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 .
Election/Restrictions
1. Applicant’s election without traverse of Group I, claims 1-25 in the reply filed on 1/20/26 is acknowledged. Claims 26-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method and container, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
2. 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.
3. Claims 1, 3, 5, 16, 17 and 21 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.
4. With specific regard to claims 1, 3, 5, 17 and 21 the term “advantageously” (claim 1) and the term “preferably” (claims 3, 5, 17 and 21) are relative terms which renders the claims indefinite. The terms “advantageously and/or preferably” 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.
5. With regard to claim 16, it is not clear what property is measured. The Examiner is not able to determine the scope of this claim for the purpose of searching and applying prior art.
Claim Rejections - 35 USC § 103
6. 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.
7. Claim(s) 1-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lebrette et al., US 20130040109 A1 in view of Im et al., US 20120270458 A1.
With regard to claims 1, 23, 24 and 25, the published patent application issued to Lebrette et al., teach forming a sterilized medical drape, gown or packing from a biodegradable monolayer (non-woven) made from cellulose fibers (abstract and paragraphs 0002, 0022-0023, 0031-0033 and 0048). With specific regard to claim 25 it is reasonable to expect that a sterilized tray would also include a tight sterilized closure. Said non-woven layer comprises cotton/cellulose fibers having a length ranging from about 0.1 millimeter to 30 millimeters and according to some embodiments of the present disclosure, from 1 to 15 millimeters (paragraph 0030). With regard to the amount of cellulose fiber, Lebrette et al., teach 15 wt. % cellulose and 60 wt. % natural fibers which can include cellulose (paragraphs 0009, 0023, 0035 and 0048). As such, the Examiner is of the position that the claimed percentage amount of 75 wt. % cellulose fibers is met. The biodegradable monolayer (non-woven) medical material may have a grammage between 25g/m.sup.2 and 200 g/m.sup.2. As such, the Examiner is of the position that the biodegradable monolayer of Lebrette et al., is sufficient to meet the claimed cardboard limitation. With regard to the claimed air permeability limitations, the Examiner is of the position that since the non-woven layer meets the claimed structural and chemical limitations (e.g., non-woven structure, fiber type, fiber length, weight range) and is used in the same capacity as a sterilized drape, gown or packaging the claimed air permeability would be expected. Lebrette et al., further discloses that the monolayer is breathable (paragraph 0016). The Patent and Trademark Office can require applicants to prove that prior art products do not necessarily or inherently possess characteristics of claimed products where claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes; burden of proof is on applicants where rejection based on inherency under 35 U.S.C. § 102 or on prima facie obviousness under 35 U.S.C. § 103, jointly or alternatively, and Patent and Trademark Office’s inability to manufacture products or to obtain and compare prior art products evidences fairness of this rejection, In re Best, Bolton, and Shaw, 195 USPQ 431 (CCPA 1977). With regard to claim 17, Lebrette et al., teach a thickness ranging from 90-100 mm (paragraph 0052). With regard to claim 19, Lebrette et al., teach that the monlayer can be calendared (paragraph 0021). With regard to claim 20, Labrette et al., does not teach treating (mercerization) the cellulose fibers; however, the Examiner is of the position that it would be within the skill of an ordinary worker in the art to treat the cellulose fibers with caustic soda or the like to improve strength, luster and durability.
With regard to the claimed pore size, Lebrette et al., does not expressly teach a pore size, but does teach that non-woven layers are breathable and can be sterilized. As such, the Examiner is of the position that the non-woven monolayer of Lebrette et al., must be also porous to allow for breathability and sterilization. “[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968) Such porous medical non-woven fabrics are also known in the art.
The published patent application issued to Im et al teach a medical non-woven fabric that can be used in barrier applications wherein the non-woven fabric has pore sizes ranging fromm 1 to 500 microns for medical uses (title, abstract, 0013-0014 and 0052). Im et al., teach that a pore size less than 1 micron deteriorates the function of the micropores between fibers to lower the absorption rate, whereas the pore size greater than 500 micron renders the micropores between fibers extremely large even when water causes gelation of the material, readily leading to a deterioration of the barrier property of the nonwoven fabric. Based on this disclosure the Examiner is of the position that one of ordinary skill in the art would recognize that the pore sizes in the non-woven monolayer of Lebrette et al., can be optimized based on desired end use (e.g., drape, gown packaging) and barrier properties. Absent a clear and convincing showing of unexpected results demonstrating the criticality of the claimed pore size, it would have been obvious to one of ordinary skill in the art to optimize this result-effective variable by routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). The Examiner considers the pore size limitations of claims 1 and 9 met.
With regard to claims 2-4, Lebrette et al., teach fibers having a length .1-30mm (see above) but does not teach a ratio of “short” cellulose fibers to “long” cellulose fibers. Absent a clear and convincing showing of unexpected results demonstrating the criticality of short to long fiber ratio, it would have been obvious to one of ordinary skill in the art to optimize this result-effective variable by routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
With regard to claims 7-8, the fibers of Lebrette et al., are biodegradable. (see above).
With regard to claims 5-6, Im et al., teach adding synthetic binder fibers of the claimed type to the non-woven fabric in the claimed amounts (Im et al., paragraph 0073-0074). The Examiner is of the position that the addition of synthetic binder fibers meets the limitation of a mixture of fibers. It would be obvious to a person of ordinary skill in the art to use synthetic fibers with suitable lengths and titers as s function of desired end use.
With regard to claims 10-11, Im et al., teach adding dispersing agents such as surfactants in the claimed amounts (Im et al., paragraph 0076-0078). The Examiner is of the position that surfactants act as wetting agents and can improve the wetting, penetration and adhesion. As such, the Examiner is of the position that the surfactants of Im et al., function in the capability of “wet strength” agents. Im et al., does not specifically teach the claimed wet strength agents; however, the Examiner is of the position that it would be within the skill of a person in the art to select a known wetting agent based desired wetting, penetration and adhesion properties. The selection of a known material based upon its suitability for the intended use is a design consideration within the skill of the art. In re Leshin, 277 F.2d 197, 199, 125 USPQ 416, 418 (CCPA 1960).
With regard to claims 12-13, Im et al., further teach adding a binder in the form of (powder or fibers). The Examiner is of the position that a powder binder can act as a sizing to the fibers (see above). Im et al., teach adding the claimed amount of binder (see above). Im et al., does not specifically teach the claimed sizing (binder) agents; however, the Examiner is of the position that it would be within the skill of a person in the art to select a known binder (sizing) agent based desired liquid penetration properties. The selection of a known material based upon its suitability for the intended use is a design consideration within the skill of the art. In re Leshin, 277 F.2d 197, 199, 125 USPQ 416, 418 (CCPA 1960).
With regard to claim 18, Im et al., teach dip coating the non-woven fabric in a polymer solution comprising a pigment (paragraph 0104).
With regard to claims 14-16, the cited prior art does not teach the claimed COBB and bacterial behavior. With specific regard to claim 16, see the above 112 2nd paragraph rejection. Though the cited prior art does not specifically teach the claimed COBB and bacterial behavior the Examiner is of the position that absent evidence to the contrary the cellulosic non-woven provided by the combination of Labrette et al., in view of Im et al., would exhibit these claimed properties. Support for said supposition is found in the use of like materials (e.g., non-woven cellulosic fabric having the claimed fiber lengths, amount of fibers, pore size, basis weight and thickness) and the use of like processes such as forming sterilized drapes, gowns and trays. The Patent and Trademark Office can require applicants to prove that prior art products do not necessarily or inherently possess characteristics of claimed products where claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes; burden of proof is on applicants where rejection based on inherency under 35 U.S.C. § 102 or on prima facie obviousness under 35 U.S.C. § 103, jointly or alternatively, and Patent and Trademark Office’s inability to manufacture products or to obtain and compare prior art products evidences fairness of this rejection, In re Best, Bolton, and Shaw, 195 USPQ 431 (CCPA 1977).
With regard to claims 21 and 22, Though the cited prior art does not specifically teach the claimed bending resistance and WVTR the Examiner is of the position that absent evidence to the contrary the cellulosic non-woven provided by the combination of Labrette et al., in view of Im et al., would exhibit these claimed properties. Support for said supposition is found in the use of like materials (e.g., non-woven cellulosic fabric having breathability, the claimed fiber lengths, amount of fibers, pore size, basis weight and thickness) and the use of like processes such as forming sterilized drapes, gowns and trays. The Patent and Trademark Office can require applicants to prove that prior art products do not necessarily or inherently possess characteristics of claimed products where claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes; burden of proof is on applicants where rejection based on inherency under 35 U.S.C. § 102 or on prima facie obviousness under 35 U.S.C. § 103, jointly or alternatively, and Patent and Trademark Office’s inability to manufacture products or to obtain and compare prior art products evidences fairness of this rejection, In re Best, Bolton, and Shaw, 195 USPQ 431 (CCPA 1977).
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDA SALVATORE whose telephone number is (571)272-1482. The examiner can normally be reached M-F.
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, Marla McConnell can be reached at 571-270-7692. 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.
/LYNDA SALVATORE/Primary Examiner, Art Unit 1789
Prosecution Insights