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 .
Election/Restrictions
Applicant’s election without traverse of Exendin 4(N-2[1H-Imidizol-5-yl]acetyl-Exendin4, SEQ ID NO: 4 and CA GLP-2 RK-PEG-Fc in the reply filed on 3/6/26 is acknowledged.
Claims 1-22 are under consideration.
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.
Claims 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of short bowel syndrome with GLP-2 in combination with GLP-1, exedin-3, exendin-4, does not reasonably provide enablement for prevention of short bowel. The claims are also not enabled for treatment or prevention of short bowel syndrome with all agonists, derivatives, fragments and variants of GLP-1, exendin-3 and exendin-4. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
As stated in MPEP 2164.01(a), “there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
The factors to be considered when determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, were described in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) as:
1. the nature of the invention;
2. the breadth of the claims;
3. the state of the prior art;
4. the relative skill of those in the art;
5. the predictability or unpredictability of the art;
6. the amount of direction or guidance presented [by the inventor];
7. the presence or absence of working examples; and
8. the quantity of experimentation necessary [to make and/or use the invention.
(1) The Nature of the Invention
Claim 1 is drawn to a method for preventing or treating short bowel syndrome in a subject in need thereof comprising administering to the subject a pharmaceutically composition comprising an insulinotropic peptide in a pharmaceutically effective amount in combination with GLP-2. Claim 3 claims the insulinotropic peptide is selected from GLP-1, exendin-4, exendin-3 and agonists, derivatives, fragments and variants thereof.
(2) The Breadth of the claims
The claims will be given its broadest reasonable interpretation. The applicable rule for interpreting the claims is that “each claim must be separately analyzed and given its broadest reasonable interpretation in light of and consistent with the written description.” See MPEP 2163(II)(1), citing In re Morris, 127 F.3d 1048, 1053-1054; 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). The instant specification defines insulinotropic peptide [PGPUB0121]:
The “insulinotropic peptide” refers to a peptide having an insulinotropic function, and can stimulate the synthesis or expression of insulin in pancreatic beta cells. The insulinotropic peptide may be, for example, glucagon-like peptide-1 (GLP-1), exendin-3 or exendin-4, but is not limited thereto. The insulinotropic peptide includes not only a native insulinotropic peptide, but also precursors, agonists, derivatives, fragments, and variants thereof, and also include long-acting conjugates to which biocompatible substances capable of increasing their in vivo half-life are bound. The insulinotropic peptide may be contained in the pharmaceutical composition in a pharmaceutically effective amount. In view of this rule, Claim 1 includes precursors, agonists, derivatives, fragments and variants thereof including long active conjugates.
The instant specification defines GLP-2 [PGPUB0132]:
In the present invention, the term “glucagon-like peptide-2” or “GLP-2” is an agonist of the glucagon-like peptide-2 receptor, and may be in the form of a polypeptide or in the form of a long-acting conjugate to which a biocompatible substance capable of increasing the in vivo half-life of the polypeptide is bound, but is not limited thereto. In the present invention, when referring to glucagon-like peptide-2 or GLP-2, not only sequences identical to native human GLP-2 but also GLP-2 derivatives are included, and glucagon-like peptide-2 or GLP-2 also covers long-acting conjugates in which biocompatible substances are bound to native GLP-2 or GLP-2 derivatives. The GLP-2 may be contained in the composition or in a separate composition in a pharmaceutically effective amount so as to be administered or used in combination with a pharmaceutical composition containing an insulinotropic peptide.
(3) The state of the prior art and (5) The predictability or unpredictability of the art
The instant application is enabling for treatment short bowel syndrome with GLP-2 in combination with GLP-1, exendin-3, exenin-4.
For example, The Mayo Clinic (<Short bowel syndrome - Symptoms and causes - Mayo Clinic> accessed 5/14/26) teaches short bowel syndrome is a condition in which the body cannot absorb enough nutrients from foods because part of the small intestine is missing or damaged. The Mayo clinic teaches that short bowel happens when parts of the small intestine have been surgically removed or portions of the small intestine are missing or damaged at birth. The Mayo clinic teaches treatment includes nutritional therapy, medicines and surgery. The Mayo clinic does not teach that small bowel syndrome can be prevented.
The prior art is supportive of treatment of short bowel syndrome with GLP-1 and GLP-2 (Madsen et al. (Regulatory Peptides 184 (2013) 30-39, cited on IDS)). Madsen et al. teach that ileocolonic brake is impaired in short bowel syndrome patients with distal bowel resections. Madsen et al. teach the study was attempting to restore the ileocolonic brake by evaluating the acute effects of continuous intravenous administration of GLP-1 and GLP-2 alone or in combination (Abstract). Madsen et al. teach that the combination of GLP-1 and GLP-2 numerically provided additive effects on intestinal absorption compared to either peptide given alone (Abstract). However, there was no evidence found that suggest short bowel syndrome could be prevented because it stems from necessary surgeries or from congenital defects.
Therefore, the state of the art at the time of the application is supportive of the treatment of short bowel syndrome with specific agents, such as GLP-2 and GLP-1 and exendin-3 or 4. However, the prior art is not supportive of preventing short bowel syndrome with any agent.
It is noted that pharmaceutical and biological art is generally unpredictable, requiring each embodiment to be individually assessed for physiological activity. Given this fact, historically the development of new drugs has been difficult and time-consuming. Adding to the unpredictability is that many treatment options may show promise in animal models, but may fail to show therapeutic improvement in clinical trials. There is no absolute predictability, even in view of the high level of skill in the art.
(4) The relative skill of those in the art
MPEP 2141.03 states (in part)” A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner’s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the skill in the art high with respect to physicians and scientists. The level of skill in the art (physicians and scientists) would be high.
(6) The amount of direction or guidance presented (by the inventor) and (7) The presence or absence of working examples
The prior art provides sufficient guidance regarding the treatment of short bowel syndrome with GLP-1 and GLP-2.
The applicant provided sufficient guidance or direction regarding the potential treatment of short bowel syndrome with CA GLP-2 RK PEG and CA-Exendin-4 PEG Fc. Applicants disclose combined administration was effective in treating short bowel syndrome as the combined administration rapidly increased the length of the small intestine without causing weight loss while also leading to the a GLP-2 induced increase in the subjects nutrient absorption through a decrease in GI motility compared to single administration groups (Example 4 and Fig. 3).
The Applicant did not provide sufficient guidance or direction regarding the potential prevention of short bowel syndrome.
Therefore, the specification and working examples provided by the applicant support treatment of short bowel syndrome.
(8) The quantity of experimentation necessary (to make and/or use the invention)
Owing to the factors listed above, especially in points 6 and 7, the amount of experimentation needed will be extensive in view of the lack of guidance by the inventor.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
The instant breadth of the claim is broader than the disclosure, specifically, the instant claims are directed to the treatment and prevention of short bowel syndrome, but the specification, prior art or instant disclosure does not provide support for this.
Claims 1-22 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Scope of the claimed genus
Claim 1 is drawn to a method for preventing or treating short bowel syndrome in a subject in need thereof comprising administering to the subject a pharmaceutically composition comprising an insulinotropic peptide in a pharmaceutically effective amount in combination with GLP-2. Claim 3 claims the insulinotropic peptide is selected from GLP-1, exendin-4, exendin-3 and agonists, derivatives, fragments and variants thereof.
The USPTO provides claim terms with broadest reasonable interpretation in light of the specification.
Assessment of whether species are support in the original specification
Two embodiment of the invention of claims 1-22 were reduced to practice at the time of filing. Applicants disclosed the long acting conjugate CA GLP-2 RK-PEG and the long acting CA-exendin-4-PEG conjugate.
There was no disclosure of other GLP-2 and insulinotropic peptides for treatment of short bowel syndrome.
In summary, for these reasons, the skilled artisan would reasonably conclude that the inventor(s), at the time the application was filed, had possession of CA GLP-2 RK PEG and CA exendin-4-PEG at the time the invention was filed.
Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
In the instant case, the disclosure of long acting conjugate CA GLP-2 RK-PEG and the long acting CA-exendin-4-PEG conjugate are not representative of the genus. The disclosure of the sequences are not representative of the entire genus encompassed by agonists, derivatives, fragments and variants.
Identifying characteristics and structure/function correlation
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. To meet this requirement in the instant case, the specification must describe the structural, physical and/or chemical properties of the insulinotropic peptide and GLP-2 peptide that leads to the claimed function of treating and preventing short bowel syndrome. The data do not suggest the physical basis for the claimed activity and therefore do not describe which modifications, substitutions, deletions or additions could be made while preserving function.
This is an issue of written description. The specification does not make clear which proteins are in the genus and which are not because it does not describe the physical basis for the claimed activity. In other words, the specification does not describe which proteins to make.
In conclusion, for the reasons presented above, the skilled artisan would reasonably conclude that the inventors, at the time the application was filed had full possession of long acting conjugate CA GLP-2 RK-PEG and the long acting CA-exendin-4-PEG conjugate.
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.
Claims 1-3, 6, 13, 14, 21 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Madsen et al. (Regulatory Peptides 184 (2013) 30-39, cited on IDS).
Madsen et al. teach that ileocolonic brake is impaired in short bowel syndrome patients with distal bowel resections. Madsen et al. teach the study was attempting to restore the ileocolonic brake by evaluating the acute effects of continuous intravenous administration of GLP-1 and GLP-2 alone or in combination (Abstract). Madsen et al. teach that the combination of GLP-1 and GLP-2 numerically provided additive effects on intestinal absorption compared to either peptide given alone (Abstract). Madsen et al. teach continuous IV infusion of GLP-1 and GLP-2 1 pmol/kg/min. (p. 31, para. 2.3). Madsen et al. teach the administration of GLP-1 and GLP-2 was effective in treating short bowel syndrome meeting the limitation of “pharmaceutically effective amount”. Therefore, Madsen et al. anticipate the limitations of claims 1 and 2.
With respect to claim 3, Madsen et al. teach GLP-1.
With respect to claim 6, Madsen et al. teach native GLP-2 (p. 31, para. 2.3).
With respect to claim 13, Madsen et al. teach that the combination of GLP-1 and GLP-2 numerically provided additive effects on intestinal absorption compared to either peptide given alone (Abstract). Furthermore, the reference would inherently have all of the activities and properties of the composition of claim 1. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzqerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,433- 34 (CCPA 1977)).” In other words, Madsen et al. teach administering the same composition (effective amount of GLP-1 and GLP-2) to the same patient population (a subject suffering from short bowel syndrome), therefore the same results would inherently occur. Moreover, MPEP 2112.01 states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Importantly, MPEP 2112 states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer” and “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference
With respect to claim 14, Madsen et al. do not teach modification of GLP-1 and GLP-2. Therefore, the C-terminus is unvaried.
With respect to claim 21, Madsen et al. teach the GLP-1 and GLP-2 in saline with albumin (p. 31, para. 2.3), meeting the limitation of pharmaceutically acceptable carrier, excipient or diluent.
With respect to claim 22, Madsen et al. teach combined administration of GLP-1 and GLP-2 (p. 31 para. 2.3).
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.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Madsen et al. as applied to claims 1-3, 6, 13, 14, 21 and 22 above, and further in view of DiMarchi et al. (US20110288003).
Madsen et al. teaches a combination of GLP-1 and GLP-2 for treatment of short bowel syndrome. Madsen et al. does not teach the insulinotropic peptide is exendin-4, however the teachings of DiMarchi et al. cure this deficiency.
DiMarchi et al. teach additional peptides are known that resemble GLP-1 in structure and have similar activities. For example, exendin-4 is a peptide that resembles GLP-1 in structure and like GLP-1 increases insulin release [0008].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute exendin-4 for the GLP-1 in the treatment of short bowel syndrome. MPEP 2143 states: Exemplary rationales that may support a conclusion of obviousness include the rationale that simple substitution of one known element for another to obtain predictable results. To reject a claim based on this rationale, Office personnel must resolve the Graham factual inquiries. Then, Office personnel must articulate the following:
(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
(2) a finding that the substituted components and their functions were known in the art;
(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
The claimed invention differs from Madsen et al. in that the claimed method requires the use of exendin-4 while the prior art teaches the use of GLP-1. DiMarchi et al. teach that exendin-4 is a peptide that resembles the structure of GLP-1 and exhibits similar activity, including stimulation of insulin secretion. One of ordinary skill in the art would have understood that exendin-4 is a known alternative to GLP-1 for achieving insulinotropic activity. Therefore, it would have been obvious to one of ordinary skill in the art to substitute exendin-4 for GLP-1 in the method of Madsen et al. because both peptides were known to perform the same function and are recognized in the art as functionally similar agents. There is a reasonable expectation of success given that the prior art teaches GLP-1 and exendin-4 are structurally and functionally similar.
With respect to claim 4, Madsen et al. teach modifications to reduce susceptibility to cleavage by dipeptidyl peptidase IV (Fig. 10, [0366]). Madsen et al. teach position 1 is substituted with desaminohistidine [0366].
With respect to claim 5, Madsen et al. teach native exendin-4 [0029]. Madsen et al. also teach modification to replace the alpha carbon amino acid with a hydroxyl group [0122].
Claims 7-12 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Madsen et al. as applied to claims 1-3, 6, 13, 14, 21 and 22 above, and further in view of Choi et al. (AU2018339210, published 4/4/2019).
Madsen et al. does not teach the GLP-2 is a GLP-2 derivative. However, the teachings of Choi et al. cure this deficiency.
Choi et al. teach a pharmaceutical composition for preventing or treating short-bowel syndrome with a GLP-2 conjugate or derivative (p. 6).
With respect to claims 7-11, Choi et al. teach GLP-2 derivatives and conjugates thereof (top of p. 1). Choi et al. teach the GLP-2 derivative (p. 3):
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Formula I meets the limitation of GLP-2 derivative with at least one amino acid in native GLP-2 is subjected to variation (claim 7), wherein the variation of at least one amino acid among amino acids 1, 2, 30 and 33 in SEQ ID NO: 1 (claim 8). Formula I of Choi et al. meets the limitations of claims 9 and 11. With respect to claim 10, Choi et al. teach (p. 3-4):
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With respect to claim 12, Choi et al. teach the GLP-2 derivative is an amino acid sequence selected from the group consisting of SEQ ID Nos: 2-8. SEQ ID Nos: 2-8 of Choi et al. are identical to instantly claimed SEQ ID Nos: 2-8.
With respect to claim 15, Choi et al. teach a long-acting formulation of GLP-2 having increased durability and stability, wherein the long-acting formulation comprises a GLP-2 conjugate. Choi et al. teach the GLP-2 derivative and an immunoglobulin Fc region are covalently linked via a non-peptidyl polymer at both termini of the polymer (p. 7), meeting the limitation of (ii). Immunoglobulin Fc region is a biocompatible substance capable of increasing in vivo half-life.
With respect to claims 16 and 19-20, Choi et al. teach the non-peptidyl polymer is PEG. Choi et al. teach CA-GLP-2 RK-PEG (3.4K or 10K) immunoglobulin Fc conjugate.
With respect to claim 17, Choi et al. teach the Fc is aglycosylated form (p. 22).
With respect to claim 18, Choi et al. teach the Fc region may be a dimer consisting of a single chain immunoglobulin of domains of the same origin (p. 23). Choi et al. teach that the polypeptides encoding a single chain immunoglobulin constant region (Fc regions) of the same origin are linked to a single chain polypeptide (p. 24 top).
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 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,530,249 in view of Madsen et al. and DiMarchi et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims the GLP-2 derivative of SEQ ID NO: 4 which is AC GLP-2 RK. The USPN states the composition for treatment of short-bowel disease. MPEP 804 states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. In the instant case, the compounds uses include treatment of short-bowel syndrome.
The USPN does not teach the GLP-2 with an insulinotropic peptide. However, the teachings of Madsen et al. and DiMarchi et al. cure this deficiency.
The teachings of Madsen et al. and DiMarchi et al. are presented above in detail.
It would have been obvious to a person of ordinary skill in the art to include an insulinotropic peptide such as GLP-1 or exendin-4 in combination with GLP-2 for treatment of short bowel syndrome because Madsen et al. teach the combination was effective for treating short bowel syndrome. There is a reasonable expectation of success given that the combination was shown effective.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17/721,048 in view of Madsen et al. and DiMarchi et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending Application claims a GLP-2 conjugate. The conjugate meets the limitations of the GLP-2 derivative and conjugate of the instant claims. The copending Application also claims treating short bowel syndrome.
The copending Application does not claim a combination with an insulinotropic peptide, however the teachings of Madsen et al. and DiMarchi et al. cure this deficiency.
It would have been obvious to a person of ordinary skill in the art to include an insulinotropic peptide such as GLP-1 or exendin-4 in combination with GLP-2 for treatment of short bowel syndrome because Madsen et al. teach the combination was effective for treating short bowel syndrome. There is a reasonable expectation of success given that the combination was shown effective.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending application 18/857,479. Although the claims at issue are not identical, they are not patentably distinct from each other. The copending Application claims a method for preventing or treating bowel disease with GLP-2 in combination with an insulinotropic peptide (claim 1), wherein the insulinotropic peptide is exendin-4 (claims 2-4). The copending Application claims GLP-2 derivatives and conjugates that meet the limitation of the instant claims (claims 5-15). The copending Application claims the bowel disease is bowel damage. The specification states bowel disease include shortened colon length [0004].
MPEP 804 states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. In the instant case, the compounds uses include treatment of short bowel. Therefore the copending application anticipates the instant claims.
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/TARA L MARTINEZ/ Examiner, Art Unit 1654
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