DETAILED ACTION
This office action is in response to applicant’s filing dated July 28, 2025.
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 .
Status of Claims
Claims 1 – 14 are pending in the instant application. Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on July 28, 2025 are acknowledged. Claims 10 – 14 remain withdrawn, as being drawn to an unelected invention or specie. Acknowledgement is made of Applicant's amendment of claim 1 Claims under consideration in the instant office action are claims 1 – 9.
Objections and/or Rejections and Response to Arguments
Applicants' arguments, filed on July 28, 2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Modified Objections and/or Rejections
Modifications Necessitated by Claim Amendment
Claim Interpretation
Claims preamble “antimicrobial composition” is not a structural limitation but mere statement of purpose or use. Regarding claim preamble, see MPEP 2111.02, 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").
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.
Claims 4 and 5 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 4 recites the limitation " The […]composition of claim 1, wherein the amide compound is a compound having chemical structure (II)" in line 1. The structure (II) is a derivative of thiourea and not a malonamide derivative.
Claim 5 recites the limitation “The […]composition of claim 1, wherein the amide compound is a compound having chemical structures (III) to (VII)" in line 1. Structures (III) to (VII) are urea derivatives and not malonamide derivatives.
Therefore, there is insufficient antecedent basis for this limitation in the claims.
Accordingly, the claims 4 and 5 not been further treated on the merits.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 6, 7 and 9 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Jacobs (US 2004/0219177 A1, hereinafter Jacobs).
Instant claims are drawn to a pharmaceutical composition comprising an antimicrobial composition comprising:
an amide compound wherein the amide compound is a malonamide derivative,
and
cis-unsaturated fatty acid with 16 – 22 carbon atoms (e.g. docosahexaenoic or arachidonic acid). The pharmaceutical composition further comprises a pharmaceutical carrier.
Jacobs teaches a therapeutic composition incorporated in a pharmaceutically acceptable carrier, where composition includes a ceramide replacement component such as bishydroxyethyl biscetyl malonamide (malonamide derivative), as a major active ingredient, and one or more free fatty acids (e.g. arachidonic acid) (page 2, [0012]).
Therefore, teachings of Jacobs anticipate the composition of instant claims 1, 6, 7 and 9.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 – 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs (US 2004/0219177 A1) in view of Shiau et al (US 10,800,732 B2, cited in IDS filed December 7, 2023, hereinafter Shiau).
Instant claims are drawn to a pharmaceutical composition comprising:
a malonamide amide derivative compound, such as compound
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;
and
cis-unsaturated fatty acid with 16 – 22 carbon atoms (e.g. docosahexaenoic or arachidonic acid) where the content of the fatty acid is greater than the content of the amide compound.
Jacobs teaches a therapeutic composition for skin moisturizing therapy, for the treatment of patients suffering from various skin diseases (page 1, [0001]). The composition of Jacobs is useful for replenishment of a human skin barrier, which barrier is composed by ceramide, cholesterol and free fatty acids, and which prevents entrance of microbial infection such as staphylococcus into the body (page 1, [0002] and [0003]). Said composition includes a ceramide replacement component such as bishydroxyethyl biscetyl malonamide (malonamide derivative), as a major active ingredient, and one or more free fatty acids (e.g. arachidonic acid), with the molar ratio of the ceramide replacement component to the free fatty acids being approximately 3:1 (page 2, [0012]).
With regards to the limitation claimed in instant claim 8, which claims an antimicrobial composition where the content of the fatty acid is greater than the content of the amide compound, Jacobs does not specifically teach the amounts claimed in instant claim 8. However, it would be within the skill of an ordinary artisan to be able to modify the weight ratio of amide compound to fatty acid in treatment combination in order to obtain the desired dosage creating a synergistic effect. It is noted that "[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).
Jacobs does not teach malonamide derivative of structure:
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.
However, Shiau teaches an antimicrobial pharmaceutical composition comprising: an effective amount of a compound of formula (I)
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(column 2, lines 28 – 35), the possible combinations of substituents R1, R2 and R3 recited in a table (columns 22 – 28). One of the example compounds encompassed by formula (I) is a compound (V):
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(column 13, lines 45 – 55 and claim 8). The composition further comprises pharmaceutically acceptable carrier (column 39, lines 3 - 7). The composition of Shiau possess bactericidal activity and is effective against Staphylococcus aureus, frequently found on the skin (column 43, lines 50 – 64).
Thus, since Jacobs teaches a therapeutic composition which includes a malonamide derivative (bishydroxyethyl biscetyl malonamide) as an active ingredient combined with omega-3 fatty acids (e.g. arachidonic acid), which composition is effective for replenishment of a skin lipid barrier, and thus for preventing entrance of microbial infection such as staphylococcus into the body, and Shiau teaches pharmaceutical composition comprising SC5005 (malonamide derivative) as an active ingredient, which is an effective antimicrobial agent against Staphylococcus aureus, frequently found on the skin, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention to substitute an active ingredient in composition of Jacobs with compound taught by Shiau, i.e. combine known in the art malonamide derivative SC5005 with cis-unsaturated fatty acids to arrive at claimed composition. The one of ordinary skills would be motivated to do so to improve a desired effect of known drug and restore natural antimicrobial skin’s lipid barrier, with the reasonable expectation of success. Since from teachings of prior art it is known that lipid depleted skin is susceptible to microbial infection e.g. S. aureus.
Therefore, taking all together, taught by prior art, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant argues:
- The amended claim 1 recites the antimicrobial composition comprising an amide compound and a fatty acid, wherein the amide compound is a malonamide derivative and fatty acid is cis-unsaturated fatty acid with 16 to 22 carbon atoms; Zhou discloses an antimicrobial combination of vancomycin, which is not a malonamide derivative;
- Shiau and Le both fail to disclose the composition of an amide compound and a fatty acid;
- According to paragraph [0004] of the specification in the present application, certain amide compounds and certain fatty acids can work together to produce unexpectable synergistic bactericidal effect against a drug-resistant bacterial strain in a relatively small amount (Table 1 and Table 2).
Examiner’s response:
Applicant's arguments have been fully considered. Examiner acknowledges that in view of amended claim 1, which now recites composition wherein “[…] amide compound is malonamide derivative” in combination with cis-unsaturated fatty acid with 16 to 22 carbon atoms, Zhou’s teachings are not applicable. However, in view of teachings of Jacobs, Applicant’s arguments are not persuasive because: as set forth above in the rejection section, Jacobs teaches a therapeutic composition, where active component malonamide derivative is combined with cis-unsaturated fatty acid. Shiau teaches a pharmaceutical composition comprising SC5005 (malonamide derivative). It is obvious to skilled artisan to take a known malonamide derivative SC5005 and combine it with cis-unsaturated fatty acid, since composition of another active agent of similar structure (malonamide derivative) combined with cis-unsaturated fatty acid is known in the art. The motivation to combine prior art teachings is discussed above (see the rejection section).
Regarding argument, that Shiau fails to teach composition where malonamide is combined with fatty acid, it is recognized that Shiau doesn’t teach the malonamide and the fatty acid together. However, as set forth above in the modified rejection, Shiau teaches a malonamide compound that reads on instant claims, thus render instant invention obvious in view of combined teachings of Shiau and Jacobs.
Regarding arguments about synergistic effect of combination of certain amide compounds and certain fatty acids, it is recognized that Tables 1 and 2 (specification, pages 25 – 27, [0086] and [0087]) demonstrate synergistic effect when compound SC5005 is combined with some fatty acids in certain concentrations. However, the instant claims are very broad and encompass vast variety of fatty acids, while not all the acids encompassed by the instant claims show synergistic effect when combined with compound SC5005. For example, recited in Table 1 gondoic acid (C20 cis-unsaturated fatty acid) and erucic acid (C22 cis-unsaturated fatty acid) do not demonstrate synergistic effect. In addition, the instant claims are very broad regarding concentrations and do not recite any concentrations or ranges of concentration at which synergistic effect should be observed.
Therefore, these limitations are not commensurate within the scope of claims.
Therefore, applicant’s arguments are not persuasive and the rejection of claims:
1, 6, 7 and 9 as anticipated by Jacobs and
1 – 3 and 8 as obvious over teachings of Jacobs in view of Shiau is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 – 3 and 6, 7 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 5 of U.S. Patent No. US 10,800,732 B2 in view of Jacobs (US 2004/0219177 A1).
Instant claims are directed to a pharmaceutical composition, comprising a malonamide amide derivative compound, such as compound
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; and cis-unsaturated fatty acid with 16 – 22 carbon atoms (e.g. docosahexaenoic acid) and a pharmaceutical carrier. The patented claims are directed to a compound of formula (I)
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and pharmaceutical composition comprising an effective amount of a compound of formula (I) e.g. a compound
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(claim 5) and a pharmaceutically acceptable carrier (claim 3). Although previously granted claims do not teach a pharmaceutical composition where a compound of formula (I) is combined with cis-unsaturated fatty acid, Jacobs teaches a therapeutic composition for skin moisturizing therapy, where composition includes a ceramide replacement component such as bishydroxyethyl biscetyl malonamide (malonamide derivative), as a major active ingredient, and one or more free fatty acids (e.g. arachidonic acid) ((page 2, [0012]).
Taking into consideration the compounds and combination therapy, taught by prior art, it would have been prima facie obvious to one of ordinary skill in the art to modify known in the art combination therapy to arrive at claimed composition. Since it is known that S. aureus destroys natural skin lipids comprising unsaturated fatty acids, the one of ordinary skills would be motivated to combine antimicrobial agent with unsaturated fatty acid do so to improve a desired effect of known drug and repair destroyed by S. aureus skin’s lipid barrier, with the reasonable expectation of success.
Response to Arguments
Applicant argues:
- Claims 1-9 of the present application are patentably distinct from the reference documents, because the present application discloses the composition of a malonamide derivative and a cis-unsaturated fatty acid with 16 to 22 carbon atoms which exhibit special synergistic bactericidal effect;
- the claimed invention of the present application cannot be obtained by simple experimentations or random selection and combination.
Examiner’s response:
Applicant's arguments have been fully considered but they are not persuasive because: as set forth above, the composition of malonamide derivative and unsaturated fatty acid is known in the art combination. The compound of SC5005 is also known in the art therapeutic agent. The reasons to combine compound SC5005 with cis-unsaturated fatty acid and arguments about synergistic effect are discussed above (see rejection section under 35 U.S.C. 103 and response to the arguments).
Therefore, Applicant’s arguments are not persuasive and the rejection of claims 1 – 3 and 6, 7 and 9 on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. US 10,800,732 B2 in view of Jacobs is maintained.
Conclusion
Claims 1 – 9 are rejected. No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELENA V VISHNYAKOVA whose telephone number is (571)272-3781. The examiner can normally be reached 7:30am - 5pm ET.
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/E.V.V./ Examiner, Art Unit 1691
/RENEE CLAYTOR/ Supervisory Patent Examiner, Art Unit 1691