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 .
DETAILED ACTION
1. Applicant’s election of Group I (claims 1-9) without traverse in the reply filed on 3/5/26 is acknowledged.
2. Claims withdrawn:
Claims 10-13 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
3. Priority
Receipt is acknowledged of papers (foreign priority filed 8/19/21) submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
4. Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
5. 35 U.S.C. § 112, first paragraph (Written Description)
Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to the following genus claims:
1: A method for producing a polyhydroxyalkanoate, comprising: (a) maintaining a culture solution at 40° C. to 80° C., wherein the culture solution comprises microbial cells containing a polyhydroxyalkanoate; and (b) adding an oxidizer to the culture solution obtained in (a), adjusting a pH of the culture solution to from 10.5 to 13.0, and maintaining the culture solution at 30° C. to 75° C.
2: The method of claim 1, wherein the oxidizer is a hydrogen peroxide solution or ozone.
3: The method of claim 1, further comprising: (c) adding an enzyme to an aqueous suspension obtained in (b) to subject the microbial cells to an enzyme treatment; and (d) adding a surfactant and an aqueous alkaline solution to the aqueous suspension obtained in (c) to adjust a pH of the aqueous suspension to from 10.0 to 12.0.
4: The method of claim 1, wherein the polyhydroxyalkanoate in the culture solution obtained in (a) has a weight average molecular weight of from 1,500,000 to 2,500,000; and the culture solution obtained in (a) has a solid content concentration of from 20% by weight to 40% by weight.
5: The method of claim 1, wherein (b) comprises maintaining, for from 0.1 hours to 30 hours, the pH which has been adjusted.
6: The method of claim 1, wherein the polyhydroxyalkanoate in the aqueous suspension obtained in (b) has a weight average molecular weight of from 100,000 to 800,000; and the aqueous suspension obtained in (b) has a solid content concentration of from 20% by weight to 40% by weight.
7: The method of claim 1, wherein, in (b), in a case where hydrogen peroxide is added to the culture solution, the hydrogen peroxide is added such that a concentration of the hydrogen peroxide in the culture solution is from 0.2% by weight to 30% by weight.
8: The method of claim 3, wherein the enzyme in (c) is a lytic enzyme, an alkaline proteolytic enzyme, or a combination thereof.
9: The method of claim 3, wherein (c) comprises adding a surfactant.
The claimed invention encompasses a genus of methods for producing a polyhydroxyalkanoate (PHA) comprising any microorganism, any oxidizer, treatment with any enzyme and control a reduction in the Molecular weight (MW) of PHA to any desired MW and the addition of any surfactant, not adequately described.
The instant specification describes: A method for producing a polyhydroxyalkanoate, comprising: (a) maintaining a Cupriavidus necator culture solution at 40° C. to 80° C., wherein the culture solution comprises Cupriavidus necator cells containing a polyhydroxyalkanoate; and (b) adding an oxidizer viz. hydrogen peroxide solution or ozone to the culture solution obtained in (a), adjusting a pH of the culture solution to from 10.5 to 13.0, and maintaining the culture solution at 30° C. to 75° C; and further comprising: (c) adding an lytic enzyme to an aqueous suspension obtained in (b) to subject the microbial cells to an enzyme treatment; and (d) adding sodium dodecyl sulfate as a surfactant and an aqueous alkaline solution to the aqueous suspension obtained in (c) to adjust a pH of the aqueous suspension to from 10.0 to 12.0.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe aninvention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what isclaimed."). Thus, an applicant complies with the written description requirement "bydescribing the invention, with all its claimed limitations, not that which makes it obvious,"and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966."Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents" of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents" of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case is discussed below.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
Moreover, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
6. Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1 & 2 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2006/0127998 A1.
Claims 1 & 2 are drawn to as follows:
1: A method for producing a polyhydroxyalkanoate, comprising: (a) maintaining a culture solution at 40° C. to 80° C., wherein the culture solution comprises microbial cells containing a polyhydroxyalkanoate; and (b) adding an oxidizer to the culture solution obtained in (a), adjusting a pH of the culture solution to from 10.5 to 13.0, and maintaining the culture solution at 30° C. to 75° C.
2: The method of claim 1, wherein the oxidizer is a hydrogen peroxide solution or ozone.
US 2006/0127998 A1 teaches: A method for purifying a 3-hydroxyalkanoic acid copolymer produced by a microorganism, which comprises treating an aqueous suspension containing the 3-hydroxyalkanoic acid copolymer separated from a microorganism with a hydrogen peroxide while controlling the pH of said aqueous suspension by adding an alkali either continuously or intermittently, wherein the pH of the aqueous suspension is controlled to be between 7 and 13; wherein the concentration of hydrogen peroxide in the aqueous suspension is in a range of 0.01 to 1% by weight and wherein the 3-hydroxyalkanoic acid copolymer is a copolymer of D-3-hydroxyhexanoate and one or more other D-3-hydroxyalkanoic acids. See claims 1-4, for example.
The object of this invention is to provide a method for purifying PHA separated from PHA-containing microbial cells in high purity without incurring any serious decrease in molecular weight. The present invention provides a method for purifying a 3-hydroxyalkanoic acid copolymer produced by a microorganism, which comprises treating an aqueous suspension containing the 3-hydroxyalkanoic acid copolymer separated from a microorganism with a hydrogen peroxide while controlling the pH of said aqueous suspension by adding an alkali either continuously or intermittently.
The reference further teaches the concentration of the 3-hydroxyalkanoic acid copolymer in "an aqueous suspension containing the 3-hydroxyalkanoic acid copolymer" in the present invention is preferably not more than 500 g/L, and more preferably not more than 300 g/L from a viewpoint of purification efficiency [0022], and the pH of the above-mentioned suspension is controlled by adding an alkali either continuously or intermittently to the said aqueous suspension, concurrently with a treatment by hydrogen peroxide. The serious decrease in molecular weight of the 3-hydroxyalkanoic acid polymers may be prevented as well as decomposition of protein (cell constituent substance remaining in the suspension) by hydrogen peroxide may be carried out by these treatments [0023]. The addition amount of hydrogen peroxide is not particularly restricted, but is preferably not more than 10% by weight, more preferably not more than 5% by weight, still more preferably not more than 1% by weight. Moreover, for obtaining an applicable purification effect, it is preferably not less than 0.01% by weight, more preferably not less than 0.05% by weight, and still more preferably 0.1% by weight [0029]. The treatment of hydrogen peroxide is preferably carried out at a temperature range of not less than room temperature to the boiling point of the aqueous suspension. For enhancing the purification effect in short time, the treatment is preferably carried out at not less than 50.degree. C., more preferably not less than 70.degree. C. Additionally, the treatment is carried out for generally from 10 minutes to 10 hours, preferably for 30 minutes to 5 hours, and more preferably for 1 hour to 3 hours [0031].
The reference, however does not teach the method of producing PHA in the sequential manner and varying the oxidizer, control a reduction in the Molecular weight (MW) of PHA to any desired MW and the addition of any surfactant among others.
It would have been obvious before the effective filing date of the claimed invention for one of ordinary skill in the art of enzymology given the disclosure described above, the reference indicates that in the method for purifying a 3-hydroxyalkanoic acid copolymer, the pH of the aqueous suspension is controlled by adding an alkali to the aqueous suspension continuously or intermittently, in parallel with the treatment of the aqueous suspension with hydrogen peroxide, and thereby decomposition of protein (a microbial constituent substance remaining in the suspension) by the hydrogen peroxide is performed and a severe decrease in molecular weight of the 3-hydroxyalkanoic acid copolymer can be prevented and do so with a reasonable expectation of success since the method for purifying PHA is well defined.
One skilled in the art would have been motivated in view of the importance of the Polyhydroxyalkanoate (PHA). PHA is a biologically-based and biodegradable polymer. PHA is considered a very promising alternative to fossil-based plastics because of its rapid and complete degradation in the environment. There is accordingly a mounting interest in PHA and other biodegradable plastics which, after disposal, would be incorporated into the natural cycle of matters and degradation products of which would not exert ecologically harmful influences, and their practical utilizations are highly desired [0002]. Thus, the claimed invention was within the ordinary skill in the art to make and use at the time was made and was as a whole, prima facie obvious.
7. IDS filed 4/25/24 is acknowledged. A signed copy of the IDS is provided with this Office Action.
8. No claim is allowed.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TEKCHAND SAIDHA whose telephone number is (571)272-0940. The examiner can normally be reached on M-F 8.00-5.30. 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, Robert B Mondesi can be reached on 408 918 7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TEKCHAND SAIDHA/
Primary Examiner, Art Unit 1652
Recombinant Enzymes, Hoteling
Telephone: (571) 272-0940
Fax: (571) 273-0940
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