DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 8/12/25 has been entered in full. The specification is amended. Claims 1-2, 5-6, 7-13 and 15-16 are amended. Claims 4, 14, and 22-31 are canceled. New claim 32 is added.
Applicants' election without traverse of Group I, currently all pending claims, was previously acknowledged.
Claims 1-3, 5-13, 15-21 and 32 are under consideration.
Information Disclosure Statement
The Information Disclosure Statement of 8/12/25 has been considered.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (2/12/25).
The objection to the specification at page 2 is withdrawn in view of the amendments to the title.
All objections and/or rejections of canceled claims 4, 14 and 22-24 are moot.
The objections to claims 12-16 at pages 2-3 are withdrawn in view of the amendments to the claims.
The rejection of claims 13-15 at pages 4-5 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn in view of the amendments to the claims, except as where indicated below.
The rejection of claim 12 at pages 8-9 under 35 U.S.C. 103(a) as being unpatentable over the Record for Clinical Trial NCT02195479 (1/20/2017), and further in view of the FDA label for Darzalex (11/2016) is withdrawn in view of Applicants’ persuasive arguments at page 11 of the 8/12/25 reply regarding objective evidence of nonobviousness in the form of unexpected results found in Example 2 of the specification with respect to superior progression-free survival with the combination of daratumumab, bortezomib, melphalan and prednisone as compared to the same without daratumumab.
The rejection of claim 21 at pages 9-10 under 35 U.S.C. 103(a) as being unpatentable over the Record for Clinical Trial NCT02195479 (1/20/2017), and further in view of Tariman et al (2014) is withdrawn for the same reasons as for the other 103(a) rejection.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 12, 15-16 and 32 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 pre-AIA the applicant regards as the invention. This rejection was set forth previously at pages 3-5 of the 2/12/25 Office action for claims 12 and 15-16; Applicants addition of new claim 32 necessitates the addition of this claim to the rejection.
Claims 12, 15-16 and 32 are each indefinite with regard to the use of the term “about” in relation to the concentrations of the components of the compositions; e.g., “about 20 mg/mL of the antibody” recited in line 2 of claim 12. Per MPEP 2173.05(b)(III)(A), “In determining the range encompassed by the term “about”, one must consider the context of the term as it is used in the specification and claims of the application”. In the instant case, the specification does not define the term, either generally, or in relation to the concentrations or amounts of the composition components daratumumab (claims 12 and 16), acetic acid (claim 12), sodium chloride (claim 12), mannitol (claim 12), polysorbate-20 (claims 15 and 16), recombinant human hylauronidase (claims 15 and 16), histidine (claims 15 and 16), sorbitol (claim 15), methionine (claims 15 and 16), or in relation to pH (claim 15, line 6), and instead merely uses the term in the same manner as in the claims. The specification does not provide any guidance such that the skilled artisan would know which concentrations, pH or amount are encompassed by the claim. Thus, due to the use of the term "about", the claim is indefinite as to what degree of variation is encompassed; for example, "about 20 mg/mL of the antibody" could encompass a range of integers 19.9 to 20.1, 19.5 to 20.5, 19 to 21, 15 to 25 or 10 to 30 or even broader; these are just several of the many alternate possibilities. For purposes of advancing prosecution, the term is interpreted as encompassing each of the alternate possibilities that the indefinite term reads upon.
Applicants’ arguments (8/12/25; page 8) as they pertain to the rejection have been fully considered but are not deemed to be persuasive for the following reasons.
In the reply, Applicants argue that one of ordinary skill in the art “would know based on the references incorporated throughout the Application that “about” means within one standard deviation per the practice in the art”; “would know which concentration [sic] are encompassed by the claims”; and “can determine that “about” means within an acceptable error range for the particular value, which will depend in part on how the value is measured or determined, i.e., the limitations of the measurement system” (page 8). Applicants conclude that, “[t]herefore, a skilled artisan would know the ranges and variations of concentrations, pH, and amounts encompassed by the claims” (page 8)
Applicants’ arguments have been fully considered but are not found persuasive. Applicants refer generally to incorporated references, but do not point to any specific references that provide a standard for the term “about” with respect to the usage in the claims. The ability to measure specific parameters and determine error rates in the measurement does not render use of the term “about” definite as error ranges can be broad or narrow and such is not determinative as to what constitutes “about”. As held in Amgen, Inc. v Chugai Pharmaceutical Co (1991; cited in MPEP 2173.05(b)(III)(A)), claims are indefinite when there is “nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term “about””.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-11 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the Record for Clinical Trial NCT02195479, version 34, dated 1/20/2017, available at https://clinicaltrials.gov/study/NCT02195479?tab=history&a=34#version-content-panel; 31 pages as printed; no author indicated (cited previously). The earliest date to which the instant application claims priority is 04/03/2018. This rejection was set forth previously at pages 5-7 of the 2/12/25 Office Action.
In response to the rejection, Applicants have amended independent claim 1 in three ways: (1) to change the intended use of the preamble from “treating multiple myeloma” to “increasing progression-free survival (PFS) in a human subject having multiple myeloma”; (2) to limit the administered anti-CD38 antibody to daratumumab (Dara); and (3) to add two concluding clauses, the first a “wherein” clause that the administration of Dara plus bortezomib, melphalan, and prednisone (BMP) results in PFS of greater than 18 months in the subject, and the second a “whereby” clause that PFS in increased relative to administration of BMP alone.
These new limitations have been fully considered but do not distinguish the instant claims from the anticipatory teachings of ‘479 set forth previously for the following reasons.
With respect to the new preamble, this has been considered in the context of the entire claim, and while it is considered to limit the method to a subject having multiple myeloma, it is other interpreted as an intended use for the method because it does not result in a manipulative difference between the method as defined by the steps and a prior art method teaching the same steps. See MPEP 2111.02. As such, this intended use does not distinguish the claimed method from the prior art method taught by ’479, which is directed to a subject having multiple myeloma. See the 2/12/25 Office Action, page 6, first complete paragraph.
With respect to the narrowing of the administered anti-CD38 antibody to daratumumab, the teachings of ‘479 cited previously that anticipate the claimed method are directed to use of an anti-CD38 antibody that is daratumumab. See the 2/12/25 Office Action, page 6, first complete paragraph. As such, this narrowing limitation does not distinguish the claimed method from the anticipatory teachings of ‘479.
With respect to the new concluding clauses, these together represent a narrower expression of the wherein clause previously set forth in dependent claim 4 (now canceled), which recited that “wherein” administration of Dara plus BMP “provides an increase” in PFS. As set forth previously in the rejection of record for claim 4 (page 6 of the 2/12/25 Office action), the concluding wherein and whereby clauses that are newly recited in independent claim 1 have been fully considered in context of the entire claim, but do not render the claimed method patentably distinct from a method taught by the prior art because they simply express the intended result of a process step positively recited. See MPEP 2111.04, which states that a "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited" (Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Specifically, the concluding wherein and wherein clauses of claim 1 as amended simply express intended results (e.g., a PFS of greater than 18 months and an increase in PFS as compared to administration of BMP alone) of a process step positively recited (administering Dara plus BMP).
For the above reasons, it is maintained that the teachings of ‘479 anticipate the claims as amended.
Applicants’ arguments (8/12/25; page 8-9) as they pertain to the rejection have been fully considered but are not deemed to be persuasive for the following reasons.
At page 8, Applicants argue that the newly added concluding clauses of claim 1 as amended, which require the method to result “in progression-free survival (PFS) of greater than 18 months in a human subject” and which is “increased relative to administration with bortezomib, melphalan, and prednisone [BMP] alone”, are “therapeutic effects” that “demand a specific level of efficacy”, and that “efficacy limitations in a separate clause indicate patentable weight”. Applicants point to the specification at Example 2, Figure 3 and Table 1 as providing evidence of the required efficacy and more specifically provide a quote from ¶ 138 in Example 2, that demonstrates that administration of Dara plus BMP “resulted in a highly significant improvement in PFS” compared to BMP alone (page 9).
This argument has been fully considered but is not found to be persuasive, because an intended result of a positively recited method step as expressed in a wherein clause is not transformed into a patentably distinct limitation simply by requiring efficacy of said result. Intended results by definition intend that the result occurs; i.e., is efficacious. Thus, the results observed in Example 2 are acknowledged but are not sufficient to distinguish the method as claimed from the teaching of the prior art.
At page 9, Applicants point to three Federal Circuit Court decisions that are argued to support that patentable weight should be given to “wherein” clauses.
Applicants first point to Los Angeles Biomedical Research Inst. v. Eli Lilly & Co. (Fed Circ. 2017), quoting a portion of the decision concerning an “arresting or regressing” step of a claimed method of treatment that is “drafted as part of a separate step of the method”, that “does not merely duplicate the wherein clause that follows”, and that “demands efficacy”.
This argument has been fully considered but are not found persuasive, because the “arresting or regressing” step of the claims under consideration in the referenced court decision is directed to an actively recited method step, not a “wherein” or “whereby” clause as recited in the instant claims, and thus is not applicable to the instant claims as amended.
Applicants next point to Allergan Sales, LLC v. Sandoz, Inc (Fed Circ. 2019), arguing that “the court gave “limiting effect to “wherein” clauses that “relate back to and clarify what is required by the count”, giving “meaning and purpose to the manipulative steps”.
This argument has been fully considered but is not found persuasive, because the Allergan decision continues beyond what is quoted by Applicants, stating in the next paragraph that:
“On the other hand, we have held that a clause that “merely states the result of the limitations” already in the claim “adds nothing to the patentability or substance of the claim.” Texas Instruments Inc. v. U.S. Int’l Trade Comm’n, 988 F.2d 1165, 1172 (Fed. Cir. 1993). Similarly, a clause in a method claim “is not given weight when it simply expresses the intended result of a process step positively recited.” Minton v. Nat’l Ass’n of Sec. Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003); see also Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (“[W]e agree with the defendants that this language is only a statement of purpose and intended result. The expression does not result in a manipulative difference in the steps of the claim.”).
Thus, the decision in Allergan is consistent with MPEP 2111.04, which also cites the same portion of Minton with regard to wherein clauses that simply express the intended result of a process step positively recited. Thus, the decision in Allergan is in accord with the statements of the rejection of record.
Finally, Applicants point to Hoffer v. Microsoft Corp (Fed. Circ. 2005), arguing that “the court held that when a ‘whereby’ clauses states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention”.
This argument has been fully considered but is not found persuasive, because MPEP 2111.04, cites Hoffer including this statement, but then continues, “However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’ Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003))." Thus, the decision in Hoffer is in accord with the statements of the rejection of record.
Specification
The disclosure is objected to because of the following informalities:
At page 20, lines 24-25, the specification contains apparent extraneous text stating “see “Error! Reference source not found.”. This text should be removed or correct.
Appropriate correction is required.
New objections and/or rejections necessitated by Applicants’ amendment
Claim Objections
Claims 15 and 16 are objected to because of the following informalities:
Claims 15 and 16 as amended recite “polysorbate 20”. However, claim 12 recites “polysorbate-20”. Either format is acceptable but should be used consistently throughout the claims.
Appropriate correction is required.
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 6-13, 15-21 and 32 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 pre-AIA the applicant regards as the invention.
Claim 6, as amended, recites “wherein administration of daratumumab, melphalan, and prednisone”, but parent claim 5 recites “wherein daratumumab, bortezomib, melphalan, and prednisone”. As such, claim 6 is indefinite with regard to the administration because it appears to limit the administration of parent claim 5 but omits one of the administered compounds (bortezomib).
Claim 8 is indefinite for the same reason as claim 6; i.e., parent claim 7 includes bortezomib in the administration, but claim 8 as amended omits it.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Conclusion
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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674