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
Upon further review, prosecution of this case is re-opened.
In view of the appeal brief filed on 4/13/2026, PROSECUTION IS HEREBY REOPENED. New grounds set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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, 3, 9-15, 18-21, and 25 have an effective filing date of 04OCT2018.
Election/Restriction
In the response filed on 3/21/2024, Applicant elected, with traverse:
Group I, claims 9-14, 16-17, and 22
Species
Crohn’s Disease
Upon further consideration Group II, claim 15 was rejoined.
Status of Claims
Claims 1, 3, 9-15, 18-21, and 25 are currently pending and presented for examination on the merits.
Claims 1, 3, 9-15, and 18-21 are amended
Claims 18-21 are withdrawn from further consideration by Examiner under 37 CFR 1.1.42(b) as being drawn to a non-elected invention.
Claims 2, 4-8, 16-17, and 22-24 are canceled.
Rejections Withdrawn
The rejections filed under 35 U.S.C. 112(a) Written Description are withdrawn by Examiner.
The rejection filed under 35 U.S.C. 112(b) Indefinite are withdrawn by Examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The broadest reasonable interpretation of claim 1 is a method of treating inflammatory bowel disease (IBD) in a subject comprising administering to the subject an agent that inhibits the recruitment of eAGR2, neutralizing the pro-inflammatory activity of eAGR2, using an antibody with specific binding for eAGR2 comprising six CDRs.
Specifications Definitions:
An agent which neutralizes the pro-inflammatory activity of eAGR2, refers to:
Any molecule that inhibits the recruitment of monocytes induced by eAGR2 [Pg. 5, line 16].
eAGR2, refers to:
The secreted form of AGR2 such as described in Fessart, D., et al [Pg. 5, line 12].
eAGR2 deems to have the same amino acid sequence as described for AGR2 [Pg. 5, line 14].
Examiner’s Interpretation:
For the sake of compact prosecution an agent which neutralizes the pro-inflammatory activity of eAGR2 is seen as any molecule that inhibits the recruitment of monocytes induced by the secreted form AGR2.
Claims Objections
Claims 9, and 12-14 are objected to for depending from a rejected claim.
New Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Villa et al (WO 2017121880 A1).
In regard to claim 1, Villa et al teaches a method of treating inflammatory bowel disease (IBD) using antibodies shown to be over-expressed in the intestine [Abstract]. Villa et al further teaches the antigen is anterior gradient protein 2 homolog [Abstract]. Villa et al further teaches anterior gradient protein 2 homolog is abbreviated as AGR2 [Pg. 8, line 25]. Villa et al further teaches the protein is located in the extracellular intestine [Pg. 28, line 24 & Table 1]. Villa et al further teaches antibodies which binds AGR2 [Pg. 8, line 25]. Villa et al further teaches the anti-AGR2 antibody CPR02 comprising SEQ ID NOs: 60 & 61 [Pg. 9, line 5]. Villa et al further teaches the anti-AGR2 antibody CPR02, binding human AGR2 antigen in colon samples [Pg. 35, line 11].
In regard to claim 3, Villa et al teaches that treating IBD includes Crohn’s Disease [Pg. 13, line 14].
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, 3, 10-11, 15, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Villa et al (WO 2017121880 A1) as applied to claims 1 and 3 above, and further in view of Li et al (US 9574012 B2).
The teachings of Villa et al are discussed above.
Villa et al does not specifically teach an anti-AGR2 antibody comprising SEQ ID NOs: 6,7,8. However, this deficiency is made up in the teachings of Li et al.
In regard to claims 10-11, Li et al teaches an anti-AGR2 antibody comprising SEQ ID NO: 3. A comparison of instant SEQ ID NOs: 6,7,8 and SEQ ID NO: 3 of Li et al is shown below. Li et al further teaches the anti-AGR2 antibody binds to the protein disulfide isomerase active domain of AGR2 [Column 2, lines 11-13]. Li et al further teaches inhibition of AGR2 [Column 3, lines 51-54].
Instant SEQ ID NOs: 6,7,8 and SEQ ID NO: 3 of Li et al.
Query Match 84.1%; Score 130.3; Length 111;
Best Local Similarity 39.7%;
Matches 31; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 RASKSVSTSGYSYMH---------------LASNLES----------------------- 22
||||||||||||||| |||||||
Db 24 RASKSVSTSGYSYMHWYQQKPGQAPRLLIYLASNLESGIPARFSGSGSGTDFTLTISRLE 83
Qy 23 ---------QHIRELPRT 31
|||||||||
Db 84 PEDFAVYYCQHIRELPRT 101
One of ordinary skill in the art, before the effective filing date, would have been motivated to substitute the antibody of Li into Villa’s method of treating IBD comprising administering an anti-AGR2 antibody, since Li teaches a method of treating diseases by administering an anti-AGR2 antibody comprising SEQ ID NO: 3. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). It would be prima facie obvious to combine Villa and Li’s methods for a methods of treating IBD comprising administering an anti-AGR2 antibody comprising SEQ ID NOs: 6,7,8, because Villa teaches treating IBD with an anti-AGR2 antibodies and Li teaches treating diseases with an anti-AGR2 antibody comprising SEQ ID NO: 3. Furthermore, Li teaches the AGR2 antibody binding to the protein disulfide isomerase active domain of AGR2 and the antibodies inhibitory effects to AGR2.
In regard to claim 15, Li et al teaches an anti-AGR2 antibody comprising SEQ ID NO: 3. A comparison of instant SEQ ID NO: 10 and SEQ ID NO: 3 of Li et al is shown below.
Instant SEQ ID NO: 10 and SEQ ID NO: 3 of Li et al.
Query Match 100.0%; Score 575; Length 111;
Best Local Similarity 100.0%;
Matches 111; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EIVLTQSPATLSLSPGERATLSCRASKSVSTSGYSYMHWYQQKPGQAPRLLIYLASNLES 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPATLSLSPGERATLSCRASKSVSTSGYSYMHWYQQKPGQAPRLLIYLASNLES 60
Qy 61 GIPARFSGSGSGTDFTLTISRLEPEDFAVYYCQHIRELPRTFGGGTKLEIK 111
|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GIPARFSGSGSGTDFTLTISRLEPEDFAVYYCQHIRELPRTFGGGTKLEIK 111
In regard to claim 25, Li et al teaches AGR2 blocking monoclonal antibodies to treat diseases at dosages of 1 μg/kg to 15 mg/kg, based on the severity of the disease [Abstract & Column 15, line 18].
With regard to the therapeutically effective amount, the therapeutically effective amount 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).
One of ordinary skill in the art would find it obvious to administer a dosage level from 0.0002 mg/kg to 20 mg/kg of body weight per day, since Li et al teaches administering AGR2 blocking antibodies of dosages of 1 μg/kg to 15 mg/kg, based on the severity of the disease.
Conclusion
Claims 1, 3, 10-11, 15, and 25 are rejected.
Claims 9, and 12-14 are objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
