DETAILED ACTION
Claims 1-10 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 .
Priority
The instant application claims priority to CN202317763659.8, filed 12/20/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
No Information Disclosure Statement has been filed in the instant application. Applicants are reminded of their duty to disclose all information known to them to be material to patentability as defined in 37 C.F.R. 1.56.
Specification
The disclosure is objected to because of the following informalities: The instant specification uses replacement opening 61 in description of the drawings [50], however the drawings do not contain a reference to “61”.
Appropriate correction is required.
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.
Claims 1-10 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.
Regarding claim 1, the limitation of “a fixation layer, a heating layer and a drug layer that are arranged in sequence” has unclear metes and bounds as it is unclear if the layer must be applied fixation layer attached to heating layer attached to the drug layer or if the sequence just means distinct layer that are attached to each other in a desired fashion, thus leading to unclear metes and bounds. For examination purposed either interpretation will be deemed to meet the instant claim limitations.
Regarding claim 1, the term “close to” in claim 1 is a relative term which renders the claim indefinite. The term “close to” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 2, the limitation of “has a shape of any or a combination of…” contains improper transitional phrase making the metes and bounds of the instant claim unclear as to whether the shape is comprising or consisting of those specifically named or includes any shape. Dependent claims 3-10 are also rejected as not resolving the ambiguity.
Regarding claim 3, the limitation of “cavity made of any of…” contains improper transitional phrase making the metes and bounds of the instant claim unclear as to whether the shape is comprising or consisting of those specifically named. It is unclear if the limitations is directed to those specifically named material or include any materials.
Regarding claim 3, the limitation of “engineering plastics” has unclear metes and bounds as the scope encompassed by “engineering” does not have a clear meaning in the art and there is no definition of examples provided in the instant specification.
Regarding claim 5, the limitation of “drug cavity is any or a combination of..” contains improper transitional phrase making the metes and bounds of the instant claim unclear as to whether the shape is comprising or consisting of those specifically named. It is unclear if the drug cavity is limited to those named or any drug cavity.
Regarding claim 5, the limitation of “far away” in claim 5 is a relative term which renders the claim indefinite. The term “far away” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 5, the limitation of “blind hole” has unclear metes and bounds as the term “blind hole” is not a known term in the art and the instant specification does not provide any definition or clarification as to what a “blind hole” encompasses.
Regarding claim 7, the limitation of “replacement opening” has unclear metes and bounds as the term “replacement openings” is not a known term in the art and the instant specification does not provide any definition or clarification as to what “replacement openings” encompasses. Are the openings covered and the covering removed? Is the fixation layer replaced? Are openings reformed after heating?
Regarding claim 8, the limitation of “far away” in claim 8 is a relative term which renders the claim indefinite. The term “far away” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 8, the limitation of “insulation layer is arranged on a side, far away from the drug layer, of the fixation layer” is confusing. The use of multiple commas and phrasing structure makes it unclear the relationship between the elements, how they are structurally connected.
Regarding claim 8, the limitation of “fixes the free end of the insulation layer near the fixed end” is unclear as it contains a relative term “near” which is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Additionally, it is unclear what “the fixed end” is referring to, the fixation member, the insulation layer, something else that is fixed.
Regarding claim 9, the limitation of “adhesive coating and a release liner are sequentially arranged on a side, facing the drug layer, of the fixation layer” is confusing. The use of multiple commas and phrasing structure makes it unclear the relationship between the elements, how they are structurally connected.
Claims 4, 6 and 10 are rejected due to their dependency on rejected claims 3, 7 and 9.
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) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0004066 as evidenced by Sondalini (Sondalini, Mike, et al., Polyethylene: Its Properties and Uses, pgs. 1-10, 2017).
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 int eh 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 claim 2, the limitation of wherein 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).
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]. Sondalini teaches polyethene is an engineering plastic (page 1, first paragraph).
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”.
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], meeting the limitation of any drug cavity, see 112(b) above.
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”.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0004066 as evidenced by Sondalini 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.
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 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 216628897as evidenced by Sondalini as applied to claims 1-6 above, and further in view of US 2010/0241089.
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) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0004066, CN 216628897 and US 2010/0241089 as evidenced by Sondalini as applied to claims 1-7 above, and further in view of US 2015/0045763.
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]).
Regarding claim 10, the limitation of wherein one heat collection cavities is provided with the heat collection cavity located in a middle of the heating layer of the heat patch is met by the ‘066 publication teaching a single heating element in the center of the heating layer (Figure 8).
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 I know to fully coat the skin contacting surface of heatable transdermal device.
Conclusion
No claims are allowed.
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.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613