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 .
Election/Restriction
Inventor’s election, with traverse, of the claims of Group I (claims 17-31), is acknowledged.
Inventor argues that the claims of Group I and II are technically linked by a single inventive feature: the instant flocculant based disinfectant composition. The examiner respectfully disagrees.
As stated in the previous Office Action:
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Inventor claims a composition of matter and its process of making (Group I) and an apparatus for use with this composition of matter (Group II). That being the case, the instant application could only possibly satisfy the criteria of category (5) above. However, the composition of matter itself is not a special technical feature of the apparatus – which is, apparently, simply a container divided in such a way that 3 components may introduced and then mixed. (What exactly this apparatus actually might be is difficult to determine, however, because of 112(b) issues with the apparatus claims. But it would appear that the instant divided or segmented container, despite its contents, would not distinguish over the pertinent container art.)
The election/restriction requirement was formulated merely in order to facilitate the reasonably complete and thorough search of the claimed subject matter to which inventor is entitled and is hereby made FINAL.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (two instances on page 4).
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(a)
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.
Claims 17-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a flocculant based disinfectant, and its method of preparation, where the poly amino acid is poly glutamic acid and the nanomaterial is an oxide of Ti, Al (boehmite), Si, or the phosphates of lanthanide elements, does not reasonably provide enablement for a flocculate based disinfectant, and its method of preparation, utilizing the universe of poly amino acids or the universe of nanomaterials. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
With regard to rejections under 35 USC 112(a) or 35 USC 112, first paragraph, the following factors are considered (MPEP 2164.01(a)): a) Breadth of claims; b) Nature of invention; c) State of the prior art; d) Level of ordinary skill in the art; e) Level of predictability in the art; f) Amount of direction and guidance provided by the inventor; g) Working examples and; h) Level of experimentation needed to make or use the invention based on the content of the disclosure.
a) The claims are extraordinarily broad: “A flocculate based disinfectant composition comprising an aqueous solution of a pH regulated poly amino acid; an aqueous sol of a nanomaterial…” (independent claim 17). Dependent claims 18-27 further define the composition and the types of medical waste. “A process of preparing a flocculate based disinfectant composition, the process comprising: mixing a poly amino acid and a base…; preparing an aqueous sol of a nanomaterial…” (independent claim 28). Dependent claims 29-31 further define the process.
b,c) The nature of the invention is determined in part by the state of the prior art.
As even a cursory perusal of the pertinent prior art reveals, the prior art teaches specific chemical compositions, exposure times, procedures, etc. for the safe disinfection and disposal of medical waste. (Note, for instance, inventor’s outlines of a variety of pertinent prior references in the specification beginning at page 2, line 24).
d) The level of skill in the art is considered to be relatively high.
e) The level of predictability in the art is considered to be relatively low.
Even more than two hundred years after Lavoisier laid the foundations of its modern practice, chemistry remains an experimental science. The chemical arts have not advanced to the point where certainty has replaced the need for laboratory and/or practical experimentation.
Note that the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art (MPEP 2164.03).
f,g) The amount of direction provided by the inventor is considered to be determined by the specification and the working examples. All of inventor’s working examples utilize a single poly amino acid: poly glutamic acid. All of inventor’s working examples utilize, as a nanomaterial: either TiO2, boehmite (an Al oxide), SiO2, or LnPO4.
h) It would clearly require an extraordinary - and thus undue - amount of experimentation in order to determine if, in fact, a composition of the universe of poly amino acids and the universe of nanomaterials would be efficacious as a flocculant based disinfectant composition – and likewise for a process of preparing such a composition. Inventor’s extrapolation from a single example of a poly amino acid to the universe of poly amino acids simply strains credulity in an unpredictable art. As does the extrapolation from a limited set of oxides, and a single phosphate, to the universe of nanomaterials.
Claim Rejections - 35 USC § 112(b)
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.
Claim 17 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.
The claim appears to teach, essentially, two separate aqueous solutions (which are related by v/v %). That being the case, it is unclear how these two separate solutions may be referred to as a composition in the preamble of the claims (“A flocculant based disinfectant composition…”). Two separate solutions are not a composition; they are two separate solutions. Note that while an applicant may be his own lexicographer, applicant may not distort art-recognized terms. Note MPEP 2173.05(a)(III).
Clarification is in order.
Claim 24 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.
The limitation “…is characterized to create a non-pourable environment…” is unclear. Characterized how exactly?
Clarification is in order.
Claim 26 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.
The limitation “…is characterized to treat solid medical waste…” is unclear. Characterized how exactly?
Clarification is in order.
Claim 30 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.
There is insufficient antecedent basis for the limitation “…the pH regulated poly-glutamic acid…” in the claim.
The examiner respectfully suggests that claim 30 should properly depend from claim 29 (not claim 28).
Claims 18-23, 25 and 27 are also 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.
The claims all depend, or ultimately depend, from an indefinite claim yet do not relieve the indefiniteness. Dependent claims 18-23, 25 and 27 are also, therefore, indefinite.
Claim Rejections - 35 USC § 112(d)
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.
Claim 31 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth 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. In the instant case, the claim fails to further limit the subject matter of the claim upon which it depends.
Claim 28, the claim from which claim 31 immediately depends, teaches a process for the preparation of the instant flocculant based disinfectant composition. Dependent claim 31 then teaches a method of utilizing this composition so prepared to disinfect a variety of types of medical waste. That is, the limitations of claim 31, all having to do with the utilization of a composition already fully prepared, do not further limit the method of its preparation. Indeed, how could they?
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.
Allowable Subject Matter
The subject matter of claims 17-31 would be allowable once the 112 rejections outlined above have been overcome. The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art appears to be CN 101823799 A, whose corresponding English language machine translation has been relied upon for purposes of this Office Action.
The reference teaches a method for treating fluoride-containing wastewater, in order to remove fluorine, utilizing a flocculation process comprising adding a calcium-containing compound to the waste water, adjusting the pH to about 4-9, adding gamma poly glutamic acid, stirring and waiting, and then removing the resulting precipitate (abstract; translation page 4, Summary of Invention). The calcium-containing substance contains at least one of calcium hydroxide, calcium oxide, or a calcium salt (translation page 4, Summary of Invention). The working examples utilize, as the calcium-containing substance, a lime milk product industrial grade powder the main components of which are calcium oxide and calcium hydroxide (translation beginning at page 6, Examples 1-3). The reference does not teach, show, suggest or make obvious the instant disinfectant or its method of preparation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 5/8/2026
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