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 .
Amendments
Claim 1 has been amended to now require the bacteriophage to be a bacteriophage deposited at the Korean Collection for Type Culture (KCTC) under accession no. KCTC14929BP, having a bactericidal activity against Salmonella spp. bacteria.
Claim 3 has had minor typographic changes consistent with the previous objections to claim 3.
Claims 4-5 are canceled.
Claim 14 has been amended to now require the bacteriophage to be a bacteriophage deposited at the Korean Collection for Type Culture (KCTC) under accession no. KCTC14929BP, having a bactericidal activity against Salmonella spp. bacteria.
Claim 18 is now directed to an antibacterial composition comprising a bacteriophage deposited at the Korean Collection for Type Culture (KCTC) under accession no. KCTC14929BP, having bactericidal activity specifically against Salmonella spp. bacteria.
Claim 19 is new and further limits the composition to comprise a polymeric compound and a plasticizer.
Drawings
Previous objections to the drawings
The drawings were objected to for minor informalities. Applicant has provided replacement drawing sheets which remedy the deficiencies identified in the previous objection. Therefore, the objection is withdrawn.
Specification
Previous objection to the specification
The specification was objected to for containing an impermissible hyperlink. Applicant has amended this portion of the specification to remove the hyperlink. Accordingly, the objection to the specification is withdrawn.
Claim Objections
Previous objections to the claims
Claims 3, 5, and 18 were objected to for minor informalities. Applicant has made the appropriate amendments to claims 3 and 18; therefore, the objection is withdrawn. Claim 5 is canceled, rendering the objection moot.
New objections to the claims
Claims 1 and 14 are objected to because the abbreviation “spp.” should not be italicized.
Claim 19 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Appropriate correction is required.
Claim Interpretation
Claims 14-16 are considered to be product-by-process claims. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP § 2113(I)). The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product (Id.). In this case, the “process” recited in claim 14 is “using a coating composition” and the “process” recited in claims 15-16 is “coating the coating composition on a substrate and drying it” at the recited temperatures for the recited amounts of time. Accordingly, because the active steps in the processes are merely “using”, “coating”, and “drying”, the structure implied by the claims is merely “a bacteriophage having a bactericidal activity against Salmonella spp. bacteria, a polymeric compound, and a plasticizer”. There is no evidence that the recited steps impart any other particular structure on the claimed “antibacterial films”.
Claim 17 is considered to recite an “intended use” because the body merely recites applicant’s intended purpose for the “antibacterial film”. There is no requirement that the “antibacterial film” actually be “for food packaging” as recited in the claim. For example, an antibacterial film which meets each of the elements of claim 14 is structurally identical to an antibacterial film which is used “for food packaging” and there is no particular structure imparted by the body of the claim. As such, prior art which teaches or renders obvious the composition of claim 14 will be considered to teach or render obvious the composition of claim 17 regardless of whether it was used “for food packaging”.
Claim 18 is now required to be an antibacterial composition. There is no particular structure imparted by this limitation and the preamble merely states what the composition does, rather than by imparting any meaningful structure on the composition. For example, the bacteriophage per se naturally possesses an antibacterial effect and it is therefore an “antibacterial composition”.
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 rejections under 35 U.S.C. § 112(a)
RE: Rejection of claims 5 and 18 under 35 U.S.C. 112(a), as failing to comply with the enablement requirement.
Claims 5 and 18 were rejected for failing to comply with the biological deposit requirement. Claim 5 is canceled, rendering the rejection moot. It is noted that the strain limitation is now incorporated into independent claims 1 and 14. A rejection has not been made over the claims, as amended because applicant has provided a statement attesting to the public availability of the deposited bacteriophage strain (see Misc. Letter dated 08/29/2025). Accordingly, the rejection of record is withdrawn.
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 under 35 U.S.C. § 101
RE: Rejection of claim 18 under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and natural phenomenon without significantly more.
Claim 18 was rejected for reciting a natural product without significantly more. Applicant states that they do not concede the merits of the rejection but have amended claim 18 to be directed to “an antibacterial composition” which allegedly renders the rejection moot.
Applicant’s argument has been fully considered but is not sufficient to overcome the rejection of record. Specifically, as discussed in the Claim Interpretation section of this action, although the composition is now required to be “an antibacterial composition”, there is no structure imparted by this preamble accordingly, the composition still merely comprises a naturally occurring bacteriophage per se and is not markedly different from the natural counterpart. Additionally, the claim does not possess additional elements which amount to significantly more.
In order to fully address applicant’s amendment to the claim, the rejection is withdrawn and a new ground of rejection is set forth below.
New grounds of rejection under 35 U.S.C. § 101
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and natural phenomenon without significantly more.
The instant claims recites laws of nature and natural phenomena. These judicial exceptions (JEs) are 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 as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A): Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
The Markedly Different Characteristics Analysis
The first step in the analysis is to select the appropriate counterpart to the nature-based product. When the nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. See MPEP § 2106.04(c)(II)(A).
The second step in the analysis is to identify appropriate characteristics to compare. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673. See MPEP § 2106.04(c)(II)(B).
The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. See MPEP § 2106.04(c)(II)(C).
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP § 2106.05(a);
Applying the judicial exception with, or by use of, a particular machine. See MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP § 2106.05(c);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP § 2106.05(d);
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP § 2106.05(e).
Step (2B). If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step 1 (direction to a process, machine, manufacture, or composition of matter):
Claim 18 is directed to a composition of matter, which is a statutory category.
Therefore, the answer to this step for claim 18 is yes.
Step 2A, Prong 1 (recitation of a law of nature, natural phenomenon, or an abstract idea):
Claim 18 is directed to “a bacteriophage…having a bactericidal activity specifically against Salmonella spp. bacteria”. Applicant discloses that the bacteriophage was “obtained from domestic sewage samples and purified through a double-layer agar assay and a plaque assay” ([87]). Accordingly, the bacteriophage is a product of nature (i.e., a law of nature and natural phenomenon). And although the composition is now required to be “an antibacterial composition”, as discussed above, the antibacterial property is a property inherently possessed by the bacteriophage. As such, merely reciting what the composition does is not sufficient to render it markedly different from its closest natural counterpart.
Therefore, the answer to this prong for claim 18 is yes.
Step 2A, Prong 2 (recitation of additional elements that integrate the JE into a practical application):
Claim 18 recites an accession number, which is merely an arbitrary identifier associated with the deposit of the bacteriophage and recites the activity of the bacteriophage. Neither of these elements integrate the JE such as by effecting a transformation or reduction of a particular article to a different state or thing or applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition.
Claim 18 further recites an antibacterial composition. As discussed above, there is no particular structure imparted by this preamble. The bacteriophage per se is naturally an “antibacterial composition” and therefore recitation of this property does not effect a transformation or reduction of the judicial exception to a different state or thing or apply or use the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition.
Step 2B (recitation of additional elements that amount to significantly different than the JE such that they provide an inventive concept):
Claim 18 recites an accession number, which is merely an arbitrary identifier associated with the deposit of the bacteriophage and recites the activity of the bacteriophage. Neither of these elements are considered to be “additional elements” which would provide an inventive concept (i.e., labeling the bacteriophage and describing its activity are not inventive).
Claim 18 further requires that the composition is an “antibacterial composition”. This is the natural activity of the judicial exception and therefore does not provide an inventive concept. And to the extent that the composition is formulated as an “antibacterial composition”, Radford et al. (Food Microbiology, 2017, Vol. 66, pages 117-128; cited previously) teaches that bacteriophages comprising bacteriophages having bactericidal activity can be formulated as coating compositions (p. 119, left col., par. 1). As such, even if the preamble imparted a particular structure, formulating the judicial exception as an “antibacterial composition” does not provide an inventive concept.
Conclusion
Claim 18 is directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
The factual inquiries 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 nonobviousness.
Previous prior art rejections
Applicant asserts that the claims, as amended, are not anticipated or obvious over the cited prior art because the claims now require a bacteriophage deposited under accession no. KCTC14929BP and neither Radford, Chen, nor Whichard provide any teachings to arrive at a composition comprising the bacteriophage deposited under this accession number.
Applicant’s arguments have been fully considered and are sufficient to overcome the rejections of record. Specifically, the prior art does not teach or suggest a bacteriophage deposited under accession no. KCTC14929BP and because each claim requires this specific bacteriophage, the claims are nonobvious over the art. As such, the prior art rejections are withdrawn.
Allowable Subject Matter
Claims 1-3 and 6-17 are allowable because they recite a unique bacteriophage which was not previously disclosed in the art and because they recite an additional components (a plasticizer), which renders the composition markedly different from the natural counterpart. Moreover, applicant has fulfilled the biological deposit requirement for the bacteriophage deposited at KCTC under accession no. KCTC14929BP by providing a statement attesting to the public availability of the strain.
An updated prior art search has been performed and did not uncover any disclosure of the bacteriophage deposited under accession no. KCTC14929BP (i.e. bacteriophage PBSE191) before the effective filing date of the claimed invention.
Conclusion
Claims 1-3 and 6-17 are allowable.
Claim 18 is not allowed.
Claim 19 would be allowable in independent form but is objected to for depending on a rejected claim.
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 GRANT C CURRENS whose telephone number is (571)272-0053. The examiner can normally be reached Monday - Thursday: 7:00-5:00.
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/GRANT C CURRENS/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651