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 .
Claim Status
Claims 1-20 are pending as filed 6/17/2026. Claims 10-20 are withdrawn as directed to a non-elected invention.
Election/Restrictions
Applicant’s election of the species of method set forth at Example 1, Table 1, Group 6, in the reply filed on 6/17/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The originally elected species of method is understood to be Example 1 (“Effects of insulin glargine and beinaglutide on blood glucose in db/db mice”), and specifically the species of Table 1 and Group 6, wherein insulin glargine (“IGla”) was subcutaneously administered at 60 U/kg, and beinaglutide (“bei”, instant SEQ ID NO: 1; His-Ala-Glu-Gly-Thr-Phe-Thr- Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys-Glu-Phe-Ile-Ala-Trp-Leu-Val-Lys-Gly-Arg; or HAEGTFTSDVSSYLEGQAAKEFIAWLVKGR) was subcutaneously administered to mice at 0.6 mg/kg, and blood glucose levels were subsequently monitored, wherein the ratio of IGa (U): Bei(mg) is 60:0.6 or 100 U:1 mg (see, e.g., Spec. filed 7/18/2022 at Example 1 at ¶¶[0034]-[0041]).
The originally elected species is understood to read upon instant claims 1-9.
Following extensive search and examination, the originally elected species has been deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III)(A),
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious...
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
Accordingly, claims 1-9 are rejected in view of the originally elected species and claims that do not read upon the originally elected species are withdrawn.
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/17/2026.
Claims 1-9 are presently considered.
Priority
The priority claim to PCT/CN2021/072268 (filed 1/15/2021) is acknowledged.
Information Disclosure Statement
The IDS filed 11/17/2023 and 12/04/2025 are each acknowledged and presently considered.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claim 1 is representative of the pending claim scope and presently recites:
Claim 1. A method of treating a condition associated with elevated blood glucose in a subject comprising administering a first effective amount of one or more first active ingredients selected from the group consisting of GLP-1 and GLP-1 analogs and a second effective amount of one or more second active ingredients selected from the group consisting of insulin and insulin analogs to a subject to treat the condition.
Accordingly, the claims are directed to methods requiring administration of (i) an effective amount of at least one GLP-1 or GLP-1 analog, and (ii) an effective amount of at least one insulin or insulin analog. Additional claim interpretations are set forth below.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
“Treating” is interpreted consistent with the instant disclosure, and understood to mean “alleviating the condition partially or entirely, decreasing the likelihood of occurrence or recurrence of the condition, slowing the progression or development of the condition, or eliminating, reducing, or slowing the development of one or more symptoms associated with the condition” (see, e.g., Spec. filed 7/18/2022 at ¶[0022]).
Claim 1 recites a genus of functionally defined conditions, namely any “condition associated with elevated blood glucose in a subject”, but no exhaustive list of conditions covered by claim 1 is provided in the originally filed disclosure. For purposes of examination, claim 1 is understood to cover at least the treatment of patient that have, or are at risk of having, type 1 or type 2 diabetes.
The term “effective amount” is functionally defined (see, e.g., Spec. filed 7/18/2022 at ¶[0021]). It is understood to read upon any prior art concentrations that show any measurable therapeutic benefit.
Claim 1 recites “one or more”, and is therefore understood to read upon a minimum of two administered compounds (e.g., at least one GLP-1 or GLP-1 analog, and at least one insulin or insulin analog), but an unlimited maximum.
“GLP-1 and GLP-1 analogs” is understood to include GLP-1(7-37), GLP-1(7-36), and GLP-1(7-35), which correspond to SEQ ID NOs: 3, 1, and 2, respectively (see, e.g., Spec. filed 7/18/2022 at ¶[0025]). For purposes of examination, “Beinaglutide” is understood to have the sequence HAEGTFTSDVSSYLEGQAAKEFIAWLVKGR (see id).
“Insulin and insulin analogs” is understood to include at least insulin lispro, insulin aspart, insulin glulisine, insuling glargine, insulin degludec, and insulin determir (see, e.g., Spec. filed 7/18/2022 at ¶[0027]).
Claims 4-5 and 8 recite “about”, which is not defined on record. The term “about” is given its ordinary meaning in view of the biochemical arts; however, no set meaning exists. More specifically “‘about’ can mean within 1 or more than 1 standard deviations” (see US 2012/0178676 at ¶[0277]); “about” can mean “within an order of magnitude” or “within 5-fold” of a value (see US 20130261065 at ¶[0031]); and can also mean “within 20 percent” (see, e.g., US 2009/0028832 A1 at ¶[0111]; see also US 2009/0105341 A1 at ¶[0049]). Accordingly, the metes and bounds of “about” in the instant usage is unspecified. For purposes of applying prior art, the term is understood to mean ±20% of a stated value.
At claim 9, the term “beinaglutide” is also known in the prior art as “benaglutide”1.
Additional claim interpretations are set forth below.
Objections to the Specification
Sequence Listing: The instant disclosure is objected to for not complying with 37 C.F.R. 1.821 as detailed in MPEP §§ 2421–2424. Specifically, the instant application does not comply with 37 C.F.R. 1.821(b)-(e). The instant claims and/or disclosure contain references or disclosures of amino acid sequences that should be accompanied by a sequence listing and identified using "SEQ ID NOs” as prescribed (see, MPEP §§ 2421–2424). Specifically, the instant application discloses at least SEQ ID NOs: 1-3 (see, e.g., Spec. filed 7/18/2022 at ¶[0025], [0036], [0044]), but no sequence listing has been placed on record.
Appropriate correction is required.
Claim Objections
Claims 4-5 and 8 are objected to because of the following informalities:
At claim 4 at line 4, the claim recites the typographical error “500:1m”, which should be “500:1,”.
Claim 4 is objected to because it contains redundant and superfluous language that fails to meaningfully limit the pending claim scope. Specifically, claim 4 recites
…a ratio of between 10:1 and 800:1, about 30:1 to about 500:1m[SIC] about 50:1 to about 250:1, about 70:1 to about 220:1, or about 100:1 to about 200:1, about 10:1, about 20:1, about 30:1, about 40:1, about 50:1, about 60:1, about 60:1, about 70:1, about 80:1, about 90:1, about 100:1, about 150:1, about 200:1, about 250:1, about 300:1, about 350:1, about 400:1, about 450:1, about 500: 1, about 550: 1, about 600: 1, about 650: 1, about 700: 1, about 750: 1, or about 800: 1.
However, the recitations of narrower ranges within a broader range recited within the same claim, are superfluous and non-limiting because all prior art that satisfies the broader range or narrower range will necessarily satisfy the broader range and therefore satisfy the claimed limitations. Redundant and superfluous language should be removed to enhance claim clarity and to minimize potential confusion. Examiner suggests the following amendments
…a ratio of between about 10:1 and about 800:1,
The proposed amendments clarify the scope of claim 4 by removing superfluous and non-limiting langauge from the claim.
Claim 5 is objected to because it contains redundant and superfluous language that fails to meaningfully limit the pending claim scope. Specifically, claim 5 recites
…in a range from about 2 U/d to about 100 U/d, about 6 U/d to about 60 U/d, about 12 U/d to about 40 U/d, about 20 U/d to about 30 U/d, or about 15 U/d.
However, the recitations of narrower ranges within a broader range recited within the same claim, are superfluous and non-limiting because all prior art that satisfies the broader range or narrower range will necessarily satisfy the broader range and therefore satisfy the claimed limitations. Redundant and superfluous language should be removed to enhance claim clarity and to minimize potential confusion. Examiner suggests the following amendments
…in a range from about 2 U/d to about 100 U/d
The proposed amendments clarify the scope of claim 4 by removing superfluous and non-limiting langauge from the claim.
Claim 8 is objected to because it contains redundant and superfluous language that fails to meaningfully limit the pending claim scope. Specifically, claim 8 recites
a daily dosage of about 0.01 mg/d to about 1 mg/d, about 0.06 mg/d to 0.6 mg/d, or about 0.12 mg/d to about 0.4 mg/d.
However, the recitations of narrower ranges within a broader range recited within the same claim, are superfluous and non-limiting because all prior art that satisfies the broader range or narrower range will necessarily satisfy the broader range and therefore satisfy the claimed limitations. Redundant and superfluous language should be removed to enhance claim clarity and to minimize potential confusion. Examiner suggests the following amendments
a daily dosage of about 0.01 mg/d to about 1 mg/d
The proposed amendments clarify the scope of claim 4 by removing superfluous and non-limiting langauge from the claim.
Appropriate corrections are required.
Drawings
The drawings are objected to because Figures 5A-G are not fully legible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 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 1 attempts to capture a genus of unknown diseases and conditions by describing the genus functionally, as any “condition associated with elevated blood glucose in a subject”, which renders the pending claim scope indefinite because it does not correspond with a structure/function relationship or otherwise correspond to any art-defined and art-recognized list of diseases. Per MPEP § 2173.05(g),
[T]he use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, 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. . .
Here, the claim merely recites a functional description of conditions to be treated, without a clear-cut indication of the scope of the subject matter embraced by the claim. Here, the conditions included or excluded by the functional description appear on nuanced meanings of “condition”, “associated with” and “elevated blood glucose”. While it is reasonable in view of the disclose and claim 2 that the claim scope is intended to encompass patients having or at risk of having type 1 or type 2 diabetes, it is uncertain if claim 1 includes the condition of normal human consumption of food (i.e., eating a meal elevates blood glucose, naturally), endocrine tumor syndromes, pheochromocytoma, Cushing’s syndrome, acromegaly, obesity, etc. Stated alternatively, what exactly constitutes “condition”, “associated with” and “elevated blood glucose” 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. Accordingly, whether or not the claim scope includes or excludes “normal eating of a meal” depends arbitrarily upon what an artisan considers a “condition”, what level of association is implied by “associated with”, and what levels of glucose constitute “elevated blood glucose”, which impacts the metes and bounds of the functional limitation and thereby alters the pending claim scope. Accordingly, the claim is rejected as indefinite. For purposes of applying prior art, claim 1 is understood to be directed to a method of treating subjects having or at risk of having diabetes.
Regarding claim 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 1-2 and the word “elevated” as used in “elevated blood glucose” and “elevated risk”, the term “elevated” is a relative term which renders the claim indefinite. The term “elevated” 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 if “elevated” means “elevated to a statistically and practically significant extent”, 1% over basal level, 10% over basal level, 7-fold more than average, etc., etc. Accordingly, claims 1-2 are rejected as indefinite.
Claims 2-9 depend from the indefinite base claim 1, but fail to reconcile the indefiniteness of the base claim, and are therefore rejected as indefinite for reasons applied to claim 1.
Accordingly, claims 1-9 are rejected as indefinite.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected 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.
Claim 7 depends from instant claim 1. Claim 1 necessarily and inherently requires that the administered GLP-1 and/or GLP-1 analog compounds be administered “before, during, or after” the administration of the insulin and/or insulin analog compounds, because these three options cover all possible timeframes. Rather than further limit the scope of claim 1 by narrowing the timeframes of administration, claim 7 merely reiterates all possible options, and thereby covers all possible timeframes already encompassed inherently and implicitly by claim 1. Accordingly, claim 7 only explicitly recites the implicitly present scope of claim 1. Therefore, claim 7 is rejected for failing to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
[Prior Art Rejection 01]
Claims 1-3 and 7 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US2014/0120120A1.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 1-2 and 7, US’120 teaches, discloses, and claims methods of treating any type of diabetes by administering a composition comprising an insulinotropic peptide such as GLP-1 (see, e.g., US’120 at claims 1, 5, 16-18), and an insulin conjugate (e.g., an “insulin analog”) (see, e.g., US’120 at claims 1-3, 16-18). Regarding instant claim 3 and GLP-1(7-37), US’120 identifies that GLP-1 is understood to include GLP-1(7-37), which is identified as being the activated form of GLP-1 (see, e.g., US’120 at ¶[0040]). Accordingly, an artisan would at once envisage the usage of GLP-1(7-37) as an insulinotropic peptide in the claimed methods (see, e.g., US’120 at claims 1, 5, 16-18). Regarding instant claims 1 and 7, and administration before, during, or after, US’120 identifies that the GLP-1 and insulin analog may be administered simultaneously, sequentially, or reversely (see, e.g., US’120 at claim 18).
Accordingly, instant claims 1-3 and 7 are anticipated by the prior art.
[Prior Art Rejection 02]
Claims 1-3 and 7 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by WO03/020201A2 (March 13, 2003; cited in IDS filed 11/17/2023 as Cite No. 4).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
WO’201 discloses that the usage of GLP-1 compounds and insulin together provides advantages, and identifies that the GLP-1 “normalizes meal-related blood glucose excursions without the risk of hypoglycemia”, and that the insulin “functions to control fasting blood glucose levels especially during bedtime hours” (see, e.g., WO’201 at 2 at lines 20-30), and generally discloses methods of treating diabetes and related conditions (see, e.g., WO’201 at 3 at lines 26-30). Regarding instant claims 1-2 and the treatment of any form of diabetes or related diseases, WO’201 explicitly claims methods of treating insulin-dependent and non-insulin dependent diabetes, hyperglycemia, obesity, etc. by administering a composition comprising both a “GLP-1 compound” and a “basal insulin” (see, e.g., WO’201 at claims 1-2, 5, and 20-23; see also WO’201 at 12 at line 26 to page 13 at line 8). Regarding instant claim 1 and “insulin and insulin analogs”, WO’201 identifies that “basal insulin” would be understood and at once envisioned as including insulin glargine (see, e.g., WO’201 at 6 at lines 9-15; “insulin glargine” is also referred to as “Lantus®” by WO’201 per p. 6 at lines 26-28). Regarding instant claims 1 and 3 and GLP-1(7-37), WO’201 identifies that “GLP-1” is used to include GLP-1 analogs and GLP-1 fragments, and derivatives thereof, including GLP-1(7-37) and GLP-1(7-36) (see, e.g., WO’201 at claims 1-4; see also id. at 14 at lines 1-14; see also id. at 14 at line 24 to page 15 at line 29). Regarding instant claim 1 and the ratio of GLP-1 to basal insulin utilized, WO’201 provides explicit guidance regarding formulation ratios (see, e.g., WO’201 at 7 at lines 15-30 and p. 8 at lines 1-5, 36 at lines 1-20), and exemplifies multiple ratios (see, e.g., WO’201 at Example 10 at page 48 at line 2 to page 50 at line 11, disclosing in vivo testing). Regarding instant claims 1, 7, and the administration of a GLP-1 compound during administration of an insulin or insulin analog, WO’201 teaches, claims, and discloses the treatment of diabetes by administering a pre-mixed formulation comprising both a GLP-1 compound and an insulin compound, and therefore such methods would necessarily and inherently result in administration of both compounds simultaneously (e.g., the GLP-1 and/or GLP-1 analog is administered “during” administration of the insulin and/or insulin analog) (see, e.g., WO’201 at claims 1-2, 5, and 20-23).
Accordingly, instant claims 1-3 and 7 are anticipated by the prior art.
[Prior Art Rejection 03]
Claims 1-2 and 4-8 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by CA2740685 (Apr. 4, 2010).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 1-2, 7, and the treatment of diabetes or a diabetes related condition by administering both a GLP-1 compound and an insulin compound, CA’685 teaches and discloses the GLP-1 compound of AVE00102 in combination with the insulin compound of insulin glargine, which is formulated together and then subcutaneously administered to diabetic mice (i.e., simultaneous administration) (see, e.g., CA’685 at Examples 7-8 at pages 39 line 12 to page 40 at line 21), wherein the treatment was identified as effective (see, e.g., id.; see also id. at Fig. 7). Regarding instant claim 4 and a ratio of U:mg for an insulin compound and the GLP-1 compound, CA’685 reduces to practice methods wherein insulin glargine and the GLP-1 compound of AVE00103 are provided in a premixed ratio of 10 µg/kg of AVE0010 with 5 U/kg of insulin glargine (see, e.g., CA’685 at Examples 7-8 at pages 39 line 12 to page 40 at line 21). Per 1 kg, the ratio is therefore 5U:10µg, or 5 U: 0.01 mg, which is a ratio of 500:1, which falls within the range recited at claim 4. Regarding instant claim 5 and the ranges of GLP-1 compound per mg/kg, CA’685 reduces to practice methods wherein insulin glargine and the GLP-1 compound of AVE00104 are provided in a premixed ratio of 10 µg/kg of AVE0010 with 5 U/kg of insulin glargine (see, e.g., CA’685 at Examples 7-8 at pages 39 line 12 to page 40 at line 21). Accordingly, CA’685 exemplifies an embodiment wherein the GLP-1 is present at 0.01 mg/kg, which is within the range recited and required by instant claim 5. Regarding claim 6 and administration once per day, Example 7-8 are understood to disclose a single injection that took place on a single day, and is therefore understood to be a once per day injection, and therefore an artisan would readily appreciate and at once envision that such experiments represented once daily treatment regimens (see, e.g., CA’685 at Examples 7-8 at pages 39 line 12 to page 40 at line 21, Fig. 7; see also id. at 8 at lines 1-2, noting that administration should be once daily). Regarding claim 7, Example 7-8 are understood to illustrate co-administration, wherein each compound is administered simultaneously (i.e., during administration of the other compound) (see, e.g., CA’685 at Examples 7-8 at pages 39 line 12 to page 40 at line 21, Fig. 7). Regarding instant claim 8, CA’685 reduces to practice methods wherein insulin glargine and the GLP-1 compound of AVE00105 are provided in a premixed ratio of 10 µg/kg of AVE0010 with 5 U/kg of insulin glargine within a single day (see, e.g., CA’685 at Examples 7-8 at pages 39 line 12 to page 40 at line 21). Accordingly, CA’685 exemplifies an embodiment wherein the GLP-1 is present at 0.01 mg/kg per day, which is within the range of “about 0.01 mg/d” as required by claim 8 since “about” is not defined. Alternatively, CA’685 also exemplifies Example 1, wherein ~15 kg beagles were subcutaneously injected with AVE0010/insulin glargine combination at 0.01 mg/kg AVE0010 and 0.3 U/kg insulin glargine (see, e.g., CA’685 at Examples 1 at page 35 line 1 to line 26), which is a 1 mg:300 U ratio, wherein 0.15 mg/d of the GLP-1 compound of AVE0010 was administered, which is within the range claimed (see id).
Accordingly, instant claims 1-2 and 4-8 are anticipated by the prior art.
[Prior Art Rejection 04]
Claims 1-3 and 6-7 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US20060057137A1 (Mar. 16, 2006).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 1-2 and 6-7, US’137 claims methods of treating diabetes and related diseases (see, e.g., US’137 at claim 1, 36-39), by administering a GLP-1 compound (see, e.g., US’137 at claims 1, 20-23) in combination with an anti-diabetic drug, such as an insulin (see, e.g., US’137 at claims 1, 24-30), wherein administration may be “about twice daily (i.v. or subQ)” (see, e.g., US’137 at claim 13), and wherein administration of the GLP-1 compound and insulin may occur at different times (see, e.g., US’137 at claim 27). Accordingly, in view of the claimed invention, an artisan would at once envisage methods of treating diabetes and related drugs by twice daily administration of a GLP-1 compound and an insulin compound, that may be administered together or at a different time. Regarding instant claim 3, US’137 explicitly identifies that a GLP-1 compound may include species such as GLP-1(7-35), GLP-1(7-36), and GLP-1(7-37) (see, e.g., US’137 at ¶¶[0041]-[0043]), and therefore an artisan would at once envisage the practice of the claimed method specifically utilizing any one of (or all) GLP-1(7-35), GLP-1(7-36), and GLP-1(7-37).
Accordingly, instant claims 1-3 and 6-7 are anticipated by the prior art.
[Prior Art Rejection 05]
Claims 1-3 and 6-7 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US20090088369A1 (Apr. 2, 2009).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 1-2, US’369 claims methods of treating diabetes by administering an analog of GLP-1 (see, e.g., US’369 at claims 1-2) and an anti-diabetic drug such as insulin or an insulin analog (see, e.g., US’369 at claims 1, 6-8). Regarding instant claim 3, US’369 claims methods of treating diabetes by administering an analog of GLP-1 (see, e.g., US’369 at claims 1-2), wherein GLP-1 analog is explicitly defined as including GLP-1(7-35) and GLP-1(7-36) (see, e.g., US’369 at claims 1-2, ¶[0044]), and therefor an artisan would at once envisage practicing such methods by utilizing either GLP-1(7-35) and GLP-1(7-36). Regarding instant claim 6 and administration timing, US’369 explicitly directs artisans to utilize once or twice daily administration (see, e.g., US’369 at ¶¶[0051], [0065]), and therefore an artisan would readily envisage such methods practiced by administering the claimed compounds once or twice daily. Regarding instant claim 7 and the administration timing of insulin compounds relative to GLP-1 compounds, US’369 explicitly identifies that the claimed and described methods may be practiced using a combined or “cocktail” approach (see, e.g., US’369 at ¶¶[0109]), and therefore an artisan would at once envisage administering insulin compounds and GLP-1 compounds together (e.g., “during administration” as recited at instant claim 7).
Accordingly, claims 1-3 and 6-7 are anticipated.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
[Prior Art Rejection 06]
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over WO03/020201A2 (March 13, 2003; cited in IDS filed 11/17/2023 as Cite No. 4) as applied to claims 1-3 and 7 above.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
The teachings of WO’201 as applied to claims 1-3 and 7 have been discussed above, and those teachings are incorporated into the instant rejection.
The teachings of WO’201 differ from the specific embodiments encompassed by claim 1 as recited at dependent claims 4-6 and 8 as follows: WO’201 does not reduce to practice treatment methods wherein the ratios and dosing frequencies recites at claims 4-6 and 8 are explicitly reduced to practice.
However, regarding instant claims 4, 6, and the ratios of GLP-1 compounds and insulin compounds administered daily, WO’201 provides guidance regarding ratios and daily dosages of insulin compounds and GLP-1 compounds (see, e.g., WO’201 at 7 at lines 15-30 and p. 8 at lines 1-5, 36 at lines 1-20). WO’201 identifies that the GLP-1 compound is formulated such that “about 0.1 to about 5 mg of GLP-1 compound will be administered per day” and that the basal insulin is formulated such that “about 0.01 to about 1 U/kg of basal insulin will be administered per day” (see, e.g., WO’201 at 7 at lines 15-30 and p. 8 at lines 1-5). Here, a normal adult patient would reasonably weigh between 50 to over 100 kg, and therefore for purposes of analysis and consideration a weight of 70 kg is used. Per WO’201, a 70 kg patient would be administered, per day, a GLP-1 compound would be administered “more preferably” at “0.5 to about 2 mg/day of GLP-1 compound” and “about” 0.7 to about 70 U of a basal insulin per day (see, e.g., WO’201 at 7 at lines 15-30 and p. 8 at lines 1-5). This is pertinent because pre-mixed dosages would therefore correspond to a ratio of U:mg of 0.7:2 to 70:0.5, or the range of about 1:2.86 to 140:1, where overlaps in scope with the instantly claimed range (compare id. with instant claims 4 and 6, noting that 140:1 is within the range of “10:1 to 800:1”; see MPEP § 2144.05(I), noting that “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”).
Regarding instant claim 5 and the daily administration of insulin compounds and the amount of GLP-1 compounds administered per kg, WO’201 identifies that the GLP-1 compound is formulated such that “about 0.1 to about 5 mg of GLP-1 compound will be administered per day” and that the basal insulin is formulated such that “about 0.01 to about 1 U/kg of basal insulin will be administered per day” (see, e.g., WO’201 at 7 at lines 15-30 and p. 8 at lines 1-5). Here, a normal adult patient would reasonably weigh between 50 to over 100 kg, and therefore for purposes of analysis and consideration a weight of 70 kg is used. Accordingly, for a hypothetical 70kg adult, WO’201 directs artisans to utilize a GLP-1 compound range of 0.0014 mg/kg to 0.0714 mg/kg, and a daily amount of insulin compound from 0.7 U/d to 70 U/d (see, e.g., WO’201 at 7 at lines 15-30 and p. 8 at lines 1-5), which overlaps in scope with the instantly claimed ranges (see MPEP § 2144.05(I), noting that “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”).
Regarding instant claim 8 and the daily administration of GLP-1 compounds administered per day, WO’201 identifies that the GLP-1 compound is formulated such that “about 0.1 to about 5 mg of GLP-1 compound will be administered per day” (see, e.g., WO’201 at 7 at lines 15-30 and p. 8 at lines 1-5), wherein the more preferably amount is “0.5 to about 2 mg/day of GLP-1 compound” (see, e.g., WO’201 at 7 at lines 15-30 and p. 8 at lines 1-5). Accordingly, the prior art ranges overlap in scope with the instantly claimed ranges (see MPEP § 2144.05(I), noting that “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”).
Regarding instant claims 4-6, 8, and the specific amounts and ratios utilized in the originally elected species, per MPEP § 2144.05(II), Examiner notes that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As noted above, WO’201 provides guidance directing artisans to utilize GLP-1 compounds and insulin-compounds, together, wherein GLP-1 compounds may be administered at about 0.1 to about 5 mg per day, and wherein insulin compounds may be administered at about 0.01 to about 1 U/kg per day (see, e.g., WO’201 at 7 at lines 15-30 and p. 8 at lines 1-5). Critically, a normal adult patient would reasonably weigh between 50 to over 100 kg, and therefore all claimed ranges and ratios appear to substantially overlap with the prior art ranges, as discussed in preceding paragraphs (see MPEP § 2144.05(I), noting that “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”). Accordingly, the selection of any particular subrange or exact ratio within the scope of the prior art is understood to result from routine optimization (see Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382, explaining that "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969), explaining that claimed compound which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions; see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989), noting that claimed ratios were obvious as being reached by routine procedures and producing predictable results; see also Smith v. Nichols, 88 U.S. 112, 118-19 (1874), explaining that a change in form, proportions, or degree "will not sustain a patent"; see also In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929), explaining that "It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions"). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the prior art teaches that the amounts and ratios of components may be varied over an overlapping range, and such resulting parameters appear to work equally as well, absent unexpected results and criticality of range, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the GLP-1 and insulin arts.
In sum, the prior art appears to teach and claim methods of administering the same compounds to the same patient populations at the same or overlapping dosage and dosage frequencies, in order to achieve the same results, namely the treatment of diabetes and associated conditions, wherein the GLP-1 compounds and insulin compounds merely perform their art-recognized functions.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): The claimed invention is the combination of known prior art elements (e.g., GLP-1 compounds like GLP-1(7-37), and insulin compounds like insulin glargine) according to prior art methods of treating diabetes and related conditions by administering a mixture of GLP-1 compounds and insulin compounds within a disclosed range of ratios, wherein such combination merely yields the predicted and expected outcome (i.e., treatment of diabetes and related conditions, wherein each component merely performs its art-recognized function in combination) (see, e.g., MPEP § 2143(I)(A), (D), (G)).
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the art to make and use known products, and well-within the ordinary skill in the art to perform a known method of treating a known patient population by administering known compounds at known concentrations and ratios, via known dosages and dosage frequencies, to obtain the exact results taught and disclosed by the prior art.
Accordingly, claims 1-8 are rejected.
[Prior Art Rejection 07]
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over WO03/020201A2 (March 13, 2003; cited in IDS filed 11/17/2023 as Cite No. 4) as applied to claims 1-8 above, and in further view of Zhang et al.6
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
The teachings of WO’201 as applied to claims 1-8 have been discussed above, and those teachings are incorporated into the instant rejection. Regarding instant claim 9 and the general usage of GLP-1 compounds, WO’210 provides broad guidance regarding GLP-1 compounds (see, e.g., WO’210 at 13 at lines 14-29, p. 14 at lines 1 to page 28 at line 20; see esp. WO’210 at SEQ ID NO: 3 at p. 17 at line 1 to p. 18 at line 27, noting that the genus of formula III of WO’210 encompasses Beinaglutide). Accordingly, although the scope of WO’210 includes beinaglutide, WO’210 does not explicitly recite beinaglutide.
The teachings of WO’201 differ from the specific embodiments encompassed by claim 1 as recited at dependent claim 9 and the originally elected species as follows: WO’201 does not reduce to practice methods wherein the GLP-1 compound utilized is beinaglutide. Therefore, the issue is whether or not it would have been obvious in view of the prior art, to utilize the GLP-1 compound of beinaglutide in the formulations and methodology disclosed by WO’201 with a reasonable expectation of success.
Zhang identifies that beinaglutide was a prior art element and an art-recognized, recombinant GLP-1(7-36) compound (see, e.g., Zhang at 367 at col I at 1st full ¶), which was tested and shown to be able to successfully treat diabetes as provide the benefits of weight loss (see, e.g., Zhang at title, abs).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): The claimed invention is the combination of known prior art elements (e.g., GLP-1 compounds like beinaglutide, and insulin compounds like insulin glargine) according to the methods of treating diabetes and related conditions by administering a mixture of GLP-1 compounds and insulin compounds within a disclosed range of ratios, exactly as taught and suggested by the primary reference, wherein such combination merely yields the predicted and expected outcome (i.e., treatment of diabetes and related conditions, wherein each component merely performs its art-recognized function in combination) (see, e.g., MPEP § 2143(I)(A), (B), (C), and (G)).
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the art to make and use known products, and well-within the ordinary skill in the art to perform a known method of treating a known patient population by administering known compounds at known concentrations and ratios, via known dosages and dosage frequencies, to obtain the exact results taught and disclosed by the prior art.
Accordingly, claims 1-9 are rejected.
[Prior Art Rejection 08]
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over CA2740685 (Apr. 4, 2010) as applied to claims 1-2 and 4-8 above, and further in view of Zhang et al.7
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
The teachings of CA’685 as applied to claims 1-2 and 4-8 have been discussed above, and those teachings are incorporated into the instant rejection.
The teachings of the primary reference differ from the specific embodiments encompassed by instant claim 1 as recited at dependent claims 3 and 9, and the originally elected species as follows: CA’685 does not reduce to practice a method of administering the GLP-1 compound utilized is beinaglutide rather than the GLP-1 compound of AVE00108.
However, CA’685 is not limited to methods utilizing and requiring AVE0010, but rather CA’685 directs artisans more broadly to GLP-1 compounds, generally (see, e.g., CA’685 at page 4 at line 16 to page 6 at line 10).
Zhang identifies that beinaglutide was a prior art element and an art-recognized, recombinant GLP-1(7-36) compound (see, e.g., Zhang at 367 at col I at 1st full ¶), which was tested and shown to be able to successfully treat diabetes as provide the benefits of weight loss (see, e.g., Zhang at title, abs).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): The claimed invention is the simple substitution of one known prior art element for another (e.g., the GLP-1 compound of beinaglutide in place of the GLP compound of AVE0010) in the exemplified methods of CA’685 (e.g., Examples 1 and 7-8 of CA’685), wherein the GLP-1 compound is administered with insulin glargine to treat diabetes and related conditions in animal models, wherein a mixture of GLP-1 compounds and insulin compounds are administered within a disclosed range of ratios, exactly as taught and suggested by the primary reference, and wherein such simple substitution would merely yield the predicted and expected outcome (i.e., treatment of diabetes and related conditions, wherein each component merely performs its art-recognized function in combination) (see, e.g., MPEP § 2143(I)(A), (B), (C), and (G)).
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the art to make and use known products, and well-within the ordinary skill in the art to perform a known method of treating a known patient population by administering known compounds at known concentrations and ratios, via known dosages and dosage frequencies, to obtain the exact results taught and disclosed by the prior art.
Accordingly, claims 1-9 are rejected.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 17/813,285 (reference application corresponding to PG Pub US2023/0081034A1). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
The applicable analysis for Nonstatutory Double Patenting is set forth at MPEP § 804(II), and specifically at MPEP § 804(II)(B). Here, although the same invention is not being claimed twice (see, e.g., MPEP § 804(II)(A), discussing Statutory Double Patenting), a Nonstatutory Double Patenting rejection is appropriate because although the conflicting claims are not identical, at least one examined application claim is not patentably distinct from the reference claims because the examined application claim is either anticipated by, or would have been obvious over, the reference claims for the reasons set forth in the following paragraph[1]: Per MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences”. Accordingly, a comparison of the teachings of the reference claims and the instant pending claims are set forth below:
Here, both copending claim sets are directed to methods of treatment of diabetes and related diseases (compare instant claims 1-2 with copending US’285 claims 1-2), by administering a GLP-1 compound and an insulin compound (compare instant claims 1, 3 with copending US’285 claims 1 and 4-5); wherein the GLP-1 compound may be GLP-1(7-36) (compare instant claims 1, 3 with copending US’285 claims 1 and 3); wherein the GLP-1 compound and the insulin compounds are administered at the same or overlapping ratios (compare instant claim 4 with copending US’285 claim 4-6); wherein the GLP-1 analog is administered at the same or overlapping ranges of mg/kg (compare instant claim 5 with copending US’285 claims 6-7); wherein administration is once or twice daily (compare instant claim 6 with copending US’285 claim 1); wherein administration of the insulin compound may be before, during, or after administration of the GLP-1 compound (compare instant claim 1 and 7 with copending US’285 claim 1, 11, noting that any administration of insulin necessarily occurs before, during, or after a GLP-1 compound administration because GLP-1 compounds are administered multiple times in the claimed methods); and wherein the GLP-1 analog is administered at the same or overlapping ranges of daily dosage (mg/d) (compare instant claims 5 and 8 with copending US’285 claims 6-7 and 8). Regarding instant claim 9, the copending-application recites GLP-1 and GLP-1 analogs, and explicitly identifies that beinaglutide is a GLP-1 analog as claimed (see, e.g., App’285 at Spec. at ¶[0004]). Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)).
Anticipation analysis: MPEP § 804(II)(B)(2)-(3) further identify that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). Here, it is the Examiner’s position that under an anticipation analysis an artisan would at once envisage the methods recited in the reference claims (see, e.g., MPEP § 804(II)(B)(2)) for the reasons discussed above.
Obviousness analysis: Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the copending claims relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims attempt to claim a different, but materially overlapping set of methods steps and combination dosages, but wherein both claim sets read upon species of patentably indistinct methods of using the same products to treat the same diseases at the same concentrations and dosing regimens, and therefore would be expected to achieve the same predicted and expected outcomes (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are directed to obvious variants of the representative claims because both copending claim sets combine the same agents at the same dosages to treat the same diseases using the same or overlapping treatment parameters (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(A)-(B), (G)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US2012/0021978A1 discloses similar subject matter as the references applied above (see, e.g., US’978 at claims 1, 7, 23), but is understood to be substantially cumulative with references already applied.
US 20230092769 A1 is the pre-grant publication corresponding to the instant application.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 Zhang et al., Beinaglutide showed significant weight-loss benefit and effective glycaemic control for the treatment of type 2 diabetes in a real-world setting: a 3-month, multicentre, observational, retrospective, open-label study. Obes Sci Pract. 2019 Jun 17;5(4):366-375. doi: 10.1002/osp4.342. PMID: 31452921; PMCID: PMC6700512; hereafter “Zhang”.
2 Identified as des Pro36exendin-4(1-39)-Lys6-NH2 at page 35 and lines 20-25 of CA’685.
3 Identified as des Pro36exendin-4(1-39)-Lys6-NH2 at page 35 and lines 20-25 of CA’685.
4 Identified as des Pro36exendin-4(1-39)-Lys6-NH2 at page 35 and lines 20-25 of CA’685.
5 Identified as des Pro36exendin-4(1-39)-Lys6-NH2 at page 35 and lines 20-25 of CA’685.
6 Zhang et al., Beinaglutide showed significant weight-loss benefit and effective glycaemic control for the treatment of type 2 diabetes in a real-world setting: a 3-month, multicentre, observational, retrospective, open-label study. Obes Sci Pract. 2019 Jun 17;5(4):366-375. doi: 10.1002/osp4.342. PMID: 31452921; PMCID: PMC6700512; hereafter “Zhang”.
7 Zhang et al., Beinaglutide showed significant weight-loss benefit and effective glycaemic control for the treatment of type 2 diabetes in a real-world setting: a 3-month, multicentre, observational, retrospective, open-label study. Obes Sci Pract. 2019 Jun 17;5(4):366-375. doi: 10.1002/osp4.342. PMID: 31452921; PMCID: PMC6700512; hereafter “Zhang”.
8 Identified as des Pro36exendin-4(1-39)-Lys6-NH2 at page 35 and lines 20-25 of CA’685.
[1] See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
Prosecution Insights