DETAILED ACTION
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 .
Shift of Invention
The general policy of the USPTO is that applicants are not permitted to shift to claim another invention after an election is made and an Office Action on the merits is made on the elected invention (MPEP 819).
Newly amended claim 13 is now directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the claim is now directed to a completely different statutory category of invention: an apparatus. Initially, the claim was directed to pharmaceutical composition. After inventor’s latest amendment, however, the claim is now directed to an microneedle array (i.e. an apparatus).
New independent claim 24 is a different and distinct method claim because it does not drawn to the antitumor formulation of the previously pending claims. In all appearance it is, in fact, a broader claim than the previously pending method claims.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 13 and 24 are withdrawn from consideration as being directed to non-elected inventions. See 37 CFR 1.142(b) and MPEP § 821.03.
Claim Objections Withdrawn
The objection to claim 7, as being dependent upon a rejected base claim but otherwise allowable, has been overcome by inventor’s amendment. The amendment rewrites the claim as an independent claim.
Claim Objections, NEW
Claim 2 is objected to because of the following informalities: for grammatical reasons, the phrase “…one or more chemotherapeutic agent is incorporated…” should properly be: …one or more chemotherapeutic agents are incorporated….
Appropriate correction is required.
Inventor’s assistance is respectfully requested in correcting any other minor grammatical and/or spelling errors which may be present in the claim set.
112(a) Rejections Withdrawn
The rejection of claims 14-20 under 35 USC 112(a) or 35 USC 112 (pre-AIA ), first paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. With respect to claim 20, the amendment cancels the claim. With respect to the remaining claims, the amendment narrows the scope of the claimed subject matter such that it is now enabled.
112(b) Rejections Withdrawn
The rejection of claim 8 under 35 USC 112(b) or 35 USC (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate.
The rejection of claim 9 under 35 USC 112(b) or 35 USC (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate.
The rejection of claim 10 under 35 USC 112(b) or 35 USC (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
The rejection of claim 11 under 35 USC 112(b) or 35 USC (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
The rejection of claim 14 under 35 USC 112(b) or 35 USC (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate.
The rejection of claim 16 under 35 USC 112(b) or 35 USC (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate.
The rejection of claims 12, 15 and 17-20 under 35 USC 112(b) or 35 USC (pre-AIA ), second paragraph, outlined in the previous Office Action (indefinite from indefinite), has been overcome by inventor’s amendment. With respect to claims 12 and 20, the amendment cancels the claims. With respect to the remaining claims, the rejection is moot.
112(d) Rejections Withdrawn
The rejection of claim 13 under 35 USC 112(d) or 35 USC (pre-AIA ), fourth paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment rewrites the claim in proper dependent form. (But, as noted above, the claim is now drawn to non-elected subject matter and has been withdrawn from consideration.)
Claim Rejections - 35 USC § 112(d), NEW
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 24 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth 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. In the present instance, the claim fails to further limit the subject matter of the claim upon which it depends (claim 14).
The pertinent limitations of claim 24 are: (a) a primary or metastatic skin tumor or (b) a primary or metastatic tumor (“…collection of cancer cells…”) anywhere else in the patient (“…that is accessed within an organ or tissue other than skin…”). That is, the limitations of claim 14 distill to simply: any and all primary or metastatic tumors. And that being the case, the claim does not further limit the claim upon which it depends (“…a cancer that forms collections of cells suitable for targeting…”).
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
102 Rejections Withdrawn
The rejection of claims 4, 10 and 11 under 35 USC 102(a)(1) over ACS Applied Materials & Interfaces (2016), 8, pp. 12609-12619, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claims.
The rejection of claims 1-6, 9-11, 14-16 and 19 under 35 USC 102(a)(1) over Journal of Controlled Release (2015), 216, pp. 9-17, outlined in the previous Office Action, has been overcome by inventor’s amendment and arguments. With respect to claims 4, 10 and 11, the amendment cancels the claims. With respect to the remaining claims, inventor’s arguments have been carefully considered and are persuasive.
Claim Rejections - 35 USC § 102, MAINTAINED and NEW
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.
Claims 1-3, 5, 6, 9, 14-16, 19, and now expanded to include new claim 24, are or remain rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by ACS Applied Materials & Interfaces (2016), 8, pp. 12609-12619, cited in the IDS. Inventor’s arguments have been carefully considered but are not persuasive.
As stated in the previous Office Action, the reference teaches an anti-tumor chemotherapeutic coformulation comprising bioadhesive nanocomplexes with a polymer core and containing hyperbranched polyglycerol having incorporated therein a chemotherapeutic agent (docetaxel) and one or more immunostimulant (MMP-9 siRNA) (abstract; page 12612, Figure 1). The examiner notes that the nanocomplexes may be considered as intrinsically bioadhesive nanocomplexes because their outer surface will be positively charged (note figure in abstract) at physiological pH and will thus be able to electrostatically bind to cell surfaces (which are generally negatively charged). The nanocomposite’s core is a hyperbranched polyglycerol derivative (HPG-18) to which a dendritic poly(L-lysine) (PLLD) has been grafted (abstract; page 12612, Figure 1).
The chemotherapeutic agent, the taxane docetaxel, is encapsulated in the core and the MMP-9 siRNA is electrostatically attached to the PLLD surface layer (page 12613. Column 2, 3.2. Docetaxel Loading and MMP-9 Binding).
The nanocomplexes are utilized in a method of treating cancer (breast) in both in vitro and in vivo (xenografted mice injected every day, tail vein, sacrificed at 21 days) studies (abstract; page 12611, column 2, 2.9. In Vivo Assay, 2.10. Biocompatibility; page 12615, column 1, 3.4. In Vitro and in Vivo Therapy).
Claim 14 is included in this rejection because the tumors “…suitable for [emphasis added] targeting with local delivery…”. That is, it is not required that they are so targeted.
Inventor argues that the siRNA of the reference is not an immunostimulant. The examiner respectfully disagrees.
As inventor correctly points out, the siRNA of the reference is utilized to decrease the expression of MMP-9. However, it is well-known in the art that MMP-9 inhibition can promote anti-tumor immunity (as evidenced by, for instance PLOS ONE (2018), 13(11): e0207255 (21 pages)). That is, the siRNA of the cited art’s formulation is acting – functionally – as an immunostimulant. And that being the case, inventor’s argument distills, essentially, to one of semantics. But no matter what label is used to describe the siRNA of the cited art, either by the art itself or counselor’s interpretation of that art, the siRNA is, in fact, acting as an immunostimulant – and so may be appropriately treated as such in a rejection. Note, that during patent examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification. (See MPEP 2111.)
Allowable Subject Matter
Claim 7 is allowed. Claims 8, 17, 18 and 21-23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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 BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 4/13/2026
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