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
Applicant’s amendments and remarks filed on September 15, 2025 are acknowledged. Claims 3, 7, 9, 10, 13, and 14 have been canceled. Claims 1, 2, 4, 6, 11, 15, and 17 were amended. Claims 1, 2, 4-6, 8, 11, 12, and 15-19 are pending.
It is noted that newly added claim 19 is drawn to a method for isolating a C2MI polynucleic acid from a cow milk sample of Group I. Therefore, claim 19 is withdrawn as being drawn to a nonelected invention.
Claims 2, 6, 8, 11, 12, 16, 18, and 19 are withdrawn.
Claims 1, 4, 5, 15, and 17 are examined on the merits herein.
This action is NON-FINAL due to new grounds of rejection not necessitated by amendment.
Priority
This application is a continuation in part of PCT/EP2020/051766, filed on January 24, 2020 which claims priority to EP19153535.0 filed on January 24, 2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Withdrawn Objections
In view of Applicant’s amendments and response, the objections to claim 2 are withdrawn.
Withdrawn Rejections
In view of Applicant’s amendments and response, the 35 U.S.C. 102 rejections are withdrawn.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of the use of the word “said”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
It is noted that the amendment to the specification filed on September 15, 2025 does not comply with the requirements of 37 CFR 1.121(b) because the amendment is not indicated with markings to show the changes relative to the immediate prior version of the specification of record. Therefore, the amendment to the specification has not been entered.
The disclosure is objected to because of the following informalities:
A period is missing at the end of paragraph [0023].
[0072] reads “(B) und (C)” and should read “(B) and (C)” (emphasis added).
Appropriate correction is required.
The use of the terms Thermo Fisher Scientific, Qiagen, and Sigma-Aldrich, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Response to Arguments
Applicant's arguments filed September 15, 2025 have been fully considered but they are not persuasive.
It is noted that the amendment to the specification filed on September 15, 2025 does not comply with the requirements of 37 CFR 1.121(b) because the amendment is not indicated with markings to show the changes relative to the immediate prior version of the specification of record. Therefore, the amendment to the specification has not been entered.
Applicant asserts that the specification was amended to correct the identified informalities. Although Applicant amended paragraph [0128] and included the “®” symbol for the term Sigma-Aldrich, the amendment is not indicated by an underline marking. In addition, contrary to Applicant’s assertions, paragraph [0128] contains the term Thermo Fisher Scientific which was not amended and paragraph [0129] contains the term Sigma-Aldrich which was not amended.
Claim Objections
Claim 1 is objected to because of the following informality:
Claim 1 recites “bovine milk and meat factors” and should recite “bovine meat and milk factors”.
Appropriate correction is required.
Claim Interpretation
Claim 1 part (c) recites “a nucleotide sequence being complementary to a nucleotide sequence of (a) or (b)”. The Examiner is interpreting the limitation as a nucleotide sequence being complementary to a nucleotide sequence of (a) or (b) without any limitation on the length of the nucleotide sequence and thus reads on a sequence that is two or more consecutive nucleotides complementary to (a) or (b).
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.
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.
Written Description
Claims 1, 4, 5, 15, and 17 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 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.
Claim 1 recites
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To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof. The specification envisions that the present invention provides polynucleic acid sequences which are redundant as a result of the degeneracy of the genetic code compared to any of the above-given nucleotide sequences. Further, the variant polynucleic acid sequences will thus encode the same amino acid sequence as the polynucleic acids they are derived from [0045]. The specification discloses the following
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However, no description is provided of any polynucleic acid sequences that is redundant as a result of the degeneracy of the genetic code.
The prior art does not appear to offset the deficiencies of the instant
specification. As evidenced by NCBI’s Open Reading Frame Viewer, the entirety of instant SEQ ID NO: 604 is not one (1) coding sequence. Thus, one skilled in the art would not know which polynucleic acid sequences are redundant are as a result of the degeneracy of the genetic code.
Claims 4, 5, 15, and 17 depend from claim 1 and are rejected for the same reasons as applied to claim 1. Therefore, the skilled artisan would have reasonably concluded that applicants were not in possession of the claimed invention for claims 1, 4, 5, 15, and 17.
Written Description
Claims 15 and 17 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 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.
Claim 15 is drawn to a genus of immunogenic compositions comprising the C2MI polynucleic acid of claim 1 and a pharmaceutically acceptable vehicle. Claim 1 is directed to a C2MI polynucleic acid. Claim 1 part a requires a nucleotide sequence comprising the sequence of SEQ ID NO: 604. Claim 1 part b requires a nucleotide sequence having at least 98% identity to a nucleotide sequence of part a. Claim 1 part c requires a nucleotide sequence being complementary to a nucleotide sequence of part a or part b. Claim 1 part d requires a nucleotide sequence which is redundant as a result of the degeneracy of the genetic code compared to any of the nucleotide sequences in parts a through c. Although the claim does not explicitly recite a vaccine, the instant specification defines a vaccine as “an immunogenic composition capable of eliciting protection against C2MI, whether partial or complete” [0119]. Thus, the rejected claims comprise a genus of immunogenic compositions comprising the C2MI polynucleic acid of claim 1 that encompass nucleotide sequences that must function as an immunogenic composition.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof. The specification envisions that a C2MI polynucleic acid may comprise (a) a nucleotide sequence depicted in any one of Figures 1(A) to 22(A); (b) a nucleotide sequence having at least 93% identity to a nucleotide sequence of (a); (c) a fragment of a nucleotide sequence of (a) or (b); (d) a nucleotide sequence being complementary to a nucleotide sequence of (a), (b), or (c); or (e) a nucleotide sequence which is redundant as a result of the degeneracy of the genetic code compared to any of the above-given nucleotide sequences [0039]. Further, the specification defines a “polynucleic acid” as a single-stranded or double-stranded nucleic acid sequence and may consist of deoxyribonucleotides or ribonucleotides, nucleotide analogues or modified nucleotides [0040]. However, the specification as filed does not describe any C2MI polynucleic acids, such as SEQ ID NO: 604, that have the ability to function as an immunogenic composition.
The specification envisions using assays to determine the function of the various polynucleic acids (e.g., paragraphs [0042]-[0044]). Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function ... does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”’).
The prior art does not appear to offset the deficiencies of the instant specification in that it does not describe C2MI polynucleic acids that are capable of functioning as an immunogenic composition.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is now is claimed." (See Vas- Cath at page 1116). As discussed above, the specification does not provide the polynucleic acid sequences that function as an immunogenic composition. The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of immunogenic compositions, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation or identification. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltc. 18USPQ2d 1016.
Claim 17 depends from claim 15 and is rejected for the same reasons as applied to claim 15. Therefore, the skilled artisan would have reasonably concluded that applicants were not in possession of the claimed invention for claims 15 and 17.
Response to Arguments
Applicant's arguments filed September 15, 2025 have been fully considered but they are not persuasive.
Applicant asserts that amending claims 15 and 17 to recite “an immunogenic composition” overcomes the 35 U.S.C. 112(a) written description requirement. Although the claims do not explicitly recite a “vaccine”, the instant specification defines a vaccine as “an immunogenic composition capable of eliciting protection against C2MI, whether partial or complete” [0119] (emphasis added). Therefore, the claims stand rejected under 35 U.S.C. 112(a) for the reasons of record discussed above.
Applicant further asserts that an immunogenic composition is commonly acknowledged as a composition containing antigens that cause the body to make an immune response against the composition. Applicant also asserts that the polynucleic acids of the invention are autonomously replicating and encode proteins, i.e. antigens. Furthermore, Applicant asserts that there is disclosed a correlation between a DNA encoding antigens and its immunogenic function when it is formulated in a composition. These arguments are not found persuasive. It is noted that an opinion has been made; however, no evidentiary support has been provided for the opinion. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness."). See MPEP 2145(I) and 716.01(c)(II). Furthermore, paragraph [0015] of the instant specification discloses that the putative rep proteins of several BMMF2 isolates did not result only from one ORF, but were compiled of more than one truncated ORF.
Enablement
Claims 1, 4, 5, 15, and 17 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.
There are many factors to be considered when determining whether there is
sufficient evidence to support a determination that a disclosure does not satisfy the
enablement requirement and whether any necessary experimentation is "undue".
These factors include, but are not limited to: (A) The breadth of the claims; (B) The
nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary
skill; (E) The level of predictability in the art; (F) The amount of direction provided by the
inventor; (G) The existence of working examples; and (H) The quantity of
experimentation needed to make or use the invention based on the content of the
disclosure. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Breadth of claims and nature of the invention:
Claim 1 is drawn to
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. The broadest reasonable interpretation of claim 1 part (c) is a nucleotide sequence being complementary to a nucleotide sequence of (a) or (b) without any limitation on the length of the nucleotide sequence and thus reads on a sequence that is two or more consecutive nucleotides complementary to (a) or (b) without requiring any function.
Claims 15 and 17 are drawn to an immunogenic composition comprising the C2MI polynucleic acid of claim 1 and a pharmaceutically acceptable vehicle. The broadest reasonable interpretation of claim 15 is that the immunogenic composition comprising the C2MI polynucleic acid of claim 1 encompasses nucleotide sequences that must function as an immunogenic composition.
State of the prior art, level of predictability in the art, and level of one of
ordinary skill:
zur Hausen et al. (Current Topics in Microbiology and Immunology 2017) discloses that red meat and dairy products have frequently been suggested to represent risk factors for certain cancers, chronic neurodegenerative diseases, and autoimmune and cardiovascular disorders [abstract]. Further, besides cancer, several chronic neurodegenerative diseases have also repeatedly been linked to dairy product consumption or to a diet rich in red meat [page 89, third full paragraph].
A review of the prior art shows that the state of the art of vaccines comprising C2MI polynucleic acids is immature and nascent.
Pardi et al. (Nat Rev Drug Discov. 2018) discloses that mRNA vaccines represent a promising alternative to conventional vaccine approaches because of their high potency, capacity for rapid development and potential for low-cost manufacture and safe administration. However, their application has until recently been restricted by the instability and inefficient in vivo delivery of mRNA [abstract]. While conventional vaccine approaches provide durable protection against a variety of diseases, there remains major hurdles to vaccine development against a variety of infectious pathogens [page 1, first paragraph].
Yang et al. (Biomaterials Research 2015) discloses that gene-based vaccines have become a favored strategy for inducing immunity. However, the lower immunogenicity of nucleic acid vaccines has hindered their progress in humans [page 7, left column, second full paragraph]. Yang et al. also discloses that challenges remain due to a lack of deep and comprehensive understanding of the in vivo behavior of delivery vectors and immunostimulative mechanism. Therefore, intensive and comprehensive understanding of the mechanism of biomaterial vector on both delivery routes and immunostimulatory are very crucial for rational design of delivery vectors for vaccines, and will accelerate the development of nucleic acid vaccine for clinical application [page 7, right column, first full paragraph].
While the state of the art of vaccines comprising C2MI polynucleic acids is immature and nascent, there is also unpredictability and challenges in nucleic acid vaccine therapeutics as evidenced by Pardi et al. and Yang et al.
Amount of direction provided by the inventor and existence of working
examples:
The specification envisions that a C2MI polynucleic acid may comprise (a) a nucleotide sequence depicted in any one of Figures 1(A) to 22(A); (b) a nucleotide sequence having at least 93% identity to a nucleotide sequence of (a); (c) a fragment of a nucleotide sequence of (a) or (b); (d) a nucleotide sequence being complementary to a nucleotide sequence of (a), (b), or (c); or (e) a nucleotide sequence which is redundant as a result of the degeneracy of the genetic code compared to any of the above-given nucleotide sequences [0039]. Further, the specification defines a “polynucleic acid” as a single-stranded or double-stranded nucleic acid sequence and may consist of deoxyribonucleotides or ribonucleotides, nucleotide analogues or modified nucleotides [0040].
However, the specification as filed does not disclose any working examples of the claimed invention. Specifically, there are no working examples of any C2MI polynucleic acids, such as SEQ ID NO: 604, that have the ability to function as an immunogenic composition.
The specification also envisions that functional fragments of the nucleotide sequences harbor a replication gene which codes for a replication protein. An autonomous replicating nucleotide sequence may comprise a nucleotide sequence of the replication gene or a fragment thereof which is capable of inducing autonomous replication [0043].
Further, the specification envisions using standard assays to determine which nucleic acid sequences are related to a nucleotide sequence of Figures 1 to 22 or are fragments thereof and still have the same function as the full length sequences [0044].
However, the examples provided in the specification only encompass DNA extraction, rolling circle amplification, polymerase chain reaction, and in silico analyses (paragraphs [0129] through [0142]. The specification does not disclose how to use the nucleic acid fragments.
Quantity of experimentation:
In view of the breadth of the claims which embrace nucleotide sequences that must function as an immunogenic composition and fragments of a nucleic acid without any required function, the state and level of predictability in the art, the lack of working examples, and the failure to provide adequate guidance to overcome the state and level of predictability of the art, one of skill would have to perform undue experimentation in order to practice the invention commensurate in scope with the claims. This type of experimentation is not routine and would require a large amount of inventive effort.
In re Vaeck, 947 F.2d 488,495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the Court ruled that a rejection under 35 U.S.C. 112, first paragraph for lack of enablement was appropriate given the relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims. Such is the case here where there is a relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims.
Response to Arguments
Applicant's arguments filed September 15, 2025 have been fully considered but they are not persuasive.
Applicant indicates that MPEP §2164.01 states the test for enablement as “is the experimentation needed to practice the invention undue or unreasonable?”. However, there are many factors to be considered when determining whether there is
sufficient evidence to support a determination that a disclosure does not satisfy the
enablement requirement and whether any necessary experimentation is "undue".
These factors include, but are not limited to: (A) The breadth of the claims; (B) The
nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary
skill; (E) The level of predictability in the art; (F) The amount of direction provided by the
inventor; (G) The existence of working examples; and (H) The quantity of
experimentation needed to make or use the invention based on the content of the
disclosure.
Applicant asserts that paragraph [0012] of the specification teaches polynucleic acids belonging to the BMMF2 group were isolated from cow milk samples and comprise a replication gene and encode for novel proteins (e.g., [0013]). Applicant further asserts that the specification teaches that the nucleotides can be formulated into a pharmaceutical composition with an appropriate carrier, vehicle, or excipient (e.g., [0113] – [0125]). Therefore, Applicant asserts that no undue experimentation is required to obtain the claimed pharmaceutical composition. These arguments are not found persuasive. The specification as filed does not disclose any working examples of the claimed invention. Specifically, there are no working examples of any C2MI polynucleic acids, such as SEQ ID NO: 604, that have the ability to function as an immunogenic composition. In addition, a review of the prior art shows that the state of the art of vaccines comprising C2MI polynucleic acids is immature and nascent. Thus, in view of the state and level of predictability in the art, the lack of working examples to show how any C2MI polynucleic acids have the ability to function as an immunogenic composition, and the failure to provide adequate guidance to overcome the state and level of predictability of the art, one of skill would have to perform undue experimentation in order to practice the invention commensurate in scope with the claims.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 5 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 5 recites a host cell transformed or modified with an expression vector according to claim 4. The specification discloses that the term “host cell” refers to cells which can be or have been, used as recipients for a recombinant vector or other transfer polynucleotide, and include the progeny of the original cell which has been transfected [0064]. In addition, paragraph [0105] discloses vectors allowing to transcribe an antisense oligonucleotide in a mammalian host wherein the vector is useful for gene therapy. Further, the C2MI polynucleotide sequences may also serve as a suitable vector itself, either composed solely of rearranged C2MI sequences or of chimeric C2MI host cell DNA sequences. Thus, in view of the specification, the broadest reasonable interpretation of the claimed cell includes a human being. Therefore, the claim is directed to nonstatutory subject matter.
Claim 1 and15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, natural phenomenon, or an abstract idea) without significantly more. Claim 1 is drawn to
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. Claim 15 is drawn to an immunogenic composition comprising the C2MI polynucleic acid of claim 1 and a pharmaceutically acceptable vehicle. As outlined below, this judicial exception is not integrated into a practical application, and does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Subject Matter Eligibility Test for Products and Processes – Claims 1 and 15
Step 1 – Is the claim to a Process, Machine, Manufacture or Composition of Matter? YES.
Claim 1 is directed to a C2MI polynucleic acid which is a composition of matter. The claim is directed to a statutory category.
Claim 15 is directed to an immunogenic composition which is a composition of matter. The claim is directed to a statutory category.
Step 2A, Prong One – Does the claim recite an Abstract Idea, Law of Nature, or Natural Phenomenon? YES.
Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature. MPEP 2106.04(c) outlines the markedly different characteristics analysis.
Claim 1 is drawn to
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. The instant specification discloses in paragraph [0012] that the full-length circular genomes of 97 isolates (16 cow milk products, 81 cow milk) belonging to the BMMF2 group were obtained ranging from 2102 to 3090 nucleotides in size and the 23 sequences (all from cow milk samples and all belonging to the BMMF2 group; C2MI) claimed in the present application are representative members thereof.
In view of the specification, the claimed C2MI polynucleic acid is not markedly different from its naturally occurring counterpart. Thus, claim 1 recites a product of nature judicial exception.
Claim 15 is drawn to an immunogenic composition comprising the C2MI polynucleic acid of claim 1 and a pharmaceutically acceptable vehicle. The instant specification discloses in paragraph [0123] that the immunogenic compositions typically will contain pharmaceutically acceptable vehicles, such as water, saline, glycerol, ethanol, etc. Additionally, auxiliary substances, such as wetting or emulsifying agents, pH buffering substances, preservatives, and the like, may be included in such vehicles. As discussed above, the claimed C2MI polynucleic acid is not markedly different from its naturally occurring counterpart and thus recites a product of nature judicial exception.
Step 2A, Prong Two – Does the Claim recite Additional Elements that Integrate the Judicial Exception into a Practical Application? NO.
The Supreme Court has long distinguished between principles themselves, which are not patent eligible, and the integration of those principles into practical applications, which are patent eligible. The phrase "integration into a practical application" requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
In the instant case, claims 1 and 15 do not recite any elements in addition to the judicial exception (i.e., natural product) that would integrate the natural product into a practical application.
Step 2B – Does the Claim recite Additional Elements that Amount to Significantly More than the Judicial Exception? NO.
The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to "significantly more" than the judicial exception(s) itself. The claim as a whole is evaluated as to whether it amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (MPEP 2106.05).
As stated above, claims 1 and 15 do not recite any elements in addition to the judicial exception (i.e., natural product). There are no additional elements to amount to significantly more than the judicial exception.
Thus, claims 1 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon or a law of nature without significantly more.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Fodor et al. (US 6,582,908).
Regarding claim 1, Fodor et al. teaches a nucleic acid array comprising a complete set 4n unique oligonucleotide sequences of a given length n wherein n is 10 [claim 5]. Further, the oligonucleotides could be RNA or DNA [column 17, lines 23-42]. Thus Fodor et al. teaches every 10 nucleotide fragment of the instantly recited SEQ ID NOS. and meets the limitations of claim 1 part (c) as currently written.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wai et al. (Nucleic Acids Research 2016).
Regarding claim 1, Wai et al. teaches that Yin Yang-1 (YY1) is a multi-functional transcription factor involved in many regulatory processes and binds DNA via four classical zinc fingers [abstract]. To assess the ability of YYI(F1-4) to bind to RNA, the construct was tested in EMSAs (electrophoretic mobility shift assays) with Pentaprobes, a set of twelve 100-bp single-stranded RNA sequences that collectively represent all possible 5-mers [page 9156, left column, first full paragraph].
Claim Rejections - 35 USC § 103
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.
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 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over De Villiers-Zur Hausen et al. (US 2017/0198018; reference previously cited by the Examiner) in view of Wai et al. (Nucleic Acids Research 2016).
Regarding claims 4 and 5, De Villiers-Zur Hausen et al. teaches a recombinant expression vector which may comprise an HCBI, MSBI, MSSI or CMI polynucleic acid operably linked to prokaryotic, eukaryotic or viral transcription and translation control elements as well as host cells containing such vector [0128]. De Villiers-Zur Hausen et al. also teaches that a vector allows to transcribe an antisense oligonucleotide e.g., in a mammalian host. Preferably, such a vector is a vector useful for gene therapy [0171]. Further, De Villiers-Zur Hausen et al. teaches that in order to achieve expression only in the target organ, the DNA sequences for transcription of the antisense oligonucleotides can be linked to a tissue specific promoter and used for gene therapy [0172].
However, De Villiers-Zur Hausen et al. does not teach the C2MI polynucleic acid of claim 1.
Wai et al. teaches that Yin Yang-1 (YY1) is a multi-functional transcription factor involved in many regulatory processes and binds DNA via four classical zinc fingers [abstract]. To assess the ability of YYI(F1-4) to bind to RNA, the construct was tested in EMSAs (electrophoretic mobility shift assays) with Pentaprobes, a set of twelve 100-bp single-stranded RNA sequences that collectively represent all possible 5-mers [page 9156, left column, first full paragraph].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the polynucleic acid of De Villiers-Zur Hausen et al. with the nucleotide sequence of Wai et al. with a reasonable expectation of success. One would have been motivated to do so in order to achieve the predictable result of transcribing an oligonucleotide in a mammalian host for expression in a target organ.
Conclusion
No claims are allowed.
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/C.T./
Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637