DETAILED ACTION
Claims 1-14 and 17-21 are pending. Of these, claim 21 is withdrawn as directed to a nonelected invention. Therefore, claims 1-14 and 17-20 are under consideration on the merits.
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 .
Status of the Rejections
Applicant has overcome the prior art rejections of record by amending claim 1 to recite that the water soluble salt is not a polyphosphate. Searching of the amended claims has been conducted to include other combinations of water soluble salt and film forming polymer over the full scope of the claims.
The 102 rejection is withdrawn in view of the amendment and replaced with new rejections.
The 103 rejections are withdrawn in view of the amendment and replaced with new rejections.
A new 112(a) rejection was necessitated by the amendment.
Claim Rejections - 35 USC § 112
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 1 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 1 has been amended to recite that if the film forming polymer is gelatin, then the water-soluble salt is not a polyphosphate. Applicant did not point to where support can be found for this limitation, and the Office has reviewed the specification but could not locate any support. The specification does provide support for specific combinations of gelatin with specific water-soluble salts that are not a polyphosphate, e.g., gelatin and sodium polyphosphate (see paragraph 47 as published). The presence of support, however, for certain species within the genus of gelatin + a water soluble salt that is not a polyphosphate does not by itself provide support for the entire genus encompassing any and all combinations of gelatin with a water soluble salt that is not a polyphosphate Therefore, the written description requirement is prima facie not satisfied.
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 1-4 and 11 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Stevens et al. (NL2011803 (published 9.15.2015; of record) as evidenced by Nutrition Facts Search Tool entry for Dry Powder Gelatin and Naharros-Molinero (Adv. Healthcare Master. 2024, 13, 2302250).
As to claims 1-4, and 11, Stevens discloses a hard capsule for oral delivery (claim 11) comprising gelatin (a “film-forming polymer’ of claims 1 and 3) and sodium polyphosphate (a water-soluble salt opacifying agent of claim 1)(page 2, 2nd full paragraph; page 3, 3rd paragraph and claims 1-3). The hard gelatin capsules are two-piece, comprising a body and a cap (Example 5 on page 14).
Naharros-Molinero is a discussion of soft gelatin capsule shells (Abstract), and discloses that gelatin is a natural biopolymer consisting of 84-90% water soluble proteins, 8-15% water, and 1-2% mineral salts.
The Nutrition Facts Search Tool provides nutrition data for over 800,000 foods, and the entry for gelatin powder discloses that gelatin comprises sodium, iron, calcium, potassium, and phosphorus minerals, the majority of which is sodium in the amount of about 2%. The skilled artisan would recognize that both sodium and potassium form water soluble salts within the scope of claims 1-2.
Stevens does not expressly teach that the opacifying agent comprises a water soluble salt that is not a calcium salt, carbonate, bicarbonate, or polyphosphate as required by claim 1 as amended. Naharros-Molinero, however, discloses that gelatin comprises 1-2% of mineral salts, and The Nutrition Facts Search Tool makes it clear that these will include salts of sodium and potassium, which are water-soluble salts. Therefore, the hard capsule of Stevens necessarily and inherently will comprise water soluble salts that are within the scope of claims 1-2 and 4.
Response to Applicant’s Arguments
Applicant’s arguments against the previous 102 rejection over Stevens will be addressed to the extent they may be relevant to the new grounds of rejection.
Applicant argues that Stevens requires the combination of gelatin and sodium polyphosphate, and nowhere discloses a hard capsule formed of a film comprising gelatin and a water soluble salt that is not a polyphosphate.
In response, the new ground of rejection relies on Naharros-Molinero and The Nutrition Facts Search Tool as evidence to establish that the gelatin of the Stevens composition itself does comprise water soluble salts that are not polyphosphates.
Claims 1, 4-6, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as anticipated by CN102499910A as evidenced by the English translation thereof.
As to claims 1, 4-6, and 11-12, CN102499910A discloses a hard shell capsule comprising pullulan (a “film-forming polymer” of claim 1) and 0.001-0.1 wt% of a moisture retaining stabilizer such as dipotassium hydrogen phosphate, potassium dihydrogen phosphate, disodium hydrogen phosphate, sodium dihydrogen phosphate, or sodium pyrophosphate (a water-soluble salt opacifying agent of claims 1, 4-6)(paragraphs 12-13, 16). CN102499910A further teaches that the capsules are made using the traditional dipping method (paragraph 37), which the skilled artisan would recognize is a process using stainless steel pins including larger pins for forming capsule bodies and smaller pins for forming caps, thereby resulting in a two-piece capsule as recited by claim 1.
As to claim 11, the capsule is for oral delivery (paragraph 4).
Regarding claim 12, CN102499910A does not disclose the addition of a white pigment, thus meeting the negative limitation of this claim.
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.
Claims 1-4, 7-9, and 11 are rejected under 35 U.S.C. 103 as unpatentable over Stevens et al. (NL2011803 (published 9.15.2015) as evidenced by Nutrition Facts Search Tool entry for Dry Powder Gelatin and Naharros-Molinero (Adv. Healthcare Master. 2024, 13, 2302250).
The teachings of Stevens, Nutrition acts Search Tool entry, and Naharros-Molinero are relied upon as discussed above, but Stevens does not further express disclose that the amount of the opacifying water soluble salt is within the ranges recited by claims 7-9.
As to claims 7-8, the gelatin film of Stevens will comprise 1-2% mineral salts, the majority of which will be sodium and potassium salts as discussed in the 102 rejection, supra. Therefore, the gelatin film is viewed as comprising more than 1 wt% of the sodium and potassium salts, which reads on the ranges of claims 7-8.
Regarding claim 9, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). Here, the 2 wt% amount for the water soluble salt that is within the range recited by claim 9 is viewed as sufficiently close to the more than 1% that would be present in the gelatin film of Stevens that the skilled artisan would have expected the claimed gelatin capsule and the gelatin capsule of Stevens to have the same properties.
Claims 10, 12, and 17-18 are rejected under 35 U.S.C. 103 as unpatentable over Stevens et al. (NL2011803 (published 9.15.2015) as evidenced by Nutrition Facts Search Tool entry for Dry Powder Gelatin and Naharros-Molinero (Adv. Healthcare Master. 2024, 13, 2302250) as applied to claims 1-4, 7-9, and 11 above, and further in view of Okayama et al. (US Pat. Pub. 2021/0038526; filed 3.5.2019).
The teachings of Stevens, Nutrition acts Search Tool entry, and Naharros-Molinero are relied upon as discussed above, but Stevens does not further expressly disclose that the capsule is free of white pigment as recited by claims 12 and 18 or is colored in a color other than white by adding a dye or pigment (claim 10).
Okayama discloses pharmaceutical capsules comprising a shell comprising gelatin and a coloring agent which may be in a variety of colors such as yellow (paragraphs 1 and 45).
As to claims 10, 12, and 18, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the teachings of Stevens, Nutrition acts Search Tool entry, and Naharros-Molinero by incorporating a coloring agent such as a yellow coloring agent in order to produce an aesthetically pleasing appearance, because Okayama expressly teaches that gelatin pharmaceutical capsules may be colored using a yellow coloring agent.
Response to Applicant’s Arguments
Applicant’s arguments against the previous 103 rejections over Stevens as primary reference will be addressed to the extent they may be relevant to the new grounds of rejection.
Applicant argues that Stevens requires the combination of gelatin and sodium polyphosphate, and that modifying Steens to omit sodium polyphosphate would render its compositions unsuitable for their intended purpose.
In response, while the amended claims recite that if the film forming polymer component is gelatin, then the water soluble salt is not a polyphosphate, this limitation does not require the absence of a polyphosphate from the composition, due to the recitation of “comprising” in the preamble, which is open ended language that allows for the presence of a polyphosphate so long as the composition also comprises a water soluble salt that is not a polyphosphate in the event that the film forming polymer is gelatin. The new grounds of rejection establish that gelatin itself does comprise such water soluble salts that are not polyphosphates.
Claims 1-5, 7-13, and 17-19 are rejected under 35 U.S.C. 103 as unpatentable over Motoune et al. (US Pat. Pub. 2005/0112189).
As to claims 1-5, 7-13, and 17-19, Motoune discloses hard capsules comprising a cellulose derivative (paragraph 26), a gelling agent such as gelatin (a “film forming polymer” that is not a polyphosphate of claims 1 and 3)(paragraph 29), and a gelling aid such as ammonium chloride, magnesium sulfate, or sodium citrate (a water soluble salt of claims 1, 4-5, 13, and 19) (paragraph 30). The capsules are two piece comprising a body and cap (paragraph 34).
As to claims 10, 12, and 18 the capsule may contain a colorant (paragraph 14) such as caramel (a “color other than white” of claim 10)(paragraph 21), and while Motoune teaches that the colorant may be titanium oxide (a “white pigment”)(paragraph 31), Motoune nowhere requires the presence of the white pigment, thereby meeting the negative limitation of claims 12 and 18.
Regarding claims 7-9, the sodium citrate salt is used in the amount of 0.01-1 wt% (paragraph 30), which reads on the range of claims 7-8 and which is slightly below the 2 wt% range of claim 9.
Regarding claims 11 and 17, the capsules may be #0 capsules (paragraph 39), which are used for oral delivery.
As to claims 1-5, 7-13, and 17-19, Motoune does not further expressly disclose a specific embodiment wherein the gelling aid is gelatin and the water soluble salt is a salt within the scope of claims 1, 5, 13, and 19 such as the sodium citrate, or that the amount of the sodium citrate salt is within the range of claim 9, or that more than one water soluble salt/gelling aid is used in combination (claim 2).
As to claims 1-5, 7-13, and 17-19, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to select gelatin as the gelling agent and sodium citrate as the gelling aid, because Motoune expressly teaches a list of gelling agents that includes gelatin and a list of gelling aids that includes sodium citrate. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." (325 U.S. at 335, 65 USPQ at 301). MPEP § 2144.07.
Regarding claim 2, it further would have been prima facie obvious to use more than one water soluble salt gelling aid in combination, for example, sodium citrate and ammonium chloride, because both sodium citrate and ammonium chloride are taught by Motoune as useful for the same purpose as gelling aids, such that the skilled artisan reasonably would have expected that a combination of sodium citrate and ammonium chloride also would be useful as a gelling aid. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
Regarding claim 9, the 2 wt% amount that is within the scope of the range recited by claim 9 is close enough to the 1 wt% taught by Motoune that the skilled artisan would have expected the Motoune composition and the claimed composition to have substantially the same properties. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Claims 1-14 and 17-20 are rejected under under 35 U.S.C. 103 as unpatentable over Sakuma et al. (EP0695544; published 11/88/00) in view of Motoune et al. (US Pat. Pub. 2005/0112189).
The teachings of Motoune are relied upon as discussed above.
As to claims 1-14 and 17-20, Sakuma discloses hard gelatin capsules formed from a film comprising gelatin as the film forming component (claims 1, 3, 5, 13-14, 19-20) along with a free radical scavenger such as sodium pyrophosphate or potassium pyrophosphate (opacifying agents that are a water soluble sodium or potassium salt of claims 1, 4-6, 13-14, 19-20)(paragraphs 1, 11, and claims 1 and 4) Sakuma teaches that hard gelatin capsules sometimes denature during storage leading to inhibition of drug release which may be caused by the production of peroxidation products, and that addition of the free radical scavenger inhibits the denaturation (paragraphs 4-5, 9-10).
Regarding claim 2, more than one of the water soluble salt salts may be used in combination as the scavenger (paragraph 19)
As to claims 7-9, the free radical scavenger is present in the amount of 0.01-5 wt%, which overlaps the ranges of claims 7-9 (paragraph 12).
Regarding claims 11 and 17, the recitation that the hard capsule is used for oral delivery is merely an intended use of the capsule and as such is not granted additional patentable weight because it does not place any additional structural limitation on the capsule that would exclude the Sakuma capsules. The skilled artisan would recognize that the Sakuma hard gelatin capsules would be suitable for use for oral delivery.
Regarding claims 12 and 18, while Sakuma teaches that the capsules may comprise a coloring agent (paragraph 19), Sakuma nowhere requires the presence of a white pigment.
As to claims 1-14 and 17-20, Sakuma does not further expressly disclose that the capsule is a two piece capsule comprising a body and a cap as recited by claim 1 which is for oral delivery (claim 11), or a that the colorant is other than white as recited by claim 10.
As to claims 1-14 and 17-20, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the teachings of Sakuma by formulating the hard gelatin capsule as a two piece capsule comprising a body and a cap for oral delivery, because Sakuma does not place any restrictions on the physical configuration of the hard gelatin capsules taught therein, and Motoune teaches that hard gelatin capsules may be formed as two pieces comprising a body and cap, such that the skilled artisan reasonably would have expected that the Kauma hard gelatin capsules could be formulated as two piece capsules comprising a body and cap. Such a modification is merely the combining of known prior art elements according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
As to claim 10, it further would have been prima facie obvious to color the capsule with a color other than white because Sakuma teaches that the capsule may comprise a color without limiting the identity of the color and Motoune expressly teaches that hard gelatin capsules may suitably include as colorants a color other than white such as caramel, such that the skilled artisan reasonably would have expected that the Sakuma capsules successfully could be colored with a caramel color. Such a modification is merely the combining of known prior art elements according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached M-F 9AM-6PM.
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, David Blanchard can be reached on 5712720827. 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.
/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600
Prosecution Insights