DETAILED ACTION
Examiner acknowledges receipt of the reply filed 12/24/2025, in response to the non-final office action mailed 7/01/2025.
Claims 1, 2, 10, 14, 15, 18, 20, 21, 33, 34, 37, 38, 40, 41, 44, 45, 50, 51, 53, and 56 are pending. Claim 12 has been canceled. Claims 33, 34, 37, 38, 40, 41, 44, 45, 50, 51, 53, and 56 are withdrawn for reasons made of record.
Claims 1, 2, 10, 14, 15, 18, 20, and 21 are being examined on the merits in this office 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 .
Examiner Comment
Claim 12 was improperly canceled. A cancelled claim should not recite any claim language. Claim 11 is a correct example of claim cancellation. Compare with claim 12.
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Drawings- withdrawn
The drawings are objected to for the following reasons. The objection is withdrawn in view of the amendment filed 12/24/2025.
Claim Objections- withdrawn
The objection of claims 1, 12, and 18 is withdrawn in view of the amendment filed 12/24/2025.
Claim Rejections - 35 USC § 112- withdrawn
The rejection of claims 1, 2, 10, 12, 14, 15, 20, and 21 under 35 U.S.C. 112, first paragraph (written description), is withdrawn in view of the amendment filed 12/24/2025.
The rejection of claims 2, 14, and 15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 12/24/2025.
The rejection of claim 2 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn in view of the amendment filed 12/24/2025.
Response to Arguments
Applicant’s amendment and arguments, filed 12/24/2025 with respect to the above objections and rejections have been fully considered and are persuasive. Therefore, the objections and rejections have been withdrawn.
Applicant's arguments filed 12/24/2025 have been fully considered but they are not persuasive with respect to the maintained rejections.
Upon further consideration, a new ground(s) of objection is made in view of the amendment to the specification filed 12/24/2025.
An action on the merits is set forth herein.
Specification
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.
New objection
Sequence Compliance- New
This is a new objection necessitated by the amendment filed 12/24/2025.
Applicant amended the figure legend of Figure 4 to correlate with Figs 4A-4F. However, Applicant removed reference to the SEQ ID NO.
This application is objected to because the peptide sequences in Fig 4 at para. [0029] is not associated with a sequence identifier (a SEQ ID NO). All sequences longer than ten nucleotides or four amino acids referenced in the specification must include a SEQ ID NO and must be included in the Sequence Listing. See MPEP § 2421-2422. Applicant must amend the specification in response to this office action and must confirm that all peptide sequences of the specification are included in the sequence listing. Examiner requests that the Applicants review the specification to confirm that all of the peptides, as required, comply with MPEP § 2421-2422.
Maintained Rejections
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.
Claim 18 remains/is 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. The rejection is maintained from the office action mailed 7/01/2025, but has been amended to reflect claims filed 12/24/2025.
Claim 18 recites the limitation "the formula (FX2)". There is insufficient antecedent basis for this limitation in the claim.
Response to Arguments
Applicant asserts that the amendments overcome the rejection (reply filed 12/24/2025, p. 14). Applicant’s amendment did not address the rejection:
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the claim still recites “the formula (FX2)”.
Examiner recommends that the claim be amended to recite “characterized by [[the]] formula (FX2)”.
Claim Rejections - 35 USC § 103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1, 2, 10, 12, 14, 15, 18, and 20 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Holt et al (J. Cardiothoracic Vasc Anest 24:330-347 (2010)- previously cited), and further in view of Tan et al (Curr Pharma Design 24:4932-4946 (2018)- previously cited) and Lau et al (J Med Chem 58: 7370-7380 (2015)- previously cited). This rejection is maintained from the office action mailed 7/01/2025, but has been amended to reflect claims filed 12/24/2025.
Holt et al teach is a review article discussing vasopressin, and its analogs terlipressin (TP) and desmopressin (DDAVP) (p. 333, Fig. 3). Vasopressin was named for the early observation of its vasoconstrictive properties (also known as arginine vasopressin and antidiuretic hormone (ADH)) (p. 330). VP is a cyclic peptide containing 9 amino acids, including 2 cysteines bridged by a disulfide bond (p. 330, Fig 3). The amino acid sequences of terlipressin and desmopressin are disclosed in Fig. 3. Vasopressin and its analogs have been used in the treatment of various disorders including hepatorenal syndrome (HRS), hemophilia, hypotension, diabetes insipidus, septic shock, and cardiac arrest (pp. 332-339).
Holt et al do not expressly teach an N-terminal aliphatic chain as required by claim 1.
Tan et al. teach half-life extension strategies for therapeutic peptides and proteins that increase the stability and bioavailability of the peptide (abstract, 4932-4933). Lipidation is a technique wherein peptides and proteins conjugate with human serum albumin (HSA) in a noncovalent manner via fatty acid binding. Biopharmaceuticals containing a fatty acid are released gradually into circulation, resulting in a protracted half-life. Lipidation has been well established and used in approved peptide pharmaceuticals. Fatty acid modifications that have been used in the art include palmitic acid (C16) and stearic acid (C18) (p. 4937).
Lau et al teach fatty acid moiety conjugates that were assessed for the GLP-1 analog semaglutide. Fatty acids included C16, C18, and C20. Fatty diacids included chain lengths of C12, C14, C16, C18, C20, and C22 (Fig 1). The reference teaches preparation of peptide- fatty acid conjugation (pp. 7377-7378).
It would have been obvious to one of ordinary skill in the art to seek strategies to expand the half-life of therapeutic compositions comprising vasopressin and its analogs (e.g., terlipressin and desmopressin). The skilled artisan would have known that Holt et al discussed vasopressin and its analogs, as well as disorders that the peptides could be used to treat. Tan et al taught various techniques and half-life extension strategies that further stabilized and improved bioavailability of peptides. Lipidation, in which a fatty acid is conjugated to a peptide, was one such technique known in the prior art. The skilled artisan would further have recognized that Lau et al taught specific fatty acids and fatty diacids that could be used in lipidation to extend the half-life of vasopressin and its analogs.
The U.S. Federal Circuit has explicitly stated that in order to make a prima facie case of obviousness, the suggestion and motivation to combine the references need not be explicitly stated in the text of the references. In DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 80 USPQ2d 1641 (Fed. Cir. 2006), the Court writes, “the suggestion test is not a rigid categorical rule. The motivation need not be found in the references sought to be combined, but may be found in any number of sources, including common knowledge, the prior art as a whole, or the nature of the problem itself. In re Dembiczak, 175 F.3d 994, 999 [50 USPQ2d 1614] (Fed. Cir. 1999). As we explained in Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461, 1472 [43 USPQ2d 1481] (Fed. Cir. 1997), ‘there is no requirement that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art.’” See Dystar at 1645. “Our suggestion test is in actuality quite flexible and not only permits, but requires, consideration of common knowledge and common sense.” See Dystar at 1650.
Additionally, it would have been obvious to one of ordinary skill in the art to combine the teachings of Holt et al and Tan et al because both Tan taught methods to further stabilize therapeutic peptides, e.g., vasopressin and terlipressin of Holt. One of ordinary skill in the art would have been be motivated to combine Lau et al because the reference explicitly taught fatty diacids that were known in the prior art and commercially used in lipidation of therapeutic peptides. One of ordinary skill in the art would be motivated to try with a reasonable expectation of success. It has been held that under KSR that “obvious to try” may be an appropriate test under 103. The Supreme Court stated in KSR, When there is motivation “to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination of permeation enhancers (e.g., sodium caprate and sodium caprylate) was obvious to try might show that it was obvious under § 103.” KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727,_,82 USPQ2d 1385, 1397 (2007).
The “problem” facing those in the art was techniques that extended the half-life of therapeutic peptides. Tan et al. taught specific strategies and Lau taught specific
fatty diacids that could be included in lipidation of vasopressin or terlipressin to prepare a compound of formula FX1. Lau et al explicitly taught 6 fatty diacids (C12, C14, C16, C18, C20, and C22 (Fig 1)). The skilled artisan would have had a reasonable expectation of success because Lau et al specific fatty diacids that were functionally useful, as well as methods of preparing the fatty diacid - peptide conjugates. Accordingly, claim 1 is rendered obvious.
Regarding claim 2, Lau et al teach that the aliphatic group of the fatty diacids can bind to the peptide via an amide bond or an organic group (Fig. 1). Regarding claim 10, Lau et al teach fatty diacids included chain lengths of C12, C14, C16, C18, C20, and C22 (Fig. 1) [reads on X1 variable]. Regarding claims 14 and 15, SEQ ID NO:1 has 100% identity with terlipressin (Holt et al at Fig 3). Regarding claim 18, FX2 includes the cyclic peptide structure of terlipressin which has a disulfide between the cysteine residues (Holt et al at Fig 3). Lau et al further teach the fatty diacid C18 can be attached to a peptide via an amide bond. Accordingly, the structure of FX2- wherein X1 is a carboxylic acid, X2 is X16, Z2 is an amide group between the carboxylic acid of C18 diacid and amino terminal group of glycine of terlipressin, and A2 is terlipressin is deemed to be obvious in view of the teachings of the cited references. Regarding claim 20, Holt et al teach that vasopressin and its analogs have been used in the treatment of various disorders including hepatorenal syndrome (HRS), hemophilia, hypotension, diabetes insipidus, septic shock, and cardiac arrest (pp. 332-339). Compositions comprising vasopressin and its analogs for purposes of medical administration and treatment is construed as reading on pharmaceutical compositions comprising the peptides.
Accordingly, claims 1, 2, 10, 14, 15, 18, and 20 are rendered obvious in view the teachings of the cited references.
Pursuant to MPEP 2121(I), when the reference relied on expressly anticipates or makes obvious all the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Moreover, MPEP 2121(III) states that a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). MPEP 716.07 states that since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969).
Response to Arguments
Applicant traverses the rejection at pages 14 -17 of the reply filed 12/24/2025. Applicant asserts that the cited references do not provide a reasonable expectation of success in arriving at the claimed compound (reply at p. 15).
Applicant asserts that Holt is limited to vasopressin and related analogs. Applicant asserts that Tan is directed to different peptides and “is a broad review of half-life extension strategies” and alleges liquidation is “used mainly for insulin and GLP-1 analogue”. Applicant asserts that Lau is limited to development of GLP-1 analogue semaglutide. Id. Applicant alleges that the office relies on a general proposition of strategies relating to half-life of therapeutic compositions but does not provide a “reasons basis, grounded in the prior art, for selecting and implementing the specific claimed albumin binding conjugate framework with a reasonable expectation of success” (reply at p. 16). Applicant asserts that Lau indicates that increasing lipophilicity tends to reduce receptor potency and the only a narrow subset of fatty acid/diacid + linker combinations preserve adequate GLP-1 receptor activity. Id. Applicant alleges that Lau does not portray limitation as a predictable “plug-and-play” modification. Applicant asserts that “there is no teaching that the GLP-1 specific solution suggested in Tan or Lau could be transplanted into the vasopressin receptor context” relating to shorter cyclic peptides. Id.
Examiner has reviewed and considered applicants arguments but is not persuaded.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Holt et al teach vasopressin, and its analogs terlipressin (TP) and desmopressin (DDAVP) (p. 333, Fig. 3). The reference discloses that vasopressin has a short half-life, and analogs with longer half-lives have been developed, e.g., terlipressin. The skilled artisan would have recognized that Tan et al taught that peptides containing a fatty acid modification (lipidated) are released gradually into circulation, resulting in a protracted half-life. Lipidation has been well established and used in approved peptide pharmaceuticals. Fatty acid modifications that have been used in the prior art include palmitic acid (C16) and stearic acid (C18) (p. 4937). Lau was cited for the purpose of establishing specific fatty acids and fatty diacid moieties (chain lengths of C12, C14, C16, C18, C20, and C22 (Fig 1); A1-X1-X2- moiety of claimed formula FX1) and known methods of preparation of peptide- fatty acid conjugation (pp. 7377-7378).
Thus, it would have been obvious to one of ordinary skill in the art to combine the teachings of Holt et al and Tan et al because both Tan taught methods to further stabilize therapeutic peptides, e.g., vasopressin and terlipressin of Holt. One of ordinary skill in the art would have been be motivated to combine Lau et al because the reference explicitly taught fatty acids and diacids that were known in the prior art and commercially used in lipidation of therapeutic peptides. One of ordinary skill in the art would be motivated to try with a reasonable expectation of success.
Examiner refers applicant to the above 103 rejection for full analysis.
Contrary to applicant’s assertions, MPEP guidelines require a “reasonable” expectation of success, there is no requirement of a guarantee of success. Conclusive proof of efficacy is NOT required to show a reasonable expectation of success. Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQe2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367-68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")). See MPEP § 2143.02.
Examiner further notes that contrary to Applicant’s assertions, Lau provides guidance for the skilled artisan to consider with regard to optimizing the fatty acid chain length and linker with respect to retaining peptide functional activity (pp. 7371-7375).
Accordingly, the rejection is maintained for at least these reasons and those previously made of record.
Claim(s) 1, 2, 10, 14, 15, 18, 20, and 21 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Holt et al (J. Cardiothoracic Vasc Anest 24:330-347 (2010)- previously cited), Tan et al (Curr Pharma Design 24:4932-4946 (2018)- previously cited) and Lau et al (J Med Chem 58: 7370-7380 (2015)- previously cited), as applied to claims 1, 2, 10, 14, 15, 18, and 20 above, and further in view of Uriz et al (J Hepatology 33:43-48 (2000)- previously cited). This rejection is maintained from the office action mailed 7/01/2025, but has been amended to reflect claims filed 12/24/2025.
The teachings of Holt et al, Tan et al, and Lau et al are set forth above. Holt et al teach that terlipressin is used in the treatment of hepatorenal syndrome (HRS) (p. 336).
Uriz et al teach that administration of a combination of terlipressin and albumin (human serum albumin, HSA) showed reversal of hepatorenal syndrome (abstract, pp. 46-47). Patients exhibited improvement in circulatory function and suppression of vasoconstrictive systems activity (plasma renin activity and plasma norepinephrine decreased) (abstract).
It would been obvious to one of ordinary skill in the art to prepare a pharmaceutical composition comprising a compound of FX2 (comprising a C18 diacid and terlipressin) and human serum albumin (HSA) for use in treating hepatorenal syndrome (HRS). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). See M.P.E.P. § 2144.06. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969).
Accordingly, claim 21 is rendered obvious.
Claims 1, 2, 10, 14, 15, 18, 20, and 21 are rendered obvious in view the teachings of the cited references.
Pursuant to MPEP 2121(I), when the reference relied on expressly anticipates or makes obvious all the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Moreover, MPEP 2121(III) states that a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). MPEP 716.07 states that since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969).
Response to Arguments
Applicant traverses the rejection at pages 17-18 of the reply filed 12/24/2025. Applicant asserts that the above rebuttal arguments also apply to the rejection over Holt, Tan, Lau, and Uriz (reply at p. 17). Applicant asserts that Uriz is limited to teaching coadministration of terlipressin and albumin, and does not teach the structural framework of formula FX1. Applicant alleges that the cited references do not teach the combination of claimed a conjugate of formula FX1 and human serum albumin, nor provide a reasonable expectation of success. Id. Applicant asserts that the albumin -containing formulations described in Uriz are applied in a different context without the structural constraints/variables of A2, X1, and X2. Id. Applicant asserts that Lau “warns the increasing albumin binding can significantly decrease the free active fraction and diminished potency, potentially requiring increased dosing” (referencing p. 7371 of Lau). Applicant asserts that Lau does not supply a generalized reasonable expectation of success the skilled artisan could apply to a different peptide class. Applicant asserts that the interaction between the claimed conjugates and HSA is not rendered obvious simply because the skilled artisan would have known that albumin could be used with unmodified terlipressin in some contexts. Id.
Examiner has reviewed and considered applicants arguments, but is not persuaded.
The Office’s rebuttal of the above arguments remains the same and is incorporated herein by reference.
As noted above, Tan provides guidance regarding established methods of lipidation that increase the stability and bioavailability [half-life] of a peptide. Lau further provides specific fatty acid and diacid moieties [reads on A1-X1-X2 of formula FX1], and methods of preparation of peptide-fatty acids. Lau taught specific examples of fatty acids and diacids that could increase the stability and bioavailability of a peptide; e.g., fatty diacid C18 can be attached to a peptide via an amide bond. Holt teach that vasopressin and its analogs can be used to treat hepatorenal syndrome (HRS). Uriz teach that a combination of terlipressin and albumin (human serum albumin, HSA) can also be used to treat hepatorenal syndrome.
The examiner finds no evidence from the prior art that suggests a pharmaceutical composition comprising a combination of human serum albumin and a compound of FX1 would not retain their individual functions and ability to treat hepatorenal syndrome. Examiner expressly notes that the A1-X1-X2 moiety of formula FX1 (e.g., fatty diacid C18- amide bond-) improved stability and bioavailability of vasopressin or an analogue thereof [A2 moiety of formula FX1]. Examiner further notes that Lau provides guidance for the skilled artisan to consider with regard to optimizing the fatty acid chain length and linker with respect to retaining peptide functional activity (pp. 7371-7375).
Accordingly, the rejection is maintained for at least these reasons and those previously made of record.
Relevant Art not relied upon
Wang et al (Environmental science and pollution research 19:609-614 (2002)- previously cited) teach reversible fatty acid-desmopressin (DDAVP) conjugates (abstract). Fatty acids included acetic acid, hexanoic acid, decanoic acid, palmitic acid, and stearic acid. The fatty acid-desmopressin (DDAVP) conjugates of Wang et al differ from the instant claims. The instant claims require an A1 variable there is a carboxylic acid group, a carboxylate anion, or carboxylate ester. The conjugates of Wang et al do not include an A1 variable. Instead, the conjugates of Wang et al begin with the aliphatic group, X1 variable of formula FX1.
Conclusion
No claims are allowed.
Claims 1, 2, 10, 14, 15, 18, 20, 21, 33, 34, 37, 38, 40, 41, 44, 45, 50, 51, 53, and 56 are pending. Claims 33, 34, 37, 38, 40, 41, 44, 45, 50, 51, 53, and 56 are withdrawn.
Claims 1, 2, 10, 14, 15, 18, 20, and 21 are rejected.
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 KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 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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/KRISTINA M HELLMAN/ Examiner, Art Unit 1654
/JULIE HA/ Primary Examiner, Art Unit 1654
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