DETAILED ACTION
Formal Matters
Claims 13-21 are cancelled. Claims 1-12 are pending and under examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a divisional application of 16/864,938 filed on 5/1/2020, which claims priority from US provisional application 62/920,487 filed on 5/2/2019.
Information Disclosure Statements
The information disclosure statements (IDS) filed on 5/14/2024 have been considered by the examiner.
Claim Rejections - 35 USC § 112(a) – Scope of Enablement
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.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for aluminum and water, and aluminum and Ca(OH)2 in water as combinations of dry chemical and liquid activator that can form H2 (hydrogen) (see paragraph 125 of applicant specification, other dry agents are found in paragraph 72 such as magnesium, zinc, and liquid activator of aqueous composition), does not reasonably provide enablement for all dry chemical and liquid activator combinations to perform this function. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to produce the invention commensurate in scope with these claims. The claims provide that contact of the dry chemical with the liquid activator generates hydrogen (H2), however, the claims do not provide what the dry chemical and the liquid activator are while the specification provides specific agents capable of this function in their system.
Testbook (Testbook.com, The metal that does not give Hydrogen on treatment with dilute HCl, downloaded June 2026, https://testbook.com/question-answer/the-metal-that-does-not-give-hydrogen-on-treatment--60705d5ee2dfa721ff194b52) teaches that copper, silver, gold and platinum will not react with dilute acid to displace hydrogen. Thus, not all dry ingredient/liquid combinations are capable of this result that the claim necessitates (generation of hydrogen).
The specification does provide some examples of making molecular hydrogen with particular dry ingredients (see examples and ingredients mentioned in paragraph 72 of specification). However, it does not provide the enablement to use items with copper, silver, gold or platinum for this reaction.
One of skill in the art would be a chemist/inorganic chemist.
Since the art recognizes that not all components are capable of generating molecular hydrogen and provides more particular compounds/substances, one of skill in the art would have to conduct undue experimentation to make items and combinations that would not normally be seen to work into forms that would be capable of generating hydrogen. This would mean trying numerous dry ingredients with numerous liquids to find which will generate hydrogen in amounts able to facilitate delivery of a therapeutic agent through the skin.
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 1-12 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.
Claim 1 recites the limitation “the liquid activator received by the first portion causes the at least one dry chemical to generate molecular hydrogen such that generated molecular hydrogen is released…”, however, the claim does not provide what the dry chemical and liquid activator are in a manner that would allow them to be able to generate molecular hydrogen. Thus, it is unclear what dry chemicals and liquid activators capable of this function would be covered by applicant’s claims. For the purpose of compact prosecution, if the prior art teaches dry agent and liquid activator species found in applicant’s specification in such a system, or if the prior art teaches a combination of its own dry and liquid agents capable of producing molecular hydrogen, then those will read on applicant’s claims. Applicant may amend claim 1 to include species of dry chemical(s) and liquid activator that are provided by applicant’s specification/examples and able to generate molecular hydrogen when combined.
Claims 2-12 are rejected as being dependent on an indefinite claim.
Claims 8 and 9 are indefinite for the recitation of “its” when these claims are indirectly dependent on claim 1, which has the entire system and also a first and second portion among other items. Thus, “its” may not necessarily be referring to the third portion, but may possibly refer to any portion, ingredient or the entire system. Applicant may consider amending the claims to delete “its” and instead provide for “change the configuration of the third portion…”.
Claim Rejections - 35 USC § 103
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Joshi US 20090326447.
Joshi teaches a transdermal delivery apparatus that has a first and second chemical reactant(s) that are compatible with skin (abstract and paragraphs 2 and 20; patch has permeable membrane to apply beneficial agent to skin). Joshi teaches the first chemical reactant includes one or more metals and the second may include water (abstract). Joshi notes that the first and second chemical reactants generate hydrogen (abstract). Joshi teaches aluminum (claim 3 of Joshi). Joshi teaches beneficial agents like antibiotics and anti-infectants (agents that are antibacterial/antimicrobial) (claim 8 of Joshi). Joshi teaches calcium hydroxide (paragraphs 42, 51 and 59). Joshi teaches separating the chemical reactants from the benefit agents (paragraph 54). Joshi teaches a compartment with the metal and a compartment with the moisture (paragraphs 57 and 58). Joshi teaches a second beneficial agent that is applied to the skin (contacts skin) (paragraphs 10 and 15). Paragraph 25 teaches water stored in patch. Joshi teaches generating multiple beneficial agents (paragraph 26). Joshi teaches a permeable or semipermeable material in the housing to allow water to penetrate to contact the chemical reactants (paragraph 39). Joshi teaches “before, during or after the product is activated, it can be applied to skin (paragraph 60). Joshi teaches a patch with an adhesive (paragraphs 56, 57, 60 and 61). Joshi teaches beneficial agents in a substance that is in direct contact with skin and the hydrogen and beneficial agent diffusing through skin (paragraph 45). Figure 8 provides for patch storing water to activate the patch (paragraph 25). Joshi teaches “In other embodiments, as will be explained in association with FIG. 8, the water may be contained within the patch 10 but may be isolated from other chemical reactants until the patch 10 is ready for use.” (paragraph 39). Paragraph 48 teaches “For example, the heat- and hydrogen-producing chemical reactants 14 a may be placed adjacent to beneficial agents 14 b. This may place more of the beneficial agents adjacent to the skin.” Thus, if the beneficial agents are adjacent to the chemical reactants, they will be separated, but next to each other. Joshi teaches “Referring to FIG. 3, in other embodiments, a membrane 30 such as a semi-permeable membrane or selectively permeable membrane may be used to enable diffusion of selected chemicals or beneficial agents through the membrane 30 for absorption by the skin” and keeps reactants in the patch (paragraph 49). Thus, Joshi via membrane 30 in figure 3 allows for selectively permeable membranes to allow diffusion of selected chemicals or beneficial agents. Joshi teaches “In other embodiments, water may also be retained within the patch 10” (paragraph 49). Joshi teaches “The membrane 30 may be selected such that the rate of diffusion depends on one or more of pressure, concentration, temperature, or the type of molecules or solutes on either side of the membrane 30.” (paragraph 49). Joshi teaches “In selected embodiments, a puncture mechanism, such as one or more spikes 84 may be provided to puncture the membrane 82 upon applying pressure to an upper surface of the housing 12.” (paragraph 56). This would be a change in configuration with pressure.
One of ordinary skill in the art at the time of instant filing would have incorporated the reagents of Joshi into the composition and forms taught by Joshi to provide formulations where hydrogen production can be initiated by water that would also have drugs like antiinfective or antibiotic agents (agents that have antibacterial activity) for contact with the skin while keeping the reactants and water within the patch/system. Joshi provides for embodiments which may have structural features and abilities of applicant’s claims in being able to delivery hydrogen and beneficial agent transdermally. This would motivate one of ordinary skill in the art to place the drug on the device where it would first contact the skin before hydrogen is released to the skin. Joshi also allows for product embodiments with adhesives that contact skin and allows for its beneficial agents to contact skin.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tsaur US 20200281866 (earliest effective filing date of 3/5/2019) – Tsaur does not teach a second portion with therapeutic agent that would be allowed to penetrate the skin. As the material of Tsaur allows the moisture to enter, it would also be considered permeable to the liquid activator.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached on M-F 9:00 am to 6:00 pm EST.
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 on (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK V STEVENS/
Examiner, Art Unit 1613
Prosecution Insights