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 .
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 1 and 5 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 1 is indefinite because it contains neither a transitional phrase nor a preamble. See MPEP 2111.02 and 2111.03. While the lack of a preamble is not necessarily indefinite, the lack of a transitional phase creates ambiguity as to the intended scope of the claim. That is, it is unclear if the Applicant is trying the claim the microbe, per se, or a composition comprising the microbe. In order for dependent claims 2-7 to be considered clear, in the context of 35 USC 112(b), it will be assumed that the transitional phrase should be a “composition comprising.”
Claim 5 is indefinite, because it is unclear what the “essence form” of the claimed bacterial strain is.
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 2-4, 6 and 7 are 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. None of the claimed products or forms appear to limit the scope of the parent claim, but are rather redefining how the parent claim should be interpreted.
With respect to claims 2 and 3, neither of these appear to affect the structure of the parent claim, nor do they provide for additional ingredients.
With respect to claims 4, 6, and 7, these claims appear to just define the product that the claimed microbe could be defined as. For example, claim 4 does not state that the composition is provided different ingredients or modified in any manner, it is merely defining the “product” of claim 3 to be a personal care product, a pharmaceutical product, or a health product. Based upon the claim language, all of these “products” are no different than their parent claim, and as such, do not further limit the scope of the parent claim. Claims 6 and 7 merely define the product as a basic care product, or a make-up product.
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 1-4, 6 and 7 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 strain of Bifidobacterium longum subsp. infantis deposited as CGMCC NO. 27851. This judicial exception is not integrated into a practical application because the claims are solely drawn to the product of nature.
For the analysis of the claims under 35 USC 101, the Applicant is directed to MPEP 2106, and particularly the flow chart provided in section III. When reviewing the flow chart, the first question asks if the claims are drawn to a statutory category. Since the claims are drawn to a microbe, they are considered a “composition of matter,” and as such, the answer to step 1 is “yes.” Step 2A asks if the claims are directed to a product of nature; since the claims are drawn to an unmodified bacterial strain, the answer is “yes.” The bacterial strain is considered “unmodified” because it does not appear to have any recombinant genetics, and is disclosed in the specification of the application as being isolated from breast-fed infants. See paragraph [0033] [0125] and Example 1. Step 2B asks if there is significantly more than the judicial exception. For this analysis, the Applicant is directed to MPEP 2106.04(c). Based upon the fact that the claims are limited to the bacterial strain, per se, and do not provide for any other elements, would suggest that there is significantly more than the claimed product-of-nature. Furthermore, the cited dependent claims do not appear to affect the ingredients of the claimed product, and just define the product into particular product-types. As such, these would also be considered products of nature.
It should be noted that claim 5 is not rejected under 35 USC 101, because these limitations provide for special physical forms that would not be expected to be found in nature.
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.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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