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 .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 07/03/2026 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims and/or persuasive remarks: (1) the 35 U.S.C. 102(a)(1) rejection of claim 1 over Barnett et al. has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-5
Withdrawn claims: 6-12
Previously canceled claims: None
Newly canceled claims: 5
Amended claims: 1
New claims: 13
Claims currently under consideration: 1-4 and 13
Currently rejected claims: 1-4 and 13
Allowed claims: None
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Barnett et al. (U.S. 2013/0157356 A1) in view of Nishino et al. (U.S. 2014/0106348 A1).
Regarding claim 1, Barnett et al. discloses a liquid composition ([0066]) comprising a mixture of Dulbecco’s Modified Eagle’s Medium (DMEM) ([0258]), glucagon-like peptide 2 (GLP-2) ([0291]), which is a vertebrate G protein-coupled receptor ligand, a phagostimulant (ATP) ([0185]), and a protein source that may be BSA ([0145], [0164], [0006]). The statement that the liquid composition is an “artificial blood-free diet composition for rearing mosquitoes” is a statement of intended use that does not structurally limit the claimed composition. MPEP 2111.02 II (“If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.”). The limitation that “the composition enables mosquito ovarian development, egg maturation, and fertility in the absence of blood” is considered an inherent attribute of the claimed mixture of components. MPEP 2112.01 II (“if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present”). The limitation that the ligands “circulate in the blood plasma and regulate reproduction and/or nutrient metabolism” is also considered to be an inherent attribute of the claimed GLP-2.
Barnett et al. does not disclose the composition as comprising cholesterol.
However, Nishino et al. discloses a similar cell culture medium ([0046]) that may comprise DMEM ([0132]), wherein cholesterol may be added to the medium ([0137]).
It would have been obvious to one having ordinary skill in the art to add cholesterol to the composition of Barnett et al. Since Barnett et al. teaches generally that various supplements may be added to a culture medium depending on the type of cell before providing several broad categories of supplements ([0066]), a skilled practitioner would be motivated to consult Nishino et al. for additional instruction regarding suitable supplements for cell culture media. Since Nishino teaches that cholesterol may be added to such media ([0137]) and further indicates that determining suitable additives is well within the ordinary skill in the art ([0136]), the addition of cholesterol to the composition of Barnett et al. would be obvious.
As for claim 2, Barnett et al. discloses that the amount of added supplement may be readily determined by one having ordinary skill in the art and that typical supplement concentrations may range from about 0.1% to about 50% w/w ([0153]-[0154]). As such, any concentration of supplement at least in the range of 0-50% w/w would be obvious to a skilled practitioner. Such a range is considered to encompass the claimed range of 0.1-100 µM of the vertebrate GPCR-ligands in the final concentration of the composition, thus rendering the range obvious.
As for claim 3, Barnett et al. discloses the selected vertebrate GPCR-ligand comprises GLP-2 ([0291]). Although Barnett et al. does not specifically disclose the component as being from a human source, Barnett et al. does describe other components obtained from a human source ([0083]), such that obtaining GLP-2 from a human source would be obvious.
As for claim 4, Barnett et al. discloses that the amount of added supplement may be readily determined by one having ordinary skill in the art and that typical supplement concentrations may range from about 0.1% to about 50% w/w ([0153]-[0154]). As such, any concentration of supplements at least in the range of 0-50% w/w would be obvious to a skilled practitioner. Such a range is considered to encompass the claimed ranges of 100-300 g/L BSA, 0.5-0.6 g/L ATP, 0.06-0.24 g/L cholesterol, and 5-10 µM GLP-2 in the final concentration of the composition, thus rendering such ranges obvious. Further, MPEP 2144.05 II A states: “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.” Since the present claim does not encompass the actual application Applicant intends for its use, the composition per se cannot be said to be based on any criticality of the claimed concentrations ranges of the claimed compositions. The claimed concentration ranges are thus considered obvious according to this rationale as well.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Barnett et al. (U.S. 2013/0157356 A1) in view of Nishino et al. (U.S. 2014/0106348 A1) as applied to claim 1 above, and further in view of admitted prior art.
Regarding claim 13, Barnett et al. and Nishino et al. disclose the composition of claim 1. Barnett et al. further discloses the composition as comprising Dulbecco’s Modified Eagle’s Medium (DMEM) ([0258]). The present specification admits that DMEM comprises the claimed components in the claimed amounts (p. 12, ¶4-¶6; p. 13, Table 2), which would consequently be obvious. MPEP 2129 (“A statement by an applicant in the specification or made during prosecution identifying the work of another as ‘prior art’ is an admission which can be relied upon for both anticipation and obviousness determinations”).
Response to Arguments
Claim Rejections - 35 U.S.C. § 102(a)(1) of claim 1 over Barnett et al.: Applicant has overcome the 35 U.S.C. § 102(a)(1) rejection of claim 1 based on amendment to the claim. Accordingly, the 35 U.S.C. § 102(a)(1) rejection has been withdrawn.
Claim Rejections - 35 U.S.C. § 103 of claims 2 and 3 over Barnett et al.; and claims 4 and 5 over Barnett et al. and Nishino et al.: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant first argued that Nishino et al. discloses the addition of cholesterol to a DMEM-based medium for a different purpose than that of the claimed composition (Applicant’s Remarks, p. 7, ¶7 – p. 8, ¶1).
However, the present claims are directed only to compositions. Examiner maintains that adequate motivation was detailed for combining the references and adequate rationale was shown deeming the claimed compositions obvious. That Applicant intends to use the composition in a manner that differs from that of the cited prior art does not render the claimed composition non-obvious. MPEP 2144 IV (“The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.”). Thus, the asserted distinction between the purpose of the cholesterol in the prior art and the claimed compositions is insufficient to render the claims non-obvious.
Applicant then argued that the claimed component concentrations are not taught or suggested by the prior art (Applicant’s Remarks, p. 8, ¶2).
Examiner maintains that the claimed concentrations were properly deemed obvious based on the disclosure of the prior art. Namely, Barnett et al. discloses that the amount of added supplement may be readily determined by one having ordinary skill in the art and that typical supplement concentrations may range from about 0.1% to about 50% w/w ([0153]-[0154]). As such, any concentration of supplements at least in the range of 0-50% w/w would be obvious to a skilled practitioner.
Applicant then argued that (i) Barnett et al. only discloses the relevant components in different embodiments but not in a single, combined fluid matrix; (ii) Barnett et al. disclosed GLP-2 only among a large number of alternatives; and (iii) Barnett et al. does not disclose GLP-2 as being human GLP-2 (Applicant’s Remarks, p. 8, ¶3).
Examiner maintains that Barnett et al. is properly interpreted as teaching the addition of the disclosed components to the overall mixed solution ([0066]). Listing components as alternatives among a broader list does not render the disclosed components non-obvious. MPEP 2131.02 II (“when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named”). The use of human GLP-2 was shown to be obvious due to other components being taught as being of human origin. Examiner maintains that all of the claim limitations were adequately addressed and properly deemed obvious.
Applicant next argued that ATP and BSA are described as being added for different purposes than presently claimed (Applicant’s Remarks, p. 9, ¶1).
As noted in paragraph 23 of the previous Office Action, though, MPEP 2144 IV states: “It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.” Since the present claims are directed only to compositions, the functionality of the claimed compositions in the context of mosquito rearing is not pertinent to the analysis. The components taught in Barnett et al. are adequately described as being suited for addition to the cell culture medium ([0066]).
Applicant asserted that the concentrations of components were improperly deemed obvious based only on generic instruction regarding component concentrations and that such broad instruction did not appreciate the necessary concentrations for mosquito egg maturation (Applicant’s Remarks, p. 9, ¶2).
Examiner maintains that the disclosure of Barnett et al.—that the amount of added supplement may be readily determined by one having ordinary skill in the art and that typical supplement concentrations may range from about 0.1% to about 50% w/w ([0153]-[0154])—is adequate to deem the claimed limitations obvious. Again, the claims are directed only to compositions and the intended use of the compositions for rearing mosquitos does not patentably distinguish the claimed compositions from the prior art.
Applicant concluded that there would be no motivation for a skilled practitioner to combine Barnett et al. and Nishino et al. to arrive at the claimed compositions, since neither reference is directed to mosquito rearing (Applicant’s Remarks, p. 9, ¶4 – p. 10, ¶1).
Examiner maintains that adequate motivation for combining Barnett et al. and Nishino et al. was detailed in the claim rejection. Specifically, since Barnett et al. teaches generally that various supplements may be added to a culture medium depending on the type of cell before providing several broad categories of supplements ([0066]), a skilled practitioner would be motivated to consult Nishino et al. for additional instruction regarding suitable supplements for cell culture media. Again, that Applicant’s intended use of the composition may differ from the cited prior art is insufficient to render the claimed composition non-obvious. MPEP 2144 IV (“The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.”).
The rejections of claims 2-4 have been maintained herein.
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.
Claims 1-4 and 13 are rejected.
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY P MORNHINWEG whose telephone number is (571)270-5272. The examiner can normally be reached 8:30AM-5:00PM.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
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