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
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-2, 6-19, 21-25, and 31-44 have an effective filing date of 28MAR2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/01/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restriction
In the response filed on 7/24/2024, Applicant elected, without traverse;
Upon further consideration the species election for a distinct improved ORR is withdrawn.
A distinct pharmaceutical composition with dosage, frequency, route, and duration of administration
pharmaceutical composition with dosage of:
about 1,800 mg of said antibody and about 30,000 U rHuPH20;
about 25 mg of lenalidomide;
about 40 mg of dexamethasone
a frequency of:
antibody and rHuPH20: once a week for one or more 4-week cycles;
lenalidomide: once daily;
dexamethasone: once a week;
a route of:
antibody and rHuPH20: subcutaneously;
lenalidomide: orally;
dexamethasone: orally or intravenously;
a duration of: one or more 4-week cycles
A distinct excipient
10 mM of the excipient histidine
Status of Claims
Claims 1-2, 6-19, 21-25, and 31-44 are currently pending and presented for examination on the merits.
Claims 13, 15-19, 34, and 36 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to non-elected invention.
Claim 1 is amended.
Claims 3-5, 20 and 26-30 are canceled.
Status of Rejections
The rejection of claim 1 filed under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendments to claim.
The rejection of claim 24 filed under 35 U.S.C. 112(b) is maintained.
The Double Patenting rejection over the claims of App. No. 17/343,150 has been withdrawn in view of Applicant abandoning App. No. 17/343,150.
The double patenting rejection of the claims over the claims of App. No. 16/797,301 and 18/100,056 have been maintained. Although the claims at issue are not identical, the instant claims are prima facie obvious over the conflicting claims in view of the cited references, as detailed in the rejection of the claims under 35 U.S.C. 103. With respect to the nonstatutory double patenting rejection over App. No. 18/100,056, nonstatutory double patenting rejections may be appropriately made over conflicting applications that are filed both before or after an application under examination. The nonstatutory double patenting rejections of record are not the only remaining rejections for the instant application, and as such it would not be appropriate to withdrawn the nonstatutory double patenting rejection over App. No. 18/100,056, even though the instant application may have a filing date that is earlier than the conflicting application.
Rejections Maintained
35 U.S.C. 112(b)
Applicant’s Arguments:
The specification provides the following detailed definition of the term "biosimilar": (of an approved reference product/biological drug, i.e., reference listed drug) refers to a biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components with no clinically meaningful differences between the biosimilar and the reference product in terms of safety, purity and potency, based upon data derived from (a) analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; (b) animal studies (including the assessment of toxicity); and/or (c) a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biosimilar. The biosimilar may be an interchangeable product that may be substituted for the reference product at the pharmacy without the intervention of the prescribing healthcare professional. To meet the additional standard of "interchangeability," the biosimilar is to be expected to produce the same clinical result as the reference product in any given patient and, if the biosimilar is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biosimilar and the reference product is not greater than the risk of using the reference product without such alternation or switch. The biosimilar utilizes the same mechanisms of action for the proposed conditions of use to the extend the mechanisms are known for the reference product. The condition or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biosimilar have been previously approved for the reference product. The route of administration, the dosage form, and/or the strength of the biosimilar are the same as those of the reference product and the biosimilar is manufactured, processed, packed or held in a facility that meets standards designed to assure that the biosimilar continues to be safe, pure and potent. The biosimilar may include minor modifications in the amino acid sequence when compared to the reference product, such as N- or C-terminal truncations that are not expected to change the biosimilar performance.”.
Examiner’s Response:
The passage in the specification that applicant cites is not sufficient to overcome the rejection of the claims under 35 U.S.C. 112(b). Said passage describes various properties of biosimilar drugs, effectively defining a biosimilar as a similar drug that produces the same results as the original drug; however this definition alone is not sufficient to allow one skilled in the art to readily determine what qualifies as a biosimilar of a particular drug. It is also noted that the specification does not appear to provide any particular examples of drugs that are biosimilar to daratumumab.
35 USC § 103
Applicant’s Arguments:
Applicant disagrees for at least the reason that the Examiner has failed to establish a prima facie case of obviousness.
Sanofi fails to supply the missing claim features for at least three reasons:
Sanofi relates to an entirely different anti-CD38 antibody (isatuximab) than presently claimed
Sanofi relates to an entirely different combination therapy (isatuximab) and an anti- PD1 antibody) than presently claimed; and
The ORR percentages in Sanofi are aspirational and unsupported by any data in the application.
The Claimed Therapy Provides Unexpected Results
Examiner’s Response:
Applicant states, “Sanofi relates to an entirely different anti-CD38 antibody (isatuximab) than presently claimed”
Applicants arguments have been considered but are not persuasive. The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 USC 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 USC 103 should be made explicit. In Ball Aerosol v. Ltd. Brands, 555 F.3d 984, 89 USPQ2d 1870 (Fed. Cir. 2009), the Federal Circuit offered additional instruction as to the need for an explicit analysis. The Federal Circuit explained that the Supreme Court’s requirement for an explicit analysis does not require record evidence of an explicit teaching of a motivation to combine in the prior art.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
It is noted that Sanofi relates to a different anti-CD38 antibody than that of claim 1; however the anti-CD38 antibody of claim 1 is taught by Elias et al. As indicted in the Non-Final Rejection, dated 06/04/2024, Sanofi teaches a chemotherapeutic regimen that comprises the administration of bortezomib and dexamethasone, as instantly claimed, and Sanofi also teaches the measurement of overall response rates (ORR). In view of the teachings of Sanofi, one of ordinary skill in the art would have been motivated to modify the teachings of Elias et al to comprise monitoring ORR in multiple myeloma patients that receive the claimed therapeutic regimen. Furthermore one skilled in the art would anticipate the invention of the prior art, which comprises administering an anti-CD38 antibody in combination with bortezomib and dexamethasone, would result in improved ORR compared to therapy with only bortezomib and dexamethasone, because the method of the prior art would further include the administration of an additional anti-cancer medicament, specifically, an anti-CD38 antibody, which has been shown by Elias et al to treat multiple myeloma.
Applicant states, “Sanofi relates to an entirely different combination therapy (isatuximab and an anti-PD1 antibody) than presently claimed”.
If a proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, there may be no suggestion or motivation to make the proposed modification. In re Gordon, 733 F.2d 900, 221 USPQ 1125 (Fed. Cir. 1984) (Claimed device was a blood filter assembly for use during medical procedures wherein both the inlet and outlet for the blood were located at the bottom end of the filter assembly, and wherein a gas vent was present at the top of the filter assembly. The prior art reference taught a liquid strainer for removing dirt and water from gasoline and other light oils wherein the inlet and outlet were at the top of the device, and wherein a pet-cock (stopcock) was located at the bottom of the device for periodically removing the collected dirt and water. The reference further taught that the separation is assisted by gravity. The Board concluded the claims were prima facie obvious, reasoning that it would have been obvious to turn the reference device upside down. The court reversed, finding that if the prior art device were turned upside down it would be inoperable for its intended purpose because the gasoline to be filtered would be trapped at the top, the water and heavier oils sought to be separated would flow out of the outlet instead of the purified gasoline, and the screen would become clogged.). But see In re Urbanski, 809 F.3d 1237, 1244, 117 USPQ2d 1499, 1504 (Fed. Cir. 2016) (The patent claims were directed to a method of enzymatic hydrolysis of soy fiber to reduce water holding capacity, requiring reacting the soy fiber and enzyme in water for about 60-120 minutes. The claims were rejected over two prior art references, wherein the primary reference taught using a longer reaction time of 5 to 72 hours and the secondary reference taught using a reaction time of 100 to 240 minutes, preferably 120 minutes. The applicant argued that modifying the primary reference in the manner suggested by the secondary reference would forego the benefits taught by the primary reference, thereby teaching away from the combination. The court held that both prior art references "suggest[ed] that hydrolysis time may be adjusted to achieve different fiber properties. Nothing in the prior art teaches that the proposed modification would have resulted in an ‘inoperable’ process or a dietary fiber product with undesirable properties." (emphasis in original)).
It is further noted that Sanofi teaches a different combination therapy (isatuximab and an anti-PD1 antibody) than presently claimed; however as indicated in the Non-Final Rejection, dated 07/01/2025, Sanofi teaches a method of treating multiple myeloma [0002]. Sanofi et al further teaches the initial chemotherapy regimen of lenalidomide and dexamethasone [0002], and Sanofi et al further teaches measuring results using Overall Response Rate (ORR) [0032]. Based upon these teachings, one skilled in the art would have had ample motivation to modify the teachings of Elias et al to include measuring ORR, as this would provide investigators with a means of determining whether a particular therapeutic regimen is effectively treating a disease.
Applicant states, “The ORR percentages in Sanofi are aspirational and unsupported by any data in the application”.
As indicated above Sanofi teaches a chemotherapeutic regimen that comprises the administration of lenalidomide and dexamethasone, as instantly claimed, and Sanofi also teaches the measurement of overall response rates (ORR). Based upon these teachings, one skilled in the art would have had ample motivation to modify the teachings of Elias et al to include measuring ORR, as this would provide investigators with a means of determining whether a particular therapeutic regimen is effectively treating a disease. Furthermore the claimed invention would be expected to improve ORR over a method that comprises only the administration of lenalidomide and dexamethasone, because the claimed invention comprises the administration of lenalidomide and dexamethasone in combination with an additional anti-cancer medicament, specifically, an anti-CD38 antibody, which has been shown by Elias et al to treat multiple myeloma.
Applicant states, “surprisingly and unexpectedly revealed an ORR of 91% for subjects who were administered the pharmaceutical composition with lenalidomide and dexamethasone”
Applicant has not demonstrated the ORR of 91% , when administering lenalidomide, dexamethasone, anti-CD38 antibody, and rHuPh20, is a greater than expected result. Richardson et al teaches treating multiple myeloma patients with lenalidomide and dexamethasone and achieving an ORR of 85.3% [Left column, 1st Paragraph, pg. 225].
Richardson et al (Lenalidomide in multiple myeloma: an evidence-based review of its role in therapy, Core Evidence 2009:4 215–245).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642