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 Rejections - 35 USC § 112—Scope of Enablement
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 1-14 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 reducing or preventing crystal formation with the addition of 2,2-di(n-propyl)acetic acid, and Neodecanoic acid, 2-bytyloctanoic acid, and isosteric acid, does not reasonably provide enablement for reducing or preventing crystal formation with the addition of branched chain fatty acid having 8 to 22 carbon atoms, generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to the reduction or prevention of crystallization in an ethanolic solution comprising zinc decarboxylate. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites Taylor (www.crystallizationsystems.com). Taylor teaches, “The impact of a polymer on the supersaturation profile depends not only on its effect on nucleation, but also on its ability to suppress crystal growth once nuclei have formed” (p. 1, 3rd paragraph).
The breadth of the claims
The breadth of the claims is broad insofar as it proposes that branched chain fatty acid having 8 to 22 carbon atoms, generally, are capable of reducing or preventing crystallization in an ethanolic composition comprising zinc dicarboxylate.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful therapeutic protocols for determining what type and concentration of branched chain fatty acid having 8 to 22 carbon atoms can prevent or reduce crystallization in an ethanolic composition comprising zinc dicarboxylate, other than 2,2-di-(n-propyl)acetic acid at 1%, neodecanoic acid at 0.5% and 0.08%, 2-butyloctanoic acid at 1.0%, and isostearic acid at 0.5% and 2.0%. The latter is corroborated by the working examples. Note: 2, 4-dimethyl-2-pentenoic acid shown in the specification at Table 1 only has 7 carbon atoms as opposed to the minimum 8, as claimed.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used branched chain fatty acid having 8 to 22 carbon atoms, generally, as inferred by the claim and contemplated by the specification. This is especially the case, since the specification applicant provides a showing where branched chain fatty acids, i.e. isostearyl alcohol, octyldodecanol, and isoamyl laurate, were unable to reduce or prevent crystal formulation in an ethanolic solution comprising a zinc dicarboxylate. Neodecanoic acid also failed to prevent crystal formation at certain concentrations. Based on the results of Table 1, it is apparent that the effect of reducing or preventing crystal formulation by a branched chain fatty acid of 5 to 22 carbon atoms, is dependent on the type of branched chain fatty acid as well as its concentration. No data has been presented establishing the criticality of a range for each branched chain fatty acid in the ethanolic solution.
Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no reasonable expectation of success.
Claim Rejections - 35 USC § 112/101
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.
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 13-14 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
The claim does not indicate how the composition is being used, by reciting a positive active step.
Claims 13-14 are also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a credible asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
Claim Rejections - 35 USC § 112—4th Paragraph
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 4 is 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. Claim 4 fails to further limit claim 1 insofar as it recites 2, 4-dimethyl-2-pentenoic acid, which has only 7 carbon atoms, whereas claim 1 requires a minimum of 8 carbon atoms for the crystallization inhibitor. 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 § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brooks (WO 2018/087148) in view of Springer et al., (US 2009/0136437).
Brooks et al. teaches deodorant compositions comprising “at least one zinc carboxylate salt and aluminium chlorohydrate” and suspended in “at least essentially anhydrous solvent”, wherein the deodorant is a “deodorant spray” (Abstract).
The prior art teaches a specific embodiment below:
PNG
media_image1.png
664
957
media_image1.png
Greyscale
(see p. 18, lines 10-15).
Here, the embodiment suffices as an ethanolic solution insofar as ethanol is the primary medium. The amount of ethanol in the compositions has not been limited but for this embodiment. It would have been obvious to modify the amount of ethanol as well as the other active ingredients recited herein. The embodiment is free of water as per claims 2-3, includes a volatile propellent, as per claim 10, and zinc neodecanoate, as per claim 12. As a spray, the compositions would have reasonably been expected to be homogenous, as per claim 11. Nothing in the refence suggests otherwise.
Brooks et al. does not teach an additional branched chain fatty acid other than neodecanoate (which suffices as a crystallization inhibitor as per claims 3-7).
Springer et al. teaches cosmetic compositions comprising a “deodorant active compound” (Abstract) and “ethanol” as a solvent (see p. 6, para. [0092]).
Springer et al. includes “isostearic acid” as an emollient (p 3, para. 28; see also p. 9, para. [0127}, Formulation Example 5, where isostearic acid is use at 1%).
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to ad isosteric acid as emollient to the compositions of Brooks et al. based on its art recognized suitability for its intended use in deodorant compositions, as taught by Springer et al. The artisan would have reasonably expected success with the combination insofar as Brooks teaches “Deodorizing composition and deodorant consumer products of the present invention may contain an emollient” (p. 13, liens 24-25).
Accordingly, it would have been obvious to modify the emollient in the compositions, as per claim 8, for improving “good skin feel or skin moisturization” as discussed Brooks et al. (p. 14, lines 11-12).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/WALTER E WEBB/Primary Examiner, Art Unit 1612
1 As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.