DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/29/2023 has been considered by the examiner.
Status of the Claims
The amendment filed 04/18/2024 is under examination.
Claims 20-31 are pending.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Objections
Claims 20 and 23 are objected to because of the following informalities: It is assumed the fabric list in claim 20 was intended to be a list of alternatives because “at least one of” does not require all of the listed materials. Claim 20, line 5, should end the list of alternatives with “or,” i.e., “or polyimide” rather than “and polyimide.” This same change should be made to the list in claim 23 Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
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.
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 22 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 22 depends from itself. The skilled artisan is unable to determine which claim 22 was intended to further limit. The skilled artisan cannot determine the metes and bounds for which claim 22 is claiming protection.
Clarification is required.
Claim 23 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 23 introduces an antibacterial agent.
It is not clear if claim 23 requires that the method further comprises a step of applying an antibacterial agent in addition to applying the occlusive composition. Alternatively, claim 23 may have been intended to further limit claim 22 by specifying the fabric, to which the occlusive composition of claim 20 is applied, further comprises an antimicrobial agent.
It is not clear if the “antibacterial agent” of claim 23 was intended to refer to the “bacteriostatic agent” of claim 20, or if the “antibacterial agent” of claim 23 was intended to be an antibacterial agent in addition to the “bacteriostatic agent” of claim 20.
Since claim 20 recites a bacteriostatic agent as part of the occlusive composition, there is no antecedent basis for an occlusive composition having an antibacterial agent.
The term antibacterial agent encompasses both bacteriostatic and bactericidal agents.
Clarification is required.
Claim 23 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.
Under the interpretation that the “antibacterial agent” in claim 23 refers to the “bacteriostatic agent” of claim 20, claim 23 does not include all the limitations of claim 20. Antibacterial agents are a genus which encompasses more agents than “bacteriostatic agents.” Antibacterial agents may be, e.g., bactericidal agents which kill bacteria as well as bacteriostatic agents which stop growth without killing.
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 24 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 24 includes the limitation of wherein the occlusive dressing contains from about 60 wt% to about 75 wt% petrolatum, from about 2 wt% to about 5 wt% bismuth tribromophenate, from about 2 wt% to about 15 wt% water, and from about 5 wt% to about 36 wt% fabric.
It is not clear how the elements of claim 24 relate to the occlusive composition and water in the method of claim 20. There is, for example, no antecedent basis for petrolatum and bismuth tribromophenate in claim 20, 22 or 23.
Clarification is required.
Claim 30 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.
There is a lack of antecedent basis for “the antimicrobial agent” in claim 30, line 1. The term is not used in any previous claim from which claim 30 depends.
Clarification is required.
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 of this title, 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.
Claims 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Patel, US 20130150764 (cited on Applicant’s IDS dated 12/29/2023) in view of Serafica, US 7390499.
Patel teaches a method for preparing an occlusive wound dressing which requires preparing an occlusive oil emulsion, i.e., comprising a hydrophobic compound, e.g., petrolatum (Patel, e.g., 0015) and comprising a bacteriostatic agent, e.g., bismuth tribromophenate (Patel, e.g., 0020). The emulsion may further comprise an antibacterial agent (Patel, e.g., 0020).
The method comprises impregnating a fabric formed with fibers (Patel, e.g., 0001, 0006-0008, 0023-0024, claims 8 and 16) which requires applying a portion of the oil emulsion to a fabric. The fabric includes fibers of cellulose acetate, cotton, and polyester (Patel, e.g., 0025).
The method comprises disposing the fabric in a sealable package (Patel, e.g., 0008, 0024, 0052, claim 19). Sealable means there is at least two packaging members to seal together.
The method comprises sealing the package, and irradiating to sterilize the wound dressing (Patel, e.g., 0052).
Patel does not expressly teach the method comprising introducing water on at least one of the coated fabric or packaging member.
Serafica suggests the water content of wound dressings may be modified (Serafica, e.g., claim 1) to enable the dressing to donate moisture to the wound to which the dressing is applied, thereby resulting in improved healing (Serafica, e.g., c3:26-45, c7:1-35). The packaging material should be moisture proof (Serafica, e.g., c7:36-57, and claim 1).
It would have been obvious before the effective filing date of the presently claimed invention to modify methods for preparing wound dressings as set forth in Patel by introducing water on at least one of the fabric and packaging with a reasonable expectation of success. The skilled artisan would have been motivated to introduce water on the fabric and/or packaging material since this was a known technique for improving the moisture content of wound dressing as reported by Serafica. The skilled artisan would have seen this modification as the use of a known technique to improve the moisture donating properties of similar wound dressings in the same way. The skilled artisan would have had a reasonable expectation of success because Serafica teaches the packaging material may be selected to prevent moisture loss from the wound dressing while also allowing sterilization.
Accordingly, the subject matter of claims 20-23 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Closest prior art
Claims 24-31 are free of the closest prior art of record.
The closest prior art of record (Patel, US 20130150764 or Moghe, US 20130150765, both cited on the IDS dated 12/29/2023) do not expressly teach a method having the steps required by claim 20 which results in an occlusive dressing having the limitations of claim 24. Claims 25-31 require the limitations of claim 24. If incorporating the limitations of claim 24 into claim 20 to overcome the prior art rejection of claim 20, the limitations of claims 21 and 22 should also be included in claim 20 to clarify the relationship between the hydrophobic compound and bacteriostatic agent with the limitations of claim 24.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 21-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-14 of US 10098789.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach a method of preparing an occlusive wound dressing, comprising: preparing a slurry of an occlusive composition consisting essentially of a petrolatum and bismuth tribromophenate; applying a portion of the occlusive composition on a fabric comprised of at least one of cotton, polyester, rayon, cellulose acetate, or polyimide to produce a coated fabric; disposing the coated fabric on a portion of a first packaging member; introducing water on at least one of the coated fabric and the portion of the first packaging member; sealing the first packaging member to a second packaging member to produce a sealed package containing the coated fabric with the occlusive composition; and irradiating the sealed package to produce the occlusive wound dressing wherein the occlusive wound dressing contains from about 60 wt % to about 75 wt % petrolatum, from about 2 wt % to about 5 wt % bismuth tribromophenate, from about 2 wt % to about 15 wt % water, and from about 5 wt % to about 36 wt % fabric. 2. The method of claim 1, further comprising applying an antibacterial agent to produce the coated fabric. 3. The method of claim 1, wherein applying the portion of the occlusive composition on the fabric comprises dipping the fabric in the slurry of occlusive composition and removing excess slurry from the dipped fabric to produce the coated fabric. 4. The method of claim 1, wherein disposing the coated fabric comprises pleating a portion of the coated fabric and cutting the coated fabric to a predetermined size. 5. The method of claim 1, further comprising providing a polyethylene film on at least one of a peripheral portion of the first packaging member and a peripheral portion of the second packaging member, and wherein sealing the first packaging member to the second packaging member comprises melting at least a portion of the polyethylene film to produce the sealed package containing the coated fabric with the occlusive composition. 6. The method of claim 1, further comprising, prior to disposing the coated fabric on the portion of the first packaging member, disposing a predetermined amount of the hydrophobic compound on at least one of the portion of the first packaging member and the coated fabric; and, prior to irradiating the sealed package, heat soaking the sealed package in an environment having a temperature of at least about 120° F. for at least about four hours. 7. The method of claim 1, wherein irradiating the sealed package comprises exposing the sealed package to a total dose of gamma radiation in a range of from about 15 kGy to about 55 kGy. 8. The method of claim 2, wherein the antimicrobial agent is selected from the group consisting of polyhexamethylene biguanide; 2,4,4′-trichloro-2′-hydroxydiphenyl ether; chlorhexidine and salts thereof; silver and salts or complexes thereof; polymyxin, tetracycline; aminoglycoside compounds; bacitracin; neomycin; chloramphenicol; miconazole; and combinations thereof. 9. The method of claim 1, further comprising creating a pocket on the first packaging member, and wherein disposing the coated fabric on the first packaging member comprises disposing at least a portion of the coated fabric in the pocket. 10. The method of claim 8, wherein the antimicrobial agent is present in the occlusive wound dressing in an amount from about 500 ppm to about 3,000 ppm. 11. The method of claim 8, wherein the antimicrobial agent is polyhexamethylene biguanide. 12. The method of claim 1, further comprising disposing a bioactive agent onto the fabric of the occlusive wound dressing. 13. The method of claim 12, wherein the bioactive agent is selected from the group consisting of polyhexamethylene biguanide and bismuth tribromophenate. 14. The method of claim 13, wherein the bioactive agent is bismuth tribromophenate.
The reference claims anticipate the subject matter of instant claims 20-31.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615