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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/19/2026 has been entered.
Claim 16 has been cancelled.
Claims 1-2, 5-6, 8, 11, 14, 17-19, 36-38, 40, 43, 46 and 48-49 are pending in this application.
Applicant elected with traverse of Group 1 (claims 1, 5-6, 8, 11, 14 and 16-19) and elected teduglutide as the species of GLP-2 analog, burns as the species of acute illness, subcutaneous injection as the species route of administration, and lungs as the species of organ in the reply filed on October 8, 2024. The traversal was not found persuasive and the restriction was deemed to be proper and made FINAL in the previous office action. Claims 2, 14, 36-38, 40, 43, 46 and 48-49 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claim 14 is withdrawn from further consideration as being drawn to nonelected species. Claims 1, 5-6, 8, 11 and 17-19 are examined on the merits in this office action.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Withdrawn Rejections
6. Rejection of claim 8 under 35 U.S.C. 112(d) is hereby withdrawn in view of Applicant’s amendment to the claim.
7. Rejection of claim 8 under 35 U.S.C. 112(b) is hereby withdrawn in view of Applicant’s amendment to the claim.
8. Rejection of claim(s) 1, 5-6, 8, 11 and 16-19 under 35 U.S.C. 103 as being unpatentable over Alagarsamy (US 2012/0231999 or issued as US Patent No. 8580918, cited in the previous office action), is hereby withdrawn in view of Applicant’s amendment to the claims.
New Rejections
U.S.C. 112(d)
9. 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.
10. Claim 6 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. 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.
11. Claim 6 recites, “The method of claim 1, wherein the acute illness is burns, major surgery, sepsis, an autoimmune disorder, vasculitis, thromboembolism, trauma or acute pancreatitis.” Claim 6 depends from claim 1. Claim 1 recites, “A method of suppressing systemic inflammation in the lung, in a human patient with acute illness…” Claim 6 recites illnesses that is not related to the lung, for example, burns, trauma, autoimmune disorder, surgery and so on. Therefore, claim 6 is broader than claim 1. Thus, claim 6 does not further limit instant claim 1.
U.S.C. 103
12. 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.
13. 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.
14. 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.
15. 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.
16. Claim(s) 1, 5-6, 8, 11 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arda-Pirincci et al (Peptides, 2012, 38: 238-247) in view of Alagarsamy et al (US 2012/0231999 or issued as US Patent No. 8580918, cited in the previous office action).
17. Arda-Pirincci et al teach that teduglutide is a long-acting synthetic analog of human glucagon-like peptide-2 (GLP-2). Glp-2 regulates cell proliferation and apoptosis as well as normal physiology in the gastrointestinal tract…possible cytoprotective and reparative effects of teduglutide were analyzed on a mouse model with lung injury induced by tumor necrosis factor-alpha (TNF-a) and actinomycin D (Act D). Arda-Pirincci et al teach subcutaneous injection of 200 mg/kg teduglutide every 12h for 10 consecutive days (see abstract). 200 mg/kg teduglutide is 0.2 mg/kg teduglutide, meeting the limitation of 0.05 to 1 mg/k of instant claim 8. Arda-Pirincci et al teach that acute injury accompanied by noncardiogenic pulmonary edema, pulmonary inflammation and severe systemic hypoxemia in the lung possessing high levels of TNF-a (see p. 244, right column, 1st paragraph of Discussion). Arda-Pirincci et al teach that acute lung injury is characterized by the acute inflammation of the air spaces and parenchyma with accumulation of inflammatory cells and loss of barrier function in both the alveolar epithelium and capillary endothelium (see p. 246, left column, last paragraph).
In regards to “identifying a human patient in need of treatment”, this implies that any observation by a physician and being determined that the patient has the disease or disorder.
Applications and patents are relevant as prior art for all they contain. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).
Furthermore, with respect to “wherein the systemic inflammation in the lung is suppressed by reducing expression or preventing an increase in the expression of one or more cytokines (claim 17); wherein the systemic inflammation in the lung is suppressed by preventing an increase in lipopolysaccharide concentrations in the patient’s portal venous blood (claim 19)” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features. Arda-Pirincci et al anticipates instant claims 1 in part, 5, 8, 11 and 17-19.
The difference between Arda-Pirincci et al and the instant claims is that the reference does not teach that the GLP-2 analog is administered between 6 hours and 12 hours after systemic inflammation is induced, the acute illness is burns, and the patient in human.
18. However, Alagarsamy et al teach GLP-2 analogs with improved pharmacokinetic properties and treatment of diseases (see abstract). Alagarsamy et al teach that “intestines can be damaged through both chemotherapy and radiation treatment for cancer. Administration of teduglutide (a GLP-2 analog) prior to gamma irradiation showed a protective effect in mice” (see for example, paragraph [0013]). Alagarsamy et al teach method of treating one of the group consisting of gastrointestinal injury…sepsis…burn-induced intestinal damage…inflammatory bowel disease…bowel trauma…Crohn’s Disease…(see paragraph [0048]). Further, Alagarsamy et al teach medicament for treating one of the group consisting of gastrointestinal injury…sepsis…burn-induced intestinal damage…irritable bowel disease…bowel trauma…Crohn’s Disease and ulcerative colitis (see paragraph [0052]). Alagarsamy et al teach further teach that the pharmaceutical composition may be adapted for oral, intravenous, topical…subcutaneous administration (see for example, paragraph [0114]). Alagarsamy et al teach that typical dosage of the compounds varies within a wide range and will depend on various factors such as the individual needs of each patient and the route of administration. The dosage may be administered once daily or more frequently than once daily…within the range of 0.01-5000 mg, e.g., from 100 to 2000 mg per day, e.g., by subcutaneous injection (see for example, paragraph [0123]).
19. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Arda-Pirincci et al and Alagarsamy to suppress systemic inflammation in the lung by administering an effective amount of a GLLP-2 analog, teduglutide, because both references teach administering teduglutide to suppress systemic inflammation in a patient in need thereof. One of ordinary skill in the art would be motivated to combine with a reasonable expectation of success, since Arda-Pirincci et al teach subcutaneous injection of teduglutide every 12h for 10 consecutive days implies that 12 hours after inflammation is induced, and Alagarsamy et al teach administration of teduglutide subcutaneous injection to treat one of the group consisting of gastrointestinal injury…sepsis…burn-induced intestinal damage…inflammatory bowel disease…bowel trauma…Crohn’s Disease. Thus, one would have a reasonable expectation that the combining the teachings would optimize the treatment of systemic inflammation including in the lungs.
Additionally, it would have been obvious to one of ordinary skill in the art to optimize the dosage and time point of administration of the pharmaceutical composition because Alagarsamy et al teach that the administration of teduglutide (a GLP-2 analog) prior to gamma irradiation showed a protective effect and that the dosage may be administered once daily or more frequently than once daily…within the range of 0.01-5000 mg, e.g., from 100 to 2000 mg per day, e.g., by subcutaneous injection, and Arda-Pirincci et al teach administering every 12 hours. The MPEP states that “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“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) (Claimed elastomeric polyurethanes 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.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).” One of ordinary skill in the art would be motivated to optimize with a reasonable expectation of success, since “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.” Additionally, the Alagarsamy et al suggests that typical dosage of the compounds varies within a wide range and will depend on various factors such as the individual needs of each patient and the route of administration. Therefore, the teachings of Arda-Pirincci et al and Alagarsamy et al are obvious over instant claims 1, 5-6, 8, 11 and 17-19.
CONCLUSION
No claim is allowed.
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/JULIE HA/Primary Examiner, Art Unit 1654
7/2/2026
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