The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment filed on 2-24-2025 is acknowledged. Claims 1, 4, 11, 31 and 55 have been amended. Claim 32 has been canceled. Claims 56-61 have been added. Claims 1-5, 9, 11-13, 15, 19, 21, 31, 33, 35, 39, 41, 47 and 55-61 are pending. Claims 11-13, 15, 19, 21, 31, 33, 35, 39, 41, 55 and 58-61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-5, 9 and 56-57 are currently under examination. It should be noted that claims 11-13, 15, 19, 21, 31, 33, 35, 39, 41 and 55 have improper claim status identifiers which must be corrected in order for any response to this action to be considered fully responsive.
Claim Rejections Withdrawn
The rejection of claims 1-2 and 5 under 35 U.S.C. 102(a)(1) as being anticipated by Stojkovic et al. (U.S. Patent 4,606,919) is withdrawn in light of the amendment thereto.
The rejection of claims 1-3 and 5 under 35 U.S.C. 103 as being unpatentable over Stojkovic et al. (U.S. Patent 4,606,919) and Clements et al. (mSphere Vol. 3, No 4, pages 1-17) is withdrawn in light of the amendment thereto.
The rejection of claims 1-5 and 9 under 35 U.S.C. 103 as being unpatentable over Stojkovic et al. (U.S. Patent 4,606,919) and Clements et al. (mSphere Vol. 3, No 4, pages 1-17) and Kandil et al. (U.S. Patent 5,837,250) is withdrawn in light of the amendment thereto.
New Grounds of Rejection
35 USC § 103
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.
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.
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.
Claims 1-3, 5, 9 and 56-57 are rejected under 35 U.S.C. 103 as being unpatentable over Pillich et al. (U.S. Patent Application Publication US 2003/0152594) and Clements et al. (mSphere Vol. 3, No 4, pages 1-17).
Pillich et al. disclose compositions comprising bacterial lysates to treat or prevent bacterial infections (see abstract). Pillich et al. further discloses that their lysates can be of Klebsiella pneumoniae (see paragraph [0008] and [0016] for example) and that said compositions can further comprise an adjuvant (see paragraph [0025]). Given that a Klebsiella pneumoniae lysate necessarily contains OmpC, OmpW, Omplolb and OmpX, all the limitations regarding the Omps within the claimed composition are met. Moreover, given that proteins are removed from their natural environ a lysate is deemed to comprise a combination of isolated proteins.
Pillich et al. differs from the claimed invention in that they don’t explicitly the use of LTA1 as the adjuvant or the use of linked adjuvants.
Clements et al. disclose that dmLT (see abstract) and LTA1 (see page 5) are useful adjuvants. Clements et al. further disclose that the use of dmLT with multiple vaccine types including whole cell vaccines (see Table 1).
It would have been obvious for one of skill in the art to utilize the dmLT and/or LTA1 of Clement et al. in the vaccine compositions of Pillich et al. in order to take advantage of their enhanced adjuvant effects.
One would have had a reasonable expectation of success as Pillich et al. disclose that a wide range of adjuvants could be used with their compositions. Moreover, The KSR decision sets forth “if a technique has been used to improve one device, and a person of skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill”. Given that Clements et al. disclose the use of an adjuvant in Klebsiella pneumoniae vaccines and the use of dmLT and LTA1 as adjuvants and the linking of adjuvants is well established in the art, the use of dmLT and/or LTA1 adjuvants (linked or unlinked) in Klebsiella pneumoniae vaccines is well within the capabilities of one of ordinary skill in the art. Hence, the requirements of obviousness under the KSR decision are met.
With regard to claims 56 and 57, said claims are drawn to recombinant Omps. Although Pillich et al. disclose the same Omps they do not disclose the claimed method of making. However, it should be noted that the instant claims constitute Product-by-Process type claims. In Product-by-Process type claims, the process of producing the product is given no patentable weight since it does not impart novelty to a product when the product is taught by the prior art. See In re Thorpe, 227 USPQ 964 (CAFC 1985); In re Marosi, 218 USPQ 289, 292-293 (CAFC 1983) and In re Brown, 173 USPQ 685 (CCPA 1972). Consequently, even if a particular process used to prepare a product is novel and unobvious over the prior art, the product per se, even when limited to the particular process, is unpatentable over the same product taught in by the prior art. See In re King, 107 F.2d 618, 620, 43 USPQ 400, 402 (CCPA 1939); In re Merz, 97 F.2d 599, 601, 38 USPQ 143-145 (CCPA 1938); In re Bergy, 563 F.2d 1031, 1035, 195 USPQ 344, 348 (CCPA 1977) vacated 438 US 902 (1978); and United States v. Ciba-Geigy Corp., 508 F. Supp. 1157, 1171, 211 USPQ 529, 543 (DNJ 1979). Finally, since the Patent Office does not have the facilities for examining and comparing Applicant’s composition with the compositions of the prior art reference, the burden is upon Applicant to show a distinction between the material, structural and functional characteristics of the claimed composition and the composition of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
Claims 1-5, 9 and 56-57 are rejected under 35 U.S.C. 103 as being unpatentable over Pillich et al. (U.S. Patent Application Publication US 2003/0152594), Clements et al. (mSphere Vol. 3, No 4, pages 1-17) and Kandil et al. (U.S. Patent 5,837,250).
Pillich et al. disclose compositions comprising bacterial lysates to treat or prevent bacterial infections (see abstract). Pillich et al. further discloses that their lysates can be of Klebsiella pneumoniae (see paragraph [0008] and [0016] for example) and that said compositions can further comprise an adjuvant (see paragraph [0025]). Given that a Klebsiella pneumoniae lysate necessarily contains OmpC, OmpW, Omplolb and OmpX, all the limitations regarding the Omps within the claimed composition are met. Moreover, given that proteins are removed from their natural environ a lysate is deemed to comprise a combination of isolated proteins.
Pillich et al. differs from the claimed invention in that they don’t explicitly the use of LTA1 as the adjuvant or the use of linked adjuvants.
Clements et al. disclose that dmLT (see abstract) and LTA1 (see page 5) are useful adjuvants. Clements et al. further disclose that the use of dmLT with multiple vaccine types including whole cell vaccines (see Table 1).
Kandil et al. disclose that linking the antigen to an adjuvant enhances the adjuvanting effect of the adjuvant.
It would have been obvious for one of skill in the art to utilize the dmLT and/or LTA1 of Clement et al. in the vaccine compositions of Pillich et al. in order to take advantage of their enhanced adjuvant effects. It would be equally obvious to link the adjuvant to the bacterial lysates of Pillich et al.
One would have had a reasonable expectation of success as Pillich et al. disclose that a wide range of adjuvants could be used with their compositions. Moreover, The KSR decision sets forth “if a technique has been used to improve one device, and a person of skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill”. Given that Clements et al. disclose the use of an adjuvant in Klebsiella pneumoniae vaccines and the use of dmLT and LTA1 as adjuvants and the linking of adjuvants is well established in the art, the use of dmLT and/or LTA1 adjuvants (linked or unlinked) in Klebsiella pneumoniae vaccines is well within the capabilities of one of ordinary skill in the art. Hence, the requirements of obviousness under the KSR decision are met.
With regard to claims 56 and 57, said claims are drawn to recombinant Omps. Although Pillich et al. disclose the same Omps they do not disclose the claimed method of making. However, it should be noted that the instant claims constitute Product-by-Process type claims. In Product-by-Process type claims, the process of producing the product is given no patentable weight since it does not impart novelty to a product when the product is taught by the prior art. See In re Thorpe, 227 USPQ 964 (CAFC 1985); In re Marosi, 218 USPQ 289, 292-293 (CAFC 1983) and In re Brown, 173 USPQ 685 (CCPA 1972). Consequently, even if a particular process used to prepare a product is novel and unobvious over the prior art, the product per se, even when limited to the particular process, is unpatentable over the same product taught in by the prior art. See In re King, 107 F.2d 618, 620, 43 USPQ 400, 402 (CCPA 1939); In re Merz, 97 F.2d 599, 601, 38 USPQ 143-145 (CCPA 1938); In re Bergy, 563 F.2d 1031, 1035, 195 USPQ 344, 348 (CCPA 1977) vacated 438 US 902 (1978); and United States v. Ciba-Geigy Corp., 508 F. Supp. 1157, 1171, 211 USPQ 529, 543 (DNJ 1979). Finally, since the Patent Office does not have the facilities for examining and comparing Applicant’s composition with the compositions of the prior art reference, the burden is upon Applicant to show a distinction between the material, structural and functional characteristics of the claimed composition and the composition of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
Conclusion
No claim is allowed.
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.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 May 28, 2025
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