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 .
Claims 1-20 are under examination on the merits.
Claim Objections
Claims 1-20 are objected to because of the following informalities: claims 1-20 appear to be word for word translation of a foreign language into English and at times are very confusing . Applicant is advised to rewrite said claims in concise English. Appropriate correction is required.
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 1-14, 16-20 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. Claims 1, 10 and 16 are grammatically incorrect as they should all start with “A”.
Further claims 2-9, 11-14, 17-20 each should start with the term “The” to be grammatically proper.
Furthermore, in claim 3, it is unclear in what way instantly claimed deposit is “derived” from Hydrogenovibrio marinus MH-110. In other wors was the deposit derived by fusion with another strain or by mutation etc.
Claim 9 is 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. In claim 9, the phrase “the plasmid” lacks antecedent basis.
Claim 10 is 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. In claim 10, it is unclear what the difference between “a chemolithoautrophic bacterium” and “the host cell” is. If said products are identical, then applicant is advised to substitute “the host cell” with “a chemolithoautrophic bacterium” for clarity.
Claim 11 is 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. In claim 11, it is unknown why the gas mixtures of part (a) are in the alternative but those in part (b) are not in the alternative and why the last gas mixture in part (b) precedes by the term “and”.
In addition, it is unclear why the 6 different gas mixtures of claim 11 are written as parts (a) and (b). If parts (a) and (b) are used at different steps of fermentation, then said steps should be recited in claim 11 and be associated with (a) and (b), for clarity.
Claims 11 and 13 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. In claims 11 and 13, the difference between “obtaining the heterologous protein” and “purification of the heterologous protein” respectively is unclear and ambiguous. If said phrases in the context used, have identical meaning, then applicant may consider deleting part (c ) of claim 10.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: growing chemolithoautotrophic bacterium of claim 1 under appropriate fermentation conditions in a culture etc.
Claim 15 is 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. In claim 15, it appears that the term “a” is missing at the beginning of the claim.
Claims 16-17 and 20 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. In claims 16-17 and 20 , the term preferably” is indefinite as said term creates confusion as to why a single species is singled out relative to the other members of the genus.
In addition, in claim 17 a narrow range is presented within a broad range in a single claim, which is indefinite.
Claims 17, 18 and 19 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. Claims 17 (and its dependent claim 18) and claim 19 depend from themselves, respectively. Also claim 18 is further confusing because its base claim has no steps (a) and/or (b).
Claims 18-19 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. In claims 18-19, the phrase “essentially consist of” is indefinite. This is because “consist of” is narrowing in scope but the term “essentially” makes the scope broader with unclear metes and bounds. Therefore, the metes and bounds of incubation atmosphere in claims 18-19 cannot be determined in terms of time used for incubation (see claim 18) and the atmosphere components and respective concentration thereof (see claim 19).
Claim 20 is 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. In claim 20, it is unclear what is meant by “circular DNA plasmid or vector”. This is because plasmids and vectors are always made of DNA and hence the term “DNA” in said phrase appears to be redundant. If by said phrase applicant is referring to “a circular plasmid or a circular vector”, then he/she should consider substituting said former phrase with the latter phrase or something equivalent for clarity.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 3 is 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
It is noted that the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, applicants may provide assurance or compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
1. during the pendency of this application, access to the invention will be afforded to the commissioner upon request;
2. all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
3. the deposit will be maintained in a public repository for a period of 30 years or 5 years after the last request or for the effective life of the patent whichever is longer; and
4. the deposit will be replaced if it should ever become inviable.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 6 is 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 6 recites a genus of “biologically active fragments” of human somatotrophin (hGH), wherein said genus is inadequately described in terms of structure.
The court of Appeals for the Federal Circuit has recently held that such a general definition does not meet the requirements of 35 U.S.C. 112, first paragraph. “ A written description of an invention involving chemical genus, like a description of a chemical species, requires a precise definition, such as be structure, formula {or} chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 1997 U.S. App. LEXIS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). The court held that “ in claims involving chemical materials, generic formulae usually indicate with specificity what generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. accordingly, such a formula is normally an adequate description of the claimed genus. In claims to genetic material, however, a generic statement such as “vertebrate insulin cDNA” or “mammalian insulin cDNA,’ without more, is not an adequate written description of the genus because it does not distinguish it from others. One skilled in the art therefore cannot, as one can do with a fully described genus visualize the identity of the members of the genus”. Here, applicant is claiming a genus of products by what they do rather than what they structurally are.
Applicant is aware that hGH is made of 217 amino acids in length and given the fact than any 3 or more amino acids can constitute a fragment of said hGH, instantly claimed fragments read on thousands and thousands of species.
The specification does not provide any examples of “biologically active fragments “ instantly claimed and fails to specify at least how many amino acids are required for an hGH fragment to retain “biological activity” and which regions within the hGH structure are crucial for retaining the biological function of said hormone.
Therefore, given the breadth of the “biologically active fragments” claimed and given the lack of structural information regarding the “biologically active fragments”, in the disclosures, one of skill in the art cannot reasonably conclude that applicant had full possession of this invention, before the effective filing of this application.
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.
Claim(s) 1-5, 8, 10-14,15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Reed et al., “Reed” (US 2020/0165733, 5/28/20, which will be used to cite relevant text, see also its corresponding US Patent No: 11,725,290).
Reed in its abstract, teaches about microorganisms and bioprocesses provided that convert gaseous C1 containing substrates, such as syngas, producer gas, and renewable H2 combined with CO2, into nutritional and other useful bioproducts, wherein some of said gases will inherently have the ratios of oxygen, carbon dioxide , nitrogen and hydrogen, recited in instant claim 11.
In [0002] according to Reed, its inventive subject matter relates to the biological production of amino acids and proteins and other biomass constituents, in a microbial system, using a gaseous substrate such as synthesis gas or producer gas or pyrolysis gas or mixtures, or H2 combined with CO2 mixtures as a carbon and energy source. It also states that amino acids, proteins, and other biomass constituents produced according to the present invention can be consumed and used as nutrients by other organisms (such as animals and humans who are mammals) for the production of food and other bio-based products.
[0082] of Reed recites: FIG. 17 shows Hydrogenovibrio marinus strain DSM 11271 (which can be assumed to be “a derivative” (see 112 second rejection above) of instantly claimed Hydrogenovibrio marinus MH-110 (whatever that is, see 112 second rejection above) growing in a bioreactor on a mixture of H2, CO2, and O2 gases.
In [0129] Reed explains: the terms “exogenous gene” means a nucleic acid that has been recombinantly introduced into a cell, which encodes the synthesis of RNA and/or protein. In some embodiments, the exogenous gene is introduced by transformation. In some embodiments, the exogenous gene is introduced into the cell by electroporation. A transformed cell may be referred to as a recombinant cell, into which additional exogenous gene(s) may be introduced. The exogenous gene put into the host species may be taken from a different species (this is called heterologous), or it may naturally occur within the same species (this is homologous as defined below).
In [0039], according to said publication, an exogenous gene is encoded by a coding sequence in the non-naturally occurring microorganism that is carried on a broad-host-range plasmid, wherein said plasmid being broad may inherently be both integrating or non-integrating.
In [0412] Reed mentions procedures for lysis and isolation of its expressed proteins or amino acids.
Therefore, it is believed that the teachings of Reed as a whole, render the above-mentioned claims obvious.
Regarding kits of instant claim 15, applicant is well aware that putting useful host cells such as Hydrogenovibrio marinus strain DSM 11271 of Reed in a portable and commercially available kit, is highly motivating and convenient and is a fully established procedure in in the prior art, before the effective filing of this application.
Claim(s) 6-7, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Reed (cited above) in view of Fares et al., “Fares” (us2015/0093358, 4/2015, which will be used to cite relevant text, see also its corresponding patent 9,908,924) .
As mentioned above, Reed teaches or suggests a Hydrogenovibrio marinus strain DSM 11271 strain as a host cell, which was used for recombinant expression of heterologous proteins and amino acids, some of which having therapeutic properties by inherency, prior to this invention.
Reed does not mention using its host cell expressing a human somatotrophin (hGH) or fragments thereof having at least 80% identity to instant SEQ ID NO:1.
Fares in [0033] discloses SEQ ID NO:23 (and/or DNA encoding it) corresponding to a growth hormone wherein said sequence has 100% identity to instant SEQ ID NO:1. In [0120], said publication mentions that said sequence is useful in restoring REM sleep.
Before the effective filing of this application, it would have been obvious to one of ordinary skill in the art to start with the Hydrogenovibrio marinus strain of Reed and transfect/transform said host cell with DNA encoding SEQ ID NO:23 of Fares.
One of ordinary skill in the art is motivated in starting with the host cell of Reed and transform/transfect it by electroporation according to Reed’s teachings using the DNA sequence of Fares. This is because, the growth hormone of Fares is a useful protein for restoring REM sleep in patients with insomnia etc., rendering claims 6-7, and 9 obvious.
Finally, one of ordinary skill in the art has a reasonable expectation of success in transforming/transfecting the host cell of Reed with the DNA sequence of Fares because such procedures were routine in the prior art, before the effective filing of this application.
Claim(s) 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Reed (cited above) in view of Hermann et al., “Hermann” (Biological Chemistry, 401(12), 1443-1468, 2020), further in view of Fares (cited above).
As mentioned above, Reed teaches a method of electroporating Hydrogenovibrio cells in a fluid utilizing an exogenous DNA . Said art does not teach ectoine as a compound present in the fluid before electroporation.
Hermann in page 1445 column 1, last paragraph, teaches that synthesis and import of ectoine contributes greatly to osmotic stress resistance in many microorganisms as their accumulation averts water loss and provides functional protection of cellular constituents and biosynthetic processes.
Hermann in its abstract further teaches that the function-preserving attributes of ectoine led to numerous biotechnological and biomedical applications.
Before the effective filing of this invention, it would have been obvious to one of ordinary skill in the art to start with host cells of Reed in solution and add the ectoine of Hermann before transfecting said host cells by electroporation method of Reed using the exogenous DNA of Fares. One of ordinary skill in the art is motivated in starting with the host cells of Reed and add the ectoine of Hermann before electroporation utilizing the exogenous DNA of Fares because such effort results in heathier and more protected and less stressed transfectants/transformants, which could later be used for fermentation, thereby producing higher yields of the hGH hormone (i.e. instant SEQ ID NO:1), rendering claim 16 of this invention obvious.
Finally, one of ordinary skill in the art has a reasonable expectation of success in starting with the host cells of Reed in solution and add the ectoine of Hermann before electroporating said host cell according to Reed using the DNA of Fares because such procedures were fully established in the prior art before the effective filing of this application.
Finally, with respect to claims 17-19, as mentioned above, said claims are confusing for the reasons explained above and therefore, said indefinite claims are also added to this rejection.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARYAM MONSHIPOURI whose telephone number is (571)272-0932. The examiner can normally be reached full-flex.
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/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651