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 (IDS) submitted on 06/03/2025, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
This Application filed on 12/29/2023, claims to priority to U.S. Provisional Application No. 63/438,286, filed on 01/11/2023.
Status of the Claims
Claims 1-20 are pending.
Objections To Specification
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are:
¶s 45, 47 and 49, recite titles (e.g., User in ¶ 45), without any statement or discussion relating to the recited titles.
¶s 46, 48, 50, 51 appear to be inserting numbers in between statements (e.g., patient 12 or a medical professional 14 in ¶ 46 and method 10 may also include communication 16 in ¶ 48), which doesn’t make any sense.
It is recommended that Applicant review the entire specification to ensure that it is written in full, clear, concise and exact terms. Appropriate correction is required.
Claim Objections
Claim 11 is objected to under 37 CFR 1.71(a), for twice reciting “wherein incrementally increasing the dose of lysine occurs over the duration of time with lower dosage applications during early dosage periods”. Appropriate correction is required.
Applicant is advised that should claim 10 be found allowable, claim 11 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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 2-11 and 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 per MPEP 2173.02, “[d]uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude. See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc).”
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
Claim 2 recites “inactive compounds which help stabilize the dose of lysine” and “inactive compounds which aid in absorption the dose of lysine”. However, one skilled in the art would not be reasonably apprised of the meets and bounds of the composition that the Applicant is claiming.
This is because the scope of “inactive compounds which help stabilize the dose of lysine” or “inactive compounds which aid in absorption the dose of lysine”, is not defined by the claims or the instant specification. There is no description as to the pharmaceutical approach that makes these results possible (i.e., what cause “inactive compounds which help stabilize the dose of lysine” and “inactive compounds which aid in absorption the dose of lysine”), nor does Applicant teach any inactive compounds or chemical approaches to avoid. The specification does not provide a standard for ascertaining the requisite degree. Thus, one of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims. Accordingly, without guidelines in the specification for how to determine “inactive compounds which help stabilize the dose of lysine” or “inactive compounds which aid in absorption the dose of lysine”, within the limits of a composition of claim 1, a person skilled in the art cannot reasonably determine the meets and bounds of the recited limitations in the claims.
For the purpose of examination, a lysine tablet disclosed in the prior art is included in the interpretation of “inactive compounds which help stabilize the dose of lysine” or “inactive compounds which aid in absorption the dose of lysine”.
It is recommended that Applicant either amend claim 24 to recite specific composition(s) that perform(s) the recited function of “inactive compounds which help stabilize the dose of lysine” or “inactive compounds which aid in absorption the dose of lysine” or delete these limitations, in order to overcome the rejection. Appropriate correction is required.
Each of claims 2-9 recites: i) “a tablet” (claims 2, 6-9) and ii) “a skin patch” (claim 3). There is insufficient antecedent basis for each of these limitations in the claims. Claims 2-9 lack antecedent basis because claim 1 from which claims 2-9 depend fails to recite a tablet or a skin patch. Claim 1 recites “injecting”, which is via a needle (see ¶ 46 of the specification).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, each of claims 10-11 recites the broad recitation “a dose of lysine is incrementally increased”, and the claims also recite “wherein incrementally increasing the dose of lysine occurs over a duration of time with lower dosage amounts during early dosage period”, which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Appropriate correction is required.
Claim 20 recites “wherein injecting a dose of lysine refers to introducing and/or causing lysine to absorb into the system of a user”, however, a person skilled in the art would not be reasonably apprised of the meets and bounds of this limitation. This is because it is not clear from either the specification or the common teachings in the art how this limitation further limits the claim. For example, it is not clear if this limitation is limiting to a certain lysine injection composition or an unnamed excipient in the composition.
The specification does not teach or provide a nexus between the functional result that Applicant claims to achieve by the claimed dose of lysine with any particular component of the composition or the manner in which it is administered.
There is no description as to the pharmaceutical approach that makes this result possible (i.e., what cause “introducing and/or causing lysine to absorb into the system of a use”), nor does Applicant teach any excipients or chemical approaches to avoid. Furthermore, it is unclear to one skilled in the art as to, for example:
a) what lysine dose of claim 20, would not exhibit the function recited in claim 20; and
b) what lysine dose of claim 20, would exhibit the function recited in claim 20.
Thus, a person of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims.
The recitation of “a user” in claim 20, also renders the claim indefinite, because it is unclear as to what the “a user”, is referring to, since claim 20 recites a method for treatment and prevention.
This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 12-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kriengsinyos et al (hereinafter “Kriengsinyos”, J. Nutr., 2002, 132, 2251-2257).
Regarding claims 12-19, Kriengsinyos teaches a method for orally and intravenously administering lysine to healthy adult men, for 36 days (6 periods of 6 days each). Please see page 2252, under the “SUBJETCS AND METHODS” section. A patient in need of prevention from dermatological reactions, would not have the dermatological reactions.
Therefore, claims 12-19 are anticipated by Kriengsinyos.
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.
Claims 1-10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Braslau (U.S. Pub. No. 20150132811, published 04/14/2015) in view of: 1) Smith (U.S. Pub. No. 20080274209, published 11/06/2008); 2) Watanabe et al (hereinafter “Watanabe” Nippon Kagaku Kaishi, 2001, 2, 103-110); 3) Kriengsinyos (J. Nutr., 2002, 132, 2251-2257); and 4) Griffith et al (hereinafter “Griffith”, Dermatologica, 1987, 175, 183-190).
By way of a background, the Applicant’s invention (see, e.g., ¶ 2 of the specification), is drawn to a method for treating or prevention of urushiol-derived contact dermatitis (also known as poison ivy and/or poison oak), with lysine.
Regarding claims 1-10 and 20, Braslau (see e.g., abstract, ¶s 0015, 0018 and 0046-0048) relates to a method for deactivation of urushiol as the underlying mechanism of action in the treatment and prevention of contact dermatitis, using a topical composition comprising chemical trap selected from a group consisting of the list the include a primary amine such as but not limited to a lysine derivative (see, e.g., ¶ 0015). The active agent can be in an amount from about 0.001 wt% to about 99.5 wt% (see ¶ 0024).
Although Braslau is not explicit in disclosing administration of lysine by injection, a person skilled in the art would have had a reasonable expectation of success treating and preventing dermatological reactions to poison (e.g., contact dermatitis), with an oral or intravenous lysine formulation. This is because at the time of the instant invention, it was known in the art that:
i) medications for treating and preventing contact dermatitis can formulated in a form for oral, injection or transdermal as a patch.
ii) lysine is a known inhibitor of urushiol.
iii) lysine can be formulated as tablet and administered orally and by injection.
For example:
i) Smith (see, e.g., abstract, ¶s, 0044 and 0079) discloses that medications for treating and preventing contact dermatitis can formulated in a form for oral, injection, transdermal as a patch or topical as a cream.
ii) Watanabe discloses that amines such lysine reacts with urushiol (see abstract and Table 1).
iii) Kriengsinyos teaches that lysine can be administered orally and by injection (see page 2252, under the “SUBJETCS AND METHODS” section).
iv) Griffith teaches lysine tablet (see abstract).
Accordingly, at the time of the instant invention, one skilled in the art would have envisioned a method for treating and preventing dermatological reactions to poison (e.g., contact dermatitis), in a subject, comprising administering to the subject, a deactivator or urushiol (e.g., lysine), in the disclosures of Braslau, Smith, Watanabe, Kriengsinyos and Griffith. A person skilled in the art would have had a reasonable expectation that the administration of a composition comprising lysine (a form for oral, injection or transdermal as a patch), to a subject suffering from or in need of prevention from dermatological reactions to poison (e.g., contact dermatitis), would treat or prevent the dermatological reactions to poison (e.g., contact dermatitis), in the subject.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Regarding claims 5-11 and 20, the recited amount of lysine and administration scheduling are results-effective variables that would have been readily optimized by one skilled in the art
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
It is noted that no criticality (emphasis added) has been demonstrated in the specification with regard to the recited amount of lysine and administration scheduling in claims 5-11 and 20.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Conclusions
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629