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 .
Any objection or rejection from the previous office action, which is not restated here, is withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group II (i.e., claims 1, 64-70, 79-82, 90-93, and 95-97 drawn to a method of treatment comprising the compounds of claim 1) in the reply filed on June 20, 2022, is acknowledged. Additionally, Applicant’s election without traverse of SEQ ID NO: 23 as a single and specific peptide in the reply filed on June 20, 2022, is acknowledged.
Please note that the species election of a single and specific peptide is withdrawn in light of the previous Examiner’s examination of all the claims.
Status of Claims
Claims 1-97 were originally filed on March 24, 2021.
The amendment received on December 9, 2021, canceled claims 2-60, 62-63, 71-78, 83-89, and 94; and amended claims 1, 61, 64-65, 67-69, 79-82, 90-93, and 95-97. The amendment received on June 20, 2022, canceled claim 2. The amendment received on November 29, 2022, amended claims 1, 64-70, 79-82, 90-93, and 95-97; and added new claims 98-110. The amendment received on April 12, 2023, amended claim 1; and added new claims 111-144. The amendment received on October 18, 2023, amended claims 1, 97, 111-113, 115-117, 123-124, and 129; and added new claims 145-148. The amendment received on May 29, 2025, amended claims 1 and 145. The amendment received on May 12, 2026, canceled claims 90, 111-119, 121, 123-124, 127, 129, 142, and 145-148; and amended claims 1, 65-66, 69, 95, 125-126, 128, 130-141, and 143-144.
Claims 1, 64-70, 79-82, 91-93, 95-110, 120, 122, 125-126, 128, 130-141, and 143-144 are currently pending and under consideration.
Priority
The present application claims status as a 371 (National Stage) of PCT/JP2019/038827 filed September 24, 2019, and claims priority under 119(e) to U.S. Provisional Application No. 62/735,510 filed on September 24, 2018.
Claim Interpretation
For purposes of applying prior art, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation set forth below, 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).
For claim 1, with respect to “treating”, it is noted that the instant specification defines “treatment” in the context of treating emesis by administering at least one of the GIP receptor agonist peptides disclosed, includes both prophylactic treatment and the treatment of emesis after a subject experiences emesis (See instant, [0410]). Prophylactic treatment includes administration of a GIP receptor agonist peptide before a subject experiences emesis, as well as administration of the GIP receptor agonist peptide before the subject is exposed to a substance, agent, or event, or before the subject contracts a condition, which results in or is likely to result in the subject experiencing emesis (See instant, [0410]). Treatment is also broadly defined as referring to clinical intervention in an attempt to alter the natural course of the individual being treated, and can be performed either for prophylaxis or during the course of clinical pathology (See instant, [0256]). Desirable effects of treatment include, preventing occurrence or recurrence of a condition, alleviation of symptoms, diminishment of any direct or indirect pathological consequences of the condition or treatment, preventing emesis, i.e., by preventing the occurrence of symptoms in whole or in part associated with a condition or side-effects known to accompany a specific treatment, decreasing the rate of progression, amelioration or palliation of the symptoms associated with emesis, and remission or improved prognosis (See instant, [0256]). Thus, the scope of claim 1 encompasses where emesis is prophylactically treated such that emesis is 100% prevented from occurring or treatment once the subject experiences emesis.
With respect to a “therapeutically effective amount”, it is noted that the instant specification defines “therapeutically effective amount” as an amount sufficient to elicit the desired biological response (See instant, [0410]). Thus, the claimed GIP receptor agonist peptide is administered to a subject in an amount sufficient to prophylactically treat or treat emesis in the subject. However, this amount is not limited.
With respect to “emesis”, it is noted that the instant specification does not define what is encompassed by the term “emesis”. Pursuant to MPEP 2111.01, under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention. Emesis is defined as an act or instance of vomiting (Merriam-Webster Dictionary, “Emesis”, available online at https://www.merriam-webster.com/dictionary/emesis, 7 pages (accessed on 11/5/25) at pg. 1). As such, emesis and vomiting are being interpreted interchangeably.
Sequence Interpretation
For claim 1, please note that the Examiner is interpreting the scope of the claim as open-ended requiring 100% identity to formula (II) and the subsequent Markush group of peptides with any N- and/or C-terminal additions.
For claim 130, please note that the Examiner is interpreting the scope of the claim as closed-ended requiring 100% identity and the same length to SEQ ID NO: 23.
Response to Arguments
Applicant’s arguments, see Response, filed 5/12/26, with respect to objection of the specification have been fully considered and are persuasive. The objection of the specification has been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to claim objections have been fully considered and are persuasive. The objections of claims 1, 69, 90, 145, and 148 have been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to improper Markush rejection have been fully considered and are persuasive. The rejection of claims 9, 90, 98-110, and 148 on the basis that it contains an improper Markush grouping of alternatives has been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to 112(b) rejection have been fully considered and are persuasive. The rejection of claims 1, 64-70, 79-82, 90-93, 95-110, 114, 118-122, 125-128, and 130-148 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 has been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to 112(b) rejection have been fully considered and are persuasive. The rejection of claims 1, 64-70, 79-82, 90-93, 95-110, 114, 118-122, 125-128, and 130-144 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 has been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to 112(b) rejection have been fully considered and are persuasive. The rejection of claim 95 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 has been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to 112(b) rejection have been fully considered and are persuasive. The rejection of claims 111-113, 115-117, 123-124, and 129 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 has been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to 112(b) rejection have been fully considered and are persuasive. The rejection of claims 145-148 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 has been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to 103(a) rejection have been fully considered and are persuasive. The rejection of claims 1, 64-65, 67, 69, 81, 82, 91-93, 95-98, 114, and 118-119 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. WO 2006/086769 A2 published on August 17, 2006, in view of Maule WF. Nausea and Vomiting. In: Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Chapter 84. Available from: https://www.ncbi.nlm.nih.gov/books/NBK410/ has been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to 103(a) rejection have been fully considered and are persuasive. The rejection of claims 1, 64-65, 67, 69, 81, 82, 91-93, 95-98, 114, and 118-119 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. WO 2006/086769 A2 published on August 17, 2006, in view of Maule WF. Nausea and Vomiting. In: Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Chapter 84. Available from: https://www.ncbi.nlm.nih.gov/books/NBK410/ has been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to 103(a) rejection have been fully considered and are persuasive. The rejection of claims 1, 65-66, 68-70, 79-80, 90, 99-102, and 105-108 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. WO 2006/086769 A2 published on August 17, 2006, in view of Maule WF. Nausea and Vomiting. In: Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Chapter 84. Available from: https://www.ncbi.nlm.nih.gov/books/NBK410/, and further in view of Virginia Cancer Institute, “Nausea and Vomiting,” Virginia Cancer Institute, available online at https://www.vacancer.com/diagnosis-and-treatment/side-effects-of-cancer/1228-2/, 11 pages (first available 2013), American Cancer Society, “Treating Breast Cancer,” American Cancer Society, available online at https://www.cancer.org/content/dam/CRC/PDF/Public/8581.00.pdf, 136 pages (first available July 2018), Gonzalez-Angulo et al., The Ochsner J. 4:163-167 (2002), and DrugBank Online, “Vincristine,” available online at https://go.drugbank.com/drugs/DB00541, 27 pages (first available February 2018) has been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to 103(a) rejection have been fully considered and are persuasive. The rejection of claims 1, 69, 90, 103, and 109 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. WO 2006/086769 A2 published on August 17, 2006, in view of Maule WF. Nausea and Vomiting. In: Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Chapter 84. Available from: https://www.ncbi.nlm.nih.gov/books/NBK410/, and further in view of Smith et al., Ann. Palliat. Med. 1:121-129 (2012) has been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to 103(a) rejection have been fully considered and are persuasive. The rejection of claims 1, 69, 90, 103, and 109 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. WO 2006/086769 A2 published on August 17, 2006, in view of Maule WF. Nausea and Vomiting. In: Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Chapter 84. Available from: https://www.ncbi.nlm.nih.gov/books/NBK410/, and further in view of Smith et al., Ann. Palliat. Med. 1:121-129 (2012) has been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to 103(a) rejection have been fully considered and are persuasive. The rejection of claims 1, 69, 90, 104, and 110 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. WO 2006/086769 A2 published on August 17, 2006, in view of Maule WF. Nausea and Vomiting. In: Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Chapter 84. Available from: https://www.ncbi.nlm.nih.gov/books/NBK410/, and further in view of Boyle et al., CNS Drugs 29:83-89 (2015) has been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to 103(a) rejection have been fully considered and are persuasive. The rejection of claims 145-148 are rejected under 35 U.S.C. 103 as being unpatentable over Dong US 2011/0136725 A1 published on June 9, 2011, in view of Levy et al. WO 2006/086769 A2 published on August 17, 2006, Maule WF. Nausea and Vomiting. In: Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Chapter 84. Available from: https://www.ncbi.nlm.nih.gov/books/NBK410/, and Nam et al., Korean J. Helicobacter Upper Gastroint. Res. 17:148-153 (2017) has been withdrawn.
Applicant’s arguments, see Response, filed 5/12/26, with respect to obviousness-type double patenting rejection have been fully considered and are persuasive. The rejection of claims 1, 64-70, 79-82, 90-93, 95-110, 136-137, and 142 as being unpatentable over claims 1-13 of U.S. Patent No. 11,174,301 B2 has been withdrawn. Please note that the instant GIP analog sequences no longer encompass where the linker between the lysine side chain and the chemical substituent, e.g., a fatty acid, is a polyglycine linker.
Applicant’s arguments, see Response, filed 5/12/26, with respect to obviousness-type double patenting rejection have been fully considered and are persuasive. The rejection of claims 1, 64-70, 79-82, 90-93, 95-110, and 134-141 as being unpatentable over claims 5-7, 10-12, and 24-56 of copending Application No. 17/554,539 (US 2022/0227830 A1) has been withdrawn. Please note that the ‘539 application has been abandoned.
Applicant’s arguments, see Response, filed 5/12/26, with respect to obviousness-type double patenting rejection have been fully considered and are persuasive. The rejection of claims 1, 64-70, 79-82, 90-93, 95-110, and 134-142 as being unpatentable over claims 1- of copending Application No. 18/739,752 (not yet published) has been withdrawn. Please note that the ‘752 application has been abandoned.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 64-70, 79-82, 91-93, 95-110, 120, 122, 125-126, 128, 130-141, and 143-144 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 is directed to a method for treating emesis in a subject by administering a therapeutically effective amount of a GIP receptor agonist peptide of SEQ ID NO: 38 where positions A40-A41-A42-A43 have been removed. However, the “wherein” clause following SEQ ID NO: 38 still recites potential residues at positions A40-A41-A42-A43. As such, it is unclear whether positions A40-A41-A42-A43 are removed from SEQ ID NO: 38.
Furthermore, claim 1 recites a second “wherein” clause reciting specific GIP receptor agonist peptide species. SEQ ID NO: 13 contains the Lys(R) residue at position A40, but position A40 was removed from SEQ ID NO: 38 as discussed supra. Moreover, SEQ ID NO: 18 has a Lys residue added at the position corresponding to position A30, and contains the Lys(R) residue at position A43. However, Lys was removed from position A30 in the first “wherein” clause, and position A43 was removed from SEQ ID NO: 38 as discussed supra. For SEQ ID NO: 24, the Lys(R) residue appears to be at position A39, but the residues do not line up from position A31 to A39 as recited in the first “wherein” clause. Last, SEQ ID NO: 25 contains Lys(R) at position A12, but Lys(R) was removed as a potential residue at position A12 in the first “wherein” clause. As such, the second “wherein” clause recites species that conflicts with SEQ ID NO: 38 and/or the first “wherein” clause. Thus, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to the identified internal discrepancies in claim 1.
Please note that the Examiner is interpreting the scope of claim 1 such that it recites only the second wherein clause reciting specific species in order to advance prosecution. Also, please note that claims 64-70, 79-82, 91-93, 95-110, 120, 122, 125-126, 128, 130-141, and 143-144 are rejected by virtue of their dependency.
Maintained/Modified Rejections in light of Applicants’ Amendments
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, 64-70, 79-82, 91-93, 95-110, 120, 122, 125-126, 128, 130-141, and 143-144 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
the treatment of emesis in a subject by administering a therapeutically effective amount of a GIP receptor agonist peptide of SEQ ID NOs: 9, 13, 18-19, 21, 23-34, and 36-37 where treatment does not encompass 100% prevention and where the emesis is caused by any disease or condition, AND
the treatment of emesis in a subject by administering a therapeutically effective amount of a GIP receptor agonist peptide of SEQ ID NOs: 19, 23, 28, and 36, where treatment is 100% prevention and where the emesis is caused by opioid analgesic,
but does not reasonably provide enablement for:
the treatment of emesis in a subject by administering a therapeutically effective amount of a GIP receptor agonist peptide of SEQ ID NOs: 21, 24, 26-27, 30-34 and 27 where treatment is 100% prevention and where the emesis is caused by any disease, condition, or induced by any therapeutic agents including PYY and Y2R agonists;
the treatment of emesis in a subject by administering a therapeutically effective amount of a GIP receptor agonist peptide of SEQ ID NOs: 18, 21, 24-27, 29-34, and 37, where treatment is 100% prevention and where the emesis is caused by opioid analgesic; AND
the treatment of emesis in a subject by administering a therapeutically effective amount of a GIP receptor agonist peptide of SEQ ID NOs: 23-34 and 36-37, where treatment is 100% prevention and where the emesis is caused by any chemotherapeutic agent.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
As stated in MPEP §2164.01(a), “there are many factors to consider when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any experimentation is ‘undue’.” These factors include, but are not limited to:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The level of skill in the art;
5. The level of predictability in the art;
6. The amount of direction provided by the inventor;
7. The presence or absence of working examples;
8. The quantity of experimentation necessary needed to make or use the invention based on the disclosure.
See In re Wands USPQ 2d 1400 (CAFC 1988).
The eight In re Wands factors are applied to Claims 1, 64-70, 79-82, 91-93, 95-110, 120, 122, 125-126, 128, 130-141, and 143-144 as follows:
The Breadth of the Claims and The Nature of the Invention
Although addressing that the subject is suffering from emesis or at risk of suffering from emesis in claim 1 by administering a therapeutically effective amount of a GIP receptor agonist peptide of SEQ ID NOs: 9, 13, 18-19, 21, 23-34, and 36-37, Applicants provide limited evidence in the specification that a therapeutically effective amount of a GIP receptor agonist peptide of SEQ ID NOs: 9, 13, 18-19, 21, 23-34, and 36-37 can prevent emesis. As discussed in the “Claim Interpretation” section supra, the instant specification defines “treatment” in the context of treating emesis by administering at least one of the GIP receptor agonist peptides disclosed, includes both prophylactic treatment and the treatment of emesis after a subject experiences emesis (See instant, [0410]). Prophylactic treatment includes administration of a GIP receptor agonist peptide before a subject experiences emesis, as well as administration of the GIP receptor agonist peptide before the subject is exposed to a substance, agent, or event, or before the subject contracts a condition, which results in or is likely to result in the subject experiencing emesis (See instant, [0410]). Treatment is also broadly defined as referring to clinical intervention in an attempt to alter the natural course of the individual being treated, and can be performed either for prophylaxis or during the course of clinical pathology (See instant, [0256]). Desirable effects of treatment include, preventing occurrence or recurrence of a condition, alleviation of symptoms, diminishment of any direct or indirect pathological consequences of the condition or treatment, preventing emesis, i.e., by preventing the occurrence of symptoms in whole or in part associated with a condition or side-effects known to accompany a specific treatment, decreasing the rate of progression, amelioration or palliation of the symptoms associated with emesis, and remission or improved prognosis (See instant, [0256]). As such, “treating” encompasses 100% prevention of emesis that is caused or induced by any disease, condition, therapeutic agent, etc., thereby encompassing emesis caused/induced by motion sickness, a bacterial or viral infection, pregnancy, vertigo, anxiety, and chemotherapeutic agents, etc. (See Chavoustie, CT, “What causes dizziness and vomiting,” Medical News Today, available online at https://www.medicalnewstoday.com/articles/322638#causes, 19 pages (2025): teaching 15 causes of dizziness and vomiting including anxiety, infections, diabetes, inner ear issues, liver problems, neurological health problems, migraine, motion sickness, cyclic vomiting syndrome, alcohol or drugs, poisoning, organ injury, pregnancy, stroke, and heart attack). Thus, the scope of claim 1 encompasses treating emesis such that emesis is 100% prevented and is caused and/or induced by any disease, condition, therapeutic agent, etc. Accordingly, claims 1, 64-70, 79-82, 91-93, 95-110, 120, 122, 125-126, 128, 130-141, and 143-144 are unduly broad with respect to preventing emesis caused and/or induced by any disease, condition, therapeutic agent, etc., by administering a therapeutically effective amount of a GIP receptor agonist peptide of SEQ ID NOs: 9, 13, 18-19, 21, 23-34, and 36-37.
The State of the Prior Art
It is noted that there is currently no prior art that teaches administering a therapeutically effective amount of a GIP receptor agonist peptide of SEQ ID NOs: 9, 13, 18-19, 21, 23-34, and 36-37 in order to prevent emesis.
The Level of Skill in the Art
Practitioners in this art (medical clinicians, pharmacists, doctors and/or pharmaceutical chemists) would presumably be highly skilled in the art for treatment of emesis in a subject where treatment encompasses 100% prevention and where emesis is caused and/or induced by any disease, condition, therapeutic agent, etc.
The Level of Predictability in the Art,
The Amount of Direction Provided by the Inventor,
The Presence or Absence of Working Examples, and
The Quantity of Experimentation Necessary
The instant claimed invention is highly unpredictable. If one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains (i.e., administering a therapeutically effective amount of a GIP receptor agonist peptide of SEQ ID NOs: 9, 13, 18-19, 21, 23-34, and 36-37 to a subject at risk of suffering from emesis excluding the limited situations identified in the rejection heading), then there is a lack of predictability in the art. Moreover, it is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. The court has indicated that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. (See In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970)). This is because it is not obvious from the disclosure of one species, what other species will work.
In the instant case, Applicants demonstrate that specific GIP receptor agonist peptides can 100% prevent emesis caused/induced by specific therapeutic agents. More specifically, Applicants demonstrate that emesis induced by morphine administration is 100% prevented only when SEQ ID NOs: 4, 7-8, 12, 14, 19-20, 23, 28, and 36 is administered (See instant Table 13). Moreover, Applicants demonstrate that SEQ ID NO: 22 was able to 100% prevent emesis caused by cisplatin administration (See instant Table 15). However, Applicants demonstrate that SEQ ID NOs: 5-6, 15, and 18 did not 100% prevent emesis induced by morphine administration (See instant Table 13), SEQ ID NO: 17 did not 100% prevent emesis induced by cisplatin administration (See instant Table 15), SEQ ID NOs: 20, 22, 29, and 30 did not 100% prevent emesis caused by Y2R agonist administration (See instant Tables 16-17). To exacerbate matters, even though SEQ ID NO: 20 100% prevented emesis induced by morphine administration, SEQ ID NO: 20 did not 100% prevent, but rather partially inhibited emesis caused/induced by cisplatin (i.e., a chemotherapeutic agent) (See instant Tables 15) or Y2R agonist administration (See instant Table 16). Similarly, even though SEQ ID NO: 22 100% prevented emesis induced by cisplatin administration, SEQ ID NO: 22 did not 100% prevent, but rather partially inhibited emesis caused/induced by Y2R agonist administration (See instant Table 17). As such, such data demonstrates that the cause/induction of the emesis and the GIP receptor agonist amino acid sequence are critical in determining whether the GIP receptor agonist peptide can 100% prevent the emesis. Thus, an ordinary skilled artisan cannot expect without undue experimentation that each of the claimed GIP receptor agonist peptides will 100% prevent emesis in a subject where the emesis is caused/induced by any condition, therapeutic agent, etc. excluding the identified situations in the rejection heading. This is because an ordinary skilled artisan cannot extrapolate the positive data provided in the specification to extend to the full scope of the claimed methods. Without more experimentation demonstrating a core structure or sequence that each GIP receptor agonist must contain in order to 100% prevent a representative number of causes of the emesis, the level of unpredictability remains high. Therefore, it is unpredictable that SEQ ID NOs: 9, 13, 18-19, 21, 23-34, and 36-37 will prevent emesis in a subject other than the limited situations identified in the rejection heading.
Conclusion of 35 U.S.C. 112(a) (Enablement) Analysis
MPEP §2164.01(a), 4th paragraph, provides that, “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 1157, 1562; 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Genentech Inc. v. Novo Nordisk A/S, 42 USPQ2d 1001, 1005 (CA FC), states that, “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable,” citing Brenner v. Manson, 383 U.S. 519, 536 (1966) (stating, in the context of the utility requirement, that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion”). The Genentech decision continued, “tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Id. at p. 1005.
After applying the Wands factors and analysis to Claims 1, 64-70, 79-82, 91-93, 95-110, 120, 122, 125-126, 128, 130-141, and 143-144, in view of the applicant’s entire disclosure, and considering the In re Wright, In re Fisher and Genentech decisions discussed above, it is concluded that the practice of the invention as claimed in Claims 1, 64-70, 79-82, 91-93, 95-110, 120, 122, 125-126, 128, 130-141, and 143-144 would not be enabled by the written disclosure excluding that of treating emesis in a subject by administering a therapeutically effective amount of a GIP receptor agonist peptide of SEQ ID NOs: 9, 13, 18-19, 21, 23-34, and 36-37 where treatment does not encompass 100% prevention and where the emesis is caused by any disease or condition, and excluding the identified situations where emesis is 100% prevented. Therefore, Claims 1, 64-70, 79-82, 91-93, 95-110, 120, 122, 125-126, 128, 130-141, and 143-144, are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to administer a therapeutically effective amount of a GIP receptor agonist peptide of SEQ ID NOs: 9, 13, 18-19, 21, 23-34, and 36-37 to a subject at risk of suffering from emesis excluding the identified situations in the rejection heading.
Response to Arguments
Applicant's arguments filed 5/12/26 have been fully considered but they are not persuasive.
Applicants assert that the amendments made to claims 1 and 69 overcome the rejection (See Applicant’s Response received on 5/12/26, pg. 19-20). However, as stated in the rejection supra, the scope of claim 1 has not been amended such that “treating” excludes 100% prevention. Although there are species of GIP receptor agonist peptides that 100% prevented emesis due to specific conditions, the claimed invention is not limited to the identified enabled subject matter. One suggestion to overcome the rejection is to exclude where treatment encompasses 100% prevention. However, other suggestions are welcomed. Therefore, contrary to Applicant’s argument, the amendments made to claims 1 and 69 do not overcome the rejection supra because the claimed invention still encompasses 100% prevention of emesis when administering any claimed sequence where emesis is caused from any condition/disease.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 69 and 98-104 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. Please note that the rejection has been updated in light of Applicants’ amendments; namely, cancellation of claim 148. Regarding claim 69, the phrase "such as" in alternatives (6) and (9) 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).
Please note that the Examiner is interpreting the scope of claim 69 such that the limitations following “such as” are separate, individual limitations recited in the Markush group in order to advance prosecution. Also please note that claims 98-104 are rejected by virtue of their dependency.
Claims 69 and 98-104 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. Please note that the rejection has been updated in light of Applicants’ amendments; namely, cancellation of claim 148. Pursuant to MPEP 2173.05(h), [a] Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. Here, claim 69 recites a Markush group as “selected from the group consisting of: ….. (2) vomiting and/or nausea induced by a chemotherapeutic drug including….; (8) pregnancy including hyperemesis gravidarium;….” (emphasis added). Pursuant to MPEP 2111.03(I), “including” is synonymous with “comprising”. Therefore, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention because it is unclear what other alternatives are intended to be encompassed by as conditions or causes that cause vomiting or nausea.
Please note that the Examiner is interpreting the scope of claim 69 such that alternative (2) recites, vomiting and/or nausea induced by a chemotherapeutic drug selected from the group consisting of….; (8) pregnancy or hyperemesis gravidarium;….” in order to advance prosecution. Also please note that claims 98-104 are rejected by virtue of their dependency.
Response to Arguments
Applicant's arguments filed 5/12/26 have been fully considered but they are not persuasive.
Applicants assert that the amendments made to claim 69 overcome the rejections (See Applicant’s Response received on 5/12/26, pg. 20). However, claim 69 still recites the language identified as rendering the claim indefinite, i.e., “such as” and “including” in a Markush group. Therefore, contrary to Applicant’s argument, the amendments made to claim 69 do not overcome the rejections supra.
Claim Rejections - 35 USC § 112
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.
Claims 65-66, 69, and 98-104 are 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. Please note that the rejection has been updated in light of Applicants’ amendments; namely, cancellation of claims 146-148. Claim 65 is directed to where the emesis comprise nausea and/or vomiting. However, as discussed in the “Claim Interpretation” section supra, emesis and vomiting are interchangeable terms since emesis is defined as the act or presence of vomiting. Thus, claim 65 encompasses an embodiment, i.e., emesis comprises vomiting, that does not further limit the scope of claim 1, which is directed to treating emesis. 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.
Please note that the Examiner is interpretating the scope of claim 65 such that the limitations are met if the limitations of claim 1 is met, in order to advance prosecution. Also, please note that claims 66, 69, and 98-104 are rejected by virtue of their dependency.
Response to Arguments
Applicant's arguments filed 5/12/26 have been fully considered but they are not persuasive.
Applicants assert that the amendments made to claim 65 overcome the rejections (See Applicant’s Response received on 5/12/26, pg. 21). However, as stated in the rejection supra, emesis and vomiting are interchangeable. Thus, the scope of claim 65 still encompasses an embodiment, i.e., vomiting, that does not further limit the scope of claim 1. Therefore, contrary to Applicant’s argument, the amendments made to claim 65 do not overcome the rejection supra.
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, 64-70, 79-82, 91-93, 95-110, and 134-141 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-7, 10-13, and 36 of copending Application No. 17/914,013 (US 2023/0143604 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘013 claims GIP receptor agonists and their use in treating emesis by administering a therapeutically effective amount of the peptide (See ‘013, claims 5-7 and 36). A peptide of ‘013 claims 5-7 encompass instant SEQ ID NOs: 27-34. As such, an ordinary skilled artisan would be motivated with a reasonable expectation of success to administer a therapeutically effective amount of one of the ‘013’s GIP peptide agonists that correspond to instant SEQ ID NOs: 27-34 in order to suppress/treat vomiting or nausea in the subject as recited in instant claims 1, 65, and 134-141 given that ‘013’s peptides were known to treat emesis. The only required agent is the GIP receptor agonist thereby constituting a monotherapy as recited in instant claim 64. Plus, the ‘013 peptide must be administered before, during or after the subject develops emesis as recited in instant claim 95.
For claims 66-70, 79-82, 91-93, and 95-97, pursuant to MPEP 804, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. See MPEP 804. Furthermore, the Federal Circuit found that “[t]he specification may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Thus, even though the instant claims recite specificities not explicitly recited by the claims of the reference application, species of the instant claims encompassed by the claims of the reference application are disclosed in the specification of the reference application, and thus the instant claims are not patentably distinct from the claims of the reference application. In the ‘013 specification, further defines what species of emesis are to be treated and subjects to be treated (See ‘013, [0051], [00230], [00378], [00384]-[00385], [00391]-[00392]); defines the therapeutically effective amount, mode of administration, and frequency of administration of the peptide (See ‘013, [0053], [00395], [00423]-[00424]). Thus, the ‘013 claimed invention encompasses the limitations as recited in instant claims 66-70, 79-82, 91-93, and 95-97. Therefore, the ‘013 claimed invention is not patentably distinct from the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 5/12/26 have been fully considered but they are not persuasive.
Applicants assert that the rejections should be withdrawn because the rejections are provisional in nature and the application is in an allowable form (See Applicant’s Response received on 5/12/26, pg. 23). However, the instant application is not in allowable form. Thus, the rejection is maintained.
Examiner Comment
Notwithstanding the 112 and obviousness-type double patenting rejections supra, the claimed invention is free of the prior art. The closest prior art is: Shelton et al. US 2017/0240609 A1 published on August 24, 2017 (cited in the Action mailed on 11/12/25). Shelton et al. teaches GIP analogues with improved half-life (See Shelton, [0010]). Shelton et al. teaches SEQ ID NOs: 12, 25, 35, and 40 as specific species of GIP analogues (See Shelton, [0383]; Table 1). SEQ ID NOs: 12, 25, 35, and 40 has the amino acid sequence of:
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35
578
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44
589
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49
575
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56
569
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See Shelton, [0383]; Table 1). As such, when comparing Shelton’s SEQ ID NO: 12 with instant SEQ ID NO: 26, there is 100% identity with the sequence, but where instant R is a C8-C20 acid (i.e., instant X), and isoGlu(PEG3)2 (i.e., instant L). When comparing Shelton’s SEQ ID NO: 25 with instant SEQ ID NO: 26, there is 100% identity with the sequence, but where instant R is a C8-C20 acid (i.e., instant X), and isoGlu(PEG3)2 (i.e., instant L). When comparing Shelton’s SEQ ID NO: 35 with instant SEQ ID NO: 25, there is 100% identity with the sequence, but where instant R is a C8-C20 acid (i.e., instant X), and isoGlu(PEG3)2 (i.e., instant L). Similarly, when comparing Shelton’s SEQ ID NO: 40 with instant SEQ ID NO: 23, there is 100% identity with the sequence, but where instant R is a C8-C20 acid (i.e., instant X), and isoGlu(PEG3)2 (i.e., instant L). However, the instant R group does not encompass where the PEG moiety is bound to the fatty acid moiety via an amino acid such as isoGlu or gammaGlu. Since there is no teaching or suggestion in the art to remove the amino acid linker, the scope of the claimed invention is free of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEA D' AMBROSIO whose telephone number is (571)270-1216. The examiner can normally be reached M-F 11:00 to 8:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654
Prosecution Insights