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 .
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 5 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.
Claim 5 is indefinite because the claim is drawn to the composition, per se, but instead of providing a compositional or structural limitation, the claim provides for a functional limitation. It is unclear how this functional limitation impacts the ingredients or structure of the claimed composition. See MPEP 2173.05(g). Since there is nothing in the instant specification to suggest that the claimed function is caused by anything other than providing the claimed composition to a subject, the claimed function must be considered inherent to the claimed composition. See MPEP 2112. Barring evidence to the contrary, if the prior art fulfills the compositional limitations, it will be assumed to also provide for any inherent functions upon administration.
Claim 10 is indefinite because it is unclear how the claimed composition is manufactured. The claim is drawn to “a method of manufacturing” a composition, comprising “using” lipase and cellulase. Since it is clear from the claims and specification that the composition is lipase and cellulase, it is unclear how the claimed composition is made by “using” the claimed components. Since there are no steps drawn to actual methods of manufacture, it is unclear how the claimed method is supposed to results in the claimed composition.
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.
Claims 6-8 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. The cited claims provide for a pharmaceutical preparation, a food additive, and a food or drink; these do not further limit the parent claim, because they merely indicate what the claimed composition can be added to, in order to facilitate administration. The cited claims do not further limit the structural or compositional elements of the claimed composition, because they do not further elaborate on other ingredients that can be added to the composition, or how the claimed material (food, food additive, pharmaceutical preparation) change the structure of the claimed enzymes. There is nothing in claims 6-8 to suggest they are different from claim 1. 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, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) a composition comprising a lipase derived from a koji mold, and a cellulase that can also be derived from a koji mold, wherein the koji mold includes members of the Aspergillus genus, like Aspergillus niger. This judicial exception is not integrated into a practical application because the claims provide for just the product of nature, and no other ingredients that provide for any markedly different characteristics. See MPEP 2106.04(c).
The independent claim is drawn to a composition comprising lipase, and cellulase, wherein the lipase is explicitly claimed as being derived from koji mold; further dependent claims indicates that the cellulase can also be derived from koji mold, wherein the koji mold is A. niger. In order to analyze the claims under 35 USC 101, the Applicant is directed to MPEP 2106, especially the flow chart provided in section III. The first question of the flow chart asks if the claims are drawn to a statutory category. Since the claims are drawn to a composition, the claims are one of the four statutory categories. Step 2A asks if the claims are drawn to a product of nature. Based upon the claims, it appears as though they describe the naturally-occurring (non-synthetic) enzymes: lipase and cellulase. Furthermore, based upon the instant specification, it appears as though these enzymes are naturally-occurring and can readily be derived from various members of the Aspergillus genus, including A. niger. This assessment is confirmed by the prior art, wherein it is shown that both lipase and cellulase are naturally produced by members of the Aspergillus genus, including A. niger. See Watanabe, et al (Nippon Shokuhin Kagaku Kaishi, 51, 698-702, 2004 [only the abstract is available in English]), page 698, “Abstract” section; see Kadota, et al (PGPub 2009/0155417), paragraph [0001] [0017] [0047].
Since the evidenced suggests that the claimed composition is comprised of natural products, the next step, step 2B, asks if the claimed composition provides for something that is significantly more than the judicial exception. As such, the composition must be examined under the markedly different characteristic analysis. See MPEP 2106.04(c). Using this analysis, it is clear that the claimed lipase performs as lipase would be expected to perform, and similarly, the claimed cellulase performs as cellulase would be expected to perform. There is no evidence to suggest that the combination provides for unexpected behaviors, like enhanced kinetics or changes in substrate specificity that would not be predicted when comparing the induvial components to their respective natural counterparts. Since there is no evidence to suggest that the claimed composition provides for any markedly different characteristics, the composition as a whole must be considered a product of nature. Furthermore, when given the broadest reasonable interpretation of the claim language, since both enzymes can be derived from the same microbe, the claims can technically comprise the naturally-occurring microbe, per se.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kadota, et al (PGPub 2009/0155417). Kadota teaches an additive to animal feed that comprises a member of the Aspergillus genus, including A. niger, and at least one of the enzymes produced from the fungus. See claim 1, paragraph [0001]. Kadota indicates that the enzymes can include lipase and cellulase. See paragraph [0047].
With respect to claim 1, Kadota teaches the claimed composition. Kadota indicates that Aspergillus mold can grow on koji. See paragraph [0005]-[0007], [0020]-[0023].
With respect to claims 2-4, Kadota indicates that both the lipase and the cellulase can be derived from the koji mold A. niger.
With respect to claim 5, Kadota indicates that the composition is capable of improving intestinal flora. See paragraph [0044]. Although, it appears as though this is inherent to the claimed composition; since the claimed composition is anticipated by Kadota, Kadota’s composition must have inherently performed the claimed action. See MPEP 2112.
With respect to claims 6-8, although Kadota explicitly describes a “feed additive,” Kadota’s composition anticipates all of the structural and compositional limitations provided. As such, Kadota’s composition can also be considered a food/drink, or pharmaceutical preparation, within the context of the instant claims and specification.
With respect to claim 9, since Kadota teaches a feed additive, it is necessarily provided in a manner consistent with that claimed. As discussed above, in addition to Kadota teaching an improvement in intestinal flora, this would have been inherent to the method. See paragraph [0017].
With respect to claim 10, Kadota describes manners of making the claimed composition from members of the Aspergillus mold genus. See paragraph [0047].
Conclusion
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651