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 .
DETAILED ACTION
Claims 1, 2, 5-8 and 10-26 are pending in the application. Claims 1, 2, 5, 7, 8 and 10-13 are rejected. Claims 6 and 14-26 are withdrawn from further consideration.
Response to Amendment / Argument
Beginning on page 2 of the response filed May 12th, 2025, Applicant traverses the rejection of claims under 35 USC 112(a). Applicant summarizes the rejection on pages 2 and 3 and argues on page 3 that the specification provides support referring to examples and lists in the specification. The Examiner has considered these disclosures; however, Applicant is merely pointing to examples that are not embraced by the instant claims for piecemeal support of an embodiment that is not disclosed. The same general rationale could have been cited in the case law cited by the Examiner (Purdue Pharma LP v. Iancu, 767 F. App'x 918, 924 (Fed. Cir. 2019)), i.e. that the specification pointed to the individual components and exemplified their use. There is no justification for why a person having ordinary skill in the art would recognize the now claimed permutation as being reasonably suggested by the disclosure as filed relative to the myriad additional permutations that could have been made.
Further on pages 3 and 4, Applicant discusses blaze marks; however, disclosing complete embodiments is not tantamount to blaze marks for a new embodiment where certain components from one embodiment are omitted and others are retained.
On page 4 of the response, Applicant discusses the use of weight percentages and open-ended language. Applicant argues “page 18 explicit discloses that solubilizers and permeability enhancers may be present in ranges from 0.01% to 95% w/w, which includes the claimed 25-75% and 20-30$ ranges.” The instant claims do not require that, for instance, propylene glycol be present at 25 to 75 weight percent. The claims require that composition comprise 25 to 75 weight of at least one solubilizer wherein the solubilizer comprises propylene glycol. Propylene glycol is only required to be present at a non-zero amount and the total amount of solubilizers must be 25 to 75 weight percent of the composition. Applicant asserts the Examiner’s interpretation rendering the claim unsupported “is speculative and not required under the written description standard.” It is not readily apparent if Applicant is disagreeing with the Examiner’s claim construction or asserting that the Examiner’s claim construction would be supported nonetheless. The Examiner’s position is that the disclosure does not support embodiments where various selections from lists are combined and (in connection with the open-ended language) only trace amounts of certain components are required.
For these reasons, the rejection below under 35 USC 112(a) is maintained.
On page 5 of the response, Applicant begins traversing the rejection of claims under 35 USC 112(b). Applicant summarizes the Examiner’s rejection and refers to various case law noting that “about” is not per se indefinite. Applicant asserts a person of skill “would readily understand the meaning of “about” to allow for standard experimental or measurement tolerances inherent in pharmaceutical formulation and manufacturing.” Applicant refers to “manufacturing variability, ingredient purity differences, rounding errors, or slight deviations due to mixing uniformity – typically on the order of ±5% or less.” Even granting the assertion that ±5% should be treated as a definition, claim 1 provides for a composition comprising up to 75% weight percent of solubilizer. The minimum weight percentages of the additional components are 1.0 delta-9-THC, 20 permeability enhancer and 35 silicone pressure sensitive adhesive. Assuming these are not required to doubly include certain components, the use of the upper limit of the solubilizer would result in 130 weight percent, far exceeding the ±5% suggested by Applicant. Applicant asserts that the “Office Action raises a concern that summing the lower bounds of the ranges could exceed 100%. However, this concern assumes simultaneous use of maximal values of components in a way that is inconsistent with standard compositional drafted and industry practice.” The Examiner has particularly addressed an embodiment where only one component is at its maximal value and the others are at their minimal values. Applicant appears to be taking the position that a person of ordinary skill in the art would immediately truncate the range of solubilizer, which illustrates the Examiner’s contention, i.e. that “about 75” is accounting for substantial variation beyond rounding and experimental error. The instant claims, however, do not clarify that similar substantial variation might be embraced by the additional ranges, i.e. to provide that the solubilizer might be present at 75 weight percent but the additional components lower limit should be considered to substantially vary beyond normal rounding or experimental error.
For these reasons, the rejection under 35 USC 112(b) is maintained.
Claim Rejections - 35 USC § 112(a)
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, 2, 5, 7, 8 and 10-13 are 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. This is a new matter rejection.
Applicant has amended claim 1 to require the presence of various individual components at various weight percentage ranges. There are at least two aspects of the newly amended claim 1 that introduce new matter. The first issue is regarding the particular combination of propylene glycol, hexylene glycol, silicon dioxide and silicone pressure sensitive adhesive. The specification indicates that compositions may contain different classes of components as follows on page 15:
PNG
media_image1.png
277
801
media_image1.png
Greyscale
The Examples beginning on page 16 refer to various classes of substances where Example 1 provides a list of solvents including propylene glycol and hexylene glycol. Example 2 on page 16 provides a list of “gelling agents and/or thickening and/or suspending agents including silicon dioxide and pressure sensitive adhesives such as “silicone polymers such as but not limited to (bio-psa 4302, bio-psa 4202 etc.)…”. Example 3 on page 17 provides a list of “permeative enhancers” including “glycols such as but not limited to (oleyl alcohol, nathanol, dodecanol, propylene glycol, glycerol etc.)…”. Example 4 on pages 17 and 18 lists plasticizers. Example 5 on page 18 lists “emollients, humectants and/or skin irritation reducing agents” including propylene glycol. Examples 6-11 list various additional possible components. There is no guidance on which possible combinations among the various listed were contemplated; however, specific examples begin on page 21 of the specification. The instant claims require (1) delta-9-THC, (2) propylene glycol, (3) hexylene glycol, (4) silicon dioxide, and (5) a silicone pressure sensitive adhesive. There are no examples that contain each of the required components. The composition having the most required components is disclosed on page 27 that contains THC, propylene glycol, hexylene glycol and a silicone adhesive. There is no disclosure or discussion regarding which of the various additional components were contemplated together with the combination disclosed on page 27. See In re Ruschig, 371 F.2d 990, 154 USPQ 118 (CCPA) 1967) which supports that the original disclosure of a large genus did not support a later filed claim to a previously unnamed single species. Furthermore, Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326, 56 USPQ2d 1481, 1486 (Fed. Cir.2000) notes that with respect to In re Ruschig, that “Ruschig makes clear that one cannot disclose a forest in the original application, and then later pick a tree out of the forest and say “here is my invention”. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.” In this situation, the individual examples would correspond to blazemarks; however, the current claims represent a new embodiment where an additional component is selected from the forest of lists of possible components to be combined with the ingredients of one particular example where the specification as filed provides no guidance or direction regarding the required selection.
The Federal Circuit (Purdue Pharma LP v. Iancu, 767 F. App'x 918, 924 (Fed. Cir. 2019)) addressed a similar issue regarding written description support in a provisional application where the provisional application provided a list of possible ingredients and the claims in a non-provisional application selected a possible combination. The Court explained written description support as follows (Id. at 924):
This Court has recognized that "simply describing a large genus of compounds is not sufficient to satisfy the written description requirement as to particular species or sub-genuses." Fujikawa v. Wattanasin, 93 F.3d 1559 , 1571 (Fed. Cir. 1996); see In re Ruschig, 379 F.2d 990 , 994-95 , 54 C.C.P.A. 1551 (CCPA 1967). In the '534 application disclosure, PEO and HPMC are merely two of many undifferentiated compounds that fall within the genus of gelling agents. Such "laundry list" disclosures do not provide adequate specificity to constitute written description support for Purdue's claim of priority. To be sure, the language "mixtures thereof" suggests the possibility of combining two or more of the listed gelling agents. Without more, however, that language fails to highlight any preference for how many and which gelling agents to combine.
A similar fact pattern exists here where the specification as filed provides laundry lists of possible ingredients with no direction towards the now-claimed combination.
Furthermore, the Federal Circuit addressed a possible argument that mentions of preferences to individual disclosures of preferences as follows (Id. at 925):
The additional references to PEO and HPMC throughout the provisional application do not constitute "blaze marks" that indicate or direct that a particular combination should be made "rather than any of the many others which could also be made." In re Ruschig, 379 F.2d at 995 .
The same rationale would apply to the disclosure of individual compositions containing a subset of the now-selected components since the instant application as filed does not provide direction on the additional combinations.
The same general rationale applies to the now recited limitations of “at least one suspending agent comprising silicon dioxide” and “at least one pressure sensitive adhesive”. The disclosure contains no indication that combinations having multiple suspending agents were specifically contemplated and that specific those involving silicon dioxide should involve multiple suspending agents. Similarly, there is no disclosure suggesting that multiple silicone pressure sensitive adhesives were particularly contemplated.
The second issue is based on the components requiring “at least one” of a class “comprising” an example. Instant claim 1 recites (1) about 25 to about 75 weight percent of at least solubilizer comprising propylene glycol, (2) about 20 to about 30 weight percent of least one permeability enhancer comprising hexylene glycol. In the remarks filed July 10th, 2024, Applicant refers to various locations for alleged support including disclosed examples and paragraph [0097] of the published application. Paragraph [0097] refers to a broadest range of 0.01%-95% w/w and the various cited examples disclosed embodiments where propylene glycol and/or hexylene glycol is included at a weight percent falling within the 0.01%-95% w/w and/or instant ranges. The language of the instant claims, however, is only defining the weight percentage of the solubilizer or permeability enhancer and where each need only “comprise” propylene glycol or hexylene glycol. Accordingly, the compositions embraced by instant claim 1 (and its various dependent claims) would include embodiments where propylene glycol is present at trace amounts (including less than 0.01% w/w) but additional solubilizers are present to result in a total of about 25 to about 75 percent solubilizers and/or where hexylene glycol is present in trace amounts (including less than 0.01% w/w) but additional permeability enhancers are present resulting in a total of about 20 to about 30 weight percent of permeability enhancers. The specification does not provide support for the now embraced embodiments where mixtures of solubilizers and/or permeability enhancers are used to arrive at the instant claimed weight percentages.
Dependent claims 2, 5, 7, 8 and 10-13 are rejected as containing new matter for the same reasons as claim 1.
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 1, 2, 5, 7, 8 and 10-13 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.
Instant claim 1 recites various weight percentages that are defined as “about” certain endpoints. MPEP 2173.05(b)(III)(A) states: “In determining the range encompassed by the term "about" , one must consider the context of the term as it is used in the specification and claims of the application. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007).” The specification uses the term “about” in the following instances when setting forth ranges of possible percentages (page 4):
PNG
media_image2.png
64
796
media_image2.png
Greyscale
PNG
media_image3.png
66
791
media_image3.png
Greyscale
The specification, however, does not set forth a definition of “about”. While the language about (in a vacuum) might suggest normal variance such as including values that could be rounded to 0.01 or 95, the instant claims are drawn to a composition comprising (at minimum) about 1.0 weight percent delta-9-THC, about 25 weight percent of at least one solubilizer, about 20 weight percent of at least one permeability enhancer and about 35 weight percent of at least one silicone pressure sensitive adhesive. The sum of the lower limits is about 81 weight percent. The instant claims, however, recite two components having a range that significantly exceeds the maximum of 100 weight percent, i.e. the at least one solubilizer and the silicone pressure sensitive adhesive. Assuming each component is not doubly included, the maximum weight percentage for either would be about 44% for the at least one solubilizer and about 54% for the silicone pressure sensitive adhesive. Given the disparity between 44% and 75% for the at least one solubilizer, there appears to be a substantial variability encompassed by “about 75 weight percent” to only embrace compositions that do not exceed 100 weight percent total. It is unclear whether this substantial variability extends to the additional instances of “about” or only instances where substantial variability is required to not exceed 100 weight percent. An additional possible interpretation is that Applicant is using the term “about” in a traditional fashion in each instance but attempting to require certain components be doubly included when a weight percent might exceed 100%. Since the instant claim 1 does not reasonably inform a person of skill in the art of the scope, claim 1 is considered indefinite.
Dependent claims 2, 5, 7, 8 and 10-13 are rejected as containing new matter for the same reasons as claim 1.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 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, Joseph McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626