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 .
1.Applicant’s election without traverse of Group I, claims 1-26 in the reply filed on January 21, 2026 is acknowledged. However, it is noted that product claim 26 should have been grouped with Group II claims and hence it will be held as non-elected based on applicant’s election. An action hereby follows on claims 1-25.
2.Claims 1-25 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.
Applicant has set forth a fixing step in claim 1, part a) and an expansion step in claim 1, part b), wherein a nanofiber mat is expanded to form an expanded nanofiber structure. However, part c) of the claim recites “attaching the nanofiber mat or the expanded nanofiber structure to an end of a string”. Does applicant intend that either the (unexpanded) mat or the expanded structure is suitable for use as the collection device? Indeed, if only the (unexpanded) mat is employed in the method—ie, attached to the end of a string to form a nanofiber collection device—then it is submitted that instant part c) would fail to further limit parts a) and b). Clarification is required as to how the first alternative recited in part c) of claim 1 further limits parts a) and b) of claim 1. If “poloxamer 407” is a tradename in claim 14 then it should be identified as such. Claim 23, line 1, “the fixed portion” technically lacks antecedent basis.
3.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.
Claim(s) 1-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over the article to Chen et al entitled “New Forms of Electrospun Nanofiber Materials for Biomedical Applications” in view of the admitted prior art at page 1, last line through page 2, line 7 of the instant specification and further in view of Moo 2005/0256427 (see paragraph 0020).
Chen et al discloses a method for forming an electrospun nanofiber device by fixing one side (ie, at least one point) of a nanofiber mat and expanding the mat using gas (bubble) foaming in sodium borohydride solution (see page 7, section 3.1.3) to form an expanded nanofiber structure or device that would be used for biomedical applications—see the Abstract. The primary reference essentially lacks forming a collection device from the expanded nanofiber structure—or indeed the nanofiber mat from which it is made—by attaching the structure to the end of a string. The admitted prior art bridging pages 1 and 2 of the instant specification teaches that a sponge material attached to a string is conventionally used as a collection device. It would have been obvious to one of ordinary skill in the art at the time of filing to have attached the expanded nanofiber structure/nanofiber mat of the primary reference to a string and thereby produce a nanofiber collection device as taught in the admitted prior art dependent on the exact biomedical use desired for the expanded nanofiber structure/nanofiber mat. Moo provides the motivation for such a combination in teaching that a cell collection means would include either a sponge or a fiber—see paragraph 0020. Based on the disclosure of Moo, one of ordinary skill in the art would have expected that a sponge and a fibrous body would both have an equivalent use as a cell collection device. Certainly, given the uses noted in the Abstract of the primary reference—ie, drug delivery, wound healing and tissue repair—for the electrospun nanofiber structure, it would have been reasonable that such a structure would also be useful for tissue or cell collection when inserted into a body orifice. Indeed, the biomedical applications noted in the primary reference for the nanofiber structure would require that the structure would be able to retain—and distribute—therapeutic agents as needed in the body and a tissue or cell collection device would also require a retention property for bodily tissues, cells or fluids it comes into contact with. The primary reference depicts expanded nanofiber structures with rounded geometry and of cylindrical shape—see Figure 3—as recited in instant claims 2 and 3. It is submitted that the formation of a spherical structure as set forth in instant claim 4 would have been an obvious variant of this dependent on the exact expansion parameters employed. Instant claims 5 and 6 are taught at page 5, section 3.1.1 of the primary reference; see page 6, section 3.1.2 for instant claims 7 and 8. The discussion of Figure 3 at page 21 of the primary reference teaches that the nanofibers are aligned as set forth in instant claim 9. It is submitted that instant claim 10 is taught throughout the primary reference, in particular the title of section 3 at page 5 thereof. The cutting of instant claim 11 is taught at page 7, section 3.1.3 of the primary reference. Section 3.1.2 of the primary reference clearly teaches expanding nanofiber mats made of PCL as recited in instant claim 12. The poloxamer of instant claims 13 and 14 is conventional in the art—Official Notice is hereby taken of this—and such would have been an obvious material selection for the nanofiber mat in the primary reference dependent on the exact properties desired for the mat. As already noted, the primary reference fixes an entire side of the mat and does so thermally—see section 3.1.3 at page 7—as set forth in instant claims 15 and 16. The admitted prior art teaches covering the collection device with gelatin capsule as set forth in instant claims 17, 18, 24 and 25 and such would have been an obvious aspect in the combination as applied. The crosslinking as recited in instant claims 19 and 20 is conventional in the art—Official Notice is hereby taken of this—and such would have been an obvious step in the combination as applied to reinforce and strengthen the collection device as is customary in the art. It is submitted that the string attachment using an adhesive or physical means as recited in instant claims 21 and 22 is conventional in the art—Official Notice is also taken of this—and such would have been an obvious feature in the combination as applied to facilitate the attachment. Finally, attaching the string to the fixed portion as set forth in claim 23 would have been an obvious step in the combination as applied dependent on ease of attachment.
4.The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Xie 2020/0277711 discloses many aspects of the instant invention and/or claims including crosslinking (paragraph 0039) with glutaraldehyde and gelatin coating (paragraph 0028). The article to Keit et al entitled “Expansion of Two-dimension Electrospun Nanofiber Mats Into Three-dimensional Scaffolds” also contains disclosure pertinent to the instant claims.
5.Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATHIEU D VARGOT whose telephone number is (571)272-1211. The examiner can normally be reached on Mon-Fri from 9 to 6.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christina A Johnson, can be reached at telephone number 571 272-1176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATHIEU D VARGOT/Primary Examiner, Art Unit 1742
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