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
The amendment after non-final office action filed July 21, 2026 is acknowledged. Claims 1-28, 30-35, 37, 39, 41-47 were cancelled, claims 29, 36, 38, 40 were amended and claims 29, 36, 38, 40 are pending.
Election/Restrictions
The restriction was deemed proper and made final in a previous office action. Claims 29, 36, 38, and 40 are examined on the merits of this office action.
Withdrawn Objections/Rejections
The rejection of Claims 29, 34, 36, 38, 40 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of amendment of the claims filed July 21, 2026.
The rejection of claim 40 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of amendment of the claims filed July 21, 2026.
The rejection of claims 36, 38 and 40 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of amendment of the claims filed July 21, 2026.
Maintained/Revised Rejections
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 29, 36, 38, 40 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10968266 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims: A peptide selected from the group consisting of: a peptide consisting of 28 contiguous amino acids of sequence (SEQ ID NO: 74),a peptide consisting of 27 contiguous amino acids of sequence (SEQ ID NO: 75),
a peptide consisting of 26 contiguous amino acids of sequence (SEQ ID NO: 76),
wherein X0a is D or E, X0b is K, A, H, R, X1 is H, A, K, F, Y and X2 is K, H or A, and a variant of any of the above peptides having one or two substitutions outside of X0a, X0b, X1 and X2…, wherein said peptide is an antagonist of a GIP receptor (GIPR), with the proviso that said peptide does not have 100% sequence identity to native hGIP3-30 (SEQ ID NO: 1), to native hGIP4-30 (SEQ ID NO: 77) or to native hGIP5-30 (SEQ ID NO: 78)” (instant claim 29).
The instant application further claims n/c- terminal acetylation or amidation (claim 29); SEQ ID NO:74 or 11 (see claim 38).
Us Patent no ‘10968266 B2 claims a method of using a peptide consisting of 28 contiguous amino acids of SEQ ID NO:74 (which is identical to instant SEQ ID NO:74) (see claim 1); c-terminal amidation or N-terminal acetylated (see claim 5) and variants thereof that encompass non-human GIP3-30. Claim 4 claims SEQ ID NO:81 that is identical to instant SEQ ID NO:81.
Response to Applicant’s Arguments
Applicant requests that any rejection on the grounds of non-statutory obviousness-type double patenting be held in abeyance. Thus, the rejection is maintained.
Claims 29, 36, 38, 40 are/remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of US Patent No. 12187773 (previously indicated as US 17/298444). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims: A peptide selected from the group consisting of: a peptide consisting of 28 contiguous amino acids of sequence (SEQ ID NO: 74),a peptide consisting of 27 contiguous amino acids of sequence (SEQ ID NO: 75),
a peptide consisting of 26 contiguous amino acids of sequence (SEQ ID NO: 76),
wherein X0a is D or E, X0b is K, A, H, R, X1 is H, A, K, F, Y and X2 is K, H or A, and a variant of any of the above peptides having one or two substitutions outside of X0a, X0b, X1 and X2…, wherein said peptide is an antagonist of a GIP receptor (GIPR), with the proviso that said peptide does not have 100% sequence identity to native hGIP3-30 (SEQ ID NO: 1), to native hGIP4-30 (SEQ ID NO: 77) or to native hGIP5-30 (SEQ ID NO: 78)” (instant claim 29).
US Patent No. ‘773 claims a GIPanalogue of SEQ ID NO:1 which is comprises instant SEQ ID NO:74 wherein X0A is D, Xob is R, X1 is K or Orn, X2 is X3 (which is R or E) which meets the limitations of a variant of SEQ ID NO:74 with one substitution and not 100% sequence identity to human GIP3-30. Regarding instant claims 36, 38, SEQ ID NO:1 of US patent NO. ‘773 meets the limitations of instant SEQ ID NO:11 with two substitutions.
Response to Applicant’s Arguments
Applicant requests that any rejection on the grounds of non-statutory obviousness-type double patenting be held in abeyance. Thus, the rejection is maintained.
Claims 29, 36, 38, 40 are/remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of co-pending 16/617698 (Now US Patent 11572399). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims: A peptide selected from the group consisting of: a peptide consisting of 28 contiguous amino acids of sequence (SEQ ID NO: 74),a peptide consisting of 27 contiguous amino acids of sequence (SEQ ID NO: 75),
a peptide consisting of 26 contiguous amino acids of sequence (SEQ ID NO: 76),
wherein X0a is D or E, X0b is K, A, H, R, X1 is H, A, K, F, Y and X2 is K, H or A, and a variant of any of the above peptides having one or two substitutions outside of X0a, X0b, X1 and X2…, wherein said peptide is an antagonist of a GIP receptor (GIPR), with the proviso that said peptide does not have 100% sequence identity to native hGIP3-30 (SEQ ID NO: 1), to native hGIP4-30 (SEQ ID NO: 77) or to native hGIP5-30 (SEQ ID NO: 78)” (instant claim 29).
US Patent NO. 11572399 claims a GIP analogue consisting of hGIP3-30 and variants thereof with 1-6 amino acid substitutions meeting the limitation of instants claims 29, 36, 38, 40 (see claim 1 of US Patent NO. ‘399). US Patent NO. 11572399 further claims wherein Xoa is D, Xob is K and X1 is H and X2 is K thus meeting the limitations of instant claim 29 (see claim 19 for example) and C-terminal amidation (see claim 20). US Patent NO. 11572399 claims SEQ ID NO:81 which is identical to instant SEQ ID NO:81 of claim 40. Regarding claims 36, 38, US Patent NO. 11572399 claims hGIP3-30 with one to two substitutions meeting the limitations of a variant of instant SEQ ID NO:11 with 1 to 2 substitutions. Claims 1-23 are anticipatory of over instant claims 29, 36, 38, 40.
Response to Applicant’s Arguments
Applicant requests that any rejection on the grounds of non-statutory obviousness-type double patenting be held in abeyance. Thus, the rejection is maintained.
Claims 29, 36, 38, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 88-107 of Co-pending AN19/168687. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims: A peptide selected from the group consisting of: a peptide consisting of 28 contiguous amino acids of sequence (SEQ ID NO: 74),a peptide consisting of 27 contiguous amino acids of sequence (SEQ ID NO: 75),
a peptide consisting of 26 contiguous amino acids of sequence (SEQ ID NO: 76),
wherein X0a is D or E, X0b is K, A, H, R, X1 is H, A, K, F, Y and X2 is K, H or A, and a variant of any of the above peptides having one or two substitutions outside of X0a, X0b, X1 and X2…, wherein said peptide is an antagonist of a GIP receptor (GIPR), with the proviso that said peptide does not have 100% sequence identity to native hGIP3-30 (SEQ ID NO: 1), to native hGIP4-30 (SEQ ID NO: 77) or to native hGIP5-30 (SEQ ID NO: 78)” (instant claim 29).
Co-pending application 19/168687 claims human GIP(3-30), (4-30) and (5-30) with 1-6 substitutions (claim 105). These sequences are instant SEQ ID NO:74-76 but do not meet the limitations of not necessarily being the sequence from human. However, Co-pending application 19/168687 encompasses functional variants with 1-6 amino acid substitutions.
Levy teaches of GIP analogues useful for treatment and prevention of metabolic diseases (see abstract). Levy modification can be made to the GIPanalgoue1-30 of lysine substitution at position 30 with alanine, arginine or histidine (see paragraph 0088, 0091). Levy teaches “Further exemplary substitutions are those derived from GIP of other (non-human) species, for example the methionine 14 replaced by leucine, the D at position 9 or 21 replaced by E, the histidine 18 replaced by alanine, arginine or lysine, the lysine at position 30 replaced by alanine, arginine or histidine, the alanine at position 13 replaced by leucine, and the alanine at position 28 replaced by serine” (paragraph 0088). Levy teaches that such substitutions are derived from known GIP variants including those from non-human species, and are useful for treatment of metabolic diseases.
It would have been obvious before the effective filing date of the claimed invention to modify the peptides of Co-pending application 19/168687 by incorporating one or more of the amino acid substitutions taught by Levy in order to obtain a peptide with for the same therapeutic purpose, treating metabolic disorders such as diabetes. The claimed modification represents application of a known technique (amino acid substitution) to an peptide to yield predictable results, namely GIP analogues useful for therapeutic purposes such as treating diabetes (see KSR, MPEP 2143). Further, it would have been obvious to try such substitutions, as Levy provides a finite number of identified, predictable substitutions at specific positions, including a conservative substitution of Histidine for Lysine at position 30 or a Glu in place of the Asp at position 9. A person of ordinary skill in the art would have had a reasonable expectation of success in generating functional variants of the Co-pending application 19/168687 peptides through such substitutions (see MPEP2143).
Additionally, the substitution of one amino acid for another, particularly among known alternatives (e.g. lysine, arginine, histidine or Asp and Glu) constitutes simple substitution of one known element for another to obtain predictable results, which is a recognized rationale supporting a conclusion of obviousness under KSR (See MPEP 2143).
Response to Applicant’s Arguments
Applicant requests that any rejection on the grounds of non-statutory obviousness-type double patenting be held in abeyance. Thus, the rejection is maintained.
Claim Rejections - 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.
Claim(s)s 29, 36, 38 and 40 remain rejected under 35 U.S.C. 103 as being unpatentable over Peri (US20050059605 A1, cited in Applicant’s IDS) in view of Levy (US20110136737) *all references cited previously.
Peri discloses a peptide consisting of GIP-3-30NH2 (see paragraph 0074, “p”). Peri teaches that the peptide consisting of GIP3-30, and other peptides encompassed by “P”, are attached to an acyl group following synthesis (see paragraph 05062, paragraph 0093). Thus, the peptide GIP3-30NH2 meets the limitations of a peptide consisting of SEQ ID NO:74. However, the peptide GIP3-30NH2 is the human sequence and thus, Peri is silent to wherein the GIP3-30NH2 does not have 100% sequence identity to hGIP3-30. Peri does teach using the analogue peptides for treating diseases associated with glucose metabolism (see claims 21 and 23, diabetes in particular).
However, Levy teaches of GIP analogues useful for treatment and prevention of metabolic diseases (see abstract). Levy modification can be made to the GIPanalgoue1-30 of lysine substitution at position 30 with alanine, arginine or histidine (see paragraph 0088, 0091). Levy teaches “Further exemplary substitutions are those derived from GIP of other (non-human) species, for example…the histidine 18 (which would be equivalent to X1 of SEQ ID NO:74) replaced by alanine, arginine or lysine, the lysine at position 30 replaced by alanine, arginine…” (paragraph 0088). Levy teaches that such substitutions are derived from known GIP variants including those from non-human species, and are useful for treatment of metabolic diseases.
It would have been obvious before the effective filing date of the claimed invention to modify the peptide disclosed in Peri by incorporating one or more of the amino acid substitutions taught by Levy in order to obtain a peptide with for the same therapeutic purpose, treating metabolic disorders such as diabetes. The claimed modification represents application of a known technique (amino acid substitution) to a known peptide (Peri’s human 3-30 GIP analogue) to yield predictable results, namely GIP analogues useful for therapeutic purposes such as treating diabetes (see KSR, MPEP 2143). Further, it would have been obvious to try such substitutions, as Levy provides a finite number of identified, predictable substitutions at specific positions, including a conservative substitution of Histidine for Lysine at position 30 or a Glu in place of the Asp at position 9. A person of ordinary skill in the art would have had a reasonable expectation of success in generating functional variants of the Peri peptide through such substitutions (see MPEP2143).
Additionally, the substitution of one amino acid for another, particularly among known alternatives (e.g. lysine, arginine, histidine or Asp and Glu at position 30 or 18) constitutes simple substitution of one known element for another to obtain predictable results, which is a recognized rationale supporting a conclusion of obviousness under KSR (See MPEP 2143).
Regarding claims 29 and 38, Peri in view of Levy discloses the human GIP3-30 sequence which corresponds to SEQ ID NO:74. Peri in view of Levy teach His in place of Lys at position 30 which meets the limitations of SEQ ID NO:74 with a Histidine at X2 and not having 100% sequence identity to native human GIP3-30.
Regarding claims 36 and 38, Peri in view of Levy discloses the human GIP3-30 sequence which corresponds to SEQ ID NO:74 and SEQ ID NO:11. Peri in view of Levy teach His in place of Lys at position 30 which meets the limitations of SEQ ID NO:11 with a Histidine at X2 and not having 100% sequence identity to native human GIP3-30.
Regarding claim 40, Peri in view of Levy discloses the human GIP3-30 sequence which corresponds to SEQ ID NO:74 and SEQ ID NO:11. Peri in view of Levy teach His in place of Lys at position 30 which meets the limitations of SEQ ID NO:91 with a Histidine at X2 and not having 100% sequence identity to native human GIP3-30.
Response to Applicant’s Arguments
Applicant argues “ while conceding the Peri fails to teach "wherein the GIP3-30NH2 does not have 100% sequence similarity to hGIP3-30," the Office Action refers to Levy and states Levy this feature. Based on this analysis, the Office Action alleges that "It would have been obvious before the effective filing date of the claimed invention to modify the peptide disclosed in Pen by incorporating one or more of the amino acid substitutions taught by Levy in order to obtain a peptide with for the same therapeutic purpose, treating metabolic disorders such as diabetes." Office Action, pp. 18-20.
Applicant respectfully traverses this rejection, submitting that the cited references do not support a prima facie obviousness case under 35 U.S.C. § 103(a) for at least the reasons that the references, either alone or in combination fail to teach or suggest each and every element of the pending claims, much less render the claimed subject matter obvious. Moreover, as will be discussed in greater detail below, an obviousness case cannot be sustained because the cited art offers no motivation to modify the reference teachings to arrive at the presently claimed invention. Failure to teach or suggest each and every element of the pending claims
Peri fails to teach or suggest several elements of the pending claims. In particular, as expressly conceded by the Office Action, Peri fails to teach or suggest a peptide consisting of 28 contiguous amino acids of SEQ ID NO: 74, or 27 contiguous amino acids of SEQ ID NO: 74, or 26 contiguous amino acids of SEQ ID NO: 76, wherein "said peptide does not have 100% sequence identity to native hGIP3-30 (SEQ ID NO: 1), to native hGIP4-30 (SEQ ID NO: 77) or to native hGIP5-30 (SEQ ID NO: 78)," recited in claim 29. In addition, Peri is complete silent regarding the specific substitutions at defined positions in the sequences of SEQ ID NO: 74, SEQ ID NO: 75, and SEQ ID NO: 76, as recited in pending claim 29.
The teachings of Levy do not cure the above deficiencies of Peri. In particular, nowhere does Levy teach or suggest a peptide consisting of 28 contiguous amino acids of SEQ ID NO: 74, or 27 contiguous amino acids of SEQ ID NO: 74, or 26 contiguous amino acids of SEQ ID NO: 76," as recited in claim 29. In addition, Levy also fails to teach or suggest the specific substitutions at defined positions within the sequences of SEQ ID NO: 74, SEQ ID NO: 75, and SEQ ID NO: 76, as recited in pending claim 29, which Peri also fails to teach or suggest.
One of skill in the art would have no motivation to combine the cited references
As for the required motivation to combine the prior art teachings, the Office Action alleges, "it would have been obvious before the effective filing date of the claimed invention to modify the peptide disclosed in Peri by incorporating one or more of the amino acid substitutions taught by Levy," and "it would have been obvious to try such substitutions, as Levy provides a finite number of identified, predictable substitutions at specific positions, including a conservative substitution of Histidine for Lysine at position 30 or a Glu in place of the Asp at position 9." Office Action, p. 19, para. 1. However, the only evidence offered by the Office Action in support of the above allegations is the statement that "the claimed modification represents application of a known technique (amino acid substitution) to a known peptide (Peri's human 3-30 GIPanalogue) to yield predictable results, namely GIP analogues useful for therapeutic purposes such as treating diabetes (see KSR, M.P.E.P § 2143)." and "... a person of ordinary skill in the art would have had a reasonable expectation of success in generating functional variants of the Peri peptide through such substitutions (see M.P.E.P § 2143)." Id., p. 19, para. 1.
Applicant respectfully submits that the above allegation are based on a fundamentally flawed reasoning. Levy's teachings generally relates to GIP hybrid polypeptides that have been modified to confer resistance to DPP-IV peptidase degradation (see, e.g., Abstract and claim 1 of Levy). In this regard, Applicant pointed out that DDP-IV is an exopeptidase that cleaves "X- proline" or "X-alanine" dipeptides from the N-terminus of polypeptides. In the present case, DDP- IV is known to specifically hydrolyze the N-terminal residues 1 and 2 of the full-length peptide hGIP and hGIP(1-30) (see also, e.g., Peri at [0007]-[0009] and Table 1). However, these residues 1 and 2 (i.e., cleavage site for DPP-IV) are not present in the claimed GIP analogues of the present invention, as illustrated in Figure 1 below.
As such, Levy's disclosure of the modification of GIPpeptides for resistance to DDP-IV peptidase is clearly irrelevant to the claimed GIP analogues in which no DDP-IV target site exists.
Thus, a skilled artisan seeking to enhance antagonism of the peptide hGlP(3-30) described in Peri would have had no motivation to modify this peptide with modifications/substitutions affecting DPP-IV cleavage site as taught by Levy to arrive at the presently claimed GIP peptide analogues. This is at least because the canonical DPP-IV cleavage site known to be targeted by DPP-IV activity is not even present in the peptide hGlP(3-30) of Peri, nor is it present in the GIP peptide analogues of the present invention. Accordingly, Levy's teachings would not have guided or suggested the claimed modifications, as alleged in the Office Action.
Taken together, when Levy is considered for what it actually discloses, there is no teaching, suggestion, or motivation for a person of ordinary skill in the art seeking to inhibit DPP-IV activity on hGLP(3-30) disclosed in Peri, or to enhance its antagonism, to combine Levy with Peri in a manner that would arrive at the presently claimed GIP peptide analogues.
Applicant’s arguments have been fully considered but not found persuasive. These arguments are not persuasive because the rejection does not rely upon a finding that one of ordinary skill would have modified Peri’s GIP3-30 specifically for the purpose of increasing resistance to DPP IV cleavage. Rather Levy is relied upon for its teaching that particular amino acids at particular positions of GIP are known alternatives. As discussed in the rejection levy teaches substitutions corresponding to the claim positions, including replacement of lysine at position 30 with alanine arginine or histidine and replacement of HIS at position 18 with alanine, arginine or lysine. Levy further teaches that exemplary substitutions may be derived from GIP of other non-human species and identifies non GIP variants containing such substitutions. Thus the fact that one purpose discussed by Levy is resistance to DPPIV degradation, does not negate Levy's additional teaching concerning known amino acid alternatives identify positions of the GIP sequence. The obviousness rationale is not dependent upon the continued presence of the DPPIV cleavage site in Peri’s GIP3-30. Furthermore as set forth in the rejection, the proposed modification represents the application of a known technique of amino acid substitution to the known GIP peptide of Peri using amino acid alternatives expressly identified in Levy. The substitutions are not selected from an unlimited universe of possible modifications. Levy identifies a finite number of alternative residues at particular positions and teaches such substitutions in known GIP variants. Accordingly one of ordinary skill in the art would have had reason to employ these known alternative in Peri’s GIP peptide and would have had a reasonable expectation of obtaining a functional GIPanalogue (see MPEP 2143, KSR Int’l Co. V. Teleflex Inc., 550 U.S. 398 (2007)).
Applicants argument that neither Peri nor Levy individually discloses the presently claimed peptide does not overcome the rejection. It is not a requirement that a single reference expressly disclosed the claim subject matter. Peri provides the GIP peptide serving as the starting sequence, while Levy provides the expressly identified amino acid substitutions. The rejection is based upon what the combined teachings would have suggested to a person of ordinary skill in the art not each reference individually (see MPEP2145, “One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because "[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012)”).
Applicant further argues that Levy does not provide a motivation to make the substitutions for the purpose of enhancing antagonism. However the reason for combining prior teachings need not be identical to the applicants stated purpose for making the claimed invention (see MPEP 2144 IV). The question is whether the prior art as a whole would have provided a reason to make the proposed modification and whether the result would have been predictable to one of ordinary skill in the art. Here Levy expressly identifies the relevant residues as known alternatives in GIP peptides, including alternatives occurring in known GIP variants, and Peri teaches GIP analogs for therapeutic use. Thus, the proposed substitution constitutes the use of a known alternative at a known position in a known peptide according to its established function. Applicant has also not identified persuasive evidence establishing that the presently claimed substitutions produce an unexpected result sufficient to rebut the prima facie case of obviousness. In particular, Applicant’s arguments concerning the absence of the DPPIV cleavage site address the asserted reason for combining the references but do not establish the substitution of the amino acids identified by Levy into Peri’s peptide produces properties that would have been unexpected to one of ordinary skill in the art. No comparative evidence has been identified demonstrating that the claim to peptide exhibits an unexpected property or degree of activity relative to the closest part of peptide or the reasonably expected products of the proposed substitutions.
To the extent applicant relies upon GIPR antagonism as distinguishing the claim peptides, applicant has not established on the present record that the claim antagonistic activity constitute an unexpected result attributable to the claim of substitutions. Attorney argument alone that levy is principally concerned with DPPIVR resistance does not demonstrate that the claim structural modifications yield unexpected properties. Moreover, the rejection relies upon the predictability of employing disclosed amino acid alternatives in the known GIP peptide rather than upon DPP IV resistance as the expected result of the combination.
Thus, Applicants arguments do not overcome the rationale that the claim modification constitutes substitution of known amino acid alternatives at known positions of a known GIP peptide to obtain a predictable GIP analog. The rejection under 35 USC 103 is therefore maintained.
New Rejections
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.
Claim 38 is 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 38 claims “,,,with the proviso that said peptide or functional variant thereof…” The limitation of said functional variant thereof lacks an acidic basis given that can 29 was amended to remove all instances of a variant.
Conclusion
No claims are allowed,
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/Primary Examiner, Art Unit 1654
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