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
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
2. Applicant’s amendment filed August 12, 2026 is acknowledged. Claims 2, 4-10, 14-24, 27-46, 50-51, 53-56 and 60-164 are canceled. Claims 1, 47 and 57 are amended. Claims 1, 3, 11-13, 25-26, 47-49, 52 and 57-59 are pending in this application and under examination in this office action.
3. Applicant’s arguments filed on August 12, 2026 have been fully considered but
they are not deemed to be persuasive for the reasons set forth below.
Drawings
4. The drawings were received on August 12, 2026. These drawings are acceptable. Thus, the objection to the drawings 2A-2B is withdrawn.
Specification
5. The objection to the specification is withdrawn in response to Applicant’s amendment to the specification.
Claim Rejections/Objections Withdrawn
6. The objection to claim 57 is withdrawn in response to Applicant’s amendment to the claim.
The rejection of claims 1, 3, 11-13, 25-26 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, lack of scope of enablement is withdrawn in response to Applicant’s amendment to the claims.
The rejection of claims 1, 3, 11-13, 26 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in response to Applicant’s amendment to the claims.
Claim Rejections/Objections Maintained
In view of the amendment filed on August 12, 2026, the following rejections are maintained.
Claim Rejections - 35 USC § 112
7. 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.
Claims 47-49, 52 and 57-59 stand rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. The rejection is maintained for the reasons of record and the reasons set forth below.
Briefly, claims 47-49 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: There are no steps of how to detect and determine the presence of a human B cell lymphoma 6 protein (BCL-6) in the sample, and there are no specific elements including detecting presence of the antigen-antibody immune complexes and no specific parameters/criteria used for determining the presence of the human BCL-6 protein, which are essential and required by the claimed method in view of p. 63-66 and p.83-84 of the instant specification. It is not known how to detect a human BCL-6 polypeptide based on the recited contacting step and the recited comparing step. There is no structural and functional cooperative relationship between the recited steps and the claimed method of detecting a human BCL-6 polypeptide. It is also not known what normal biological samples with no known pathological angiogenesis are, which render the claims indefinite.
ii. Claims 52 and 57-59 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: There is no structurally and functionally cooperative relationship between administering to a tissue and treating an angiogenesis-dependent condition recited in claim 52.
Response to Arguments
On p. 9 of the response, Applicant argues that the rejection has been overcome in view of amendment to the claims.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant' s arguments, the examiner asserts that based on MPEP§2171-MPEP§2173, the claims are indefinite because:
i. Regarding claims 47-49, there is no structurally and functionally cooperative relationship between the recited steps and the claimed method of detecting a human BCL-6 polypeptide in a sample. It is not known how to detect a human BCL-6 polypeptide based on the recited contacting step and the recited comparing step. It is not known what normal biological samples with no known pathological angiogenesis are, and how to detect and determine the presence of human BCL-6 based on the recited steps. There are no steps as to how to detect and determine the presence of a human B cell lymphoma 6 protein (BCL-6) in the sample, and there are no specific elements including detecting the presence of the antigen-antibody immune complexes and no specific parameters/criteria for how to determine the presence of the human BCL-6 protein, which are essential and required by the claimed method in view of p. 63-66 and p.83-84 of the instant specification but are missing. Thus, the claims are indefinite.
ii. Regarding claims 52 and 57-59, there is no structurally and functionally cooperative relationship between administering to a tissue and treating an angiogenesis-dependent condition recited in claim 52. It is not known what a tissue is. The subject with a specific condition or disorder or the recited condition is essential and required for the step of administering the claimed anti-human BCL-6 antibody, but is missing. Thus, the claims are indefinite.
Accordingly, the rejection of claims 47-49, 52 and 57-59 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is maintained.
Claim Rejections - 35 USC § 112
8. 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 47-49, 52 and 57-59 stand rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as based on a disclosure which is not enabling. The rejection is maintained for the reasons of record and the reasons set forth below.
Claims 47-49, 52 and 57-59 stand rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for inhibiting proliferation of capillary tube formation in both HMDEC and HUVEC cells seeded and allowed to grow on Matrigel and treated with an anti-BCL-6 antibody in vitro when compared to an IgG as negative control and bevacizumab as a positive control, inhibiting proliferation of HUVEC or inhibiting proliferation of human bladder cancer cell line T24 by anti-BCL-6 antibody when compared to treatment with a normal IgG or reducing tumor growth that is established by injection of the parental human bladder cancer T24 cells in athymic mice by an anti-BCL-6 antibody when compared to no treatment, wherein the anti-Bcl-6 antibody comprises two heavy chains each comprising SEQ ID NO:21 and two light chain each comprising SEQ ID NO:22, does not reasonably provide enablement for a method for treating all forms of angiogenesis-dependent condition including different diseases recited in claim 57 by administration of the claimed anti-BCL-6 antibody or variants thereof as broadly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. In addition, the specification does not enable the invention of claims 52 and 57-59 that is directed to a method of prevention and curing. The rejection is maintained for the reasons of record and the reasons set forth below.
Claims 47-49 are drawn to a method for detecting a human BCL-6 protein polypeptide, comprising contacting a sample with the claimed anti-BCL-6 antibody, and comparing a level of BCL-6 of the sample with a control, wherein the control is the level of BCL-6 in normal biological samples with no known pathological angiogenesis.
Briefly, the specific steps and elements, parameters or criteria are critical or essential to the practice of the invention for determining the presence of the claimed human BCL-6 protein in the method recited in claims 47-49, but not included in the claim(s). Thus, the claimed method is not enabled by the disclosure. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). The specific steps of detecting, quantifying and comparing and specific elements, parameters and criteria are required by the method of detection recited in claims 47-49 in view of p. 63-66 and p. 83-84 of the specification. The human BCL-6 protein cannot be detected without these specific steps of detecting, quantifying and comparing and specific elements, parameters and criteria to determine the presence of human BCL-6 protein in a sample, for example “measuring and detecting the presence of the immune complexes of human BCL-6 protein and the antibody, comparing and detecting levels of BCL-6 in a test sample and in a healthy normal control, wherein detecting an increased level of BCL-6 in the test sample when compared to the level of BCL-6 in the healthy normal control indicates the presence of the BCL-6 in the test sample”.
Claims 52 and 57-59 as amended are drawn to a method for treating an angiogenesis-dependent condition by administering the claimed anti-BCL-6 antibody having a VH having CDRs1-3 of SEQ ID NOs: 5-7, respectively and a VL having CDRs1-3 of SEQ ID NOs: 12-14, respectively.
Briefly, the subject with a specific condition is critical or essential to the step of administering and to the practice of the invention that is directed to a method of treatment as recited in claims 52 and 57-59, but not included in the claim(s). Thus, the claimed is not enabled by the disclosure. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). The method recited in claims 52 and 57-59 cannot be performed without a subject with a specific condition or with the recited condition because the subject is required by the step of administering recited in claim 52.
In addition, claims 52 and 57-59 encompass a method for treating, preventing and curing all forms of angiogenesis-dependent condition including retinopathy, age-related macular degeneration (AMD), chronic articular rheumatism and psoriasis, diabetic retinopathy, neovascular glaucoma, restenosis, capillary proliferation in atherosclerotic plaques and osteoporosis, solid tumors, solid tumor metastases, angiofibromas, retrolental fibroplasia, hemangiomas, kaposi’s sarcoma, cancer using the claimed anti-BCL-6 antibody in view of paragraph [0154] of the instant specification (based on published application). Based on the paragraph [0154] of the published application, the limitation “treating an angiogenesis-dependent condition …" encompasses preventing and curing all forms of angiogenesis-dependent condition including retinopathy, diabetic retinopathy, AMD neovascular glaucoma… solid tumor metastases…. cancer recited in claim 57.
[0154] “Treatment” refers broadly to both therapeutic treatment and prophylactic or preventative measures…..which the disorder is to be prevented. …the term “treating,” refers broadly to treating a disease, arresting, or reducing the development of the disease …Therapy encompasses but is not limited to precluding the appearance of signs and/or symptoms anytime….and eliminating existing signs and/or symptoms. …treating or preventing relapses or the recurrence of signs and/or symptoms.
However, neither the specification nor the prior art provides guidance as to how to prevent a person from having any form of angiogenesis-dependent condition including retinopathy, diabetic retinopathy, AMD….solid tumor metastases……cancer caused by all possible mechanisms or cure all forms of angiogenesis-dependent condition including retinopathy, diabetic retinopathy, AMD….solid tumor metastases……cancer recited in claim 57 caused by all possible mechanisms. Neither the specification nor the prior art teaches that administration of the claimed anti-BCL-6 antibody can prevent a person from getting any form of angiogenesis-dependent condition including retinopathy, diabetic retinopathy, AMD….solid tumor metastases……cancer caused by all possible mechanisms or cure any form of angiogenesis-dependent condition including retinopathy, diabetic retinopathy, AMD….solid tumor metastases……cancer caused by all possible mechanisms. For example, there is no cure for diabetic retinopathy, AMD, solid tumor metastases or cancer caused by all possible mechanisms (see the factsheets of diabetic retinopathy, AMD, solid tumor metastases or cancer from the Stanford medicine Health care website or the Cleveland Clinic website retrieved on 05/12/2026).
The specification only discloses that:
i) Bcl-6 can be detected in human endothelial cells, bladder cells, prostate cell, lung cells, colon cells and breast cells; and Bcl-6 levels were highest in prostate (LNCaP and PC-3) and bladder (UROtsa and UMUC-3); secreted Bcl-6 can be detected in supernatants from the same cell types with the highest seen associated with endothelial cells (Example 4, Figures 1 and 3).
ii) an anti-Bcl-6 antibody (comprising two heavy chains each comprising SEQ ID NO:21 and two light chain each comprising SEQ ID NO:22) inhibits capillary tube formation in both HMDEC and HUVEC cells seeded and allowed to grow on Matrigel and treated with anti-BCL-6 antibody in vitro when compared to an IgG as negative control and bevacizumab as a positive control (See Example 5, Figures 4-5).
iii) an anti-BCL-6 neutralizing antibody (comprising two heavy chains each comprising SEQ ID NO:21 and two light chain each comprising SEQ ID NO:22) reduced cellular viability of both HDMEC and HUVEC cells and completely inhibited proliferation of HUVEC or inhibited proliferation of human bladder cancer cell line T24 when compared to treatment with a normal IgG (Examples 6 and 8; Figures 6-7, 9).
iv) The level of Bcl-6 in the urine of patients with bladder cancer is higher than that of control subjects (Example 7, Figure 8).
v) an anti-Bcl-6 antibody (comprising two heavy chains each comprising SEQ ID NO:21 and two light chain each comprising SEQ ID NO:22) reduced tumor growth that is established by injection of parental T24 cells in athymic mice when compared to no treatment (Example 9, Figure 10).
However, the specification provides no well-established structural and functional relationship or correlation between reducing tumor growth that is established by injection of parental T24 cells in athymic mice when compared to no treatment shown in Example 9 and Figure 10 and treating, preventing and curing all forms of angiogenesis-dependent condition including retinopathy, diabetic retinopathy, AMD…. caused by all possible mechanisms recited in claims 52 and 57-59. There is no correlation between tumor growth that is established by injection of parental human bladder cancer cell line T24 in athymic mice and the pathogeneses or causes of all forms of angiogenesis-dependent condition including retinopathy, diabetic retinopathy, AMD…. caused by all possible mechanisms. Thus, it is unpredictable whether administering to a tissue can treat, prevent or cure all forms of angiogenesis-dependent conditions, indicating that undue experimentation is required by a skilled artisan to perform while practicing the claimed invention.
Therefore, in view of the breadth of the claims, the lack of guidance in the specification, the limited examples, the unpredictability of inventions, and the current status of the art, undue experimentation would be required by one of skill in the art to perform in order to practice the full scope of the claimed invention as it pertains to an anti-anti-BCL-6 antibody comprising at most one conservative substitution in SEQ ID NOs: 5-7 and 12-14 for HCDR1-3 and LCDR1-3 respectively and methods of the claimed anti-BCL-6 antibody for detection and treatment of angiogenesis-dependent condition.
Response to Arguments
On p. 9 of the response, Applicant argues that the rejection has been overcome in view of amendment to the claims.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2164, MPEP §§2164.01-2164.06(b) & 2164.08, the specification provides insufficient guidance to enable a skilled artisan to practice the full scope of the claimed invention without undue experimentation because of the following:
i. There is no structural and functional relationship or correlation between comparing the claimed genus of controls with no known pathological angiogenesis and detecting increased levels of BCL-6 in urine samples of patients with bladder cancer compared to the levels of control subjects with no cancer (see Example 7, [00336]).
Based on Applicant’s own admission, BCL-6 can be detected in most cells including human endothelial cells, bladder cells, prostate cells, lung cells, colon cells and breast cells (see Example 4 of the instant specification). The specification fails to teach what controls with no known pathological angiogenesis are and can be used for detecting a human BCL-6 polypeptide recited in claims 47-49. The specification fails to provide sufficient information to demonstrate that Applicant is in possession of a method of detecting a human BCL-6 polypeptide recited in claims 47-49 using undefined controls with no known pathological angiogenesis. The specification fails to teach what other specific common structures and sequences are for the claimed genus of controls with no known pathological angiogenesis.
ii. The specification provides no well-established structural and functional relationship or correlation between reducing tumor growth that is established by injection of parental T24 cells in athymic mice when compared to no treatment shown in Example 9 and Figure 10 and treating, preventing and curing all forms of angiogenesis-dependent condition including retinopathy, diabetic retinopathy, AMD…. caused by all possible mechanisms recited in claims 52 and 57-59. There is no correlation between tumor growth that is established by injection of parental human bladder cancer cell line T24 in athymic mice and the pathogeneses or causes of all forms of angiogenesis-dependent condition including retinopathy, diabetic retinopathy, AMD…. caused by all possible mechanisms.
The specification provides no well-established structural and functional relationship or correlation between inhibiting capillary tube formation in both HMDEC and HUVEC cells seeded and allowed to grow on Matrigel in vitro by the claimed anti-human BCL-6 antibody and treatment of all forms of angiogenesis-dependent condition with the claimed anti-human BCL-6 antibody in vivo. The specification provides no well-established structural and functional relationship or correlation between inhibiting proliferation of HUVEC or human bladder cancer cell line T24 in vitro by the claimed anti-human BCL-6 antibody when compared to an IgG control and treatment of all forms of angiogenesis-dependent condition with the claimed anti-human BCL-6 antibody in vivo. The specification provides no well-established structural and functional relationship or correlation between reducing tumor growth that is established by injection of parental T24 cells in athymic mice by the claimed anti-human BCL-6 antibody when compared to no treatment and treatment of all forms of angiogenesis-dependent condition with the claimed anti-human BCL-6 antibody in vivo.
The specification fails to provide sufficient guidance to enable a skilled artisan to practice the claimed invention without unude experimentation because there is no well-established reducing tumor growth that is established by injection of parental T24 cells in athymic mice by the claimed anti-human BCL-6 antibody when compared to no treatment and treatment of all forms of angiogenesis-dependent conditions caused by all possible mechanisms using the claimed anti-human BCL-6 antibody in vivo. Thus, it is unpredictable whether administering to a tissue can treat, prevent or cure all forms of angiogenesis-dependent conditions, indicating that undue experimentation is required by a skilled artisan to perform while practicing the claimed invention.
Note that the scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without such guidance, it is unpredictable whether all forms of angiogenesis-dependent conditions caused by all possible mechanisms can be treated, prevented or cured by the claimed anti-human BCL-6 antibody; and thus the experimentation left to those skilled in the art is extensive and undue. See Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Int. 1986). Thus, the skilled artisan cannot readily know how to use the claimed invention as currently claimed without further undue experimentation. In re Marzocchi, 439 F.2d 220, 223-24, 169 USPQ 367, 369-70 (CCPA 1971)” See MPEP § 2164.03.
Therefore, in view of the breadth of the claims, the lack of guidance in the specification, limited working examples, the unpredictability of inventions, and the current status of the art, undue experimentation would be required by a skilled artisan to perform in order to practice the claimed invention as it pertains to a method for treating an angiogenesis-dependent condition by administration of the claimed anti-human BCL-6 antibody.
Accordingly, the rejection of claims 47-49, 52 and 57-59 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, lack of scope of enablement is maintained.
Claim Rejections - 35 USC § 112
9. Claims 25, 47-49, 52 and 57-59 stand 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. The rejection is maintained for the reasons of record and the reasons set forth below.
Claim 25 as amended encompasses a genus of structurally and functionally undefined detectable label.
Claims 47-49 as amended encompass using a genus of control with no known pathological angiogenesis for detecting a human BCL-6 protein polypeptide.
Claims 52 and 57-59 encompass treating a genus of angiogenesis-dependent condition by the claimed anti-BCL-6 antibody or antigen-binding fragment.
Applicant has not disclosed sufficient species for the broad genus of detectable label, the broad genus of control with no known pathological angiogenesis or treating the broad genus of angiogenesis-dependent condition.
The specification only discloses i. detecting BCL-6 in different cells including most cells including human endothelial cells, bladder cells, prostate cells, lung cells, colon cells and breast cells (see Example 4 of the instant specification); and ii) detecting an increased level of BCL-6 in urine samples of patients with bladder cancer compared to those of healthy controls with no cancer (see Example 7, [00336]); iii. inhibiting capillary tube formation in both HMDEC and HUVEC cells seeded and allowed to grow on Matrigel in vitro by the claimed anti-BCL-6 antibody when compared to an IgG as negative control and bevacizumab as a positive control (See Example 5, Figures 4-5); iv. inhibiting proliferation of HUVEC or human bladder cancer cell line T24 by the anti-BCL-6 antibody when compared to treatment with a normal IgG (Examples 6 and 8; Figures 6-7, 9) and v. reducing tumor growth that is established by injection of parental T24 cells in athymic mice by the anti-BCL-6 antibody when compared to no treatment (Example 9, Figure 10).
The specification provides no well-established structural and functional relationship or correlation between inhibiting capillary tube formation in both HMDEC and HUVEC cells seeded and allowed to grow on Matrigel in vitro by the claimed anti-human BCL-6 antibody and treatment of all forms of angiogenesis-dependent condition with the claimed anti-human BCL-6 antibody in vivo. The specification provides no well-established structural and functional relationship or correlation between inhibiting proliferation of HUVEC or human bladder cancer cell line T24 in vitro by the claimed anti-human BCL-6 antibody when compared to an IgG control and treatment of all forms of angiogenesis-dependent condition with the claimed anti-human BCL-6 antibody in vivo. The specification also provides no well-established structural and functional relationship or correlation between reducing tumor growth that is established by injection of parental T24 cells in athymic mice by the claimed anti-human BCL-6 antibody when compared to no treatment and treatment of all forms of angiogenesis-dependent condition with the claimed anti-human BCL-6 antibody in vivo.
Response to Arguments
On p. 9 of the response, Applicant argues that the rejection has been overcome in view of amendment to the claims.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2163, MPEP §§2163.01-2163.03, the specification fails to provide sufficient description or information or evidence to demonstrate that Applicant is in possession of the claimed genus of structurally and functionally undefined detectable label or using the claimed genus of undefined control with no known pathological angiogenesis for detecting a human BCL-6 protein polypeptide, or treating the claimed genus of angiogenesis-dependent condition because:
i. There is no structural and functional relationship or correlation between the claimed genus of structurally and functionally undefined detectable label and the structurally and functionally defined fluorescent, luminescent, radioactive, colorimetric or enzymatic labels shown in para. [00258]-[0260] of the instant specification. The specification fails to teach what other specific common structures and sequences are for the claimed genus of detectable labels.
ii. There is no structural and functional relationship or correlation between comparing the claimed genus of controls with no known pathological angiogenesis and detecting increased levels of BCL-6 in urine samples of patients with bladder cancer compared to the levels of control subjects with no cancer (see Example 7, [00336]).
Based on Applicant’s own admission, BCL-6 can be detected in most cells including human endothelial cells, bladder cells, prostate cells, lung cells, colon cells and breast cells (see Example 4 of the instant specification). The specification fails to teach what controls with no known pathological angiogenesis are and can be used for detecting a human BCL-6 polypeptide recited in claims 47-49. The specification fails to provide sufficient information to demonstrate that Applicant is in possession of a method of detecting a human BCL-6 polypeptide recited in claims 47-49 using undefined controls with no known pathological angiogenesis. The specification fails to teach what other specific common structures and sequences are for the claimed genus of controls with no known pathological angiogenesis.
iii. There is no well-established structural and functional relationship or correlation between inhibiting capillary tube formation in both HMDEC and HUVEC cells seeded and allowed to grow on Matrigel in vitro by the claimed anti-human BCL-6 antibody and treatment of all forms of angiogenesis-dependent condition with the claimed anti-human BCL-6 antibody in vivo.
There is no well-established structural and functional relationship or correlation between inhibiting proliferation of HUVEC or human bladder cancer cell line T24 in vitro by the claimed anti-human BCL-6 antibody when compared to an IgG control and treatment of all forms of angiogenesis-dependent condition with the claimed anti-human BCL-6 antibody in vivo.
There is no well-established structural and functional relationship or correlation between reducing tumor growth that is established by injection of parental T24 cells in athymic mice by the claimed anti-human BCL-6 antibody when compared to no treatment and treatment of all forms of angiogenesis-dependent condition with the claimed anti-human BCL-6 antibody in vivo.
The specification fails to provide sufficient information to demonstrate Applicant is in possession of a method of treating the broad genus of angiogenesis-dependent condition by the claimed anti-human BCL-6 antibody because there is no well-established reducing tumor growth that is established by injection of parental T24 cells in athymic mice by the claimed anti-human BCL-6 antibody when compared to no treatment and treatment of all forms of angiogenesis-dependent condition with the claimed anti-human BCL-6 antibody in vivo.
Taken together, since the common characteristics/features of other detectable labels, other controls with no known pathological angiogenesis and other angiogenesis-dependent conditions are unknown, a skilled artisan cannot envision the functional correlations of the claimed genus with the claimed invention.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of detectable labels, the genus of controls with no known pathological angiogenesis and the genus of angiogenesis-dependent conditions.
Based on MPEP § 2161.01 and §2163, “to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116”.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of detectable labels, the genus of controls with no known pathological angiogenesis and treatment of the genus of angiogenesis-dependent conditions, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483 and Centocor v. Abbott, 636 F.3d1341 (Fed. Cir. 2011) and AbbVie v. Janssen, 759 F.3d 1285 (Fed. Cir.2014). One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483.
Therefore, the claimed detectable label and the claimed methods of using the claimed anti-BCL-6 antibody for detection and treatment have not met the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115). Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 "Written Description" Requirement. See MPEP § 2161.01 and 2163.
Accordingly, the rejection of claims 25, 47-49, 52 and 57-59 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 is maintained.
Conclusion
Allowable Subject Matter
10. Claims 1, 3 and 11-13 are allowed.
11. Claim 26 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
12. Claims 25, 47-49, 52 and 57-59 are rejected.
13. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO2022256739 (priority 06/04/2021) teach an anti-BCL-6 antibody comprising a VH having SEQ ID NOs: 6-7 and 12-14 for HCDR1-3 and LCDR1-3 respectively (see the sequence alignment below).
SEQ ID NO:5-SEQ ID NO:6-SEQ ID NO:7
BMB47760
ID BMB47760 standard; protein; 112 AA.
XX
AC BMB47760;
XX
DT 19-JAN-2023 (first entry)
XX
DE Anti-BCL-6 monoclonal antibody HC variable Region (VH), SEQ ID:3.
XX
KW B cell lymphoma 6; Bcl-6 protein; Heavy chain variable region;
KW age related macular degeneration; angiogenesis disorder;
KW antibody production; antibody therapy; cancer; cytostatic;
KW diabetic retinopathy; glaucoma; hemangioma; hybridoma; kaposis sarcoma;
KW monoclonal antibody; osteoporosis; protein detection; psoriasis;
KW respiratory disease; restenosis; retinopathy; retinopathy of prematurity;
KW rheumatism; solid tumor; therapeutic; vasotropic.
XX
OS Unidentified.
XX
FH Key Location/Qualifiers
FT Region 25..31
FT /note= "CDR-H1"
FT Region 51..56
FT /note= "CDR-H2"
FT Region 98..101
FT /note= "CDR-H3"
XX
CC PN WO2022256739-A2.
XX
CC PD 08-DEC-2022.
XX
CC PF 06-JUN-2022; 2022WO-US032373.
XX
PR 04-JUN-2021; 2021US-0197112P.
XX
CC PA (NONA-) NONAGEN THERAPEUTICS CORP.
XX
CC PI Rosser CJ, Furuya H;
XX
DR WPI; 2022-F1823J/004.
XX
CC PT New recombinant and/or isolated antibody having heavy and light chain
CC PT variable domains having complementarity-determining regions 1-3, is B
CC PT cell lymphoma 6 inhibitor used to treat e.g. acute respiratory failure,
CC PT retinopathy and cancer.
XX
CC PS Claim 5; SEQ ID NO 3; 124pp; English.
XX
CC The present invention relates to a novel recombinant and/or isolated
CC antibody against a human B cell lymphoma 6 protein (BCL-6). The anti-BCL-
CC 6 antibody comprises a heavy chain variable region (VH) of SEQ ID NO: 3
CC (see BMB47760), VH complementarity-determining regions (CDRs) of SEQ ID
CC NO: 5-7 (see BMB47762-BMB47764), VH framework region (FRs) of SEQ ID NOs:
CC 8-11 (see BMB47765-BMB47768), a light chain variable region (VL) of SEQ
CC ID NO: 4 (see BMB47761), VL CDRs of SEQ ID NOs: 12-14 (see BMB47769-
CC BMB47771), VL framework regions (FRs) of SEQ ID NOs: 15-18 and 23 (see
CC BMB47772-BMB47775 and BMB47780), a heavy chain of SEQ ID NO: 21 (see
CC BMB47778, a heavy chain constant region of SEQ ID NO: 19 (see BMB47776),
CC a light chain of SEQ ID NO: 22 (see BMB47779) and a light chain constant
CC region of SEQ ID NO: 20 (see BMB47777). The invention further discloses:
CC (1) a fusion protein comprising the recombinant and/or isolated
CC antibodies; (2) a polynucleotide comprising a nucleic acid sequence
CC encoding the recombinant and/or isolated antibodies and the fusion
CC protein; (3) an isolated BCL-6 polypeptide of SEQ ID NO: 1 (see BMB47758)
CC and its epitope of SEQ ID NO: 2 (see BMB47759); (4) a vector, a host cell
CC and a composition comprising the fusion protein, the polynucleotides; (5)
CC a method for detecting the human BCL-6 polypeptide by contacting a sample
CC with the isolated and/or recombinant antibodies and treating an
CC angiogenesis-dependent condition by administering an amount of the
CC isolated and/or recombinant antibodies; (6) a kit comprising the isolated
CC and/or recombinant antibodies; (7) an major histocompatibility complex
CC (MHC)-peptide complex comprising the BCL-6 polypeptide; (8) a method for
CC making hybridoma cell that produces the anti-BCL-6 monoclonal antibody;
CC (9) a composition comprising the BCL-6 epitope peptide and further
CC comprises an adjuvant, and/or a pharmaceutically acceptable carrier. The
CC antibodies are useful for detecting BCL-6 polypeptide, and in composition
CC for treating angiogenesis-dependent condition, where the condition is
CC acute respiratory failure, retinopathy, age related macular degeneration,
CC chronic articular rheumatism and psoriasis, disorders associated with
CC inappropriate or inopportune invasion of vessels e.g. diabetic
CC retinopathy, neovascular glaucoma, restenosis, capillary proliferation in
CC atherosclerotic plaques and osteoporosis, and cancer associated
CC disorders, e.g. solid tumors, solid tumor metastases, angiofibromas,
CC retrolental fibroplasia, hemangiomas, Kaposi's sarcoma.
XX
SQ Sequence 112 AA;
Query Match 72.7%; Score 69.1; Length 112;
Best Local Similarity 23.4%;
Matches 18; Conservative 0; Mismatches 0; Indels 59; Gaps 2;
Qy 1 GFSFNKD-------------------YAGSSGS--------------------------- 14
||||||| |||||||
Db 25 GFSFNKDAVCWVRQAPGKGLEWIACIYAGSSGSTYYATWAKGRFTISETSSTTVTLRMTS 84
Qy 15 -------------GTNV 18
||||
Db 85 LTAADTATYFCSRGTNV 101
SEQ ID NO:12-SEQ ID NO:13-SEQ ID NO:14
BMB47761
ID BMB47761 standard; protein; 113 AA.
XX
AC BMB47761;
XX
DT 19-JAN-2023 (first entry)
XX
DE Anti-BCL-6 monoclonal antibody LC variable vegion (VL), SEQ ID:4.
XX
KW B cell lymphoma 6; Bcl-6 protein; Light chain variable region;
KW age related macular degeneration; angiogenesis disorder;
KW antibody production; antibody therapy; cancer; cytostatic;
KW diabetic retinopathy; glaucoma; hemangioma; hybridoma; kaposis sarcoma;
KW monoclonal antibody; osteoporosis; protein detection; psoriasis;
KW respiratory disease; restenosis; retinopathy; retinopathy of prematurity;
KW rheumatism; solid tumor; therapeutic; vasotropic.
XX
OS Unidentified.
XX
FH Key Location/Qualifiers
FT Region 25..35
FT /note= "CDR-L1"
FT Region 51..57
FT /note= "CDR-L2"
FT Region 90..103
FT /note= "CDR-L3"
XX
CC PN WO2022256739-A2.
XX
CC PD 08-DEC-2022.
XX
CC PF 06-JUN-2022; 2022WO-US032373.
XX
PR 04-JUN-2021; 2021US-0197112P.
XX
CC PA (NONA-) NONAGEN THERAPEUTICS CORP.
XX
CC PI Rosser CJ, Furuya H;
XX
DR WPI; 2022-F1823J/004.
XX
CC PT New recombinant and/or isolated antibody having heavy and light chain
CC PT variable domains having complementarity-determining regions 1-3, is B
CC PT cell lymphoma 6 inhibitor used to treat e.g. acute respiratory failure,
CC PT retinopathy and cancer.
XX
CC PS Claim 5; SEQ ID NO 4; 124pp; English.
XX
CC The present invention relates to a novel recombinant and/or isolated
CC antibody against a human B cell lymphoma 6 protein (BCL-6). The anti-BCL-
CC 6 antibody comprises a heavy chain variable region (VH) of SEQ ID NO: 3
CC (see BMB47760), VH complementarity-determining regions (CDRs) of SEQ ID
CC NO: 5-7 (see BMB47762-BMB47764), VH framework region (FRs) of SEQ ID NOs:
CC 8-11 (see BMB47765-BMB47768), a light chain variable region (VL) of SEQ
CC ID NO: 4 (see BMB47761), VL CDRs of SEQ ID NOs: 12-14 (see BMB47769-
CC BMB47771), VL framework regions (FRs) of SEQ ID NOs: 15-18 and 23 (see
CC BMB47772-BMB47775 and BMB47780), a heavy chain of SEQ ID NO: 21 (see
CC BMB47778, a heavy chain constant region of SEQ ID NO: 19 (see BMB47776),
CC a light chain of SEQ ID NO: 22 (see BMB47779) and a light chain constant
CC region of SEQ ID NO: 20 (see BMB47777). The invention further discloses:
CC (1) a fusion protein comprising the recombinant and/or isolated
CC antibodies; (2) a polynucleotide comprising a nucleic acid sequence
CC encoding the recombinant and/or isolated antibodies and the fusion
CC protein; (3) an isolated BCL-6 polypeptide of SEQ ID NO: 1 (see BMB47758)
CC and its epitope of SEQ ID NO: 2 (see BMB47759); (4) a vector, a host cell
CC and a composition comprising the fusion protein, the polynucleotides; (5)
CC a method for detecting the human BCL-6 polypeptide by contacting a sample
CC with the isolated and/or recombinant antibodies and treating an
CC angiogenesis-dependent condition by administering an amount of the
CC isolated and/or recombinant antibodies; (6) a kit comprising the isolated
CC and/or recombinant antibodies; (7) an major histocompatibility complex
CC (MHC)-peptide complex comprising the BCL-6 polypeptide; (8) a method for
CC making hybridoma cell that produces the anti-BCL-6 monoclonal antibody;
CC (9) a composition comprising the BCL-6 epitope peptide and further
CC comprises an adjuvant, and/or a pharmaceutically acceptable carrier. The
CC antibodies are useful for detecting BCL-6 polypeptide, and in composition
CC for treating angiogenesis-dependent condition, where the condition is
CC acute respiratory failure, retinopathy, age related macular degeneration,
CC chronic articular rheumatism and psoriasis, disorders associated with
CC inappropriate or inopportune invasion of vessels e.g. diabetic
CC retinopathy, neovascular glaucoma, restenosis, capillary proliferation in
CC atherosclerotic plaques and osteoporosis, and cancer associated
CC disorders, e.g. solid tumors, solid tumor metastases, angiofibromas,
CC retrolental fibroplasia, hemangiomas, Kaposi's sarcoma.
XX
SQ Sequence 113 AA;
Query Match 84.5%; Score 134.3; Length 113;
Best Local Similarity 40.5%;
Matches 32; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 QASQTINSYLA---------------RASTLAS--------------------------- 18
||||||||||| |||||||
Db 25 QASQTINSYLAWYQQKPGQPPKLLIYRASTLASGAPSRFKGSGSGTQFTLTISDLECADA 84
Qy 19 -----QSYYYSSNTAYGNT 32
||||||||||||||
Db 85 ATYYCQSYYYSSNTAYGNT 103
14. THIS ACTION IS MADE FINAL. 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.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANG-YU WANG whose telephone number is (571)272-4521. The examiner can normally be reached Monday-Thursday, 7:00am-5:00pm EST.
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, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Chang-Yu Wang
October 14, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675
