DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicants’ election with traverse of Group I (i.e., claims 1-9 and 12-18, drawn to a compound represented by the formula or a pharmaceutically acceptable salt thereof, SEQ ID NOs: 1, 2, 3, 4) in the reply filed on 03/23/2026 is acknowledged. The traversal is on the ground(s) that Group I and Group II share common technical features and Group III and Group IV are respectively treatment methods comprising the compounds of Group I and Group II; all the groups should be examined together without any undue burden being placed on the Examiner. This is not found persuasive because, the chemical compounds of Group I and Group II do not share a common special technical relationship, thus do not relate to a single general inventive concept under PTC Rule 13.1. With respect to the search burden, undue search burden is not a criteria for election/restriction purposes under 35 USC §121 and 35 USC § 372. The requirement is still deemed proper and is therefore made FINAL.
Applicants’ election of a single and specific compound represented by a single and specific pharmaceutically acceptable salt thereof, including ALL variables to arrive at a compound represented by SEQ ID NOs: 1, 2, 3 or 4 (Applicants’ elected species: compound WX-001 which falls within the scope of SEQ ID NO: 1) in the reply filed on 03/23/2026 is acknowledged.
Claims 11 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 5, 9-10, 14 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
Applicant timely traversed the restriction (election) requirement in the reply filed on 03/23/2026.
Claim Status
Claims 1-11 were originally filed and amended on 05/31/2023. The amendment added new claims 12-19; and amended claims 2-11.
The amendment filed on 03/23/2026, amended claim 10.
Priority
The present application claims status as a 371 (National Stage) of PCT/CN2021/135180 filed 12/02/2021, and claims priority under 119(a)-(d) to Chinese Application No. 202110587056.1 filed on 05/27/2021; Chinese Application No. 202110432060.0 filed on 04/21/2021; Chinese Application No. 202011402979.7 filed on 12/02/2020; and Chinese Application No. 202011409947.X filed on 12/02/2020.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) Application No. 202110587056.1; Application No. 202011402979.7; Application No. 202011409947.X and Application No. 202110432060.0 which papers have been placed of record in the file. However, the above mentioned applications are in a foreign language and thus cannot be verified.
Information Disclosure Statement
The Information Disclosure Statements filed on 09/01/2023; 03/21/2024; 09/04/2024; 05/21/2025 and 01/05/2026 have been considered by the Examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: The claim recites 4 different amino acid sequences, which are identified by a sequence identification number which should be abbreviated as SEQ ID NO: followed by an integer (e.g., SEQ ID NO: 1). Additionally, each sequence should be separated by a punctuation mark (e.g., comma or semicolon). Appropriate correction is required.
Claim Interpretation
Regarding claim 1, the scope of a compound represented by the formula or pharmaceutically acceptable salt of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3 or SEQ ID NO: 4 is being interpreted as requiring the full-length sequence with 100% identity to any of SEQ ID NO: 1 or SEQ ID NO: 2 or SEQ ID NO: 3 or SEQ ID NO: 4 with any N-/C- terminal additions.
With respect to the scope of the lysine represented by K1 in instant SEQ ID NO: 1 and Applicants’ elected species for X-X1-X2 wherein X is
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; X1 is
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m is 2 and n is 2; and X2 is
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. The Examiner is interpreting Applicants’ election for X as a carbonyl group attached to a methylene group (i.e., -C(=O)-CH2), for X1 as AEEA-AEEA-γGlu, and for X2 as a lipophilic moiety with a hydrocarbon chain of 17 C atoms.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
103 - KSR Examples of 'Rationales' Supporting a Conclusion of Obviousness
(Consistent with the "Functional Approach" of Graham)
Further regarding 35 USC 103(a) rejections, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) (KSR) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Also, a reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
1. Claims 1-5, 6-8, 12-13 and 15-17, are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0299281 A1 Pub. Date: Oct. 22, 2015 (herein after “Just et al.”); US 9,474,780 B2 Date of Patent: Oct. 25, 2016 (herein after “Bokvist et al”); and WO2015/184177 A1 International Publication Date: Dec. 3, 2015 (herein after “Nestor”).
Regarding claim 1, Just et al. teach GIP-GLP dual acting receptor agonist, which are closely related to the instantly claimed compounds. In particular, Just et al. teach a GIP analogue represented by the general Formula I, SEQ ID NO: 59 (see pg. 8, para[0044]). Just et al.’s Formula I, comprises Aib at X2, Aib at X13, Lys at X17 (i.e., instant K1), Gln at X19 (i.e., instant Z0 ), Lys at X20 (i.e., instant K0), Ala at X21 (i.e., instant Z1), Val at X23 (i.e., instant Z2), Glu at X24 (i.e., instant E0); R2 is OH or NH2 (i.e., amidated as in instant S0). Thereby, Just et al.’s SEQ ID NO: 59 corresponds to a compound or a pharmaceutically acceptable salt thereof represented by YAibEGTFTSDYSIAibLDKK1AZ0K0Z1FZ2E0WLZ3AGG PSSGAPPPS0 (i.e., instant SEQ ID NO: 1).
Moreover, Just et al. also teach that in certain embodiments, a GIP analogue of the invention is conjugated with a lipophilic substituent to one or more of amino acid positions 16, 17, 19, 20, 24, 27, 28, 30 and 32 (see pg. 22, para[0111]). And that it is thought that the lipophilic substituent binds albumin in the blood stream, thus shielding the GIP analogue compounds from enzymatic degradation which can enhance the half-life of the compounds; additionally, the lipophilic substituent may also modulate the potency of the compound, e.g., with respect to the GIP receptor and/or the GLP-1 receptor. (see pg. 21, para[0100]).
However, Just et al. do not expressly teach wherein K1 indicates that the amino group on the side chain of the lysine is connected to -X-X1-X2 wherein X
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, X1
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m is 2, n is 2; X2 is
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, as recited in instant claim 1.
Bokvist et al. teach GLP-1/GIP dual agonist comprising a Lys utilized for conjugation, in particular the lys at position 20 is chemically modified through conjugation to the epsilon-amino group of the K side-chain with ([2-(2-Amino-ethoxy)-ethoxy]-acetyl)2-(γGlu)a-CO—(CH2)b—CO2H wherein a is 1 to 2 and b is 10 to 20 (see column 2, lines 42-62). Thereby Bokvist et al.’s ([2-(2-Amino-ethoxy)-ethoxy]-acetyl)2-(γGlu)1 read on K1 wherein the amino group on the side chain of the lysine is connected to X1 (i.e.,
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where m is 2 and nis 2), and CO—(CH2)b—CO2H corresponds to instant X2 wherein q is 17 (i.e.,
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).
Bokvist et al. add that the fatty acid is conjugated to the epsilon amino group of a lysine side-chain through a linker and that the linker comprises 2-(2-Amino-ethoxy)-ethoxy-acetyl)- (γGlu)a, wherein a is 1 to 2 (see column 7, lines 18-21). The fatty acid and the gamma glutamic acid in the linker act as albumin binders, and provide the potential to generate long-acting compounds (see column 7, lines 22-24). Thus Bokvist ([2-(2-Amino-ethoxy)-ethoxy]-acetyl)2-(γGlu)a-CO—(CH2)b—CO2H wherein a is 1 to 2 and b is 10 to 20, reads on X1-X2 wherein X1
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m is 2, n is 2; and X2 is
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, as recited in instant claim 1.
With respect to wherein X in K1 is
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wherein R1 and R2 are independently selected from H: Pursuant to MPEP 2144.09, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990). Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007).
From the teachings of the references, the Examiner recognizes that it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Just et al. with those of Bokvist et al. in order to arrive at the claimed compound wherein K1 indicates that the amino group on the side chain of the lysine is connected to -X-X1-X2 as recited in instant claim 1. One of ordinary skill in the art would have been motivated to do so because Just et al.’s GIP-GLP dual acting receptor agonist represented by the general Formula (I), i.e., SEQ ID NO: 59, is the same length as instant SEQ ID NO: 1, and comprises a Lys at position X17, thereby corresponding to instant K1; and because the GIP-GLP co-agonist of Just et al. can be chemically modified by introducing a lipophilic substituent at a lysine residue, in particular at one or more of amino acid positions 16, 17, 19, 20, 24, 27, 28, 30 and 32. One of ordinary skill in the art would have been motivated to do so because it was known that that lipophilic substituents bind albumin in the blood stream, thus shielding the GIP analogue compounds from enzymatic degradation thereby enhancing the half-life of the compounds; and modulating the potency of the compound, e.g., with respect to the GIP receptor and/or the GLP-1 receptor, as taught by Just et al.
Thus, one of ordinary skill in the art would have had a reasonable expectation of success to modify the lysine at position 17 in Just et al.’s SEQ ID NO: 59 given that Bokvist et al.’s GLP-1/GIP dual agonist comprises a Lys modified through conjugation to the epsilon-amino group of the K side-chain with ([2-(2-Amino-ethoxy)-ethoxy]-acetyl)2-(γGlu)a-CO—(CH2)b—CO2H wherein a is 1 to 2 and b is 10 to 20. One of ordinary skill would have had a reasonable expectation of success given that the fatty acid and the gamma glutamic acid in the linker act as albumin binders, and provide the potential to generate long-acting compounds, as taught by Bokvist; and given that some GIP analogues taught by Just et al. comprise a lipophilic substituent to one or more of amino acid positions 16, 17, 19, 20, 24, 27, 28, 30 and 32. Therefore, combining the teachings of Just et al. with the teachings of Bokvist et al. would support the instantly claim compound represented by the following formula or pharmaceutically acceptable salt thereof, SEQ ID NO: 1 YAibEGTFTSDYSIAibLDKK1AZ0K0Z1FZ2E0WLZ3AGGPSSGAPPPS0 wherein K1 indicates that the amino group on the side chain of the lysine is connected to -X-X1-X2; by constitution some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention, pursuant to KSR.
With respect to wherein E0 and K0 indicate that the carboxyl group on the side chain of the glutamic acid and the amino group on the side chain of the lysine jointly form a lactam structure wherein K0Z1FZ2E0 has a structure of
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, as recited in instant claim 1.
Just et al. teach that the GIP-GLP co-agonist can be chemically modified by introducing an intramolecular bridge between a Glu and a Lys residue, or introduce a lipophilic substituent at a lysine residue (see pg. 25, para[0139]). Just et al. do not expressly teach an intramolecular bridge between any particular Glu and Lys residues comprised by Formula I; however it is described that that in preferred embodiments, the GIP analogue comprises Glu at position 24 (see pg. 8, para[0043]). Since the residue at position X20 in Just et al. SEQ ID NO: 59 is lys; it would follow that the intramolecular bridge would form between the Lys at position X20 and the preferred Glu at position X24.
Furthermore, Nestor is in the field of improved peptide pharmaceuticals for insulin resistance (see front pg., Title), and describes covalently modified peptides and/or proteins (for example GLP-1, glucagon, related analogs or the like) that allow for longer duration of action and /or improved bioavailability upon administration of the modified peptides and/or proteins (see para[004]). In particular Nestor teaches a peptide of formula II (i.e., SEQ ID NO: 1), which is comprises 37 amino acids in length (i.e., aa1-aa37) and wherein any two of aa1-aa37 are optionally cyclized through their side chains to form a lactam linkage (see para[006]). Some of Nestor’s embodiments denote the lactam linkage with an asterisk on the two residues so linked, for example a Lys* side chain forms a cyclic lactam with the side chain of Glu* or that the lactam structures are reversed and are formed from a Glu* and a Lys* (see para[028]). Nestor also teaches that the lactam linkages in some instances are known to stabilize alpha helical structures in peptides (see para[028]).
Additionally, even if Nestor did not expressly teach that the carboxyl group on the side chain of the glutamic acid and the amino group on the side chain of the lysine jointly form a lactam structure wherein K0Z1FZ2E0 has a structure of
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. Since Nestor teaches glucagon related analogs or the like, wherein any two of the aa1-aa37 residues are optionally cyclized through their side chains, and wherein Lys and Glu residues denoted with an asterisk form the lactam linkage, thereby constituting a well-known lactam linkage, the functional properties of the amino group on the side chain of the lysine (i.e., K0) and the carboxyl group on the side chain of the glutamic acid (i.e., E0)as claimed and the known Lys and Glu amino acids would necessarily read upon the same. The discovery of a previously unappreciated property of a prior art composition, or a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of “new” functional properties (i.e., lactam structure
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formed by K0 and E0 as part of K0Z1FZ2E0) which would necessarily read upon the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 4333 (CCPA 1977). Thereby Nestor’s teachings read on a lactam bridge formed between the lysine represented by K0 and the glutamate represented by E0 in instant SEQ ID NO: 1, and also read on an amidated serine represented by S0 in instant SEQ ID NO: 1.
Therefore an ordinary skilled artisan would have been motivated with reasonable expectation of success to incorporate Nestor’s teachings as part of Just et al.’s GIP-GLP dual acting receptor agonist in order to arrive at the instantly claimed compound represented by the following formula or a pharmaceutically acceptable salt thereof, SEQ ID NO: 1 YAibEGTFTSDYSIAibLDKK1AZ0K0Z1FZ2E0WLZ3AGG PSSGAPPPS0 wherein K0Z1FZ2E0 has a structure of
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. One of ordinary skill in the art would have been motivated with reasonable expectation of success because it was known that lactam linkages stabilize alpha helical structures in peptides; and because it was also known that any two residues in the GLP-1 analog of Nestor, in particular Lys and Glu, are cyclized through their side chains to form a lactam linkage. Thus, combining the teachings of Just et al. with the teachings of Nestor would support the instantly claimed invention by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention; and/or the use of known technique to improve similar devices (methods, or products) in the same way, pursuant to KSR.
Regarding claim 2; MPEP 2112.01(II) states that “[p]roducts of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. As previously mentioned; Just et al. teach a GIP analogue represented by the general Formula I, SEQ ID NO: 59 (see pg. 8, para[0044]). Just et al.’s Formula I, comprises Lys at X20 which corresponds to instant K0; Ala at X21 which corresponds to instant Z1; Val at X23 which corresponds to instant Z2; Glu at X24 which corresponds to instant E0. Just et al. also teach that in preferred embodiments, the GIP analogue comprises Glu at position 24 (see pg. 8, para[0043]). Since Just et al. teach that the GIP-GLP co-agonist can be chemically modified by introducing an intramolecular bridge between a Glu and a Lys residue; it would follow that that the intramolecular bridge would form between the Lys at position X20 and the preferred Glu at position X24. Thereby, Just et al.’s SEQ ID NO: 59 reads on a compound or a pharmaceutically acceptable salt thereof represented by YAibEGTFTSDYSIAibLDKK1AZ0K0Z1FZ2E0WLZ3AGG PSSGAPPPS0 (i.e., instant SEQ ID NO: 1) and also represented by (P-1) as recited in instant claim 2.
Regarding claims 3-4, 6-8, 12-13 and 15-17, Bokvist et al.’s teachings pertain to a modified lysine which carries a ([2-(2-Amino-ethoxy)-ethoxy]-acetyl)2-(γGlu)a-CO—(CH2)b—CO2H wherein a is 1 to 2 and b is 10 to 20, through conjugation of the epsilon-amino group of the K side-chain (see column 2, lines 42-62). As previously discussed, Bokvist et al.’s ([2-(2-Amino-ethoxy)-ethoxy]-acetyl)2-(γGlu)a-CO—(CH2)b—CO2H wherein a is 1 to 2 and b is 10 to 20 read on X-X1-X2 wherein X
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, as recited in instant claim 1.
Additionally, pursuant to MPEP 2144.09, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990). Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007).
Thus, an ordinary skilled artisan would have been motivated with reasonable expectation of success, after reading Bokvist et al. to attach ([2-(2-Amino-ethoxy)-ethoxy]-acetyl)2-(γGlu)a-CO—(CH2)b—CO2H wherein a is 1 to 2 and b is 10 to 20, to the amino group on the side chain of the lysine represented by K1 in instant SEQ ID NO: 1. One of ordinary skill would have done so because ([2-(2-Amino-ethoxy)-ethoxy]-acetyl)2-(γGlu)a- wherein a is 1 corresponds to instant
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wherein m is 2 and n is 2; and -CO—(CH2)b—CO2H wherein b is 10 to 20 corresponds to instant
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wherein q is 17. Since all the claimed elements were known in the prior art and since one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions; the combination would have yielded predictable results at the time of the invention.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 U.S.C 103. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references discussed above.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLAUDIA E ESPINOSA whose telephone number is (703)756-4550. The examiner can normally be reached Monday-Friday 9:30-5:30 EST.
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/CLAUDIA ESPINOSA/ Patent Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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