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 .
Applicant's response to the previous Office action, dated September 8, 2026, has been received. By way of this submission, Applicant has amended claim 11 and introduced new claims 26-30.
Claims 1-30 are pending in the application and under examination before the Office.
The rejections of record can be found in the previous Office action, dated July 15, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 8, 2026 was filed after the mailing date of the first Office action on the merits on July 15, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 11 was previously objected to due to minor informalities.
Applicant's amendments to the claims have addressed this issue, and this objection is hereby withdrawn.
Response to Arguments
Claims 1-9, 18-20 and 23 were previously rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Smith (US20100158903A1, cited in IDS).
Applicant argues that a person of ordinary skill reading Smith in its entirety would not have envisaged a combination of a 920 mg dose of ocrelizumab and subcutaneous administration, as Smith teaches ranges of 0.3 to 4.0 grams, without explicitly teaching the claimed dosage of 920 mg, and Smith preferentially teaches intravenous administration.
Applicant’s arguments are persuasive, and this rejection is hereby withdrawn.
Claims 10-15, 21-22, and 24-25 were previously rejected under 35 U.S.C. 103 as being unpatentable over Smith as applied to claims 1 and 23 above, and further in view of Alder (US20110076273A1, cited in IDS).
Claims 16 and 17 were previously rejected under 35 U.S.C. 103 as being unpatentable over Smith as applied to claim 1 above, and further in view of Steinman (N Engl J Med. 2022 Aug 25;387(8):704-714).
Applicant argues that Smith only discloses a prophetic example of a clinical trial evaluating the efficacy and safety of ocrelizumab in subjects with multiple sclerosis, and there would be no reasonable expectation of success in combining the teachings of Smith and Alder.
Applicant further argues that Smith and Alder do not disclose a dose of 920 mg ocrelizumab and does not correlate that dose with subcutaneous administration.
Applicant further argues that intravenous infusions of 300 mg and 600 mg ocrelizumab were associated with skin-related adverse effects, and one of ordinary skill would not have had a reasonable expectation of success in treating multiple sclerosis using the claimed methods.
Applicant also argues that the claimed method has been praised by others, including the FDA and the United Kingdom's National Health Service.
Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")). MPEP 2143.02(I).
Both Smith (Figure 7) and Alder (para. 0137 and 0174) are explicit in teaching that ocrelizumab is useful to treat multiple sclerosis. Both Smith (para. 0197) and Alder (para. 0105) teach that ocrelizumab may be administered subcutaneously. This is an express motivation to combine the teachings of Smith and Alder, and a reasonable expectation of success that subcutaneous administration of ocrelizumab could treat multiple sclerosis. The fact that intravenous ocrelizumab produces skin-related adverse effects does not diminish the fact that the ability to treat multiple sclerosis is expressly taught.
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). MPEP 2144.06(I).
Furthermore, Alder teaches that subcutaneous administration could significantly simplify treatment, shortening administration to less than 10 minutes and improving patient experience (para. 0239). This is another motivation to pursue subcutaneous administration.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). MPEP 2144.05.
Smith teaches a dosage of between about 0.6 grams to about 1.0 grams of the claimed antibody (para. 0188). Alder teaches dosages of from 0.1 mg/kg to 20 mg/kg body weight (para. 0186). Assuming a 70 kg patient, 920 mg would be about 13.1 mg/kg, which is well within the ranges taught by Alder. Alder also teaches that ultimate dose determination is at the discretion of the attending physician, factoring in the type (species, gender, age, weight, etc.) and condition of the patient being treated and the severity of the disease or condition being treated (para. 0186). This is a teaching to optimize the dose of the antibody for maximum therapeutic efficacy.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05(II)(A).
It is also noted that the applicants of the instant application are also the applicants of record listed on Smith (Hoffmann La Roche) and Alder (Genentech)
The above rejections are therefore maintained and extended to include claims 1-9, 18-20 and 23, and new claims 26-30.
Claims 1-25 were previously provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-17, and 19 of copending Application No. 19/444,781 (reference application).
Applicant argues that the '781 application is currently abandoned, and therefore this rejection is rendered moot.
As of the writing of this Office action on September 22, 2026, there is no Notice of Abandonment filed in the '781 application. If it is Applicant's intent to abandon this application, Applicant is invited to file an express abandonment to expedite the process.
This rejection is therefore maintained and extended to encompass new claims 26-27 and 29.
Claims 1-25 were previously rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 16 of U.S. Patent No. 11,424,031 in view of Smith, Alder, and Steinman.
Applicant argues that none of Smith, Alder, and Steinman teach the claimed dosage of 920 mg or correlates any specific dose with subcutaneous administration. This is not found to be persuasive, for reasons described supra.
This rejection is therefore maintained and extended to encompass new claims 26-30.
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.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-15 and 18-30 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US20100158903A1, cited in IDS) in view of Alder (US20110076273A1, cited in IDS).
Smith teaches a method of treating progressive multiple sclerosis in a patient comprising administering to the patient an effective amount of an anti-CD20 antibody (para. 0020). Smith further teaches that the anti-CD20 antibody may be ocrelizumab (para. 0027). Smith further teaches that the dosage is between about 0.3 to about 1.5 grams (para. 0026). Applicant's claimed dosage falls within this range.
Smith further teaches that the antibody is administered subcutaneously (para. 0197).
Smith further teaches that the patient has never been previously treated with an anti-CD20 antibody (para. 0196), which is pertinent to claims 2-4.
Smith further teaches administering two doses of an anti-CD20 antibody, at a dosage of between about 0.6 grams to about 1.0 grams, and that the doses are administered six months apart (para. 0118-0190), which is pertinent to claims 7-8 and 26-27. In this case, the patient receiving a second dose would have received a prior treatment with ocrelizumab. Smith therefore also teaches the subject matter of claims 5-6.
Smith further teaches that the anti-CD20 antibody may be the only drug administered to the patient to treat the multiple sclerosis (para. 0198), which is pertinent to claim 9.
Smith further teaches that the multiple sclerosis may be relapsing multiple sclerosis, secondary progressive multiple sclerosis, or primary progressive multiple sclerosis (para. 0021), which is pertinent to claims 18-20.
Smith further teaches that the anti-CD20 antibody may be formulated into a pharmaceutical formulation with 40 mg/ml (para. 0316), which is pertinent to claim 23.
Smith also teaches that the formulation may comprise trehalose, polysorbate 20, and a pH of 5.0.
Smith also teaches that the patient may also be administered a corticosteroid such as dexamethasone (para. 0143).
Smith also teaches that the patient may also be administered an oral antihistamine prior to antibody treatment (para. 0447).
However, Smith does not teach the claimed formulation.
Alder teaches a pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody comprising an anti-CD20 antibody, about 1 to 100 mM of a buffering agent providing a pH of 3.5-7.5, about 1 to 500 mM of one or two stabilizers, about 0.01 to 0.1% of a nonionic surfactant, and an effective amount of a hyaluronidase enzyme (claim 1).
Alder further teaches that the stabilizers may be trehalose (para. 0129) or methionine (para. 0016).
Alder further teaches that the nonionic surfactant may be polysorbate 20 (claim 11).
Alder further teaches that the hyaluronidase enzyme may be 1,000 U/mL (claim 3), and may be rHuPH20 (claim 13), which is pertinent to claims 13-15 and 29.
Alder further teaches that the buffering agent may be sodium acetate (para. 0129).
Alder further teaches that the pharmaceutical formulation may be administered by subcutaneous injection within a time of 10 minutes (para. 0192), which is pertinent to claims 21-22 and 23-25.
Alder also teaches that an effective amount of the hyaluronidase enzyme can easily be determined by the person skilled in the art (para. 0121). Additionally, at an antibody concentration of 40 mg/ml as taught by Smith and a hyaluronidase enzyme concentration of 1,000 U/mL, a 920 mg dose would be 23 mL, resulting in 23,000 units of hyaluronidase.
Alder also teaches that the anti-CD20 antibody may be ocrelizumab (para. 0137 and claim 15).
Alder also teaches that anti-CD20 antibodies are useful for treating autoimmune diseases (para. 0175), and the autoimmune disease may be multiple sclerosis (para. 0080).
Alder also teaches that ultimate dose determination is at the discretion of the attending physician, factoring in the type (species, gender, age, weight, etc.) and condition of the patient being treated and the severity of the disease or condition being treated (para. 0186). This is a teaching to optimize the dose of the antibody for maximum therapeutic efficacy.
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Smith and Alder to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both Smith and Alder are concerned with anti-CD20 antibodies. Both Smith and Alder teach that anti-CD20 antibodies such as ocrelizumab are useful in treating multiple sclerosis. Starting from the method of treatment taught by Smith, one of ordinary skill could formulate the anti-CD20 antibody into a pharmaceutical formulation according to Alder to arrive at the claimed invention, with each component of the combination performing its known, usual function and affecting a predictable result.
While Smith and Alder do not explicitly teach the claimed dosage of 920 mg or 23,000 units of hyaluronidase, determination of dosage is routinely determined by the ordinary artisan as of the effective filing date of the claimed invention, and was known as a result effective variable that depends on the conditions of the patients. It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). One of ordinary skill in the art would appreciate the amount or dosage of the antibody in the therapy could be adjusted to achieve optimum therapeutic efficacy, especially given the teachings of Alder described above.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Smith and Alder as applied to claim 1 above, and further in view of Steinman (N Engl J Med. 2022 Aug 25;387(8):704-714).
The teachings of Smith and Alder have been discussed supra. However, Smith and Alder do not teach the patient has been subject to oral dexamethasone and antihistamine prior to the subcutaneous administration of the anti-CD20 antibody.
Steinman teaches administering 20 mg oral dexamethasone and oral antihistamine prior to treatment with an anti-CD20 antibody for the treatment of multiple sclerosis (page 705, right column, last paragraph).
Steinman also teaches that ocrelizumab is useful in treating multiple sclerosis (page 705, left column, first paragraph).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Smith, Alder, and Steinman to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both Smith and Steinman are concerned with treating multiple sclerosis with anti-CD20 antibodies. Smith teaches methods of treating multiple sclerosis with ocrelizumab. Steinman teaches a course of oral dexamethasone and antihistamine prior to the administration of an anti-CD20 antibody for the purpose of treating multiple sclerosis. Starting from the method of treatment taught by Smith, one of ordinary skill could apply the pretreatment of oral dexamethasone and oral antihistamine according to Steinman to arrive at the claimed invention, with each component of the combination performing its known, usual function and affecting a predictable result.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-27 and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-17, and 19 of copending Application No. 19/444,781 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to identical methods.
The '781 application claims a method of treating multiple sclerosis in a patient comprising subcutaneously administering an anti-CD20 antibody to the patient at a dose of about 920 mg (claim 1).
The '781 application further claims that the anti-CD20 antibody is ocrelizumab (claim 14).
The '781 application further claims that the patient has not been subjected to a prior intravenous administration of the anti-CD20 antibody (claim 3).
The '781 application further claims that the patient has received a prior treatment with an anti-CD20 antibody (claim 5).
The '781 application further claims subcutaneously administering more than one dose of the anti-CD20 antibody (claim 6).
The '781 application further claims that the anti-CD20 antibody is administered at a frequency of about once every 6 months (claim 9).
The '781 application further claims that the anti-CD20 antibody is the only medicament administered to the patient to treat multiple sclerosis (claim 10).
The '781 application further claims that the anti-CD20 antibody is in a pharmaceutical formulation, wherein the pharmaceutical formulation comprises about 40 mg/ml anti-CD20 antibody, about 20 mM sodium acetate providing a pH of about 5.3, about 240 mM trehalose, about 10 mM methionine, about 0.06% (w/v) polysorbate 20, and about 1000 U/ml hyaluronidase (claim 11).
The '781 application further claims that the patient has been subject to oral dexamethasone and antihistamine shortly prior to the subcutaneous administration of the anti- CD20 antibody (claim 12).
The '781 application further claims that the multiple sclerosis is relapsing multiple sclerosis (claim 15).
The '781 application further claims that the patient has a clinical isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS) (claim 16).
The '781 application further claims that the multiple sclerosis is a primary progressive multiple sclerosis (PPMS) (claim 17).
The '781 application further claims that the subcutaneous administration takes no more than about 10 minutes (claim 19).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 16 of U.S. Patent No. 11,424,031 in view of Smith, Alder, and Steinman.
The '031 patent claims a method of administering an anti-CD20 antibody to a patient that has multiple sclerosis (claim 15).
The '031 patent further claims that the anti-CD20 antibody is ocrelizumab (claim 16).
However, the '031 patent does not claim subcutaneous administration or a dosage of 920 mg.
Smith teaches a method of treating progressive multiple sclerosis in a patient comprising administering to the patient an effective amount of an anti-CD20 antibody (para. 0020). Smith further teaches that the anti-CD20 antibody may be ocrelizumab (para. 0027). Smith further teaches that the dosage is between about 0.3 to about 1.5 grams (para. 0026). Applicant's claimed dosage falls within this range. Smith further teaches that the antibody is administered subcutaneously (para. 0197).
Smith further teaches that the patient has never been previously treated with an anti-CD20 antibody (para. 0196), which is pertinent to claims 2-4.
Smith further teaches administering two doses of an anti-CD20 antibody, at a dosage of between about 0.6 grams to about 1.0 grams, and that the doses are administered six months apart (para. 0118-0190), which is pertinent to claims 7-8. In this case, the patient receiving a second dose would have received a prior treatment with ocrelizumab. Smith therefore also teaches the subject matter of claims 5-6.
Smith further teaches that the anti-CD20 antibody may be the only drug administered to the patient to treat the multiple sclerosis (para. 0198), which is pertinent to claim 9.
Smith further teaches that the multiple sclerosis may be relapsing multiple sclerosis, secondary progressive multiple sclerosis, or primary progressive multiple sclerosis (para. 0021), which is pertinent to claims 18-20.
Smith further teaches that the anti-CD20 antibody may be formulated into a pharmaceutical formulation with 40 mg/ml (para. 0316), which is pertinent to claim 23.
Smith also teaches that the formulation may comprise trehalose, polysorbate 20, and a pH of 5.0.
Smith also teaches that the patient may also be administered a corticosteroid such as dexamethasone (para. 0143).
Smith also teaches that the patient may also be administered a oral antihistamine prior to antibody treatment (para. 0447).
Alder teaches a pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody comprising an anti-CD20 antibody, about 1 to 100 mM of a buffering agent providing a pH of 3.5-7.5, about 1 to 500 mM of one or two stabilizers, about 0.01 to 0.1% of a nonionic surfactant, and an effective amount of a hyaluronidase enzyme (claim 1).
Alder further teaches that the stabilizers may be trehalose (para. 0129) or methionine (para. 0016).
Alder further teaches that the nonionic surfactant may be polysorbate 20 (claim 11).
Alder further teaches that the hyaluronidase enzyme may be 1,000 U/mL (claim 3), and may be rHuPH20 (claim 13).
Alder further teaches that the buffering agent may be sodium acetate (para. 0129).
Alder further teaches that the pharmaceutical formulation may be administered by subcutaneous injection within a time of 10 minutes (para. 0192), which is pertinent to claims 21-25.
Alder also teaches that an effective amount of the hyaluronidase enzyme can easily be determined by the person skilled in the art (para. 0121). Additionally, at an antibody concentration of 40 mg/ml as taught by Smith and a hyaluronidase enzyme concentration of 1,000 U/mL, a 920 mg dose would be 23 mL, resulting in 23,000 units of hyaluronidase.
Alder also teaches that the anti-CD20 antibody may be ocrelizumab (para. 0137 and claim 15).
Alder also teaches that anti-CD20 antibodies are useful for treating autoimmune diseases (para. 0175), and the autoimmune disease may be multiple sclerosis (para. 0080).
Alder also teaches that ultimate dose determination is at the discretion of the attending physician, factoring in the type (species, gender, age, weight, etc.) and condition of the patient being treated and the severity of the disease or condition being treated (para. 0186). This is a teaching to optimize the dose of the antibody for maximum therapeutic efficacy.
Steinman teaches administering 20 mg oral dexamethasone and oral antihistamine prior to treatment with an anti-CD20 antibody for the treatment of multiple sclerosis (page 705, right column, last paragraph).
Steinman also teaches that ocrelizumab is useful in treating multiple sclerosis (page 705, left column, first paragraph).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the claims of the '031 patent with the teachings of Smith, Alder, and Steinman to arrive at the claimed invention. The '031 patent claims the use of ocrelizumab for the treatment of multiple sclerosis. All of Smith, Alder, and Steinman also teach the use of ocrelizumab for the treatment of multiple sclerosis. The methods and formulations taught by Smith, Alder, and Steinman could therefore be applied to the claims of the '031 patent to arrive at the instantly claimed invention. One of ordinary skill could combine these teachings by known methods, with no change in their respective functions, and the combination would yield nothing more than predictable results.
While the above references do not explicitly teach the claimed dosage of 920 mg or 23,000 units of hyaluronidase, determination of dosage is routinely determined by the ordinary artisan as of the effective filing date of the claimed invention, and was known as a result effective variable that depends on the conditions of the patients. It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). One of ordinary skill in the art would appreciate the amount or dosage of the antibody in the therapy could be adjusted to achieve optimum therapeutic efficacy, especially given the teachings of Alder described above.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 6:00 to 2:00.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PETER JOHANSEN/Primary Examiner, Art Unit 1644
Prosecution Insights