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 .
Claims Status
The remarks filed 5/19/2026 are acknowledged.
Claims 1-23 are pending.
Claims 1-15 are amended.
Claims 16-23 are new.
Applicant’s election without traverse of Group I, claims 1-20, in the reply filed on 5/19/2026 is acknowledged. Applicant’s election of the following species without traverse in the reply filed 05/19/2026 is acknowledged: Administration weekly during the first treatment cycle.
Claims 18 and 21-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/19/2026.
Therefore, claims 1-17, 19, and 20 are under examination.
Priority
The instant application is a 371 of PCT/EP2022/055080 and claims priority to EP Application EP21159860.2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Priority is given with the earliest effective filing date of 03/01/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/12/2024, 06/11/2024, 01/27/2025, 06/12/2025, 10/30/2025, 02/26/2026, 03/12/2026, 06/05/2026, and 06/15/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Drawings
The drawings are objected to because Figure 1 comprises multiple panels. 37 CFR 1.84(u) states that the different views must be numbered in consecutive Arabic numerals and that "partial views intended to form one complete view, on one or several
sheets, must be identified by the same number followed by a capital letter". Each panel
should be separately numbered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other forms of browser-executable code (see page 22, line 4 of the specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http://, www., or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1, 10, and 12 are objected to because of the following informalities: The claims recite an acronym (i.e. CD38, HLA, and DQ5). The first time an acronym is used, it must be accompanied by the definition of the abbreviation. Appropriate correction is required.
Claims 3 and 4 are objected to for the following informalities: the claims contain internal periods (i.e. “SEQ ID NO.:”). “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).” MPEP 608.01(m)." Appropriate correction is required.
Claim 15 is objected to for the following informalities: Claim 15 recites “according the Chronic Kidney Disease Epidemiology Collaboration”. This is grammatically awkward and the Examiner recommends amending the claim to recite “according to the Chronic Kidney Disease Epidemiology Collaboration”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
Enablement
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 1-17, 19, and 20 are 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 a method for treatment of antibody-mediated rejection of an organ transplant in a human subject comprising administering to the subject an anti-CD38 antibody or antibody fragment, does not reasonably provide enablement for a method of prevention of antibody-mediated rejection of an organ transplant in a human subject comprising administering to the subject an anti-CD38 antibody or antibody fragment. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and
Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v.
Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
(6) the amount of direction or guidance presented; (7) the presence or absence of working examples:
The claim is drawn to a method for the treatment or prevention of antibody-mediated rejection of an organ transplant in a human subject comprising administering to the subject an anti-CD38 antibody or antibody fragment.
The term "prevention" is generally understood in the art to encompass a total protection from disease or injury. Thus, given the high level of required effect, a high level of evidence showing prevention is also required. However, there are no working examples in the specification directed to prevention of antibody-mediated rejection of an organ transplant in a human subject encompassed by the instant claim. Applicant has provided evidenced of treating antibody-mediated rejection of an organ transplant in a human subject comprising administering to the subject the anti-CD38 antibody of felzartamab [see Example 1 of the instant specification]. However, Applicant provides no substantive evidence of preventing antibody-mediated rejection of an organ transplant in a human subject comprising administering to the subject an anti-CD38 antibody or antibody fragment. A demonstration of treatment does not provide support for prevention. Therefore, the instant specification does not provide evidence or substantial guidance commensurate in scope with the claimed method to prevent antibody-mediated rejection of an organ transplant in a human subject.
In conclusion, the claimed invention does not provide enablement for preventing antibody-mediated rejection of an organ transplant in a human subject encompassed by the instant claim. Thus for the reasons outlined above, the specification is not considered to be enabling for one skilled in the art to make and use the claimed invention as the amount of experimentation required is undue, due the lack of guidance and working examples provided in the specification. Therefore, the specification is not representative of the instant claim and the specification is not fully enabled for the instant claim. In view of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention.
Claims 2-17, 19, and 20, which depend from claim 1, are therefore rejected for the same reasons.
Written Description
Claims 1-2, 5-6, 8-17, 19, and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is drawn to a method for the treatment or prevention of antibody-mediated rejection of an organ transplant in a human subject comprising administering to the subject an anti-CD38 antibody or antibody fragment.
It is possible, given the language of “antibody fragment”, that a single amino acid would suffice to meet the limitations of the claims. Because function of any protein, including an antibody, is dependent on the presence of each specific amino acid residue, and with the possibility of added, deleted, or substituted amino acids, a wide variety of antibodies is encompassed by the instant claim. The phrase “antibody fragment” allows any fragment, including a single amino acid, to be encompassed in the instant claim. This would in theory encompass any possible antibody on earth. These antibodies have no correlation between their structure or function. Amending the claim to recite “antigen-binding fragment thereof” would likely overcome the rejection.
The specification teaches the anti-CD38 antibody felzartamab, which comprises specific sequences for the HCDRs, LCDRs, VH, and VL. However, the specification does not teach a functional antibody comprising anything less than these full sequences for each of the six CDRs.
One means of providing adequate written description and evidence of possession of a claimed genus is through providing 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. In this case, there is no disclosure for an anti-CD38 antibody fragment that only contains a single amino acid sequence. One of skill in the art could not envisage such a structure that would bind to CD38.
The art recognizes that a complete set of six CDRs comprise the binding region of an antibody (see Sela-Culang, et al., 2013; instant PTO-892), and that even a single amino acid change to these regions can completely abrogate the binding specificity of an antibody (see Kussie, et al., 1994; instant PTO-892). Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such changes with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "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.)
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held
that:
...To fulfill the written description requirement, a patent specification must
describe an invention and does so in sufficient detail that one skilled in the art can
clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re
Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed."). Thus, an applicant complies with the written
description requirement "by describing the invention, with all its claimed limitations, not
that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention."
Lockwood, 107 F.3d at 1572, 41 USPQ2d 1966.
A "representative number of species" means that the species, which are
adequately described, are representative of the entire genus. Thus, when there is
substantial variation within the genus, one must describe a sufficient variety of species
to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if
the disclosure "indicates that the patentee has invented species sufficient to constitute
the gen[us]. "See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v.
Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir.
2004) "[A] patentee of a biotechnological invention cannot necessarily claim a genus
after only describing a limited number of species because there may be unpredictability
in the results obtained from species other than those specifically enumerated."). "A
patentee will not be deemed to have invented species sufficient to constitute the genus
by virtue of having disclosed a single species when ... the evidence indicates ordinary
artisans could not predict the operability in the invention of any species other than the
one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir.
2004).
Thus, based on the teachings of the instant specification and the art, Applicant has failed to meet the written description of an antibody fragment that binds to CD38 that has only a single amino acid. Therefore, one of skill in the art would not conclude that Applicant was in possession of the claimed invention.
Claims 2, 5-6, 8-17, 19, and 20, which depend from claim 1, are therefore deficient for the same reasons above and do not meet the written description requirement.
Note: Claims 3-4 and 7 require specific sequences and/or structure and therefore are not included in this rejection.
Claim Rejections - 35 USC § 112(b)
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 1-2, 5-6, 8-17, 19, and 20 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.
Claim 1 recites the limitation “an anti-CD38 antibody or antibody fragment”. It is unclear what the metes and bounds are of an “antibody fragment”. There is no requirement that the antibody fragment bind to CD38 and it is further unclear if the fragment must be a fragment of the anti-CD38 antibody. Therefore, the scope of this claim is indefinite.
The Examiner recommends amending the claim to recite “antigen-binding fragment thereof” to overcome this rejection.
Claims 2, 5-6, 8-17, 19, and 20, which depend from claim 1, are therefore deficient for the same reasons.
Note: Claims 3-4 and 7 require specific sequences and/or structure and therefore are not included in this rejection.
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.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Jordan (WO2020185672; 04/12/2024 10 page IDS).
Regarding claims 1, Jordan teaches a method for treating antibody-mediated rejection of an organ transplant in a subject comprising administering an effective amount of an anti-CD38 antibody [0113; claim 2] and that the subject may be a human [0059].
Regarding claim 2, Jordan teaches that the organ is a kidney, heart, lung, pancreas, or intestines [page 48, claims 6 and 7].
Regarding claims 3-4 and 7, Jordan teaches that the anti-CD38 antibody or fragment thereof can be MOR-202.
Applicant defines felzartamab as also being termed MOR202, which comprises SEQ ID NOs: 1-3 for the HCDRs 1-3, respectively, SEQ ID NOs: 4-6 for the HCDRs 4-6, respectively, SEQ ID NO: 7 for the VH and SEQ ID NO: 8 for the VL [see page 9, lines 29-37 – page 10, lines 1-18 of the instant specification]. Therefore, the MOR202 anti-CD38 antibody as taught by Jordan is the same as the claimed felzartamab.
Regarding claim 5, Jordan teaches the anti-CD38 antibody may be a IgG1 isotype [page 49, claim 8].
Regarding claim 6, Jordan teaches that the antibody can be a human antibody [0042].
Regarding claims 8-12, these claims are included in this rejection because they merely recite effects or results of administering an anti-CD38 antibody. Since Jordan teaches administering an anti-CD38 antibody to treat antibody-mediated rejection of an organ transplant in a subject, a person of ordinary skill in the art would have reasonably expected these effects to occur, absent evidence to the contrary.
Regarding claim 13, Jordan teaches that the antibody may be administered intravenously at a dose of about 12-16 mg/kg/week or 16-20 mg/kg/week [page 49, claim 13].
Regarding claim 14, Jordan teaches that the antibody may be administered at last least 2 weeks, at least 3 weeks, at least 4 weeks, at least 5 weeks, at least 6 weeks, at least 7 weeks, at least 8 weeks, at least 3 months, at least 4 months, at least 5 months, at least 6 months, at least 7 months, at least 8 months, at least 9 months, at least 10 months, at least 11 months, at least 12 months, at least 18 months, at least 24 months, or at least 36 months (i.e. doses) [page 49, claim 15].
Claims 1-2, 5, and 8-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spica et al., 2019 (04/12/2024 10 page IDS).
Regarding claims 1-2, Spica teaches administering daratumumab, a monoclonal antibody targeting CD38 on plasma cells, for therapy-refractory antibody-mediated rejection (AMR) due to blood group antibodies in a 59-year-old man (human subject) who received a living ABO-incompatible kidney transplantation, and that after the administration of daratumumab, blood group antibody titers decreased and remained at low levels without further immunoadsorption and allowed kidney graft function to recover (method of treating antibody-mediated rejection of an organ transplant in a human subject) [see Abstract].
Regarding claim 5, Spica teaches daratumumab [see Abstract], which is an IgG1 monoclonal antibody as evidenced by Raedler et al., 2016 (instant PTO-892), who teaches that daratumumab is a humanized IgG1 kappa monoclonal antibody [page 72, right column, seventh paragraph].
Regarding claims 8-12, these claims are included in this rejection because they merely recite effects or results of administering an anti-CD38 antibody. Since Spica teaches administering daratumumab, an anti-CD38 antibody, a person of ordinary skill in the art would have reasonably expected these effects to occur, absent evidence to the contrary.
Regarding claims 13 and 14, Spica teaches that daratumumab is administered at a dose of 16 mg/kg of body weight and is administered by infusion (intravenous) and the patient received a total of six infusions (doses) of daratumumab [page 152, second paragraph].
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 (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 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, 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 for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1-14, 16-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jordan (WO2020185672; 04/12/2024 10 page IDS), as applied to claims 1-14 above.
Regarding claims 16-17 and 19-20, Jordan teaches that the anti-CD38 antibody can be administered weekly, biweekly, or monthly [0116], administered over 1-18 doses [0117], and/or is administered at any of the doses described at least 1-7 times/week, 1-7 times/month, 1-12 times/year for up to 18 months [0118].
However, Jordan does not explicitly teach the claim limitations in a manner as required by 35 U.S.C. 102.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have picked among the various
embodiments of Jordan to arrive at the claimed dosing schedule(s) because Jordan teaches that how often and on which days administration takes place of the anti-CD38 antibody is a result effective variable. Therefore, through routine optimization, one of ordinary skill in the art would arrive at the specific dosing schedule(s) as claimed. See MPEP 2144.05(II).
Claims 1-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jordan (WO2020185672; 04/12/2024 10 page IDS), as applied to claims 1-14, 16-17, and 19-20 above, in view of Delanaye et al., 2016 (instant PTO-892).
The teachings of Jordan are above.
However, Jordan does not specifically teach that the subject is characterized by an estimated glomerular filtration rate (eGFR) ≥20 ml/min/1.73 m2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Regarding claim 15, Delanaye teaches that the CKD-EPI prognosis consortium demonstrates a significant higher risk of death when eGFR is below 60 ml/min/1.73 m2 and also has a statistically significant risk of mortality [page 19, right column, first paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to specifically treated a subject characterized by an estimated glomerular filtration rate (eGFR) ≥20 ml/min/1.73 m2 according to the CKD-EPI formula, as taught by Delanaye, with the method of Jordan. One would have been motivated to treat the patient population of Delanaye with the method of Jordan because Jordan teaches that the organ transplant can be kidney and Delanaye teaches that the patient population with an eGFR below 60 ml/min/1.73 m2 demonstrates a significant higher risk of death and also has a statistically significant risk of mortality, thereby indicating that this patient population is in need of treatment. Thus, one would want to treat the patient population with a kidney transplant of Jordan and an (eGFR) ≥20 ml/min/1.73 m2 of Delanaye with the method of Jordan. Further, MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.”
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Spica et al., 2019 (04/12/2024 10 page IDS), as applied to claims 1-2, 5, and 8-14 above, and further in view of Tesar (WO2007042309; 04/12/2024 10 page IDS).
The teachings of Spica are above.
However, Spica does not specifically teach that the anti-CD38 antibody comprises SEQ ID NOs: 1-3 for the HCDRs 1-3, respectively, SEQ ID NOs: 4-6 for the LCDRs 1-3, SEQ ID NO: 7 for the VH, SEQ ID NO: 8 for the VL, that the antibody is a human antibody, or that the antibody is felzartamab.
Regarding claims 3-4 and 6-7, Tesar teaches an anti-CD38 antibody termed MOR03087 [page 12, lines 19-21].
Applicant defines felzartamab as also being termed MOR202, MOR03087, and MOR3087, with the terms being used interchangeably, which is a human anti-CD38 antibody that comprises SEQ ID NOs: 1-3 for the HCDRs 1-3, respectively, SEQ ID NOs: 4-6 for the HCDRs 4-6, respectively, SEQ ID NO: 7 for the VH and SEQ ID NO: 8 for the VL [see page 9, lines 29-37 – page 10, lines 1-18 and 32-35 of the instant specification]. Therefore, the MOR03087 anti-CD38 antibody as taught by Tesar is the same as the claimed human anti-CD38 antibody felzartamab with the claimed sequences.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anti-CD38 antibody of Spica to be the anti-CD38 antibody of Tesar (i.e. MOR03087; felzartamab). One would have been motivated to have modified the anti-CD38 antibody of Spica to be the anti-CD38 antibody of Tesar because the antibody of Tesar is a known anti-CD38 antibody in the art, and it is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F). Further, it is prima facie obvious to substitute equivalents known for the same purpose (see MPEP 2144.06 (II)).
Claims 1-2, 5, and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Spica et al., 2019 (04/12/2024 10 page IDS), as applied to claims 1-2, 5, and 8-14 above, and further in view of Delanaye et al., 2016 (instant PTO-892).
The teachings of Spica are above.
However, Spica does not specifically teach that the subject is characterized by an estimated glomerular filtration rate (eGFR) ≥20 ml/min/1.73 m2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Regarding claim 15, Delanaye teaches that the CKD-EPI prognosis consortium demonstrates a significant higher risk of death when eGFR is below 60 ml/min/1.73 m2 and also has a statistically significant risk of mortality [page 19, right column, first paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to specifically treated a subject characterized by an estimated glomerular filtration rate (eGFR) ≥20 ml/min/1.73 m2 according to the CKD-EPI formula, as taught by Delanaye, with the method of Spica. One would have been motivated to treat the patient population of Delanaye with the method of Spica because Delanaye teaches that the patient population with an eGFR below 60 ml/min/1.73 m2 demonstrates a significant higher risk of death and also has a statistically significant risk of mortality, thereby indicating that this patient population is in need of treatment. Thus, one would want to treat the patient population with a kidney transplant of Spica and an (eGFR) ≥20 ml/min/1.73 m2 of Delanaye with the method of Spica. Further, MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.”
Claims 1-2, 5, 8-14, 16-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Spica et al., 2019 (04/12/2024 10 page IDS), as applied to claims 1-2, 5, and 8-14 above, and further in view of Doshi (WO2016187546; instant PTO-892).
The teachings of Spica are above.
However, Spica does not specifically teach that the anti-CD38 antibody is administered over 6 treatment cycles, that each treatment cycle is 28 days, that the antibody is administered weekly during the first treatment cycle, or that the antibody is administered once per cycle for treatment cycles 2-6.
Regarding claims 16-17 and 19-20, Doshi teaches an anti-CD38 antibody and that the administration of the antibody can be repeated after one day, two days, three days, four days, five days, six days, one week, two weeks, three weeks, one month, five weeks, six weeks, seven weeks, two months, three months, four months, five months, six months or longer, repeated courses of treatment are also possible, as is chronic administration, and the repeated administration may be at the same dose or at a different dose [page 32, sixth paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically administered the anti-CD38 antibody of Spica over 6 treatment cycles, wherein each treatment cycle is 28 days, and administered the antibody weekly during the first treatment cycle and once per cycle for treatment cycles 2-6. One would have been motivated to have administered the anti-CD38 antibody of Spica at this specific dosing regimen because Doshi teaches that how often and on which days administration takes place of an anti-CD38 antibody is a result effective variable. Therefore, through routine optimization, one of ordinary skill in the art would arrive at the specific dosing schedule as claimed. See MPEP 2144.05(II).
Conclusion
No claims are allowed.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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