DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment
1) Acknowledgment is made of Applicant’s preliminary amendment filed 09/12/24.
Election
2) Acknowledgment is made of Applicant’s election filed 06/25/26 in response to the restriction and the species election requirement mailed 05/13/26. Applicant has elected invention I and the Mycoplasma synoviae strain K5885 species. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (M.P.E.P § 818.03(a)).
Status of Claims
3) Claims 10, 17, 32, 34 and 35 have been amended via the preliminary amendment filed 09/12/24.
Claims 2, 3, 8, 12, 13, 15, 18, 19, 25-28, 30, 31 and 33 were canceled via the preliminary amendment filed 09/12/24.
Claims 1, 4-7, 9-11, 14, 16, 17, 20-24, 29, 32, 34 and 35 are pending.
Claims 20-24, 29, 32, 34 and 35 are withdrawn from consideration as being directed to a non-elected species. See 37 CFR 1.142(b) and M.P.E.P § 821.03.
Claims 1, 4-7, 9-11, 14, 16 and 17 are examined on the merits.
Drawings
4) Applicant’s’ drawings filed 09/12/24 are acknowledged.
Priority
5) The instant AIA application, filed 09/12/24, is the national stage 371 application of PCT/US2023/015103 filed 03/13/2023, which claims priority to the provisional application 63/319,532 filed 03/14/2022.
Rejection(s) under 35 U.S.C § 101
6) 35 U.S.C § 101 states:
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.
7) Claims 1, 4-7, 9-11, 14, 16 and 17 are rejected under 35 U.S.C § 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 4 recite an isolated Mycoplasma pneumoniae strain K5885 deposited as PTA-127167. Claims 5-6 are directed to a composition comprising respectively said strain and water and a pharmaceutically acceptable carrier, for example, inert water. The composition of the dependent claim 7 comprises an adjuvant, which encompasses naturally occurring endogenous peptidoglycan, lipopolysaccharide, membrane vesicles etc. Because these elements are composed of matter, at least one embodiment encompassed within the broadest reasonable interpretation (BRI) of the instant claims is directed to a statutory category, i.e., a composition of matter (Step 1: YES). The as-filed specification states that the claimed Mycoplasma pneumoniae strain K5885 was isolated from broiler chickens. Thus, the claimed strain, or its progeny as claimed in claim 16, is a naturally occurring element. Since the claimed strain is not purified, it is expected to contain at least endogenous residual LPS adjuvant. There is no evidence that the claimed strain of Mycoplasma pneumoniae strain K5885 is markedly different from what exists in nature. Supreme Court has made it clear in Myriad that eligibility requires the creation of something not naturally occurring, which is markedly different from what exists in nature. Unlike the Chakrabarty bacterium, which was new “with markedly different characteristics from any found in nature” 447 U.S., at 310, 100 S. Ct. 2204, 65 L. Ed. 2d 144, due to the multiple additional plasmids and resultant “capacity for degrading oil”, there is no indication that the instantly claimed strain is genetically manipulated or structurally modified in any marked or significant way such that the structural difference results in change of properties of the strain. Furthermore, adding a pharmaceutically acceptable carrier such water to the strain to form a composition does not markedly change the strain or the water. The naturally occurring Mycoplasma pneumoniae strain K5885 or a progeny thereof and inert water or naturally occurring endogenous adjuvant are judicial exceptions (JE). The claim limitations such as “vaccine” or “kit” in claims 11 and 14 or claims 16 and 17 represent a field of use or technological environment in which to apply the judicial exceptions and therefore fail to provide meaningful limits on the claims. All the qualities, properties or characteristics of the naturally occurring strain are its inherent qualities, properties or characteristics inseparable therefrom and therefore are a handiwork of nature. Note that “….. patents cannot issue for the discovery of phenomena of nature”. Le Roy v. Tatham, 14 How. 156, 175. The qualities of the said strain, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none.” See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. at 130, 1948. In Funk Brothers, the Court held that the composition was not patent eligible because the patent holder did not alter the bacteria in any way. In the instant case, the naturally occurring Mycoplasma pneumoniae strain K5885 or a progeny thereof and inert water or naturally occurring endogenous adjuvant are judicial exceptions (JE) (Step 2A Prong One: YES). Judicial exceptions include all natural products including those derived from natural sources or patients such as naturally occurring microorganisms, bacteria, proteins, peptides, glycoproteins, glycopeptides, carbohydrates, and other substances found in nature or derived therefrom such as a ‘derivative thereof’ as recited in instant claim 16, or derived from nature. Next, the claims as a whole are analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claims amount to significantly more than the JEs. Having water with the strain to form a composition, or having it in a kit or packaging material, or having it in a frozen form or orally administrable liquid form with water, does not amount to significantly more. The limitations such as ‘vaccine’ and ‘kit’ are not affirmative limitations because they are merely indicating how the claimed strain or composition might be used. These limitations do not apply or use the exception(s) in any meaningful way and do not integrate the law of nature into a practical application. There is nothing that provides significantly more or that integrates the claimed naturally occurring strain and naturally occurring water, i.e., the judicial exceptions (JE), into a practical application (Step 2A Prong Two: NO). These limitations merely limit the use of the judicial exception(s) to a particular technological environment, or merely instruct to implement or use the strain or the composition. The claims as a whole do not amount to significantly more than a ‘product of nature’ (Step 2B: NO). Therefore, instant claims are not directed to a patent eligible subject matter.
The rationale for this determination is formed in view of the 2019 PEG, the 2015 Update of the 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 4618) (hereafter Interim Eligibility Guidance) dated 16 December 2014, the Life Sciences Examples issued in May 2016, and in view of Myriad v Ambry, CAFC 2014-1361, -1366, 17 December 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June13, 2013).
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ), First Paragraph
8) The following is a quotation 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 35 U.S.C. § 112 (pre-AIA ), first paragraph:
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 the invention.
9) Claims 1 and 16 and the dependent claims 4-7, 9-11, 14 and 17 are rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, as containing 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, because the specification does not provide evidence that the claimed biological material is (1) known and readily available to the public; (2) reproducible, e.g. sequenced; or (3) deposited.
Claims 1 and 16 recite Mycoplasma synoviae strain K5885 deposited as PTA-127167.
It is apparent that the claimed strain is required to practice the claimed invention. As the required element, the specifically claimed Mycoplasma synoviae strain K5885 must be known and be readily available to the public, or obtainable by a reproducible method set forth in the specification. If not so obtainable or available, the enablement requirements of 35 U.S.C § 112(a) may be satisfied by a deposit of the claimed strain at an acceptable depository. The as-filed specification on page 8 states that Mycoplasma synoviae strain K5885 was deposited with the ATCC as PTA-127167 on 12 November 2021 in accordance with Budapest Treaty. If this deposit has been made under the provisions of the Budapest Treaty, then a statement, an affidavit or declaration by Applicant or assignee(s) having the authority and control over the conditions of the deposit, or a statement by an attorney of record who has a registration number over his or her signature, is required. The statement should state that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced, if viable samples cannot be dispensed by the depository. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each state. The statement should identify the deposited bacterial strain by its depository accession number, establish that the deposited strain is the same as the one described in the specification/claim, and establish that the deposited strain was in Applicant’s possession at the time of filing. It is noted that a copy of the contract or the notice from the ATCC of the deposition of viable Mycoplasma synoviae strain K5885 as PTA-127167 has been made of record in the instant application.
Applicant’s attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 C.F.R § 1.801-1.809 for further information concerning deposit practice.
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ) Second Paragraph
10) 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.
11) Claim 16 is 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 inventor or a joint inventor, or for the pre-AIA the Applicants regard as the invention.
Claim 16 is indefinite and ambiguous in the limitation ‘derivative thereof’, because it is unclear what does it represent structurally, with regard to its precise structure. The specification does not provide a standard for ascertaining the requisite structure, and one of ordinary skill in the art would not be reasonably apprised of the scope of the claim. What precise structure or what contents or parts of the Mycoplasma synoviae strain K5885, or how many genetic or structural changes a strain must possess compared to the Mycoplasma synoviae strain K5885 in order to qualify as a ‘derivative thereof’ is not clear.
Claim(s) Interpretation
12) Per the as-filed specification, isolated progeny or isolated derivatives of Mycoplasma pneumoniae (MS) strain K5885 are interpreted as those Mycoplasma pneumoniae (MS) strains with equivalent or similar biological, serological, and/or genetic characteristics. As per the as-filed specification, said progeny or derivatives have favorable protective properties and said derivatives include genetically modified versions of strain K5885. See page 8.
Notice Re Prior Art Available under Both Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C § 102 and 35 U.S.C § 103 (or as subject to pre-AIA 35 U.S.C § 102 and 35 U.S.C § 103) is incorrect, any correction of the statutory basis 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.
Rejection(s) under 35 U.S.C § 102
13) 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.
14) Claim 16 is rejected under 35 U.S.C § 102(a)(1) as being anticipated by EP 0846468 A1.
EP 0846468 A1 disclosed a live Mycoplasma synoviae strain MS1 that is derived from a NAD-dependent strain of a Mycoplasma synoviae strain, i.e., a derivative. A vaccine comprising a suitable amount of said strain for the protection of poultry against Mycoplasma synoviae infection. Said vaccine further comprised a pharmaceutically acceptable carrier or water and an adjuvant. See section (57) on page 1; lines 6-8, 24, 25, 35-40, 47-50 and 52 on page 2; lines 8-14 on page 13; and claims 1, 3, 6, 7, 9 and 10. The prior art Mycoplasma synoviae strain derivative having the capacity to protect birds against a Mycoplasma synoviae infection qualifies as a “derivative thereof” as claimed in claim 16 since it has a similar capacity to protect birds against a Mycoplasma synoviae infection.
Claim 16 is anticipated by EP 0846468 A1.
Conclusion
15) No claims are allowed.
Correspondence
16) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's Supervisor, Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
17) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
July, 2026
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