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 .
Amendments
Claim 1 has been amended to now recite a method by which the Bacillus velezensis QMHF-G5 is obtained. Claim 1 also now recites the 16S rDNA sequence of QMHF-G5.
Claims 2 and 10 are canceled.
Claim 8 has had a minor typographic change.
Claim Status
Claims 1 and 3-9 are currently pending and have been examined on the merits.
Drawings
Previous objection to the drawings
The drawings were objected to for the following reasons:
Colors were required to convey the content of figures 1-14 and 17;
The height of the text in figures 18-19 was smaller than the minimum required height.
Applicant traverses the objection by arguing the following.
With respect to the first objection, applicant asserts that photographs are the only practicable medium for illustrating the claimed invention.
Applicant’s argument has been fully considered but is not sufficient to overcome the objection. As discussed in the objection, applicant’s specification discussed in detail the colors “shown” in the black and white drawings (see [0065], [0071], [0076], [0084], [0089]-[0092], [0096], [0101], [0106], [0111], [0114], [0120], and [0130]). Accordingly, although photographs may be the only practicable medium for illustrating the claimed invention, it is improper to discuss colors shown in the photographs when the photographs are not color drawings.
In the interest of compact prosecution, it is recommended that applicant either file a Petition for Color Drawings or amend the specification to remove mention of color details allegedly shown in the black and white drawings.
With respect to the second aspect of the objection, receipt is acknowledged of amended figures 18-19. These changes are sufficient to overcome this aspect of the objection to the drawings.
Maintained objection to the drawings
The drawings are objected to for the following reason.
Photographs are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention (37 CFR 1.84(b)(1)). In this application, it is noted that figures 1-19 are photographs. Although colors are not needed to convey the content of figures 15-16 and 18-19, the other figures require color. See applicant’s description of the figures which discuss colors, color changes, and details which require color ([0065], [0071], [0076], [0084], [0089]-[0092], [0096], [0101], [0106], [0111], [0114], [0120], and [0130]).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Previous objection to the claims
Claim 1 was objected to because it did not establish the abbreviation CGMCC. Applicant has made the appropriate correction and the objection of record is withdrawn.
New objection to the claims
Claim 1 is objected to for the following reasons:
The taxonomic abbreviation B. velezensis is already established in line 1 of the claim and should not be reestablished in line 5.
The abbreviation “LB” should be fully defined when first used in the claim. For example, applicant may amend line 12 to read “lysogeny broth (LB)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112:
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.
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.
Previous rejection under 35 U.S.C. § 112(a)
RE: Rejection of claims 1-10 are rejected under 35 U.S.C. 112(a), as failing to comply with the enablement requirement.
Claims 1-10 were rejected as failing to comply with the enablement (biological deposit) requirement.
Claims 2 and 10 are canceled, rendering the rejection moot.
With respect to claims 1 and 3-9, applicant has provided a Declaration from co-inventor Fuyu Yang, which avers compliance with the biological deposit requirement. Accordingly, applicant is considered to have met the Biological Deposit requirement and the rejection under 35 U.S.C. § 112(a) is withdrawn.
New rejection under 35 U.S.C. § 112(b)
Claims 1 and 3-9 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 has been amended such that it now recites a method by which “the Bacillus velezensis (B. velezensis) QMHF-G5 is obtained”. The newly introduced claim language reads similar to a product-by-process claim limitation but is not considered to be a true “product-by-process” claim because it is unclear if the claim actually requires the strain to be derived by this method or if it merely describes how the strain can be derived.
Specifically, the lack of clarity arises because applicant’s claim uses the past tense and narrative form rather than setting forth actual active steps to “obtain” B. velezensis QMHF-G5”. For example, the claim recites “Vespula flaviceps individuals were collected and placed”, “sterile normal saline was added”, “Vespula flaviceps individuals were ground”, “the homogenate was vortexed”, etc. Thus, it is reasonable to read these limitations as merely setting forth a narrative of how applicant arrived at the strain and the claim is therefore indefinite.
Claims 3-9 are indefinite because they inherit the indefinite language discussed above.
Examiner’s Interpretation: In the interest of compact prosecution, this language is interpreted to be product-by-process language. For the reasons discussed throughout this action, the newly added product-by-process language is not considered to impart any meaningful structural limitation on the claims because applicant has not demonstrated that B. velezensis QMHF-G5 derived from this method is in any way different from B. velezensis QMHF-G5 derived by some other process. Although the consideration of product-by-process language is generally related to prior art consideration, applicant nonetheless has a burden of showing how the recited process causes B. velezensis QMHF-G5 derived by this process to differ from QMHF-G5 derived from another process. For at least these reasons, the claims remain directed to B. velezensis QMHF-G5 per se and have been examined as such.
Claim Rejections - 35 USC § 101
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.
Previous rejections under 35 U.S.C. § 101
RE: Rejection of claims 1-9 under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and natural phenomenon without significantly more.
Claim 2 is canceled, rendering the rejection moot (although it is noted that the limitation of claim 2 has been incorporated into claim 1 and this limitation was not considered to impart subject matter eligibility).
With respect to claims 1 and 3-9, Applicant argues that the amended claims are subject matter eligible for the following reasons.
First, applicant asserts that the QMHF-G5 of the present application is obtained via a specific isolation and purification process. The strain obtained by this process allegedly exhibits markedly superior antifungal and antibacterial activity compared to B. velezensis strains prepared using conventional techniques and this assertion is “supported by rigorous, quantitative experimental data” (Remarks, p. 8, par. 4). Specifically, applicant asserts that the B. velezensis QMHF-G5 of the present application produces an inhibitory zone width of more than or equal to 14.12 mm for Fusarium graminearum but Taghavi et al. merely shows an inhibitory zone without any numerical millimeter measurement and does not provide any quantitative value. Applicant concludes that this demonstrates that Taghavi’s strain’s inhibitory performance is “substantially inferior” to the high activity of QMHF-G5.
Second, applicant asserts that Taghavi et al. fails to disclose any inhibitory activity of B. velezensis against Aspergillus tubingensis, Cochliobolus sativus, Valsa mali Miyabe et Yamada, Micrococcus flavus, and Paenibacillus larvae and the present strain “displays potent inhibitory effects against all of the aforementioned pathogens” (Remarks, p. 9, par. 3). Applicant concludes that this demonstrates that the QMHF-G5 strain “possesses remarkably broader antimicrobial spectrum than the strain disclosed in Taghavi et al.” (Remarks, p. 9, par. 3).
Third, applicant asserts that QMHF-G5 “is not a naturally occurring wild-type strain” and is instead an “artificially screened product possessing distinct technical characteristics obtained via Applicant’s specific isolation and purification process” (Remarks, p. 9, par. 5-6). Specifically, applicant argues that the claimed strain is “a highly specific strain artificially screened and purified from complex microbial consortia by Applicant through an exclusive full isolation and purification process” (Remarks, p. 9, par. 6).
Applicant’s arguments have been fully considered but are not sufficient to overcome the rejection of record.
Applicant’s amendment to claim 1 has introduced “product-by-process” language (MPEP § 2113; see interpretation above). That is to say, the claims remain directed to Bacillus velezensis QMHF-G5 per se. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself (MPEP § 2113(I)). MPEP § 2106.04(c)(I)(B) states how to analyze a product-by-process limitation for subject matter eligibility and teaches “[f]or a product-by-process claim (e.g., a claim to a cloned farm animal produced by a nuclear transfer cloning method), the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart. Thus, although the claim now recites a particular process, it is still relevant to determine how B. velezensis QMHF-G5 differs from its naturally occurring counterpart.
Applicant has attempted to overcome the rejection by arguing that its strain is different from another prior art strain of B. velezensis (Taghavi et al.; US 2018/0020676 A1), which was previously identified by the Examiner as the closest prior art but was not relied upon in the rejection of record. Taghavi’s B. velezensis is not the appropriate naturally occurring counterpart. The appropriate naturally occurring counterpart is B. velezensis found in nature.
Assuming arguendo that Taghavi’s strain is the appropriate counterpart, Taghavi’s silence as to the ability of RTI301 to inhibit certain pathogens does not mean that its strain is incapable of such an effect. Indeed, Taghavi is not required to list every property associated with its strain and applicant has not demonstrated that RTI301 is incapable of this effect. Similarly, applicant’s strain is not “markedly different” merely because Taghavi did not measure a zone of inhibition.
As discussed above, comparing RTI301 to QMHF-G5 is not the appropriate comparison. Instead, applicant must show that its strain is markedly different from naturally occurring B. velezensis, not markedly different from another strain disclosed in an unrelated prior art document.
Based upon applicant’s disclosure (and the amended claim), it is apparent that B. velezensis is a product of nature as it is derived from a living organism (Vespula flaviceps). Thus, to the extent that Taghavi’s teachings are relevant, it is not sufficient to show that the instant strain is superior to a prior art strain if the instant strain is nonetheless a product of nature. And although it is acknowledged that applicant does not consider its strain to be a product of nature, applicant has provided no evidence that the recited strain is somehow changed when compared to its natural counterpart. Thus, for the purpose of determining subject matter eligibility, QMHF-G5 is considered to be naturally occurring because it is isolated from nature. Although the amended claim may lay out a rigorous process by which the strain was isolated from a microbial consortium, that does not mean that it is “artificial”. See MPEP § 2106.04(b)(II) which states that “neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.". “Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention” (MPEP § 2106.04(b)(II)).
Applicant has not provided any evidence that the recited method of isolation and culturing actually imparted the characteristics that they have assert to be “markedly different” (i.e., applicant has not demonstrated that naturally occurring B. velezensis would not be capable of such an effect if isolated and cultured under other conditions or as they exist in nature). Indeed, a person having ordinary skill in the art would not expect that isolating and culturing B. velezensis on/in lysogeny broth in some way imparts a wide spectrum of new characteristics, especially when considering that Taghavi also teaches the ability to kill fungal pathogens. If the culture conditions are relevant to imparting such an ability, applicant must actually demonstrate this to be the case.
For at least these reasons, the examiner maintains that the claims are directed to a product of nature and are not subject matter eligible under 35 U.S.C. § 101. In the interest of fully responding to applicant’s amendment to claim 1, the rejection of record is withdrawn and new grounds of rejection are set forth below.
RE: Rejection of claims 10 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Applicant has canceled claim 10, rendering the rejection moot.
New grounds of rejection under 35 U.S.C. § 101
Claims 1 and 3-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and natural phenomenon without significantly more.
The instant claims recites laws of nature and natural phenomena. These judicial exceptions (JEs) are not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A): Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
The Markedly Different Characteristics Analysis
The first step in the analysis is to select the appropriate counterpart to the nature-based product. When the nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. See MPEP § 2106.04(c)(II)(A).
The second step in the analysis is to identify appropriate characteristics to compare. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673. See MPEP § 2106.04(c)(II)(B).
The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. See MPEP § 2106.04(c)(II)(C).
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP § 2106.05(a);
Applying the judicial exception with, or by use of, a particular machine. See MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP § 2106.05(c);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP § 2106.05(d);
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP § 2106.05(e).
Step (2B). If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step (1)(direction to a process, machine, manufacture, or composition of matter):
Claims 1 and 3-9 are directed to a composition of matter (Bacillus velezensis and “a biological agent or inhibition agent” containing the same), which is a statutory category.
Therefore, the answer to this step for claims 1 and 3-9 is yes.
Step 2A Prong 1 (recitation of a law of nature, natural phenomenon, or an abstract idea):
Claims 1 and 3-9 recite the microorganism Bacillus velezensis strain QMHF-G5, which was isolated from the intestinal tract of Vespula flaviceps ([0062], Table 1; Claim 4). Accordingly, the claims recite a product of nature (a law of nature or natural phenomenon).
Because the claims recite a product of nature, the next appropriate test is whether the recited product of nature is markedly different from its natural counterpart. In this case, the natural counterpart is B. velezensis in nature. There is no evidence that the bacterium has been changed in any way from its natural counterpart.
Therefore, the answer to this prong for claims 1 and 3-9 is yes.
Step 2A Prong 2 (recitation of additional elements that integrate the JE into a practical application):
Claim 1 is directed to the bacterium per se. Claim 1 additionally recites an accession number for the bacterial strain (CGMCC No. 27713). This is an arbitrary identifier assigned by the depository. It does not effect a transformation or reduction of the JE to a different state or thing.
Claim 1 now recites a method by which the strain was obtained. There is no evidence that the specific method recited in this claim causes the judicial exception to be transformed or reduced to a different state or thing.
Claim 1 additionally now recites the 16S rDNA sequence inherently possessed by this strain. This limitation does not effect a transformation or reduction of the JE to a different state or thing.
Claim 3 merely recites a gene sequence (QMHF-G5gyrB). This limitation does not effect a transformation or reduction of the JE to a different state or thing.
Claim 4 merely recites where the strain was isolated. This limitation does not effect a transformation or reduction of the JE to a different state or thing.
Claims 5-6 merely recite inherent properties of the judicial exception (inhibition zones). These limitations do not effect a transformation or reduction of the JE to a different state or thing.
Claim 7 recites a “biological agent or inhibition agent for inhibiting fungi and bacteria”. As discussed in the Claim Interpretation section of this action, this preamble does not impart any structure on the composition. For example, a biological agent or inhibition agent can be a DFM. Additionally, the purpose is merely the inherent activity of the strain. As such, this additional element does not effect a transformation or reduction of the JE to a different state or thing.
Claims 8-9 merely limit the fungi and bacteria inhibited in the intended use. This is an inherent property of the bacterium. As such, this additional element does not effect a transformation or reduction of the JE to a different state or thing.
Therefore, the answer to this prong for claims 1 and 3-9 is no.
Step (2B)(recitation of additional elements that amount to significantly different than the JE such that they provide an inventive concept):
As discussed above, claims 1 and 3-9 merely recite additional elements which are descriptive of inherent properties of the B. velezensis QMHF-G5 bacterium. As such, these elements do not provide an inventive concept.
And although it is noted that claim 1 recites a particular method by which the B. velezensis strain was isolated, as discussed above, the claim is directed to a judicial exception and the method by which the judicial exception was obtained does not provide an inventive concept.
Therefore, the answer to step (2B) for claims 1 and 3-9 is no.
Conclusion
Claims 1 and 3-9 are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. § 101.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRANT C CURRENS whose telephone number is (571)272-0053. The examiner can normally be reached Monday - Thursday: 7:00-5:00.
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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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/GRANT C CURRENS/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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