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 .
THIS IS A SECOND NON-FINAL OFFICE ACTION.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-18, 20, 21, in the reply filed on 9/19/24 is acknowledged.
Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/19/24.
Applicant’s election without traverse of the isolated peptide corresponding to the amino acid sequence of SEQ ID NO:83, which applicant states claims 1-11, 14-18, 20 and 21 read on, in the reply filed on 9/19/24 is acknowledged.
The isolated peptide corresponding to the amino acid sequence of SEQ ID NO:83 was searched and found free of the art.
In accordance with MPEP 803.02 III A, the search was extended to a nonelected species.
This species is the “Triagonist” set forth in Figure 1 of Finan et al., nature medicine VOLUME 21, NUMBER 1, JANUARY 2015, pp 27-36 (plus 3 online methods pages, copy provided), the amino acid sequence being: H-Aib-QGTFTSDKSKYLDERAAQDFVQWLLDGGPSSGAPPPS-NH2. As taught at least by the Abstract and Figure 1 with its legend, this sequence is a triple agonist that meets claim 1’s functional limitation as reasonably interpreted, and also falls within claim 4’s General Formula I genus.
The examiner has withdrawn all claims that do not read on this nonelected species. See MPEP 803.02 III A. The prior art search is not extended unnecessarily to cover all nonelected species. Claims 6-12 and 15 are withdrawn as not reading on the elected species (note that K, lysine, of the Finan Triagonist sequence is lysine, which is not permitted for withdrawn claims 6-12 at position 10, nor is the Finan “Triagonist” nonelected sequence under examination identical to any of those sequence of claim 15.
Based on applicant’s 7/2/25 claim amendments, the claims no longer read on the first nonelected species.
The search was extended to a second nonelected species, this being the peptide identified in prior art PGPUB 20110166062, DiMarchi and Tao, published 7/7/2011, as SEQ ID NO:60, see page 70, copied below:
PNG
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427
515
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.
The single letter sequence is: YXQGTFTSDY SIYLDEQAAK EFVCWLLAGG PSSGAPPPS, where the position 2 X is Aib, see above.
Claims previously examined that were not cancelled 7/2/25 are examined herein.
Claim Status
Claims 4-15, 18-22 are pending.
Claims 1-3, 16, 17 are cancelled.
Claim 19 was withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/19/24.
Claims 6-12 and 15 were withdrawn because they did not read on the first nonelected species under examination.
Claims 4, 5, 13, 14, 18, 20, 21 and new claim 22 are pending and under examination.
Claims 4, 5, 13, 14, 18, and 20-22 are rejected.
Priority
The instant application, filed 03/21/2022 is a Continuation of 16370057 , filed 03/29/2019 ,now U.S. Patent # 11332508
16370057 is a Continuation of 16023994 , filed 06/29/2018 ,now U.S. Patent # 10370426 and having 1 RCE-type filing therein
16023994 is a Continuation of PCT/KR2016/015554 , filed 12/30/2016
claims foreign priority to 10-2015-0191082, filed 12/31/2015
claims foreign priority to 10-2016-0163737, filed 12/02/2016.
Claim Objections
Response to Arguments
Applicant’s arguments, see page 14, filed 7/2/25, and claim amendments, with respect to the objections to claims 3, 4 and 7 have been fully considered and are persuasive. The objections to claims 3, 4 and 7 have been withdrawn.
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.
Response to Arguments
Applicant's arguments filed 7/2/25 have been fully considered but they are not persuasive.
For completeness of the record and in response to arguments, the following is provided under this section, and also in the rejection that follows:
Attorney for applicant states, “The results in Table 2 generally indicate a non-zero effect, signifying a measurable effect,” page 15 of 7/2/25 Remarks, and “Furthermore, a value below 0.1 also indicates non-zero activity, and the claimed peptide exhibits “agonist activity” as supported by the results in Table 2 of the specification,” page 17 of 7/2/25 Remarks. No evidence is provided to support these assertions.
In contrast to these assertions, Hunter and Glass, Jl. of Pharmacological and Toxicological Methods 71 (2015) 42–45 (“HG”), teaches a refinement of the LANCE cAMP detection kit (“LANCE kit”), this kit being what applicant employed to obtain the data in its Table 2 (see specification, pages 44-48). HG teaches that when using the LANCE kit, “the validity of the data is dependent on all of the samples falling within the linear range of the standard curve,” such “standard curve generates a sigmoidal response curve with a robust span, but with a relatively limited dynamic range,” and when measuring using a Victor (a brand of instrument used in a referenced source publication by the LANCE kit manufacturer), “the linear range of the standard curve (between 10 and 90%) occurs between approximately 0.3 nM and 25 nM,” pages 42 to 43. The latter indicates a range of two orders of magnitude. HG continues, “From our own laboratory's experience with this assay, we have found that despite substantial optimization of conditions including cell number and duration of incubation, data frequently fell on the non-linear portion of the curve, thereby rendering the results meaningless,” Id., emphasis added.
The majority of the HG article discloses a modification of the LANCE kit protocol to enable it to be used on cell lysates. This modification allows for “samples falling outside of the range of the standard curve can be reassayed at an appropriate dilution to ensure that they fall within the linear range,” Id.
There is no evidence of record that the data in Table 2 utilized sufficient dilutions to obtain a valid value when disclosing values designated as “<0.1”. If the “<0.1” values on Table 2 were obtained in the non-linear portion of whatever standard curve applicant employed, then per HG such results are meaningless, not valid, and therefore not indicative of agonist activity for that data point. Given that there are values reported in Table 2 that are as high as 151%, for SEQ ID NO:32, assuming that this was in the linear range of the standard curve (or alternatively that a value such as 83.1% for SEQ ID NO:27 was in the linear range of the standard curve), then the noted two orders of magnitude for the range of the standard curve would not include a value of “<0.1%”, the latter being three orders of magnitude lower. This analysis indicates the “<0.1%” results are meaningless, not valid, and not indicative of respective agonist activity by a peptide having such result. HG provides prior art evidence that is in conflict with applicant’s assertions.
(end of what is also in the rejection below)
Applicant may consider providing evidence to rebut what is set forth above.
Considering applicant’s claim amendments, data, statements, and the prior art reference HG, the examiner maintains and modifies the indefiniteness rejection. The rejection below makes clear that contrary to applicant’s assertion on page 15 that “one skilled in the art would clearly understand the metes and bounds of the scope of the claimed peptide,” there are three alternative interpretations of the scope of claim 4, and that one of ordinary skill in the art would not ‘clearly understand’ claim 4’s metes and bounds.
The examiner acknowledges the correction to claim 20 and withdrawal of the specific previous basis for rejection under this section.
Claims 4, 5, 13, 14, 18, and 20-22 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 4 is directed to a very large genus of peptides that are encompassed by its General Formula 1, SEQ ID NO:3, which includes over the length of its first 29 amino acids from two to six amino acid alternatives at 20 positions. By calculation, the product of the respective number of alternatives at each of these 20 positions when multiplied together results in 64,497,254,400 alternatives for peptide sequences.
Claim 4 also states as to the claimed peptide, “having agonist activities to a glucagon receptor, a glucagon-like peptide-1 (GLP-1) receptor, and a glucose-dependent insulinotropic polypeptide (GIP) receptor.” This imparts a functional limitation for the claim 4 peptides, and could further limit the claim 4 peptides to a subgenus smaller than the General Formula 1 very large genus.
The specification discloses triple agonist(s) that are stated to have activities to all of glucagon, GLP-1, and GIP receptors, page 1, lines 20-21, and discloses an isolated peptide similarly stated to have such activities, page 2 lines 2-4, to these same receptors. Elsewhere in some embodiments the isolated peptide includes an amino acid sequence represented by General Formula I, page 4 line 29 to page 6, line 29.
The only activities applicant discloses in the application as filed are related to binding with the receptors, see Table 2, this for measured in vitro activities of 102 peptide sequences, identified by SEQ ID number, when compared with respective native agonists. Immediately below Table 2 applicant states that the “novel glucagon analogs prepared above have the function of triple agonists which can activate all of GLP-1 receptors, GIP receptors, and glucagon receptors,” page 49 lines 1-2.
Yet many of these peptides are stated to have measured activities against one or more receptors of “<0.1”. Because such “<0.1” percent result, having this less than symbol, would suggest to many of ordinary skill in the art no measurable activity, the data showing many results as “<0.1”, and the statement about this data, such as the “novel glucagon analogs prepared above have the function of triple agonists which can activate all of GLP-1 receptors, GIP receptors, and glucagon receptors,” page 49 lines 1-2, at least creates a tension with, and more likely contradicts, what one of ordinary skill in the art would consider activity.
This, particularly in view of the prior art reference discussed below, contributes to the lack of clarity as to the metes and bounds of what is encompassed by the claims. As to which species within the claim 4 very large genus of General Formula 1 peptides possess the required activities, it is not clear whether each of the species of this genus need to have at least a “<0.1” result, or more substantial measurements of activities, or whether meeting the activities limitations is based on the type of evaluation and/or an applicant-specific interpretation of ‘activity’. This is considered in greater detail below in this rejection.
In response to the previous rejection under this section, prior to 7/2/25 claim amendments, attorney for applicant states, “The results in Table 2 generally indicate a non-zero effect, signifying a measurable effect,” page 15 of 7/2/25 Remarks, and “Furthermore, a value below 0.1 also indicates non-zero activity, and the claimed peptide exhibits “agonist activity” as supported by the results in Table 2 of the specification,” page 17 of 7/2/25 Remarks. No evidence is provided to support these assertions.
In contrast to these assertions, the prior art reference Hunter and Glass, Jl. of Pharmacological and Toxicological Methods 71 (2015) 42–45 (“HG”), teaches a refinement of the LANCE cAMP detection kit (“LANCE kit”), this kit being what applicant employed to obtain the data in its Table 2 (see specification, pages 44-48). HG teaches that when using the LANCE kit, “the validity of the data is dependent on all of the samples falling within the linear range of the standard curve,” such “standard curve generates a sigmoidal response curve with a robust span, but with a relatively limited dynamic range,” and when measuring using a Victor (a brand of instrument used in a referenced source publication by the LANCE kit manufacturer), “the linear range of the standard curve (between 10 and 90%) occurs between approximately 0.3 nM and 25 nM,” pages 42 to 43. The latter indicates a range of two orders of magnitude. HG continues, “From our own laboratory's experience with this assay, we have found that despite substantial optimization of conditions including cell number and duration of incubation, data frequently fell on the non-linear portion of the curve, thereby rendering the results meaningless,” Id., emphasis added.
The majority of the HG article discloses a modification of the LANCE kit protocol to enable it to be used on cell lysates. This modification allows for “samples falling outside of the range of the standard curve can be reassayed at an appropriate dilution to ensure that they fall within the linear range,” Id.
There is no evidence of record that the data in Table 2 utilized sufficient dilutions to obtain valid values when disclosing values designated as “<0.1”. If the “<0.1” values on Table 2 were obtained in the non-linear portion of whatever standard curve applicant employed, then per HG such results are meaningless, not valid, and therefore not indicative of agonist activity for that data point. Given that there are values reported in Table 2 that are as high as 151%, for SEQ ID NO:32, assuming that this was in the linear range of the standard curve (or alternatively that a value such as 83.1% for SEQ ID NO:27 was in the linear range of the standard curve), then the noted two orders of magnitude for the range of the standard curve would not include a value of 0.1% or <0.1%, these being three orders of magnitude lower. This analysis based on the prior art HG reference indicates the “<0.1%” results are meaningless, not valid, and not indicative of respective agonist activity by a peptide having such result. HG provides prior art evidence that is in conflict with applicant’s assertions.
Per MPEP 2173.02 II, when considering whether claims are definite or indefinite:
“The essential inquiry pertaining to this requirement is whether the claims set out and circumscribe a particular subject matter with a reasonable degree of clarity and particularity. "As the statutory language of ‘particular[ity]' and 'distinct[ness]' indicates, claims are required to be cast in clear—as opposed to ambiguous, vague, indefinite—terms. It is the claims that notify the public of what is within the protections of the patent, and what is not." Packard, 751 F.3d at 1313, 110 USPQ2d at 1788. Definiteness of claim language must be analyzed, not in a vacuum, but in light of:
(A) The content of the particular application disclosure;
(B) The teachings of the prior art; and
(C) The claim interpretation that would be given by one possessing the ordinary level of skill in the pertinent art at the time the invention was made.
In reviewing a claim for compliance with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, the examiner must consider the claim as a whole to determine whether the claim apprises one of ordinary skill in the art of its scope and, therefore, serves the notice function required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent.”
From MPEP 2173.05(a) I entitled “THE MEANING OF EVERY TERM SHOULD BE APPARENT”:
The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." In re Packard, 751 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014). Applicants need not confine themselves to the terminology used in the prior art, but are required to make clear and precise the terms that are used to define the invention whereby the metes and bounds of the claimed invention can be ascertained. During patent examination, the pending claims must be given the broadest reasonable interpretation consistent with the specification. In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997); In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969). See also MPEP § 2111 - § 2111.01. When the specification states the meaning that a term in the claim is intended to have, the claim is examined using that meaning, in order to achieve a complete exploration of the applicant’s invention and its relation to the prior art. In re Zletz, 893 F.2d 319, 13 USPQ2d 1320 (Fed. Cir. 1989).
From MPEP 2173.05(a) III, entitled TERMS USED CONTRARY TO THEIR ORDINARY MEANING MUST BE CLEARLY REDEFINED IN THE WRITTEN DESCRIPTION:
Consistent with the well-established axiom in patent law that a patentee or applicant is free to be his or her own lexicographer, a patentee or applicant may use terms in a manner contrary to or inconsistent with one or more of their ordinary meanings if the written description clearly redefines the terms.
Considering the activities functional limitations as having weight, the broadest reasonable interpretation of claim 4’s requirement for activities could be that any peptide encompassed by the claim 4 General Formula 1 that, per the LANCE kit test following use of this kit as done by applicant, that achieves at least “<0.1%” compared to the respective natural agonist possesses the required activities to fall within the claim scope.
However this interpretation appears in tension with the prior art teachings of HG, including that any value that falls on the non-linear portion of the curve provides a meaningless result, this supported by the analysis that such value is well below the two orders of magnitude range that includes higher values in Table 2.
The examiner has considered whether applicant has clearly redefined the meaning of activities in the application as filed, and is not persuaded that the specification clearly redefines the meaning of activities. It may be just stating a level of activity, <0.1%, as activity, that others in the art, such as HG, would not consider activity.
One of ordinary skill in the art reasonably would be confused as to the metes and the bounds of what is being claimed in claim 4 at least based on the conflict with HG and the uncertainty as to when a particular peptide within the General Formula 1 genus (and also as to peptides of Table 2 that have <0.1 values) does not have all three required activities, so, under one interpretation, falls outside of the claim’s metes and bounds. There is a clear discontinuity between the prior art HG teachings and applicant’s specification and statements.
This leads to corollary considerations regarding claim scope when considering the very large size of the genus of General Formula 1 peptides, these leading to three alternative interpretations of claim scope:
All peptides in the genus meet the three activities requirement, whether due to a) applicant’s approach to using the LANCE kit test is such that any of the genus’ peptide’s activity when measured is measured has a result no less than “<0.1%” (please note however in Table 2 SEQ ID NO:80 has one result value of “0.0” – it is not clear if this is a typographical error nor how this was determined, and if not an error, then it conflicts with applicant’s assertions), and/or b) applicant, as its own lexicographer, is defining activity such that all peptides of Table 2 have all three activities, and based, somehow, on this reflecting the entire genus, all species of the genus have the three claimed activities. The latter is problematic because it is not clear that applicant has clearly redefined this term, and attorney for applicant arguments do not specifically indicate an “own lexicographer” argument. This alternative also appears implausible given the number of alternatives at the 20 of the first 29 amino acid positions when considering the known specificity of receptors, this also supported at least by a zero value in Table 2. (The part b analysis also would mean that the claim with or without the activities limitations would have the same scope, so begs the question of why the activities functional limitations were added).
Only peptides having activities that are measured at least or higher than the “<0.1%” have activity, this based on applicant’s statements and disregarding the teachings of HG. This imparts functional limitations that limit the breadth of claim 4, so would exclude peptides of the very large General Formula 1 genus that have measured activities of zero, however what structure(s)/core(s) is/are required to meet the functional limitations under this alternative is/are not found in claim 4.
Only peptides having activities that are measured within the linear portion of a standard curve are determined to have a valid activity, and based on HG the “<0.1%” results do not. Under this alternative the claim 4 genus is limited to those peptides having activities that are measured within the linear portion of a standard curve. This is in tension with statements in the specification and also attorney for applicant’s Remarks, above, however is more consistent with the prior art teachings of HG, and, the examiner believes, more reasonable for one of ordinary skill in the art (who also may consider, even without knowledge of HG, a reading of <0.1 percent as noise and not activity).
Following from #2 and #3 immediately above, claim 4 setting forth such functional limitations should provide structural or other limitations as a way to achieve those functions, e.g., the structure/sequence/core required to achieve them, rather than merely expressing a problem or goal to be achieved. See MPEP 2173.05(g), stating in part, “when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear.” This is a fact-specific analysis. Here there is nothing in claim 4 to further limit, such as by structure or required core sequence, the at least1 64,497,254,400 alternatives for peptide sequences of General Formula 1 of claim 4 to a smaller genus of peptides, each of which possesses validly measurable activity against all three claimed receptors. Such is not provided, leading to a further basis for indefiniteness of the claim 4 activities functional limitations.
Based on the above analyses and differences between what is stated in the specification and applicant Remarks, these in conflict at least with a value in Table 2 that is zero, and more broadly in conflict with the prior art teachings of HG as to measurement and validity of values using the same LANCE kit that applicant used, and including the lack of relevant structure claim limitations – such as core sequence requirements or combinations of amino acids at particular locations that provide for the functional limitations, one of ordinary skill in the art, particularly one who understands the importance of measurements within a particular range of a standard curve is needed to obtain valid results, would not reasonably conclude that the metes and bounds of claim 4 are clear and definite.
Based on the above analyses, claim 4 is rejected under this section as indefinite.
Claims 5, 13, 14, 18, and 20-22 do not resolve the bases for indefiniteness of claim 4, and also are rejected under this section. Note that claim 22’s “about 0.1% or more includes values below the two orders of magnitude that cover the range that includes 151%, for SEQ ID NO:32 (assuming that this was in the linear range of the standard curve) or alternatively 83.1% for SEQ ID NO:27.
New claim 22 is additionally and separately rejected under this section. The term “about” in claim 22 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what values below 0.1% fall within the claim 22 “about 0.1%” lower end of its open-ended range.
Claim Rejections - 35 USC § 112
Response to Arguments
Applicant’s arguments, see page 13, filed 7/2/25, and claim amendment, with respect to the rejection of claim 20 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph have been fully considered and are persuasive. The rejection of claim 20 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Response to Arguments
Applicant's arguments filed 7/2/25 have been fully considered but they are not persuasive.
First, as to attorney for applicant’s statement that support for new claim 22 is supported by, for example, paragraph [0219] of published Application No. US 20220213164A, this paragraph does not modify 0.1 % with an “about”. See new matter rejection below based on the lack of support for “about” in claim 22.
Applicant page 17 states in part that “all variables corresponding to Xaa1 through Xaa30 and R1 represent all variables of the peptides of SEQ ID Nos. 1 to 102 prepared in Table 1 and evaluated in Table 2.” This is not persuasive because inclusion of those variables in the 102 peptides does not reflect the very high number of diverse combinations that are encompassed in the General Formula 1.
Applicant’s statement also on page 17 as to “a value below 0.1 also indicates non-zero activity” is addressed above and no further response is required for the rejection under this section.
Based on the number of possible combinations encompassed by the claim 4 General Formula 1, based on the product of the respective number of alternatives at each of these 20 positions when multiplied together, this is 64,497,254,400 alternatives for peptide sequences, the examiner does not agree that “the peptides defined by present claim 4 are supported by the specification which describes sufficient representative species across the genus of General Formula 1.” Further, given the lack of structural or other relevant limitations that result in the claimed activities, claim 4 also cannot be reasonably considered to satisfy written description across its possible breadth.
Applicant on page 18 refers to a maintaining a core scaffold, however the examiner is not persuaded that all members of the genus of General Formula 1, which includes diverse types of amino acids as alternatives at a number of positions, are represented by the 102 evaluated species.
Applicant further states that Table 2 provides “detailed structure-activity relationship data.” The examiner does not perceive how this data instructs one or ordinary skill in the art to determine what other peptides in the very large genus are within the activities-limitation subgenus of claim 4, so fall within the scope of claim 4. The structural framework appears to have more variables than cores, and the examiner, after reviewing the data of Table 2, does not perceive a clear and well-defined and predictable structure-activity relationship. It may benefit applicant’s position to more clearly articulate how the data of Table 2 leads one of ordinary skill in the art to determine which of the over 64,497,254,400 alternatives for peptide sequences within General Formula 1 meet the three-activities limitations. The examiner does not believe, at this time, that sufficient structural framework is provided, but is open to better understanding how applicant perceives and can demonstrate it use in determining which peptides within the scope of General Formula 1 achieve the three-activities limitations.
Claims 4, 5, 13, 14, 18, and 20-22 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 4 is directed to a very large genus of peptides that are encompassed by its General Formula 1, SEQ ID NO:3, which includes over the length of its first 29 amino acids from two to six amino acid alternatives at 20 positions. By calculation, the product of the respective number of alternatives at each of these 20 positions when multiplied together results in 64,497,254,400 alternatives for peptide sequences.
Claim 4 also states as to the claimed peptide, “having agonist activities to a glucagon receptor, a glucagon-like peptide-1 (GLP-1) receptor, and a glucose-dependent insulinotropic polypeptide (GIP) receptor.” This imparts a functional limitation for the claim 4 peptides of this very large genus.
The alternatives for “activities” as applied to claim 4 are set forth above in the rejection regarding indefiniteness. For this rejection the third alternative is considered.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
There is nothing in claim 4 that indicates and delineates, by way of specific combinations of substitutions, which of the peptides that fall within this very large and diverse genus achieve the claim 1 “activities” functions. Further, there is substantial breadth and diversity of possible peptide sequences given multiple alternatives in many positions – four or more amino acid alternatives in 12 positions – many amino acid alternatives at positions being different in physicochemical properties, such as for position 24, adjacent Trp-Leu (which may be a ‘core’ by applicant’s consideration) alanine, glutamine, cysteine, aspartic acid all having different properties, plus fewer alternatives at other positions, and upon review the examiner finds that the 102 species for which evaluations were conducted do not span the range of possible structural combinations for the genus of claim 4, nor for any of the claims depending from it.
This is a subgenus/genus situation with regard to structure/function relationship. Here the number of species of a subgenus having structure and activities set forth in Table 2 is not representative of the entire claimed genus, for claim 4, as well as for claims depending therefrom further limiting some amino acid alternatives, as far as possible variations in sequence and structure. There is a very large disparity between the species of the subgenus for which there is a structure/function relationship and the broader genus claimed. Considering the size of the General Formula 1 genus and variability at particular positions of the peptides per that formula, relative to the Table 2 species, there is an insufficient disclosure of species to represent the entire respective genera of the claims to demonstrate possession.
The importance of structure/function correlations has been highlighted by the courts (Abbvie Deutschland v. Janssen Biotech and Centorcor Biologics, App. No. 2013-1338, -1346 (Fed. Cir. , July 1, 2014)). The Abbvie case involved antibodies and written description. The court stated: “We have held that “a sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id. at 1350 (quoting Eli Lilly, 119 F.3d at 1568– 69).”. The courts then further stated: “With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus.” (emphasis added) and then state: " Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Ariad, 598 F.3d at 1351 (“[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011).
In the instant case, lacking readily understood structure/function relationships to activities, one could not visualize or recognize from the species for which there is data that applicant is in possession of the claimed genus with the activities as claimed.
Even considering the level of skill in the art at the time of filing the application, which is moderately high, and the state of the art including knowledge in the art, due to the above lack of sufficiently representative species demonstrating possession across the genera and subgenera claimed, and also considering the lack of high predictability when considering activities of multi-function peptides, and after having considered the amount of direction as well as the working examples, there is insufficient provision of functional characteristics coupled with a known or disclosed correlation between structure and function, and after full consideration including of respective claims’ scopes the examiner concludes that one of ordinary skill in the art would not recognize that applicant was in possession of the necessary common attributes or features of the claimed genera and subgenera in view of the species disclosed.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals Appellant hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Accordingly, claims 4, 5, 13, 14, 18, and 20-22 are rejected under this section.
Additionally, new claim 22 is also rejected on the basis of new matter. Applicant in the 7/2/25 Remarks states:
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Said para 0219 states:
[0219] The triple agonist having a significant level of activities to glucagon, GLP-1, and GIP receptors may exhibit in vitro activities of 0.1% or higher, 1% or higher, 2% or higher, 3% or higher, 4% or higher, 5% or higher, 6% or higher, 7% or higher, 8% or higher, 9% or higher, 10% or higher, 20% or higher, 30% or higher, 40% or higher, 50% or higher, 60% or higher, 70% or higher, 80% or higher, 90% or higher, and 100% or higher, to one or more receptors, specifically two or more receptors, and more specifically all three of the receptors among the glucagon, GLP-1, and GIP receptors, compared to native ligands of the corresponding receptors (native glucagon, native GLP-1, and native GIP), but is not particularly limited thereto.
There is no support for the use of “about” before and to modify “0.1”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 4, 13, 14, 18, 20, 21, 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claim(s) recite(s) a large genus which encompasses exendin-4, a 39 amino acid naturally occurring peptide, identified in the venom of a reptile, see below. This judicial exception is not integrated into a practical application because there is nothing more in the claims that indicate or demonstrate a markedly different characteristic relative to the naturally occurring peptide alone. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not add sufficient distinguishing limitations; the claims as a whole do not add more, any functional limitations/characteristics/properties are insufficient to result in a markedly different characteristic of what is claimed relative to the naturally occurring peptide by itself.
This rejection is based on the natural peptide identified in the art as exendin-4, which was identified in the venom of a reptile, so is a natural product. The sequence of this natural product is
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. See also Eng et al., J. Biol. Chem., 267(11) pp 7402-7405 (1992), copy provided.
The analysis is as follows.
Step 1: YES, claims 4, 13, 14, 18, 21, 22 are directed to a peptide genus that encompasses a natural product, exendin-4, and claim 20 to a pharmaceutical composition, the latter only requiring in substance the peptide according to claim 4 (with the preamble’s “for treating metabolic syndrome” having no material effect on the peptide of claim 4, merely reciting an intended use). So all claims are to one of the four statutory categories.
Step 2A Prong 1: YES, all of claims 4, 13, 14, 18, 20, 21, 22 comprise (encompass) a natural product, exendin-4, and as reasonably interpreted as to the activities required, there is not markedly different characteristic between the natural product exendin-4 peptide and what is claimed in claim 4.
Claim 4 states claims “A peptide having agonist activities to a glucagon receptor, a glucagon-like peptide-1 (GLP-1) receptor, and a glucose-dependent insultinotropic polypeptide (GIP) receptor,” where in the peptide comprises the amino acid sequence of General Formula 1. Exendin-4 is encompassed by that General Formula 1.
As to the stated activities in claim 4, see 35 USC 112b rejection above, the rejection in this section adopts the more extensive interpretation alternative, the first alternative.
As further support for claimed activities, Exendin-4 is known as a GLP-1 receptor agonist, see Hansotia et al., Clin Invest. 2007;117(1):143-152, Abstract, and from its Figure 6A on page 149 by visual comparison the exendin-4 result is very slightly higher than the PBS result, providing a result comparable to (or potentially greater than) what applicant asserts is activity when its data provides a “<0.1%” result. Also, Glucagon.com, 2015, copy provided, on its first page indicates that exendin-4 regulates glucagon secretion, suggesting a role as an agonist.
Step 2A Prong 2: NO, claims 4, 13, 14, 18, 20, 21, 22 do not recite additional elements that amount to significantly more than the judicial exception.
Step 2B, NO, there are no specifically stated additional limitations in claims 4, 13, 14, 18, 20, 21, 22 that amount to significantly more that the natural product judicial exception itself.
Based on the above analysis, claims 4, 13, 14, 18, 20, 21, 22 are rejected under this section.
Claim Rejections - 35 USC § 102
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 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.
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) 4, 5, 13, 14, 18, and 20-22 are rejected under 35 U.S.C. 102(a)(1) as anticipated by US 20110166062, inventors DiMarchi and Tao, published 7/7/2011 (“DT”).
Claim 4 is directed to a peptide stated to have three activities and falling within the vary large genus of claim 4’s General Formula 1.
DT teaches a peptide, identified as SEQ ID NO:60, that falls within General Formula 1:
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The single letter sequence is as follows: YXQGTFTSDY SIYLDEQAAK EFVCWLLAGG PSSGAPPPS.
DT, Abstract, teaches that its peptides are “Glucagon peptides that exhibit GIP agonist activity in addition to glucagon and/or GLP-I activity are provided,” so generally indicating that DT’s peptides include peptides that exhibit agonist activities with receptors of glucagon, GLP-1 and GIP.
As SEQ ID NO:60 specifically, based on Example 21, see pages 40-41, the peptide corresponding to SEQ ID NO:60, also identified as mt-158, clearly has activity at all three of Glucagon, GLP-1 and GIP receptors. Excerpts of Table 1 from page 41 follow:
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.
DT at para 513, page 42, states that “Based on these data, it was determined that Peptides mt-140, mt-147, mt-151, mt-152, mt-158, mt-164, mt-165, mt-166, mt-169, mt-170, mt-172, mt-175, and mt-179 were exemplary GLP-1/GIP/glucagon triagonist peptides, …”.
DT SEQ ID NO:60 therefore clearly meets all limitations of claim 4, and anticipates claim 4.
DT SEQ ID NO:60 comprises leucine at position 14 and aspartic acid at position 15, and therefore anticipates claim 5.
DT SEQ ID NO:60 comprises PSSGAPPPS immediately after the 30th amino acid of its sequence, this corresponding to claim 13’s PSSGAPPPS (SEQ ID NO:115) for R1, and therefore anticipates claim 13.
DT SEQ ID NO:60 comprises a lactam bridge between its positions 16 and 20, see above, and therefore anticipates claim 14.
DT para 512, the first para of Example 21, states “Peptides of SEQ ID NOs: 5-94 (each of which comprised an amide in place of the C-terminal carboxylate) were synthesized as essentially described above and tested in vitro for activity at the GIP receptor, GLP-1 receptor, and glucagon receptors by Example 16. The EC50 of each peptide are shown in Table 1.” Therefore DT SEQ ID NO:60 was amidated at its C-terminus when evaluated to be an exemplary ‘triple’ agonist, see para 513 referenced above, and DT SEQ ID NO:60 anticipates claim 18.
Regarding the claim 20 preamble’s “for treating metabolic syndrome” this preamble is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” after consideration and determination this statement regarding “no significance to claim construction” applies here for the intended use limitations of claims 20 and 21.
DT teaches that its peptides are in pharmaceutical compositions, Abstract, paras 441, 444, and at least given that per para 513, SEQ ID NO:60, corresponding to mt-158, is among a short list of “exemplary GLP-1/GIP/glucagon triagonist peptides,” a pharmaceutical composition comprising SEQ ID NO:60 is at once envisaged, claims 20 and 21 are rejected under this section as anticipated. Please also note that DT teaches its peptides for the same treatment uses encompassed by claim 20 and 21 intended use phrasing, see for example Title, paras 7, 455-460. To the extent the intended use phrases of claims 20 and 21 have weight, arguendo, DT’s SEQ ID NO:60 when considering these DT teachings is at once envisaged to treat these conditions, and claims 20 and 21 are anticipated.
DT SEQ ID NO:60 clearly anticipates claim 22 because its activities for the three receptors as demonstrated for claim 4 clearly and substantially are more than “about 0.1%”, so falling within the open-ended range of claim 22.
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.
Examination for nonstatutory double patenting expands beyond the second nonelected species.
Response to Arguments
Applicant's arguments filed 7/2/25 have been fully considered but they are not persuasive.
First, the examiner acknowledges the filing and approval for Terminal Disclaimers with respect to US 11332508, US 10370426, and US 10400020.
A new non-statutory double patent rejection is required, below, for a fourth issued US patent.
Regarding applicants arguments against provisional non-statutory rejections of record, the argument of these having ‘later in time’ filing dates is not persuasive under current practice following the existing MPEP procedures. Specific aspects regarding the provisional non-statutory rejections are set forth below.
Claims 4, 5, 13 and 20-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 8 of U.S. Patent No. US 9422349 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the genus and subgenera of the reference patent claims 1, 2 and 8 fall within the instantly claimed genera of claim 4, and would achieve the claim 4-required activities based on the first alternative set forth above in the 35 USC 112b rejection.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 9422349 (reference patent), as applied above to claim 4, in view of US 20110166062, inventors DiMarchi and Tao, published 7/7/2011 (“DT”).
Claim 4 is rejected above.
Reference patent claim 1 does not claim that per instant claim 18 the peptide’s C-terminus is amidated.
However, DT clearly teaches that the C-terminus is amidated for the peptides it evaluated and found very effective, see para 512, the first para of Example 21, which states “Peptides of SEQ ID NOs: 5-94 (each of which comprised an amide in place of the C-terminal carboxylate) were synthesized as essentially described above and tested in vitro for activity at the GIP receptor, GLP-1 receptor, and glucagon receptors by Example 16. The EC50 of each peptide are shown in Table 1,” and para 513, page 42, which states that “Based on these data, it was determined that Peptides mt-140, mt-147, mt-151, mt-152, mt-158, mt-164, mt-165, mt-166, mt-169, mt-170, mt-172, mt-175, and mt-179 were exemplary GLP-1/GIP/glucagon triagonist peptides, …”, triple agonists, as set forth in DT, referring to agonist activity at all of Glucagon, GLP-1 and GIP receptors. Given these results with C-terminus amidated peptides, there would have been a motivation to provide such amidation, as well as a reasonable expectation of success, so that claim 18 would have been obvious and is rejected under this section.
Claims 4, 5, 13, 14, and 20-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 10, 13 and 15 of U.S. Patent No. US 10981967 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the genus and subgenera of the reference patent claims 1, 3, and 4 fall within the instantly claimed genera of claim 4, and also anticipate instant dependent claims 5, 13, 14 and 20-22. Please also note that reference patent claims 11 and 12 track the intended use limitations of instant claims 20 and 21.
Claim 18 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10981967 (reference patent), as applied above to claim 4, in view of US 20110166062, inventors DiMarchi and Tao, published 7/7/2011 (“DT”).
Claim 4 is rejected above.
Reference patent claim 1 does not claim that per instant claim 18 the peptide’s C-terminus is amidated.
However, DT clearly teaches that the C-terminus is amidated for the peptides it evaluated and found very effective, see para 512, the first para of Example 21, which states “Peptides of SEQ ID NOs: 5-94 (each of which comprised an amide in place of the C-terminal carboxylate) were synthesized as essentially described above and tested in vitro for activity at the GIP receptor, GLP-1 receptor, and glucagon receptors by Example 16. The EC50 of each peptide are shown in Table 1,” and para 513, page 42, which states that “Based on these data, it was determined that Peptides mt-140, mt-147, mt-151, mt-152, mt-158, mt-164, mt-165, mt-166, mt-169, mt-170, mt-172, mt-175, and mt-179 were exemplary GLP-1/GIP/glucagon triagonist peptides, …”, triple agonists, as set forth in DT, referring to agonist activity at all of Glucagon, GLP-1 and GIP receptors. Given these results with C-terminus amidated peptides, there would have been a motivation to provide such amidation, as well as a reasonable expectation of success, so that claim 18 would have been obvious and is rejected under this section.
Claims 4, 5, 13, 14, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of copending Application No. 17414682 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because what the reference application claims are administered in its claims 1 and 3 read on the instantly claimed peptides. (see 7 page claim set of 7/3/25). Note that at least respective instant and reference SEQ ID Nos. 1, 2 and 21 are identical, so have the same properties, also meet instant claim 5’s limitations, and reference SEQ ID NO:21 meets instant claim 14’s ‘ring’ limitation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 18 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17414682 (reference application), as applied to claim 4 above, in view of US 20110166062, inventors DiMarchi and Tao, published 7/7/2011 (“DT”).
Claim 4 is rejected above.
Reference patent claim 1 does not claim that per instant claim 18 the peptide’s C-terminus is amidated.
However, DT clearly teaches that the C-terminus is amidated for the peptides it evaluated and found very effective, see para 512, the first para of Example 21, which states “Peptides of SEQ ID NOs: 5-94 (each of which comprised an amide in place of the C-terminal carboxylate) were synthesized as essentially described above and tested in vitro for activity at the GIP receptor, GLP-1 receptor, and glucagon receptors by Example 16. The EC50 of each peptide are shown in Table 1,” and para 513, page 42, which states that “Based on these data, it was determined that Peptides mt-140, mt-147, mt-151, mt-152, mt-158, mt-164, mt-165, mt-166, mt-169, mt-170, mt-172, mt-175, and mt-179 were exemplary GLP-1/GIP/glucagon triagonist peptides, …”, triple agonists, as set forth in DT, referring to agonist activity at all of Glucagon, GLP-1 and GIP receptors. Given these results with C-terminus amidated peptides, there would have been a motivation to provide such amidation, as well as a reasonable expectation of success, so that claim 18 would have been obvious and is rejected under this section.
This is a provisional nonstatutory double patenting rejection.
Claims 4, 5, 13, 14, 18 and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 23, 24, 25, and 30 of copending Application No. 17416880 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other at least because reference application SEQ ID NO:42, recited and/or encompassed in the indicated claims, is identical with instant SEQ ID NO:42, so falls within the breadth of instant claim 4, and also instant claim 5 based on Leu at position 14 and Asp at position 15, and instant claim 13 based on its C-terminus subsequence corresponding to SEQ ID NO:117 of instant claim 13. Reference application claim 24 corresponds to instant claim 14, and reference application claim 25 corresponds to instant claim 18. Instant claims 20-22 are also rejected over reference application claim 1 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application recited ‘triple agonist’ peptides in reference claim 1 have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4, 5, 13, 14, 18, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6 of copending Application No. 17792228 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 claims the same peptides evaluated in Table 2 of the instant application, these encompassed by instant claim 4 General Formula 1, and per statements in the application as filed having the claimed three agonist activities. These 102 sequences of reference application claim 1 include those with the instant claim 5 further limitations for positions 14 and 15, and also clearly meet instant claim 13. Reference application claim 6 corresponds to instant claim 14, and reference application claim 3 corresponds to instant claim 18. Instant claims 20-22 are also rejected over reference application claim 1 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application recited ‘triple agonist’ peptides in reference claim 1 have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection, as well as based on statements in the instant specification to such activities for the Table 2 peptides, which are the same peptides.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4, 5, 13, 14, 18, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 17917846 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims, including claim 1 with identical or substantially overlapping limitations and genus, clearly make obvious all of the instant claims under examination. Reference application claim 11 recites all but one of the sequences of instant Table 2, which are encompassed in instant claims 4 and 5 (in part), also making obvious instant claim 13. Reference application claim 12 corresponds to instant claim 14, Reference application claim 13 corresponds to instant claim 18. Instant claims 20-22 are also rejected over reference application claim 1 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application recited ‘triple agonist’ peptides in reference claim 1 have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection, as well as based on statements in the instant specification to such activities for the Table 2 peptides, which are the same peptides.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4, 5, 13, 14, 18, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7 of copending Application No. 18028424 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 claims in its method administering the same peptides evaluated in Table 2 of the instant application, these encompassed by instant claim 4 General Formula 1, and per statements in the application as filed having the claimed three agonist activities. These 102 sequences of reference application claim 1 include those with the instant claim 5 further limitations for positions 14 and 15, and also clearly meet instant claim 13. Reference application claim 7 corresponds to instant claim 14, and reference application claim 3 corresponds to instant claim 18. Instant claims 20-22 are also rejected over reference application claim 1 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application recited ‘triple agonist’ peptides in reference claim 1 have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection, as well as based on statements in the instant specification to such activities for the Table 2 peptides, which are the same peptides.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4, 5, 13, 14, 18, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7 of copending Application No. 18028348 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 claims in its method administering the same peptides evaluated in Table 2 of the instant application, these encompassed by instant claim 4 General Formula 1, and per statements in the application as filed having the claimed three agonist activities. These 102 sequences of reference application claim 1 include those with the instant claim 5 further limitations for positions 14 and 15, and also clearly meet instant claim 13. Reference application claim 7 corresponds to instant claim 14, and reference application claim 3 corresponds to instant claim 18. Instant claims 20-22 are also rejected over reference application claim 1 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application recited ‘triple agonist’ peptides in reference claim 1 have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection, as well as based on statements in the instant specification to such activities for the Table 2 peptides, which are the same peptides.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4, 5, 13, 14, 18, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-33 of copending Application No. 18250150 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 24 claims peptides, such as its SEQ ID NO:1, that are encompassed within the instant application claim 4’s General Formula 1 and because reference application claim 24 specifically states its peptide(s) having the same agonist activities as claimed in instant claim 4. At least SEQ ID NO:1 of reference application claim 24 also meets the claim 5 further limitations for positions 14 and 15, and also clearly meets instant claim 13. Reference application claim 32 corresponds to instant claim 14, and reference application claim 33 corresponds to instant claim 18. Instant claims 20-22 are also rejected over reference application claim 1 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application recited ‘triple agonist’ peptides in reference claim 24 have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4, 5, 13, 14, 18, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 14-18 of copending Application No. 18032076 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 12 claims in its method administering the same peptides evaluated in Table 2 of the instant application, these encompassed by instant claim 4 General Formula 1, and per statements in the application as filed having the claimed three agonist activities. These 102 sequences of reference application claim 1 include those with the instant claim 5 further limitations for positions 14 and 15, and also clearly meet instant claim 13. Reference application claim 18 is directed to a narrower scope of peptides encompassed by instant claim 14 that also form the required ring, so making instant claim 14 obvious (narrower subgenus anticipating a broader genus), and reference application claim 14 corresponds to instant claim 18. Instant claims 20-22 are also rejected over reference application claim 1 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application recited peptides of its claim 12 have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection, as well as based on statements in the instant specification to such activities for the Table 2 peptides, which are the same peptides.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4, 5, 13, 14, 18, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7 of copending Application No. 18031940 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 claims the same 102 peptides evaluated in Table 2 of the instant application, these encompassed by instant claim 4 General Formula 1, and per statements in the application as filed having the claimed three agonist activities (and/or applying the first alternative interpretation of the above 35 USC 112b rejection). These 102 sequences of reference application claim 1 include those with the instant claim 5 further limitations for positions 14 and 15, and also clearly meet instant claim 13. Reference application claim 7 corresponds to instant claim 14, and reference application claim 3 corresponds to instant claim 18. Instant claims 20-22 are also rejected over reference application claim 1 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application claim 1 102 peptides have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection, as well as based on statements in the instant specification to such activities for the Table 2 peptides, which are the same peptides.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4, 5, 13, 14, 18, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27, 32, 33 of copending Application No. 18041151 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 27 claims in its method administering the same peptides evaluated in Table 2 of the instant application, these encompassed by instant claim 4 General Formula 1, and per statements in the application as filed having the claimed three agonist activities. These 102 sequences of reference application claim 27 include those with the instant claim 5 further limitations for positions 14 and 15, and also clearly meet instant claim 13. Reference application claim 33 makes obvious instant claim 14’s ring forming at least given the particular sequences within its SEQ ID Nos. 1 to 102 that are indicated in the sequence listing to form rings between amino acids 16 and 20, and reference application claim 32 corresponds to instant claim 18. Instant claims 20-22 are also rejected over reference application claim 1 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application recited peptides of its claim 27 have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection, as well as based on statements in the instant specification to such activities for the Table 2 peptides, which are the same peptides, and also based on the data in the reference application table that is identical in results as the instant application Table 2.
Claims 4, 5, 13, 14, 18, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-9 of copending Application No. 18565628 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 claims in its method administering the same peptides evaluated in Table 2 of the instant application, these encompassed by instant claim 4 General Formula 1, and per statements in the application as filed having the claimed three agonist activities. These 102 sequences of reference application claim 1 include those with the instant claim 5 further limitations for positions 14 and 15, and also clearly meet instant claim 13. Reference application claim 9 makes obvious instant claim 14’s ring forming at least given the particular sequences within its SEQ ID Nos. 1 to 102 that are indicated in the sequence listing to form rings between amino acids 16 and 20, and reference application claim 8 corresponds to instant claim 18. Instant claims 20-22 are also rejected over reference application claim 1 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application recited peptides of its claim 1 have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection, as well as based on statements in the instant specification to such activities for the Table 2 peptides, which are the same peptides, and also based on the data in the reference application table that is identical in results as the instant application Table 2.
Claims 4, 5, 13, 14, 18, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7 of copending Application No. 18028420 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 claims in its method administering the same peptides evaluated in Table 2 of the instant application, these encompassed by instant claim 4 General Formula 1, and per statements in the application as filed having the claimed three agonist activities. These 102 sequences of reference application claim 1 include those with the instant claim 5 further limitations for positions 14 and 15, and also clearly meet instant claim 13. Reference application claim 7 corresponds to instant claim 14, and reference application claim 3 corresponds to instant claim 18. Instant claims 20-22 are also rejected over reference application claim 1 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application recited peptides of its claim 1 have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection, as well as based on statements in the instant specification to such activities for the Table 2 peptides, which are the same peptides, and also based on the data in the reference application table that is identical in results as the instant application Table 2.
Claims 4, 5, 13, 14, 18, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5 and 6 of copending Application No. 18016145 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 claims in its method administering the same peptides encompassed by instant claim 4 General Formula 1, and reference claim 1 refers to these as triple agonists. These limitations of reference claims 1 and 2 meet instant claims 5 and 13. Reference application claim 5 corresponds to instant claim 14, and reference application claim 6 corresponds to instant claim 18. Instant claims 20-22 are also rejected over reference application claim 1 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application recited peptides of its claim 1 have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection, as well as based on statements in the instant specification to such activities for the Table 2 peptides, which are the same peptides, and also based on the data in the reference application table that is identical in results as the instant application Table 2.
Claims 4, 5, 13, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18031958 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 claims in its method administering the same peptides evaluated in Table 2 of the instant application, these encompassed by instant claim 4 General Formula 1, and per statements in the application as filed having the claimed three agonist activities. These 102 sequences of reference application claim 1 include those with the instant claim 5 further limitations for positions 14 and 15, and also clearly meet instant claim 13. Instant claims 20-22 are also rejected over reference application claim 1 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application recited peptides of its claim 1 have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection, as well as based on statements in the instant specification to such activities for the Table 2 peptides, which are the same peptides, and also based on the data in the reference application table that is identical in results as the instant application Table 2.
Claims 4, 5, 13, 14, 18, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 22-25 of copending Application No. 18723182 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 23 claims in its method administering the same peptides evaluated in Table 2 of the instant application, these encompassed by instant claim 4 General Formula 1, and per statements in the application as filed having the claimed three agonist activities. These 102 sequences of reference application claim 23 include those with the instant claim 5 further limitations for positions 14 and 15, and also clearly meet instant claim 13. Reference application claim 24 corresponds to instant claim 14, and reference application claim 26, which depends from claim 22, makes obvious instant claim 18, see also claim 25. Instant claims 20-22 are also rejected over reference application claim 1 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application recited peptides of its claim 23 have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection, as well as based on statements in the instant specification to such activities for the Table 2 peptides, which are the same peptides, and also based on the data in the reference application table that is identical in results as the instant application Table 2.
Claims 4, 5, 13, 14, 18, and 20-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8 and 9 of copending Application No. 18285753 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claims 1-5 claim subgenera comprising the same peptides encompassed by instant claim 4 General Formula 1, and these would necessarily include those having the claimed activities limitations. The peptides of reference claims 1-5 include and so meet instant claims 5 and 13. Reference application claim 9 corresponds to instant claim 14, and reference application claim 8 corresponds to instant claim 18. Instant claims 20-22 are also rejected over reference application claims 1-5 because for claims 20 and 21 the claim 20’s preamble “for preventing or treating metabolic syndrome” is interpreted as intended use, see MPEP 2111.02 II, which includes the statement, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction,” so that after consideration and determination this applies here for claims 20 and 21, and as to claim 22 because the reference application recited peptides of its claim 1 have the required activity at least based on the first of the three alternative interpretations set forth for claim 4 in the above 35 USC 112b rejection, as well as based on statements in the instant specification to such activities for the Table 2 peptides at least some of which are encompassed in reference claims 1-5.
Conclusion
No claim is allowed.
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/JOSEPH FISCHER/Examiner, Art Unit 1658
1 At least because the alternatives to position 30, which could be absent, were not included in the calculation.