Notice of Pre-AIA or AIA Status
1. 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
Claim Status
2. This Office Action is in response to the preliminary amendment filed 10 October 2023, wherein claims 1 and 4-5 were amended, claims 6-20 were canceled, and new claims 21-35 were added.
Claims 1-5 and 21-35 are under consideration.
Priority
3. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
The U.S. effective filing date of all claims under examination is set at 10/10/2023.
Drawings
4. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Figure 5 appears to be in color.
Specification
5. 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.
6. The use of the term “NCBI” in ¶ [0076], 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.
Note that “NCBI” is merely an example and all improper uses of trademarks in the specification should be identified by Applicant and properly addressed.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 28-35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 28-35, method claims with no active steps are indefinite as it is unclear how the method is to be practiced. MPEP § 2173.05(q) states “[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon” was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).” Claims 28 and 31-32 recite intended use and claim 33 recites a dose, but no claims recite an active step. Thus, all are indefinite here.
9. 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.
10. Claims 1-5 and 21-35 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.
The claims are drawn to a Burkholderia gladioli phage vB_BgIM_WTB that has been deposited with the accession number M 2023525. However, not all statements or declarations have been provided as described below related to the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent. Furthermore, the specification does not recite any deposit information as detailed in the MPEP under 37 CFR 1.809(d).
It is apparent that M 2023525 is required to practice the claimed invention because it is a necessary limitation for the success of the invention as stated in the claims. As a required element it must be known and readily available to the public or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the enablement requirements of 35 U.S.C. § 112, first paragraph, may be satisfied by a deposit of M 2023525. See 37 CFR 1.802. One cannot practice the claimed invention without this specific phage. One cannot determine whether a phage has the necessary characteristics without access to M 2023525. Therefore, access to M 2023525 is required to practice the invention. The specification does not provide a repeatable method for M 2023525 without access to the same samples from which it was isolated and it does not appear to be readily available material.
Deposit of M 2023525 in a recognized deposit facility would satisfy the enablement requirements of 35 U.S.C. 112., because the strains would be readily available to the public to practice the invention claimed, see 37 CFR 1.801- 37 CFR 1.809.
If a deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made at an acceptable depository and that the following criteria have been met:
(a) during the pendency of this application, access to the invention will be afforded to one determined by the Commissioner to be entitled thereto;
(b) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained for a term of at least thirty (30) years and at least five (5) years after the most recent request for the furnishing of a sample of the deposited material;
(d) a viability statement in accordance with the provisions of 37 CFR 1.807; and
(e) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.803 - 37 CFR 1.809 for additional explanation of these requirements.
Applicant has already deposited the material in a recognized facility and identified the date, location, and materials deposited in the Instant Specification. However, Applicant is missing declaration as listed above.
11. 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.
12. Claims 2-3, 21-24, 26-27, and 29-30 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.
Claims 2-3, 21-24, 26-27, and 29-30 recite the phage’s genome length, as well as its stable pH and temperature ranges. These are properties which are inherent to the isolated phage with the accession number M 2023525 and thus do not further limit the claims.
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 as long as no duplicates are made, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
13. 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.
14 Claims 1-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The claims recite a phage with accession number M 2023525, a lysate, and a preparation. See MPEP 2106 for analysis framework.
The instant claims are drawn to a phage, lysate, and preparation. As such, the instant claims are drawn to a product, which is statutory category of matter (Step 1: Yes).
The instant claims are drawn to a judicial exception of a natural product, more specifically a naturally-occurring phage that was isolated from sewage (¶ [0054]) and its lysate. As for the preparation, it can include “Chinese herb extracts or compositions, natural compounds, and chemically synthesized compounds or compositions thereof.” (¶ [0041]). Therefore, the preparation can include other naturally-occurring materials, including water. The combination of the phage and water is also naturally-occurring. Thus, the claim is directed to at least one exception, which may be termed as a product a nature (Step 2A, Prong 1: Yes). The instant claims are drawn solely to a judicial exception which is not integrated into a practical application because the claimed invention is not used to provide a particular treatment or prophylaxis for a disease or medical condition. Further, the claimed invention does not apply or use the judicial exception in a meaningful way and there is no inventive concept in the claims. A naturally-occurring product, or a combination of naturally-occurring products is not novel when the combination does not change the structure, function, or properties of the naturally-occurring components (see MPEP 2106.05(h) and Example 28, Claim 3 (Vaccines) of the Subject Matter Eligibility Examples: Life Sciences found at https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf)). Therefore, the instant claims do not recite any additional elements that integrate the exception into a practical application (Step 2A, Prong 2: No).
The instant claims are drawn to a judicial exception and do not recite any additional elements that amount to significantly more than the judicial exception. The discovery of a naturally-occurring product does not amount to significantly more: “Groundbreaking, innovative, or even brilliant discovery
does not by itself satisfy the § 101 inquiry.” Myriad, 133 S. Ct. at 2117. (Step 2B: No).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. § 101.
Conclusion
15. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTINA E. LY/Examiner, Art Unit 1671
/Michael Allen/Supervisory Patent Examiner, Art Unit 1671