DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s Amendment
1) Acknowledgment is made of Applicant’s amendment filed 05/26/2026 in response to the non-final Office Action mailed 02/24/26.
Status of Claims
2) Claims 2-37 are pending.
Claims 16 and 18 are under examination.
Prior Citation of Title 35 Sections
3) The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office Action References.
Prior Citation of References
4) The references cited or used as prior art in support of one or more rejections in the instant Office Action and not included on an attached form PTO-892 or form PTO-1449 have been previously cited and made of record.
Rejection(s) under 35 U.S.C § 103 Maintained
5) 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 of this title, 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 claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 148 USPQ 459, that are applied 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 unobviousness.
6) The rejection of claims 16 and 18 set forth in paragraph 12 of the Office Action mailed
02/24/26 under 35 U.S.C § 103 as being unpatentable over WO 2014078270 A1 (of record) in view of Charles et al. (Clin. Vaccin. Immunol. 17: 1188-1195, 2010, of record) is maintained.
Applicant’s arguments and the Office’s rebuttal are set forth below:
Applicant submits that the test that must be met for a reference or a combination of references to establish obviousness has not been satisfied. According to the U.S. Supreme Court ruling in Graham V. John Deere, 383 U.S. 1 (1960), in making a case for obviousness, the Examiner must: (1) determine the scope and content of the prior art; (2) ascertain the differences between the prior art and the claims at issue; (3) resolve the level of ordinary skill in the pertinent art; and (4) evaluate evidence of secondary considerations. These principles have been reconfirmed by the Supreme Court in KSR International Co. V. Teleflex Inc., 550 USPQ2d 1385 (2007).
Establishing a prima facie case of obviousness of a claimed invention “requires a suggestion of all limitations in a claim” in the prior art. 35 U.S.C. § 103(a); CFMT, Inc. V. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974); see also In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995). Therefore, in order to render the instant claims obvious under 35 U.S.C. §103(a), the cited references must teach or suggest each and every element of the claims.
In response, the rejection with the articulated reasoning was indeed set forth after conducting full analysis and all basic factual enquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 17 (1966). The teachings of the cited references render obvious instant claims.
Applicant submits that ‘270 and Charles, each alone or in combination, do not teach or suggest each and every element of claim 16, from which claim 18 depends. Applicant submits that ‘270 does not teach or suggest a method of inducing an immune response against S. typhi or S. paratyphi in a subject by administering to the subject a composition comprising the specific PltC antigen. Rather, ‘270 teaches detecting the presence of Salmonella enterica serotype Typhi (S. Typhi) antigens in a biological sample. Applicant submits that Charles does not make up the deficiencies of ‘270 because Charles does not teach or suggest a method of inducing an immune response against S. typhi or S. paratyphi in a subject by administering to the subject a composition comprising PltC. Rather, Charles teaches assays for identifying immunogenic S. Typhi antigens expressed during human infection.
First, Applicant should note that if WO ‘270 and Charles RC et al. taught the claimed method, each would have been applied as anticipatory art under 35 U.S.C § 102. Second, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). See MPEP 2145. The rejection of record as set forth via the teachings of WO ‘270 as modified by Charles RC et al. renders obvious instant claims.
Applicant further submits that ‘270 and Charles merely provide a broad, generic listing of Salmonella typhi antigens, without any specific teaching, guidance, or exemplification related to administering to a subject the specific PltC antigen recited in the claims and methods of inducing an immune response using that antigen. In fact, Charles identifies 57 other S. Typhi antigens that are recognized by antibodies in infected individuals. Given the large number of identified antigens, Charles provides no guidance or teaching that would lead a person of ordinary skill in the art to select the specific PltC antigen, much less the specific amino acid sequence recited in the claims, for administration to a subject to induce an immune response against S. Typhi. Moreover, the mere fact that a protein is recognized by antibodies in infected individuals does not render that protein an obvious vaccine antigen. Numerous bacterial proteins elicit antibody responses during natural infection but are unsuitable or ineffective as vaccine antigens.
To establish a prima facie case of obviousness, a reference or combination of references must: (1) suggest to those of ordinary skill in the art that they should make the claimed invention, and (2) reveal to those of ordinary skill in the art that they would have a reasonable expectation of success. In re Vaeck, 20 USPQ2d 1438, 1442 (Fed. Cir. 1991). Both the suggestion and the reasonable expectation of success must be found in the prior art and not in the Applicant’s disclosure. In re Dow Chemical Company, 5 USPQ2d 1529, 1531 (Fed. Cir. 1988). However, there is nothing in any of the cited references that would motivate one of ordinary skill in the art to combine the teachings of these references to produce the presently claimed invention.
“Reasonable expectation of success” is premised on predictability. In other words, to have a reasonable expectation of success, the ordinarily skilled artisan must be able to predict the likely outcome for an experiment. A direct corollary of this fact is that if one cannot predict the likely outcome for an experiment, one cannot have a reasonable expectation of success in achieving a given outcome. Indeed, the USPTO clearly recognizes the relationship between predictability and reasonable expectation of success. Specifically, MPEP 2143E articulates how to determine if a claim can be rejected on an “obvious-to-try” rationale using the following language:
Office personnel must articulate the following:
(1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. (emphasis added).
Thus, it is the ability to predict the outcome of a solution that underlies a reasonable expectation of success for pursuing that solution.
In response, the only step that is required to be met is the claimed method of inducing an immune response against S. typhi or S. paratyphi by administration to a subject a composition comprising PltC, wherein the PltC comprises the amino acid sequence set forth in SEQ ID NO: 3. The teachings of WO ‘270 as modified by Charles RC et al. as set forth meet this step. Each of WO ‘270 and Charles RC et al. specifically taught Salmonella enterica serovar Typhi CT18 STY1364 (PltC) protein biomarker antigen. WO ‘270 referred to Charles RC et al. who specifically identified the STY1364 in S. Typhi infected patients. WO ‘270 disclosed the amino acid sequence of said PltC that is 100% identical to the instantly recited amino acid sequence of SEQ ID NO: 3. Contrary to Applicant’s assertion, Charles RC et al. specifically exemplified or identified the STY1364 as being present in S. Typhi, and rarely found in other Salmonella serovars thus teaching its S. Typhi-specificity. See 1st full sentence of 1st full paragraph of page 1193. Charles RC et al. further identified the STY1364 (PltC) protein as the IgG-inducing immunogenic protein. What is specifically taught in a prior art reference is disclosed even though it appears ‘without special emphasis in a longer list. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that ‘the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is described ...).
Most importantly, none of the claims being examined recite a ‘vaccine’ antigen. The only step that is required to be met in the claimed method is the induction of an immune response against S. typhi or S. paratyphi by administration to a subject a composition comprising PltC, wherein the PltC comprises the amino acid sequence set forth in SEQ ID NO: 3. Applicant has provided no evidence showing that the prior art PltC (STY1364) protein that is as large as 141 amino acids in length and that was known in the art to be a S. typhi-specific immunogenic protein being recognized by antibodies induced in the plasma of patients having S. Typhi bacteremia is not predictably capable of “inducing an immune response against S. typhi or S. paratyphi” as claimed upon its administration to a subject. One of ordinary skill in the art would readily recognize that there would be a reasonable expectation of success of inducing an immune response against S. typhi by administration to a subject a composition comprising S. typhi-specific PltC, wherein the PltC comprises the 141 amino acid-long sequence that is identical to the instantly recited SEQ ID NO: 3. Given the teachings of the prior art, one of ordinary skill in the art would have predicted a composition comprising the 141 amino acid-long S. typhi-specific PltC that is structurally identical to the instantly recited SEQ ID NO: 3 to induce an immune response against S. typhi.
To establish obviousness, it is not necessary that the motivation come explicitly from the reference itself. It should be noted that what would reasonably have been known and used by one of ordinary skill in the art need not be explicitly taught. See In re Nilssen, 851 F.2d 1401, 7 USPQ2d 1500 (Fed. Cir. 1988). The test of obviousness is not express suggestion of the claimed invention in any and all of the references, but rather what the references taken collectively would reasonably have suggested to those of ordinary skill in the art presumed to be familiar with them. In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981). Obviousness does not require absolute predictability (see In re Lamberti, 192 USPQ 278), but only a reasonable expectation of success (see In re O’Farrell, 7 USPQ 2d 1673, Fed. Cir. 1988).
Applicant’s arguments have been carefully considered, but are not persuasive.
Conclusion
7) No claims are allowed.
8) THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 C.F.R 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 extension fee pursuant to 37 C.F.R 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.
Correspondence
9) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's Supervisor, Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
10) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
August, 2026
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