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 .
RESPONSE TO AMENDMENT
The substitute specification filed 5-4-2026 has been entered into the record..
The declaration for a Budapest Deposit filed 5-4-2026 has been entered into the record.
The amendment and response filed 7-7-2026 has been entered into the record. Claim 3 has been cancelled. Claims 1, 2 and 4-7 are pending. Claims 1 and 2 are under examination.
The text of Title 35 of the U.S. Code not reiterated herein can be found in the previous office action.
Election/Restrictions
Newly submitted claims 4-7 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The inventions are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the examined product(s) can be used to make a recombinant protein or used in the manufacture of a food or drug product.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 4-7 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant traverses the distinction in that the method of claims 4-7 uses the product of claim 1 and therefore the claimed product and as such is not properly divisible form the method. This is not persuasive as the product can be used in different methods as set forth above and, in the notice, mailed 5-8-2026. It is noted that restriction is proper when either of the two conditions are met. The restriction is therefore found proper and made final.
Rejections Withdrawn
Claims 1 and 2 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 is withdrawn in view of Deposit Declaration filed by inventor Yi Ding.
The rejection of claim 3 under 35 U.S.C. 102(a)(1) as being anticipated by Wen et al et al Accession Number BMR83399, May 18, 2023 is withdrawn in view of the cancelation of the claim.
The rejections based on art over claim 3 are withdrawn in view of the cancellation of that claim. Rejections over art for claims 1 and 2 are maintained for reasons made of record set forth below.
Rejections Maintained
Claims 1 and 2 stand rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter for reasons made of record in the Office Action mailed 2-9-2026.
Applicant’s arguments have been carefully considered but are not persuasive. Applicant argues that the isolated strain with specific defined characteristics that are the product of human intervention and is markedly different from naturally occurring bacteria under Diamond v. Chakrabarty, 447 U.S. 303 (1980), and Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013). Applicants essentially argue that a product that is naturally occurring when isolated, purified and characterized is patent eligible because it can be used in therapy. Applicants provide no single additional property of the bacterium that is present upon purification that does not exist in nature. No genetic alteration has been made to the microorganism as in Diamond v. Chakrabarty, and as such the analysis is directed at the any property of the purified isolated bacterium that is markedly different. Isolation, purification and further characterization of the product do not convey patentability under 35 USC 101 unless it provides properties are markedly different of the bacterium per se. Here, the specification does not alter the characteristics of the bacterium but merely characterizes the properties of a bacterium that is purified from nature. The extensive nature of characterization of the properties does not lend patentability to a bacterium that has been isolated, purified and characterized without the process providing a markedly different property or the bacterium changed in a manner that distinguishes it from that which is naturally occurring. The inquiry is based upon the structural characteristics of the product and not how it is used. Note that “….. patents cannot issue for the discovery of phenomena of nature”. Le Roy v. Tatham, 14 How. 156, 175 (1853). The qualities of the bacteria, 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. This finding was upheld and cited by The Supreme Court in Myriad, 133, S.Ct, at 2117. Bacteria similar to other nature based products such as proteins, antibodies and nucleic acids that have been merely purified and characterized and have not been changed to have markedly different characteristics, do not meet the threshold for patentability under 35 USC 101. The analysis is to the bacterium per se, not to methods of use as argued. The analysis rests on the properties of the bacterium and not methods of use. Here as in other natural products cited above, the isolation and purification has not been demonstrated to have markedly different properties of the bacterium per se. The precedent cited by Applicant has been superseded by more recent Supreme Court decisions. The reliance on the therapeutic use of a isolated natural product does not make the natural product per se patentable under 35 USC 101. Purified insulin may be useful for treatment of diabetes, but that does not render the natural product, insulin, patentable, even in a purified form in view of the Supreme Court precedent and Federal Circuit president applied herein. Arguments directed to process of use are not addressed herein as these claims have been withdrawn from consideration. For all the foregoing reasons the rejection is maintained.
Claims 1-2 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yi et al (CN115927106A;4-7-2023; google English translation) for reasons made of record in the Office Action mailed 2-9-2026.
Applicant argues that this publication is subject to the 1 year exception as it was filed by the inventor. This is not persuasive the publication names Zihuan Wang who is not a named inventor and as such it is not filed by the inventors. Applicant is directed to 717.01(a) for Declarations or Affidavits under 37 CFR 1.130(a) to explain the author(s) who are not named inventors in the instant application in order to provide for a 35 USC 102(b)(1) exclusion. When a prior art document names more/different inventors than the instant application, an assertion of grace period exclusion is insufficient to exclude the art.
Claims 1-2 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yi et al (CN115927106B; 9-8-2023; google English translation) for reasons made of record in the Office Action mailed 2-9-2026.
Applicant’s argue that this publication is subject to the 1 year exception as it was filed by the inventor. This is not persuasive the publication names Zihuan Wang who is not a named inventor and as such it is not filed by the inventors.
Applicant argues that this publication is subject to the 1 year exception as it was filed by the inventor. This is not persuasive the publication names Zihuan Wang who is not a named inventor and as such it is not filed by the inventors. Applicant is directed to 717.01(a) for Declarations or Affidavits under 37 CFR 1.130(a) to explain the author(s) who are not named inventors in the instant application in order to provide for a 35 USC 102(b)(1) exclusion. When a prior art document names more/different inventors than the instant application, an assertion of grace period exclusion is insufficient to exclude the art.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al (Gut, 72:(Suppl 1) special issue ppA73 June 10-11, 2023) for reasons made of record in the Office Action mailed 2-9-2026.
Applicant’s argue that this publication is subject to the 1 year exception as it was filed by individuals in addition to the inventor. This is not persuasive, the publication names Hongying Fan who is not a named inventor and as such it is not filed by the inventors.
Applicant argues that this publication is subject to the 1 year exception as it was filed by the inventor. This is not persuasive the publication names Zihuan Wang who is not a named inventor and as such it is not filed by the inventors. Applicant is directed to 717.01(a) for Declarations or Affidavits under 37 CFR 1.130(a) to explain the author(s) who are not named inventors in the instant application in order to provide for a 35 USC 102(b)(1) exclusion. When a prior art document names more/different inventors than the instant application, an assertion of grace period exclusion is insufficient to exclude the art.
Status of Claims
Claims 1 and 2 stand rejected. Claims 4-7 are withdrawn from consideration.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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