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 .
DETAILED ACTION
Claims 1-10, and 12-23 are canceled. Claims 24-30 are new. Claims 11, and 24-30 are pending and under consideration in this action.
Response to Amendment
The amendment filed 08/08/2025 is entered.
The objections to claims 22 and 23 are obviated because the claims are canceled. However, new objections are discussed below.
The §112(a) new matter rejection of claims 21-23 is withdrawn because the claims are canceled. However, the §112(a) new matter rejection of claim 11 is maintained/modified to address the amendment; and new §112(a) rejections necessitated by amendment are discussed below.
The §112(b) rejection of claims 11 and 21 is withdrawn in light of the amendment. However, a new §112(b) rejection necessitated by amendment is discussed below.
Applicants' amendments and arguments filed on 08/08/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims 24-30 are entitled to an effective filing date of 02/07/2018 to CN20180125673.8 because the priority document was received in English on 01/25/2024.
However, the disclosure of CN20180125673.8, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, CN20180125673.8 does not provide support for claim 11 because claim 11, as amended 08/08/2025 requires incubating a mixture of the host strain CVCC533, fecal sewage, and LB medium “for 8-12 hours” and administering a drug that has a concentration of a bacteriophage that is “not less than 1x108 PFU/mL”. Such limitations are not supported in CN20180125673.8 and constitute as new matter, as discussed in depth below.
Claim Objections
(New objection) Claim 11 is objected to because of the following informalities:
Claim 11, as amended, depends from claim 24. However a claim in dependent form must refer only to a claim or claims previously set forth. See MPEP 608.01(n)(F). To obviate this rejection, claim 11 may be canceled and presented as new claim 31.
Claim 11 recites “the Salmonella bacteriophage” twice within the last 3 lines of the claim, which should be replaced with “the SP4 bacteriophage” for claim language consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Enablement
(New rejection necessitated by amendment) Claims 11 and 24-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the relevant art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that Salmonella pullorum CVCC533 is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the Salmonella pullorum CVCC533.
The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. The host strain Salmonella pullorum CVCC 533 appears to be necessary for obtaining the SP4 bacteriophage. The specification teaches adding fecal sewage to the host strain CVCC 533 and then adding LB medium. The sample is soaked and incubated overnight at 37˚C. The next day, 5mL of the resulting liquid is taken out, centrifuged for 10 min and the supernatant is filtered through a sterile microporous membrane to obtain a bacteriophage stock solution [of the SP4 bacteriophage]. See lines 17-22 on page 5. Thus, the instantly claimed method does not appear repeatable without the Salmonella pullorum Chinese Veterinary Culture Collection (CVCC) 533 strain being readily available.
In the instant case, there is no indication in the specification as to public availability. Therefore, a deposit at a recognized depository may be made to obviate this rejection.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
Written Description
(New rejection necessitated by amendment) Claims 11, 24, and 26-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor, at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a genus of SP4 bacteriophages that can be used to treat infections caused by Salmonella pullorum in chickens. Although the instant specification teaches a siphoviridae bacteriophage named SP4 with a deposit number CGMCC No. 14332, claims 11, 24, and 26-30 do not limit the SP4 bacteriophage to that specific embodiment deposited as CGMCC No. 14332. See page 3 lines 4-5 of the instant specification. In other words, claims 11, 24 and 26-39 do not substantially limit the structure of the SP4 bacteriophage, because any bacteriophage can arbitrarily be named SP4. Therefore, the claims 24 and 26-39 encompass any bacteriophage that provide the requisite function of treating infections caused by S. pullorum in chickens, and claim 11 encompasses any bacteriophage that can be obtained by the claimed method and used to treat infections caused by S. pullorum in chickens. The specification does not disclose a representative number of species of the claimed genus by reduction to practice, and does not provide adequate guidance with regard to the structural features of the SP4 bacteriophage that is required to provide the recited properties. Therefore, one of skill cannot immediately envision which bacteriophages will have the required functional characteristics, and one could not conclude that Applicant was in possession of the claimed genus of SP4 bacteriophages at the time the filing, as discussed more fully below.
For claims drawn to a genus, MPEP § 2163(3)(a)(ii) indicates the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e., structure or other physical and/ or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The instant specification reduces to practice one example of an SP4 bacteriophage that is deposited under CGMCC No. 14332. In example 9, the specification teaches dividing one hundred and twenty healthy one-day-old chicks into 3 groups, a control group, an infected group and a treatment group, with 40 chicks in each group. The infection is established by picking and inoculating a single colony of S. pullorum CVCC 533 into 5 mL of LB medium, culturing for 24 h and adjusting the concentration to 10x108 CFU/mL. The control group does not receive bacteria but each chick in the infected group is given 100 µL of the bacteria orally; in the treatment group bacteria is given orally at the same time as the bacteriophage SP4; in the infected group, PBS of the same volume is given orally; the experiments are conducted for 5 consecutive days, followed by normal feeding for 14 days. The results showed that the bacteriophage SP4 can reduce the mortality rage in chicks infected with S. pullorum by 60%. See the first two paragraphs on page 11.
MPEP 2163(3)(a)(ii) states that “the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation. Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date”. Considering the lack of guidance provided in the specification, one would appraise support from the state of the art to extrapolate the correlation between bacteriophage structure and the prophylactic function.
With respect to the state of the art on treating S. pullorum infections in chickens, Tie (as relied upon in the action mailed 10/25/2023) teaches orally administering various inoculations of S. pullorum (1×101, 1×103, 1×105, 1×107, 1×109, or 1 × 1011 cfu/chicken in 500 μL phosphate-buffered saline) to determine the dose required to produce diarrhea and a 50% mortality rate over a 15-day follow-up period (the median lethal dose [LD50]). Arbor Acres Plus broilers are used. See the first and second paragraphs in the right column on page 448. Tie teaches orally treating chickens with YSP2 bacteriophage at various concentrations (1×106, 1×108, or 1× 1010 PFU/mL, 80 μL/chicken) following infection with 2 × LD50 (5 × 107 cfu/chicken) of S. pullorum. The survival rate is recorded everyday for 10 days. See the paragraph spanning pages 448-449. Thus, Tie illustrates the unpredictability in art because Tie suggests that the YSP2 bacteriophage is capable of serving the same function as instantly claimed.
With respect to the state of the art on obtaining an SP4 bacteriophage, Bao (Poultry science, 2011, 90(10), 2370-2377) teaches purchasing Salmonella enterica serovar Pullorum CMCC 533 from the China Veterinary Culture Collection Center (CVCC, Beijing, China). Bao teaches incubating Salmonella Pullorum isolates in selenite cystine broth, which is inoculated onto Salmonella-Shigella (SS) agar selective media and incubated again at 37˚C for 24 hours. Up to 5 colonies are selected from each plate. See the left column of page 2371. To isolate bacteriophages, Bao teaches using 13 S. pullorum clinical isolates for the enrichment of bacteriophages. Samples, chicken excretion sewage, are obtained from local commercial chicken farms. A water sample is centrifuged and the supernatants are filtered. Five milliliters of each filtrate is combined with 5 mL of TSB and 0.1 mL, ~108 cfu, of each S. pullorum strain. The mixture is incubated with shaking at 37˚C overnight. Following incubation, Bao teaches removing bacteria by centrifugation and filtering the supernatants. Bacteriophage activity in the supernatant is tested by a spot assay with different Salmonella Pullorum strains. The plates are checked for plaques after 18 h at 37°C. Plaques of lysis positive supernatants are isolated and purified using the double agar layered method. Bacteriophage titers are also determined using the double agar layered method. The isolated bacteriophages are propagated on their respective host bacteria. Two purified bacteriophage pellets are obtained. See the right column of page 2371. The phages PSPu-95 and PSPu-4-116 show wide host ranges. See the last passage of the left column on page 2374. For example, the PSPu-95 bacteriophage shows a clear spot diameter when inoculated with S. pullorum CMCC 533 and PSPu-4-116 shows a faint spot when inoculated with S. pullorum CMCC 533, wherein CMCC=China Veterinary Culture Collection. See table 1 and the caption. Thus, Bao teaches two different bacteriophages that can use S. pullorum CMCC 533 as a host, and Bao indicates that the S. pullorum CMCC 533 may be the same strain as S. pullorum CVCC 533. The teachings of Bao illustrate the unpredictability in the art because Bao suggests that multiple different bacteriophages may be obtained using the same host strain.
In view of the prior art, the instant disclosure does not satisfy the written description requirement because the species disclosed do not adequately represent the substantial variation within the claimed genus. As discussed above, the breadth of potential structures embraced by the claims is substantial, because the instant claims do not limit the SP4 bacteriophage to the SP4 deposited as CGMCC 14332. Prior to the effective filing date, it was well known that bacteriophages can be used to treat S. pullorum infections in chicks, as evidenced by Tie. Although instant claim 11 requires the SP4 bacteriophage to be obtained from the specific Salmonella pullorum CVCC 533 strain, the teachings of Bao suggest that other bacteriophages can use S. pullorum CMCC 533 as a host, and the S. pullorum CMCC 533 of Bao may be identical to S. pullorum CVCC 533. The instant specification reduced to practice one example of an SP4 bacteriophage capable of treating S. pullorum CVCC 533 infections in chicks. This represents a fraction of the possible number of bacteriophage species within the breadth of the claims. Consequently, one of skill could not conclude that Applicant was in possession of the claimed genus of SP4 bacteriophages at the time the application was filed.
New Matter
(Maintained/Modified to address amendment) Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The underlined limitations below are newly added subject matter.
Claim 11, as filed on 08/08/2025, recites the method according to claim 24, wherein the bacteriophage SP4 is obtained by the following method: picking up a bacterial liquid of a host strain Salmonella pullorum CVCC 533; streaking the bacterial liquid on a first plate containing a SS agar medium to obtain a first inoculated plate; culturing the first inoculated plate at 37 °C for 16 to 24 hours to grow single colonies on the SS agar medium; selecting a single colony from the single colonies cultured on the SS agar medium; using the selected single colony to inoculate a quantity of lysogeny broth (LB) to obtain a proliferation solution; adding the host strain CVCC533 to a sample of fecal sewage collected from a chicken farm and then adding LB culture medium to form an incubation mixture, incubating the incubation mixture at 37 °C for 8-12 hours, removing a portion of the incubated mixture liquid and centrifuging and removing a portion of the supernatant to obtain a bacteriophage stock solution; mixing the bacteriophage stock solution with the CVCC533 proliferation solution, separating the bacteriophage using a double-layer plate method, and obtaining a double-layer plate with the bacteriophage; wherein the double-layer plate method uses a top agar plate and a bottom agar plate in sequence, wherein the temperature of the top agar plate is 50°C and the concentration of the top agar is 0.7%, and wherein the temperature of the bottom agar plate is 37°C and the concentration of the bottom agar is 1.5%; picking a single plaque from the double-layer plate with the bacteriophage and placing it in LB broth to obtain a leaching solution, culturing the leaching solution and the CVCC533 proliferation liquid in LB culture medium to obtain a bacteriophage proliferation solution; purifying the bacteriophage proliferation solution to obtain a purified bacteriophage suspension comprising bacteriophage SP4; adjusting the concentration of the host strain CVCC533 to 1x105 colony-forming units (CFU)/mL, and then mixing with different concentrations of the bacteriophage SP4, wherein the host strain is completely lysed when the concentration of the bacteriophage SP4 is 108 PFU/mL, and the lysis rate gradually decreases when the concentration of the bacteriophage SP4 is < 107 PFU/ml;Salmonella pullorum, wherein, the concentration of the Salmonella bacteriophage in the drug is not less than 1x 108 PFU/mL.
Applicant’s amendment, filed 08/08/2025, argues that the amendment is sufficient to remove the previously introduced new matter. However, the original claims and specification do not provide sufficient written description of the above underlined limitations.
Claim 11 contains new matter because the specification does not teach: (1) incubating the mixture of the host strain CVCC533, the fecal sewage and LB culture medium for 8-12 hours, and (2) an administration step in which the Salmonella bacteriophage in the drug is not less than 1x 108 PFU/mL.
(1) The specification teaches adding 500 µL of the host strain CVCC 533 to 50 mL of the fecal sewage from the chicken farm, and then LB medium is added to a final volume of 200 mL. The sample is soaked and incubated overnight at 37˚C. See page 5 lines 17-19. Therefore, the specification teaches incubating a mixture of the host strain CVCC533, fecal sewage and LB culture medium overnight, and not 8-12 hours as claimed.
(2) The specification teaches a bacteriophage safety test in which twenty one-day-old SPF chicks are divided into two groups: an experimental group and a black control group. The experimental group is fed with the bacteriophage SP4 proliferation solution at a dose of 1x1010 PFU/mL/0.25mL/chick. See page 10 lines 20-24. Therefore, the specification teaches administering 1x1010 PFU/mL to chicks but the specification does not teach the instantly claimed range of “not less than 1x108 PFU/mL”.
Such limitations recited in the instant claim 11, which did not appear in the specification or original claims, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in the instant claim 11. Applicant can remove the new matter limitations from the claims to obviate this rejection.
Response to Arguments
Applicant's arguments filed 08/08/2025 have been fully considered to the extent that they might apply to the new grounds of rejection set forth above, but they are unpersuasive.
With respect to the § 112(a) new matter rejection of claim 11, Applicant argues that the amendment is sufficient to remove the previously introduced “new matter” and improve the clarity of the claims. See the second paragraph on page 7 of the remarks. Furthermore, Applicant asserts that the specification and drawings are sufficient to allow those of ordinary skill in the art to practice the methods recited in claims 11 and 24-30. See the third paragraph on page 7.
This argument is unpersuasive because the amendment filed 08/08/2025 includes a previously discussed new matter limitation, and the amendment introduces additional new matter. Claim 11 includes a previously discussed new matter limitation, because the claim requires “incubating the incubation mixture..for 8-12 hours” and the specification does not teach incubating a mixture of host strain CVCC533, fecal sewage and LB medium for that time period. Rather, the specification teaches an overnight incubation period. See lines 17-19 on page 5 of the instant specification and see the non-final rejection mailed 05/08/2025, specifically the paragraph spanning pages 8-9 and the first paragraph on page 10. The amendment to claim 11 introduced additional new matter because the claim now requires an administration step in which the “concentration of the Salmonella bacteriophage in the drug is not less than 1x108 PFU/mL” and the specification only provides support for administering 1x1010 PFU/mL to chicks and not the breadth encompassed by the “not less than 1x108 PFU/mL” range.
Claim Rejections - 35 USC § 112(b)
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.
(New rejection necessitated by amendment) Claims 11 and 24-30 are 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.
Claim 11 recites the term “gradually” (see the last full line on page 3), which is a relative term which renders the claim indefinite. The term “gradually” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. To obviate this rejection, the term “gradually” can be deleted.
Claim 11 recites “the chickens”, which is indefinite because it is unclear which chickens are being referenced. Specifically, claim 11 states “administering a medicament comprising an effective quantity of the Salmonella bacteriophage to the chickens to treat the infection caused by Salmonella pullorum”. However, it is unclear whether the claim intends to reference the chicks infected with Salmonella pullorum CVCC533, as recited in claim 24, or different chickens.
Claim 11 recites “the infection caused by Salmonella pullorum”, which is indefinite because it is unclear whether claim 11 intends to reference the Salmonella pullorum CVCC533 of claim 24 or any Salmonella pullorum infection.
Claim 11 recites the limitation “the drug” in the last line. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether “the drug” intends to reference the medicament recited earlier in claim 11 or a separate drug.
Claim 24 requires “orally administering 0.25 mL/chick of bacteriophage SP4 to the chicks infected with Salmonella pullorum CVCC533 for 5 consecutive days”, which renders the claim indefinite because there are multiple reasonable interpretations of this limitation. In the first interpretation, the claim requires orally administering the SP4 each day for 5 consecutive days. In the second interpretation, the claim requires the subject of the administration to be chicks infected with Salmonella pullorum CVCC533 for 5 consecutive days. In this second interpretation, it is unclear whether the chicks are required to have an infection that lasts 5 consecutive days prior to the bacteriophage administration; or whether the chicks are required to be infected multiple times, such that the chicks are infected each of the 5 consecutive days. The instant specification teaches an example in which the bacteria are given orally at the same time as the bacteriophage SP4 and “the experiments were conducted for 5 consecutive days”. See lines 8-9 on page 11. However, this description in the specification is insufficient because “the experiments” may reference one administration is observed over 5 days, or multiple administrations. As such, one of ordinary skill in the art cannot ascertain the metes and bounds of the oral administration.
Claims 25-30 depend from claim 24 and are rejected for the reason set forth above.
Claims 11, 24, 26, and 30 recite “bacteriophage SP4”, which render the claims indefinite because the scope of the bacteriophage is unclear. The specification teaches a Siphoviridae bacteriophage with a wide host spectrum and a strong lytic activity against S. pullorum, whose deposit number is CGMCC No. 14332. The bacteriophage is named SP4. The bacteriophage is disclosed as having a polyhedral head structure and a non-constrictive tail. The head diameter is about 53 nm and the tail length is about 108 nm. See the first two paragraphs on page 3. However, it is unclear whether the claims intend to limit the bacteriophage to the SP4 embodiment disclosed in the specification, or encompass any bacteriophage. Claims 27-29 are rejected for the same reason because they depend from claim 24 but do not clarify the scope of the claimed “bacteriophage SP4”.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(New rejection necessitated by amendment) Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 does not clearly limit the same administration step of claim 24, from which it depends. Claim 24 requires “(2) orally administering 0.25 mL/chick of bacteriophage SP4 to the chicks infected with Salmonella pullorum CVCC533”. However, claim 11 requires “administering a medicament comprising an effective quantity of the Salmonella bacteriophage to the chickens to treat the infection caused by Salmonella pullorum, wherein, the concentration of the Salmonella bacteriophage in the drug is not less than 1x 108 PFU/mL”. Therefore, claim 11 may intend to broaden the scope of: the administration method, the administered composition and the Salmonella pullorum infection. In other words, claim 11 may reasonably be interpreted as encompassing: any administration method, any medicament comprising an effective quantity of the SP4 Salmonella bacteriophage or any drug that does not include less than 1x 108 PFU/mL SP4, and any chicken infected by any Salmonella pullorum strain. Therefore, claim 11 does not clearly limit the same embodiment as claim 24.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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/K.C.B./Examiner, Art Unit 1657
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1657
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