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 .
Response to Election/Restriction
Applicant claims priority as follows:
PNG
media_image1.png
94
626
media_image1.png
Greyscale
Response to Election/Restriction
Applicant’s election of Group I, claims 1-15, drawn to an antimicrobial composition and species dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride as the specific water-soluble organosilane (i), benzalkonium chloride (BAC) as the specific quaternary ammonium compound (ii) and cocomidopropyl betaine as the specific non-ionic, amphoteric, or sarcosine anionic surfactant (ii) in the reply filed on August 5, 2026 is acknowledged. Claims 1-15 read on the elected group of species.
Claims 16 and 23-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 August 5, 2026.
Examination
Examination will begin with the elected species. In accordance with MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
Pursuant to M.P.E.P. §803.02, the claims were examined with respect to the elected species and further to the extent necessary to determine patentability of the claims directed to elected subject matter. The elected group of species was searched, and applicable art was identified. The search was stopped, and art has been applied against the claims. While searching for the elected species, other species of the claimed invention were also found and examined/used in the rejections below for the purpose of a compact prosecution. The entire scope of claims 1-15 has not yet been examined in accordance with Markush search practice. See MPEP 803.02.
Subject matter outside of the examined scope are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions there being no allowable generic or linking claim.
Claims 1-15 are the subject of this Office Action.
Specification Objection - Title
Applicant is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive. See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be more descriptive of what is claimed. Currently, the title does not indicate the type of compounds of the invention with their common core. A new title is required that is clearly indicative of the invention to which the claims are directed. See MPEP 606.01.
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.
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 pre-AIA the applicant regards as the invention.
Claim 10 recites that chlorhexidine is selected from a polymeric biguanide. However, chlorhexidine is not polymeric.
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 10 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 10 recites that chlorhexidine is selected from a polymeric biguanide of claim 9. However, chlorhexidine is not polymeric and therefore, claim 10 does not further limit claim 9.
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 § 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) 1-3, 5-6 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Avery et al. (EP 0640122 B1).
The prior art disclosed antimicrobial compositions to be applied to surfaces, to the hands, to be used as mouthwashes, or as disinfecting carpet shampoos, etc. The percentages of ingredients varied depending on the use of the composition.
Examples 8 and 10 teach compositions comprising i) dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride (DOW CORNING 5772) in 0.15 wt%, ii) cetyl pyridinium chloride monohydrate in 0.2 wt% or 0.4 w% and iii) Tween® 20 in 0.5 wt%, with a pH of 6.5. The compositions also contain glycerin, which is a chelating agent, and alcohol (carrier/excipient). These compositions read on claims 1-3, 5-6 and 11-15.
Claim 13 recites “the composition is formulated for topical administration”. However, the compositions of Examples 8 and 10 of the prior art have the same ingredients as the claimed composition and nothing precludes their use as instantly recited. According to MPEP 2111.02, Section II, 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. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”). In the instant case, the body of the claims intrinsically set forth all of the limitations of the composition of the claim.
Claims 14 and 15 recite “the composition is antibacterial”, and “the composition is anti-biofilm”, respectively. The composition disclosed by the prior art recites all of the structural limitations required in the claims, therefore it would have been expected that the same properties would be present. This is because an identical composition must necessarily produce the same effects, since products of identical chemical composition cannot have mutually exclusive properties. MPEP § 2112: There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004).
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over by Avery et al. (EP 0640122 B1) applied to claims 1-3, 5-6 and 11-15 above, in view of DiTizio (US 2021/0299017) and Pre-fense™ (product label available on May 15, 2020 at DailyMed) or Softis™(product label available on September 9, 2020 at DailyMed).
Applicant’s Invention
Applicant claims
PNG
media_image2.png
188
626
media_image2.png
Greyscale
Avery
The teachings of Avery discussed above are incorporated herein. Avery is drawn to antimicrobial compositions comprising an aqueous solution of water soluble quaternary ammonium functional organosilanes, a water soluble organic non-silicon quaternary ammonium compound and at least one of nonionic, amphoteric, sarcosine anionic, and certain types of cationic surfactants. The compositions have improved stability and broader range of pH stability. See at least page 2.
At page 5 Avery discloses:
PNG
media_image3.png
131
724
media_image3.png
Greyscale
PNG
media_image4.png
112
724
media_image4.png
Greyscale
At pages 8-10 Avery further discloses that the presence of such an organic quaternary ammonium compounds assists in stabilizing the water soluble organosilanes. The quaternary ammonium compounds which have anti-microbial properties are typically useful as quaternary ammonium surfactants in the present invention and benzalkonium chloride is preferred.
PNG
media_image5.png
126
726
media_image5.png
Greyscale
PNG
media_image6.png
60
730
media_image6.png
Greyscale
PNG
media_image7.png
108
724
media_image7.png
Greyscale
PNG
media_image8.png
131
724
media_image8.png
Greyscale
Thus, Avery provides concentration ranges for the various ingredients in the antimicrobial compositions. For ingredient (i) in an amount of from about 0.001% to 5% by weight, more preferably from 0.01% to 2%, and most preferably from 0.05% to 0.5%; ingredient (ii) in an amount of from about 0.05% to 10% by weight, more preferably from 0.1% to 5%, and most preferably from 0.1% to 1.2%; and ingredient (iii) in an amount of from about 0.5% to 30% by weight, more preferably from about 1% to 5%, and most preferably from about 1% to 2.2%. Avery also disclosed appropriate pH of the compositions, such as 5.0 or 6.7 or 6.5.
See Examples 2 and 3:
PNG
media_image9.png
376
438
media_image9.png
Greyscale
for antimicrobial compositions that only differ from the instant claims in the total concentration of surfactants ingredient (iii) (within the box). The compositions of Examples 2 and 3 contain about 2.12 wt % of surfactants while the instant claims recite a concentration of about 0.05% to about 1% w/v.
See also Examples 5 and 6:
PNG
media_image10.png
362
684
media_image10.png
Greyscale
for antimicrobial compositions that use the amphoteric surfactant VELVETEX BK-35 (Cocamidopropyl betaine), the quaternary ammonium compound BARDAC 2250 (DDAC), the organosilane 3-(trimethoxysilyl)propyldimethyloctadecyl ammonium chloride (Dow Corning 5772) and biguanide chlorhexidine digluconate. Examples 5 and 6 only differ from the instant claims in the total concentration of ingredient (ii) and (iii). The pH of the composition is as instantly claimed.
See additional examples, such as Examples 26-29.
DiTizio
DiTizio teaches
PNG
media_image11.png
158
502
media_image11.png
Greyscale
PNG
media_image12.png
34
358
media_image12.png
Greyscale
PNG
media_image13.png
94
360
media_image13.png
Greyscale
PNG
media_image14.png
154
360
media_image14.png
Greyscale
PNG
media_image15.png
33
356
media_image15.png
Greyscale
PNG
media_image16.png
188
358
media_image16.png
Greyscale
PNG
media_image17.png
80
354
media_image17.png
Greyscale
PNG
media_image18.png
50
354
media_image18.png
Greyscale
[0088] The compositions may comprise additional agent. For example, water hardness controlling excipienst such as disodium EDTA may be included.
Pre-fense™
Pre-fense™ is a hand sanitizer that has been on sale before the effective filing date of the instant invention. It contains benzalkonium chloride in an amount of 0.12% and
PNG
media_image19.png
192
346
media_image19.png
Greyscale
. Citric acid is a chelating agent. The percentages of the inactive ingredients were not disclosed.
Softis™
Softis™ are hand sanitizing wipes with antibacterial soap that have been on sale before the effective filing date of the instant invention. It contains benzalkonium chloride in an amount of 0.12% w/w, polyaminopropyl biguanide in 0.5% w/w, and
PNG
media_image20.png
50
710
media_image20.png
Greyscale
Citric acid is a chelating agent. The percentages of the inactive ingredients were not disclosed.
Ascertainment of the Difference Between the Prior Art and the Claims
(MPEP §2141.012)
The differences between the compositions of Avery and the instant claims are the concentration ranges of the ingredients in the composition.
For example, the antimicrobial composition of Examples 2 and 3 only differ in the total concentration of surfactants ingredient (ii). These compositions contain about 2.12 wt % of surfactants while the instant claims recite a concentration of about 0.05% to about 1% w/v.
The difference between the compositions of Pre-fense™or Softis™ and instant claims 1-7 and 9-15 is only that the amounts of inactive ingredients were not disclosed in the label of the products.
Finding of prima facie obviousness--rational and motivation (MPEP §2142-2413)
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationales A and G, it would have been prima facie obvious to one of ordinary skill in the art to modify the weight percentage values taught by the art above and arrive at the instantly claimed weight/volume for each of the components in the claimed antimicrobial composition. “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.” In re Williams, 36 F.2d 436, 438 (CCPA 1929).
The weight percentage ranges taught by the art overlap the instantly claimed weight/vol percentage values. Pursuant to MPEP 2144.05:
PNG
media_image21.png
386
580
media_image21.png
Greyscale
Therefore, in the absence of unexpected results, it would have been obvious to one of ordinary skill to adjust, as part of routine optimization, the weight percentage values taught by the art to arrive at the instantly claimed weight percentage values. One of ordinary skill would have been motivated to make these adjustments to determine the optimum amount of each component to yield the desired antimicrobial effect in an antimicrobial composition. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 13 recites “the composition is formulated for topical administration”. However, the compositions of the prior art have the same ingredients as the claimed composition and nothing precludes their use as instantly recited. According to MPEP 2111.02, Section II, 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. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”). In the instant case, the body of the claims intrinsically set forth all of the limitations of the composition of the claim.
Claims 14 and 15 recite “the composition is antibacterial”, and “the composition is anti-biofilm”, respectively. The compositions disclosed by the prior art recite all of the structural limitations required in the claims, particularly, the antibacterial compounds recited in the claims, therefore it would have been expected that the same properties would be present. This is because an identical composition must necessarily produce the same effects, since products of identical chemical composition cannot have mutually exclusive properties. MPEP § 2112: There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004).
Conclusion
Claims 1-15 are rejected. No claim is in condition for allowance.
Not every piece of prior art found in the search has been applied against the instant claims. See MPEP 904.03.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-5:30pm.
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, Clinton Brooks can be reached at 571-270-7682. 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.
/VALERIE RODRIGUEZ-GARCIA/ Primary Examiner, Art Unit 1621
Prosecution Insights