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 1-51, and 53-63 have an effective filing date of 11FEB2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/9/2023, 8/9/2023, 2/24/2026, and 06/18/2026 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 5/7/2026, Applicant elected, without traverse:
Group I, claims 1-51
Species
HCC
HBV
A chemotherapeutic agent
Every three weeks
350 mg
Status of Claims
Claims 1-51, and 53-63 are currently pending and presented for examination on the merits.
Claims 53-63 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claim 52 is canceled.
Claims 1, 3-23, 25-30, 34-51, 53, 54, 56-58, and 61-63 are amended.
Claim Rejections - 35 USC § 112
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 12-18, 23-33, and 45-51 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites an “HCDR1 having an amino acid sequence of SEQ ID NO: 3.” This recitation is indefinite, because an HCDR1 having an amino acid sequence of SEQ ID NO: 3 would encompass, for example, an HCDR1 having only a single amino acid residue of SEQ ID NO: 3. As such one skilled in the art would be unable to readily delineate the metes and bounds of the claim.
Applicant is encouraged to amend the recitation of an “HCDR1 having an amino acid sequence of SEQ ID NO: 3” to read an “HCDR1 comprising the amino acid sequence of SEQ ID NO: 3.” Applicant is also encouraged to make similar claim amendments to claims 13-18 and 23-30.
Claims 31-33 and 45-51 are included in this rejection, because these claims depend from claim 23 but do not cure the deficiencies of claim 23 with respect to 35 U.S.C. 112(b).
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.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-51 are rejected under 35 U.S.C. 103 as being unpatentable over Tipton et al (WO2017011580 A2), and further in view of Ho et al (Integrated immunological analysis of a successful conversion of locally advanced hepatocellular carcinoma to resectability with neoadjuvant therapy, J Immunother Cancer, 8:e000932, 2020).
In regards to claims 1-2, 8-9, 13-15, 19-23, 25-27, 31-34, Tipton et al teaches a method of treating cancer [0446]. Tipton et al further teaches the cancer is liver cancer [0447]. Tipton teaches a PD-1 antibody comprising SEQ ID NO: 1558. A comparison of instant SEQ ID NO: 1 and SEQ ID NO: 1558 of Tipton et al is shown below.
Instant SEQ ID NO: 1 and SEQ ID NO: 1558 of Tipton et al.
Query Match 100.0%; Score 625; Length 117;
Best Local Similarity 100.0%;
Matches 117; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLLESGGVLVQPGGSLRLSCAASGFTFSNFGMTWVRQAPGKGLEWVSGISGGGRDTYF 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLLESGGVLVQPGGSLRLSCAASGFTFSNFGMTWVRQAPGKGLEWVSGISGGGRDTYF 60
Qy 61 ADSVKGRFTISRDNSKNTLYLQMNSLKGEDTAVYYCVKWGNIYFDYWGQGTLVTVSS 117
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNSKNTLYLQMNSLKGEDTAVYYCVKWGNIYFDYWGQGTLVTVSS 117
Tipton further teaches a PD-1 antibody comprising SEQ ID NO: 1585. A comparison of instant SEQ ID NO: 2 and SEQ ID NO: 1585 of Tipton et al is shown below.
Instant SEQ ID NO: 2 and SEQ ID NO: 1585 of Tipton et al.
Query Match 100.0%; Score 559; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSLSASVGDSITITCRASLSINTFLNWYQQKPGKAPNLLIYAASSLHGGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSLSASVGDSITITCRASLSINTFLNWYQQKPGKAPNLLIYAASSLHGGVPS 60
Qy 61 RFSGSGSGTDFTLTIRTLQPEDFATYYCQQSSNTPFTFGPGTVVDFR 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTIRTLQPEDFATYYCQQSSNTPFTFGPGTVVDFR 107
Tipton et al does not specifically teach treating with PD-1 inhibitor and surgically resecting the liver cancer tumor. However, this deficiency is made up in the teachings of Ho et al.
Ho et al teaches a method of treating a patient with a PD-1 antibody before resecting a liver cancer tumor [Abstract]. Ho et al further teaches treating a patient with hepatitis C with a PD-1 antibody [Left column, 2nd Paragraph, pg. 2].
One of ordinary skill in the art, before the effective filing date, would have been motivated to combine Tipton’s method of treating liver cancer comprising administering a PD-1 inhibitor antibody comprising SEQ ID NOs: 1558 and 1585, with Ho’s method of treating a patient with a PD-1 inhibitor antibody and then resecting the tumor. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Tipton and Ho’s methods for a method of treating liver cancer in a patient comprising administering a PD-1 inhibitor and surgically resecting the liver cancer tumor, because Tipon teaches treating liver cancer with a PD-1 inhibitor and Ho teaches treating with a PD-1 inhibitor before surgically resecting the tumor. There would have been a reasonable expectation that the invention of Tipton et al and Ho is effective in treating liver cancer.
In regards to claims 3-4, Tipton et al teaches the cancer is hepatocellular carcinoma [0446].
In regards to claims 5-6, Tipton et al teaches treatment with a PD-1 antibody is administered to a patient at any stage of cancer from early to metastatic [0450].
In regards to claim 7, Ho et al teaches downstaging the tumor with a PD-1 antibody and then subsequent curative resection [Abstract].
In regards to claim 10, Tipton et al teaches treating tumors with PD-L1 expression [0445].
In regards to claim 11, Ho et al teaches resecting the liver 28 days after finishing PD-1 antibody [Right column, 1st Paragraph, pg. 2].
In regards to claims 12 and 24, Tipton et al teaches a PD-1 antibody comprising SEQ ID NO: 1558. A comparison of instant SEQ ID NOs: 3,4,5 and SEQ ID NO: 1558 is shown below.
Instant SEQ ID NOs: 3,4,5 and SEQ ID NO: 1558 of Tipton et al.
Query Match 82.9%; Score 123.5; Length 117;
Best Local Similarity 32.1%;
Matches 26; Conservative 0; Mismatches 0; Indels 55; Gaps 2;
Qy 1 GFTFSNFG-----------------ISGGGRDT--------------------------- 16
|||||||| ||||||||
Db 26 GFTFSNFGMTWVRQAPGKGLEWVSGISGGGRDTYFADSVKGRFTISRDNSKNTLYLQMNS 85
Qy 17 -----------VKWGNIYFDY 26
||||||||||
Db 86 LKGEDTAVYYCVKWGNIYFDY 106
Tipton et al further teaches a PD-1 antibody comprising SEQ ID NO: 1585. A comparison of instant SEQ ID NOs: 6,7,8 and SEQ ID NO: 1585 of Tipton et al is shown below.
Instant SEQ ID NOs: 6,7,8 and SEQ ID NO: 1585 of Tipton et al.
Query Match 71.3%; Score 62.7; Length 107;
Best Local Similarity 25.4%;
Matches 18; Conservative 0; Mismatches 0; Indels 53; Gaps 2;
Qy 1 LSINTF-----------------AAS---------------------------------- 9
|||||| |||
Db 27 LSINTFLNWYQQKPGKAPNLLIYAASSLHGGVPSRFSGSGSGTDFTLTIRTLQPEDFATY 86
Qy 10 --QQSSNTPFT 18
|||||||||
Db 87 YCQQSSNTPFT 97
In regards to claims 16-18, 28-30, Tipton et al teaches an anti-PD-1 antibody comprising SEQ ID NO: 1588. A comparison of instant SEQ ID NO: 9 and SEQ ID NO: 1588 of Tipton et al is shown below.
Instant SEQ ID NO: 9 and SEQ ID NO: 1588 of Tipton et al.
Query Match 100.0%; Score 2371; Length 444;
Best Local Similarity 100.0%;
Matches 444; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLLESGGVLVQPGGSLRLSCAASGFTFSNFGMTWVRQAPGKGLEWVSGISGGGRDTYF 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLLESGGVLVQPGGSLRLSCAASGFTFSNFGMTWVRQAPGKGLEWVSGISGGGRDTYF 60
Qy 61 ADSVKGRFTISRDNSKNTLYLQMNSLKGEDTAVYYCVKWGNIYFDYWGQGTLVTVSSAST 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNSKNTLYLQMNSLKGEDTAVYYCVKWGNIYFDYWGQGTLVTVSSAST 120
Qy 121 KGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLY 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLY 180
Qy 181 SLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLF 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLF 240
Qy 241 PPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVV 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 PPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVV 300
Qy 301 SVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQV 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 SVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQV 360
Qy 361 SLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVF 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 SLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVF 420
Qy 421 SCSVMHEALHNHYTQKSLSLSLGK 444
||||||||||||||||||||||||
Db 421 SCSVMHEALHNHYTQKSLSLSLGK 444
Tipton et al teaches an anti-PD-1 antibody comprising SEQ ID NO: 1592. A comparison of instant SEQ ID NO: 10 and SEQ ID NO: 1592 of Tipton et al is shown below.
Instant SEQ ID NO: 10 and SEQ ID NO: 1592 of Tipton et al.
Query Match 100.0%; Score 1112; Length 214;
Best Local Similarity 100.0%;
Matches 214; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSLSASVGDSITITCRASLSINTFLNWYQQKPGKAPNLLIYAASSLHGGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSLSASVGDSITITCRASLSINTFLNWYQQKPGKAPNLLIYAASSLHGGVPS 60
Qy 61 RFSGSGSGTDFTLTIRTLQPEDFATYYCQQSSNTPFTFGPGTVVDFRRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTIRTLQPEDFATYYCQQSSNTPFTFGPGTVVDFRRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
In regards to claims 35-36, Ho et al teaches a near pathologic response of 80-100% necrosis [Abstract].
In regards to claim 37, Tipton et al teaches a method of treating comprising administering the anti-PD-1 antibody with a chemotherapeutic [0422].
In regards to claims 38-39, 45-46, Tipton et al teaches administering the anti-PD-1 antibody every three weeks [Table 22, pg. 451].
In regards to claims 40-43, and 47-50, Tipton et al teaches administering an anti-PD-1 antibody at dosages of between 1-20 mg/kg [Table 16, pg. 371]. Furthermore, Ho et al teaches administering an anti-PD-1 antibody at a dosage of 240 mg [Right column, 1st Paragraph, pg. 2].
With regard to antibody dosages, the amount of the antibody administered is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention.
The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."(Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
In regards to claims 44 and 51, Tipton et al teaches administering the treatment via intravenous and subcutaneous routes [0816].
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 1-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, and 18-28 of copending Application No. 18/551,679 ('679) in view of Tipton et al (WO2017011580 A2) and Ho et al (Integrated immunological analysis of a successful conversion of locally advanced hepatocellular carcinoma to resectability with neoadjuvant therapy, J Immunother Cancer, 8:e000932, 2020).
The teachings of Tipton et al and Ho et al are discussed above.
Claims 1 are not patentably distinct from claims 1-2, 18-28 of ‘679. Specifically, a method of treating liver cancer comprising administering a PD-1 inhibitor antibody comprising SEQ ID NOs: 1 and 2. Although the claims at issue are not identical, they are not patentably distinct from each other, because both sets of claims recite a) a method of treating liver cancer comprising administering an anti-PD-1 antibody comprising SEQ ID NOs: 1 & 2 (claims 1, 9, and 23), b) an anti-PD-1 antibody comprising SEQ ID NOs: 3,4,5,6,7,&8 (claim 12 and 24), c) a PD-1 antibody with HCVR comprising SEQ ID NO: 1 (claims 13, 20, and 25), d) a PD-1 antibody with LCVR comprising SEQ ID NO: 2 (claims 14, 21, and 26), e) a PD-1 antibody comprising SEQ ID NOs: 1/2 (claims 15 and 27), f) an anti-PD-1 antibody comprising SEQ ID NO: 9 (claims 16 and 28), g) an anti-PD-1 antibody comprising SEQ ID NO: 10 (claims 17 and 29), h) an anti-PD-1 antibody comprising SEQ ID NOs: 9 & 10 (claims 18 and 30, i) an anti-PD-1 antibody comprising SEQ ID NOs: 1 and 2 with 90% sequence identity (claims 20-22 and 31-33), j) the antibody is cemiplimab (claim 19), k) administration frequency and dosages (claims 38-43, and 45-50) l) route of administration (44 and 51).
With respect to claims 2-4, Tipton et al teaches the cancer is liver cancer [0447]. Tipton et al further teaches the cancer is hepatocellular carcinoma [0446].
In regards to claims 5-6, and 34, Tipton et al teaches treatment with a PD-1 antibody is administered to a patient at any stage of cancer from early to metastatic [0450].
In regards to claim 7, Ho et al teaches downstaging the tumor with a PD-1 antibody and then subsequent curative resection [Abstract].
In regards to claim 8, Ho et al teaches a method of treating a patient with a PD-1 antibody before resecting a liver cancer tumor [Abstract]. HO et al further teaches treating a patient with hepatitis C with a PD-1 antibody [Left column, 2nd Paragraph, pg. 2].
In regards to claim 10, Tipton et al teaches treating tumors with PD-L1 expression [0445].
In regards to claim 11, Ho et al teaches resecting the liver 28 days after finishing PD-1 antibody [Right column, 1st Paragraph, pg. 2].
In regards to claims 35-36, Ho et al teaches a near pathologic response of 80-100% necrosis [Abstract].
In regards to claim 37, Tipton et al teaches a method of treating comprising administering the anti-PD-1 antibody with a chemotherapeutic [0422].
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
Prosecution Insights