DETAILED ACTION
Claims 1 and 3-10 are currently pending and under examination.
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 .
Drawings
The drawings were received on 04/22/2026. These drawings are entered.
Withdrawn Rejections
The objection to the specification is withdrawn as a result of Applicant providing amendments to the drawing to denote reference character 61.
The prior rejection of Claims 1-10 under 112(b) is withdrawn based on Applicant’s claim amendment to clear up the ambiguity of the claims.
Examiner’s Note
Applicant's amendments and arguments filed 04/22/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 04/22/2026, it is noted that claims 1, 3, 5, 7-10 are amended.
New Rejections/Objection:
The following rejections are newly applied based on Applicant’s claim amendments.
Claim Objections
Claims 7 is objected to because of the following informalities: Claim 7 contains “is any of…” wherein proper transitional phrase language should be used, such as “selected from the group consisting of”. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – New Matter
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3 contains the newly added limitation “polyethylene, polyamide”. Support can be found in the instant specification engineering plastic, however the instant specification does not contain any recitation of what falls into engineering plastics nor does it contain polyethylene or polyamide in the instant specification.
Alternatively, if Applicant believes that support for claim 3, drawn to “wherein the heat collection cavity is made of material selected from the group consisting of … polyethylene, polyamide..', is present and clearly envisaged in the instant application or earlier filed priority documents, applicant must, in responding to this Office Action, point out with particularity, where such support may be found.
Applicant does not indicate where these limitations are supported by the original specification, or how, as is Applicant's burden. See MPEP §714.02, last sentence of the third paragraph from the end and MPEP §2163.06 (I) last sentence.
Claim Rejections - 35 USC § 112 (b)
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.
Claim 9 is 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.
Claim 9 contains the limitation “adhesive coating and release liner are sequentially arranged on a side of the fixation layer that faces the drug layer”. It is unclear how the fixation layer may be coated on the side of the drug layer, as the drug layer would be intervening. It is unclear how the release liner can be sequentially applied to the fixation layer, wherein a heating layer and a drug layer would be intervening layers.
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, 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0004066 (previously applied) in view of EP 1269947.
Regarding claim 1, the limitation of a heat patch capable of targeted drug delivery based on a Monroe effect, comprising: a fixation layer, a heating layer and a drug layer that are arranged in sequence is met by the ‘066 publication teaching a pouch, heating element, drug patch and skin adhesive layered sequentially (Figure 8). The limitation of wherein a heating assembly is arranged in the heating layer, a heat collection cavity that is provided with an opening facing the drug layer is provided in a side, close to the drug layer, in the heating layer and a drug is contained at a portion corresponding to the opening of the heat collection cavity in the drug layer is met by the ‘066 publication teaching a heating element secured to the dermal drug delivery patch and a freely transferable enhancing element is placed within the heating element compartment (abstract, Figure 8). The heating element is defined by air impermeable walls comprising iron powder, wherein the top way has a plurality of holes therethrough [0034]. The heating element top to the drug patch [0066]. The claimed structure is taught and therefore would be capable of delivery based on the Monroe effect absent factual evidence to the contrary.
Regarding the limitation of wherein the heat collection cavity comprising a concave recess configured to collect and converge heat into a concentrated heat flow, the heat collection cavity has a shape of any or a combination of semicircle, cone and semi-elliptic shape is met by the ‘066 publication teaching a semi-circle shape (Figure 3, Figure 8) wherein any variety of different shape, such as but not limited to square, rectangular, circular, oval, triangle and those shown in figures 1-20 may be used. The heating element is taught to occupy only part of the hating layer (figure 8) and my have any shape such as semicircle (Figure 3) and thus would meet the structure of concave recess and semi-circular shape and thus would necessarily collect and converge heat, absent factual evidence to the contrary.
Regarding claim 3, the limitation of wherein the heat collection cavity is made of any of stainless steel, high-carbon steel, engineering plastics, memory alloys and non-woven fiber elastic cotton is met by the ‘066 publication teaching the heat generating membrane is formed from polyethylene film [0065].
Regarding claim 4, the limitation of wherein the ratio between a height h and a diameter d of the heat collection cavity is from 0.3-1 and the diameter is d less than or equal to 10cm is met by the ‘066 publication teaching heating element has a thickness of 1/8 inch with an outer dimension of 2.25 inches by 4 inches [0065] which leads to a thickness of 0.3175 cm, outer dimension of 5.715 cm by 10.16 cm. Any number of shapes and sizes are taught for the heating element ([0026], [0069], Fig 1-20). As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
The ‘066 publication does not specifically teach the sequence in order of fixation layer, heating layer and the drug layer (claim 1).
The ‘947 publication teaches an adhesive bandage comprising a backing material, an adhesive and a wound contacting pad that has improved comfort and improved resistance to unraveling when the body part to which it is adhered is flexed (abstract). A variety of adhesive bandage designs and shapes are commercially available to attend to different patient needs [0002]. The bandage comprises a backing material, an adhesive and a wound contacting pad [0005]. A portion of the adhesive serves to secure the pad to backing material and a portion of the adhesive is used to secure the bandage to the skin during use using any convention adhesives [0009].
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example, a transdermal drug delivery with a heating element compartment containing pores and drug layer) from within the prior art disclosure of the ‘066 publication, to arrive at the instantly claimed transdermal drug delivery “yielding no more than one would have expected from such an arrangement”.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to extend the adhesive across the heating element as the ‘066 publication teaches an adhesive at the sides walls (Figure 20) and the ‘947 publication teaches an adhesive to be used across the device to adhere a backing layer and to further attach the device to the skin, thus rending it obvious to use an adhesive across the full backing of the device to adhere to the skin as the ‘066 publication teaches a transdermal device using an adhesive to adhere to the skin and the ‘947 publication teaches an adhesive layer to adhere to the skin with improved comfort.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0004066 as applied to claims 1-5 above, and further in view of CN 216628897.
As mentioned in the above 103 rejection, all of the limitations of claims 1-5 are taught by the ‘066 publication.
Regarding claim 5, the limitation of wherein the drug layer is provided with a drug cavity that is configured to contain the drug corresponding to the heat collection cavity, the drug cavity is blind hole, the drug cavity is located in side, far away from the heating layer, of the drug layer, and the drug contained in the drug cavity is any or a combination of drug powder, a pill, ointment and a drug liquid is met by the ‘066 publication teaching a heating patch layer attached to a transdermal drug patch (reservoir or matrix) (Fig 2). The heating pouch contains the heating element and defined at least one opening to active the heating element [0066] wherein the active agent is any number of drugs in a transdermal drug patch [0067],
The ‘066 publication does not specifically teach the drug cavity is a hole that does not extend entirely through the drug layer, the drug cavity is selected from a group which includes a pill (claim 5).
The ‘066 publication does not specifically teach wherein a heat dissipation hole is provided between the drug cavity and the heat collection cavity (claim 6).
The ‘897 publication teaches a heating navel patch structure (title). The device contains a heating assembly having an upper surface cotton cloth layer, an aerogel, the lower end of heating assembly extends through the cotton cloth layer to the interior of the medicine bag and the heating assembly is located inside the aerogel. A pill is taught in the medicine bag (page 1, second to last paragraph). A carbon fiber strip is taught as a condition strip (page 1, last paragraph, Figure 4, page 2, last paragraph). A pill is taught in the medicine bag (page 1, second paragraph). The heating layer is taught to comprise an iron powder (page 2, second paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have a heat dissipation hole between the drug cavity and the heat collection cavity, wherein the drug cavity includes a pill as the ‘897 publication teaches that is known to provide a heat conducting step between a heating assembly a drug layer and the ‘066 publication teaches direct contact between a heating layer and a drug releasing layer wherein heating achieves steady state release of the active agent. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention that the heating element in contact with the drug layer and improve the effect of heat generated as taught by the ‘897 publication for the heated drug releasing device taught by the ‘066 publication.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0004066 and CN 216628897 as applied to claims 1-6 above, and further in view of US 2010/0241089 (previously applied).
As mentioned in the above 103 rejection, all of the limitations of claims 1-6 are taught by the ‘066 publication.
Regarding claim 7, the limitation of wherein the heating layer comprises a heating sleeve located peripherally and the heating assembly located inside, the heating assembly is iron powder heating bag, and the heating sleeve and the fixation layer are provided with replacement openings is met by the ‘066 publication teaching a pouch, an insulating layer, a heating disk element and a drug patch (figure 8, Figure 13) wherein the heating element is snuggly disposed in the heating element compartment area of restrain and sealed and secured to a drug patch [0022]. When the heating element stops generating heat, the device is deactivated and the couch opens or is more readily opened along that portion [009] and the heating element may be intentionally dislodged from the drug patch [0030]. Iron powder is taught to be a heating element [0034], wherein holes may be selectively covered or uncovered during the duration of administration [0034].
The combination of references does not specifically teach powder vermiculite heating bag (claim 7).
The ‘089 publication teaches a skin patch which includes a heating layer and a medicated patch. The warmer was taught to include exothermic agents as a powder mixture of iron powder, water, vermiculite, active carbon, salts and the like mixed together.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to include vermiculite in the heating element taught by the ‘066 publication as the ‘066 publication teaches the combination of activated carbon, iron powder, sodium chloride and water [0034] and the ‘089 publication teaches activated carbon, iron powder salts and water and additionally comprising vermiculite in the heating element. One of ordinary skill in the art would be motivated to use the ‘089 publication warming mixture of that in the ’066 publication as the ‘089 publication and the ‘066 publication are both directed to warming elements for drug delivery skin contacting device containing overlapping elements with the desire for heating. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0004066, CN 216628897 and US 2010/0241089 as applied to claims 1-7 above, and further in view of US 2015/0045763 (previously applied).
As mentioned in the above 103 rejection, all of the limitations of claims 1-6 are taught by the ‘066 publication.
Regarding claim 8, the limitation of wherein the heating assembly is iron powder vermiculite heating bag, an insulation layer is arranged on a side far away from the drug layer is met by ‘066 publication teaching an iron powder heating bag, and insulation layer arranged far away from the drug layer (Fig 8, [0034]).
The combination of references does not specifically teach the insulation layer arranged far away from the drug layer of the fixation layer, the insulation layer comprising a fixed end connected to the fixation layer and a windable free end and the fixation layer is provided with a fixation membrane that is detachably fixes the free end of the insulation layer near the fixed end.
The ’763 publication teaches a warming patch (abstract). The warming patch can comprise a removable protective cover that prevents activation of the active agent until the removable protective cover is removed. The removable protective cover can comprise an adhesive release liner, a sealed layer. The removable protective cover can be removable adhered to the non-electric warming patch by a releasable pressure sensitive adhesive ([0016], [0024]). The protective cover can be reapplied to adhesive bead to seal off warm member once adequate temperature of the solution is reached [0028]. Figure 2 demonstrates a removable protective layer (62) and adhesive layer 64 ([0031]-[0032]). The removable protective layer reads on windable insulation layer and release liner as the instant specification provides no definitions and the protective layer is taught as removable by peeling [0030].
It would have been obvious to one of ordinary skill in the art to use an adhesive layer fully covering the skin contacting surface wherein the adhesive layer is covered by a removable protective layer (insulation layer) because the ‘066 publication is directed to a heatable skin contacting device applied by adhesive and the ‘763 publication teaches an adhesive layer covered by a protective layer is know to fully coat the skin contacting surface of heatable transdermal device.
Allowable Subject Matter
Claim 10 is 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. The ‘066 publication, the ‘897 publication, the ‘089 publication and the ‘763 publication do not teach the use of at least two heat collection cavities.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103:
Applicant argues the ‘066 publication (Stanley) does not teach or suggest a heat collection cavity “comprises a concave recess configured to collect and converge heat into a concentrated heat flow” as recited in claim 1. The heating element is rectangular chamber. This heating element is flat, rectangular structure, not a concave recess configured to collect and converge heat into concentrate heat flow. The holes are taught to be upward away from the drug patch for oxygen entry to active the exothermic reaction not downward toward the drug layer to convert heat. It does not have a semicircle, cone, or a semi-elliptic shape as recited in amended claim 1.
In response, the ‘066 publication teaches a semicircular cavity for heat collection wherein the heating element may be any variety of different shape such as, but not limited to, square, rectangular, circular, oval, triangle as shown in figured 1-20 (Figure 3, [0067]) wherein the heat is taught to controlled on the patients skin and drug patch to result in an increased absorption rate that allows the patient to obtain a steady concentration in the systemic circulation more quickly than a patient without the heating element [0063]. The ‘066 publication teaching a semi-circle shape (Figure 3, Figure 8) wherein any variety of different shape, such as but not limited to square, rectangular, circular, oval, triangle and those shown in figures 1-20 may be used. The heating element is taught to occupy only part of the hating layer (figure 8) and my have any shape such as semicircle (Figure 3) and thus would meet the structure of concave recess and semi-circular shape and thus would necessarily collect and converge heat, absent factual evidence to the contrary.
Applicant argues the other cited references fail to cure the deficiency of the ‘066 publication.
In response, Applicant’s arguments regarding the ‘066 publication are addressed above as first presented.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
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