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 .
Information Disclosure Statement
The information disclosure statement filed 5/22/23 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. There are numerous Foreign Documents and Non-Patent Literature documents cited on the IDS that do not appear to have been provided in the instant application or in the parent application. These references have been crossed out on the IDS and have not been considered.
Claim Objections
Claims 11-20 are objected to because of the following informalities:
As to claim 11, “skin contact element” in line 9 should be amended to “a skin contact element” for proper introduction.
As to claim 12, “wherein the protrusion configured” should be amended to “wherein the protrusion is configured” for grammar.
Claims 12-20 are objected to as they depend from an objected-to claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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(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.
Claims 1-20 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.
As to claim 1, the wording of “a pump having a pump case with a lower surface configured to contact the periphery of the flexible adhesive patch and a bump configured to extend through the opening” is unclear as to whether the bump is specifically being claimed as part of the pump case/lower surface or as a separate element of the pump. The examiner will assume the bump is intended to be claimed as part of the pump case.
Claim 5 recites the limitation "the patch pump" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the patch pump" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the controller" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the controller" in line 2. There is insufficient antecedent basis for this limitation in the claim.
As to claim 11, the wording of “the pump having a pump case including a lower surface configured to adhere to the periphery of the adhesive patch and a protrusion that extends through the opening” is unclear as to whether the protrusion is specifically being claimed as part of the pump case/lower surface or as a separate element of the pump. The examiner will assume that the protrusion is intended to be claimed as part of the pump case.
Claim 12 recites the limitation "the photoplethysmographic module" in line 2. There is insufficient antecedent basis for this limitation in the claim (note this is not necessarily the same thing as the plethysmographic module of claim 11).
Claims 13-14 are rejected as they depend from rejected claim 12.
Claim 18 recites the limitation "the photoplethysmographic module" in line 2. There is insufficient antecedent basis for this limitation in the claim (note this is not necessarily the same thing as the plethysmographic module of claim 11).
Claims 2-10 and 12-20 are rejected as they depend from at least one rejected claim.
Allowable Subject Matter
Claims 1-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 1, the closest prior art appears to be Newberry et al. (US 2017/0014572 A1, hereafter “Newberry”). Newberry discloses:
A medication infusion device comprising:
a flexible adhesive patch (700) configured to be removably attached to a wearer's skin (see para 0006-0008, 0032, 0065), the flexible adhesive patch having a periphery that defines an opening (706);
a pump (100) having a pump case (not numbered but depicted surrounding internal components in at least Figs. 1A-1B and 7A) with a lower surface configured to contact the periphery of the flexible adhesive patch (Fig. 7A), the pump case configured to be coupled to the flexible adhesive patch to transcutaneously deliver doses of medication from a cartridge (102) disposed within the pump case to the wearer (Fig. 2, para 0033); and
a photoplethysmographic module (110; see para 0035), the photoplethysmographic module having an LED (1120), and a detector (1130a).
Newberry is silent to a bump configured to extend through the opening, and thus the photoplethysmographic module being disposed within the bump, the photoplethysmographic module including at a skin contact element including at least one transparent window, wherein the LED emits light to and the detector receives reflected light from, the wearer's skin through the at least one transparent window, Newberry is silent to the pump case being configured to be removably coupled to the flexible adhesive patch, and Newberry is silent to the cartridge being a replaceable single-use cartridge. No reference was found that would have made it obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Newberry to satisfy all the limitations of claim 1.
The examiner acknowledges the International Preliminary Report on Patentability for corresponding PCT/IB2021/060766, but disagrees with the assessment of Wang et al. (US 2020/101219 A1, hereafter “Wang”). The mapping of Wang interprets the claim 1 “lower surface” by citing “Figure 5, Items 55”. However, Wang describes 55 as a “temperature sensing module 55”. The mapping of Wang also fails to cite any feature(s) of Wang as the pump, the pump case, the replaceable single-use cartridge, or the bump as required by the claim. The examiner also disagrees with the International Preliminary Report on Patentability regarding Newberry for the reasons cited above.
Claims 2-10 depend from claim 1.
Claim 11 recites limitations that are largely similar to claim 1, and is thus considered allowable for the same reasons noted above.
Claims 12-20 depend from claim 11.
Conclusion
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/James D Ponton/Primary Examiner, Art Unit 3783