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 .
Claim Status
Claims 13-22 were pending.
Claims 1-12, 15, 18, 21-22 are canceled.
Claims 13, 14, 20 are amended.
Claims 23-30 are new.
Claims 13-14, 16-17, 19-20, 23-30 are under consideration.
Drawings
(previous objection, withdrawn) The drawings were objected to because there are brackets around the figure labels, e.g., [FIG. 1]. For correction, remove the brackets, for example, FIG. 1, for all three figures.
Applicant contends: Applicant hereby submits a replacement drawing as suggested by the office.
Office response: Applicant corrected the initial issue that led to an objection, e.g. removing the brackets. However, the applicant changed FIG. 1, for example, to Fig. 1 which is problematic. See new objection as necessitated by amendment below.
(new objection, necessitated by amendment) The drawings are objected to because the drawings are indicated by “Fig.” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)). The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
(previous objection, withdrawn) The abstract of the disclosure was objected to because of misspellings of the word therefore.
Change “therefor” to “therefore” after additives.
Applicant contends: Applicant hereby submits a replacement abstract.
Office response: Based on the amended, replacement abstract, the objection is withdrawn.
Claim Objections
(previous objection, withdrawn) Claim 22 is objected to because of the following informalities:
Claim 22: Change “claim 200” to “claim 20”.
Appropriate correction is required.
Applicant contends: Applicant has cancelled claim 22, rendering this objection moot.
Office response: Applicant canceled claim 22, and so its objection is withdrawn.
Claim Interpretation
Regarding claim 14, “A method for preventing or treating infectious disease caused by Clostridium perfringens (CP)” is interpreted to only include disease directly caused by C. perfringens and not, for example, an opportunistic infection.
Applicant contends: Applicant submits that Applicant does not necessarily concede with the Examiner’s interpretations but nonetheless has amended claims, rendering the Examiner’s interpretation moot.
Office response: The interpretation is maintained and was applied herein to claim 14, as amended.
Claim Rejections - 35 USC § 112
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.
(previous rejection, withdrawn) 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.
Deposit
Claims 13-22 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 claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant contends: In response, applicant respectfully files herewith the Deposit Receipt and a deposit statement to satisfy the deposit requirement, as suggested by the office.
Office response: Based on the applicant’s submission, the rejection of claims 13-22 is withdrawn.
Scope of Enablement
Claims 14-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the Specification, while being enabling for treating an infectious disease caused by Clostridium perfringens (CP), does not reasonably provide enablement for preventing any infectious disease caused by Clostridium perfringens. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Applicant contends: No response.
Office response: No response provided on pages 6-7, however, it is noted that claim 14 has been amended and based on the amendment, the rejections of claims 14 and 16 are withdrawn. Claim 15 is canceled and so its rejection is also withdrawn.
(previous rejection, withdrawn) 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.
Claims 15, 18, and 22 are 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. The term “specific bactericidal activity” is an inherent function of the bacteriophage. As such it does not further limit the claim. 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.
Applicant contends: Without acquiescing to the merits of the rejection, Applicant has cancelled the rejected claims, rendering the rejection moot.
Office response: Claims 15, 18, and 22 are canceled and so their rejections are withdrawn as moot.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
(previous rejection, modified as to claims 13, 20 as necessitated by amendment, withdrawn as to canceled claims 21, 22) Claims 13, 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106 for analysis framework.
See claims 13 and 20 as submitted 08/20/2026.
The instant claims are drawn to a bacteriophage in formulation of emulsion, capsule, powder, or syrup which is a statutory category of invention, i.e., a composition of matter (Step 1: YES).
The instant Specification evidences that KCCM12933P was isolated from fecal samples and was not altered (p. 17-19). As such, KCCM12933P is a naturally occurring bacteriophage. Moreover, the broadest reasonable interpretation of an additive recited by instant claim 20 encompasses, e.g., water.
Regarding an emulsion formulation, an emulsion would include naturally found mixtures of fat and water such as milk. Regarding a syrup formulation, a syrup would include naturally found maple syrup. Regarding a powder formulation, a powder would include bacteriophage in the absence of a liquid. Regarding a capsule, bacteriophage powders can be naturally compressed and formulated using usually naturally occurring components, e.g., gelatin, cellulose, pectin, etc., which would not impart any markedly different characteristics with respect to structure, function, or any other property to distinguish the claimed bacteriophage from its naturally occurring counterparts.
Isolating naturally occurring bacteriophage and, in some embodiments, combining the naturally occurring bacteriophage with water, an emulsion, syrup, in dehydrated form, or within a capsule would not, absent evidence to the contrary, result in any markedly different characteristics with respect to structure, function, or any other property to distinguish the bacteriophage from its naturally occurring counterpart. As such, the claims recite a judicial exception (JE) in the form of a natural phenomenon (STEP 2A, Prong One: YES).
Accordingly, the instant claims recite a natural phenomenon, i.e., naturally occurring bacteriophage, which is a judicial exception (JE) (STEP 2A, Prong One: YES).
The instant claims are drawn solely to the JE, and not a method of using the JE for, e.g., a specific treatment or prophylaxis. As such the instant claims do no recite any additional elements that integrate the JE into a practical application (STEP 2A, Prong Two: NO).
At the time of filing, it was well understood, routine and conventional to formulate compositions with phage contained in emulsions, capsules, powders or syrups as exemplified by Hajitou et al. (Hajitou)(US20170340684A1)(2017) who states “The recombinant bacteriophage and pharmaceutical compositions of the invention may be administered orally in the form of a sterile solution or suspension containing other solutes or suspending agents (for example, enough saline or glucose to make the solution isotonic), bile salts, acacia, gelatin, sorbitan monoleate, polysorbate 80 (oleate esters of sorbitol and its anhydrides copolymerized with ethylene oxide) and the like. The recombinant bacteriophage according to the invention can also be administered orally either in liquid or solid composition form. Compositions suitable for oral administration include solid forms, such as pills, capsules, granules, tablets, and powders, and liquid forms, such as solutions, syrups, elixirs, and suspensions. Forms useful for parenteral administration include sterile solutions, emulsions, and suspensions [0084]. Thus, the generic formulations - emulsion, capsule, powder, or syrup – as recited in claims 13 and 20, do not amount to significantly more than the JE, especially since, for example, syrup itself is a JE.
Since the instant claims are limited to only the JE, the instant claims do not recite any additional elements that amount to significantly more than the JE (STEP 2B: NO).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. §101.
Applicant contends: Without acquiescing to the merits of the rejection, Applicant has amended independent claims 13 and 20, from which the remaining rejected claims depend, to better capture commercial embodiments.
As discussed during the interview, Applicant respectfully submits that the present claim is not directed to a judicial exception and qualifies as eligible subject matter. As described in Example 3 of the 2014 Interim Eligibility Guidance (Nature-Based Products), a pharmaceutical composition in a non- natural structure (i.e., a core of amazonic acid surrounded by a layer of natural polymeric material) is structurally different from the naturally occurring substances, and this structural difference results in the claimed composition having different functional characteristics in vivo from those of the naturally occurring substances themselves (i.e., amazonic acid is not released until certain points). Therefore, these different structural and functional characteristics rise to the level of a marked difference; thus, the claim is not directed to an exception (Step 2A: NO) and qualifies as eligible subject matter. See Example 3 of the 2014 Interim Eligibility Guidance (Nature-Based Products).
Similarly, the present claim reciting that "the bacteriophage is contained in emulsion, capsule, powder, or syrup" is structurally different from the naturally occurring substance itself (i.e., bacteriophage by itself), and this structural difference results in the claimed composition having different functional characteristics in vivo (e.g., the bacteriophage is not released until the composition reaches certain points). Therefore, these different structural and functional characteristics rise to the level of a marked difference, with the result that the claimed composition is not a "product of nature" exception according to the 2014 Interim Eligibility Guidance.
Emulsion: As described in attached Esteban et al., Bacteriophage K/nano-emulsion formulations have greater antimicrobial activity than freely suspended bacteriophage. See Abstract and Figure 9 of Esteban. Accordingly, Applicant respectfully submits that the bacteriophage would possess a different characteristic when it is contained in an emulsion.
Capsule: As described in attached Richards et al., unencapsulated phages exposed to pH 1.5 were not detectable after 5 min of acid exposure, while encapsulated phages could be detected, teaching that the process of encapsulation has a marked effect on protecting the phages from acid damage. See Page 16, lines 18-20 of Richards. Therefore, a bacteriophage formulated in a capsule would have different pharmaceutical-performance characteristics from the same free, unformulated bacteriophage.
Powder: As shown in Figure 5 of attached Liang et al. below, the morphology of phages changed after lysophyilization, providing evidence that the process used to produce a phage powder can change the physical morphology of the phage particles.
Syrup: As described in attached Vadym et al., the addition of carbohydrates affects the lytic replication cycle of bacteriophage. As shown in Figure 4, infectivity or replication performance can be affected by the presence of sucrose.
Accordingly, Applicant respectfully requests reconsideration and withdrawal of the above rejection because the bacteriophage can possess different characteristics when it is contained in emulsion, capsule, powder, and syrup.
Office response: Applicant's arguments filed 08/20/2026 have been fully considered but they are not persuasive.
Please see USC 101 rejection with broadest reasonable interpretation above for what could constitute emulsion, capsule, powder and syrup.
As discussed above, under the broadest reasonable interpretation of the claims, formulating a composition with a naturally occurring bacteriophage using naturally occurring components, e.g., gelatin, cellulose, pectin, etc., would not impart any markedly different characteristics with respect to structure, function, or any other property to distinguish the claimed bacteriophage from its naturally occurring counterpart. For example, formulating a naturally occurring bacteriophage within a gelatin capsule would not result in a bacteriophage having any markedly different characteristics with respect to structure, function, or any other property to distinguish the claimed bacteriophage from its naturally occurring counterpart. Rather, the capsule functions as a generic carrier for the bacteriophage. With respect to additive as recited in claim 20, an additive can be water and as such in combination with the bacteriophage and, for example, the capsule, the water would not result in a bacteriophage having any markedly different characteristics with respect to structure, function, or any other property to distinguish the claimed bacteriophage from its naturally occurring counterpart. Therefore, these formulations do not rise to the level of a marked difference. Furthermore, as noted above, with evidence from Hajitou, the different formulations recited broadly in the claims were well understood in the art prior to the filing date.
Regarding emulsion, Esteban also notes that “Enhancement of infectivity of Bacteriophage-K against S. aureus by nano-emulsion has been demonstrated…but the mechanisms of enhancement are not specifically understood” (p. 937). It is unclear if the emulsion itself had more of the effect, than the actual phage. Additionally, using broadest reasonable interpretation, the “emulsion” recited in claims 13 and 20 read on any emulsion.
Regarding encapsulation, while a capsule itself appears to provide a barrier for the phage, it does not impart markedly different characteristics to the phage when compared to its naturally occurring counterpart. Rather, the capsule functions as a generic container for the phage.
Regarding powder, Liang teaches TEM images of rehydrated phage CP30A suggest that the titer loss during lyophilization was caused by broken, deformed, or detached capsid structures compared to the morphology of untreated phage, an observation that could be related to the formation of ice crystals. The successful rehydration of phage preparations with low titer losses demonstrated that phage remained intact and viable. The broken, deformed, or detached capsid structures were not the intended or preferred outcome. And in fact, in some studies, the research team turned to the inclusion of excipients (i.e., sugar) to protect/stabilize the phage and retain viability (pp. 9-10). As noted above, successful rehydration of phage preparations resulted in phage that were not markedly different from their naturally occurring counterparts. Additionally, using broadest reasonable interpretation, the “powder” recited in claims 13 and 20 reads on any powder.
Regarding syrup, Vadym evaluated the effect of 21 different carbohydrates in the nutrient medium on the infection and amplification of bacteriophages and their bacterial hosts (p. 1, Abstract). Interestingly, Vadym showed that the addition of the carbohydrates can either inhibit or enhance plaque formation. However, Vadym also notes “Based on the experimental data, it can be hypothesized that different carbohydrates, including glucose affect one of the components of the bacterial cell during phage replication – metabolic pathways necessary for the synthesis of new progeny virions or the structure of the cell wall, which is used by bacteriophages for attachment and penetration into the bacterial cell”(p. 6-7). As such, the issue at hand appears to be the carbohydrate – bacteria relationship or how the carbohydrate changes the bacteria in culture and how that influences subsequent phage infection and lytic replication. Vadym does not address a composition as proposed by the claims.
Vadym, however, does make an important point which could be applied to the all of the studies cited above and that is about the limitations of their experiment. Vadym states, “our study also has certain limitations that should be considered when interpreting the data and planning further research. The main limitation is that the study focused on exclusively on a single type of bacteriophage -St12f, which restricts the ability to extrapolate the results to other bacteriophages, especially those with different morphology, genomic organization, or host specificity”(p. 11).
All of the references noted above in the arguments feature phage other than KCCM12933P. Additionally, the claims read on any emulsion, capsule, powder, or syrup, not just those discussed in the studies cited above.
Thus, the different formulations - emulsion, capsule, powder, or syrup - do not rise to the level of a marked difference.
Conclusion
Claims 14, 16, 17, 19, 23-26, 27-30 are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Claire Cornelius whose telephone number is (571)272-0860. The examiner can normally be reached M-F, 0930-1700.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached at (571) 270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.C./Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
