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 .
Election/Restrictions
Claims 19-25 and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/20/2026.
Claim Objections
Claim 15 is objected to because of the following informalities: the claim includes a double negative; it would be clearer if it read “wherein the medium comprises a vegetarian compliant hemoprotein.” Appropriate correction is required.
Claim 18 is objected to because of the following informalities: most of the compounds listed are not proper nouns and do not need their first letter to be capitalized; while there are some compounds listed that are proper nouns, these are Trademarked names and are rejected accordingly (see the 35 USC 112(b) rejection, below). Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 2, 4, 5, 14 and 18 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.
Claims 2 and 4 are indefinite because it is unclear what “native biological catalytic activity” is supposed to mean in the context of the claimed hemoprotein, and if the claims are trying to claim active and inactive forms of the protein. This is further confused by the fact that, given the broadest reasonable interpretation of the term, “without native biological catalytic activity” does not mean that the protein is inactive, just that it does not have native catalytic activity. Without a clear definition of what native is supposed to mean, and how this affects biological catalytic activity there is no reasonable manner to interpret what the Applicant is trying to claim. For the sake of examining the claims on their merit, it will be assumed that claims 2 and 4 are drawn to enzymes (hemoproteins with catalytic activity), and non-enzyme proteins (hemoproteins without catalytic activity), respectively.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation “less than 10 hours,” and the claim also recites “less than 8 hours,” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 13 and 14 are indefinite because it is unclear how the hemoprotein is inactivated. Based upon claim 13, the isolated hemoprotein is produced in an “inactivated” form (assumed as a non-functional enzyme), but this does not appear to be supported by the specification. It is unclear how to treat this limitation, since the method steps are not clearly described. When looking at the limitation in the specification, Example 1 is the only place that describes inactivating a specific hemoprotein - catalase. When looking at this step, the catalase is not produced by the claimed microbes, but is rather provided in the initial stock solution, and inactivated prior to any fermentation steps. However, the steps provided in the specification do not reasonably match the interpretation of the currently claimed limitations, and cannot reasonably be imported into the claimed subject matter. See MPEP 2111.
Claim 14 recites the limitation "the heat inactivated hemoprotein" in the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 contains the trademark/trade name Triton X-100, Pluronic (F68, F88, F-127), and Brij 35. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademarks are used to identify specific surfactants, and accordingly, the description is indefinite.
Claim Rejections - 35 USC § 102/103
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.
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 1-9 and 13-18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Jensen (US Pat. 5,681,725). Jensen teaches a method of making extracellular heme proteins by providing microbes with a fermentation medium that includes heme. Jensen provides a definition for “heme protein,” that is consistent with the claimed hemoprotein. See column 1, lines 5 and 6; column 2, lines 1-27. This assessment of “heme protein” is confirmed by the fact that Jensen provides for the same enzymatic hemoprotein as that claimed (catalase and peroxidase). See column 4, lines 1-4. Jensen provides for applied examples, wherein the fermentate is harvested. See columns 7 and 8, Example 2. Although Jensen does not explicitly state a step of harvesting the microbial culture, following the fermentation step, there would be no reason to, since the ordinary artisan understands that living microbial cultures can be used indefinitely, and as such, would be implicitly motivated to harvest the cells, in addition to the hemoprotein-containing fermentate. Since the artisan wholly understands that living cells can be used indefinitely, there would be no reason for Jensen to explicitly state that the microbial strain should be harvested. Since it seems that the reuse of the culture would be implied, Jensen anticipates the claimed method; if the Applicant can provide rationale to suggest that Jensen would not anticipate the claims, as discussed above, there is nothing non-obvious about harvesting cells that can be used indefinitely.
With respect to claim 1, Jensen teaches all of the claimed steps, but is not explicit in the step of harvesting the microbial strain. However, as stated above, those familiar with the art would not need to explicitly state that the useful culture that is expected to produce product indefinitely, could be harvested and used at a later date. Harvesting a useful culture would either be an expectation from the artisan, and implicitly anticipated by Jensen; otherwise, it would be clearly obvious to the ordinary artisan to harvest the cells, because a cell culture that produces a value-product, and can be maintained indefinitely, would obviously have a use for later.
With respect to claims 2, 3, 8 and 16, Jensen teaches both catalase and peroxidase. See column 4, lines 1-4.
With respect to claim 4, Jensen broadly states that any hemoprotein can be made using the cited method. See column 2, lines 16-27. As such, this would necessarily include hemoproteins that lack native biological catalytic activity.
With respect to claim 5, Jensen does not discuss any oxygen consumption. As such, there is no reasonable manner to compare this limitation to that of Jensen. However, since Jensen appears to anticipate the claimed method, Jensen’s culture must have also provided for the same oxygen consumption rate. This is underscored by the fact that there are no method steps to suggest that the artisan must do anything to achieve this consumption level. See MPEP 2112(III).
With respect to claims 6 and 7, Jensen teaches Aspergillus. See column 2, line 31.
With respect to claim 9, Jensen adds the hemoglobin to the medium as a means of enhancing hemoprotein synthesis, and further provides for administration rates that overlap with those claimed. See column 4, lines 8-27. Hemoglobin is a hemoprotein, and as such, reads upon the claimed hemoprotein.
With respect to claim 15, the enzyme is produced by Aspergillus and not an animal. As such, it must necessarily be vegetarian.
With respect to claims 17 and 18, Jensen teaches many of the claimed compounds. See the tables in column 7 and column 9.
Claim Rejections - 35 USC § 103
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US Pat. 5,681,725) and evidenced by Mehrotra, et al (Applied Microbiology, 6, 179-183, 1958). Jensen neither teaches, nor suggests, lyophilization or freezing of the culture. Mehrotra provides a paper discussing the lyophilization of many different microbes, including Aspergillus. See page 179, left column, 1st paragraph. Mehrotra notes that lyophilization techniques can allow for long-term storage of viable microbes. See page 183, “Summary” section. Additionally, it is an industry standard to freeze or lyophilize microbial strains, as a means of long-term storage; this would have been known, and obvious, to the ordinary artisan. Therefore, it the ordinary artisan is making a useful microbial culture, that must be stored for a long period of time, it would be obvious to freeze or lyophilize the culture. Since lyophilization removes water from the culture, it would necessarily provide for the claimed step of “concentrating.” Finally, the ordinary artisan understands that lyophilized microbes must be contained, and would obviously package them in a container.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Christensen, et al (WO2000039322A1); Krainer, et al (Microbial Cell Factories, 14, 4, 2015).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
