DETAILED ACTION
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 .
Status of the Claims
Claims 15-23 are currently pending and are subject to this Office Action.
Information Disclosure Statement
The references cited on the information disclosure statement(s) were considered and have been made of record.
Withdrawn Claim Rejections
In view of the Applicant’s claim amendments: the previous rejections under 35 U.S.C. 112(b), 35 U.S.C. 103, and NSDP are hereby withdrawn.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The earliest effective U.S. filing date afforded the instantly claimed invention has been determined to be 31 January 2017, the filing date of foreign application No. SG10201700775Y to which the instant application claims priority via its status as a continuation of application No. 16/928,129.
New Claim Rejections, Necessitated by Amendment - 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.
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 15-23 are rejected under 35 U.S.C. 103 as being unpatentable over Ruike (US20160176954A1; cited on the IDS and in previous Action) in view of Andrien (US20150299305A1; cited in previous Action), Natarajan (US20190085095A1; priority date of 25 January 2017; cited in previous Action), and Murata (WO2016117346A1; Publication Date 07/28/2016; cited in previous Action).
Ruike teaches anti-C5 antibodies, and methods of use (see entire document, e.g., Abstract, Drawings, Background, Brief Summary, Brief Description of the Drawings /Figures, Detailed Description, Definitions, Compositions and Methods, including Exemplary Anti-C5 Antibodies, Antibody Affinity, Antibody Fragments, Human Antibody, Multispecific Antibodies, Antibody Variants, Fc Region Variants, Antibody Derivatives, Recombinant Methods and Compositions, Assays, Methods, including eculizumab, in particular, see paragraphs [0014], [0042], [0046], [0047], [0063], [0361], [0363], [0372]-[0377], [0396], [0401]; Table 10) and 305L05 variants, e.g., variant 305LO15-SG115 which comprises sequences that share 100% id. with instant SEQ ID NOs: 2, 13, 6, and 18 (see Ruike, SEQ ID NOs: 106, 114, 111, and 37 respectively; also see search results on GenBase/SCV; also see, e.g., paragraphs [0040], [0047], [0048], [0057]-[0059], [0268], [0270], [0365], [0376]-[0382], [0391], [0397]-[0405]; Tables 6-10), including compositions for diagnostics and detection, including Pharmaceutical Formulations (see paragraphs [0305]-[0301], Therapeutic Methods and Compositions (see, e.g., paragraphs [0312]-[348], wherein “the method of administration, the scheduling of administration, and other factors known to medical practitioners” see [0346 in particular] including effective amounts depending on the type and severity of the disease about 0.1 μg/kg to 15 mg/kg, etc.; see paragraphs [0037], [0090], [0306]-403], including paragraph [0347]; reads on the dosages in mg set forth in instant claims 15(a)-(b), 16-20, 22-23), including various diseases or conditions which involve excessive or uncontrolled activation of C5, including PNH (see, e.g., paragraphs [0012]-[0014] [0035], [0303], [0313], [0316], [0317], [0335], [0401]; reads on instant claims 15, 21), including combination therapy (see, e.g., paragraphs [0109], [0343]. [0347], [0350]), including various known methods of administration, including intravenous, subcutaneous etc. administration (see, e.g., paragraphs [0055],[0056], [00066], [0067], [0247], [0345], [0350], [0388], [0389], [0404], [0405]), including wherein the human subject has not been administered the anti-CS antibody before (see, e.g., paragraphs [0298]), including wherein the administration is over 0-3 days (e.g., see paragraphs [0344], [0347], [0357], [0384], [0403], including Examples and Claims), including wherein following administration of the antibody results in complement activity suppressed to less than 20% (see, e.g., paragraphs [0227], [0286], [0361], [0397], [0400], Example 9, and Fig. 20; reads on instant claim 15), including wherein the complement activity is determined by a liposome immunoassay (see, e.g., Examples 5 and 9; reads on instant claim 15).
Andrien teach Anti-C5 Antibodies Having Improved Pharmacokinetics (see entire document, including Drawings, including Technical Field, Background, Summary, Brief Description of the Sequences, Brief Description of the Drawings, Detailed Description, including Antibodies, Modifications to the Fc Regions, Methods for Producing the Anti-C5 Antibodies And Antigen-binding Fragments thereof, Recombinant Antibody Expression and Purifications, Modification of the Antibodies or Antigen-Binding Fragments Thereof, including eculizumab; see, e.g., paragraphs [0011]-[0013], [0029], [0041], -[0043]. [0059]-[0102], [0121]-[0126], [0132], [0133], [0140]-[0148], [0163]-[0164], [0273]; Tables 1-9; Examples), including combination therapy (see, e.g., [0236], [0256], [0258], [0260], [0268], [0272], [0273]), including Pharmaceutical Compositions and Formulations, Applications, Examples, including Methods for Treatment (see, e.g., [0217]-[0274]), including, Pharmaceutical Compositions and Formulations (see, e.g., paragraphs ([0217]-[0236]), including Methods for Treatment of patients afflicted with a complement-associated conditions, including PNH (see, e.g., paragraphs [0052], [0256], [0267]; ; reads on instant claims 15, 21), including various modes of administration, including intravenous, subcutaneous, etc. (see, e.g., paragraphs [0077], [0219], [0239]-[0274]), including dosages / dosage regimens including 0.1-1000 mg/kg, etc. of effective / therapeutically effective amounts of compositions, which could vary according to various factors, including eliciting a desired response and amelioration of at least one condition, of at least one condition, of at last one symptom of a complement–mediated disorder for example (see, e.g., paragraphs [0220] [0257]-[0259]), including 0-3 days (see, e.g., paragraphs [0043], [0164], [0274]; also reads on the dosages in mg set forth in instant claims 15(a)-(b), 16-20, 22-23), including treating complement associated disorders (see, e.g., paragraphs including [0010], [0052], [0265]-[0271])
Note that the claims SEQ ID NOS. and the limitations of claim 15-16 are explicitly taught or inherent properties of the prior art eculizumab variants or 305LO5 variants anti-C5 antibodies for example1.
Ruike and Andrien differ from the claimed invention by not explicitly teaching administering two anti-C5 antibodies intravenously and subcutaneously and the particular dosing regimens claimed.
Natarajan teach Anti-C5 Antibodies with Enhanced pH Switch (see entire document, including Abstract, Background, Summary of the Invention, Definitions, Brief Description of the Drawings, Description of Invention, Antibodies, Including antibodies), engineered antibodies including anti-C5 antibodies (see e.g., paragraphs [0154]-[0189]), including Methods of Treatment of complement-associated conditions amenable to C5 blockade, including PNH (see, e.g., paragraph [0191]-[0198]; [paragraphs [0191]-[0231]), including Formulation and Administration (paragraphs [0232]-[0258]), including decreasing the concentration of C5 in plasma (see, e.g., paragraphs [0333]) in therapeutically effective amounts; see, e.g., paragraphs [0222], [0256]-[0259]), including combination therapy ([0077], [0193], [0254], [0256], [0260]-[0270]), including ranges of 0.001-1000 mg/kg and exemplary ranges ([0233], [0255]), including various routes of administration, including intravenous and subcutaneous, (see, e.g., paragraphs [0086], [0088], [0229], [0237], [0238], [0249], [0311]-[0335]), including as a single treatment strategy where intravenous and subcutaneous administration may be concurrent or non-concurrent (see, e.g., paragraphs [0229], [0311), including Formulations and Administration (e.g., [0222], [0232]-[0259]).
Murata teaches a combination of two or more anti-C5 antibodies and methods of use, including inhibition of excessive or uncontrolled action of the complement cascade to provide clinical benefits to patients with such disorders, including PNH (pages 1-3), including anti-C5 antibodies, including eculizumab and combination two or more anti-C5 antibodies, included antibodies that do compete with one another (pages 3-14; Exemplary Anti-C5 Antibodies pages 24-56), including methods of treating individual having a complement-mediated disease or condition which involves excessive or uncontrolled action of C5 to enhance the clearance of C5 from plasma (see page 14) (Pharmaceutical Formulations And Therapeutic Methods and Compositions (see pages 62-70), including the treatment of complement-mediated disease or conditions which involves excessive or uncontrolled action of C5, including PNH (see entire document, Abstract, Technical Field, Background Art, Solution to Problem, Brief Description of Drawings, Description of Embodiments, Definitions, Compositions, Pharmaceutical Formulations And Therapeutic Methods and Compositions and Methods, Examples, Sequence Listing, Claims, Drawings).
In turn, an ordinary artisan would have been motivated to a first and second anti-C5 antibody, including 305LO5 and eculizumab antibodies, in therapeutic regimens to inhibit undesirable, unregulated and/or excessive complement activation.
When there is a design need or marker pressure to solve a problem and there are a finite number of identified, predictable solution, a person of ordinary skill has good reason to purse the known options within his or her technical grasp. If this leads to the anticipate success, it likely the product not of innovation but of ordinary skill and common sense.
Obviousness Analysis: In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than:
applying a known technique (e.g., administering the anti-C5 antibody both by intravenous and subcutaneous routes as components of single treatment strategy, as taught by Natarajan; and administering 305LO5 as a first antibody and eculizumab as the second antibody) to a known method (e.g., the methods of Ruike and Andrien) ready for improvement to yield predictable results, namely complement inhibition (MPEP 2143(I)(D), (G)); and
combining prior art elements (e.g., various dosing and dosing regimens to via intravenous and subcutaneous administration, including the combination of intravenous and subcutaneous administration of therapeutic amounts of anti-C5 antibodies to treat PNH based upon the needs of the patient) were known in the prior art and one skilled in the art could have arrived at the claimed invention with no change in their respective functions and the combination would have yielded nothing more than predictable results (MPEP 2143(I)(A), (G)): that all of the claimed elements were made part of ordinary capabilities of one skilled in the art based upon the teachings of the prior art; that all of the claimed elements were particular known techniques recognized as part of the ordinary capabilities of one skilled in the art that was ready for improvement where the results would have been predictable to one of ordinary skill in the art; that all of the claimed elements were known options not of innovation but of ordinary skill and common sense; and that all of the claimed elements because it would have been obvious to try taking advantages of manipulating doses and dosing regimens, including the combination of intravenous and subcutaneous administration as well as combination therapy in the treatment of a chronic disease / condition such as PNH with a reasonable expectation of success; and routine optimization, as doses and dosage regimens and monitoring and adjusting for effective therapeutic regimens are result effective variables2, and are well known by medical practitioners, as disclosed by Ruike, and thus can be easily developed by those skilled in the art through routine optimization3. The claimed doses, dosage regimens and intravenous / subcutaneous administrations of anti-C5 antibodies to treat complements associated diseases, including PNH were obvious, given the prior art teachings of effective amounts dosages / dosage regimens including 0.1-1000 mg/kg, 0.001-1000 mg/kg and exemplary ranges ([0233], [0255]), and about 0.1 μg/kg to 15 mg/kg, etc.) as well as dosing regimens over days, weeks and months depending on the type and severity of the disease and other factors4.
From the teachings of the references, it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary5.
Given that the prior art goal was to provide effective amounts of anti-C5 antibodies to treat a variety of complement associated diseases, including PNH, incorporating effective amounts of intravenous / subcutaneous anti-C5 antibodies, including eculizumab and 305L05 variants in therapeutic regimens to treat PNH over days, weeks and months based upon the needs of the patient to achieve therapeutic efficacy in a chronic condition such as PNH would have been routine to the ordinary artisan at the time the invention was made and therefore obvious in designing such therapeutic regimens at the time the invention was made.
Accordingly, claims 15-23 are rejected.
New Claim Rejections, Necessitated by Amendment - 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.
Copending Application No.: 17/263,691 (US20210301004)
Claims 15-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 60-77 of copending Application No. 17/263,691 (reference application) in view of Ruike (supra) and Andrien (supra).
The disclosures of Ruike and Andrien are discussed above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 15-23, the reference application claims essentially the same method, wherein the anti-C5 antibody comprises CDR sequences identical to those set forth in instant claim 1 (see reference claims; SEQ ID NOs: 3-5 and 7-9). While the entire antibody sequence is not specifically claimed, it is disclosed by the reference application (see reference SEQ ID NOs: 2, 13, 6, 18), and is known in the prior art of Ruike, as set forth above. Furthermore, although the particular intravenous dose set forth in the reference application is outside the claimed range, this deficiency is remedied by the prior art teachings/disclosures set forth in references, Ruike and Andrien, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to simply substitute the reference antibody with that of Ruike (i.e., substituting the species for the genus, where the species is the reference antibody and the genus is that of Ruike) when applying the limitations of the reference claims to obtain predictable results See, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (B), (G)).
Lastly, doses and dosage regimens and monitoring and adjusting for effective therapeutic regimens are result effective variables, and are well known by medical practitioners, as disclosed by Ruike, and thus can be easily developed by those skilled in the art through routine optimization. Accordingly, the present claims are directed to obvious variants of the reference claims.
Copending Application No.: 17/630,046 (US20220275070)
Claims 15-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 15-17, 19-20 of copending Application No. 17/630,046 (reference application) in view of Ruike (supra) and Andrien (supra).
The disclosures of Ruike and Andrien are discussed above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 15-23, the reference application claims essentially the same method, wherein Crovalimab comprises sequences identical to those set forth in instant claim 1 (see reference claims; SEQ ID NOs: 3-4). One of ordinary skill in the art would have been motivated to administer the therapeutic agents within the particular administration order cited within the claims with a reasonable expectation of success by teachings well known and noted herein that dosages of any pharmaceutical composition may be adjusted and optimized. And while the particular subcutaneous dose set forth in the reference application is outside the claimed range, this deficiency is remedied by the prior art teachings/disclosures set forth in references, Ruike and Andrien, as discussed above. See, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (G)).
Furthermore, doses and dosage regimens and monitoring and adjusting for effective therapeutic regimens are result effective variables, and are well known by medical practitioners, as disclosed by Ruike, and thus can be easily developed by those skilled in the art through routine optimization. Accordingly, the present claims are directed to obvious variants of the reference claims.
Copending Application No.: 17/630,050 (US20220275071)
Claims 15-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 15-17, 19-20 of copending Application No. 17/630,050 (reference application) in view of Ruike (supra) and Andrien (supra).
The disclosures of Ruike and Andrien are discussed above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 15-23, the reference application claims essentially the same method, wherein Crovalimab comprises sequences identical to those set forth in instant claim 1 (see reference claims; SEQ ID NOs: 3-4). One of ordinary skill in the art would have been motivated to administer the therapeutic agents within the particular administration order cited within the claims with a reasonable expectation of success by teachings well known and noted herein that dosages of any pharmaceutical composition may be adjusted and optimized. And while the particular subcutaneous dose set forth in the reference application is outside the claimed range, this deficiency is remedied by the prior art teachings/disclosures set forth in references, Ruike and Andrien, as discussed above. See, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (G)).
Furthermore, doses and dosage regimens and monitoring and adjusting for effective therapeutic regimens are result effective variables, and are well known by medical practitioners, as disclosed by Ruike, and thus can be easily developed by those skilled in the art through routine optimization. Accordingly, the present claims are directed to obvious variants of the reference claims.
Copending Application No.: 18/905,476 (US20250236661)
Claims 15-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 copending Application No. 18/905,476 (reference application) in view of Ruike (supra).
The disclosures of Ruike and Andrien are discussed above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 15-23, the reference application claims essentially the same method steps, wherein Crovalimab comprises sequences identical to those set forth in instant claim 1 (see reference claims). The reference claims differ from the presently claimed invention as follows: the reference application claims a method of treating the C5-related disease, GUILLAN-BARRE SYNDROME. However, it would have been prima facie obvious to one of ordinary skill in the art to have arrived at the presently claimed invention in view of the reference application and prior art because it amounts to no more than: simple substitution of one known element for another to obtain predictable results (e.g., using the reference method to treat PNH instead of GUILLAN-BARRE SYNDROME, as PNH is known as a C5-related disease, as taught by Ruike). See, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A),(B), (G)). Furthermore, specific doses and dosage regimens and monitoring and adjusting for effective therapeutic regimens are result effective variables, and are well known by medical practitioners, as disclosed by Ruike, and thus can be easily developed by those skilled in the art through routine optimization. Accordingly, the present claims are directed to obvious variants of the reference claims.
Copending Application No.: 18/905,654 (US20250236662)
Claims 15-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 copending Application No. 18/905,476 (reference application) in view of Ruike (supra).
The disclosures of Ruike and Andrien are discussed above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 15-23, the reference application claims essentially the same method steps, wherein Crovalimab comprises sequences identical to those set forth in instant claim 1 (see reference claims). The reference claims differ from the presently claimed invention as follows: the reference application claims a method of treating the C5-related disease, GUILLAN-BARRE SYNDROME. However, it would have been prima facie obvious to one of ordinary skill in the art to have arrived at the presently claimed invention in view of the reference application and prior art because it amounts to no more than: simple substitution of one known element for another to obtain predictable results (e.g., using the reference method to treat PNH instead of GUILLAN-BARRE SYNDROME, as PNH is known as a C5-related disease, as taught by Ruike). See, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A),(B), (G)). Furthermore, specific doses and dosage regimens and monitoring and adjusting for effective therapeutic regimens are result effective variables, and are well known by medical practitioners, as disclosed by Ruike, and thus can be easily developed by those skilled in the art through routine optimization. Accordingly, the present claims are directed to obvious variants of the reference claims.
Response to Arguments
Applicant's arguments filed 30 January 2026 have been fully considered but they are not persuasive. Applicable arguments pertaining to the rejections are addressed below.
In view of the Applicant’s claim amendments, the previous claim rejections under 35 U.S.C. 112(b), 35 U.S.C. 103, and NSDP are rendered moot.
The previous claim rejections under 35 U.S.C. 103 and NSDP are revised in view of the Applicant’s claim amendments, as set forth above.
In response to Applicant’s argument that “None of the cited documents teach or suggest a method of delivering an anti-C5 antibody mediated treatment to a subject in need thereof comprising the intravenous administration of a single fixed dose followed by the subcutaneous administration of fixed doses delivered at specific time intervals… The cited documents merely generically disclose… exemplary antibody doses based on the patient's body weight (e.g., Ruike's alleged disclosure of a dose of "about 0.1 mg/kg to 15 mg/kg" (Office Action, page 5), or that "a single treatment strategy where intravenous and subcutaneous administration may be concurrent or non-concurrent”: the instant claims as written do not require a fixed dose and are absent any language implying that the claimed dose range must be fixed and not based on weight.
Furthermore, in response to applicant's argument that “the skilled person would have had to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave no direction as to which of many possible choices is likely to be successful”: the prior art expressly teaches intravenous and subcutaneous modes of administration, as well as the two together in a single treatment strategy, and provides support for the general dosage range and frequency that the antibody should be administered through these routes (see above); accordingly, the prior art does provide direction to a skilled artisan, who would only be varying the parameters of dosage and dose frequency.
Further, even if Applicant overcomes the obvious to try rationale, doses and dosage regimens and monitoring and adjusting for effective therapeutic regimens are result effective variables, and are well known by medical practitioners, as disclosed by Ruike, and thus can be easily developed by those skilled in the art through routine optimization. The claimed doses, dosage regimens and intravenous/subcutaneous administrations of anti-CS antibodies to treat complements associated diseases, including PNH were obvious, given the prior art teachings of effective amounts dosages/ dosage regimens including 0.1-1000 mg/kg, 0.001-1000 mg/kg and exemplary ranges ([0233],[0255]), and about 0.1 μg/kg to 15 mg/kg, etc.) as well as dosing regimens over days, weeks and months depending on the type and severity of the disease and other factors.
Further, it is the Examiner's understanding that Applicant is attempting to rebut a determination of obviousness based upon the difference statements set forth in the rejections under 35 USC § 103. This is not persuasive because, as noted at MPEP § 2141.02, ascertaining the differences between the prior art and the claims at issue is part of the formation of a proper rejection under 35 USC § 103 (see also MPEP § 2141(II), discussing the basic factual inquiries of an obviousness determination). Accordingly, any argument premised upon the identification of differences set forth by the Examiner are insufficient to establish non-obviousness absent evidence addressing the remainder of the rejection. Here, the claimed invention has been identified as obvious for multiple exemplary rationales, including MPEP § 2143(I)(A), (B), (D), and (G), (see above). In the absence of evidence that the elements of such rationales were not fully satisfied, a prima facie case of obviousness has presumably been established based upon at least one or more of such rationales.
Accordingly, any arguments suggesting that a reasonable artisan in the arts would be unaware of the reference or otherwise just dismiss the reference is not persuasive, because such arguments amount to an attempt to simply dismiss the existence of the prior art teachings for multiple myeloma treatment strategies set forth in Hilbert, Smith, Timmers, and Hoos. Rather, the reference is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)).
If Applicant means to allege the existence of unexpected results, Applicant is directed to MPEP §716, §716.01, and §716.02. To establish unexpected results, the evidence must establish that the expected results occur to an unexpected extent (see, e.g., MPEP § 716.02(a)(I)), on the basis of statistically and practically significant evidence (see, e.g., MPEP § 716.02(b)(I)), which is fully explained (see, e.g., MPEP § 716.02(b)(II)), commensurate in scope with the claimed invention (see, e.g., MPEP § 716.02(d)), and wherein a comparison of the claimed invention with the closest prior art of record is provided (see, e.g., MPEP § 716.02(e)). Furthermore, even if evidence satisfying MPEP §§ 716.02, 716.02(a), 716.02(b), 716.02(d), and 716.02(e) is set forth on record, such evidence may not be sufficient to rebut prima facie obviousness because the evidence of expected and unexpected results must be weighed (see, e.g., MPEP § 716.02(c)(I)) and the totality of the record considered (see, e.g., MPEP § 716.02(f)), including teachings in the prior art and evidence of expected results which weigh in favor of a determination of obviousness (see, e.g., MPEP § 716.02(c)(II)).
In the absence of any unexpected results set forth by Applicant, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than applying a known technique to a known method ready for improvement to yield predictable results, namely complement inhibition; combining prior art elements according to known methods to yield predictable results; as well as routine optimization (See MPEP 2143(I)(A), (D), (E),(G), and MPEP 2144.05(II))) as discussed above.
Lastly, in response to the Applicant’s request that the NSDP rejection be held in abeyance, and after further consideration, the prior examiner’s NSDP rejections have been updated, and are now fully supported through revision, as discussed above.
Conclusion
Claims 15-23 are rejected.
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 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.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 Products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
Also, in In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides.
The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.”
When the reference is silent with regard to the exact sequence does not make a claim patentable unless the claimed polypeptide is actually different from that which was disclosed in the prior art.
Therefore, the prior art anti-C5 antibodies, including eculizumab and 305L015 variants have the structure, including that recited in claims15-16 with SEQ ID NOS.
2 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). “[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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
3 As both doses and dosage regimens were known to the ordinary artisan, it would have been obvious and routine to optimize both the dosages and dosage regimens, including the combination of intravenous / subcutaneous administration to treat PNH patients, particularly given the nature of this chronic disease and the known applicability of anti-C5 antibodies to treat complement associated diseases, including PNH. Given the teachings of the prior art to provide a range of antibody doses in a dosage regimen that extends over weeks and months in order to treat the PNH, one of ordinary skill in the art at the time the invention was made would have been motivated to provide effective amounts of anti-C5 antibody in various doses and dosing regimens and combination of administration regiments, including intravenous and subcutaneous administration over extended periods of times to treat PNHs, wherein the doses would have optimized to achieve the desired immunosuppression at the time the invention was made, wherein said doses and dosage regimens as well as antibody concentrations of administration were taught / known by the prior art or would have been obvious in view of such teachings to optimize the efficacy of said effective amounts of anti-C5 antibodies treatment depending on a variety of well-known factors, including the nature the disease / PNH and the needs of the patient with an expectation of success. See MPEP § 2144.05(II).
4 Note that the claimed doses, dosing regimens and combination of intravenous / subcutaneous administration as well as the breadth of the claimed limitations are obvious values in delivering effective amounts of anti-C5 antibodies treatment depending on a variety of well-known factors, including the nature the disease / PNH and the needs of the patient with an expectation of success.
5 “The test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them.” See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965).
“There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art.” Motorola, Inc. v. Interdiqital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir. 1997).
An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
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