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
Applicant’s remarks and amendments filed 1/2/2026, in response to the non-final rejection mailed 10/2/2025, are acknowledged and have been fully considered. Applicant’s amendment to the claims is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Claims 1-3 and 5-10 are pending and have been examined on the merits.
Any previous rejection or objection not mentioned herein is withdrawn.
Claim Rejections - 35 USC § 112(b)
(modified as necessitated by Amendment)
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 1-3, 5-7, and 10 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.
Amended claim 1 recites “wherein the liquid media is VnM9v2 or VnM9v3” (previously recited in now-cancelled claim 4). The terms “VnM9v2” and “VnM9v3” are not defined in the claims such that the scope of the claimed method is clearly set forth, and the terms are indefinite because the specification does not clearly and specifically define the terms.
These components of these media compositions are not explicitly defined in the claim. Further, these are not commonly known media nor terms in the art (i.e. LB). The specification provides recipes and descriptions of both “VnM9v2” (see [0024] and [0025]) and “VnM9v3” (see [0028] and [0029]). From the specification, it is apparent that these media compositions were developed and optimized by the inventors through experimentation and not otherwise known to the art (see [0016] and [0021]). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention and the resulting claim language is indefinite.
It is noted that the description of the media in claim 8 appears to be the same as the description of “VnM9v3” from the specification. Thus, one possible amendment to overcome this rejection is to amend claim 1 with language similar to claim 8, and recite the specific compositions and concentrations that constitute “VnM9v2” and “VnM9v3”.
Claims 2-3 and 5-7 depend directly or indirectly from the rejected claim 1 without clarifying the indefinite terms and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim 10 recites the limitation "reducing the temperature to said greater than 25°C and less than 37°C" in line 3. There is insufficient antecedent basis for this limitation in the claim. There is no earlier recitation of “greater than 25°C and less than 37°C". It appears that the claim may be referencing “a temperature between 26°C and 35°C, inclusive” which is recited in claim 8. However the second recited range is not the same as that recited in claim 8. Thus the resulting claim is indefinite.
Response to Arguments
Applicant's arguments regarding the rejections under 35 U.S.C. 112(b) for indefiniteness on page 6-8 of the remarks filed 1/2/2026 have been fully considered but they are not persuasive.
Applicant argues that the new terms are defined in the specification (paragraph [0016]) and states that the specification has defined the new term "VnM9v2" as a liquid formulation stock ([0023]) and a recipe for preparing one liter ([0024]) and the new term "VnM9v3" as a liquid formulation stock (paragraph [0027]) and a recipe for preparing one liter (paragraph [0028]). Applicant argues that the coined terms would be well understood in the art, in accordance with the “well documented practice of using coined terms as a lexicographer”.
Applicant’s argument that the specification has adequately defined these new terms so that their meaning can be understood by one of ordinary skill in the art is not persuasive.
Regarding the argument that the specification has defined the claim terms, it is noted that the section from [0011]-[0014] of the specification is titled “Definitions” and there is no recitation of the two terms at issue here. There are no special definitions provided for "VnM9v2" and "VnM9v3". Further the specification states that “Before describing the present invention in detail, it is to be understood that the terminology used in the specification is for the purpose of describing particular embodiments, and is not necessarily intended to be limiting.”. One cannot determine what parts of the specification are not limiting and which are specially defined terms, such that the use of the term in a claim results in defined boundaries of the subject matter for which protection is sought. Turning to the portions of the specification that were cited by the Applicant in the argument, [0016] states that: “[0016] A defined minimal media was developed, optimized for V natriegens growth, focusing on a number of factors including essential elemental sources/concentrations (nitrogen, sulfur, phosphorous), salt concentrations (NaCl), carbon sources and concentrations (such as glucose and glycerol as well as alternative carbon sources (xylose, citrate, lactose, etc.). Also examined were additional supplements (such as casamino acids, buffers, aspartate, thiamine, and metals). This work led to a media formulation termed "VnM9v2."”. There is no explicit description of VnM9v2 in this cited portion such that one would understand the metes and bounds of protection sought.
The portions of the specification that Applicant states are the formulations and recipes ([0023]-[0026] for “VnM9v2” and [0027]-[0030] for “VnM9v3”) are clearly part of the Examples. There is no indication that these are to be considered special definitions and not particular embodiments. Examples and preferred embodiments are not read into claims from the specification. “To act as their own lexicographer, the applicant must clearly set forth a special definition of a claim term in the specification that differs from the plain and ordinary meaning it would otherwise possess.” CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 13 (see MPEP § 2111.01.IV.) Further, MPEP § 2173.05(a) states that: “The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." In re Packard, 751 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014). Applicants need not confine themselves to the terminology used in the prior art, but are required to make clear and precise the terms that are used to define the invention whereby the metes and bounds of the claimed invention can be ascertained. During patent examination, the pending claims must be given the broadest reasonable interpretation consistent with the specification. In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997); In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969)”. The claims, read in light of the specification, must reasonably apprise those skilled in the art both of the utilization and scope of the invention (see MPEP 2173.05(a).II).
In the instant case, although the recipes to prepare embodiments of these stocks are provided, the language used does must clearly set forth a special definition of a claim term.
Further, the specification in other embodiments demonstrates varying concentrations of components of the media: e.g. [0033]: “the growth media can have a chloride ion concentration in the range of 25 - 75 mM while maintaining sufficient sodium for V. natriegens growth (typically by using a non-chloride salt as a sodium source to reach at least 100 mM sodium). In further aspects, the growth media can have a phosphate ion concentration in the range of 10 - 30 mM.”. Further, both [0024] and [0028] recite “an appropriate concentration of selective antibiotic”, and thus it is also unclear if an antibiotic must be present in the recited claim limitation, and if so, what antibiotic concentration is required to practice the claimed invention.
Therefore, it has been determined that there is no defined meaning nor specific composition for the claim components “VnM9v2” or “VnM9v3”, considered in light of the specification, such that one skilled in the art would be apprised of the metes and bounds of protection sought. Thus, amended claim 1 has been rejected for indefiniteness for essentially the same reasons as claim 4 in the previous non-final rejection.
Regarding claim 10, Applicant’s arguments have been fully considered but are not persuasive. Applicant argues that the limitation "greater than 25°C and less than 37°C" is supported by line 3 of paragraph [6] in the specification. The argument is not persuasive.
The dependent claim recites “reducing the temperature to said greater than 25°C and less than 37°C" while claim 8 recites “a temperature between 26°C and 35°C, inclusive”. As described previously, the claim is indefinite because there is no antecedent basis for this limitation. It unclear what the “said temperature” of 25°C-37°C is in reference to because only a temperature of 26°C - 35°C for the growth stage is recited in the independent claim. Although the exact language used appears in the specification as pointed out by the Applicant, the claim is claim is indefinite because the metes and bounds of the protection sought is unclear.
MPEP § 2173.05(e) describes a similar situation where “A claim is indefinite when it contains words or phrases whose meaning is unclear. In re Packard, 751 F.3d 1307, 1314, 110 USPQ2d 1785, 1789 (Fed. Cir. 2014). The lack of clarity could arise where a claim refers to "said lever" or "the lever," where the claim contains no earlier recitation or limitation of a lever and where it would be unclear as to what element the limitation was making reference.” Here, it is unclear whether the claim is meant to recite 26°C - 35°C, and thus mean that the temperature is adjusted to that of the previously recited growth phase, or if this was meant to introduce an entirely new temperature stage, one after the 37°C and separate from the growth phase. These constitute distinct methods but it is unclear which the claims are drawn to.
Allowable Subject Matter
Claims 8 and 9 have been found allowable because the subject matter recited therein is not explicitly taught nor suggested in the art. As set forth in the previous action, the prior art does not teach a media for producing melanin by the culturing of recombinant Vibrio natriegens having all of these claimed components at these specific concentrations.
From the disclosure, it is evident that this media composition was developed and optimized by the inventors through experimentation. The success of such a media would not have been predictable to one of ordinary skill (as discussed in [0016] and [0021] of the specification). Culturing of Vibrio natriegens expressing a recombinant tyrosinase in this media results in improved melanin production (see Figure 1, iteration 6).
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
Applicant's amendment necessitated the modified grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655