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 Status
Applicant’s amendment after final is received and entered. Claims 1-2 are amended. Claims 5-10 and 13 remain withdrawn as being directed to non-elected inventions. Accordingly, claims 1 and 2 are pending and under current examination.
This is a second non-final office action. The Examiner has reconsidered the pending claims, and the prosecution is re-open.
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 1-2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (a product of nature) without reciting additional elements that amount to significantly more than the exception.
The claim 1 is directed to a composition of matter (a basal medium based on poultry egg for cultivating mammalian cells, wherein the basal medium consists of poultry egg content and a phosphate-buffered saline diluent at a ratio of 1:50–1:10). As such, the claim falls within a statutory category (Step 1: YES). However, the claimed composition recites only nature-based components, namely poultry egg content and a diluent of phosphate-buffered saline (PBS), combined at a specified ratio for the conventional purpose of cultivating mammalian cells. Poultry egg content is a naturally occurring material, and PBS is a mixture of naturally occurring ions (sodium, potassium, chloride, phosphate) in water formulated to approximate physiological conditions. When viewed as a whole, the claimed basal medium is therefore a nature-based product combination that must be analyzed to determine whether it is “markedly different” from its naturally occurring counterparts under the markedly different characteristics analysis set forth in MPEP 2106.04(c) and related guidance.
Under Step 2A, Prong 1, the claim recites a nature-based product limitation, namely a mixture of poultry egg content and PBS. Under Step 2A, Prong 2, the mixture of poultry egg content and PBS is compared to its closest natural counterparts, which are poultry egg content by itself, egg content as it may be naturally diluted by bodily fluids, and saline environments containing similar ions. The claim does not positively recite any structural, functional, or other property of the mixture that is different from, or improved over, the properties of egg content and physiological saline as they occur in nature. The egg content in the claimed medium remains egg content, and the PBS remains a standard aqueous salt buffer; there is no indication in the claim of a change in structure (e.g., fractionation, chemical modification, or formation of a new substance) or of a new functional characteristic (e.g., unexpected or improved cell-growth behavior) that is markedly different from the natural products themselves. Merely combining natural products in a mixture, even at a non-naturally occurring ratio, does not by itself confer markedly different characteristics when the components retain their natural properties, as explained in USPTO examples and case law applying the product-of-nature exception. Accordingly, the claimed composition is directed to a product-of-nature judicial exception (Step 2A: YES).
Under Step 2B, the claim is evaluated to determine whether any additional elements, individually or in combination, amount to significantly more than the product-of-nature exception. The only elements in the claim are the nature-based product components (poultry egg content, PBS) and their ratio, together with the statement of intended use (for cultivating mammalian cells). The recited use of the medium for cultivating mammalian cells is a field-of-use limitation that does not impose any structural or functional requirement on the medium beyond its natural cell-nutrient and buffering properties, and therefore does not amount to significantly more than the judicial exception. The specified ratio of egg content to PBS (1:50–1:10) merely reflects routine optimization or selection of concentrations for a known purpose and does not add a meaningful limitation that transforms the nature-based mixture into a patent-eligible application. The claim as a whole therefore does not include any additional features that integrate the product-of-nature exception into a practical application, nor does it add an inventive concept sufficient to amount to significantly more than the judicial exception itself.
For these reasons, claim 1 and the dependent claim 2 are rejected under 35 U.S.C. 101 as being directed to a judicial exception (a product of nature) without reciting additional elements that amount to significantly more than the exception.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1)as being anticipated by Fisher et al. (WO 9511986 A1), as evidenced by Sigma (July, 1988).
Instant claims are directed to a product, which consists of a poultry egg content and a diluent, wherein the diluent is phosphate-buffered saline, and the poultry egg content and the diluent have a ratio of 1:50-1:10. The preamble “for cultivating mammalian cells” is an intended use. The purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. Moreover, instant claims are directed to a product, MPEP 2112.01 states "products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990), therefore the recitation “a basal medium” would be considered as an inherent property of the product consist of a poultry egg content and a diluent, wherein the diluent is phosphate-buffered saline, and the poultry egg content and the diluent have a ratio of 1:50-1:10, as recited in instant claims.
Fisher et al. teach a method of generating a subtracted cDNA library of a cell (p2, parag 3).
Regarding claims 1-2, Fisher et al. teach using 2% egg albumin/PBS solution (p38, parag 8). This is egg albumin diluted in PBS solution and has the ratio of 1:50. Besides, the egg albumin is a chicken albumin as known in the art and evidenced by Sigma. Sigma product sheet teaches egg albumin (Product No. 17642, see p2) is albumin from chicken (hen) egg white. Therefore Fisher et al. anticipates instant claims.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Sasaki et al. ( J Clin Microbiol. 1983 Nov;18(5):1167-73).
Instant claims are directed to a product, which consists of a poultry egg content and a diluent, wherein the diluent is phosphate-buffered saline, and the poultry egg content and the diluent have a ratio of 1:50-1:10. The preamble “for cultivating mammalian cells” is an intended use. The purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. Moreover, instant claims are directed to a product, MPEP 2112.01 states "products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990), therefore the recitation “a basal medium” would be considered as an inherent property of the product consist of a poultry egg content and a diluent, wherein the diluent is phosphate-buffered saline, and the poultry egg content and the diluent have a ratio of 1:50-1:10, as recited in instant claims.
Sasaki et al. teach chicken egg yolk broth medium containing 10% (vol/vol) phosphate-buffered saline extract of egg yolk instead of horse serum showed better growth-promoting activity for Mycoplasma pneumoniae than did Chanock medium and was effective in promoting the growth of small numbers of M. pneumoniae (Abstract).
Regarding claim 1, Sasaki et al. teach preparation of EY: fresh unfertilized chicken eggs were disinfected in 0.1% (wt/vol) Hibitane digluconate solutions for 10 min and air dried. The egg yolks were suspended in sterile phosphate-buffered saline without Ca2+ and Mg2+ [PBS(-)] at a concentration of 20% (wt/vol). This teaching reads on a medium/solution consists of a poultry egg content and a diluent, wherein the diluent is phosphate-buffered saline, and the poultry egg content and the diluent have a ratio of 1:5, which is higher than the ratio of 1:50-1:10 as recited in instant claim. However, it is prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the ratio of egg yolks and PBS according to their needs or in order to achieve a better result.
It is not inventive to find optimal workable ranges by routine experimentation. See Jn re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 2, following the discussion above, Sasaki et al. teach using chicken (hen) eggs.
Conclusion
No claim is allowed.
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/Q.G./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633