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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election of claims 1-13 in the reply filed on 3/5/26 is acknowledged. Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 3/5/26.
Claim Rejections - 35 USC § 112
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 6 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 6 recites the limitation "the cross-linking of the microneedle scaffold comprises” and fails to further limit the subject matter of claim 1 from which it depends. Claim 1 states that cross-linking of the microneedle scaffold is optional. 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 § 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-5, 7-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Boyden et al (US 2010/0111854, already of record).
For claims 1-5 and 13, Boyden et al teach a method for fabricating a cryomicroneedle, comprising: a microneedle scaffold is made by a process comprising: (A) providing a mold which would have a plurality of voids ([0672]); (B) providing a scaffold precursor solution comprising polyglycolic acid (PGA) and/or polylactic acid (PLA) which would be precursors to a hydrogel ([0337], [0706]); (C) casting the scaffold precursor solution into the mold; (D) filling the plurality of voids with the scaffold precursor; (E) the scaffold precursor solution would be cross-linked to form a scaffold comprising a plurality of pores and it is well-known to cross-link by light exposure, radiation exposure or copolymerization initiation; (G) demoulding the scaffold from the mold to form a microneedle scaffold ([0672]). Though Boyden et al do not teach (F) lyophilizing the scaffold, lyophilizing is well known in the art and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to lyophilize the scaffold in order to preserve its structure. Boyden et al further teach (A) providing a microneedle scaffold comprising a plurality of pores (see above discussion); (B) providing a suspension comprising a biological agent, including a cell ([0312]-[0313]); (C) loading the biological agent into the microneedle scaffold by immersing the microneedle scaffold in the suspension to form a loaded microneedle scaffold ([0675]); and (D) the loaded microneedle scaffold would be frozen to provide the cryomicroneedle.
For claim 7, Boyden et al teach the microneedle scaffold comprises a metal ([0367]).
For claims 8-9, Boyden et al do not explicitly teach the microneedle scaffold has a needle length of from about 25 µm to about 2000 µm; and the microneedle scaffold has a needle base width of from about 10 µm to about 750 µm. However, Boyden et al do teach frozen particle compositions or frozen piercing implements that have at least one major dimension of approximately ten micrometers or less ([0318]) and since the claimed ranges and the prior art ranges overlap or do not overlap but are close enough that one skilled in the art would have expected them to have the same properties, a prima facie case of obviousness exists. Please see MPEP 2144.05 and Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227USPQ 773 (Fed. Cir. 1985) for further details.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Boyden et al (US 2010/0111854, already of record) in view of Zhang et al (US 2019/0037832).
Boyden et al do not teach the suspension further comprises a cryoprotective agent selected from the group consisting of a cell membrane-penetrating cryoprotectant, a non-penetrating cryoprotectant, and a combination thereof; (A) the cell membrane-penetrating cryoprotectant is selected from the group consisting of dimethyl sulfoxide (DMSO), methanol, butanediol, proline glycerol, ethylene glycol, propylene glycol, diethylene glycol, triethylene glycol, glyceryl glucoside, formamide, acetamide, dimethylacetamide, trimethylamine, a cell-penetrating zwitterionic cryoprotectant and a combination thereof; and (B) the non-penetrating cryoprotectant is selected from the group consisting of a non-permeable zwitterionic cryoprotectant, a polymeric cryoprotectant and a combination thereof; or a polymeric cryoprotectant selected from the group consisting of polyethylene glycol (PEG), polyvinyl pyrrolidone, polyvinyl alcohol (PVA), hydroxyethyl starch (HES), methyl cellulose (MC), carboxymethyl cellulose (CMC), dextran, polyproline, hyaluronic acid, alginic acid, carboxylated poly-L-lysine, poly(ampholytes) and a combination thereof; and the zwitterionic cryoprotectant comprises betaine.
However, in a related field of endeavor pertaining to cell cryopreservation, Zhang et al teach the suspension further comprises a cell membrane-penetrating cryoprotectant; (A) the cell membrane-penetrating cryoprotectant is dimethyl sulfoxide (DMSO) or a cell-penetrating zwitterionic cryoprotectant; and the zwitterionic cryoprotectant comprises betaine ([0002] & Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zhang et al with those of Boyden et al by using Zhang et al’s cryoprotectant in order to carry out cell cryopreservation in a non-toxic and efficient manner, resulting in an extremely high post-thaw cell survival rate and without requiring stepwise cryopreservation as suggested by Zhang et al (Abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES SANDERS whose telephone number is (571)270-7007. The examiner can normally be reached on M-F 11-7.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Galen Hauth can be reached on 571-270-5516. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES SANDERS/Primary Examiner, Art Unit 1743
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