods, His-tagged antibody expression).
It is proper to "take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741,82 USPQ2d 1385, 1396 (2007). See also Id. At 1742, 82 USPQ2d 1397 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").
It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See the recent Board decision Ex parte Smith, —USPQ2d—, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925 .pdf).
The cited prior art meets the criteria set forth in both Graham and KSR, and the teachings of the cited prior art provide the requisite teachings and motivations with a clear, reasonable expectation of success. Thus, the invention as a whole is prima facie obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
20. Claims 53, 57, 60, 64, 66-67, and 69-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 23, 34, 36, and 41-48 of copending Application No. 17/687,246 (reference application; claim set filed March 23, 2026). Although the claims at issue are not identical, they are not patentably distinct from each other.
‘246 recites primary human B cells whose genomes have been modified with insertion of heterologous nucleic acids encoding heavy and light chains of a therapeutic monoclonal antibody, each of which comprise at least the respective heavy and light chain variable regions. Instant claims do not exclude the presence of other heavy and light chain domains present in the ‘246 antibodies.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
21. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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KEVIN K. HILL
Examiner
Art Unit 1638
/KEVIN K HILL/Primary Examiner, Art Unit 1638
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