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
Claims 1-16 are pending in the application. Claims 1-9 and 13-16 are rejected. Claims 10-12 are withdrawn from further consideration.
Election/Restrictions
Applicant’s election of the following species:
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to prosecute the invention of Group I, claims 1-9 and 13-16 in the reply filed on December 16th, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species is not allowable. MPEP 803.02 states:
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. […]
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration. […]
If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush claim and claims to the elected species will be rejected, and claims to the nonelected species will be held withdrawn from further consideration.
As the elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 1-9 and 13-16 have been examined to the extent that they are readable on the elected embodiment. Since the elected species is not allowable, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration.
Additional issues under 35 USC 112(b) were discovered incidental to the search of the elected species and are presented below in the interest of compact prosecution.
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/KR2022/009359, filed June 29th, 2022, which claims priority under 35 U.S.C. 119(a-d) to KR10-2021-0110455, filed August 20th, 2021.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on December 5th, 2024, August 14th, 2024 and April 7th, 2023.
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 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 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 Scope (MPEP 2163(II)(A)(1)
MPEP 2163 outlines the methodology for determining adequacy of written description. MPEP 2163(II)(A)(1) instructs “For Each Claim, Determine What the Claim as a Whole Covers”.
The instant claims embrace antibacterial deodorant compositions comprising a first compound and a second compound different from the first compound where the first compound is cross-linked to at least a portion of the second compound. The scope of first compound under examination is limited to the elected species having the following formula:
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The instant claim 1 is further limited based on a particular property defined by Method A where the composition must produce certain results when treating artificial urine.
There are multiple aspects of instant claim 1 that are not particularly limited. First, instant claim 1 places no limitation on the identity of the second compound other than it must be cross-linkable, which would include an incredible variety of polymeric structures. Second, instant claim 1 places no limitation on the relative amount of either compound in the composition. Method A of instant claim 1 is based on placing 1 g of the composition in the bottle and performing a test. Instant claim 1 is nonetheless generic to any amount of the first and second compounds and any relative ratio between them. Third, instant claim 1 requires no particular arrangement between the first and second compound. For instance, instant claim 1 would embrace compositions where the first and second compounds are cross-linked on an interior of a larger structure.
Disclosed Support (MPEP 2163(II)(A)(2))
MPEP 2163(II)(A)(2) instructs “Review the Entire Application to Understand How Applicant Provides Support for the Claimed Invention Including Each Element and/or Step”. The specification generally discusses the intent of the invention of page 3 as follows:
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The specification discloses that a monomer (corresponding to instant Chemical Formula 1) is present and particularly refers to “a form in which the surface is cross-linked”. The specification describes various desirable properties (including the property of instant claim 1) on pages 3-7 and 11-12. The specification discloses the Chemical Formula 1 and subgeneric embodiments on pages 8-11; however as noted above, the scope under examination is limited to the elected species. Regarding the second compound, the specification provides generic descriptions on pages 12-20 where the second compound can be a super absorbent polymer, a hydrous gel polymer or an acrylate-based polymer having various structures and/or cross-linking.
For specific examples, the specification discloses monomers on pages 31-34 and provides preparation of two super absorbent resins on pages 34-35. Both resins (corresponding to the instant second compound) are acrylic acid polymers where the second example (Preparation Example 3) additionally contains an antibacterial deodorant monomer. Regarding incorporation of the instant first compound, the specification discloses surface cross-linking on pages 36 and 38 where the first compound is applied along with ethylene carbonate onto Super Absorbent Resin 1. Regarding compositions having the property of instant claim 1, the specification discloses Table 4 on pages 42 and 43. Table 4 contains several informative comparisons. For instance, Comparative Example 8 (where only Super Absorbent Resin 2 was tested, i.e. a composition having antibacterial deodorant monomer distributed throughout the Resin instead of located primarily on the surface) provided a diacetyl level above 30 ng. Comparative Example 7 (having a shorter period of surface cross-linking) provided levels exceeding each limit of instant claim 1.
As further noted in MPEP 2163(II)(A)(2), “Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art.” In this situation, a person of ordinary skill in the art would have been familiar with generation of cross-linked structures having antibacterial monomers. For instance, Wynne et al. (ACS Appl. Mater. Interfaces 2011, 3, 2005-2011) disclose (abstract): “Five novel diol-functionalized quaternary ammonium bromide salts were designed, synthesized, and cross-linked with a commercial polyisocyanate to afford novel multifunctional self-decontaminating coatings.” Wynne et al. disclose the following synthesis on page 2007:
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Regarding the prior art variable R, the authors teach octyl bis(2-hydroxyethyl)methyl ammonium bromide and decyl bis(2-hydroxyethyl)methyl ammonium bromide as compounds 3c and 3d, both of which correspond to the instant Chemical Formula 1. The prior art, however, is silent on the resulting polymers relative to the instantly claimed Method A. There would appear to be several possibilities: (1) the compositions of Wynne et al. possess the instantly claimed property, (2) the compositions do not possess the instantly claimed property but could be modified by some change to the polymeric structures to arrive at compositions possessing the instantly claimed property or (3) the prior art polymeric structures cannot be modified to arrive at compositions possessing the instantly claimed property. Neither the prior art nor instant specification inform a person having ordinary skill in the art whether or how such structures could be modified to obtain the instantly recited property. Subsequent to the Wynne et al. disclosure, Coneski et al. (Langmuir 2012, 28, 7039-7048) disclose analogous polymers containing poly(ethylene glycol) units as follows on page 7041:
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Coneski et al. (RSC Adv., 2012, 2, 12824-12834) further disclose a different polymer backbone but still containing a quaternary ammonium diol as follows on page 12826:
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Both Coneski et al. references are similarly silent on the particular properties relative to instant Method A. The above disclosures, however, demonstrate that is possible to incorporate the instant Chemical Formula 1 in numerous types of polymers.
Determination of Sufficient Support (MPEP 2163(II)(A)(3))
MPEP 2163(II)(A)(3) instructs “Determine Whether There is Sufficient Written Description to Inform a Skilled Artisan That Inventor was in Possession of the Claimed Invention as a Whole at the Time the Application Was Filed”. This section of the MPEP further provides the following guidance:
Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
In this situation and as discussed above, Applicant claims a generic second compound along with various aspects such as ratios, structural arrangement, etc. being unlimited while requiring a particular desirable result to occur according to Method A. The specification contains one specific approach demonstrated to achieve the claimed result. The disclosure is thereof limited in scope relative to the claims and does not demonstrate that Applicant was in possession of the structural attributes across the full genus that would possess the instantly claimed property. MPEP 2163 (II)(A)(3)(a)(ii) discusses support for a generic claim as follows:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above).
The same section notes the following:
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014)
In this situation, Applicant has failed to provide “disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus.” The original disclosure discloses limited examples falling within the scope of the instant claims and even provides one example (Comparative Example 7) that otherwise possesses the structural aspects of various claims but that fails to satisfy Method A. As noted above, the instant generic second compound is not even limited to the same types of polymers tested in the instant specification and would extend to polymeric backbones that have been previously applied in the prior art and polymeric backbones that have yet to be applied in any context. The instant claims, however, would cover any embodiments that might prove to satisfy instant Method A despite the specification containing no description of which embodiments would be expected to satisfy Method A.
Regarding dependent claims 2-9, the same general rationale applies where the various dependent claims fail to define the identity of the second compound with any specificity, fail to define the relative amounts of the first and second compound and/or fail to define the relative arrangement of the first and second compound.
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.
Claims 7 and 14-16 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.
Claim 7 recites the limitation "the cultured solution is diluted" in the second to last line of the claim. There is insufficient antecedent basis for this limitation in the claim. Method B only previously refers to “the resulting mixture” being cultured as opposed to a solution. It is unclear if claim 7 is only embracing deodorant compositions that would necessarily be solutions at the noted point in Method B or if Method B is otherwise incomplete or inaccurately defined.
Claim 7 recites the limitation "the physiological saline solution" in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim. Method B only previously refers to “a saline solution”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 14 recites:
the broad recitation “a broth type medium”, and the claim also recites “Nutrient broth, BD DIFCP., 8 g/L” which is the narrower statement of the range/limitation; and
the broad recitation “mixing is performed”, and the claim also recites “vortexing” which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Dependent claims 15 and 16 are rejected as indefinite for the same reason since they do not correct the issues.
Claim Rejections - 35 USC § 102
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.
Claim(s) 13-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. RSC Adv. 2019, 9, 41616-41627.
Wang et al. teach the preparation of N,N-bis(2-hydroxyethyl)-N-methyldodecan-1-aminium bromide on page 41617 (Section 2.1) corresponding to the following structure (page 41621):
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The compound corresponds to Applicant’s elected species and is embraced by instant Chemical Formula 1 where one of R1-R3 is an alkyl group having 2 carbon atoms and substituted by a hydroxyl group, another of R1-R3 is an alkyl group having 1 carbon atom, the last of R1-R3 is an alkyl group having 12 carbon atoms and X is halogen.
Regarding the limitation of a “deodorant composition,” claim 13 only requires the presence of the compound itself. MPEP 2111.02(II) states: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, 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. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”.
Regarding the limitation of claims 14-16, 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). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.’ The instantly recited Method E was performed on page 40 of the specification using “0.01 g of the first compound (antibacterial deodorant monomer) in Table 1” such that no additional components appear to be required to produce the claimed result. The instant elected species corresponds to Monomer C that produces inhibition rates according to instant claims 15 and 16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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