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 .
Claims Status
Applicant’s election without traverse of Group 1 claims 1-11 and 17-18 and the species of polysorbate 80 surfactant in the reply filed on 12/24/2025 is acknowledged. Examiner notes that the species of pH buffer citrate-citric acid (claim 5), and fragrance or essential oil (claim 10) is rejoined with the polysorbate 80 surfactant election.
Claims 12-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/24/2025.
Claims 1-11 and 17-18 are under current examination to the extent of the elected species to: polysorbate 80 which is rejoined with citrate-citric acid buffer and fragrance or essential oil.
Information Disclosure Statements
Information Disclosure Statements (IDS) filed on 07/11/2024 and 06/13/2024 have been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
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 2-3 and 17 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 2 and 17 recite that the concentration of CMC is sufficient such that CMC interact with PVP-I to form CMC-I, thereby causing the composition to be anisotropic. The instant specification does not define the sufficient concentration causing the composition to be anisotropic. A sufficient CMC concentration to cause the composition to be anisotropic is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Paragraph [0021] of the instant specification merely tests a 2-4% CMC concentration which shows the composition as anisotropic, however this is merely an exemplary embodiment. Claim 1 recites a concentration of 0.1-5% by weight. Instant claim 18 suggests that the concentration can be 0.1-5% by weight which causes the composition to be anisotropic. Thus, it is unclearwhat concentration of CMC is required by the claim. . For the purpose of examination, claim 2 will be interpreted as 0.1-5% by weight concentration required to cause the composition to be anisotropic since claim 18 suggests that this concentration enables the composition to be anisotropic. It is suggested that Applicants can amend claim 2 to delete “the concentration of CMC is sufficient”, and Applicants can amend claim 17 to delete “ a concentration sufficient” to overcome this rejection.
Claim 3 recites “which interacts with salts present in the solution”. However, claim 3 depends from claim 1 and no “solution” is required by the claim. Thus, it is unclear which solution claim 3 is referring to. It is suggested that claim 3 can recite “which interacts with salts present in a solution, without decreasing the viscosity of the final product.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 11 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simon et al. (United States Patent 4592487)
Simon et al. discloses CMC (12HP) present at 1.3% by weight together with PVP-I at 10% by weight, cee claim 12. This anticipates the claimed PVP-I present from 5-10% with CMC present from 0.1-5% by weight. Regarding instant claim 3, in another example, sodium carboxymethylcellulose (Na-CMC) is present at 1.25% with PVP-I at 6.66% by weight, see claim 11. Regarding instant claim 11, in another example, CMC (12HP) is present at 3% by weight, PVP-I at 10% by weight and water at 50.5% by weight, see example 3. This example anticipates having a majority of water present which is interpreted at greater than 50% by weight. The instant specification discloses that the concentration of CMC can be from 2-4% causing the composition to be anisotropic (paragraph [0021]. The concentration of CMC in one embodiment at example 3 of Simon et al. is 3% by weight, thus would necessarily cause the composition to be anisotropic. The compositions of Simon et al. are antimicrobial, see abstract. Simon et al. teach sodium CMC, thus the limitation “which interacts with salts present in the solution without decreasing viscosity of the final product” would necessarily follow. "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).
Accordingly, Simon anticipates instant claims 1-3, 11, and 17-18.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 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.
Claims 1-9, 11, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Baldwin et al. (United States Patent Publication 20170266294) in view of Crawford et al. (US20140255332-see IDS filed on 07/11/2024).
Baldwin et al. teach aqueous antimicrobial compositions which comprise PVP-I present from 0.01-10% by weight and CMC from 0.01-2% by weight, see claims 1-5 and 12-13. This concentration of PVP-I and CMC taught by Baldwin overlaps and therefore renders obvious the claimed range of 5-10% by weight PVP-I and 0.1-5% by weight of CMC. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The CMC acts as a viscosity adjusting agent, see paragraph [0114]. The composition can further comprise polysorbate 80 surfactant present from 0.01-2% by weight, see claim 11, claims 20-21 and 23 and paragraph [0021], [0063]-[0065]. This amount of polysorbate 80 overlaps and therefore renders obvious the claimed range of 0.01-4% by weight. Acids or basis may be added to the composition to adjust the pH and buffer the composition, see paragraph [0050]. The instant specification discloses that in one embodiment the concentration of CMC can be from 2-4% which enables the composition to be anisotropic (paragraph [0021). The concentration of CMC of Baldwin is inclusive of 2% by weight, thus would necessarily be anisotropic. Table 16 demonstrates that water can be added to comprise a majority of the composition which is present at 100g (equivalent to 100ml) . The composition can be applied to the nose, see abstract, claim 18 and paragraphs [0027] and [0056].
Baldwin et al. do not expressly teach wherein the pH buffer is citrate-citric acid or that the CMC is Na-CMC (sodium carboxymethylcullulose) (instant claims 2 and 5).
However, Crawford et al. teach antimicrobial compositions which comprise citrate-citric acid buffer, see abstract and paragraph [0019] and [0033]-[0036] and claim 9. The antimicrobial composition can comprise PVP-I and carboxymethylcellulose or sodium carboxymethylcullulose to increase the viscosity of the formulations, see claims 1, 7, and paragraph [0031].
It would have been prima facie obvious to one of ordinary skill in the art before the effecting filing date of the claimed invention to substitute the pH buffer of Baldwin et al. for a citrate-citric acid buffer and to substitute the viscosity increasing agent of CMC of Baldwin et al. for Na-CMC.
One of ordinary skill in the art would have been motivated to substitute the buffer of Baldwin et al. for citrate-citric acid to achieve the desired pH of the antimicrobial composition. The simple substitution of one known buffer for another would yield predictable results. One of ordinary skill in the art would have been motivated to substitute the CMC viscosity increasing agent of Baldwin et al. for Na-CMC because Crawford et al. teach that CMC and Na-CMC are both recognized as viscosity increasing agents for antimicrobial formulations containing PVP-I. The simple substitution of one known viscosity increasing agent for another would yield predictable viscosity increasing results.
There would have been a reasonable expectation of success because Baldwin et al. teach the use of acid or bases to adjust the pH range of the antimicrobial composition, and Crawford et al. teach that buffers including sodium citrate-citric acid are used to adjust the antimicrobial compositions pH range. Furthermore, Baldwin et al. teach the use of viscosity adjusting agents such as CMC and Crawford et al. teach that an alternative viscosity adjusting agent to CMC is Na-CMC for increasing the viscosity of antimicrobial compositions.
Regarding instant claim 2, since Baldwin et al. in view of Crawford et al. teach sodium CMC, the limitation “which interacts with salts present in the solution without decreasing viscosity of the final product” is a recitation characterizing the natural result of the sodium CMC.
Accordingly, claims 1-9, 11, and 17-18 are rendered prima facie obvious over the teachings of Baldwin et al. in view of Crawford et al.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Baldwin et al. (United States Patent Publication 20170266294) and Crawford et al. (US20140255332-see IDS dated 07/11/2024) as applied to all claims 1-9, 11, and 17-18 above and further in view of Dyer et al. (United States Patent Publication 20160366879-see IDS dated 07/11/2024).
The teachings of Baldwin et al. and Crawford et al. are discussed above.
Neither Baldwin et al. nor Crawford et al. teach the limitation of claim 10 which requires a fragrance or an essential oil from 0.1-5% w/w.
However, Dyer et al. teach antimicrobial compositions which comprise povidone iodine, see paragraphs [0176] and [0179]. Thickening agents include cellulose ethers, see paragraph [0189]-[0190]. The composition can be applied the nose, see abstract. The composition contains fragrance at 1% or less to aesthetically improve odor characteristics, see paragraph [0148].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to incorporate fragrance at 1% or less w/w to the antimicrobial composition of Baldwin et al. with the motivation to improve the odor characteristics of the antimicrobial composition of Baldwin et al. This concentration overlaps the claimed range of 0.1-5% w/w. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
There would have been a reasonable expectation of success because both Baldwin et al. and Crawford et al. teach antimicrobial compositions which comprise PVP-I and a cellulose thickening composition for treating nasal passageways.
Conclusion
Currently, no claims are allowed and claims 1-11 and 17-18 are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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, David Blanchard can be reached at 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH ALAWADI/Primary Examiner, Art Unit 1619